[Title 9 CFR ]
[Code of Federal Regulations (annual edition) - January 1, 2004 Edition]
[From the U.S. Government Printing Office]



[[Page i]]



                    9


          Parts 1 to 199

                         Revised as of January 1, 2004

Animals and Animal Products





          Containing a codification of documents of general 
          applicability and future effect
          As of January 1, 2004
          With Ancillaries
          Published by
          Office of the Federal Register
          National Archives and Records
          Administration

A Special Edition of the Federal Register

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                     U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2004



  For sale by the Superintendent of Documents, U.S. Government Printing 
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      Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 9:
          Chapter I--Animal and Plant Health Inspection 
          Service, Department of Agriculture                         3
  Finding Aids:
      Material Approved for Incorporation by Reference........     895
      Table of CFR Titles and Chapters........................     897
      Alphabetical List of Agencies Appearing in the CFR......     915
      List of CFR Sections Affected...........................     925

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                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 9 CFR 1.1 refers to 
                       title 9, part 1, section 
                       1.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, January 1, 2004), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in 11 separate 
volumes. For the period beginning January 1, 2001, a ``List of CFR 
Sections Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call (202) 741-6010.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I). A list of CFR titles, chapters, 
and parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

[[Page vii]]


REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-741-6000 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408 or e-mail 
[email protected].

SALES

    The Government Printing Office (GPO) processes all sales and 
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ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, The United States 
Government Manual, the Federal Register, Public Laws, Public Papers, 
Weekly Compilation of Presidential Documents and the Privacy Act 
Compilation are available in electronic format at www.gpoaccess.gov/
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293-6498 (toll-free). E-mail, [email protected].
    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.archives.gov/federal--
register. The NARA site also contains links to GPO Access.

                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

January 1, 2004.

[[Page ix]]



                               THIS TITLE

    Title 9--Animals and Animal Products is composed of two volumes. The 
first volume contains chapter I--Animal and Plant Health Inspection 
Service, Department of Agriculture (parts 1-199). The second volume 
contains chapter II--Packers and Stockyards Administration, Department 
of Agriculture and chapter III--Food Safety and Inspection Service, 
Department of Agriculture (part 200-End). The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of January 1, 2004.

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[[Page 1]]



                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS




                   (This book contains parts 1 to 199)

  --------------------------------------------------------------------

  Editorial Note: Other regulations issued by the Department of 
Agriculture appear in title 7, title 36, chapter II, and title 41, 
chapter 4.
                                                                    Part

chapter i--Animal and Plant Health Inspection Service, 
  Department of Agriculture.................................           1

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  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE



  --------------------------------------------------------------------

                      SUBCHAPTER A--ANIMAL WELFARE
Part                                                                Page
1               Definition of terms.........................           7
2               Regulations.................................          13
3               Standards...................................          42
4               Rules of practice governing proceedings 
                    under the Animal Welfare Act............         122
11              Horse protection regulations................         123
12              Rules of practice governing proceedings 
                    under the Horse Protection Act..........         140

   SUBCHAPTER B--COOPERATIVE CONTROL AND ERADICATION OF LIVESTOCK OR 
                            POULTRY DISEASES
49              Rules of practice governing proceedings 
                    under certain acts......................         141
50              Animals destroyed because of tuberculosis...         141
51              Animals destroyed because of brucellosis....         151
52              Swine destroyed because of pseudorabies.....         159
53              Foot-and-mouth disease, pleuropneumonia, 
                    rinderpest, and certain other 
                    communicable diseases of livestock or 
                    poultry.................................         163
54              Control of scrapie..........................         168
55              Control of chronic wasting disease..........         181
56              [Reserved]

 SUBCHAPTER C--INTERSTATE TRANSPORTATION OF ANIMALS (INCLUDING POULTRY) 
                           AND ANIMAL PRODUCTS
70              Rules of practice governing proceedings 
                    under certain acts......................         187
71              General provisions..........................         187
72              Texas (splenetic) fever in cattle...........         205
73              Scabies in cattle...........................         211

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74              Prohibition of interstate movement of land 
                    tortoises...............................         217
75              Communicable diseases in horses, asses, 
                    ponies, mules, and zebras...............         217
76              [Reserved]
77              Tuberculosis................................         221
78              Brucellosis.................................         249
79              Scrapie in sheep and goats..................         286
80              Johne's disease in domestic animals.........         308
82              Exotic Newcastle Disease (END) and 
                    chlamydiosis............................         309
85              Pseudorabies................................         323
88              Commercial transportation of equines for 
                    slaughter...............................         336
89              Statement of policy under the Twenty-Eight 
                    Hour Law................................         339

SUBCHAPTER D--EXPORTATION AND IMPORTATION OF ANIMALS (INCLUDING POULTRY) 
                           AND ANIMAL PRODUCTS
91              Inspection and handling of livestock for 
                    exportation.............................         341
92              Importation of animals and animal products: 
                    procedures for requesting recognition of 
                    regions.................................         358
93              Importation of certain animals, birds, and 
                    poultry, and certain animal, bird, and 
                    poultry products; requirements for means 
                    of conveyance and shipping containers...         360
94              Rinderpest, foot-and-mouth disease, fowl 
                    pest (fowl plague), exotic newcastle 
                    disease, African swine fever, classical 
                    swine fever, and bovine spongiform 
                    encephalopathy: prohibited and 
                    restricted importations.................         469
95              Sanitary control of animal byproducts 
                    (except casings), and hay and straw, 
                    offered for entry into the United States         511
96              Restriction of importations of foreign 
                    animal casings offered for entry into 
                    the United States.......................         524
97              Overtime services relating to imports and 
                    exports.................................         531
98              Importation of certain animal embryos and 
                    animal semen............................         537
99              Rules of practice governing proceedings 
                    under certain acts......................         561

SUBCHAPTER E--VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS 
                               AND VECTORS
101             Definitions.................................         563
102             Licenses for biological products............         568

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103             Experimental production, distribution, and 
                    evaluation of biological products prior 
                    to licensing............................         572
104             Permits for biological products.............         573
105             Suspension, revocation, or termination of 
                    biological licenses or permits..........         576
106             Exemption for biological products used in 
                    department programs or under department 
                    control or supervision..................         577
107             Exemptions from preparation pursuant to an 
                    unsuspended and unrevoked license.......         578
108             Facility requirements for licensed 
                    establishments..........................         579
109             Sterilization and pasteurization at licensed 
                    establishments..........................         582
112             Packaging and labeling......................         583
113             Standard requirements.......................         592
114             Production requirements for biological 
                    products................................         722
115             Inspections.................................         732
116             Records and reports.........................         733
117             Animals at licensed establishments..........         735
118             Detention; seizure and condemnation.........         737
121             Possession, use, and transfer of biological 
                    agents and toxins.......................         738
122             Organisms and vectors.......................         752
123             Rules of practice governing proceedings 
                    under the Virus-Serum-Toxin Act.........         754
124             Patent term restoration.....................         754

                         SUBCHAPTER F--USER FEES
130             User fees...................................         759

                    SUBCHAPTER G--POULTRY IMPROVEMENT
145             National Poultry Improvement Plan...........         778
146             [Reserved]
147             Auxiliary provisions on National Poultry 
                    Improvement Plan........................         819

                       SUBCHAPTER H--ANIMAL BREEDS
151             Recognition of breeds and books of record of 
                    purebred animals........................         861

      SUBCHAPTER I--VOLUNTARY INSPECTION AND CERTIFICATION SERVICE
156             Voluntary inspection and certification 
                    service.................................         872

     SUBCHAPTER J--ACCREDITATION OF VETERINARIANS AND SUSPENSION OR 
                    REVOCATION OF SUCH ACCREDITATION
160             Definition of terms.........................         875

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161             Requirements and standards for accredited 
                    veterinarians and suspension or 
                    revocation of such accreditation........         876
162             Rules of practice governing revocation or 
                    suspension of veterinarians' 
                    accreditation...........................         881

                    SUBCHAPTER K--PUBLIC INFORMATION
165             Availability of information.................         883

                  SUBCHAPTER L--SWINE HEALTH PROTECTION
166             Swine health protection.....................         884
167             Rules of practice governing proceedings 
                    under the Swine Health Protection Act...         890
168-199         [Reserved]

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                       SUBCHAPTER A_ANIMAL WELFARE





PART 1_DEFINITION OF TERMS--Table of Contents




    Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.



Sec.  1.1  Definitions.

    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.
    AC Regional Director means a veterinarian or his designee, employed 
by APHIS, who is assigned by the Administrator to supervise and perform 
the official work of APHIS in a given State or States. As used in part 2 
of this subchapter, the AC Regional Director shall be deemed to be the 
person in charge of the official work of APHIS in the State in which the 
dealer, exhibitor, research facility, intermediate handler, carrier, or 
operator of an auction sale has his principal place of business.
    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 means the Administrator of the Animal and Plant Health 
Inspection Service, U.S. Department of Agriculture, or any other 
official of the Animal and Plant Health Inspection Service to whom 
authority has been delegated to act in his stead.
    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, and 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. 
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.
    Buffer area means that area in a primary enclosure for a swim-with-
the-dolphin program that is off-limits to

[[Page 8]]

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., Monday through Friday, except for legal Federal holidays, 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.
    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'' (Sec.  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'' 
(Sec.  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'' (Sec.  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 for 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, unless 
such store sells any animal to a research facility, an exhibitor, or a 
dealer (wholesale); any retail outlet where dogs are sold for hunting, 
breeding, or security purposes; or any person who does not sell or 
negotiate the purchase or sale of any wild or exotic animal, dog, or cat 
and who derives no more than $500 gross income from the sale of animals 
other than wild or exotic animals, dogs, or cats during any calendar 
year.
    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.

[[Page 9]]

    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, zoos, and educational exhibits, 
exhibiting such animals whether operated for profit or not. This term 
excludes retail pet stores, horse and dog races, organizations 
sponsoring and all persons participating in State and county fairs, 
livestock shows, rodeos, field trials, coursing events, purebred dog and 
cat 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, or horses, 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, 
and chinchilla, when they are used solely for purposes of meat or fur, 
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

[[Page 10]]

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.
    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.

[[Page 11]]

    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, and hamsters. 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.
    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 any outlet 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, 
chinchilla, domestic ferrets, domestic farm animals, birds, and 
coldblooded species. Such definition excludes--

[[Page 12]]

    (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 (except birds), such as skunks, raccoons, nonhuman 
primates, squirrels, ocelots, foxes, coyotes, etc.;
    (3) Any establishment or person selling warmblooded animals (except 
birds, and laboratory rats and mice) for research or exhibition 
purposes; and
    (4) Any establishment wholesaling any animals (except birds, rats 
and mice).
    (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 an animal has become accustomed to take solid food 
and has so done, without nursing, for a period of at least 5 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.

[54 FR 36119, Aug. 31, 1989, as amended at 55 FR 12631, Apr. 5, 1990; 58 
FR 39129, July 22, 1993; 62 FR 43275, Aug. 13, 1997; 63 FR 47148, Sept. 
4, 1998; 63 FR 62926, Nov. 10, 1998; 65 FR 6314, Feb. 9, 2000; 68 FR 
12285, Mar. 14, 2003]

[[Page 13]]


    Effective Date Note: At 64 FR 15920, Apr. 2, 1999, the definitions 
of buffer area, interactive area, interactive session, sanctuary area, 
and swim-with-the-dolphin (SWTD) program were suspended, effective Apr. 
2, 1999.



PART 2_REGULATIONS--Table of Contents




                           Subpart A_Licensing

Sec.
2.1 Requirements and application.
2.2 Acknowledgement of regulations and standards.
2.3 Demonstration of compliance with standards and regulations.
2.4 Non-interference with APHIS officials.
2.5 Duration of license and termination of license.
2.6 Annual license fees.
2.7 Annual report by licensees.
2.8 Notification of change of name, address, control, or ownership of 
          business.
2.9 Officers, agents, and employees of licensees whose licenses have 
          been suspended or revoked.
2.10 Licensees whose licenses have been suspended or revoked.
2.11 Denial of initial license application.

                         Subpart B_Registration

2.25 Requirements and procedures.
2.26 Acknowledgement of regulations and standards.
2.27 Notification of change of operation.

                      Subpart C_Research Facilities

2.30 Registration.
2.31 Institutional Animal Care and Use Committee (IACUC).
2.32 Personnel qualifications.
2.33 Attending veterinarian and adequate veterinary care.
2.34 [Reserved]
2.35 Recordkeeping requirements.
2.36 Annual report.
2.37 Federal research facilities.
2.38 Miscellaneous.

      Subpart D_Attending Veterinarian and Adequate Veterinary Care

2.40 Attending veterinarian and adequate veterinary care (dealers and 
          exhibitors).

                   Subpart E_Identification of Animals

2.50 Time and method of identification.
2.51 Form of official tag.
2.52 How to obtain tags.
2.53 Use of tags.
2.54 Lost tags.
2.55 Removal and disposal of tags.

                        Subpart F_Stolen Animals

2.60 Prohibition on the purchase, sale, use, or transportation of stolen 
          animals.

                            Subpart G_Records

2.75 Records: Dealers and exhibitors.
2.76 Records: Operators of auction sales and brokers.
2.77 Records: Carriers and intermediate handlers.
2.78 Health certification and identification.
2.79 C.O.D. shipments.
2.80 Records, disposition.

         Subpart H_Compliance With Standards and Holding Period

2.100 Compliance with standards.
2.101 Holding period.
2.102 Holding facility.

                         Subpart I_Miscellaneous

2.125 Information as to business; furnishing of same by dealers, 
          exhibitors, operators of auction sales, intermediate handlers, 
          and carriers.
2.126 Access and inspection of records and property.
2.127 Publication of names of persons subject to the provisions of this 
          part.
2.128 Inspection for missing animals.
2.129 Confiscation and destruction of animals.
2.130 Minimum age requirements.
2.131 Handling of animals.
2.132 Procurement of random source dogs and cats, dealers.
2.133 Certification for random source dogs and cats.

    Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.

    Source: 54 FR 36147, Aug. 31, 1989, unless otherwise noted.



                           Subpart A_Licensing



Sec.  2.1  Requirements and application.

    (a)(1) Any person operating or desiring to operate as a dealer, 
exhibitor, or operator of an auction sale, except persons who are 
exempted from the licensing requirements under paragraph (a)(3) of this 
section, must have a valid license. 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 AC Regional Director in the State in 
which that person operates or intends to operate. The applicant shall 
provide

[[Page 14]]

the information requested on the application form, including a valid 
mailing address through which the licensee or applicant can be reached 
at all times, and a valid premises address where animals, animal 
facilities, equipment, and records may be inspected for compliance. The 
applicant shall file the completed application form with the AC Regional 
Director.
    (2) If an applicant for a license or license renewal operates in 
more than one State, he or she shall apply in the State in which he or 
she has his or her principal place of business. All premises, 
facilities, or sites where such person operates or keeps animals shall 
be indicated on the application form or on a separate sheet attached to 
it. The completed application form, along with the application fee 
indicated in paragraph (d) of this section, and the annual license fee 
indicated in table 1 or 2 of Sec.  2.6 shall be filed with the AC 
Regional Director.
    (3) The following persons are exempt from the licensing requirements 
under section 2 or section 3 of the Act:
    (i) Retail pet stores which sell nondangerous, pet-type animals, 
such as dogs, cats, birds, rabbits, hamsters, guinea pigs, gophers, 
domestic ferrets, chinchilla, rats, and mice, for pets, at retail only: 
Provided, That, Anyone wholesaling any animals, selling any animals for 
research or exhibition, or selling any wild, exotic, or nonpet animals 
retail, must have a license;
    (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 to a research 
facility, an exhibitor, a dealer, or a pet store during any calendar 
year and is not otherwise required to obtain a license;
    (iii) Any person who maintains a total of three (3) or fewer 
breeding female dogs and/or cats and who sells only the offspring of 
these dogs or cats, which were born and raised on his or her premises, 
for pets or exhibition, and is not otherwise required to obtain a 
license;
    (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. 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 or fiber (including fur);
    (vii) Any person who breeds and raises domestic pet animals for 
direct retail sales to another person for the buyer's own use and who 
buys no animals for resale and who sells no animals to a research 
facility, an exhibitor, a dealer, or a pet store (e.g., a purebred dog 
or cat fancier) and is not otherwise required to obtain a license;
    (viii) 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) Any person who sells fewer than 25 dogs or cats per year for 
research or teaching purposes and who is not otherwise required to 
obtain a license may obtain a voluntary license, provided the animals 
were born and raised on his or her premises. A voluntary licensee shall 
comply with the requirements for dealers set forth in this part and the 
Specifications for the Humane Handling, Care, Treatment, and 
Transportation of Dogs and Cats set forth in part 3 of this subchapter 
and shall agree in writing on a form furnished by APHIS to comply with 
all the requirements of the Act and this subchapter. Voluntary licenses 
will not be issued to any other persons. To obtain a voluntary license 
the applicant shall submit to the AC Regional Director the application 
fee of $10 plus an annual license fee. The class of license issued and 
the fee for a voluntary license shall be that of a Class ``A'' licensee 
(breeder). Voluntary licenses will not be issued to any other persons or 
for any other class of license.

[[Page 15]]

    (c) No person shall have more than one license.
    (d) A license will be issued to any applicant, except as provided in 
Sec. Sec.  2.10 and 2.11, when the applicant:
    (1) Has met the requirements of this section and of Sec. Sec.  2.2 
and 2.3; and
    (2) Has paid the application fee of $10 and the annual license fee 
indicated in Sec.  2.6 to the AC Regional Director and the payment has 
cleared normal banking procedures.
    (e)(1) On or before the expiration date of the license, a licensee 
who wishes a renewal shall submit to the AC Regional Director a 
completed application form and the application fee of $10, plus the 
annual license fee indicated in Sec.  2.6 by certified check, cashier's 
check, personal check, or money order. A voluntary licensee who wishes a 
renewal shall also submit the $10 application fee plus an annual license 
fee. An applicant whose check is returned by the bank will be charged a 
fee of $15 for each returned check. One returned check will be deemed 
nonpayment of fees and will result in denial of license. Payment of fees 
must then be made by certified check, cashier's check, or money order. 
An applicant will not be licensed until his or her payment has cleared 
normal banking procedures.
    (2) The $10 application fee must also be paid if an applicant is 
applying for a changed class of license. The applicant may pay such fees 
by certified check, cashier's check, personal check, or money order. An 
applicant whose check is returned by a bank will be charged a fee of $15 
for each returned check and will be required to pay all subsequent fees 
by certified check, money order, or cashier's check. A license will not 
be issued until payment has cleared normal banking procedures.
    (f) 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.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998]



Sec.  2.2  Acknowledgement of regulations and standards.

    (a) Application for initial license. APHIS will supply a copy of the 
applicable regulations and standards to the applicant with each request 
for a license application. The applicant shall acknowledge receipt of 
the regulations and standards and agree to comply with them by signing 
the application form before a license will be issued.
    (b) Application for license renewal. APHIS will supply a copy of the 
applicable regulations and standards to the applicant for license 
renewal with each request for a license renewal. Before a license will 
be renewed, the applicant for license renewal shall acknowledge receipt 
if the regulations and standards and shall certify by signing the 
applications form that, to the best of the applicant's knowledge and 
belief, he or she is in compliance with the regulations and standards 
and agrees to continue to comply with the regulations and standards.

[60 FR 13895, Mar. 15, 1995]



Sec.  2.3  Demonstration of compliance with standards and regulations.

    (a) Each applicant must demonstrate that his or her premises and any 
animals, facilities, vehicles, equipment, or other premises used or 
intended for use in the business comply with the regulations and 
standards set forth in parts 2 and 3 of this subchapter. Each applicant 
for an initial license or license renewal must make his or her animals, 
premises, facilities, vehicles, equipment, other premises, 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 standards and regulations.
    (b) In the case of an application for an initial license, the 
applicant must demonstrate compliance with the regulations and 
standards, as required in paragraph (a) of this section, before APHIS 
will issue a license. If the applicant's animals, premises, facilities, 
vehicles, equipment, other premises, or records do not meet the 
requirements of this subchapter, APHIS will advise the applicant of 
existing deficiencies and the corrective measures that must

[[Page 16]]

be completed to come into compliance with the regulations and standards. 
The applicant will have two more chances to demonstrate his or her 
compliance with the regulations and standards through re-inspection by 
APHIS. If the applicant fails the third inspection he or she will 
forfeit the application fee and cannot re-apply for a license for a 
period of 6 months following the third inspection. Issuance of the 
license will be denied until the applicant demonstrates upon inspection 
that the animals, premises, facilities, vehicles, equipment, other 
premises and records are in compliance with all regulations and 
standards in this subchapter.



Sec.  2.4  Non-interference with APHIS officials.

    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.



Sec.  2.5  Duration of license and termination of license.

    (a) A license issued under this part shall be valid and effective 
unless:
    (1) The license has been revoked or suspended pursuant to section 19 
of the Act.
    (2) The license is voluntarily terminated upon request of the 
licensee, in writing, to the AC Regional Director.
    (3) The license has expired or been terminated under this part.
    (4) The applicant has failed to pay the application fee and the 
annual license fee as required in Sec. Sec.  2.1 and 2.6. There will be 
no refund of fees if a license is terminated prior to its expiration 
date.
    (b) Any person who is licensed must file an application for a 
license renewal and an annual report form (APHIS Form 7003/VS Form 18-3) 
as required by Sec.  2.7, and pay the required fees, on or before the 
expiration date of the present license or the license shall expire and 
automatically terminate on its anniversary date. The licensee will be 
notified by certified mail at least 60 days prior to the expiration date 
of the license. Failure to comply with the annual reporting 
requirements, or to pay the required license fees prior to the 
expiration date of the license, shall result in automatic termination of 
such license on the anniversary date of the license.
    (c) Licensees must accept delivery of registered mail or certified 
mail notice and provide the AC Regional Director notice of their address 
in conformity with the requirements in Sec.  2.1.
    (d) Any person who seeks the reinstatement of a license that has 
been automatically terminated must follow the procedure applicable to 
new applicants for a license set forth in Sec.  2.1.
    (e) Licenses are issued to specific persons for specific premises 
and do not transfer upon change of ownership, nor are they valid at a 
different location.
    (f) A license which is invalid under this part shall be surrendered 
to the AC Regional Director. If the license cannot be found, the 
licensee shall provide a written statement so stating to the AC Regional 
Director.

[54 FR 36147, Aug. 31, 1989, as amended at 60 FR 13895, Mar. 15, 1995; 
63 FR 62926, Nov. 10, 1998]



Sec.  2.6  Annual license fees.

    (a) In addition to the application fee of $10 required to be paid 
upon the application for a license, license renewal, or changed class of 
license under Sec.  2.1, each licensee shall submit to the AC Regional 
Director the annual license fee prescribed in this section. Paragraph 
(b) of this section indicates the method used to calculate the 
appropriate fee. The amount of the fee is determined from Table 1 or 2 
in paragraph (c) of this section.
    (b)(1) Class ``A'' license. The annual license renewal fee for a 
Class ``A'' dealer shall be based on 50 percent of the total gross 
amount, expressed in dollars, derived from the sale of animals to 
research facilities, dealers, exhibitors, retail pet stores, and persons 
for use as pets, directly or through an auction sale, by the dealer or 
applicant during his or her preceding business year (calendar or fiscal) 
in the case of a person who operated during such a year. If animals are 
leased, the lessor shall pay a fee based on 50 percent of any 
compensation received from the leased animals and the lessee shall pay a 
fee based upon the net compensation

[[Page 17]]

received from the leased animals, as indicated for dealers in Table 1 in 
paragraph (c) of this section.
    (2) Class ``B'' license. The annual license renewal fee for a Class 
``B'' dealer shall be established by calculating the total amount 
received from the sale of animals to research facilities, dealers, 
exhibitors, retail pet stores, and persons for use as pets, directly or 
through an auction sale, during the preceding business year (calendar or 
fiscal) less the amount paid for the animals by the dealer or applicant. 
This net difference, exclusive of other costs, shall be the figure used 
to determine the license fee of a Class ``B'' dealer. If animals are 
leased, the lessor and lessee shall each pay a fee based on the net 
compensation received from the leased animals calculated from Table 1 in 
paragraph (c) of this section.
    (3) The annual license renewal fee for a broker or operator of an 
auction sale shall be that of a class ``B'' dealer and shall be based on 
the total gross amount, expressed in dollars, derived from commissions 
or fees charged for the sale of animals, or for negotiating the sale of 
animals, by brokers or by the operator of an auction sale, to research 
facilities, dealers, exhibitors, retail pet stores, and persons for use 
as pets, during the preceding business year (calendar or fiscal).
    (4) In the case of a new applicant for a license as a dealer, broker 
or operator of an auction sale who did not operate during a preceding 
business year, the annual license fee will be based on the anticipated 
yearly dollar amount of business, as provided in paragraphs (b)(1), (2), 
and (3) of this section, derived from the sale of animals to research 
facilities, dealers, exhibitors, retail pet stores, and persons for use 
as pets, directly or through an auction sale.
    (5) The amount of the annual fee to be paid upon application for a 
class ``C'' license as an exhibitor under this section shall be based on 
the number of animals which the exhibitor owned, held, or exhibited at 
the time the application is signed and dated or during the previous 
year, whichever is greater, and will be the amount listed in Table 2 in 
paragraph (c) of this section. Animals which are leased shall be 
included in the number of animals being held by both the lessor and the 
lessee when calculating the annual fee. An exhibitor shall pay his or 
her annual license fee on or before the expiration date of the license 
and the fee shall be based on the number of animals which the exhibitor 
is holding or has held during the year (both owned and leased).
    (c) The license fee shall be computed in accordance with the 
following tables:

 Table 1--Dealers, Brokers and Operators of an Auction Sale Class ``A''
                            and ``B'' License
------------------------------------------------------------------------
                                                     But Not
                       Over                            Over       Fee
------------------------------------------------------------------------
$0................................................       $500        $30
500...............................................      2,000         60
2,000.............................................     10,000        120
10,000............................................     25,000        225
25,000............................................     50,000        350
50,000............................................    100,000        475
100,000...........................................  .........        750
------------------------------------------------------------------------


                Table 2--Exhibitors--Class ``C'' License
------------------------------------------------------------------------
                        Number of Animals                           Fee
------------------------------------------------------------------------
1 to 5..........................................................     $30
6 to 25.........................................................      75
26 to 50........................................................     175
51 to 500.......................................................     225
501 and up......................................................     300
------------------------------------------------------------------------

    (d) If a person meets the licensing requirements for more than one 
class of license, he shall be required to obtain a license and pay the 
fee for the type business which is predominant for his operation, as 
determined by the Secretary.
    (e) In any situation in which a licensee shall have demonstrated in 
writing to the satisfaction of the Secretary that he or she has good 
reason to believe that the dollar amount of his or her business for the 
forthcoming business year will be less than the previous business year, 
then his or her estimated dollar amount of business shall be used for 
computing the license fee for the forthcoming business year: Provided, 
however, That if the dollar amount upon which the license fee is based 
for that year does in fact exceed the amount estimated, the difference 
in amount of the fee paid and that which was due under paragraphs (b) 
and (c) of this section based upon the actual dollar business upon which 
the

[[Page 18]]

license fee is based, shall be payable in addition to the required 
annual license fee for the next subsequent year, on the anniversary date 
of his or her license as prescribed in this section.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998]



Sec.  2.7  Annual report by licensees.

    (a) Each year, within 30 days prior to the expiration date of his or 
her license, a licensee shall file with the AC Regional Director an 
application for license renewal and annual report upon a form which the 
AC Regional Director will furnish to him or her upon request.
    (b) A person licensed as a dealer shall set forth in his or her 
license renewal application and annual report the dollar amount of 
business, from the sale of animals, upon which the license fee is based, 
directly or through an auction sale, to research facilities, dealers, 
exhibitors, retail pet stores, and persons for use as pets, by the 
licensee during the preceding business year (calendar or fiscal), and 
any other information as may be required thereon.
    (c) A licensed dealer who operates as a broker or an operator of an 
auction sale shall set forth in his or her license renewal application 
and annual report the total gross amount, expressed in dollars, derived 
from commissions or fees charged for the sale of animals by the licensee 
to research facilities, dealers, exhibitors, retail pet stores, and 
persons for use as pets, during the preceding business year (calendar or 
fiscal), and any other information as may be required thereon.
    (d) A person licensed as an exhibitor shall set forth in his or her 
license renewal application and annual report the number of animals 
owned, held, or exhibited by him or her, including those which are 
leased, during the previous year or at the time he signs and dates the 
report, whichever is greater.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998]



Sec.  2.8  Notification of change of name, address, control, or 
ownership of business.

    A licensee shall promptly notify the AC Regional Director by 
certified mail of any change in the name, address, management, or 
substantial control or ownership of his business or operation, or of any 
additional sites, within 10 days of any change.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998]



Sec.  2.9  Officers, agents, and employees of licensees whose licenses 
have been suspended or revoked.

    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 violation upon which the order of 
suspension or revocation was based will not be licensed within the 
period during which the order of suspension or revocation is in effect.



Sec.  2.10  Licensees whose licenses have been suspended or revoked.

    (a) Any person whose license has been suspended for any reason shall 
not be licensed 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 during that period. Any person whose license has been suspended 
for any reason may apply to the AC Regional Director, in writing, for 
reinstatement of his or her license.
    (b) Any person whose license has been revoked shall not be licensed 
in his or her own name or in any other manner; nor will any partnership, 
firm, corporation, or other legal entity in which any such person has a 
substantial interest, financial or otherwise, be licensed.
    (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.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998]



Sec.  2.11  Denial of initial license application.

    (a) A license will not be issued to any applicant who:
    (1) Has not complied with the requirements of Sec. Sec.  2.1, 2.2, 
2.3, and 2.4 and has not paid the fees indicated in Sec.  2.6;

[[Page 19]]

    (2) Is not in compliance with any of the regulations or standards in 
this subchapter;
    (3) Has had a license revoked or whose license is suspended, as set 
forth in Sec.  2.10;
    (4) Has been fined, sentenced to jail, or pled nolo contendere (no 
contest) under State or local cruelty to animal laws within l year of 
application, except that if no penalty is imposed as a result of the 
plea of nolo contendere the applicant may reapply immediately; or
    (5) Has made any false or fraudulent statements, or provided any 
false or fraudulent records to the Department.
    (b) An applicant whose license application has been denied may 
request a hearing in accordance with the applicable rules of practice 
for the purpose of showing why the application for license should not be 
denied. The license denial shall remain in effect until the final legal 
decision has been rendered. Should the license denial be upheld, the 
applicant may again apply for a license l year from the date of the 
final order denying the application.
    (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.



                         Subpart B_Registration



Sec.  2.25  Requirements and procedures.

    (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 AC Regional Director. The registration form shall be filed with 
the AC Regional Director 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 AC Regional Director.
    (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.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998]



Sec.  2.26  Acknowledgment of regulations and standards.

    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 AC Regional Director.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998]



Sec.  2.27  Notification of change of operation.

    (a) A registrant shall notify the AC Regional Director 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 AC Regional Director a 
registrant shall notify the AC Regional Director 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 AC Regional Director. The 
former registrant is responsible for reregistering and demonstrating its 
compliance with the Act and regulations should it start using, handling, 
or

[[Page 20]]

transporting animals at any time after its registration is canceled.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998]



                      Subpart C_Research Facilities



Sec.  2.30  Registration.

    (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 AC Regional Director. The registration form shall 
be filed with the AC Regional Director for the State in which the 
research facility has its 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 AC Regional Director. 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 AC 
Regional Director.
    (c) Notification of change of operation. (1) A research facility 
shall notify the AC Regional Director by certified mail 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.
    (2) A research facility 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 AC Regional Director. A 
research facility shall file an annual report of its status (active or 
inactive). A research facility shall notify the AC Regional Director in 
writing at least 10 days before using, handling, or transporting animals 
again after being in an inactive status.
    (3) A research facility which goes out of business or which ceases 
to function as a research facility, 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 at any time in 
the future, may have its registration canceled by making a written 
request to the AC Regional Director. The research facility 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.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998]



Sec.  2.31  Institutional Animal Care and Use Committee (IACUC).

    (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.

[[Page 21]]

    (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;

[[Page 22]]

    (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 non-rodents 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 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;

[[Page 23]]

    (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, Sec.  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 continuing reviews of activities covered 
by this subchapter at appropriate intervals as determined by the IACUC, 
but not less than annually;
    (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:

[[Page 24]]

    (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.

[54 FR 36147, August 31, 1989, as amended by 59 FR 67611, Dec. 30, 1994; 
63 FR 62926, Nov. 10, 1998]



Sec.  2.32  Personnel qualifications.

    (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 
Sec.  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.



Sec.  2.33  Attending veterinarian and adequate veterinary care.

    (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

[[Page 25]]

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.



Sec.  2.34  [Reserved]



Sec.  2.35  Recordkeeping requirements.

    (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 Sec.  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 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 Sec.  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.
    (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;

[[Page 26]]

    (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/VS Form 18-1) and Record 
of Aquisition and Dogs and Cats on Hand (APHIS Form 7005/VS Form 18-5) 
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/VS Form 18-1) and Record 
of Disposition of Dogs and Cats (APHIS Form 7006/VS Form 18-6) 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 Sec.  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.

[54 FR 36147, Aug. 31, 1989, as amended at 58 FR 39129, July 22, 1993; 
60 FR 13895, Mar. 15, 1995]



Sec.  2.36  Annual report.

    (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 AC Regional Director for the State where the 
facility is located on or before December 1 of each calendar year. The 
report shall be signed and certified by the CEO or Institutional 
Official, and shall cover the previous Federal fiscal year.
    (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

[[Page 27]]

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.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998]



Sec.  2.37  Federal research facilities.

    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 Sec.  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.



Sec.  2.38  Miscellaneous.

    (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 names of research facilities subject to the 
provisions of this part. APHIS will publish lists of research facilities 
registered in accordance with the provisions of this subpart in the 
Federal Register. The

[[Page 28]]

lists may be obtained upon request from the AC Regional Director.
    (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 Sec.  2.35.

[[Page 29]]

    (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\1/4\ inches in 
diameter, or oblong and flat in shape and not less than 2 inches by \3/
4\ inch, and riveted to an acceptable collar.
    (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.\1\ At the time the research 
facility is registered, the Department will assign identification 
letters and numbers to be used on the official tags.
---------------------------------------------------------------------------

    \1\ A list of the commercial manufacturers who produce these tags 
and are known to the Department may be obtained from the AC Regional 
Director. Any manufacturer who desires to be included in the list should 
notify the Administrator.
---------------------------------------------------------------------------

    (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

[[Page 30]]

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/VS Form 18-1) 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 AC Regional Director, 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/VS Form 18-9 shall be used for 
approval.
    (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 Sec.  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 random source 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 Sec.  2.133 of subpart I of this part.

[54 FR 36147, Aug. 31, 1989, as amended at 58 FR 39129, July 22, 1993; 
59 FR 67612, Dec. 30, 1994; 60 FR 13895, Mar. 15, 1995; 63 FR 62926, 
Nov. 10, 1998]



      Subpart D_Attending Veterinarian and Adequate Veterinary Care



Sec.  2.40  Attending veterinarian and adequate veterinary care 
(dealers and exhibitors).

    (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

[[Page 31]]

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.



                   Subpart E_Identification of Animals



Sec.  2.50  Time and method of identification.

    (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 
Sec.  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\, or shall be identified by a 
distinctive and legible tattoo marking acceptable to and approved by the 
Administrator.
---------------------------------------------------------------------------

    \2\ In general, well fitted collars made of leather or plastic will 
be acceptable under this provision. The use of certain types of chains 
presently used by some dealers may also be deemed acceptable. APHIS will 
determine the acceptability of a material proposed for usage as collars 
from the standpoint of humane considerations on an individual basis in 
consultation with the dealer or exhibitor involved. The use of materials 
such as wire, elastic, or sharp metal that might cause discomfort or 
injury to the dogs or cats is not acceptable.
---------------------------------------------------------------------------

    (2) Live puppies or kittens, less than 16 weeks of age, shall be 
identified by:
    (i) An official tag as described in Sec.  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 Sec.  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 
Sec.  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 \3\; or
---------------------------------------------------------------------------

    \3\ See footnote 2 in Sec.  2.50(a)(1).
---------------------------------------------------------------------------

    (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 Sec. Sec.  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 Sec.  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 Sec.  2.51.
    (4) When any dealer has made a reasonable effort to affix an 
official tag to

[[Page 32]]

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 Sec.  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 Sec. Sec.  2.75 and 2.77.
    (2) When one or more animals, other than dogs or cats, 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.
    (3) 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 
Sec.  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.



Sec.  2.51  Form of official tag.

    (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\1/4\ inches in diameter, 
or
    (2) Oblong and flat in shape, not less than 2 inches by \3/4\ inch 
and riveted to an acceptable collar.
    (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

[[Page 33]]

number more than once within a 5-year period.



Sec.  2.52  How to obtain tags.

    Dealers or exhibitors may obtain, at their own expense, official 
tags from commercial tag manufacturers.\4\ At the time the dealer or 
exhibitor is issued a license or is registered, the Department will 
assign identification letters and numbers and inform them of the 
identification letters and numbers to be used on the official tags.
---------------------------------------------------------------------------

    \4\ A list of the commercial manufacturers who produce these tags 
and are known to the Department may be obtained from the AC Regional 
Director. Any manufacturer who desires to be included in the list should 
notify the Administrator.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62927, Nov. 10, 1998]



Sec.  2.53  Use of tags.

    Official tags obtained by a dealer, exhibitor, or research facility, 
shall be applied to dogs or cats in the manner set forth in Sec.  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.



Sec.  2.54  Lost tags.

    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 Sec.  2.50, and record the tag number on the official 
records.



Sec.  2.55  Removal and disposal of tags.

    (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.



                        Subpart F_Stolen Animals



Sec.  2.60  Prohibition on the purchase, sale, use, or transportation 
of stolen animals.

    No person shall buy, sell, exhibit, use for research, transport, or 
offer for transportation, any stolen animal.



                            Subpart G_Records



Sec.  2.75  Records: Dealers and exhibitors.

    (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 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;

[[Page 34]]

    (vi) The official USDA tag number or tattoo assigned to a dog or cat 
under Sec. Sec.  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 Aquisition and 
Dogs and Cats on Hand (APHIS Form 7005/VS Form 18-5) and Record of 
Disposition of Dogs and Cats (APHIS Form 7006/VS Form 18-6) 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/VS Form 18-5 and 
APHIS Form 7006/VS Form 18-6 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/VS Form 18-5 and APHIS Form 7006/VS 
Form 18-6.
    (i) The request for a variance must consist of a written statement 
describing why APHIS Form 7005/VS Form 18-5 and APHIS Form 7006/VS Form 
18-6 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/VS Form 18-5 and APHIS Form 7006/VS 
Form 18-6 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/VS Form 18-5 and APHIS Form 7006/VS Form 18-6.
    (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/VS Form 18-1) may be used 
by dealers and exhibitors to make, keep, and maintain the information 
required by Sec.  2.79.
    (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 Sec.  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 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 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;

[[Page 35]]

    (iii) The vehicle license number and state, and the driver's license 
number 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/VS Form 18-19) and Record of Acquisition, Disposition, or Transport 
of Animals (other than dogs and cats) (APHIS Form 7020/VS Form 18-20) 
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 Sec.  
2.79.
    (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.

[54 FR 36147, Aug. 31, 1989, as amended at 58 FR 39129, July 22, 1993; 
58 FR 45041, Aug. 26, 1993; 60 FR 13895, Mar. 15, 1995]



Sec.  2.76  Records: Operators of auction sales and brokers.

    (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 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 Sec. Sec.  2.50 and 2.54;
    (7) A description of the animal which shall include:
    (i) The species and breed or type of animal;
    (ii) The sex of the animal; and
    (iii) The date of birth or approximate age; and
    (iv) The color and any distinctive markings;
    (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.



Sec.  2.77  Records: Carriers and intermediate handlers.

    (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

[[Page 36]]

copy of the consignor's written guarantee for the payment of 
transportation charged for any animal not claimed as provided in Sec.  
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 Sec.  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 
Sec.  2.79, tendered with each live dog, cat, or nonhuman primate.



Sec.  2.78  Health certification and identification.

    (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/VS Form 18-1) may be used 
for health certification by a licensed veterinarian as required by this 
section.

[54 FR 36147, August 31, 1989, as amended at 59 FR 67612, Dec. 30, 1994; 
60 FR 13896, Mar. 15, 1995; 63 FR 62927, Nov. 10, 1998]



Sec.  2.79  C.O.D. shipments.

    (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,

[[Page 37]]

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.



Sec.  2.80  Records, disposition.

    (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.



         Subpart H_Compliance With Standards and Holding Period



Sec.  2.100  Compliance with standards.

    (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.

[[Page 38]]



Sec.  2.101  Holding period.

    (a) Any live dog or cat acquired by a dealer \5\ or exhibitor shall 
be held by him or her, under his or her supervision and control, for a 
period of not less than 5 full days, not including the day of 
acquisition, after acquiring the animal, excluding time in transit: 
Provided, however:
---------------------------------------------------------------------------

    \5\ An operator of an auction sale is not considered to have 
acquired a dog or cat which is sold through the auction sale.
---------------------------------------------------------------------------

    (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 Sec.  
2.131.



Sec.  2.102  Holding facility.

    (a) If any dealer or exhibitor obtains the prior approval of the AC 
Regional Director, he may arrange to have another person hold animals 
for the required period provided for in paragraph (a) of Sec.  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 Sec.  2.1 to have animals held for purposes of 
this section by another licensed dealer or exhibitor. APHIS Form 7009/VS 
Form 18-9 shall be used for approval.
    (b) If any intermediate handler obtains prior approval of the AC 
Regional Director, 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.

[54 FR 36147, Aug. 31, 1989, as amended at 60 FR 13896, Mar. 15, 1995; 
63 FR 62927, Nov. 10, 1998]



                         Subpart I_Miscellaneous



Sec.  2.125  Information as to business; furnishing of same by dealers, 
exhibitors, operators of auction sales, intermediate handlers, and carriers.

    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

[[Page 39]]

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.



Sec.  2.126  Access and inspection of records and property.

    (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 shall be extended to APHIS officials by the dealer, exhibitor, 
intermediate handler or carrier.



Sec.  2.127  Publication of names of persons subject to the provisions 
of this part.

    APHIS will publish lists of persons licensed or registered in 
accordance with the provisions of this part in the Federal Register. The 
lists may be obtained upon request from the AC Regional Director.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62927, Nov. 10, 1998]



Sec.  2.128  Inspection for missing animals.

    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.



Sec.  2.129  Confiscation and destruction of animals.

    (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.

[[Page 40]]

    (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.

[54 FR 36147, Aug. 31, 1989, as amended at 66 FR 239, Jan. 3, 2001]



Sec.  2.130  Minimum age requirements.

    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.



Sec.  2.131  Handling of animals.

    (a)(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.
    (b)(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.
    (c)(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.
    (d) 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.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 10498, Mar. 4, 1998]



Sec.  2.132  Procurement of random source dogs and cats, dealers.

    (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

[[Page 41]]

which it is located as an animal pound or shelter, such as a humane 
shelter or contract pound.
    (b) A class ``B'' dealer shall not obtain live random source dogs 
and cats from individuals who have not bred and raised the dogs and cats 
on their own premises.
    (c) Live nonrandom source dogs and cats may be obtained from persons 
who have bred and raised the dogs and cats on their own premises, such 
as hobby breeders.
    (d) No person shall obtain live random source dogs or cats by use of 
false pretenses, misrepresentation, or deception.
    (e) 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 Sec. Sec.  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 random source 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 
Sec.  2.101.



Sec.  2.133  Certification for random source dogs and 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,

[[Page 42]]

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.

[58 FR 39129, July 22, 1993]



PART 3_STANDARDS--Table of Contents




 Subpart A_Specifications for the Humane Handling, Care, Treatment, and 
                     Transportation of Dogs and Cats

                   Facilities and Operating Standards

Sec.
3.1 Housing facilities, general.
3.2 Indoor housing facilities.
3.3 Sheltered housing facilities.
3.4 Outdoor housing facilities.
3.5 Mobile or traveling housing facilities.
3.6 Primary enclosures.

                  Animal Health and Husbandry Standards

3.7 Compatible grouping.
3.8 Exercise for dogs.
3.9 Feeding.
3.10 Watering.
3.11 Cleaning, sanitization, housekeeping, and pest control.
3.12 Employees.

                        Transportation Standards

3.13 Consignments to carriers and intermediate handlers.
3.14 Primary enclosures used to transport live dogs and cats.
3.15 Primary conveyances (motor vehicle, rail, air, and marine).
3.16 Food and water requirements.
3.17 Care in transit.
3.18 Terminal facilities.
3.19 Handling.

 Subpart B_Specifications for the Humane Handling, Care, Treatment, and 
               Transportation of Guinea Pigs and Hamsters

                   Facilities and Operating Standards

3.25 Facilities, general.
3.26 Facilities, indoor.
3.27 Facilities, outdoor.
3.28 Primary enclosures.

[[Page 43]]

                  Animal Health and Husbandry Standards

3.29 Feeding.
3.30 Watering.
3.31 Sanitation.
3.32 Employees.
3.33 Classification and separation.
3.34 [Reserved]

                        Transportation Standards

3.35 Consignments to carriers and intermediate handlers.
3.36 Primary enclosures used to transport live guinea pigs and hamsters.
3.37 Primary conveyances (motor vehicle, rail, air, and marine).
3.38 Food and water requirements.
3.39 Care in transit.
3.40 Terminal facilities.
3.41 Handling.

 Subpart C_Specifications for the Humane Handling, Care, Treatment and 
                        Transportation of Rabbits

                   Facilities and Operating Standards

3.50 Facilities, general.
3.51 Facilities, indoor.
3.52 Facilities, outdoor.
3.53 Primary enclosures.

                  Animal Health and Husbandry Standards

3.54 Feeding.
3.55 Watering.
3.56 Sanitation.
3.57 Employees.
3.58 Classification and separation.
3.59 [Reserved]

                        Transportation Standards

3.60 Consignments to carriers and intermediate handlers.
3.61 Primary enclosures used to transport live rabbits.
3.62 Primary conveyances (motor vehicle, rail, air, and marine).
3.63 Food and water requirements.
3.64 Care in transit.
3.65 Terminal facilities.
3.66 Handling.

 Subpart D_Specifications for the Humane Handling, Care, Treatment, and 
                   Transportation of Nonhuman Primates

                   Facilities and Operating Standards

3.75 Housing facilities, general.
3.76 Indoor housing facilities.
3.77 Sheltered housing facilities.
3.78 Outdoor housing facilities.
3.79 Mobile or traveling housing facilities.
3.80 Primary enclosures.
3.81 Environment enhancement to promote psychological well-being.

                  Animal Health and Husbandry Standards

3.82 Feeding.
3.83 Watering.
3.84 Cleaning, sanitization, housekeeping, and pest control.
3.85 Employees.

                        Transportation Standards

3.86 Consignments to carriers and intermediate handlers.
3.87 Primary enclosures used to transport nonhuman primates.
3.88 Primary conveyances (motor vehicle, rail, air, and marine).
3.89 Food and water requirements.
3.90 Care in transit.
3.91 Terminal facilities.
3.92 Handling.

 Subpart E_Specifications for the Humane Handling, Care, Treatment, and 
                    Transportation of Marine Mammals

                   Facilities and Operating Standards

3.100 Special considerations regarding compliance and/or variance.
3.101 Facilities, general.
3.102 Facilities, indoor.
3.103 Facilities, outdoor.
3.104 Space requirements.

                  Animal Health and Husbandry Standards

3.105 Feeding.
3.106 Water quality.
3.107 Sanitation.
3.108 Employees or attendants.
3.109 Separation.
3.110 Veterinary care.
3.111 Swim-with-the-dolphin programs.

                        Transportation Standards

3.112 Consignments to carriers and intermediate handlers.
3.113 Primary enclosures used to transport marine mammals.
3.114 Primary conveyances (motor vehicle, rail, air, and marine).
3.115 Food and drinking water requirements.
3.116 Care in transit.
3.117 Terminal facilities.
3.118 Handling.

 Subpart F_Specifications for the Humane Handling, Care, Treatment, and 
 Transportation of Warmblooded Animals Other Than Dogs, Cats, Rabbits, 
      Hamsters, Guinea Pigs, Nonhuman Primates, and Marine Mammals

                   Facilities and Operating Standards

3.125 Facilities, general.
3.126 Facilities, indoor.
3.127 Facilities, outdoor.

[[Page 44]]

3.128 Space requirements.

                  Animal Health and Husbandry Standards

3.129 Feeding.
3.130 Watering.
3.131 Sanitation.
3.132 Employees.
3.133 Separation.
3.134-3.135 [Reserved]

                        Transportation Standards

3.136 Consignments to carriers and intermediate handlers.
3.137 Primary enclosures used to transport live animals.
3.138 Primary conveyances (motor vehicle, rail, air, and marine).
3.139 Food and water requirements.
3.140 Care in transit.
3.141 Terminal facilities.
3.142 Handling.

    Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.

    Source: 32 FR 3273, Feb. 24, 1967, unless otherwise noted.



 Subpart A_Specifications for the Humane Handling, Care, Treatment, and 
                   Transportation of Dogs and Cats \1\

    Source: 56 FR 6486, Feb. 15, 1991, unless otherwise noted.

                   Facilities and Operating Standards



Sec.  3.1  Housing facilities, general.

    (a) Structure; construction. Housing facilities for dogs and cats 
must be designed and constructed so that they are structurally sound. 
They must be kept in good repair, and they must protect the animals from 
injury, contain the animals securely, and restrict other animals from 
entering.
---------------------------------------------------------------------------

    \1\ These minimum standards apply only to live dogs and cats, 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, 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 
Sec.  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

[[Page 45]]

methods provided in Sec.  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.



Sec.  3.2  Indoor housing facilities.

    (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 [deg]F 
(10 [deg]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 [deg]F (10 [deg]C). 
The ambient temperature must not fall below 45 [deg]F (7.2 [deg]C) for 
more than 4 consecutive hours when dogs or cats are present, and must 
not rise above 85 [deg]F (29.5 [deg]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.

[[Page 46]]

    (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 [deg]F (29.5 [deg]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).

[56 FR 6486, Feb. 15, 1991, as amended at 63 FR 10498, Mar. 4, 1998]



Sec.  3.3  Sheltered housing facilities.

    (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 [deg]F (10 [deg]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 [deg]F (10 [deg]C). The ambient temperature 
must not fall below 45 [deg]F (7.2 [deg]C) for more than 4 consecutive 
hours when dogs or cats are present, and must not rise above 85 [deg]F 
(29.5 [deg]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 [deg]F 
(29.5 [deg]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,

[[Page 47]]

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.

[56 FR 6486, Feb. 15, 1991, as amended at 63 FR 10498, Mar. 4, 1998]



Sec.  3.4  Outdoor housing facilities.

    (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 [deg]F (10 [deg]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 [deg]F (10 [deg]C). Additional clean, dry bedding is 
required when the temperature is 35 [deg]F (1.7 [deg]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.



Sec.  3.5  Mobile or traveling housing facilities.

    (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 [deg]F (10 [deg]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 [deg]F (10 [deg]C). The ambient temperature 
must not fall below 45 [deg]F (7.2 [deg]C) for more than 4 consecutive 
hours when dogs or cats are present, and

[[Page 48]]

must not exceed 85 [deg]F (29.5 [deg]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 [deg]F (29.5 [deg]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.

[32 FR 3273, Feb. 24, 1967, as amended at 63 FR 10498, Mar. 4, 1998]



Sec.  3.6  Primary enclosures.

    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 Sec.  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) Primary enclosures constructed on or after February 20, 1998 
and floors replaced on or after that date, must comply with the 
requirements in this paragraph (a)(2). On or after January 21, 2000, all 
primary enclosures must be in compliance with the requirements in this 
paragraph (a)(2). If the suspended floor of a primary enclosure is 
constructed of metal strands, the strands must either be greater than 
\1/8\ of an inch in diameter (9 gauge) or coated with a material such as 
plastic or fiberglass. The suspended floor of any primary enclosure must 
be strong enough so that the floor does not sag or bend between the 
structural supports.
    (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) Prior to February 15, 1994 each cat housed in any primary 
enclosure shall be provided a minimum of 2\1/2\ square feet of floor 
space;

[[Page 49]]

    (ii) On and after February 15, 1994:
    (A) Each primary enclosure housing cats must be at least 24 in. high 
(60.96 cm);
    (B) Cats up to and including 8.8 lbs (4 kg) must be provided with at 
least 3.0 ft\2\ (0.28 m\2\);
    (C) Cats over 8.8 lbs (4 kg) must be provided with at least 4.0 
ft\2\ (0.37 m\2\);
    (iii) 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
    (iv) 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 Sec.  3.14 of this 
subpart other than the marking requirements in Sec.  3.14(a)(6) of this 
subpart. 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) x (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.

[[Page 50]]

    (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 Sec.  3.14 of this 
subpart other than the marking requirements in Sec.  3.14(a)(6) of this 
subpart. 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.

(Approved by the Office of Management and Budget under control number 
0579-0093)

[56 FR 6486, Feb. 15, 1991, as amended at 62 FR 43275, Aug. 13, 1997; 63 
FR 3023, Jan. 21, 1998; 63 FR 37482, July 13, 1998]

                  Animal Health and Husbandry Standards



Sec.  3.7  Compatible grouping.

    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.



Sec.  3.8  Exercise for dogs.

    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

[[Page 51]]

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 Sec.  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 Sec.  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 Sec.  
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.

(Approved by the Office of Management and Budget under control number 
0579-0093)



Sec.  3.9  Feeding.

    (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

[[Page 52]]

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 Sec.  3.11(b) of 
this subpart. Sanitization is achieved by using one of the methods 
described in Sec.  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 Sec.  3.11(b) of 
this subpart. Measures must be taken to ensure that there is no molding, 
deterioration, and caking of feed.



Sec.  3.10  Watering.

    If potable water is not continually available to the dogs and cats, 
it must be offered to the dogs and 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. Water 
receptacles must be kept clean and sanitized in accordance with Sec.  
3.11(b) of this subpart, and before being used to water a different dog 
or cat or social grouping of dogs or cats.



Sec.  3.11  Cleaning, sanitization, housekeeping, and pest control.

    (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 [deg]F (82.2 [deg]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

[[Page 53]]

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.

[56 FR 6486, Feb. 15, 1991, as amended at 63 FR 3023, Jan. 21, 1998]



Sec.  3.12  Employees.

    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.

                        Transportation Standards



Sec.  3.13  Consignments to carriers and intermediate handlers.

    (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 Sec.  3.16 of this subpart. 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 
Sec. Sec.  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 Sec.  3.14 of this subpart. 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 Sec. Sec.  3.18 and 3.19 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 required in Sec. Sec.  3.18 and 3.19 of this subpart. Even if

[[Page 54]]

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 [deg]F (2.2 [deg]C) for more than 4 
consecutive hours when dogs or cats are present, as set forth in Sec.  
3.18, nor lower than 45 [deg]F (2.2 [deg]C) for more than 45 minutes, as 
set forth in Sec.  3.19, 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 
Sec. Sec.  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 [deg]F (10 [deg]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.

(Approved by the Office of Management and Budget under control number 
0579-0093)



Sec.  3.14  Primary enclosures used to transport live dogs and cats.

    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,

[[Page 55]]

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 Sec.  
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

[[Page 56]]

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 Sec.  3.13(c).

(Approved by the Office of Management and Budget under control number 
0579-0093)

[56 FR 6486, Feb. 15, 1991, as amended at 63 FR 3023, Jan. 21, 1998]



Sec.  3.15  Primary conveyances (motor vehicle, rail, air, and marine).

    (a) The animal cargo space of primary conveyances used to transport

[[Page 57]]

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 [deg]F (29.5 [deg]C). Moreover, the 
ambient temperature may not exceed 85 [deg]F (29.5 [deg]C) for a period 
of more than 4 hours; nor fall below 45 [deg]F (7.2 [deg]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.

[56 FR 6486, Feb. 15, 1991, as amended at 63 FR 10498, 10499, Mar. 4, 
1998]



Sec.  3.16  Food and water requirements.

    (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 Sec.  
3.13(c) of this subpart. 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 Sec.  3.13(c) of this subpart.
    (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

[[Page 58]]

be designed, constructed, and installed so that a dog or cat cannot 
leave the primary enclosure through the food or water opening.

(Approved by the Office of Management and Budget under control number 
0579-0093)



Sec.  3.17  Care in transit.

    (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 Sec.  3.15(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 Sec.  3.15(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) Except during the cleaning of primary enclosures, as required in 
Sec.  3.14(b) of this subpart, 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 Sec.  3.6 or Sec.  3.14 of this subpart.
    (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.



Sec.  3.18  Terminal facilities.

    (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 Sec.  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 [deg]F (29.5 [deg]C) or higher
    (d) Temperature. The ambient temperature in an animal holding area 
containing dogs or cats must not fall below 45 [deg]F (7.2 [deg]C) or 
rise above 85 [deg]F (29.5 [deg]C) for more than four consecutive hours 
at any time dogs or cats are present. The ambient temperature

[[Page 59]]

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 Sec.  3.13(f) of this subpart.

[56 FR 6486, Feb. 15, 1991, as amended at 63 FR 10499, Mar. 4, 1998]



Sec.  3.19  Handling.

    (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 
[deg]F (29.5 [deg]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 Sec.  3.18(d) of 
this subpart. 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 [deg]F (10 [deg]C). 
The dogs or cats must not be exposed to an ambient temperature below 45 
[deg]F (7.2 [deg]C) for a period of more than 45 minutes, unless they 
are accompanied by a certificate of acclimation to lower temperatures as 
provided in Sec.  3.13(e). The temperature must be measured in the 
manner provided in Sec.  3.18(d) of this subpart. 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

[[Page 60]]

primary conveyance or terminal facility, and to or from a terminal 
facility or a primary conveyance.

(Approved by the Office of Management and Budget under control number 
0579-0093)

[56 FR 6486, Feb. 15, 1991, as amended at 63 FR 10499, Mar. 4, 1998]



 Subpart B_Specifications for the Humane Handling, Care, Treatment, and 
               Transportation of Guinea Pigs and Hamsters

                   Facilities and Operating Standards



Sec.  3.25  Facilities, general.

    (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.

[32 FR 3273, Feb. 24, 1967, as amended at 44 FR 63492, Nov. 2, 1979]



Sec.  3.26  Facilities, indoor.

    (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 [deg]F. nor to exceed 
85 [deg]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 [deg]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.



Sec.  3.27  Facilities, outdoor.

    (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.



Sec.  3.28  Primary enclosures.

    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.

[[Page 61]]

    (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\1/2\ inches.
    (ii) Each guinea pig housed in a primary enclosure shall be provided 
a minimum amount of floor space in accordance with the following table:

------------------------------------------------------------------------
                                                                Minimum
                                                               space per
                 Weight or stage of maturity                  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\1/2\ inches, except that in the case of 
dwarf hamsters, such interior height shall be at least 5 inches.
    (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:

------------------------------------------------------------------------
                                           Minimum space per
                                            hamster (square     Maximum
                   Age                          inches)       population
                                         --------------------     per
                                            Dwarf     Other    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 
adequte 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:

------------------------------------------------------------------------
                                                           Minimum floor
                                                               space
               Weight or stage of maturity               ---------------
                                                          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:

[[Page 62]]



------------------------------------------------------------------------
                        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.

[32 FR 3273, Feb. 24, 1967, as amended at 55 FR 28882, July 16, 1990]

                  Animal Health and Husbandry Standards



Sec.  3.29  Feeding.

    (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.



Sec.  3.30  Watering.

    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.



Sec.  3.31  Sanitation.

    (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.

[[Page 63]]

    (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 [deg]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.



Sec.  3.32  Employees.

    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.



Sec.  3.33  Classification and separation.

    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.



Sec.  3.34  [Reserved]

                        Transportation Standards

    Authority: Sections 3.35 through 3.41 issued under secs. 3, 5, 6, 
10, 11, 14, 16, 17, 21; 80 Stat. 353; 84 Stat. 1561, 1562, 1563, 1564; 
90 Stat. 418, 419, 420, 423; (7 U.S.C. 2133, 2135, 2136, 2140, 2141, 
2144, 2146, 2147, 2151); 37 FR 28464, 28477, 38 FR 19141.



Sec.  3.35  Consignments to carriers and intermediate handlers.

    (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 govenment 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 
Sec.  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 Sec.  3.36 of the standards, unless such primary enclosure 
is obviously defective or damaged

[[Page 64]]

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 Sec. Sec.  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 [deg]C. (45 [deg]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.

[42 FR 31563, June 21, 1977, as amended at 43 FR 22163, May 16, 1978; 44 
FR 63492, Nov. 2, 1979]



Sec.  3.36  Primary enclosures used to transport live guinea pigs 
and hamsters.

    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

[[Page 65]]

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 tranported 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 tranport 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
------------------------------------------------------------------------
                                                    Square      Square
                 Weight (grams)                  centimeters    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
----------------------------------------------------------------------------------------------------------------
                                                                           Dwarf                   Other
                                                                 -----------------------------------------------
                               Age                                   Square      Square      Square      Square
                                                                  centimeters    inches   centimeters    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 Sec.  3.31 of the standards, if previously used. Such 
primary enclosures shall contain clean

[[Page 66]]

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.

[42 FR 31563, June 21, 1977, as amended at 43 FR 21163, May 16, 1978; 55 
FR 28882, July 16, 1990]



Sec.  3.37  Primary conveyances (motor vehicle, rail, air, and marine).

    (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 [deg]F (23.9 [deg]C) 
or higher. The ambient temperature within the animal cargo space shall 
not exceed 85 [deg]F (29.5 [deg]C) or fall below 45 [deg]F (7.2 [deg]C), 
except that the ambient temperature in the cargo space may be below 45 
[deg]F (7.2 [deg]C) for hamsters if the hamsters are accompanied by a 
certificate of acclimation to lower temperatures, as provided in Sec.  
3.35(c) of this part.

[42 FR 31563, June 21, 1977, as amended at 55 FR 28882, July 16, 1990]



Sec.  3.38  Food and water requirements.

    (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

[[Page 67]]

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.

[42 FR 31563, June 21, 1977]



Sec.  3.39  Care in transit.

    (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.

[42 FR 31563, June 21, 1977]



Sec.  3.40  Terminal facilities.

    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 Sec.  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 [deg]C. (75. [deg]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 [deg]C. (45 [deg]F.) 
nor be allowed to exceed 29.5 [deg]C. (85 [deg]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

[[Page 68]]

between the top and bottom of such primary enclosure.

[43 FR 56215, Dec. 1, 1978, as amended at 55 FR 28883, July 16, 1990]



Sec.  3.41  Handling.

    (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 [deg]C. (85 [deg]F.), and which shall 
be measured and read in the manner prescribed Sec.  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 [deg]C. (50 [deg]F.), and such live 
guinea pigs and hamsters shall not be subjected to surrounding air 
temperatures which fall below 7.2 [deg]C. (45 [deg]F.), and which shall 
be measured and read in the manner prescribed in Sec.  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.

[43 FR 21163, May 16, 1978, as amended at 43 FR 56216, Dec. 1, 1978; 55 
FR 28883, July 16, 1990]



 Subpart C_Specifications for the Humane Handling, Care, Treatment and 
                        Transportation of Rabbits

                   Facilities and Operating Standards



Sec.  3.50  Facilities, general.

    (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.

[32 FR 3273, Feb. 24, 1967, as amended at 44 FR 63492, Nov. 2, 1979]



Sec.  3.51  Facilities, indoor.

    (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

[[Page 69]]

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 [deg]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.



Sec.  3.52  Facilities, outdoor.

    (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 [deg]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 
[deg]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.



Sec.  3.53  Primary enclosures.

    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:

------------------------------------------------------------------------
                                                                Minimum
                                                               space per
              Category                  Individual weights      rabbit
                                             (pounds)           (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:

[[Page 70]]



----------------------------------------------------------------------------------------------------------------
                                       Individual weights        Minimum floor space     Minimum interior height
                                   -----------------------------------------------------------------------------
                                         kg          lbs          m\2\        ft\2\          cm           in
----------------------------------------------------------------------------------------------------------------
Individual rabbits (weaned).......           <2         <4.4         0.14          1.5        35.56           14
                                            2-4      4.4-8.8         0.28          3.0        35.56           14
                                          4-5.4     8.8-11.9         0.37          4.0        35.56           14
                                               0.46          5.0        35.56           14
                                            5.4         11.9
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                    Weight of nursing female    Minimum floor space/     Minimum interior height
                                   --------------------------      female & litter     -------------------------
                                                             --------------------------
                                         kg          lbs          m\2\        ft\2\          cm           in
----------------------------------------------------------------------------------------------------------------
Females with litters..............           <2         <4.4         0.37          4.0        35.56           14
                                            2-4      4.4-8.8         0.46          5.0        35.56           14
                                          4-5.4     8.8-11.9         0.56          6.0        35.56           14
                                               0.70          7.5        35.56           14
                                            5.4         11.9
----------------------------------------------------------------------------------------------------------------

    (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.

[32 FR 3273, Feb. 24, 1967, as amended at 55 FR 28883, July 16, 1990]

                  Animal Health and Husbandry Standards



Sec.  3.54  Feeding.

    (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.



Sec.  3.55  Watering.

    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.



Sec.  3.56  Sanitation.

    (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 [deg]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

[[Page 71]]

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.



Sec.  3.57  Employees.

    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.



Sec.  3.58  Classification and separation.

    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.



Sec.  3.59  [Reserved]

                        Transportation Standards

    Authority: Sections 3.60 through 3.66 issued under secs. 3, 5, 6, 
10, 11, 14, 16, 17, 21; 80 Stat. 353; 84 Stat. 1561, 1562, 1563, 1564; 
90 Stat. 418, 420, 423 (7 U.S.C. 2133, 2135, 2136, 2140, 2141, 2144, 
2146, 2147, 2151); 37 FR 28464, 28477, 38 FR 19141.

    Source: Sections 3.60 through 3.66 appear at 42 FR 31565, June 21, 
1977, unless otherwise noted.



Sec.  3.60  Consignments to carriers and intermediate handlers.

    (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 Sec.  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 Sec.  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

[[Page 72]]

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 Sec. Sec.  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 [deg]C. (45 [deg]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.

[42 FR 31565, June 21, 1977, as amended at 43 FR 21164, May 16, 1978; 44 
FR 63493, Nov. 2, 1979]



Sec.  3.61  Primary enclosures used to transport live rabbits.

    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 stuctural 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

[[Page 73]]

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 specie 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 Sec.  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 works ``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.

[42 FR 31565, June 21, 1977, as amended at 43 FR 21164, May 16, 1978; 55 
FR 28883, July 16, 1990]



Sec.  3.62  Primary conveyances (motor vehicle, rail, air, and marine).

    (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

[[Page 74]]

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 
[deg]F (23.9 [deg]C) or higher. The ambient temperature within the 
animal cargo space shall not exceed 85 [deg]F (29.5 [deg]C) or fall 
below 45 [deg]F (7.2 [deg]C), except that the ambient temperature in the 
cargo space may be below 45 [deg]F (7.2 [deg]C) if the rabbits are 
accompanied by a certificate of acclimation to lower temperatures, as 
provided in Sec.  3.60(c) of this part.

[42 FR 31565, June 21, 1977, as amended at 55 FR 28883, July 16, 1990]



Sec.  3.63  Food and water requirements.

    (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.



Sec.  3.64  Care in transit.

    (a) During surface transportation, it shall be th 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 disress 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.



Sec.  3.65  Terminal facilities.

    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 Sec.  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

[[Page 75]]

any animal holding area containing live rabbits when the air temperature 
within such animal holding area is 23.9 [deg]C. (75 [deg]F.) or higher. 
The air temperature around any live rabbit in any animal holding area 
shall not be allowed to fall below 7.2 [deg]C. (45 [deg]F.) nor be 
allowed to exceed 29.5 [deg]C. (85 [deg]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.

[43 FR 56216, Dec. 1, 1978, as amended at 55 FR 28883, July 16, 1990]]



Sec.  3.66  Handling.

    (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 
[deg]C. (85 [deg]F.), and which shall be measured and read in the manner 
prescribed in Sec.  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 [deg]C. (50 [deg]F.), and such live rabbits shall not be 
subjected to surrounding air temperatures which fall below 7.2 [deg]C. 
(45 [deg]F.), and which shall be measured and read in the manner 
prescribed in Sec.  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 Sec.  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.

[43 FR 21164, May 16, 1978, as amended at 43 FR 56216, Dec. 1, 1978; 55 
FR 28883, July 16, 1990]



 Subpart D_Specifications for the Humane Handling, Care, Treatment, and 
                 Transportation of Nonhuman Primates \2\

    Source: 56 FR 6495, Feb. 15, 1991, unless otherwise noted.

                   Facilities and Operating Standards



Sec.  3.75  Housing facilities, general.

    (a) Structure: construction. Housing facilities for nonhuman 
primates must

[[Page 76]]

be designed and constructed so that they are structurally sound for the 
species of nonhuman primates housed in them. They must be kept in good 
repair, and they must protect the animals from injury, contain the 
animals securely, and restrict other animals from entering.
---------------------------------------------------------------------------

    \2\ Nonhuman primates include a great diversity of forms, ranging 
from the marmoset weighing only a few ounces, to the adult gorilla 
weighing hundreds of pounds, and include more than 240 species. They 
come from Asia, Africa, and Central and South America, and they live in 
different habitats in nature. Some have been transported to the United 
States from their natural habitats and some have been raised in 
captivity in the United States. Their nutritional and activity 
requirements differ, as do their social and environmental requirements. 
As a result, the conditions appropriate for one species do not 
necessarily apply to another. Accordingly, these minimum specifications 
must be applied in accordance with the customary and generally accepted 
professional and husbandry practices considered appropriate for each 
species, and necessary to promote their psychological well-being.
    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 
Sec.  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 
Sec.  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

[[Page 77]]

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.



Sec.  3.76  Indoor housing facilities.

    (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 [deg]F (7.2 [deg]C) for more than 4 consecutive hours when 
nonhuman primates are present, and must not rise above 85 [deg]F (29.5 
[deg]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 [deg]F (29.5 [deg]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

[[Page 78]]

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.



Sec.  3.77  Sheltered housing facilities.

    (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 [deg]F (7.2 
[deg]C) for more than 4 consecutive hours when nonhuman primates are 
present, and must not rise above 85 [deg]F (29.5 [deg]C) for more than 4 
consecutive hours when nonhuman primates are present, unless 
temperatures above 85 [deg]F (29.5 [deg]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 [deg]F (29.5 [deg]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

[[Page 79]]

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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0093)



Sec.  3.78  Outdoor housing facilities.

    (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 [deg]F (7.2 [deg]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

[[Page 80]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0093)



Sec.  3.79  Mobile or traveling housing facilities.

    (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 [deg]F (7.2 [deg]C) for more 
than 4 consecutive hours when nonhuman primates are present, and must 
not rise above 85 [deg]F (29.5 [deg]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 [deg]F (29.5 [deg]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.



Sec.  3.80  Primary enclosures.

    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

[[Page 81]]

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 Sec.  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) Prior to February 15, 1994:
    (i) Primary enclosures must be constructed and maintained so as to 
provide sufficient space to allow each nonhuman primate to make normal 
postural adjustments with adequate freedom of movement; and
    (ii) Each nonhuman primate housed in a primary enclosure must be 
provided with a minimum floor space equal to an area at least three 
times the area occupied by the primate when standing on four feet.
    (2) On and after February 15, 1994:
    (i) 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\3\ and will be calculated 
by using the following table: \4\
---------------------------------------------------------------------------

    \3\ The different species of nonhuman primates are divided into six 
weight groups for determining minimum space requirements, except that 
all brachiating species of any weight are grouped together since they 
require additional space to engage in species-typical behavior. The 
grouping provided is based upon the typical weight for various species 
and not on changes associated with obesity, aging, or pregnancy. These 
conditions will not be considered in determining a nonhuman primate's 
weight group unless the animal is obviously unable to make normal 
postural adjustments and movements within the primary enclosure. 
Different species of prosimians vary in weight and should be grouped 
with their appropriate weight group. They have not been included in the 
weight table since different species typically fall into different 
weight groups. Infants and juveniles of certain species are 
substantially lower in weight than adults of those species and require 
the minimum space requirements of lighter weight species, unless the 
animal is obviously unable to make normal postural adjustments and 
movements within the primary enclosure.
    \4\ Examples of the kinds of nonhuman primates typically included in 
each age group are:
    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)(ii) of this section, and brachiating species.

----------------------------------------------------------------------------------------------------------------
                                                 Weight                   Floor area/animal         Height
             Group              --------------------------------------------------------------------------------
                                        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)

[[Page 82]]

 
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)
----------------------------------------------------------------------------------------------------------------

    (ii) 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)(2)(i) of this section, to allow 
for normal postural adjustments.
    (iii) 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.
    (iv) 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)(2)(i) 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 paragraphs (b)(1) and (b)(2) 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.

(Approved by the Office of Management and Budget under control number 
0579-0093)



Sec.  3.81  Environment enhancement to promote psychological well-being.

    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

[[Page 83]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0093)

[[Page 84]]

                  Animal Health and Husbandry Standards



Sec.  3.82  Feeding.

    (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 Sec.  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.



Sec.  3.83  Watering.

    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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0093)



Sec.  3.84  Cleaning, sanitization, housekeeping, and pest control.

    (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

[[Page 85]]

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 [deg]F (82.2 [deg]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.



Sec.  3.85  Employees.

    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.

                        Transportation Standards



Sec.  3.86  Consignments to carriers and intermediate handlers.

    (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

[[Page 86]]

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 
Sec.  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 Sec.  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 
Sec. Sec.  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 Sec. Sec.  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 [deg]F (10 
[deg]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

[[Page 87]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0093)



Sec.  3.87  Primary enclosures used to transport nonhuman primates.

    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 Sec.  
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

[[Page 88]]

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 Sec.  3.86(c) of this subpart.

(Approved by the Office of Management and Budget under control number 
0579-0093)



Sec.  3.88  Primary conveyances (motor vehicle, rail, air, and marine).

    (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.

[[Page 89]]

    (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 [deg]F (7.2 [deg]C) and 85 [deg]F (30 [deg]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.



Sec.  3.89  Food and water requirements.

    (a) Each nonhuman primate that is 1 year of age or more must be 
offered food \5\ at least once every 24 hours. Each nonhuman primate 
that is less than 1 year of age must be offered food at least once every 
12 hours. Each nonhuman primate must be offered potable water at least 
once every 12 hours. These time periods apply to dealers, exhibitors, 
and research facilities, including Federal research facilities, who 
transport nonhuman primates in their own primary conveyances, starting 
from the time the nonhuman primate 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 certification provided under Sec.  3.86(c) of this 
subpart. Each nonhuman primate 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 nonhuman primate was offered food and potable water 
within the 4 hours preceding delivery of the nonhuman primate 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 Sec.  3.86(c) of this subpart.
---------------------------------------------------------------------------

    \5\ Proper food for purposes of this section is described in Sec.  
3.82 of this subpart, with the necessities and circumstances of the mode 
of travel taken into account.
---------------------------------------------------------------------------

    (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

[[Page 90]]

leave the primary enclosure through the food or water opening.

(Approved by the Office of Management and Budget under control number 
0579-0093)



Sec.  3.90  Care in transit.

    (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 Sec.  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 
Sec.  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 Sec.  
3.80 or Sec.  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.



Sec.  3.91  Terminal facilities.

    (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 Sec.  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

[[Page 91]]

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 [deg]F (29.5 
[deg]C) or higher.
    (d) Temperature. The ambient temperature in an animal holding area 
containing nonhuman primates must not fall below 45 [deg]F (7.2 [deg]C) 
or rise above 85 [deg]F (29.5 [deg]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 Sec.  3.86(f) of this subpart.



Sec.  3.92  Handling.

    (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 [deg]F (29.5 [deg]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 Sec.  
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 [deg]F (7.2 [deg]C). 
A nonhuman primate must not be exposed to an ambient air temperature 
below 45 [deg]F (7.2 [deg]C) for a period of more than 45 minutes, 
unless it is accompanied by a certificate of acclimation to lower 
temperatures as provided in Sec.  3.86(e) of this subpart. The ambient 
temperature must be measured in the manner provided in Sec.  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

[[Page 92]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0093)



 Subpart E_Specifications for the Humane Handling, Care, Treatment, and 
                    Transportation of Marine Mammals

    Source: 44 FR 36874, June 22, 1979, unless otherwise noted.

                   Facilities and Operating Standards



Sec.  3.100  Special considerations regarding compliance and/or variance.

    (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,\6\ by the Deputy Administrator, from one or more 
specified provisions of Sec.  3.104. The provisions of this subpart 
shall not apply, however, in emergency circumstances where compliance 
with one or more requirements would not serve the best interest of the 
marine mammals concerned.
---------------------------------------------------------------------------

    \6\ Written permission from the Deputy Administrator to operate as a 
licensee or registrant under the Act without being in full compliance 
with one or more specified provisions of Sec.  3.104.
---------------------------------------------------------------------------

    (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

[[Page 93]]

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.

[49 FR 26681, June 28, 1984; 63 FR 2, Jan. 2, 1998]



Sec.  3.101  Facilities, general.

    (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 Sec.  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.
    (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,

[[Page 94]]

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.

[66 FR 251, Jan. 3, 2001]



Sec.  3.102  Facilities, indoor.

    (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.\7\
---------------------------------------------------------------------------

    \7\ Lighting intensity and duration must be consistent with the 
general well-being and comfort of the animal involved. When possible, it 
should approximate the lighting conditions encountered by the animal in 
its natural environment. At no time shall the lighting be such that it 
will cause the animal discomfort or trauma.

[44 FR 36874, June 22, 1979; 63 FR 2, Jan. 2, 1998]



Sec.  3.103  Facilities, outdoor.

    (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

[[Page 95]]

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.

[44 FR 36874, June 22, 1979, as amended at 64 FR 56147, Oct. 18, 1999]



Sec.  3.104  Space requirements.

    (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 Sec.  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

[[Page 96]]

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 \8\ ), 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 two times the average adult length of the longest species of 
Group I cetacean housed therein, whichever is greater.
---------------------------------------------------------------------------

    \8\ The body length of a Monodon monoceros (narwhale) is measured 
from the tip of the upper incisor tooth to the notch in the tail fluke. 
If the upper incisor is absent or does not extend beyond the front of 
the head, then it is measured like other cetaceans, from the tip of the 
upper jaw to the notch in the tail fluke. Immature males should be 
anticipated to develop the ``tusk'' (usually left incisor tooth) 
beginning at sexual maturity.
---------------------------------------------------------------------------

    (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        Minimum horizontal       Minimum required depth    Volume of water required for
       adult lengths              dimension (MHD)      ----------------------------  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

[[Page 97]]

 
       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      Minimum horizontal        Minimum required depth     Volume of water required
           length                   dimension (MHD)      ---------------------------     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\
------------------------------------------------------------------------
                                                         Average adult
                                                            length
             Species                  Common name    -------------------
                                                         In
                                                       meters    In feet
------------------------------------------------------------------------
Group I Cetaceans:
    Balaenoptera acutorostrata..  Minke whale.......      8.50      27.9
    Cephalorhynchus commersonii.  Commerson's             1.52       5.0
                                   dolphin.
    Delphinapterus leucas.......  Beluga whale......      4.27      14.0
    Monodon monoceros...........  Narwhale..........      3.96      13.0
    Globicephala melaena........  Long-finned pilot       5.79      19.0
                                   whale.
    Globicephala macrorhynchus..  Short-finned pilot      5.49      18.0
                                   whale.
    Grampus griseus.............  Risso's dolphin...      3.66      12.0
    Orcinus orca................  Killer whale......      7.32      24.0
    Pseudorca carassidens.......  False killer whale      4.35      14.3
    Tursiops truncatus            Bottlenose dolphin      2.74       9.0
     (Atlantic).
    Tursiops truncatus (Pacific)  Bottlenose dolphin      3.05      10.0
    Inia geoffrensis............  Amazon porpoise...      2.44       8.0
    Phocoena phocoena...........  Harbor porpoise...      1.68       5.5
    Pontoporia blainvillei......  Franciscana.......      1.52       5.0
    Sotalia fluviatilis.........  Tucuxi............      1.68       5.5
    Platanista, all species.....  River dolphin.....      2.44       8.0
Group II Cetaceans:
    Delphinus delphis...........  Common dolphin....      2.59       8.5
    Feresa attenuata............  Pygmy killer whale      2.44       8.0
    Kogia breviceps.............  Pygmy sperm whale.      3.96      13.0
    Kogia simus.................  Dwarf sperm whale.      2.90       9.5
    Lagenorhynchus acutus.......  Atlantic white-         2.90       9.5
                                   sided dolphin.
    Lagenorhynchus cruciger.....  Hourglass dolphin.      1.70       5.6
    Lagenorhynchus obliquidens..  Pacific white-          2.29       7.5
                                   sided dolphin.
    Lagenorhynchus albirostris..  White-beaked            2.74       9.0
                                   dolphin.
    Lagenorhynchus obscurus.....  Duskey dolphin....      2.13       7.0
    Lissodelphis borealis.......  Northern right          2.74       9.0
                                   whale dolphin.
    Neophocaena phocaenoides....  Finless porpoise..      1.83       6.0
    Peponocephala electra.......  Melon-headed whale      2.74       9.0
    Phocoenoides dalli..........  Dall's porpoise...      2.00       6.5

[[Page 98]]

 
    Stenella longirostris.......  Spinner dolphin...      2.13       7.0
    Stenella coeruleoalba.......  Striped dolphin...      2.29       7.5
    Stenella attenuata..........  Spotted dolphin...      2.29       7.5
    Stenella plagiodon..........  Spotted dolphin...      2.29       7.5
    Steno bredanensis...........  Rough-toothed           2.44       8.0
                                   dolphin.
------------------------------------------------------------------------
\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.


----------------------------------------------------------------------------------------------------------------
                                                                                   Average adult length
                                                                         ---------------------------------------
                  Species                            Common name               In meters            In feet
                                                                         ---------------------------------------
                                                                            Male     Female     Male     Female
----------------------------------------------------------------------------------------------------------------
Group I Pinnipeds:
    Arctocephalus gazella**...............  Antarctic Fur Seal..........      1.80      1.20      5.9       3.9
    Arctocephalus tropicalis**............  Amsterdam Island Fur Seal...      1.80      1.45      5.9       4.75
    Arctocephalus australis**.............  South American Fur Seal.....      1.88      1.42      6.2       4.7
    Arctocephalus pusillis**..............  Cape Fur Seal...............      2.73      1.83      8.96      6.0
    Callorhinus ursinus**.................  Northern Fur Seal...........      2.20      1.45      7.2       4.75
    Eumetopias jubatus**..................  Steller's Sea Lion..........      2.86      2.40      9.4       7.9
    Hydrurga leptonyx.....................  Leopard Seal................      2.90      3.30      9.5      10.8
    Mirounga angustirostris**.............  Northern Elephant Seal......      3.96      2.49     13.0       8.2
    Mirounga leonina**....................  Southern Elephant Seal......      4.67      2.50     15.3       8.2
    Odobenus rosmarus**...................  Walrus......................      3.15      2.60     10.3       8.5
    Otaria flavescens**...................  South American Sea Lion.....      2.40      2.00      7.9       6.6
    Phoca caspica.........................  Caspian Seal................      1.45      1.40      4.75      4.6
    Phoca fasciata........................  Ribbon Seal.................      1.75      1.68      5.7       5.5
    Phoca larga...........................  Harbor Seal.................      1.70      1.50      5.6       4.9
    Phoca vitulina........................  Habor Seal..................      1.70      1.50      5.6       4.9
    Zalophus californianus................  California Sea Lion.........      2.24      1.75      7.3       5.7
    Halichoerus grypus**..................  Grar Seal...................      2.30      1.95      7.5       6.4
    Phoca sibirica........................  Baikal Seal.................      1.70      1.85      5.6       6.1
    Phoca groenlandica....................  Harp Seal...................      1.85      1.85      6.1       6.1
    Leptonychotes weddelli**..............  Weddell Seal................      2.90      3.15      9.5      10.3
    Lobodon carcinophagus**...............  Crabeater Seal..............      2.21      2.21      7.3       7.3
    Ommatophoca rossi**...................  Ross Seal...................      1.99      2.13      6.5       7.0
Group II Pinnipeds:
    Erignathus barbatus...................  Bearded Seal................      2.33      2.33      7.6       7.6
    Phoca hispida.........................  Ringed Seal.................      1.35      1.30      4.4       4.3
    Cystophora cristata...................  Hooded Seal.................      2.60      2.00      8.5       6.6
----------------------------------------------------------------------------------------------------------------
Note. **Any Group I animals maintained together will be considered as Group II when the animals maintained
  together include two or more sexually mature males from species marked with a double asterisk (**) regardless
  of whether the sexually mature males from the same species.


------------------------------------------------------------------------
                                                         Average adult
                                                            length
             Species                  Common name    -------------------
                                                         In
                                                       meters    In feet
------------------------------------------------------------------------
Sirenia:
    Dugong dugong...............  Dugong............      3.35      11.0
    Trichechus manatus..........  West Indian             3.51      11.5
                                   Manatee.
    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

[[Page 99]]

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:
[GRAPHIC] [TIFF OMITTED] TC14NO91.010


When there are more than two Group I cetaceans housed in a primary 
enclosure pool, the additional volume of water required for each 
additional Group I cetacean in excess of two is based on the following 
formula:
[GRAPHIC] [TIFF OMITTED] TC14NO91.011


See Table I for required volumes.
    (ii) The minimum volume of water required for up to four Group II 
cetaceans is based upon the following formula:
[GRAPHIC] [TIFF OMITTED] TC14NO91.012


When there are more than four Group II cetaceans housed in a primary 
enclosure pool, the additional volume of water required for each 
additional Group II cetacean in excess of four is based on the following 
formula:

Volume = (Average Adult Length)\2\ x 3.14 x depth

See Table II for required volumes.

    (iii) When a mixture of both Group I and Group II cetaceans are 
housed together, the MHD must be satisfied as stated in Sec.  
3.104(b)(1), and the minimum depth must be satisfied as stated in Sec.  
3.104(b)(2). Based on these figures, the resulting volume must then be 
calculated
[GRAPHIC] [TIFF OMITTED] TC14NO91.013


Then the volume necessary for the cetaceans to be housed in the pool 
must be calculated (by obtaining the sum of the volumes required for 
each animal). If this volume is greater than that obtained by using the 
MHD and depth figures, then the additional volume required may be added 
by enlarging the pool in its lateral dimensions or by increasing its 
depth, or both. The minimum surface area requirements discussed next 
must also be satisfied.
    (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:
[GRAPHIC] [TIFF OMITTED] TC14NO91.014


[[Page 100]]



In a pool containing more than two Group I cetaceans or more than four 
Group II cetaceans,\9\ the additional surface area which may be required 
when animals are added must be calculated for each such animal.
---------------------------------------------------------------------------

    \9\ A pool containing up to two Group I cetaceans or up to four 
Group II cetaceans which meets the required MHD and depth will have the 
necessary surface area and volume required for the animals contained 
therein.
---------------------------------------------------------------------------

    (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.\10\ The larger of the two figures represents the 
surface area which is required for a pool housing a mixture of Group I 
and Group II cetaceans. Pool surfaces where the depth does not meet the 
minimum requirements cannot be used in determining the required surface 
area.
---------------------------------------------------------------------------

    \10\ Since the MHD represents the diameter of a circle, the surface 
area based on the MHD is calculated by use of the following formula:
    SA = [pi] x (MHD / 2)\2\.
---------------------------------------------------------------------------

    (iii) Surface area requirements are given in Table IV.

        Table IV--Minimum Surface Area Required for Each Cetacean
------------------------------------------------------------------------
    Average adult length of each        Surface area required for each
              cetacean                             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/9x0.8361.

    (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

[[Page 101]]

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:
(average adult length)\2\ of 1st Group I pinniped+(average adult 
          length)\2\ of 2nd Group I pinniped=Total DRA for two pinnipeds
    DRA for one pinniped=2x(average adult length of Group I pinniped)\2\
    (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.

Examples: DRA for 1 Group II Pinniped = [(Average adult length)\2\ x 
1.5] + [(Average adult length)\2\ x 1.4]

1st pinniped (avg. adult length)\2\x1.5=social and DRA required
2nd pinniped (avg. adult length)\2\x1.4=social and DRA required
3rd pinniped (avg. adult length)\1\x1.3=social and DRA required
4th pinniped (avg. adult length)\2\x1.2=social and DRA required
5th pinniped (avg. adult length)\2\x1.1=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)\2\x1.5] + [(8.5)\2\x1.4] 
+[(6.6)\2\x1.3] + [(6.6)\2\x1.2].

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.

[[Page 102]]

    (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       Resting area             Pool Volume
       sea otter        ------------------------------------------------
------------------------   Square      Square       Cubic
   Meters       Feet       meters       Feet       meters     Cubic feet
------------------------------------------------------------------------
      1.25         4.1        1.96        6.44        2.23        79.17
------------------------------------------------------------------------


[44 FR 36874, June 22, 1979, as amended at 45 FR 63261, Sept. 24, 1980; 
49 FR 26682, 26685, June 28, 1984; 49 FR 27922, July 9, 1984; 63 FR 2, 
Jan. 2, 1998; 63 FR 47148, Sept. 4, 1998; 66 FR 252, Jan. 3, 2001]

[[Page 103]]

                  Animal Health and Husbandry Standards



Sec.  3.105  Feeding.

    (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 [deg]C (0 [deg]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.

[66 FR 252, Jan. 3, 2001]



Sec.  3.106  Water quality.

    (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

[[Page 104]]

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. Rec ords must be kept documenting the time when all such 
samples were taken and the results of the sampling. Rec ords 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.



Sec.  3.107  Sanitation.

    (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 Sec.  
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 [deg]C, 180 [deg]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.

[66 FR 253, Jan. 3, 2001]



Sec.  3.108  Employees or attendants.

    (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

[[Page 105]]

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.

[66 FR 253, Jan. 3, 2001]



Sec.  3.109  Separation.

    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 Sec.  
3.104.

[66 FR 253, Jan. 3, 2001]



Sec.  3.110  Veterinary care.

    (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 it is determined that 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 Sec.  3.104. Holding facilities used only 
for medical treatment and medical training need not meet the minimum 
space requirements as outlined in Sec.  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.

[[Page 106]]

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.

[66 FR 253, Jan. 3, 2001]



Sec.  3.111  Swim-with-the-dolphin programs.

    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 Sec.  
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:
    [GRAPHIC] [TIFF OMITTED] TR04SE98.022
    

[[Page 107]]


    (ii) Three cetaceans:
    [GRAPHIC] [TIFF OMITTED] TR04SE98.023
    
    (iii) Additional SA for each animal in excess of three:
    [GRAPHIC] [TIFF OMITTED] TR04SE98.024
    
    (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:

Volume = SA x 9

    (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 Sec.  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 Sec.  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 
Sec.  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.

[[Page 108]]

    (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 \11\ 
regarding conditions and procedures for maintaining compliance with 
paragraph (e)(4) of this section; for the termination of a session when 
removal of a cetacean is not possible; and regarding criteria and 
protocols for handling program animal(s) exhibiting unsatisfactory, 
undesirable, or unsafe behaviors, including retraining time and 
techniques, and removal from the program and/or facility, if 
appropriate. The head trainer/behaviorist shall determine when 
operations will be terminated, and when they may resume. In the absence 
of the head trainer/behaviorist, the determination to terminate a 
session shall be made by the trainer/supervising attendant. Only the 
head trainer/behaviorist may determine when a session may be resumed.
---------------------------------------------------------------------------

    \11\ Send to Administrator, c/o Animal and Plant Health Inspection 
Service, Animal Care, 4700 River Road Unit 84, Riverdale, Maryland 
20737-1234.
---------------------------------------------------------------------------

    (f) Recordkeeping. (1) Each facility shall provide APHIS \12\ with a 
description of its program at least 30 days prior to initiation of the 
program, or in the case of any program in place before September 4, 
1998, not later than October 5, 1998. The description shall include at 
least the following:
---------------------------------------------------------------------------

    \12\ See footnote 11 in Sec.  3.111(e)(8).
---------------------------------------------------------------------------

    (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;

[[Page 109]]

    (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 \13\ on a semi-annual basis.
---------------------------------------------------------------------------

    \13\ See footnote 11 in Sec.  3.111(e)(8).
---------------------------------------------------------------------------

    (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.\14\ Within 7 days of any such 
incident, a written report shall be submitted to the Administrator.\15\ 
The report shall provide a detailed description of the incident and 
shall establish a plan of action for the prevention of further 
occurrences.
---------------------------------------------------------------------------

    \14\ Telephone numbers for APHIS, Animal Care, regional offices can 
be found in local telephone books.
    \15\ See footnote 11 in Sec.  3.111(e)(8).
---------------------------------------------------------------------------

    (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,\16\ length, axillary girth, appetite, and behavior. The 
attending veterinarian shall also conduct a general examination to 
evaluate body condition, skin, eyes, mouth, blow hole and cardio-
respiratory system, genitalia, and feces (gastrointestinal status). The 
examination shall also include a complete blood count and serum 
chemistry analysis. Fecal and blow hole smears shall be obtained for 
cytology and parasite evaluation.
---------------------------------------------------------------------------

    \16\ Weight may be measured either by scale or calculated using the 
following formulae:
    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

[[Page 110]]

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.

(Approved by the Office of Management and Budget under control numbers 
0579-0036 and 0579-0115)

[63 FR 47148, Sept. 4, 1998]

    Effective Date Note: At 64 FR 15920, Apr. 2, 1999, Sec.  3.111 was 
suspended, effective Apr. 2, 1999.

                        Transportation Standards



Sec.  3.112  Consignments to carriers and intermediate handlers.

    (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 Sec.  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 
Sec.  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.

[[Page 111]]

    (c) Carriers or intermediate handlers whose facilities fail to 
maintain a temperature within the range of 7.2 [deg]C (45 [deg]F) to 
23.9 [deg]C (75 [deg]F) allowed by Sec.  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 Sec. Sec.  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.

[66 FR 254, Jan. 3, 2001]



Sec.  3.113  Primary enclosures used to transport marine mammals.

    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

[[Page 112]]

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 Sec.  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.

[66 FR 255, Jan. 3, 2001]



Sec.  3.114  Primary conveyances (motor vehicle, rail, air and marine).

    (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

[[Page 113]]

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.

[66 FR 255, Jan. 3, 2001]



Sec.  3.115  Food and drinking water requirements.

    (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.

[66 FR 256, Jan. 3, 2001]



Sec.  3.116  Care in transit.

    (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 Sec.  Sec.  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

[[Page 114]]

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.

[66 FR 256, Jan. 3, 2001]



Sec.  3.117  Terminal facilities.

    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 Sec.  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 [deg]C (75 [deg]F) or higher. 
The air temperature around any marine mammal in any animal holding area 
must not be allowed to fall below 7.2 [deg]C (45 [deg]F). The air 
temperature around any polar bear must not be allowed to exceed 29.5 
[deg]C (85 [deg]F) at any time and no polar bear may be subjected to 
surrounding air temperatures that exceed 23.9 [deg]C (75 [deg]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).

[66 FR 256, Jan. 3, 2001]

[[Page 115]]



Sec.  3.118  Handling.

    (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 [deg]C (75 
[deg]F) unless accompanied by an acclimation certificate in accordance 
with Sec.  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 [deg]C (45 [deg]F) unless accompanied by an acclimation 
certificate in accordance with Sec.  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.

[66 FR 257, Jan. 3, 2001]



 Subpart F_Specifications for the Humane Handling, Care, Treatment, and 
 Transportation of Warmblooded Animals Other Than Dogs, Cats, Rabbits, 
      Hamsters, Guinea Pigs, Nonhuman Primates, and Marine Mammals

    Source: 36 FR 24925, Dec. 24, 1971, unless otherwise noted. 
Redesignated at 44 FR 36874, July 22, 1979.

                   Facilities and Operating Standards



Sec.  3.125  Facilities, general.

    (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

[[Page 116]]

sinks, shall be provided to maintain cleanliness among animal 
caretakers.

[36 FR 24925, Dec. 24, 1971. Redesignated at 44 FR 36874, June 22, 1979, 
and amended at 44 FR 63492, Nov. 2, 1979]



Sec.  3.126  Facilities, indoor.

    (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.



Sec.  3.127  Facilities, outdoor.

    (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

[[Page 117]]

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 farm 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.

[36 FR 24925, Dec. 24, 1971. Redesignated at 44 FR 36874, July 22, 1979, 
as amended at 64 FR 56147, Oct. 18, 1999; 65 FR 70770, Nov. 28, 2000]



Sec.  3.128  Space requirements.

    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.

                  Animal Health and Husbandry Standards



Sec.  3.129  Feeding.

    (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.



Sec.  3.130  Watering.

    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.



Sec.  3.131  Sanitation.

    (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,

[[Page 118]]

ectoparasites, and avian and mammalian pests shall be established and 
maintained.



Sec.  3.132  Employees.

    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.



Sec.  3.133  Separation.

    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.



Sec. Sec.  3.134-3.135  [Reserved]

                        Transportation Standards

    Source: Sections 3.136 through 3.142 appear at 42 FR 31569, June 21, 
1977, unless otherwise noted. Redesignated at 44 FR 36874, July 22, 
1979.



Sec.  3.136  Consignments to carriers and intermediate handlers.

    (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 Sec.  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 Sec.  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 Sec. Sec.  3.141 and 3.142. A copy

[[Page 119]]

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 [deg]C. (45 [deg]F.)''); 
and
    (4) The signature of the USDA accredited veterinarian, assigned 
accrediation 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.

[42 FR 31569, June 21, 1977, as amended at 43 FR 21166, May 16, 1978. 
Redesignated at 44 FR 36874, July 22, 1979, and amended at 44 FR 63493, 
Nov. 2, 1979]



Sec.  3.137  Primary enclosures used to transport live animals.

    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 opernings 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

[[Page 120]]

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 Sec.  3.131 of 
the standards, if previously used. Such primary enclosures shall contain 
clean litter of a suitable absorbant 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.

[42 FR 31569, June 21, 1977, as amended at 43 FR 21166, May 16, 1978. 
Redesignated at 44 FR 36874, July 22, 1979]



Sec.  3.138  Primary conveyances (motor vehicle, rail, air, and marine).

    (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.



Sec.  3.139  Food and water requirements.

    (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,

[[Page 121]]

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.



Sec.  3.140  Care in transit.

    (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.



Sec.  3.141  Terminal facilities.

    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 Sec.  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

[[Page 122]]

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[deg]C. (75.[deg]F.) or higher. The air temperature around any live 
animal in any animal holding area shall not be allowed to fall below 
7.2[deg]C. (45[deg]F.) nor be allowed to exceed 29.5[deg]C. (85[deg]F.) 
at any time: Provided, however, That no live animal shall be subjected 
to surrounding air temperatures which exceed 23.9[deg]C. (75[deg]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.

[43 FR 56217, Dec. 1, 1978. Redesignated at 44 FR 36874, July 22, 1979]



Sec.  3.142  Handling.

    (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[deg]C. (85[deg]F.), and which shall be measured and read in the 
manner prescribed in Sec.  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[deg]C. (50[deg]F.) and such live animals shall not be 
subjected to surrounding air temperatures which fall below 7.2[deg]C. 
(45[deg]F.), and which shall be measured and read in the manner 
prescribed in Sec.  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 Sec.  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.

[43 FR 21167, May 16, 1978, as amended at 43 FR 56217, Dec. 1, 1978. 
Redesignated at 44 FR 36874, July 22, 1979]



PART 4_RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE ANIMAL 
WELFARE ACT--Table of Contents




                            Subpart A_General

Sec.
4.1 Scope and applicability of rules of practice.

                Subpart B_Supplemental Rules of Practice

4.10 Summary action.
4.11 Stipulations.

    Authority: 7 U.S.C. 2149 and 2151; 7 CFR 2.22, 2.80, and 371.7.

    Source: 42 FR 10959, Feb. 25, 1977, unless otherwise noted.



                            Subpart A_General



Sec.  4.1  Scope and applicability of rules of practice.

    The Uniform Rules of Practice for the Department of Agriculture 
promulgated in subpart H of part 1, subtitle A,

[[Page 123]]

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.



                Subpart B_Supplemental Rules of Practice



Sec.  4.10  Summary action.

    (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 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 Sec.  4.10(b), upon written 
notification given to such person of the suspension of his license 
pursuant to Sec.  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 Sec.  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.



Sec.  4.11  Stipulations.

    (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 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.



PART 11_HORSE PROTECTION REGULATIONS--Table of Contents




Sec.
11.1 Definitions.
11.2 Prohibitions concerning exhibitors.
11.3 Scar rule.
11.4 Inspection and detention of horses.
11.5 Access to premises and records.
11.6 Inspection space and facility requirements.
11.7 Certification and licensing of designated qualified persons 
          (DQP's).
11.20 Responsibilities and liabilities of managment.
11.21 Inspection procedures for designated qualified persons (DQP's).
11.22 Records required and disposition thereof.
11.23 Inspection of records.
11.24 Reporting by management.
11.40 Prohibitions and requirements concerning persons involved in 
          transportation of certain horses.
11.41 Reporting required of horse industry organizations or 
          associations.

    Authority: 15 U.S.C. 1823-1825 and 1828; 7 CFR 2.22, 2.80, and 
371.7.

    Source: 44 FR 25179, Apr. 27, 1979, unless otherwise noted.



Sec.  11.1  Definitions.

    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

[[Page 124]]

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 Sec.  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

[[Page 125]]

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.\1\
---------------------------------------------------------------------------

    \1\ Information as to the name and address of the Regional Director 
for the State or States concerned can be obtained by writing to the 
Animal and Plant Health Inspection Service, Animal Care, 4700 River Road 
Unit 84, Riverdale, MD 20737-1234.
---------------------------------------------------------------------------

    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.

[44 FR 1561, Jan. 5, 1979, as amended at 53 FR 14782, Apr. 26, 1988; 53 
FR 28372, July 28, 1988; 56 FR 13749, Apr. 4, 1991; 59 FR 67612, Dec. 
30, 1994; 63 FR 62927, Nov. 10, 1998]



Sec.  11.2  Prohibitions concerning exhibitors.

    (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.

[[Page 126]]

    (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 accomplsihed 
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 \3/4\ inch in length. That portion of caulk at the rear of 
a horseshoe in excess of \3/4\ of an inch shall be added to the height 
of the heel in determining the heel/toe ratio.
    (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\1/2\ inches back from the point of 
the toe, or which would cause, or could reasonably be expected to cause, 
an unsteadiness of stance in the horse with resulting muscle and tendon 
strain due to the horse's weight and balance being focused upon a small 
fulcrum point.\2\
---------------------------------------------------------------------------

    \2\ This prohibition is not intended to disallow corrective devices, 
such as Memphis bars which consist of a metal bar(s) crossing from the 
ground surface of one side of the horseshoe to the ground surface of the 
other side of the horseshoe, and the purpose of which is to correct a 
lameness or pathological condition of the foot: Provided, That such 
metal bar(s) do not act as a single fulcrum point so as to affect the 
balance of the horse.
---------------------------------------------------------------------------

    (15) Metal hoof bands, such as used to anchor or strengthen pads and 
shoes, placed less than \1/2\ inch below the coronet band.

[[Page 127]]

    (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.

[44 FR 25179, Apr. 27, 1979, as amended at 53 FR 14782, Apr. 26, 1988, 
53 FR 15641, May 2, 1988, 53 FR 28372, July 28, 1988, 53 FR 41562, Oct. 
24, 1988, 53 FR 45854, Nov. 14, 1988; 54 FR 7178, Feb. 17, 1989]



Sec.  11.3  Scar rule.

    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:

[[Page 128]]

    (a) The anterior and anterior-lateral surfaces of the fore pasterns 
(extensor surface) must be free of bilateral granulomas,\5\ other 
bilateral pathological evidence of inflammation, and, other bilateral 
evidence of abuse indicative of soring including, but not limited to, 
excessive loss of hair.
---------------------------------------------------------------------------

    \3-4\ [Reserved]
    \5\ Granuloma is defined as any one of a rather large group of 
fairly distinctive focal lesions that are formed as a result of 
inflammatory reactions caused by biological, chemical, or physical 
agents.
---------------------------------------------------------------------------

    (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.

[44 FR 25179, Apr. 27, 1979, as amended at 53 FR 14782, Apr. 26, 1988, 
53 FR 28373, July 28, 1988]



Sec.  11.4  Inspection and detention of horses.

    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.

[[Page 129]]

    (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]

[44 FR 25179, Apr. 27, 1979, as amended at 56 FR 13750, Apr. 4, 1991]



Sec.  11.5  Access to premises and records.

    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

[[Page 130]]

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.

[44 FR 25179, Apr. 27, 1979, as amended at 56 FR 13750, Apr. 4, 1991]



Sec.  11.6  Inspection space and facility requirements.

    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.

[44 FR 25181, Apr. 27, 1979, as amended at 56 FR 13750, Apr. 4, 1991]



Sec.  11.7  Certification and licensing of designated qualified persons (DQP's).

    (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:

[[Page 131]]

    (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 \6\ a formal request in writing for 
certification of its DQP program and a detailed outline of such program 
for Department approval. Such outline shall include the organizational 
structure of such organization or association and the names of the 
officers or persons charged with the management of the organization or 
association. The outline shall also contain at least the following:
---------------------------------------------------------------------------

    \6\ Animal and Plant Health Inspection Service, Animal Care, 4700 
River Road, Unit 84, Riverdale, Maryland 20737-1234.
---------------------------------------------------------------------------

    (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.\6\
    (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 \6\ in writing at least 30 days prior to such course.
    (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.\6\
    (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

[[Page 132]]

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.\6\ 
Notification of the actual date, time, duration, subject matter, and 
geographic location of such clinics or seminars must be sent to the 
Administrator \6\ at least 10 days prior to each such clinic or seminar.
    (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.

The horse industry organizations or associations that have formally 
requested Department certification of their DQP training, enforcement, 
and maintenance program will receive a formal notice of certification 
from the Department, or the reasons, in writing, why certification of 
such program cannot be approved. A current list of certified DQP 
programs and licensed DQP's will be published in the Federal Register at 
least once each year, and as may be further required for the purpose of 
deleting programs and names of DQP's that are no longer certified or 
licensed, and of adding the names of programs and DQP's that have been 
certified or licensed subsequent to the publication of the previous 
list.
    (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 \6\ of names and addresses 
including street address or post office box and zip code, of all DQP's 
that have successfully completed the certified DQP program and have been 
licensed under the Act and regulations by such horse industry 
organization or association;
---------------------------------------------------------------------------

    \6\ See footnote 6 to this section.
---------------------------------------------------------------------------

    (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

[[Page 133]]

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.

Copies of the above records shall be submitted by the involved DQP to 
the horse industry organization or association that has licensed said 
DQP within 72 hours after the horse show, horse exhibition, horse sale, 
or horse auction is over.
    (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 rec ords 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

[[Page 134]]

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 pruchase 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,

[[Page 135]]

and inspection under the Act, after notice and opportunity for a 
hearing,\7\ when the Secretary finds that such person is unfit to 
perform such diagnosis, detection, or inspection because he has failed 
to perform his duties in accordance with the Act or regulations, or 
because he has been convicted of a violation of any provision of the Act 
or regulations occurring after July 13, 1976, or has paid any fine or 
civil penalty in settlement of any proceeding regarding a violation of 
the Act or regulations occurring after July 13, 1976.
---------------------------------------------------------------------------

    \7\ Hearing would be in accordance with the Uniform Rules of 
Practice for the Department of Agriculture in subpart H of part 1, 
subtitle A, title 7, Code of Federal Regulations (7 CFR 1.130 et seq.)
---------------------------------------------------------------------------

    (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 Sec.  
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,\7\ that there is sufficient 
cause for the committee's determination regarding license cancellation, 
he shall issue a decision sustaining such determination. If he does not 
find that there was sufficient cause to cancel the license, the 
licensing organization or association shall reinstate the license.
    (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 section, 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\6\ in writing within 30 days after the date of such 
revocation and, if requested, shall be afforded an opportunity for a 
hearing.\7\ All DQP licenses issued by a horse industry organization or 
association whose DQP program certification has been revoked shall 
expire 30 days after the date of such revocation, or 15 days after the 
date the revocation becomes final after appeal, unless they

[[Page 136]]

are transferred to a horse industry organization or association having a 
program currently certified by the Department.
---------------------------------------------------------------------------

    \6-7\ See previous footnotes 6 and 7.

(Approved by the Office of Management and Budget under control number 
---------------------------------------------------------------------------
0579-0056)

[44 FR 1563, Jan. 5, 1979, as amended at 44 FR 25182, Apr. 27, 1979; 48 
FR 57471, Dec. 30, 1983; 55 FR 41993, Oct. 17, 1990; 56 FR 13750, Apr. 
4, 1991; 59 FR 67612, Dec. 30, 1994; 63 FR 62927, Nov. 10, 1998]



Sec.  11.20  Responsibilities and liabilities of management.

    (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.\8\ However, management should immediately 
notify, in writing, the Department \6\ and the organization or 
association that licensed the DQP, as to why the performance of said DQP 
was inadequate or otherwise unsatisfactory. Management which designates 
and appoints a DQP shall immediately disqualify or disallow from being 
shown, exhibited, sold, or auctioned any horse identified by the DQP to 
be sore or otherwise in violation of the Act or regulations or any horse 
otherwise known by management to be sore or in violation of the Act or 
regulations. Should management fail to disqualify or disallow from being 
shown, exhibited, sold or auctioned any such horse, said management 
shall assume full responsibility for and liabilities arising from the 
showing, exhibition, sale, or auction of said horses.
---------------------------------------------------------------------------

    \8\ The duration of the show, exhibition, or sale or auction.
---------------------------------------------------------------------------

    (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.

[[Page 137]]

Such physical examination shall be conducted in accordance with the 
inspection procedures provided for in Sec.  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 exhibitioin 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.

(Approved by the Office of Management and Budget under control number 
0579-0056)

[44 FR 25182, Apr. 27, 1979, as amended at 48 FR 57471, Dec. 30, 1983; 
55 FR 41993, Oct. 17, 1990; 56 FR 13750, Apr. 4, 1991; 57 FR 62175, Dec. 
30, 1992]



Sec.  11.21  Inspection procedures for designated qualified persons (DQP's).

    (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 
Sec.  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 Sec.  11.2(a) through Sec.  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

[[Page 138]]

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 certified DQP organization shall assess appropriate 
penalties for violations, as set forth in the rule book of the certified 
program under which the DQP is licensed, or as set forth by the 
Department, and shall report all violations, in accordance with Sec.  
11.20(b)(3) of this part.

[55 FR 41993, Oct. 17, 1990; as amended at 56 FR 13750, Apr. 4, 1991; 57 
FR 62175, Dec. 30, 1992]



Sec.  11.22  Records required and disposition thereof.

    (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 Sec.  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 rec ords 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.

(Approved by the Office of Management and Budget under control numbers 
0579-0056, and 0579-0058)

(44 U.S.C. 3506)

[44 FR 25179, Apr. 27, 1979, as amended at 48 FR 57471, Dec. 30, 1983. 
Redesignated at 55 FR 41993, Oct. 17, 1990; 56 FR 13750, Apr. 4, 1991]



Sec.  11.23  Inspection of records.

    (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

[[Page 139]]

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 
rec ords 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.

[44 FR 25179, Apr. 27, 1979. Redesignated at 55 FR 41993, Oct. 17, 1990, 
as amended at 56 FR 13750, Apr. 4, 1991]



Sec.  11.24  Reporting by management.

    (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\1\ for the State in 
which the show, exhibition, sale or auction was held, the information 
required by Sec.  11.22(a)(1) through (6) for each horse excused or 
disqualified by management or its representatives from being shown, 
exhibited, sold or auctioned, and the reasons for such action. If no 
horses are excused or disqualified, the management shall submit a report 
so stating.
---------------------------------------------------------------------------

    \1\ See footnote 1 to Sec.  11.1.
---------------------------------------------------------------------------

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0056)

[44 FR 25179, Apr. 27, 1979, as amended at 48 FR 57471, Dec. 30, 1983; 
55 FR 41994, Oct. 17, 1990; 56 FR 13750, Apr. 4, 1991; 63 FR 62927, Nov. 
10, 1998]



Sec.  11.40  Prohibitions and requirements concerning persons involved 
in transportation of certain horses.

    (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 Sec.  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]

(Approved by the Office of Management and Budget under control number 
0579-0056)

[44 FR 25179, Apr. 27, 1979, as amended at 48 FR 57471, Dec. 30, 1983; 
56 FR 13750, Apr. 4, 1991]



Sec.  11.41  Reporting required of horse industry organizations or 
associations.

    Each horse industry organization or association which sponsors, or 
which sanctions any horse show, horse exhibition, or horse sale or 
auction, shall

[[Page 140]]

furnish the Department\6\ by March 1 of each year with all such 
organization or association rulebooks, and disciplinary procedures for 
the previous year pertaining to violations of the Horse Protection Act 
or regulations, applicable to such horse show, horse exhibition, or 
horse sale or auction. Rulebooks and information relating to 
disciplinary procedures for violations of the Horse Protection Act or 
regulations should be readily available to all exhibitors, trainers, and 
owners of horses at such show, exhibition, sale, or auction. Each horse 
industry organization or association shall furnish the Department\6\ 
with a quarterly report of all disciplinary actions taken against the 
management or any horse show, horse exhibition, horse sale, or horse 
auction, any exhibitor, or any licensed DQP, for violation of the Horse 
Protection Act or regulations, and the results thereof.
---------------------------------------------------------------------------

    \6\ See footnote 6 to Sec.  11.7.

(Approved by the Office of Management and Budget under control number 
---------------------------------------------------------------------------
0579-0056)

[44 FR 25179, Apr. 27, 1979, as amended at 48 FR 57471, Dec. 30, 1983]



PART 12_RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE HORSE 
PROTECTION ACT--Table of Contents




                            Subpart A_General

Sec.
12.1 Scope and applicability of rules of practice.

                Subpart B_Supplemental Rules of Practice

12.10 Stipulations.

    Authority: 15 U.S.C. 1825 and 1828; 7 CFR 2.22, 2.80, and 371.7.



                            Subpart A_General



Sec.  12.1  Scope and applicability of rules of practice.

    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.

[42 FR 10959, Feb. 25, 1977, as amended at 68 FR 6342, Feb. 7, 2003]



                Subpart B_Supplemental Rules of Practice



Sec.  12.10  Stipulations.

    (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.

[42 FR 10960, Feb. 25, 1977, as amended at 68 FR 6342, Feb. 7, 2003]

[[Page 141]]



SUBCHAPTER B_COOPERATIVE CONTROL AND ERADICATION OF LIVESTOCK OR POULTRY 
                                DISEASES





PART 49_RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER CERTAIN 
ACTS--Table of Contents




                            Subpart A_General

Sec.
49.1 Scope and applicability of rules of practice.

                Subpart B_Supplemental Rules of Practice

49.10 Stipulations.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 48 FR 30094, June 30, 1983, unless otherwise noted.



                            Subpart A_General



Sec.  49.1  Scope and applicability of rules of practice.

    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:

Act of May 29, 1884, commonly known as the Animal Industry Act, section 
7, as amended (21 U.S.C. 117),
Act of February 2, 1903, commonly known as the Cattle Contagious 
Diseases Act of 1903, section 3, as amended (21 U.S.C. 122),
Act of March 3, 1905, Section 6, as amended (21 U.S.C. 127),
Act of July 2, 1962, section 6(a), as amended (21 U.S.C. 134e).
The Animal Health Protection Act (7 U.S.C. 8301 et seq.)


In addition, the Supplemental Rules of Practice set forth in subpart B 
of this part shall be applicable to such proceedings.

[48 FR 30094, June 30, 1983, as amended at 68 FR 6342, Feb. 7, 2003]



                Subpart B_Supplemental Rules of Practice



Sec.  49.10  Stipulations.

    (a) At any time prior to the issuance of a complaint seeking a civil 
penalty under any of the Acts listed in Sec.  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.



PART 50_ANIMALS DESTROYED BECAUSE OF TUBERCULOSIS--Table of Contents




Sec.
50.1 Definitions.

                       Subpart A_General Indemnity

50.2 Applicability of this subpart; cooperation with States.
50.3 Payment to owners for animals destroyed.
50.4 Classification of cattle, bison, captive cervids, and other 
          livestock as infected, exposed, or suspect.
50.5 Record of tests.
50.6 Identification of animals to be destroyed because of tuberculosis.
50.7 Destruction of animals.
50.8 Payment of expenses for transporting and disposing of infected, 
          exposed, and suspect animals.
50.9 Appraisals.
50.10 Report of appraisals.

[[Page 142]]

50.11 Report of salvage proceeds.
50.12 Claims for indemnity.
50.13 Disinfection of premises, conveyances, and materials.
50.14 Claims not allowed.
50.15-50.16 [Reserved]

   Subpart B_Dairy Cattle and Facilities in the El Paso, Texas, Region

50.17 Payment.
50.18 Identification and disposal of cattle.
50.19 Report of salvage proceeds.
50.20 Claims for payment.
50.21 Schedule of payments.
50.22 Claims not allowed.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 40 FR 27009, June 26, 1975, unless otherwise noted.



Sec.  50.1  Definitions.

    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

[[Page 143]]

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 Sec.  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.

[40 FR 27009, June 26, 1975, as amended at 45 FR 32287, May 16, 1980; 51 
FR 33735, Sept. 23, 1986; 52 FR 1317, Jan. 13, 1987; 52 FR 39614, Oct. 
23, 1987; 56 FR 36998, Aug. 2, 1991; 58 FR 34698, June 29, 1993; 60 FR 
37808, July 24, 1995; 63 FR 34263, June 24, 1998; 63 FR 72122, Dec. 31, 
1998; 67 FR 7590, Feb. 20, 2002; 67 FR 48750, July 26, 2002]



                       Subpart A_General Indemnity



Sec.  50.2  Applicability of this subpart; cooperation with States.

    (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.

[67 FR 48751, July 26, 2002]



Sec.  50.3  Payment to owners for animals destroyed.

    (a) The Administrator is authorized to agree on the part of the 
Department to pay indemnity to owners of the following animals:

[[Page 144]]

    (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 Sec.  
50.9. Additionally, the Department will in no case pay more than $3,000 
for an animal that is destroyed.

[67 FR 7591, Feb. 20, 2002]



Sec.  50.4  Classification of cattle, bison, captive cervids, and 
other livestock as infected, exposed, or suspect.

    (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.

[40 FR 27009, June 26, 1975, as amended at 52 FR 39614, Oct. 23, 1987; 
56 FR 36998, Aug. 2, 1991; 60 FR 37809, July 24, 1995; 63 FR 34264, June 
24, 1998; 67 FR 7591, Feb. 20, 2002]



Sec.  50.5  Record of tests.

    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.

[40 FR 27009, June 26, 1975, as amended at 52 FR 39614, Oct. 23, 1987; 
56 FR 36998, Aug. 2, 1991; 60 FR 37809, July 24, 1995; 63 FR 34264, June 
24, 1998]



Sec.  50.6  Identification of animals to be destroyed because of 
tuberculosis.

    (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

[[Page 145]]

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 Sec.  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.

[67 FR 7591, Feb. 20, 2002]



Sec.  50.7  Destruction of animals.

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[40 FR 27009, June 26, 1975, as amended at 45 FR 32287, May 16, 1980; 52 
FR 39614, Oct. 23, 1987; 56 FR 36998, Aug. 2, 1991; 60 FR 37809, July 
24, 1995; 63 FR 34264, June 24, 1998; 67 FR 7591, Feb. 20, 2002]

[[Page 146]]



Sec.  50.8  Payment of expenses for transporting and disposing of 
infected, exposed, and suspect animals.

    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.

[62 FR 49592, Sept. 23, 1997; as amended at 63 FR 34264, June 24, 1998; 
67 FR 7591, Feb. 20, 2002]



Sec.  50.9  Appraisals.

    (a) Livestock to be destroyed because of tuberculosis under Sec.  
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.

[67 FR 7591, Feb. 20, 2002]



Sec.  50.10  Report of appraisals.

    Appraisals of livestock made in accordance with Sec.  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.

[40 FR 27009, June 26, 1975, as amended at 52 FR 39614, Oct. 23, 1987; 
56 FR 36998, Aug. 2, 1991; 60 FR 37809, July 24, 1995; 63 FR 34264, June 
24, 1998; 67 FR 7592, Feb. 20, 2002]



Sec.  50.11  Report of salvage proceeds.

    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 Sec.  
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

[[Page 147]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0001)

[40 FR 27009, June 26, 1975, as amended at 48 FR FR 57471, Dec. 30, 
1983; 52 FR 39614, Oct. 23, 1987; 56 FR 36998, Aug. 2, 1991; 60 FR 
37809, July 24, 1995; 63 FR 34264, June 24, 1998; 67 FR 7592, Feb. 20, 
2002]



Sec.  50.12  Claims for indemnity.

    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 Sec.  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.

[40 FR 27009, June 26, 1975, as amended at 52 FR 39614, Oct. 23, 1987; 
56 FR 36998, Aug. 2, 1991; 60 FR 37809, July 24, 1995; 63 FR 34264, June 
24, 1998; 67 FR 7592, Feb. 20, 2002]



Sec.  50.13  Disinfection of premises, conveyances, and materials.

    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.

[40 FR 27009, June 26, 1975, as amended at 52 FR 39614, Oct. 23, 1987; 
60 FR 37809, July 24, 1995; 67 FR 7592, Feb. 20, 2002]



Sec.  50.14  Claims not allowed.

    Claims for compensation for livestock destroyed because of 
tuberculosis will not be allowed in any of the following cases:

[[Page 148]]

    (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 Sec.  77.1 of this 
chapter; or
    (2)(i) Be from a herd that tested negative to an official tuberculin 
test, as defined in Sec.  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 Sec.  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.

[67 FR 7592, Feb. 20, 2002]



Sec. Sec.  50.15-50.16  [Reserved]



   Subpart B_Dairy Cattle and Facilities in the El Paso, Texas, Region

    Source: 67 FR 48751, July 26, 2002, unless otherwise noted.



Sec.  50.17  Payment.

    (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

[[Page 149]]

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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0193)

[67 FR 48751, July 26, 2002, as amended at 68 FR 10361, Apr. 4, 2003]



Sec.  50.18  Identification and disposal of cattle.

    (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

[[Page 150]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0193)



Sec.  50.19  Report of salvage proceeds.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0193)



Sec.  50.20  Claims for payment.

    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.\3\ On the claim form, the owner 
must certify that the animals or other property are, or are not, subject 
to any mortgage. If the owner states that there is a mortgage, the claim 
form must be signed by the owner and by each person holding a mortgage 
on the cattle or other property, who must agree that the person 
specified on the claim form may receive any payment due. The APHIS 
veterinarian in charge or the official designated by him or her will 
record on the claim form the amount of payment that appears to be due to 
the owner, and the owner will be furnished a copy of the APHIS payment 
claim form. The veterinarian in charge or official designated by him or 
her will then forward the APHIS payment claim form to the appropriate 
APHIS official for further action on the claim. The Department will not 
pay any costs arising from the holding of the cattle pending slaughter, 
or for trucking and other transportation costs, yardage, commission, 
slaughtering charges, or for any other costs related to having the 
cattle slaughtered. The owner of the reverse osmosis plant must submit 
copies of

[[Page 151]]

the relevant documentation for relocation of equipment to the 
veterinarian in charge.

(Approved by the Office of Management and Budget under control number 
0579-0193)



Sec.  50.21  Schedule of payments.
---------------------------------------------------------------------------

    \3\ Claim forms may obtained from the veterinarian in charge. The 
location of the veterinarian in charge may be obtained by writing to 
National Animal Health Program VS, APHIS, 4700 River Road Unit 43, 
Riverdale, MD 20737, or by referring to the local telephone book.
---------------------------------------------------------------------------

    (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 Sec.  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.



Sec.  50.22  Claims not allowed.

    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.



PART 51_ANIMALS DESTROYED BECAUSE OF BRUCELLOSIS--Table of Contents




Sec.
51.1 Definitions.
51.2 Cooperation with States.
51.3 Payment to owners for animals destroyed.
51.4 Record of tests.
51.5 Identification of animals to be destroyed because of brucellosis.
51.6 Destruction of animals; time limit for destruction of animals.
51.7 Claims for indemnity.
51.8 Disinfection of premises, conveyances, and materials.
51.9 Claims not allowed.
51.10 Part 53 of this chapter not applicable.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.



Sec.  51.1  Definitions.

    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.

[[Page 152]]

    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 Sec.  78.1 of 
this chapter.
    Claimant. A person who files a claim for indemnity under Sec.  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 Sec.  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 Part 
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.

[[Page 153]]

    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.\1\
---------------------------------------------------------------------------

    \1\ A list of recognized slaughtering establishments is available 
upon request from the Animal and Plant Health Inspection Service, 4700 
River Road Unit 37, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    Registered breed association. An association formed and perpetuated 
for the maintenance of records of pure breeding 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 Asssociation, 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\3\ Cattle Company, National Beefmaster Association, North 
American Limousin Foundation, Pan American Zebu Association, Red and 
White Dairy Cattle Association, Red Angus Association of America, Red 
Poll Beef Breeders International, Red Poll Cattle Club of America, Santa 
Gertrudis Breeders International, Simbrah Association, South Devon Breed 
Society, Sussex Cattle Association of America, Texas Longhorn Breeders 
Association of America, and White Park Cattle Association of America.
    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

[[Page 154]]

accordance with Sec.  71.20 of this chapter, for assembling cattle or 
bison for sale.\2\
---------------------------------------------------------------------------

    \2\ Notices containing lists of specifically approved stockyards are 
published in the Federal Register. Lists of specifically approved 
stockyards also may be obtained from the State animal health official, 
State representatives, or APHIS representatives.
---------------------------------------------------------------------------

    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 Sec.  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 offical animal health work of the Animal and Plant Health 
Inspection Service, in the State concerned.

[42 FR 64336, Dec. 23, 1977]

    Editorial Note: For Federal Register citations affecting Sec.  51.1, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



Sec.  51.2  Cooperation with States.

    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.

[42 FR 64336, Dec. 23, 1977, as amended at 54 FR 32435, Aug. 8, 1989]



Sec.  51.3  Payment to owners for animals destroyed.

    (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.\3\ In 
all cases, the amount of Federal indemnity will be determined in 
accordance with the regulations in this part that were in effect on the 
date that reactors were found or the date that whole-herd depopulation 
or destruction of individual animals was approved. Prior to payment of 
indemnity, proof of destruction \4\ must be furnished to the 
Veterinarian in Charge.
---------------------------------------------------------------------------

    \3\ The Administrator shall authorize payment of Federal indemnity 
by the U.S. Department of Agriculture at the maximum per-head rates in 
Sec.  51.3: (a) As long as sufficient funds appropriated by Congress 
appear to be available for this purpose for the remainder of the fiscal 
year; (b) in States or areas not under Federal quarantine; (c) in States 
requesting payment of Federal indemnity; and (d) in States not 
requesting a lower rate.
    \4\ The Veterinarian in Charge shall 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 animal; (d) a written, sworn 
statement by the owner or caretaker of the animal attesting to the 
destruction of the animal; (e) a permit (VS Form 1-27) consigning the 
animal from a farm or livestock market directly to a recognized 
slaughtering establishment; or (f) in unique situations where the 
documents listed above are not available, other similarly reliable forms 
of proof of destruction.
---------------------------------------------------------------------------

    (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

[[Page 155]]

    (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 Sec.  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 Sec.  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.\3\ The method chosen must be used for all animals to be 
destroyed. Owners have the option of having an appraisal done prior to 
choosing the method used. Appraisals will be conducted by an independent 
appraiser selected by the Administrator. The cost of the appraisals will 
be borne by APHIS.
    (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 \3\ the payment of Federal indemnity by the United States 
Department of Agriculture to an owner whose breeding swine are destroyed 
as brucellosis reactors. The indemnity shall not exceed $25 per head for 
registered, inbred, or hybrid swine, or $10 per head for all other 
breeding swine. Prior to payment of indemnity, proof of destruction \4\ 
shall be furnished to the Veterinarian in Charge.
    (2) Herd depopulation. The Administrator may authorize \3\ the 
payment of Federal indemnity by the United States Department of 
Agriculture to an owner whose herd of breeding swine or whose whole herd 
is destroyed because of brucellosis. The indemnity shall not exceed $150 
per head for registered, inbred, or hybrid breeding swine, and $65 per 
head for all other breeding swine, except that in the case of whole herd 
depopulation, indemnity payments shall be paid on all swine in the herd 
at fair market value, as determined by the Administrator, based on an 
appraisal conducted by an independent appraiser assigned by the 
Administrator. In cases where indemnity is paid for whole herd 
depopulation, indemnity payments, plus any salvage, must not exceed the 
appraised value of each animal. Indemnity payment shall be made only for 
brucellosis exposed swine or for swine from a herd known to be affected 
and only when the Administrator determines that the destruction of all 
swine in the herd will contribute to the Brucellosis Eradication 
Program. Prior to payment of indemnity, proof of destruction \4\ shall 
be furnished to the Veterinarian in Charge.
    (3) Exposed swine. The Administrator may authorize \3\ the payment 
of Federal indemnity by the United States Department of Agriculture to 
an owner whose breeding swine are destroyed because of brucellosis. The 
indemnity shall not exceed $150 per head for registered, inbred, or 
hybrid swine, or $65 per head for all other breeding swine. Indemnity 
payment shall be made only

[[Page 156]]

for such brucellosis exposed swine and only when the Administrator 
determines that the destruction of such swine will contribute to the 
Brucellosis Eradication Program. Prior to payment of indemnity, proof of 
destruction \4\ shall be furnished to the Veterinarian in Charge.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[42 FR 64336, Dec. 23, 1977, as amended at 45 FR 43679, June 27, 1980; 
46 FR 13673, Feb. 23, 1981; 46 FR 57027, Nov. 20, 1981; 47 FR 53323, 
Nov. 26, 1982; 48 FR 57472, Dec. 30, 1983; 50 FR 11993, Mar. 27, 1985; 
51 FR 11300, Apr. 2, 1986; 54 FR 32435, Aug. 8, 1989; 56 FR 18505, 
18506, Apr. 23, 1991; 57 FR 49376, Nov. 2, 1992; 57 FR 60086, Dec. 18, 
1992; 59 FR 12533, Mar. 17, 1994, 59 FR 21635, Apr. 26, 1994; 59 FR 
52235, Oct. 17, 1994; 63 FR 15284, Mar. 31, 1998; 63 FR 47423, Sept. 8, 
1998]



Sec.  51.4  Record of tests.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[42 FR 64336, Dec. 23, 1977, as amended at 48 FR 57472, Dec. 30, 1983; 
54 FR 32435, Aug. 8, 1989; 56 FR 18506, Apr. 23, 1991]



Sec.  51.5  Identification of animals to be destroyed because of brucellosis.

    (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 Sec.  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

[[Page 157]]

by the Administrator, upon request in specific cases, attached to the 
left ear of each animal.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[42 FR 64336, Dec. 23, 1977, as amended at 47 FR 53324, Nov. 26, 1982; 
48 FR 57472, Dec. 30, 1983; 50 FR 11993, Mar. 27, 1985; 54 FR 32435, 
Aug. 8, 1989; 56 FR 18506, Apr. 23, 1991; 60 FR 48367, Sept. 19, 1995]



Sec.  51.6  Destruction of animals; time limit for destruction of animals.

    (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; \5\ except that in the case of indemnity for whole herd 
depopulation, as provided for in Sec.  51.3, swine shall be destroyed, 
if possible, on the premises where the animals are held or penned at the 
time the indemnity is approved, or may be moved for destruction to 
another location when movement to the location is approved in advance by 
an APHIS representative. In cases where the swine are destroyed other 
than at a slaughtering establishment, the carcasses of the swine shall 
be disposed of by burial, incineration, or other disposal means 
authorized by applicable State law. The destruction and disposition of 
animals destroyed in accordance with this section other than at a 
slaughtering establishment shall be performed in the presence of an 
APHIS representative.
---------------------------------------------------------------------------

    \5\ Markets are approved by the Administrator in accordance with 
Sec.  76.18 of this chapter.
---------------------------------------------------------------------------

    (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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[42 FR 64336, Dec. 23, 1977, as amended at 45 FR 43680, June 27, 1980; 
45 FR 86410, Dec. 31, 1980; 46 FR 5861, Jan. 21, 1981; 47 FR 53324, Nov. 
26, 1982; 48 FR 57472, Dec. 30, 1983; 50 FR 11993, Mar. 27, 1985; 51 FR 
11300, Apr. 2, 1986; 51 FR 32599, Sept. 12, 1986; 54 FR 32435, Aug. 8, 
1989; 56 FR 18506, Apr. 23, 1991; 59 FR 12533, Mar. 17, 1994]



Sec.  51.7  Claims for indemnity.

    (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

[[Page 158]]

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 
Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[42 FR 64336, Dec. 23, 1977. Redesignated at 46 FR 13674, Feb. 23, 1981, 
and 47 FR 53324, Nov. 26, 1982, and amended at 47 FR 53324, Nov. 26, 
1982; 48 FR 57472, Dec. 30, 1983; 50 FR 11993, Mar. 27, 1985; 54 FR 
32435, Aug. 8, 1989; 56 FR 18506, Apr. 23, 1991]



Sec.  51.8  Disinfection of premises, conveyances, and materials.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[42 FR 64336, Dec. 23, 1977. Redesignated at 46 FR 13674, Feb. 23, 1981, 
and 47 FR 53324, Nov. 26, 1982; 48 FR 57472, Dec. 30, 1983; 50 FR 11993, 
Mar. 27, 1985; 54 FR 32435, Aug. 8, 1989; 56 FR 18506, Apr. 23, 1991]



Sec.  51.9  Claims not allowed.

    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

[[Page 159]]

the results of an official test, as defined in Sec.  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 Sec.  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 slaugher, 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 Sec.  78.1 of this chapter) was not 
in effect at the time the claim was filed.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[42 FR 64336, Dec. 23, 1977. Redesignated at 46 FR 13674, Feb. 23, 1981, 
and 47 FR 53324, Nov. 26, 1982, and amended at 47 FR 53324, Nov. 26, 
1982; 48 FR 57472, Dec. 30, 1983; 50 FR 11993, Mar. 27, 1985; 50 FR 
47036, Nov. 14, 1985; 51 FR 11300, Apr. 2, 1986; 54 FR 32435, Aug. 8, 
1989; 56 FR 18506, Apr. 23, 1991; 63 FR 47423, Sept. 8, 1998]



Sec.  51.10  Part 53 of this chapter not applicable.

    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.

[42 FR 64336, Dec. 23, 1977. Redesignated at 46 FR 13674, Feb. 23, 1981, 
and 47 FR 53324, Nov. 26, 1982; 50 FR 11993, Mar. 27, 1985]



PART 52_SWINE DESTROYED BECAUSE OF PSEUDORABIES--Table of Contents




Sec.
52.1 Definitions.
52.2 Payment of indemnity.
52.3 Appraisal of swine.
52.4 Presentation of claims.
52.5 Report of net salvage proceeds.
52.6 Claims not allowed.
52.7 Disinfection of premises, conveyances, and materials.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 64 FR 2549, Jan. 15, 1999, unless otherwise noted.



Sec.  52.1  Definitions.

    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

[[Page 160]]

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.\1\
---------------------------------------------------------------------------

    \1\ The names and addresses of laboratories approved by the 
Administrator to conduct approved differential pseudorabies tests are 
published in the Notices Section of the Federal Register. A list of 
approved laboratories is also available upon request from the Animal and 
Plant Health Inspection Service, 4700 River Road Unit 37, Riverdale, 
Maryland 20737-1231. State, Federal, and university laboratories will be 
approved by the Administrator when he or she determines that the 
laboratory: employs personnel trained at the National Veterinary 
Services Laboratories assigned to supervise the testing; follows 
standard test protocols; meets check test proficiency requirements; and 
will report all test results to State and Federal animal health 
officials. Before the Administrator may withdraw approval of any 
laboratory for failure to meet any of these conditions, the 
Administrator must give written notice of the proposed withdrawal to the 
director of the laboratory, and must give the director an opportunity to 
respond. If there are conflicts as to any material fact, a hearing will 
be held to resolve the conflict.
---------------------------------------------------------------------------

    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

[[Page 161]]

Immunoassay (PCFIA) Test. \2\ State, Federal, and university 
laboratories will be approved by the Administrator following his 
determination that the laboratory: has personnel trained at the 
Veterinary Services Diagnostic Laboratory at Ames, Iowa, assigned to 
supervise the test; follows standard test protocol; meets check test 
proficiency requirements; and will report all test results to State and 
Federal animal health officials.\3\
---------------------------------------------------------------------------

    \2\ Copies of the test protocols (Recommended Minimum Standards for 
Diagnostic Tests Employed in the Diagnosis of Pseudorabies (Aujeszky's 
Disease) are available upon request from the Animal and Plant Health 
Inspection Service, Veterinary Services, Operational Support, 4700 River 
Road Unit 33, Riverdale, MD 20737-1231.
    \3\ Before the Administrator withdraws the approval of any 
laboratory, the Director of the laboratory will be given a notice by the 
Administrator of the proposed disapproval and the reasons for it, and 
the Director will have the opportunity to respond. In those instances 
where there are conflicts as to the facts, a hearing will be held to 
resolve such conflicts.
---------------------------------------------------------------------------

    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. \4\
---------------------------------------------------------------------------

    \4\ A list of recognized slaughtering establishments is available 
upon request from the Animal and Plant Health Inspection Service, 4700 
River Road Unit 37, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    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.

[64 FR 2549, Jan. 15, 1999, as amended at 65 FR 20711, Apr. 18, 2000; 68 
FR 6342, Feb. 7, 2003]



Sec.  52.2  Payment of indemnity.

    (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

[[Page 162]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0151)

[65 FR 20711, Apr. 18, 2000]



Sec.  52.3  Appraisal of 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.

(Approved by the Office of Management and Budget under control number 
0579-0137)

[64 FR 2549, Jan. 15, 1999, as amended at 65 FR 20711, Apr. 18, 2000]



Sec.  52.4  Presentation of claims.

    (a) When swine have been destroyed under Sec.  52.2(a), any claim 
for indemnity must be presented, along with the report of net salvage 
proceeds required under Sec.  52.5, to the veterinarian in charge on a 
form furnished by APHIS.
    (b) When swine have been destroyed under Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0137)

[65 FR 20711, Apr. 18, 2000]



Sec.  52.5  Report of net salvage proceeds.

    A report of the amount for net salvage derived from the sale of each 
animal for which a claim for indemnity is made under Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0151)

[65 FR 20712, Apr. 18, 2000]



Sec.  52.6  Claims not allowed.

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0137)

[64 FR 2549, Jan. 15, 1999. Redesignated at 65 FR 20711, Apr. 18, 2000]



Sec.  52.7  Disinfection of premises, conveyances, and materials.

    All premises, including barns, stockyards and pens, and all cars and 
other

[[Page 163]]

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.

[64 FR 13065, Mar. 17, 1999. Redesignated at 65 FR 20711, Apr. 18, 2000]



PART 53_FOOT-AND-MOUTH DISEASE, PLEUROPNEUMONIA, RINDERPEST, AND 
CERTAIN OTHER COMMUNICABLE DISEASES OF LIVESTOCK OR POULTRY--Table of Contents




Sec.
53.1 Definitions.
53.2 Determination of existence of disease; agreements with States.
53.3 Appraisal of animals or materials.
53.4 Destruction of animals.
53.5 Disinfection or destruction of materials.
53.6 Disinfection of animals.
53.7 Disinfection of premises, conveyances, and materials.
53.8 Presentation of claims.
53.9 Mortgage against animals or materials.
53.10 Claims not allowed.
53.11 Payments arising from low pathogenic avian influenza; conditions 
          for payment.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Cross Reference: For non-applicability of part 53 with respect to 
certain claims for indemnity, see Sec.  51.10 of this chapter.



Sec.  53.1  Definitions.

    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.
    Department. The United States Department of Agriculture.
    Disease. Foot-and-mouth disease, rinderpest, contagious 
pleuropneumonia, exotic Newcastle disease, highly pathogenic avian 
influenza, infectious salmon anemia, 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.
    Exotic Newcastle Disease (END). Any velogenic Newcastle disease. 
Exotic Newcastle disease is an acute, rapidly spreading, and usually 
fatal viral disease of birds and poultry.
    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.

[[Page 164]]

    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.
    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.
    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.

[61 FR 56882, Nov. 5, 1996, as amended at 67 FR 17610, Apr. 11, 2002]



Sec.  53.2  Determination of existence of disease; agreements with 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 Sec.  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, except as 
provided in Sec.  53.11, to pay 50 percent (and in the case of exotic 
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 and 
materials required to be destroyed because of being contaminated by or 
exposed to such disease: Provided, however, That if the animals were 
exposed to such disease prior to or during interstate movement and 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 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 Cooperative Agreements,\1\ 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.
---------------------------------------------------------------------------

    \1\ Agreements between the Departments and the particular State 
involved relating to cooperative animal (including poultry) disease 
prevention, control, and eradication.

[37 FR 5689, Mar. 18, 1972, as amended at 49 FR 3448, Jan. 27, 1984; 49 
FR 26712, June 29, 1984; 61 FR 56883, Nov. 5, 1996; 67 FR 17610, Apr. 
11, 2002; 67 FR 67095, Nov. 4, 2002]



Sec.  53.3  Appraisal of animals or materials.

    (a) Animals 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

[[Page 165]]

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.

[28 FR 5935, June 13, 1963, as amended at 35 FR 13981, Sept. 3, 1970; 36 
FR 25217, Dec. 30, 1971; 56 FR 51974, Oct. 17, 1991; 68 FR 6343, Feb. 7, 
2003]



Sec.  53.4  Destruction of animals.

    (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 infectious salmon anemia, 
salvageable fish may be sold for rendering, processing, or any other 
purpose approved by the Administrator. In the case of poultry 
depopulated because of low pathogenic avian influenza related to the 
2002 disease situations in Virginia and Texas associated with the H5 or 
H7 virus, poultry may be slaughtered and sold. The proceeds gained from 
the sale of the fish or poultry will be subtracted from any payment from 
APHIS for which the producer or owner is eligible under Sec.  53.2(b) or 
Sec.  53.11.
    (b) 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, the value of poultry depopulated because of the disease may be 
calculated following destruction and disposal of the poultry, based on 
the number, type, and age of the animals destroyed.
    (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.

[28 FR 5935, June 13, 1963, as amended at 56 FR 51974, Oct. 17, 1991; 67 
FR 67095, Nov. 4, 2002; 68 FR 42569, July 18, 2003]



Sec.  53.5  Disinfection or destruction of materials.

    (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 Sec.  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.

[28 FR 5935, June 13, 1963, as amended at 56 FR 51974, Oct. 17, 1991]



Sec.  53.6  Disinfection of animals.

    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.

[28 FR 5935, June 13, 1963, as amended at 56 FR 51974, Oct. 17, 1991]



Sec.  53.7  Disinfection of premises, conveyances, and materials.

    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

[[Page 166]]

the agreement reached under Sec.  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.

[68 FR 42569, July 18, 2003]



Sec.  53.8  Presentation of claims.

    (a) Except for claims made under Sec.  53.11, 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) In the case of claims made under Sec.  53.11, claims for 
compensation for losses from poultry, eggs, and poultry semen destroyed 
or to be destroyed must be presented to APHIS, through the inspector in 
charge, on a form approved by the Administrator. The claim must specify 
the number, type, and age of the poultry; the number and type of eggs; 
and the type and amount of semen, as applicable.
    (c) To be considered by the Department, claims made under Sec.  
53.11 must be submitted to APHIS within 90 days after December 9, 2002, 
or the destruction of poultry, whichever is later, except that claims 
made for eggs or poultry semen, and claims made for other eligible 
losses associated with the disease situation in Texas, must be submitted 
to APHIS within 90 days after July 18, 2003 or the destruction of the 
eggs, semen, or poultry, whichever is later.

(Approved by the Office of Management and Budget under control number 
0579-0208)

[67 FR 67095, Nov. 4, 2002, as amended at 68 FR 42570, July 18, 2003]



Sec.  53.9  Mortgage against animals or materials.

    When animals 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 
or materials shall certify that the animals 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 or materials, consenting to the payment of any indemnity 
allowed to the person specified thereon.

[28 FR 5935, June 13, 1963, as amended at 56 FR 51974, Oct. 17, 1991]



Sec.  53.10  Claims not allowed.

    (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 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 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.

[[Page 167]]

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0192)

[28 FR 5935, June 13, 1963, as amended at 45 FR 86411, Dec. 31, 1980; 56 
FR 51974; 67 FR 17611, Apr. 11, 2002]



Sec.  53.11  Payments arising from low pathogenic avian influenza; 
conditions for payment.

    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, the Administrator may pay claims, subject to available funding, 
as follows:
    (a) For contract growers. The Administrator may pay a contract 
grower up to 100 percent of the losses identified in accordance with the 
LPAI compensation plan, up to the amount that the owner is eligible to 
receive before grower compensation is deducted.
    (b) For owners. The Administrator, in accordance with Sec.  53.4, 
may pay an owner up to 75 percent of the value of the poultry, eggs, and 
semen destroyed plus 75 percent of the costs of destruction and disposal 
of the poultry, eggs, and semen, in accordance with the LPAI 
compensation plan, minus the amount paid in accordance with paragraph 
(a) of this section to the contract grower of the poultry.
    (c) Conditions. Payments to be made in accordance with paragraph (a) 
or (b) of this section are conditioned on each claimant's complying with 
all applicable requirements of this part and, additionally, agreeing to 
and complying with the specific conditions set forth in the ``Avian 
Influenza Depopulation Agreement'' regarding cleaning and

[[Page 168]]

disinfection, restocking, surveillance, and other disease prevention 
measures.

(Approved by the Office of Management and Budget under control number 
0579-0208)

[67 FR 67095, Nov. 4, 2002, as amended at 68 FR 42570, July 18, 2003]



PART 54_CONTROL OF SCRAPIE--Table of Contents




Sec.
54.1 Definitions.
54.2 Cooperative agreements and memoranda of understanding with States.

                Subpart A_Scrapie Indemnification Program

54.3 Animals eligible for indemnity payments.
54.4 Application by owners for indemnity payments.
54.5 Certification by owners.
54.6 Amount of indemnity payments.
54.7 Procedures for destruction of animals.
54.8 Requirements for flock plans and post-exposure management and 
          monitoring plans.
54.9 Waiver of requirements for scrapie control pilot projects.
54.10 Tests for scrapie.
54.11 Approval of laboratories to run official scrapie tests and 
          official genotype tests.

              Subpart B_Scrapie Flock Certification Program

54.20 Administration.
54.21 Participation.
54.22 State scrapie certification boards.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 66 FR 43982, Aug. 21, 2001, unless otherwise noted.



Sec.  54.1  Definitions.

    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 Sec.  54.11 to conduct one or more scrapie tests, or 
genotype tests, on one or more tissues.
    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 Sec.  54.10.
    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 listed in Sec.  
151.9 of this chapter 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.
    Certificate. An official document issued in accordance with Sec.  
79.5 of this chapter by an APHIS representative, State representative, 
or accredited veterinarian at the point of origin of an interstate 
movement of animals.
    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. 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.

[[Page 169]]

    Destroyed. (1) Euthanized by means other than slaughter, and the 
carcass disposed of, by means authorized by the Administrator; or
    (2) In the case of exposed or high-risk animals that are not known 
to be infected, either euthanized or disposed of by slaughter; or
    (3) Moved to a quarantined research facility if the movement has 
been approved by the Administrator.
    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. (1) Any animal that has been in the same flock at 
the same time as a scrapie-positive female animal, excluding limited 
contacts; or
    (2) Any animal born in a flock after a scrapie-positive animal was 
born into that flock or lambed in that flock, if born before that flock 
completes the requirements of a flock plan; or
    (3) Any animal that was commingled with a scrapie-positive female 
animal during or up to 30 days after she lambed, kidded, or aborted, or 
while a visible vaginal discharge was present, or that was commingled 
with any other scrapie-positive female animal for 24 hours or more, 
including during activities such as shows and sales or while in 
marketing channels; or
    (4) Any animal in a noncompliant flock.
    Exposed flock. Any flock in which a scrapie-positive animal was born 
or lambed. Any flock that currently contains a female high-risk, 
exposed, or suspect animal, or that once contained a female high-risk, 
exposed, or suspect animal that lambed in the flock and from which 
tissues were not submitted for official testing and found negative. A 
flock that has completed a post-exposure management and monitoring plan 
following the exposure will no longer be an exposed flock.
    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 Sec.  54.7(e). 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 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

[[Page 170]]

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 Sec.  54.8(a) through (f).
    Flock sire. A sexually intact male animal that has ever been used 
for breeding in a flock.
    High-risk animal. A sexually intact animal, excluding male sheep 
that have tested RR at codon 171 and AA at codon 136 using an official 
genotype test, that is:
    (1) The progeny of a scrapie-positive dam; or
    (2) Born in the same flock during the same lambing season as progeny 
of a scrapie-positive dam, unless the progeny of the scrapie-positive 
dam are from separate contemporary lambing groups; or
    (3) Born in the same flock during the same lambing season that a 
scrapie-positive animal was born, or during any subsequent lambing 
season, if born before that flock completes the requirements of a flock 
plan; or
    (4) An exposed female sheep that has not tested QR, HR, or RR at 
codon 171 using an official genotype test.
    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.
    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 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.\1\
---------------------------------------------------------------------------

    \1\ The names and addresses of laboratories approved by the 
Administrator to conduct live-animal screening tests will be published 
in the Notices Section of the Federal Register. A list of approved 
laboratories is also available upon request from the Animal and Plant 
Health Inspection Service, Veterinary Services, National Animal Health 
Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235. 
State, Federal, and university laboratories will be approved by the 
Administrator when he or she determines that the laboratory: (a) Employs 
personnel trained by the National Veterinary Services Laboratories 
assigned to supervise the testing; (b) follows standard test protocols; 
(c) meets check test proficiency requirements; and (d) will report all 
test results to State and Federal animal health officials. Before the 
Administrator may withdraw approval of any laboratory for failure to 
meet any of these conditions, the Administrator must give written notice 
of the proposed withdrawal to the director of the laboratory and must 
give the director an opportunity to respond. If there are conflicts as 
to any material fact, a hearing will be held to resolve the conflicts.
---------------------------------------------------------------------------

    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

[[Page 171]]

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 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 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 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. Any test to determine the genotype of a live 
or dead animal that is conducted at either an approved laboratory or at 
the National Veterinary Services Laboratories, when the animal is 
officially identified and the samples used for the test are collected 
and shipped to the laboratory by either an accredited veterinarian or a 
State or APHIS representative
    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 
Sec.  54.8.
    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 Flock Certification Program (SFCP). The cooperative Federal-
State-industry voluntary program for the control of scrapie conducted in 
accordance with this subpart.
    Scrapie Flock Certification Program standards. Cooperative 
procedures and standards adopted by APHIS and State scrapie 
certification boards for reducing the incidence and controlling the

[[Page 172]]

spread of scrapie through flock certification.\2\
---------------------------------------------------------------------------

    \2\ Individual copies of the Scrapie Flock Certification Program 
standards may be obtained on the World Wide Web at URL http://
www.aphis.usda.gov/vs/scrapie, or from the Animal and Plant Health 
Inspection Service, National Animal Health Programs Staff, 4700 River 
Road Unit 43, Riverdale, MD 20737-1235.
---------------------------------------------------------------------------

    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 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 test method approved by the Administrator in 
accordance with Sec.  54.10.\3\
---------------------------------------------------------------------------

    \3\ The names and addresses of laboratories approved by the 
Administrator to conduct tests are published in the Notices Section of 
the Federal Register. A list of approved laboratories is also available 
upon request from the Animal and Plant Health Inspection Service, 
Veterinary Services, National Animal Health Programs Staff, 4700 River 
Road Unit 43, Riverdale, MD 20737-1235. State, Federal, and university 
laboratories will be approved by the Administrator when he or she 
determines that the laboratory: (a) Employs personnel trained by the 
National Veterinary Services Laboratories assigned to supervise the 
testing; (b) follows standard test protocols; (c) meets check test 
proficiency requirements; and (d) will report all test results to State 
and Federal animal health officials. Before the Administrator may 
withdraw approval of any laboratory for failure to meet any of these 
conditions, the Administratr must give written notice of the proposed 
withdrawal to the director of the laboratory and must give the director 
an opportunity to respond. If there are conflicts as to any material 
fact, a hearing will be held to resolve the conflict.
---------------------------------------------------------------------------

    Separate contemporary lambing groups. To be a separate contemporary 
lambing group, the group must be maintained separately such that the 
animals cannot come into physical contact with other lambs, kids, ewes 
or does or birth fluids or placenta from other ewes or does. This 
separate maintenance must preclude contact through a fence, during 
lambing and for 60 days following the date the last lamb or kid is born 
in a lambing season, and must preclude using the same lambing facility 
as other ewes or does, unless the lambing facility is cleaned and 
disinfected under supervision by an APHIS representative, State 
representative, or an accredited veterinarian between lambings in 
accordance with Sec.  54.7(e). 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. The flock owner must maintain adequate records to 
document which animals were maintained in each contemporary lambing 
group and to document when cleaning and disinfection was performed and 
who supervised it.
    Slaughter channels. Animals in slaughter channels include any animal 
that is sold, transferred, or moved either directly to a slaughter 
facility, to an individual for custom slaughter, or for feeding for the 
express purpose of improving the animals' condition for movement to 
slaughter. Any sexually intact animal that is commingled with breeding 
animals or that has been bred is not in slaughter channels. When selling 
animals for slaughter, owners should note on the bill of sale that the 
animals are sold only for slaughter.
    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

[[Page 173]]

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 Sec.  79.4 of this chapter if it is:
    (1) A sheep or goat that exhibits any of the following possible 
signs of scrapie and that has been determined to be suspicious for 
scrapie by an accredited veterinarian or a State or APHIS 
representative: Weight loss despite retention of appetite; behavioral 
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.
    (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.
    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.



Sec.  54.2  Cooperative agreements and memoranda of understanding with States.

    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 
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 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 Flock 
Certification Program.

(Approved by the Office of Management and Budget under control number 
0579-0101)



                Subpart A_Scrapie Indemnification Program



Sec.  54.3  Animals eligible for indemnity payments.

    (a) Indemnity may be paid for an animal only after the owner of the 
animal

[[Page 174]]

has applied for indemnification and been approved in accordance with 
Sec.  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) No indemnity will be paid for an animal if the owner of the 
animal fails to provide APHIS, within 30 days of request, animal 
registration certificates, sale and movement records, or other records 
requested in accordance with Sec.  54.5. 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 Sec.  54.7(e). 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. Premises or portions of premises may be exempted from 
the cleaning and disinfecting requirements if a designated scrapie 
epidemiologist determines, based on 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 indemnity will be paid to 
an owner if the owner assembled or increased his flock for the purpose 
of collecting or increasing indemnity.



Sec.  54.4  Application by owners for indemnity payments.

    (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). If the registration papers are unavailable, the owner may 
choose to accept a lesser indemnity in accordance with Sec.  54.6(b)(2) 
or the area 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; 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 
Sec.  54.3.

[[Page 175]]



Sec.  54.5  Certification by owners.

    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, slaughtered, or 
euthanized and necropsied and tissues removed for diagnostic or other 
purposes.



Sec.  54.6  Amount of indemnity payments.

    (a) Indemnity paid for sheep in accordance with Sec.  54.3 will be 
set based on the following price reports published by the Agricultural 
Marketing Service (AMS). If pricing information is unavailable from 
these markets during a given week or month or if the numbers of animals 
sold are too low to give an accurate market value, the preceding week or 
month's value will be used. The AMS reports from the most recent week or 
month prior to the date APHIS offers to pay an owner indemnity shall be 
used to calculate the indemnity for that owner's sheep:
    (1) The weekly weighted average Choice/Prime slaughter lamb price 
per pound at Greeley, CO;
    (2) The weekly weighted average Utility slaughter ewe price per 
pound at San Angelo, TX;
    (3) The monthly weighted average commercial western ewe lamb 
replacement price per head;
    (4) The monthly weighted average commercial western yearling ewe 
replacement price per head;
    (5) The monthly weighted average commercial western running age ewe 
price per head.
    (6) The monthly weighted average commercial western aged ewe price 
per head.
    (b) For animals under 1 year of age, the basic indemnity shall equal 
the price per pound from paragraph (a)(1) of this section times the 
greater of 50 lbs or the actual weight of the animal; except that, for 
ewe lambs under 1 year of age, the indemnity shall equal the per-head 
price from paragraph (a)(3) of this section if that price is higher. For 
sexually intact sheep 8 years of age or older and castrated animals 1 
year of age or older, the basic indemnity shall equal the price per 
pound from paragraph (a)(2) of this section times 150, based on an 
average weight of 150 lbs. For sexually intact sheep at least 1 year of 
age and under 2 years of age, the indemnity shall equal the greater of 
the price per head from paragraph (a)(4) of this section, or the price 
per pound from paragraph (a)(2) of this section times 150, based on an 
average weight of 150 lbs. For sexually intact sheep at least 2 years of 
age and under 6 years of age, the basic indemnity shall equal the 
greater of the price per head from paragraph (a)(5) of this section or 
the price per pound from paragraph (a)(2) of this section times 150, 
based on an average weight of 150 lbs. For sexually intact sheep at 
least 6 years of age and under 8 years of age, the basic indemnity will 
equal the greater of the price per head from paragraph (a)(6) of this 
section or the price per pound from paragraph (a)(2) of this section 
times 150, based on an average weight of 150 lbs. A premium shall be 
added to the basic indemnity for each registered animal, equal to $100 
for each registered animal under 1 year of age, $200 for each registered 
animal at least 1 year of age and under 4 years of age, and $100 for 
each registered animal at least 4 years of age and under 8 years of age. 
An additional premium of $50 will be added to the basic indemnity for 
each flock sire. The owner

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must provide adequate records to qualify for these premiums. When the 
animals to be indemnified are goats, or are sheep that fall outside the 
classes covered previously in this paragraph, the Administrator may take 
into consideration the producer's purchase records and sales records for 
the preceding 12 to 24 months in determining the indemnity amount, but 
the indemnity shall not exceed the maximum indemnity calculated for 
registered sheep in accordance with this section.
    (1) 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.
    (2) Any animal that is not registered at the time indemnity is first 
offered, but is eligible to be registered, will receive the registered 
animal premium reduced by $50.
    (c) For animals destroyed by slaughter, the owner will retain the 
salvage value (the amount paid by a slaughter plant for the animal) of 
the animals in lieu of receiving the base indemnity. If the salvage 
value, less transport costs, is less than the base indemnity, APHIS will 
pay the owner the difference. APHIS will also indemnify the owner in the 
amount of any registered animal or flock sire premiums for which the 
animal qualifies.
    (d) If the owner disagrees with the average weight estimate, he may 
have the sheep weighed at a public scale at his own expense, provided 
that the sheep 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 times the AMS weekly average price.
    (e) Indemnity will be paid to an owner only for animals actually in 
a flock at the time indemnity is first offered. Animals removed from the 
flock as part of a post-exposure management and monitoring plan will be 
paid indemnity based on the AMS average prices at the time an APHIS 
representative designates the animals for removal.



Sec.  54.7  Procedures for destruction of animals.

    (a) Scrapie-positive and suspect 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. Animals that are not scrapie-positive or 
suspect animals for which indemnification is sought may be:
    (1) Slaughtered when moved in accordance with part 79 of this 
chapter and with the prior written approval of the APHIS representative 
involved;
    (2) Destroyed on the premises where they are held, pastured, or 
penned at the time indemnity is approved;
    (3) Moved to an approved research facility; or
    (4) Moved to another location for destruction if an APHIS 
representative approves the movement in advance.
    (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 scrapie-
positive and suspect 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.

[[Page 177]]

The Administrator may also authorize payment of up to half the 
reasonable disposal costs for animals that are eligible to be destroyed 
by slaughter under this section but for which slaughter is not a 
practical or cost efficient means of disposal; Provided that, APHIS may 
pay more than one-half of the expenses when the Administrator determines 
that doing so will contribute to scrapie eradication. For reimbursement 
to be made, the owner of the animals must present the area 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 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 Flock Certification Program standards and the 
Scrapie Eradication Uniform Methods and Rules:
    (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 animals or wildlife.
    (2) Cement, wood, metal, and other non-earth surfaces, tools, 
equipment, instruments, feed, hay, bedding, and other materials. Remove 
all organic material and compost or incinerate. 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 the following 
methods:
    (i) Incinerate items by high-temperature incineration methods;
    (ii) Autoclave instruments, small tools, and other items at 136 
[deg]C for 1 hour;
    (iii) To clean dry surfaces, apply a 2-percent chlorine bleach 
solution at room temperature (at least 18.3 [deg]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.



Sec.  54.8  Requirements for flock plans and post-exposure management 
and monitoring plans.

    (a) The owner of the flock or his or her agent must identify all 
animals 1 year of age or over within the flock. All animals less than 1 
year of age must be identified when a change of ownership occurs, with 
the exception of those animals under 1 year of age moving within 
slaughter channels that must be identified in accordance with Sec. Sec.  
79.2 and 79.3 of this chapter. The form of identification must be an 
electronic implant, flank tattoo, ear tattoo, or tamper-resistant ear 
tag approved for this use by APHIS. In the case of goats, the form of 
identification may alternatively be a tail fold tattoo. 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.
    (b) Upon request by a State or APHIS representative, 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.
    (c) Upon request by a State or APHIS representative, the owner of 
the flock or his or her agent must make animals in the flock and the 
records required to be kept as a part of these plans available for 
inspection.
    (d) The owner of the flock or his or her agent must meet 
requirements found necessary by a State or APHIS representative 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; restrictions on the animals that may be moved 
from the flock; segregated lambing; cleaning and disinfection of lambing 
facilities; and/or education of the owner of the flock and personnel 
working with the

[[Page 178]]

flock in techniques to recognize clinical signs of scrapie and to 
control the spread of scrapie.
    (e) 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, 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; 
biting at legs or side; lip smacking; motor abnormalities such as 
incoordination, high stepping gait of forelimbs, bunny hop movement of 
rear legs, 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 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.
    (f) Requirements for flock plans only. (1) 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. The animals must be 
removed either by movement to an approved research facility or by 
euthanization and disposal of the carcasses by burial, incineration, or 
other methods in accordance with local, State, and Federal laws, or, in 
the case of high-risk animals, by movement to slaughter in accordance 
with the provisions of part 79 of this chapter, or upon request in 
individual cases by another means determined by the Administrator to be 
sufficient to prevent the spread of scrapie;
    (2) The premises of a flock under a flock plan must be cleaned and 
disinfected in accordance with Sec.  54.7(e). 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. Premises or portions of premises 
may be exempted from the cleaning and disinfecting requirements if a 
designated scrapie epidemiologist determines, based on 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 area where a 
scrapie-positive animal lambed or aborted may be exempted;
    (3) The owner of the flock, or his or her agent, must request breed 
associations and registries, livestock markets, 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; and
    (4) The flock owner must agree to conduct post-exposure management 
and monitoring.
    (g) Requirements for post-exposure management and monitoring plans 
only: The plan must require that a State or APHIS representative inspect 
the flock and flock records at least once every 12 months. The owner of 
the flock or his or her agent must maintain, and keep for a minimum of 5 
years after an animal dies or is otherwise removed from a flock, the 
following records for each animal in the flock:
    (1) Any identifying marks or tags present on the animal, including 
the animal's individual official identification number from its 
electronic implant, flank tattoo, ear tattoo, tamper resistant ear tag, 
or, in the case of goats, tail fold tattoo, and any secondary form of 
identification the owner of the flock may choose to maintain;
    (2) Sex, year of birth, breed, and when possible to determine, the 
following: sire, dam, and offspring of the animal;
    (3) Date of acquisition and previous flock, if the animal was not 
born in the flock; and
    (4) Disposition of the animal, including the date and cause of 
death, if known, or date of removal from the

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flock and name and address of the person to whom the animal was 
transferred.
    (h) Modification of flock plans and post-exposure management and 
monitoring plans. A designated scrapie epidemiologist may modify the 
requirements of a flock plan or post-exposure management and monitoring 
plan to accommodate the situation of a particular flock if the modified 
plan requires:
    (1) That a State or APHIS representative inspect the flock and flock 
records at least once every 12 months;
    (2) The testing of animals at a level that will result in 99 percent 
confidence of detecting a 1 percent prevalence in the flock (for flock 
plans only);
    (3) The official identification of all animals upon leaving the 
premises of the flock for purposes other than slaughter and of all 
animals over 18 months of age (as evidenced by the eruption of the 
second incisor) in slaughter channels; and
    (4) Recordkeeping including:
    (i) For acquired animals, the date of acquisition, name and address 
of the person from whom the animal was acquired, any identifying marks 
or tags present on the animal including the animal's individual official 
identification number from its electronic implant, flank tattoo, ear 
tattoo, tamper resistant ear tag, or, in the case of goats, tail fold 
tattoo, and any secondary form of identification the owner of the flock 
may choose to maintain.
    (ii) For animals leaving the premises of the flock, the disposition 
of the animal, including, for those animals that are required to be 
identified, any identifying marks or tags present on the animal, 
including the animal's individual official identification number from 
its electronic implant, flank tattoo, ear tattoo, tamper resistant ear 
tag, 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.
    (iii) Maintenance of these records for 5 years.
    (5) Requirements equivalent to those contained in paragraphs (b), 
(c), (d), and (e) of this section.
    (i) Post-exposure management and monitoring plans for exposed flocks 
that were not source flocks and in which a scrapie infected animal did 
not lamb. A designated scrapie epidemiologist shall determine the 
testing and monitoring requirements for these flocks based on the 
exposure risk of the individual flock.



Sec.  54.9  Waiver of requirements for scrapie control pilot projects.

    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.



Sec.  54.10  Tests for scrapie.

    (a) The Administrator may approve new tests for the diagnosis of 
scrapie conducted on live or dead animals for use in the Scrapie 
Eradication 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 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

[[Page 180]]

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.
    (b) To be approved, a scrapie test must be able to be replicated at 
the National Veterinary Services Laboratories, or another reliable, 
timely, and cost effective method of check testing must be available to 
APHIS.
    (c) A test or combination of tests may be approved for the 
identification of suspect animals, for the identification of 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 have a specificity comparable to the specificity 
of the currently approved tests. For a test to be approved as a live 
animal screening test for the identification of suspect animals, the 
test must be usually reliable but need not be definitive for diagnosing 
scrapie.
    (d) Specific guidelines for use of approved scrapie tests within the 
Scrapie Eradication Program or Scrapie Flock Certification Program will 
be added to this part as tests are approved and will also be contained 
in the Scrapie Eradication UM&R and the Scrapie Flock Certification 
Program standards based on the characteristics of the test, including 
specificity, sensitivity, and predictive value.
    (e) 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:
    (1) The test was run as part of a bona fide research protocol 
designed to evaluate an unapproved test in which the owner is not 
informed of the test result; or
    (2) The test protocol includes appropriate measures to prevent the 
spread of scrapie.



Sec.  54.11  Approval of laboratories to run official scrapie tests 
and official genotype tests.

    (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 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;
    (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 the laboratory without notice during 
normal business hours; and
    (8) Will report all test results to State and Federal animal health 
officials within agreed timeframes. An inspection may include, but is 
not limited to, review and copying of records, examination of slides, 
observation of the test being conducted, and interviewing of personnel.
    (b) A laboratory may request approval to conduct one or more types 
of 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 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 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

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fact concerning the reason for withdrawal, a hearing will be held to 
resolve the conflicts.



              Subpart B_Scrapie Flock Certification Program



Sec.  54.20  Administration.

    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.



Sec.  54.21  Participation.

    Any owner of a sheep or goat flock may apply to enter the Scrapie 
Flock Certification Program by sending a written request to a State 
scrapie certification board or to the area veterinarian in charge. A 
notice containing a current list of flocks participating in the Scrapie 
Flock Certification Program, and the certification status of each flock, 
may be obtained from the APHIS web site at URL http://
www.aphis.usda.gov/vs/scrapie. A list of noncompliant flocks may also be 
obtained from this site, and either list may be obtained by writing to 
the Animal and Plant Health Inspection Service, National Animal Health 
Programs Staff, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-
1235.

(Approved by the Office of Management and Budget under control number 
0579-0101)



Sec.  54.22  State scrapie certification boards.

    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.



PART 55_CONTROL OF CHRONIC WASTING DISEASE--Table of Contents




Sec.
55.1 Definitions.

        Subpart A_Chronic Wasting Disease Indemnification Program

55.2 Payment of indemnity.
55.3 Appraisal and destruction of captive cervids.
55.4 Disinfection of premises, conveyances, and materials.
55.5 Presentation of claims for indemnity.
55.6 Mortgage against animals.
55.7 Claims not allowed.
55.8 Official CWD tests and approval of laboratories to conduct official 
          CWD tests.

Subpart B [Reserved]

    Authority: 21 U.S.C. 111-113, 114, 114a, 114a-1, 120, 121, 125, and 
134b; 7 CFR 2.22, 2.80, and 371.4.

    Source: 67 FR 5931, Feb. 8, 2002, unless otherwise noted.



Sec.  55.1  Definitions.

    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. Any captive cervid.
    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

[[Page 182]]

by the Administrator to do any work or perform any duty in connection 
with the control and eradication of disease.
    Captive. Animals that are privately or publicly maintained or held 
for economic or other purposes within a perimeter fence or confined 
space. Animals that are held for research purposes are not included.
    Cervid. All members of the family Cervidae and hybrids, including 
deer, elk, moose, caribou, reindeer, and related species.
    Chronic wasting disease, CWD. A transmissible spongiform 
encephalopathy of cervids.
    CWD exposed animal. An animal that is part of a CWD positive herd, 
or that was part of a herd within 5 years prior to that herd's 
designation as CWD positive, or an animal that has been housed with or 
been in direct contact with a positive animal, or an animal that has 
been on a contaminated premises.
    CWD positive animal. An animal that has had a diagnosis of CWD 
confirmed by means of an official CWD test.
    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 suspect animal. An animal for which an APHIS employee has 
determined that laboratory evidence or clinical signs suggest a 
diagnosis of CWD.
    Department. The United States Department of Agriculture.
    Herd. A group of 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 management agreement developed by APHIS 
with input from the herd owner, State representatives, and other 
affected parties. A herd plan sets out the steps to be taken to 
eradicate CWD from a CWD positive herd, or to prevent introduction of 
CWD into another 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 signs of disease; reporting to 
a State or APHIS representative of any signs of central nervous system 
disease in herd animals; 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, 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 condition of the herd and its premises, 
including but not limited to: 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; depopulation or 
selective culling of animals; restrictions on sharing and movement of 
possibly contaminated livestock equipment; cleaning and disinfection 
requirements, or other requirements. APHIS may review and revise a herd 
plan at any time 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.
    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.
    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 Sec.  55.8 of this part.

[[Page 183]]

    Person. Any individual, corporation, company, association, firm, 
partnership, society, joint stock company, or other legal entity.
    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.



        Subpart A_Chronic Wasting Disease Indemnification Program



Sec.  55.2  Payment of indemnity.

    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 Sec.  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 Sec.  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.



Sec.  55.3  Appraisal and destruction of captive cervids.

    (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

[[Page 184]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0189)



Sec.  55.4  Disinfection of premises, conveyances, and materials.

    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 Sec.  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.



Sec.  55.5  Presentation of claims for indemnity.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0189)



Sec.  55.6  Mortgage against animals.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0189)



Sec.  55.7  Claims not allowed.

    (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 Sec.  
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

[[Page 185]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0189)



Sec.  55.8  Official CWD tests and approval of laboratories to 
conduct official CWD tests.

    (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 \1\ the laboratory without notice 
during normal business hours; and
---------------------------------------------------------------------------

    \1\ An inspection may include, but is not limited to, review and 
copying of records, examination of slides, observation of the test being 
conducted, and interviewing of personnel.

---------------------------------------------------------------------------

[[Page 186]]

    (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.

Subpart B [Reserved]

                           PART 56 [RESERVED]

[[Page 187]]



 SUBCHAPTER C_INTERSTATE TRANSPORTATION OF ANIMALS (INCLUDING POULTRY) 
                           AND ANIMAL PRODUCTS





PART 70_RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER CERTAIN ACTS--Table of Contents




                            Subpart A_General

Sec.
70.1 Scope and applicability of rules of practice.

                Subpart B_Supplemental Rules of Practice

70.10 Stipulations.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 48 FR 30094, June 30, 1983, unless otherwise noted.



                            Subpart A_General



Sec.  70.1  Scope and applicability of rules of practice.

    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:

Act of May 29, 1884, commonly known as the Animal Industry Act, section 
7, as amended (21 U.S.C. 117),
Act of February 2, 1903, commonly known as the Cattle Contagious 
Diseases Act of 1903, Section 3, as amended (21 U.S.C. 122),
Act of March 3, 1905, Section 6, as amended (21 U.S.C. 127),
Act of July 2, 1962, Section 6(a), as amended (21 U.S.C. 134e).
The Animal Health Protection Act (7 U.S.C. 8301 et seq.).
Sections 901-905 of the Federal Agriculture Improvement and Reform Act 
of 1996 (7 U.S.C. 1901 note).


In addition, the Supplemental Rules of Practice set forth in subpart B 
of this part shall be applicable to such proceedings.

[48 FR 30094, June 30, 1983, as amended at 66 FR 63615, Dec. 7, 2001; 68 
FR 6343, Feb. 7, 2003]



                Subpart B_Supplemental Rules of Practice



Sec.  70.10  Stipulations.

    (a) At any time prior to the issuance of a complaint seeking a civil 
penalty under any of the Acts listed in Sec.  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.



PART 71_GENERAL PROVISIONS--Table of Contents




Sec.
71.1 Definitions.
71.2 Secretary to issue rule governing quarantine and interstate 
          movement of diseased animals, including poultry.
71.3 Interstate movement of diseased animals and poultry generally 
          prohibited.
71.4 Maintenance of certain facilities and premises in a sanitary 
          condition required; cleaning and disinfection, when required; 
          animals classed as ``exposed.''
71.5 Unsanitary railroad cars, trucks, boats, aircraft or other means of 
          conveyance; interstate movement restricted.
71.6 Carrier responsible for cleaning and disinfecting of railroad cars, 
          trucks, boats, aircraft or other means of conveyance.
71.7 Means of conveyance, facilities, premises, and cages and other 
          equipment; methods of cleaning and disinfecting.
71.10 Permitted disinfectants.
71.11 Cresylic disinfectant as permitted disinfectant; specifications.

[[Page 188]]

71.12 Sodium orthophenylphenate as permitted disinfectant for premises 
          infected with tuberculosis.
71.13 Inspection of shipments in transit by APHIS representative.
71.14 Slaughter of poultry or other animals to prevent spread of 
          disease; ascertainment of value and compensation.
71.15 Movement from quarantined to free area and shipment therefrom; 
          conditions under which permitted.
71.16 Inspection and certification of poultry or other animals for 
          interstate movement.
71.17 Interstate movement of dead poultry or other animals prohibited in 
          same car with live poultry or other animals.
71.18 Individual identification of certain cattle 2 years of age or over 
          for movement in interstate commerce.
71.19 Identification of swine in interstate commerce.
71.20 Approval of livestock facilities.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 28 FR 5937, June 13, 1963, unless otherwise noted.



Sec.  71.1  Definitions.

    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).
    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 under State or 
Federal veterinary supervision where livestock are assembled and that 
has been approved under Sec.  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.
    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.
    Department. The United States Department of Agriculture.
    Feeder swine. Swine under 6 months of age that are not slaughter 
swine.
    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.
    Horses. Horses, asses, mules, ponies, and zebras.
    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

[[Page 189]]

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. Horses, cattle, bison, sheep, and swine.
    Livestock market. A stockyard, buying station, concentration point, 
or any other premises where livestock are assembled for sale or sale 
purposes.
    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 along the way, such as at a stockyard 
or dealer premises for feed, water, rest, or sale.
    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 eartag approved by APHIS as being 
tamper-resistant and providing unique identification for each animal. An 
official eartag may conform to the alpha-numeric National Uniform 
Eartagging System, or it may bear a valid premises identification number 
that is used in conjunction with the producer's livestock production 
numbering system to provide a unique identification number.
    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.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, or joint stock company, or other legal entity.
    Premises identification number. A unique number assigned by the 
State animal health official to a livestock production unit that is, in 
the judgment of the State animal health official or area veterinarian in 
charge, epidemiolog- ically distinct from other livestock production 
units. A premises identification number shall consist of the State's 
two-letter postal abbreviation followed by the premises' assigned 
number. A 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.
    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

[[Page 190]]

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 Department of Agriculture 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.

[28 FR 5937, June 13, 1963, as amended at 29 FR 14489, Oct. 22, 1964; 35 
FR 14197, Sept. 9, 1970; 38 FR 18011, July 6, 1973; 50 FR 45987, Nov. 6, 
1985; 51 FR 32599, Sept. 12, 1986, 53 FR 40385, Oct. 14, 1988; 55 FR 
11155, 11156, Mar. 27, 1990; 55 FR 15320, Apr. 23, 1990; 62 FR 27933, 
May 22, 1997; 62 FR 54758, Oct. 22, 1997; 66 FR 65602, Dec. 20, 2001; 68 
FR 62226, Nov. 3, 2003]



Sec.  71.2  Secretary to issue rule governing quarantine and 
interstate movement of diseased animals, including poultry.

    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.

[34 FR 15641, Oct. 9, 1969]

[[Page 191]]



Sec.  71.3  Interstate movement of diseased animals and poultry generally 
prohibited.

    (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, 
rinderpest, African swine fever, classical swine fever, Teschen disease, 
contagious bovine pleuropneumonia, European fowl pest, 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 Sec.  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.
    (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.

[[Page 192]]

    (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) 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.

[28 FR 5937, June 13, 1963]

    Editorial Note: For Federal Register citations affecting Sec.  71.3, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



Sec.  71.4  Maintenance of certain facilities and premises in a sanitary 

condition required; cleaning and disinfection, when required; animals 
classed as ``exposed.''

    (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 Sec. Sec.  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

[[Page 193]]

cleaned and disinfected under the supervision of an APHIS or State 
representative or an accredited veterinarian in accordance with 
Sec. Sec.  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.

[34 FR 15641, Oct. 9, 1969, as amended at 55 FR 11156, Mar. 27, 1990; 55 
FR 15320, Apr. 23, 1990; 62 FR 27933, May 22, 1997]



Sec.  71.5  Unsanitary railroad cars, trucks, boats, aircraft or 
other means of conveyance; interstate movement restricted.

    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 
Sec. Sec.  71.7 and 71.10 through 71.12.

[34 FR 15641, Oct. 9, 1969, as amended at 55 FR 11156, Mar. 27, 1990; 55 
FR 15320, Apr. 23, 1990; 62 FR 27933, May 22, 1997]



Sec.  71.6  Carrier responsible for cleaning and disinfecting of 
railroad cars, trucks, boats, aircraft or other means of conveyance.

    (a) Railroad cars, trucks, boats, aircraft, and other means of 
conveyance which have been used in the interstate transportation 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), 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 Sec. Sec.  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 Sec.  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 Sec. Sec.  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 Sec. Sec.  71.7 and 71.10 through 71.12.

[34 FR 15641, Oct. 9, 1969, as amended at 37 FR 25337, Nov. 30, 1972; 39 
FR 4465, Feb. 4, 1974; 55 FR 11156, Mar. 27, 1990; 55 FR 15320, Apr. 23, 
1990; 62 FR 27934, May 22, 1997]



Sec.  71.7  Means of conveyance, facilities, premises, and cages and 
other equipment; methods of cleaning and disinfecting.

    (a) Railroad cars, trucks, aircraft, or other means of conveyance, 
except boats, required by the regulations in

[[Page 194]]

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 Sec. Sec.  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 Sec. Sec.  71.10 through 71.12.

[34 FR 15642, Oct. 9, 1969, as amended at 61 FR 56883, Nov. 5, 1996]



Sec.  71.10  Permitted disinfectants.

    (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\1/2\ 
ounce can to 5 gallons of water. Due to the extreme caustic nature of 
sodium hydroxide solution, precautionary measures such as the wearing of 
rubber gloves, boots, raincoat, and goggles should be observed. An acid 
solution such as vinegar shall be kept readily available in case any of 
the sodium hydroxide solution should come in contact with the body.
    (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.

[28 FR 5937, June 13, 1963, as amended at 32 FR 19157, Dec. 20, 1967; 37 
FR 8864, May 2, 1972; 37 FR 9460, May 11, 1972; 55 FR 11156, Mar. 27, 
1990; 55 FR 15320, Apr. 23, 1990; 61 FR 56883, Nov. 5, 1996]

[[Page 195]]



Sec.  71.11  Cresylic disinfectant as permitted disinfectant; specifications.

    The following specifications will be employed for determining the 
suitability of cresylic disinfectant for use under the provisions of 
Sec.  71.10(b)(3):
    (a) The product shall remain a uniform liquid when held at 0 [deg]C. 
(32 [deg]F.) for 3 hours (chill test).
    (b) The product shall dissolve completely in 30 parts of distilled 
water at 25 [deg]C. (77 [deg]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\6\H\5\OH).
    (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.



Sec.  71.12  Sodium orthophenylphenate as permitted disinfectant for 
premises infected with tuberculosis.

    (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 [deg]F. or over. Whenever the temperature of the 
building to be disinfected is below 60 [deg]F., as indicated by a wall 
thermometer, the solution shall be heated to 120 [deg]F. and higher in 
very cold weather, to insure effective disinfection.



Sec.  71.13  Inspection of shipments in transit by APHIS representative.

    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.

[28 FR 5937, June 13, 1963, as amended at 34 FR 15642, Oct. 9, 1969; 55 
FR 11156, Mar. 27, 1990; 55 FR 15320, Apr. 23, 1990; 62 FR 27934, May 
22, 1997]



Sec.  71.14  Slaughter of poultry or other animals to prevent spread 
of disease; ascertainment of value and compensation.

    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

[[Page 196]]

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.

[28 FR 5937, June 13, 1963, as amended at 34 FR 15642, Oct. 9, 1969]



Sec.  71.15  Movement from quarantined to free area and shipment therefrom; 
conditions under which permitted.

    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.

[28 FR 5937, June 13, 1963, as amended at 34 FR 15642, Oct. 9, 1969]



Sec.  71.16  Inspection and certification of poultry or other animals 
for interstate movement.

    (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.

[28 FR 5937, June 13, 1963, as amended at 34 FR 15642, Oct. 9, 1969; 55 
FR 11156, Mar. 27, 1990; 55 FR 15320, Apr. 23, 1990; 62 FR 27934, May 
22, 1997]



Sec.  71.17  Interstate movement of dead poultry or other animals 
prohibited in same car with live poultry or other animals.

    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.

[28 FR 5937, June 13, 1963, as amended at 34 FR 15642, Oct. 9, 1969]

[[Page 197]]



Sec.  71.18  Individual identification of certain cattle 2 years of 
age or over for movement in interstate commerce.

    (a) No cattle 2 years of age or over, except steers and spayed 
heifers and cattle of any age which are being moved interstate during 
the course of normal ranching operations without change of ownership to 
another premises owned, leased, or rented by the same individual as 
provided in Sec. Sec.  78.9(a)(3)(ii), 78.9(b)(3)(iv), and 
78.9(c)(3)(iv) of this chapter, shall be moved in interstate commerce 
other than in accordance with the requirements of this section. Any 
movement in interstate commerce of any cattle shall also comply with the 
other applicable provisions in this part and other parts of this 
subchapter.
    (1) When permitted under such other provisions, cattle subject to 
this section:
    (i) May be moved in interstate commerce from any point to any 
destination, if such cattle, when moved in interstate commerce, are 
identified by a Department-approved backtag\1\ affixed a few inches from 
the midline and just behind the shoulder of the animal, or by such other 
means approved by the Administrator, upon request in specific cases, and 
if except as provided in paragraph (a)(5) of this section such cattle 
when moved interstate are accompanied by a statement signed by the owner 
or shipper of the cattle, or other document\2\ stating: (A) The point 
from which the animals are moved interstate; (B) the destination of the 
animals; (C) the number of animals covered by the statement, or other 
document; (D) the name and address of the owner at the time of the 
movement; (E) the name and address of the previous owner if ownership 
changed within four months prior to the movement of the cattle; (F) the 
name and address of the shipper; and (G) the identifying numbers of the 
backtags or other approved identification applied: Provided, That 
identification numbers are not required to be recorded on such statement 
or document for cattle moved from a stockyard posted under the 
provisions of the Packers and Stockyards Act, 1921, as amended (7 U.S.C. 
181 et seq.),\3\ directly to a recognized slaughtering establishment as 
defined in Sec.  78.1 of this chapter; or
---------------------------------------------------------------------------

    \1\ Department-approved backtags are available at recognized 
slaughtering establishments and specifically approved stockyards and 
from State representatives and APHIS representatives. A list of 
recognized slaughtering establishments and specifically approved 
stockyards may be obtained as indicated in Sec.  78.1 of this chapter. 
The terms ``State representative'' and ``APHIS representative'' are 
defined in Sec.  78.1 of this chapter.
    \2\ Other document means a shipping permit, an official health 
certificate, an official brand inspection certificate, a bill of lading, 
a waybill, or an invoice on which is listed the required information.
    \3\Posted stockyards are designated by posting notice at such 
stockyards and by publication in the Federal Register. Information 
concerning posted stockyards may also be obtained from the Washington 
office or the area offices of the Packers and Stockyards Administration.
---------------------------------------------------------------------------

    (ii) May be moved in interstate commerce only from a farm, ranch, or 
feedlot to a recognized slaughtering establishment as defined in Sec.  
78.1 of this chapter; or to a stockyard posted under the provisions of 
the Packers and Stockyards Act, 1921, as amended (7 U.S.C. 181 et seq.), 
for sale and shipment to such a slaughtering establishment, if such 
cattle are identified upon arrival at such slaughtering establishment or 
stockyard by the application of Department-approved backtags or by other 
approved identification as prescribed in paragraph (a)(1)(i) of this 
section and, except as provided in paragraph (a)(5) of this section when 
moved interstate, are accompanied by a statement signed by the owner or 
shipper of the cattle, or other document\2\ stating: (A) The point from 
which the animals are moved interstate; (B) the destination of the 
animals; (C) the number of animals covered by the statement or other 
document; and (D) the name and address of the owner at the time of 
movement; (E) the name and address of the previous owner if ownership 
changed within four months prior to the movement of the cattle; and (F) 
the name and address of the shipper: Provided, That the application of 
backtags is not required if such cattle are moved in interstate commerce 
to a recognized slaughtering establishment as defined in Sec.  78.1 of 
this chapter and if, when

[[Page 198]]

moved in interstate commerce, such cattle are identified by a brand 
registered with an official brand inspection agency and are accompanied 
by an official brand inspection certificate: And provided, further, That 
the application of backtags is not required when such cattle are moved 
in interstate commerce to a recognized slaughtering establishment as 
defined in Sec.  78.1 of this chapter, which maintains records of 
ownership of cattle by slaughter lot number;\4\ or
---------------------------------------------------------------------------

    \4\ It is the responsibility of the person who causes the interstate 
movement to determine whether the establishment maintains such records. 
As evidence that the establishment does maintain such records such 
person should obtain a statement to that effect from the management of 
the establishment and retain it for a period of five years from the date 
of shipment.
---------------------------------------------------------------------------

    (iii) May be moved in interstate commerce for any purpose other than 
slaughter if such cattle, when moved in interstate commerce, are 
identified by Animal and Plant Health Inspection Service-approved 
eartags in lieu of backtags, and, except as provided in paragraph (a)(5) 
of this section, are accompanied when moved interstate by an owner's 
statement or other document\2\ stating: (A) The point from which the 
animals are moved interstate, (B) the destination of the animals, (C) 
the number of animals covered by the statement or other document, (D) 
the identifying numbers of the eartags, and (E) the name and address of 
the owner at the time of movement; (F) the name and address of the 
previous owner if ownership changed within four months prior to the 
movement of the cattle; and (G) the name and address of the shipper: 
Provided, That identification by eartag is not required if such animals 
are registered purebred animals which are moved in interstate commerce 
for any purpose other than slaughter and are identified in a manner 
acceptable to the appropriate breed association for registration 
purposes; or are identified by a brand registered with an official brand 
inspection agency and are accompanied by an official brand inspection 
certificate as prescribed in paragraph (a)(1)(ii) of this section.
    (2) The owner's or shipper's statement or other document\2\ or 
registered purebred identification required by this section for cattle 
moved under paragraph (a)(1)(i) or (ii) of this section shall be 
delivered to the management of the stockyard or slaughtering 
establishment at the time of delivery of the cattle;\5\ and documents 
accompanying animals moved under paragraph (a)(1)(iii) of this section 
for breeding or dairy purposes shall be delivered to the consignee. All 
such documents shall be made available for inspection on request by a 
State or Federal representative or an accredited veterinarian, as 
defined in Sec.  78.1, at any time within the year from the date of such 
delivery.
---------------------------------------------------------------------------

    \5\ The backtag or other identification numbers should be included 
on the receiving document of the stockyard or establishment for all such 
cattle identified by backtags or other identification after arrival at 
such stockyard or establishment.
---------------------------------------------------------------------------

    (3) Each person who ships, transports, or otherwise causes the 
cattle to be moved in interstate commerce is responsible for the 
identification of the cattle as required by this section.
    (4) No person shall remove or tamper with or cause the removal of or 
tampering with a backtag, eartag, brand, or other identification device 
required to be on cattle pursuant to this section while such cattle are 
being moved in interstate commerce, 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.
    (5) Cattle that would otherwise be required to be accompanied by an 
owner-shipper statement or other document \2\ as a condition of movement 
in interstate commerce under paragraph (a)(1) of this section, shall not 
be required to be accompanied by such an owner-shipper statement or 
other document \6\ if the following conditions are met: if the cattle 
are moved to a recognized slaughtering establishment as defined

[[Page 199]]

in Sec.  78.1 of this chapter or to a stockyard specifically approved 
under Sec.  71.20; if the cattle are moved from a farm or other premises 
where the cattle to be moved interstate have been kept for not less than 
four months prior to the date of movement; and if such farm or other 
premises has not had on the premises any cattle or bison from any other 
premises within four months prior to the date of movement.
---------------------------------------------------------------------------

    \6\ Other document means a shipping permit, an official health 
certificate, an official brand inspection certificate, a bill of lading, 
a waybill, or an invoice on which is listed the required information.

[38 FR 22768, Aug. 24, 1973, as amended at 47 FR 55656, Dec. 13, 1982; 
50 FR 45987, Nov. 6, 1985; 51 FR 32599, Sept. 12, 1986; 52 FR 2987, Jan. 
30, 1987; 55 FR 11156, Mar. 27, 1990; 62 FR 27934, May 22, 1997; 68 FR 
62226, Nov. 3, 2003]



Sec.  71.19  Identification of swine in interstate commerce.

    (a)(1) Except as provided in paragraphs (c) and (h) 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 backtags, 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 Sec.  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; and
    (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.
    (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 
backtags 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

[[Page 200]]

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 backtags, 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) Written requests for approval of swine identification devices 
and markings not listed in paragraph (b) of this section should be sent 
to the Animal and Plant Health Inspection Service, Veterinary Services, 
Cattle Diseases and Surveillance, 4700 River Road Unit 36, Riverdale, 
Maryland 20737-1231. If the Administrator determines that the devices 
and markings will provide a means of tracing swine in interstate 
commerce, a proposal will be published in the Federal Register to add 
the devices and markings to the list of approved means of swine 
identification.
    (h) 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.

[[Page 201]]

    (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.
    (i) 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

[[Page 202]]

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.

[53 FR 40385, Oct. 14, 1988, as amended at 55 FR 11156, Mar. 27, 1990; 
55 FR 15320, Apr. 23, 1990; 59 FR 67612, Dec. 30, 1994; 62 FR 27934, May 
22, 1997; 62 FR 54758, Oct. 22, 1997; 66 FR 65603, Dec. 20, 2001]



Sec.  71.20  Approval of livestock facilities.

    (a) To qualify for approval by the Administrator as an approved 
livestock facility \7\ and to retain such designation, the individual 
legally responsible for the day-to-day operations of the livestock 
facility shall execute the following agreement:
---------------------------------------------------------------------------

    \7\ A list of approved livestock facilities may be obtained by 
writing to National Animal Health Programs, VS, APHIS, 4700 River Road 
Unit 36, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

 AGREEMENT--APPROVED LIVESTOCK FACILITY FOR HANDLING LIVESTOCK PURSUANT 
              TO TITLE 9 OF THE CODE OF FEDERAL REGULATIONS

    [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).

                               Cooperation

    (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, 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, or 
suspect, or that show signs of possibly being infected, with any 
infectious, contagious, or communicable disease.
    (5) Any reactor, suspect, or exposed livestock shall be held in 
quarantined pens apart from all other livestock at the facility.
    (6) No reactor, suspect, or exposed livestock, nor any livestock 
that show signs of being infected with any infectious, contagious, or 
communicable disease, may be sold at the facility, except as authorized 
by an APHIS representative, State representative, or accredited 
veterinarian.

                                 Records

    (7) Documents such as weight tickets, sales slips, and records of 
origin, identification, and destination that relate to livestock that 
are in, or that have been in, the facility shall be maintained by the 
facility for a period of 2 years. APHIS representatives and State 
representatives shall be permitted to review and copy those documents 
during normal business hours.

[[Page 203]]

                             Identification

    (8) All livestock must be officially identified in accordance with 
the applicable regulations in 9 CFR parts 71, 75, 78, and 85 at the time 
of, or prior to, entry into the facility.

                        Cleaning and Disinfection

    (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.

               General Facilities and Equipment Standards

    (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 before being used to pen livestock that are not reactor, 
suspect, or exposed animals.
    (12) Quarantined pens shall have adequate drainage, and the floors 
and those parts of the walls of the quarantined pens with which reactor, 
or suspect, or exposed 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.

          Standards for Handling Different Classes of Livestock

(By his or her initials, the operator of the facility shall signify the 
class or classes of livestock that the facility will handle.)
    (14) Cattle and bison:
--This facility will handle cattle and bison: [Initials of operator, 
date]
--This facility will handle cattle and bison known to be brucellosis 
reactors, suspects, or exposed: [Initials of operator, date]
--This facility will not handle cattle and bison known to be brucellosis 
reactors, suspects, or exposed and such cattle and bison will not be 
permitted to enter the facility: [Initials of operator, date]
    (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:

--This facility will handle breeding swine: [Initials of operator, date]
--This facility will handle slaughter swine: [Initials of operator, 
date]
--This facility will handle feeder swine: [Initials of operator, date]

[[Page 204]]

--This facility will handle pseudorabies reactor, suspect, or exposed 
swine: [Initials of operator, date].
--This facility will not handle swine known to be pseudorabies reactor, 
suspect, or exposed swine and such swine will not be permitted to enter 
the facility: [Initials of operator, date].

    (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:

--This facility will handle horses: [Initials of operator, date]
--This facility will handle equine infectious anemia (EIA) reactors: 
[Initials of operator, date]
--This facility will not handle horses known to be EIA reactors and will 
not permit EIA reactors to enter the facility: [Initials of operator, 
date]

    (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.

                                Approvals

    (17) 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 (16) of this agreement. I acknowledge that I 
have received a copy of 9 CFR parts 71, 75, 78 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, and 85 constitutes a basis for the withdrawal of this 
approval. [Printed name and signature of operator, date of signature]
    (18) Pre-approval inspection of livestock facility conducted by 
[printed name and title of APHIS representative] on [date of 
inspection].
    (19) 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]
    (20) 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

[[Page 205]]

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.

[62 FR 27934, May 22, 1997, as amended at 62 FR 54758, Oct. 22, 1997; 63 
FR 32119, June 12, 1998; 68 FR 62226, Nov. 3, 2003]



PART 72_TEXAS (SPLENETIC) FEVER IN CATTLE--Table of Contents




Sec.
72.1 Ticks [Boophilus annulatus (Margaropus annulatus), Boophilus 
          microplus, or Rhipicephalus evertsi evertsi]; interstate 
          movement of infested or exposed animals prohibited.
72.2 Splenetic or tick fever in cattle in Texas, the Virgin Islands of 
          the United States and vectors of said disease in the Northern 
          Mariana Islands, the Commonwealth of Puerto Rico and the 
          Island of Guam: Restrictions on movement of cattle.
72.3 Areas quarantined in the Virgin Islands of the United States, the 
          Northern Mariana Islands, the Commonwealth of Puerto Rico, and 
          the Island of Guam.
72.4 [Reserved]
72.5 Area quarantined in Texas.
72.6 Interstate movement of cattle from quarantined areas not 
          eradicating ticks.
72.7 Interstate movement of cattle from cooperating States.
72.8 Interstate movement of cattle from free premises upon inspection 
          and certification by APHIS inspector.
72.9 Interstate movements of cattle; inspection and certification by 
          APHIS inspector required.
72.10 Inspected or dipped and certified cattle subject to restrictions 
          of State of destination.
72.11 Quarantined area; cattle considered infested; requirements for 
          placing in noninfectious pens or premises.
72.12 Cattle; exposure to tick infestation after treatment or inspection 
          prohibited.
72.13 Permitted dips and procedures.
72.14 [Reserved]
72.15 Owners assume responsibility; must execute agreement prior to 
          dipping or treatment waiving all claims against United States.
72.16 Designated dipping stations to be approved by the Administrator, 
          APHIS on recommendations of State authorities; facilities.
72.17 Unloading noninfected cattle for rest, feed, and water only, 
          permitted in authorized pens for such purpose.
72.18 Movement interstate; specification by the Deputy Administrator, 
          Veterinary Services of treatment required when dipping 
          facilities unavailable.
72.19 Interstate shipments and use of pine straw, grass, litter from 
          quarantined area; prohibited until disinfected.
72.20 Exhibition of noninfected cattle in the quarantined area; 
          restrictions under which permitted.
72.21 Animals infested with or exposed to ticks subject to same 
          restrictions as cattle.

[[Page 206]]

72.22 Cars, vehicles, and premises; cleaning and treatment after 
          containing infested or exposed animals.
72.23 Cars or other vehicles having carried infested or exposed cattle 
          in quarantined area shall be cleaned and treated.
72.24 Litter and manure from carriers and premises of tick-infested 
          animals; destruction or treating required.
72.25 Dipping methods.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 28 FR 5940, June 13, 1963, unless otherwise noted.



Sec.  72.1  Ticks [Boophilus annulatus (Margaropus annulatus), Boophilus 

microplus, or Rhipicephalus evertsi evertsi]; interstate movement of 
infested or exposed animals prohibited.

    No animals infested with ticks [Boophilus annulatus (Margaropus 
annulatus), Boophilus microplus, or Rhipicephalus evertsi evertsi] or 
exposed to tick infestation shall be shipped, trailed, driven, or 
otherwise moved interstate for any purpose, except as provided in this 
part.



Sec.  72.2  Splenetic or tick fever in cattle in Texas, the Virgin Islands 

of the United States and vectors of said disease in the Northern Mariana 
Islands, the Commonwealth of Puerto Rico and the Island of Guam: 
          Restrictions on movement of cattle.

    Notice is hereby given that the contagious, infectious, and 
communicable disease known as splenetic 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 Sec. Sec.  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.

[43 FR 60864, Dec. 29, 1978]



Sec.  72.3  Areas quarantined in the Virgin Islands of the United States, 

the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the 
Island of Guam.

    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.

[43 FR 60864, Dec. 29, 1978]



Sec.  72.4  [Reserved]



Sec.  72.5  Area quarantined in Texas.

    The area quarantined in Texas is the permanent quarantined area 
described in the regulations of the Texas Animal Health Commission 
(TAHC) contained in Sec.  41.2 of title 4, part II, of the Texas 
Administrative Code (4 TAC 41.2), effective April 8, 2001, 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 41.2 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, Emergency 
Programs, Suite 3B08, 4700 River Road, Riverdale, MD, or at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC.

[64 FR 41266, July 30, 1999, as amended at 67 FR 18467, Apr. 16, 2002]



Sec.  72.6  Interstate movement of cattle from quarantined areas 
not eradicating ticks.

    Cattle in quarantined areas where tick eradication is not being 
conducted\3\ may be shipped or transported interstate in accordance with 
Sec. Sec.  72.9

[[Page 207]]

through 72.15 under the following conditions: The cattle must have been 
dipped twice with a permitted dip as provided in Sec.  72.13, with an 
interval of 7 to 12 days between dippings immediately preceding 
shipment, at a designated dipping station approved under Sec.  72.16 and 
located in the State of origin of the shipment or, in specific cases, 
after having been otherwise treated at a designated dipping station 
under the supervision of an APHIS inspector and in a manner approved by 
the Administrator. In all cases, the cattle must be inspected by an 
APHIS inspector just prior to final dipping, found to be apparently free 
of ticks, and be certified as such by APHIS before the cattle may be 
released for interstate movement.
---------------------------------------------------------------------------

    \3\ Information regarding the identities of such areas may be 
obtained from the Animal and Plant Health Inspection Service, Veterinary 
Services, National Animal Health Programs, 4700 River Road Unit 43, 
Riverdale, Maryland 20737-1231.

[66 FR 21061, Apr. 27, 2001]



Sec.  72.7  Interstate movement of cattle from cooperating States.

    Cattle in areas where tick eradication is being conducted in 
cooperation with State authorities,\3\ which on inspection by an APHIS 
inspector are found to be apparently free from ticks, may, after one 
dipping, with a permitted dip as provided in Sec.  72.13, under the 
supervision of an APHIS inspector and certification by the inspector, be 
shipped or transported interstate for dip as provided in Sec.  72.13, 
under the supervision of an APHIS inspector and certification by the 
inspector, be shipped or transported interstate for any purpose upon 
compliance with the requirements set forth in Sec. Sec.  72.9 through 
72.15.

[36 FR 20358, Oct. 21, 1971, as amended at 56 FR 51975, Oct. 17, 1991]



Sec.  72.8  Interstate movement of cattle from free premises upon 
inspection and certification by APHIS inspector.

    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 Sec. Sec.  72.9, 72.10, 
72.12.

[28 FR 5940, June 13, 1963, as amended at 56 FR 51975, Oct. 17, 1991]



Sec.  72.9  Interstate movements of cattle; inspection and certification 
by APHIS inspector required.

    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 Sec.  72.6 or by 
Sec.  72.7 and are free of ticks, or have been inspected as required by 
Sec.  72.8 and are free of ticks); all such certificates shall be 
handled, delivered, kept, and preserved in accordance with the 
provisions of Sec.  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.

[28 FR 5940, June 13, 1963, as amended at 56 FR 51975, Oct. 17, 1991]



Sec.  72.10  Inspected or dipped and certified cattle subject to 
restrictions of State of destination.

    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.



Sec.  72.11  Quarantined area; cattle considered infested; requirements 
for placing in noninfectious pens or premises.

    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.

[[Page 208]]



Sec.  72.12  Cattle; exposure to tick infestation after treatment or 
inspection prohibited.

    The cattle shall not be exposed to tick infestation after treatment 
and/or inspection.



Sec.  72.13  Permitted dips and procedures.

    (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.\4\
---------------------------------------------------------------------------

    \4\ Care is required when treating animals and in maintaining the 
required concentration of chemicals in dipping baths. Detailed 
information concerning the use of, criteria for, and names of 
proprietary brands of permitted dips--as well the use of compressed air, 
vat management techniques, and other information--is available from the 
Animal and Plant Health Inspection Service, Veterinary Services, 
National Animal Health Programs, 4700 River Road Unit 43, Riverdale, MD 
20737-1231.
---------------------------------------------------------------------------

    (b) Permitted dips. The dips at present permitted by the Department 
in official dipping for interstate movement are:
    (1) Approved proprietary brands of a Dioxathion (Delnav[reg]) 
emulsifiable concentrate used at a concentration of 0.125 to 0.150 
percent.\4\
    (2) Approved proprietary brands of coumaphos (Co-Ral[reg]), 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.\4\
    (3) Approved proprietary brands of organophosphorous insecticides 
(Prolate[reg]) if used in a Prolate-water bath where the concentration 
level is at least 0.15 percent and if used in accordance with the EPA 
approved label.
    (4) Approved proprietary brands of organophosphorous insecticides 
(Ciodrin[reg]) if used in a concentration of 0.44 to 0.54 percent and if 
used in accordance with the EPA approved label.
    (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.

[33 FR 18089, Dec. 5, 1968, as amended at 34 FR 12214, July 24, 1969; 36 
FR 19157, Sept. 30, 1971; 36 FR 19972, Oct. 14, 1971; 37 FR 13529, July 
11, 1972; 38 FR 19012, July 17, 1973; 40 FR 12768, Mar. 21, 1975; 42 FR 
19854, Apr. 15, 1977; 47 FR 11002, Mar. 15, 1982; 49 FR 19799, May 10, 
1984; 49 FR 32540, Aug. 15, 1984; 50 FR 430, 431, Jan. 4, 1985; 56 FR 
51974, Oct. 17, 1991; 66 FR 21062, Apr. 27, 2001]



Sec.  72.14  [Reserved]



Sec.  72.15  Owners assume responsibility; must execute agreement prior 
to dipping or treatment waiving all claims against United States.

    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

[[Page 209]]

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.

[28 FR 5940, June 13, 1963, as amended at 56 FR 51975, Oct. 17, 1991]



Sec.  72.16  Designated dipping stations to be approved by the 
Administrator, APHIS on recommendations of State authorities; facilities.

    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 Sec.  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.

[28 FR 5940, June 13, 1963, as amended at 50 FR 430, Jan. 4, 1985; 56 FR 
51974, Oct. 17, 1991]



Sec.  72.17  Unloading noninfected cattle for rest, feed, and water only, 
permitted in authorized pens for such purpose.

    (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.

[28 FR 5940, June 13, 1963, as amended at 56 FR 51975, Oct. 17, 1991]

[[Page 210]]



Sec.  72.18  Movement interstate; specification by the Deputy Administrator, 
Veterinary Services of treatment required when dipping facilities unavailable.

    (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 Sec.  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 Sec.  
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 Sec.  72.6 or Sec.  72.7 
or inspected in the manner provided in Sec.  72.8 shall not be shipped 
or moved interstate until they have been treated in the same manner as 
cattle under Sec.  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.

[28 FR 5940, June 13, 1963, as amended at 50 FR 430, Jan. 4, 1985; 56 FR 
51974, Oct. 17, 1991]



Sec.  72.19  Interstate shipments and use of pine straw, grass, litter 
from quarantined area; prohibited until disinfected.

    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 Sec.  72.24.



Sec.  72.20  Exhibition of noninfected cattle in the quarantined area; 
restrictions under which permitted.

    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.

[28 FR 5940, June 13, 1963, as amended at 56 FR 51974, Oct. 17, 1991]



Sec.  72.21  Animals infested with or exposed to ticks subject to same 
restrictions as cattle.

    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 Sec. Sec.  72.9 through 72.15 and 
Sec.  72.18 of this part governing the interstate movement of cattle.



Sec.  72.22  Cars, vehicles, and premises; cleaning and treatment after 
containing infested or exposed animals.

    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 Sec.  72.13 under supervision of a State 
or Federal inspector or an accredited veterinarian.

[38 FR 21996, Aug. 15, 1973]

[[Page 211]]



Sec.  72.23  Cars or other vehicles having carried infested or exposed 
cattle in quarantined area shall be cleaned and treated.

    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 Sec.  72.13 before being moved interstate under supervision of 
a State or Federal inspector or an accredited veterinarian.

[38 FR 21996, Aug. 15, 1973]



Sec.  72.24  Litter and manure from carriers and premises of tick-infested 
animals; destruction or treating required.

    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 Sec.  72.13, or shall be 
otherwise disposed of under prior permission received from the 
Administrator, APHIS.

[38 FR 21996, Aug. 15, 1973, as amended at 56 FR 51974, 51975, Oct. 17, 
1991]



Sec.  72.25  Dipping methods.

    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.

[50 FR 430, Jan. 4, 1985]



PART 73_SCABIES IN CATTLE--Table of Contents




Sec.
73.1 Interstate movement prohibited.
73.1a [Reserved]
73.1b Quarantine policy.
73.1c Definitions.
73.2 Interstate shipment for immediate slaughter from quarantined or 
          nonquarantined areas; conditions under which permitted.
73.3 Shipment for purposes other than slaughter; conditions under which 
          permitted.
73.4 Interstate shipment of exposed but not visibly diseased cattle from 
          a quarantined or nonquarantined area; conditions under which 
          permitted.
73.5 Interstate shipment of undiseased cattle from quarantined area; 
          when permitted.
73.6 Placarding means of conveyance and marking billing of shipments of 
          treated scabby cattle or cattle exposed to scabies.
73.7 Movement from quarantined to free area and shipment therefrom; 
          restrictions under which permitted.
73.8 Cattle infected or exposed during transit.
73.9 Owners assume responsibility; must execute agreement prior to 
          dipping or treatment waiving all claims against United States.
73.10 Permitted dips; substances allowed.
73.11 Treatment of means of conveyance and premises having contained 
          scabby cattle.
73.12 Ivermectin.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.



Sec.  73.1  Interstate movement prohibited.

    (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.

[28 FR 5945, June 13, 1963, as amended at 41 FR 5384, Feb. 6, 1976]



Sec.  73.1a  [Reserved]



Sec.  73.1b  Quarantine policy.

    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

[[Page 212]]

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.

[38 FR 31671, Nov. 16, 1973, as amended at 68 FR 6343, Feb. 7, 2003]



Sec.  73.1c  Definitions.

    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.

[41 FR 5384, Feb. 6, 1976, as amended at 56 FR 52463, Oct. 21, 1991]



Sec.  73.2  Interstate shipment for immediate slaughter from quarantined 
or nonquarantined areas; conditions under which permitted.

    (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 Sec.  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 Sec.  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

[[Page 213]]

when accompanied by a certificate from such inspector showing the cattle 
to be free from disease.

[31 FR 8907, June 28, 1966, as amended at 36 FR 23996, Dec. 17, 1971; 38 
FR 18011, July 6, 1973; 41 FR 5384, Feb. 6, 1976; 49 FR 10530, Mar. 20, 
1984; 49 FR 33120, Aug. 21, 1984; 56 FR 52463, Oct. 21, 1991; 66 FR 
21062, Apr. 27, 2001]



Sec.  73.3  Shipment for purposes other than slaughter; conditions under 
which permitted.

    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 
Sec.  73.6.

[28 FR 5945, June 13, 1963, as amended at 41 FR 5384, Feb. 6, 1976; 49 
FR 10530, Mar. 20, 1984; 49 FR 33120, Aug. 21, 1984; 56 FR 52463, Oct. 
21, 1991; 66 FR 21062, Apr. 27, 2001]



Sec.  73.4  Interstate shipment of exposed but not visibly diseased cattle 
from a quarantined or nonquarantined area; conditions under which permitted.

    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 Sec.  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.

[28 FR 5945, June 13, 1963, as amended at 41 FR 5384, Feb. 6, 1976; 56 
FR 52463, Oct. 21, 1991]



Sec.  73.5  Interstate shipment of undiseased cattle from quarantined 
area; when permitted.

    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 Sec.  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

[[Page 214]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[31 FR 8907, June 28, 1966 as amended at 36 FR 23996, Dec. 17, 1971; 38 
FR 10252, Apr. 26, 1973; 38 FR 18011, July 6, 1973; 41 FR 5384, Feb. 6, 
1976; 48 FR 57472, Dec. 30, 1983; 49 FR 10530, Mar. 20, 1984; 49 FR 
33120, Aug. 21, 1984; 56 FR 52463, Oct. 21, 1991; 66 FR 21062, Apr. 27, 
2001]



Sec.  73.6  Placarding means of conveyance and marking billing of 
shipments of treated scabby cattle or cattle exposed to scabies.

    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\1/2\ by 8 
inches in size, on which shall be printed with permanent black ink in 
boldfaced letters, not less than 1\1/2\ inches in height, the words, 
``Treated Scabby Cattle,'' or ``Cattle Exposed to Scabies,'' as the case 
may be. These placards shall also show the name of the place from which 
the shipment was made, the date of the shipment (which must correspond 
to the date of the waybills and other papers), the name of the 
transportation company, and the name of the place of destination. The 
carrier issuing the waybills, conductors' manifests, memoranda, and 
bills of lading pertaining to such shipments shall plainly write or 
stamp upon the face of each such paper the words, ``Treated Scabby 
Cattle,'' or ``Cattle Exposed to Scabies,'' as the case may be. If for 
any reason the placards required by this part have not been affixed to 
the means of conveyance as aforesaid, or the placards have been removed, 
destroyed, or rendered illegible, or the cattle are rebilled or are 
transferred to other means of conveyance, the placards shall be 
immediately affixed or replaced by the carrier, and the new waybills 
shall be marked as aforesaid by the carrier issuing them, the intention 
being that the billing accompanying the shipment shall be marked and the 
means of conveyance containing the cattle shall be placarded ``Treated 
Scabby Cattle,'' or ``Cattle Exposed to Scabies,'' as the case may be, 
from the time of shipment until the cattle arrive at destination or 
point of dipping and the disposition of the means of conveyance is 
indicated by an APHIS inspector or State inspector.

[28 FR 5945, June 13, 1963, as amended at 41 FR 5384, Feb. 6, 1976; 49 
FR 10530, Mar. 20, 1984; 49 FR 33120, Aug. 21, 1984; 56 FR 52463, Oct. 
21, 1991; 66 FR 21062, Apr. 27, 2001]



Sec.  73.7  Movement from quarantined to free area and shipment 
therefrom; restrictions under which permitted.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

(44 U.S.C. 3506)

[28 FR 5945, June 13, 1963, as amended at 41 FR 5384, Feb. 6, 1976; 48 
FR 57472, Dec. 30, 1983; 56 FR 52463, Oct. 21, 1991]

[[Page 215]]



Sec.  73.8  Cattle infected or exposed during transit.

    (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 Sec. Sec.  71.4 through 71.11 of this subchapter.

[28 FR 5945, June 13, 1963, as amended at 41 FR 5384, Feb. 6, 1976; 56 
FR 52463, Oct. 21, 1991]



Sec.  73.9  Owners assume responsibility; must execute agreement prior 
to dipping or treatment waiving all claims against United States.

    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.

[41 FR 4012, Jan. 28, 1976, as amended at 56 FR 52463, Oct. 21, 1991]



Sec.  73.10  Permitted dips; substances allowed.

    (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[reg]), 25 
percent wettable powder or flowable form used at a concentration of 0.30 
percent.
    (4) Approved proprietary brands of organophosphorous insecticides 
(Prolate[reg]) 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 [deg] to 105 [deg]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

[[Page 216]]

baths approved by the APHIS.\1\ The dipping bath for toxaphene emulsions 
must be kept within a temperature range of 40[deg]-80 [deg]F., and at a 
concentration between 0.50 and 0.60 percent throughout the dipping 
operations. \2\
---------------------------------------------------------------------------

    \1\ The field test for lime-sulphur dipping baths is described in 
U.S. Department of Agriculture Bulletin 163, for sale by the 
Superintendent of Documents, Government Printing Office, Washington, 
D.C. 20402, at 5 cents a copy.
    \2\ Care must be exercised in dipping animals and in maintaining the 
bath at the standard concentration. Detailed instructions will be issued 
for the guidance of employees who may be called upon to use them in the 
scabies eradication program.
---------------------------------------------------------------------------

    (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 
\3\ 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 is efficacy and stability have been 
demonstrated; that trials have been conducted to determine that its 
concentration can be maintained and that under actual filed conditions 
the dipping of cattle in a bath of definite strength will effectually 
eradicate scabies infection without injury to the animals dipped.
---------------------------------------------------------------------------

    \3\ Information as to the names of such dips may be obtained from 
the APHIS or a APHIS inspector.

[34 FR 7443, May 8, 1969, as amended at 39 FR 39715, Nov. 11, 1974; 40 
FR 12768, Mar. 21, 1975; 40 FR 42179, Sept. 11, 1975; 41 FR 5384, Feb. 
6, 1976; 41 FR 37307, Sept. 3, 1976; 50 FR 431, Jan. 4, 1985; 56 FR 
52463, Oct. 21, 1991]



Sec.  73.11  Treatment of means of conveyance and premises having 
contained scabby cattle.

    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 
Sec.  73.10 under supervision of a State or Federal inspector or an 
accredited veterinarian.

[38 FR 21996, Aug. 15, 1973, as amended at 41 FR 5384, Feb. 6, 1976]



Sec.  73.12  Ivermectin.\1\

    (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\ Tissue residues remain following treatment with ivermectin. 
Cattle treated with ivermectin are not allowed to 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.). Further, 
the animal drug regulations in 21 CFR parts 522 and 556 promulgated 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
contain limitations on the use of ivermectin and contain tolerances for 
ivermectin in edible cattle tissue. With respect to the limitations 21 
CFR part 522 provides the following: ``For subcutaneous use only. Not 
for intramuscular use. Do not treat cattle within 35 days of slaughter. 
Because a withdrawal time in milk has not been established, do not use 
in female dairy cattle of breeding age. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.''
---------------------------------------------------------------------------

    (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

[[Page 217]]

the billing marked in accordance with Sec.  73.6.
    Note: 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 Sec.  73.6.

[49 FR 10530, Mar. 20, 1984 and 49 FR 33120, Aug. 21, 1984; 56 FR 52463, 
Oct. 21, 1991; 66 FR 21062, Apr. 27, 2001]



PART 74_PROHIBITION OF INTERSTATE MOVEMENT OF LAND TORTOISES--Table of Contents




    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.



Sec.  74.1  General prohibition.

    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.

[66 FR 37128, July 17, 2001]



PART 75_COMMUNICABLE DISEASES IN HORSES, ASSES, PONIES, MULES, AND ZEBRAS--Table of Contents




                       Dourine in Horses and Asses

Sec.
75.1-75.3 [Reserved]

                 Equine Infectious Anemia (Swamp Fever)

75.4 Interstate movement of equine infectious anemia reactors and 
          approval of laboratories, diagnostic facilities, and research 
          facilities.

                    Contagious Equine Metritis (CEM)

75.5-75.10 [Reserved]

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

[[Page 218]]


    Source: 28 FR 5950, June 13, 1963, unless otherwise noted.

                       Dourine in Horses and Asses



Sec. Sec.  75.1-75.3  [Reserved]

                 Equine Infectious Anemia (Swamp Fever)



Sec.  75.4  Interstate movement of equine infectious anemia reactors 
and approval of laboratories, diagnostic facilities, and research facilities.

    (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 Sec.  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 Sec.  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.
    Official test. Any test for the laboratory diagnosis of equine 
infectious anemia that utilizes a diagnostic product that is: (1) 
Produced under license from the Secretary of Agriculture, and found to 
be efficacious for that diagnosis, under the Virus-Serum-Toxin Act of 
March 4, 1913, and subsequent amendments (21 U.S.C. 151 et seq.); and 
(2) conducted in a laboratory approved by the Administrator.
    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'',\1\ which markings shall be permanently 
applied to the reactor by an APHIS representative, State representative 
or accredited veterinarian who shall use for the purpose a hot iron or 
chemical brand, freezemarking or a lip tattoo. If hot iron or chemical 
branding or freezemarking is used, the markings shall be not less than 
two inches high and shall be applied to the left shoulder or left side 
of the neck of the reactor. If a lip tattoo is used, each character of 
the tattoo shall be not less than one inch high and three-fourths of an 
inch wide and shall be applied to the inside surface of the upper lip of 
the reactor.
---------------------------------------------------------------------------

    \1\ Information as to the National Uniform Tag code number system 
can be obtained from the Animal and Plant Health Inspection Service, 
Veterinary Services, National Animal Health Programs, 4700 River Road 
Unit 43, Riverdale, Maryland 20737-1231.

---------------------------------------------------------------------------

[[Page 219]]

    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 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 individial 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.
    (c) Approval of Laboratories, and Diagnostic or Research Facilities. 
(1) The Administrator will approve laboratories to conduct the official 
test only after consulting with the State animal

[[Page 220]]

health official in the State in which the laboratory is located and 
after determining that the laboratory:
    (i) Has technical personnel assigned to conduct the official test 
who have received training prescribed by the National Veterinary 
Services Laboratories;
    (ii) Uses United States Department of Agriculture licensed antigen;
    (iii) Follows standard test protocol prescribed by the National 
Veterinary Services Laboratories;
    (iv) Meets check test proficiency requirements prescribed by the 
National Veterinary Services Laboratories; and
    (v) Reports all official test results to the State animal health 
official and the Veterinarian in Charge.\2\
---------------------------------------------------------------------------

    \2\ Training requirements, standard test protocols, and check test 
proficiency requirements prescribed by the National Veterinary Services 
Laboratories, and the names and addresses of approved laboratories can 
be obtained from the Animal and Plant Health Inspection Service, 
Veterinary Services, National Animal Health Programs, 4700 River Road 
Unit 43, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (2) The Administrator will approve diagnostic or research facilities 
to which reactors may be moved interstate under paragraph (b)(2) of this 
section, after a determination by the Administrator that the facility 
has facilities and employs procedures which are adequate to prevent the 
transmission of equine infectious anemia from reactors to other equine 
animals.\3\
---------------------------------------------------------------------------

    \3\ Facilities and procedures which are adequate to prevent the 
transmission of equine infectious anemia, and the names and addresses of 
approved diagnostic or research facilities, can be obtained from the 
Animal and Plant Health Inspection Service, Veterinary Services, 
National Animal Health Programs, 4700 River Road Unit 43, Riverdale, 
Maryland 20737-1231.
---------------------------------------------------------------------------

    (d) Denial and withdrawal of approval of laboratories and diagnostic 
or research facilities. The Administrator may deny or withdraw approval 
of any laboratory to conduct the official test, or of any diagnostic or 
research facility to receive reactors moved interstate, upon a 
determination that the laboratory or diagnostic or research facility 
does not meet the criteria for approval under paragraph (c) of this 
section.
    (1) In the case of a denial, the operator of the laboratory or 
facility will be informed of the reasons for 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 laboratory or 
facility was wrongfully denied approval to conduct the official test or 
receive reactors moved interstate. 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 laboratory or facility will be informed of the reasons 
for the proposed withdrawal. The operator of the laboratory or 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 laboratory or facility to conduct the official test or 
receive reactors moved interstate. 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, the 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 laboratory or 
facility. In the event of oral notification, written confirmation shall 
be given as promptly as circumstances allow. The withdrawal shall 
continue in effect pending the completion of the proceeding, and any

[[Page 221]]

judicial review thereof, unless otherwise ordered by the Administrator.
    (3) Approval for a laboratory to conduct the official test will be 
automatically withdrawn by the Administrator when the operator of the 
approved laboratory notifies the National Veterinary Services 
Laboratories in Ames, Iowa, in writing, that the laboratory no longer 
conducts the official test.
    (4) Approval for a diagnostic or research facility to receive 
reactors moved interstate will be automatically withdrawn by the 
Administrator when the operator of the approved diagnostic or research 
facility notifies the Administrator, in writing, that the diagnostic or 
research facility no longer receives reactors moved interstate.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[51 FR 12597, Apr. 14, 1986, as amended at 51 FR 30327, Aug. 26, 1986; 
55 FR 13506, 13507, Apr. 11, 1990; 57 FR 2440, Jan. 22, 1992; 57 FR 
57337, Dec. 4, 1992; 59 FR 67133, Dec. 29, 1994; 59 FR 67613, Dec. 30, 
1994; 60 FR 14619, Mar. 20, 1995; 62 FR 27936, May 22, 1997; 66 FR 
21062, Apr. 27, 2001]

                    Contagious Equine Metritis (CEM)



Sec. Sec.  75.5-75.10  [Reserved]

                           PART 76 [RESERVED]



PART 77_TUBERCULOSIS--Table of Contents




                      Subpart A_General Provisions

Sec.
77.1 Material incorporated by reference.
77.2 Definitions.
77.3 Tuberculosis classifications of States and zones.
77.4 Application for and retention of zones.

                       Subpart B_Cattle and Bison

77.5 Definitions.
77.6 Applicability of this subpart.
77.7 Accredited-free States or zones.
77.8 Interstate movement from accredited-free States and zones.
77.9 Modified accredited advanced States or zones.
77.10 Interstate movement from modified accredited advanced States and 
          zones.
77.11 Modified accredited States or zones.
77.12 Interstate movement from modified accredited States and zones.
77.13 Accreditation preparatory States or zones.
77.14 Interstate movement from accreditation preparatory States and 
          zones.
77.15 Nonaccredited States or zones.
77.16 Interstate movement from nonaccredited States and zones.
77.17 Interstate movement of cattle and bison that are exposed, 
          reactors, or suspects, or from herds containing suspects.
77.18 Other movements.
77.19 Cleaning and disinfection of premises, conveyances, and materials.

                        Subpart C_Captive Cervids

77.20 Definitions.
77.21 Applicability of this subpart.
77.22 Accredited-free States or zones.
77.23 Interstate movement from accredited-free States and zones.
77.24 Modified accredited advanced States or zones.
77.25 Interstate movement from modified accredited advanced States and 
          zones.
77.26 Modified accredited States or zones.
77.27 Interstate movement from modified accredited States and zones.
77.28 Accreditation preparatory States or zones.
77.29 Interstate movement from accreditation preparatory States and 
          zones.
77.30 Nonaccredited States or zones.
77.31 Interstate movement from nonaccredited States and zones.
77.32 General restrictions.
77.33 Testing procedures for tuberculosis in captive cervids.
77.34 Official tuberculosis tests.
77.35 Interstate movement from accredited herds.
77.36 Interstate movement from qualified herds.
77.37 Interstate movement from monitored herds.
77.38 Interstate movement from herds that are not accredited, qualified, 
          or monitored.
77.39 Other interstate movements.
77.40 Procedures for and interstate movement to necropsy and slaughter.
77.41 Cleaning and disinfection of premises, conveyances, and materials.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 65 FR 63517, Oct. 23, 2000, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  77.1  Material incorporated by reference.

    Uniform Methods and Rules--Bovine Tuberculosis Eradication. The 
Uniform Methods and Rules--Bovine Tuberculosis Eradication (January 22, 
1999,

[[Page 222]]

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 Office of the Federal 
Register Library, 800 North Capitol Street NW., Suite 700, Washington, 
DC;
    (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.



Sec.  77.2  Definitions.

    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.
    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.
    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.
    Certificate. An official document issued by an APHIS representative, 
a State representative, or an accredited veterinarian at the point of 
origin of a shipment of livestock to be moved under this part, which 
shows the identification tag, tattoo, or registration number or similar 
identification of each animal to be moved; the number, breed, sex, and 
approximate age of the animals covered by the document; the purpose for 
which the animals are to be moved; the date and place of issuance; the 
points of origin and destination; the consignor and the consignee; and 
which states that the animal or animals identified on the certificate 
meet the requirements of this part.
    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.
    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.
    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

[[Page 223]]

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.
    Livestock. Cattle, bison, 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, as well as previously free-ranging cervids 
that are captured, identified, and moved interstate.
    Moved. Shipped, transported, or otherwise moved, or delivered or 
received for movement.
    Moved directly. Moved without stopping or unloading at livestock 
assembly points of any type. Livestock being moved directly may be 
unloaded from the means of conveyance while en route only with 
permission of the State animal health official and only if the animals 
are isolated so that they cannot mingle with any livestock other than 
those with which they are being shipped.
    Official eartag. An eartag approved by the Administrator as 
providing unique identification for each individual animal by conforming 
to the alpha-numeric National Uniform Eartagging System.
    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 of origin identification. Either an APHIS-approved eartag 
or tattoo bearing the premises of origin identification code that 
consists of the State postal abbreviation followed by a unique number or 
name assigned by a State or Federal animal health official to the 
premises on which the animals originated that, in the judgment of the 
State animal health official or area veterinarian in charge, is 
epidemiologically distinct from other premises; or a brand registered 
with an official brand registry.
    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.)
    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.

[65 FR 63517, Oct. 23, 2000, as amended at 66 FR 7592, Feb. 20, 2002]



Sec.  77.3  Tuberculosis classifications of States and zones.

    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

[[Page 224]]

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.



Sec.  77.4  Application for and retention of zones.

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0146)



                       Subpart B_Cattle and Bison



Sec.  77.5  Definitions.

    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

[[Page 225]]

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.
    Affected herd. A herd in which tuberculosis has been disclosed in 
any cattle or bison by an official tuberculin test or by post mortem 
examination.
    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.
    Approved slaughtering establishment. A slaughtering establishment 
operating under the provisions of the Federal Meat Inspection Act (21 
U.S.C. 601 et seq.) or a State-inspected slaughtering establishment that 
has inspection by a State inspector at the time of slaughter.
    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

[[Page 226]]

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 
Sec. Sec.  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.''
    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 Sec.  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.



Sec.  77.6  Applicability of this subpart.

    All references in this subpart to the tuberculosis status of States 
and zones pertain to such status for cattle and bison only.



Sec.  77.7  Accredited-free States or zones.

    (a) The following are accredited-free States: Alabama, Alaska, 
Arizona, Arkansas, 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 York, North 
Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto 
Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, 
Vermont, Virginia, the Virgin Islands of the United States, Washington, 
West Virginia, Wisconsin, and Wyoming.
    (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 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 Sec.  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

[[Page 227]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0146)

[65 FR 63517, Oct. 23, 2000, as amended at 65 FR 70286, Nov. 22, 2000; 
67 FR 38844, June 6, 2002; 68 FR 20336, Apr. 25, 2003; 68 FR 43621, July 
24, 2003]



Sec.  77.8  Interstate movement from accredited-free States and zones.

    Cattle or bison that originate in an accredited-free State or zone 
may be moved interstate without restriction.



Sec.  77.9  Modified accredited advanced States or zones.

    (a) The following are modified accredited advanced States: 
California, New Mexico, and Texas.
    (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 
Sec.  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

[[Page 228]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0146)

[65 FR 63517, Oct. 23, 2000, as amended at 65 FR 70286, Nov. 22, 2000; 
67 FR 38844, June 6, 2002; 68 FR 20336, Apr. 25, 2003; 68 FR 43621, July 
24, 2003]



Sec.  77.10  Interstate movement from modified accredited advanced 
States and zones.

    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 under one of the following 
conditions:
    (a) The cattle or bison are moved directly to slaughter at an 
approved slaughtering establishment.
    (b) The cattle or bison are sexually intact heifers moved to an 
approved feedlot, or are steers or spayed heifers; and are either 
officially identified or identified by premises of origin 
identification.
    (c) The cattle or bison are from an accredited herd and are 
accompanied by a certificate stating that the accredited herd completed 
the testing necessary for accredited status with negative results within 
1 year prior to the date of movement.
    (d) The cattle or bison are sexually intact animals; are not from an 
accredited herd; are officially identified; and are accompanied by a 
certificate stating that they were negative to an official tuberculin 
test conducted within 60 days prior to the date of movement.

(Approved by the Office of Management and Budget under control numbers 
0579-0146, 0579-0220, and 0579-0229)

[65 FR 63517, Oct. 23, 2000, as amended at 68 FR 20336, Apr. 25, 2003; 
68 FR 43621, July 24, 2003]



Sec.  77.11  Modified accredited States or zones.

    (a) The following are modified accredited States: Michigan.
    (b) The following are modified accredited 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 Sec.  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

[[Page 229]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0146)

[65 FR 63517, Oct. 23, 2000; 65 FR 64479, Oct. 27, 2000]



Sec.  77.12  Interstate movement from modified accredited States and zones.

    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 under one of the following 
conditions:
    (a) The cattle or bison are moved directly to slaughter at an 
approved slaughtering establishment.
    (b) The cattle or bison are sexually intact heifers moved to an 
approved feedlot, or are steers or spayed heifers; are either officially 
identified or identified by premises of origin identification; and are 
accompanied by a certificate stating that they were classified negative 
to an official tuberculin test conducted within 60 days prior to the 
date of movement.
    (c) The cattle or bison are from an accredited herd and are 
accompanied by a certificate stating that the accredited herd completed 
the testing necessary for accredited status with negative results within 
1 year prior to the date of movement.
    (d) The cattle or bison are sexually intact animals; are not from an 
accredited herd; are officially identified; and are accompanied by a 
certificate 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.

(Approved by the Office of Management and Budget under control number 
0579-0146)



Sec.  77.13  Accreditation preparatory States or zones.

    (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 Sec.  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

[[Page 230]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0146)



Sec.  77.14  Interstate movement from accreditation preparatory States 
and zones.

    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 under one of the following 
conditions:
    (a) The cattle or bison are moved directly to slaughter at an 
approved slaughtering establishment.
    (b) The cattle or bison are sexually intact heifers moved to an 
approved feedlot, or are steers or spayed heifers; are officially 
identified or identified by a premises of origin identification; and are 
accompanied by a certificate 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.
    (c) The cattle or bison are from an accredited herd; are officially 
identified; and are accompanied by a certificate 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.
    (d) The cattle or bison are sexually intact animals; are not from an 
accredited herd; are officially identified; and are accompanied by a 
certificate 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

[[Page 231]]

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 6 months following the whole herd test.

(Approved by the Office of Management and Budget under control number 
0579-0146)



Sec.  77.15  Nonaccredited States or zones.

    (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.



Sec.  77.16  Interstate movement from nonaccredited States and zones.

    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 an approved slaughtering establishment.



Sec.  77.17  Interstate movement of cattle and bison that are exposed, 
reactors, or suspects, or from herds containing suspects.

    (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 an approved 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 
transportation document 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 
Sec. Sec.  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 Sec.  50.16 of this 
chapter, exposed cattle or bison may be moved interstate only if they 
are moved directly to

[[Page 232]]

slaughter to an approved 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 
an approved slaughtering establishment.

(Approved by the Office of Management and Budget under control number 
0579-0051)



Sec.  77.18  Other movements.

    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.



Sec.  77.19  Cleaning and disinfection of premises, conveyances, and 
materials.

    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.



                        Subpart C_Captive Cervids



Sec.  77.20  Definitions.

    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 three consecutive official tuberculosis tests of all 
eligible captive cervids in accordance with Sec.  77.33(f) and that 
meets the standards set forth in Sec.  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

[[Page 233]]

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.
    Affected herd. A herd of captive cervids that contains or that has 
contained one or more captive cervids infected with Mycobacterium bovis 
(determined by bacterial isolation of M. bovis) and that has not tested 
negative to the three whole herd tests as prescribed in Sec.  77.39(d) 
of this part.
    Blood tuberculosis (BTB) test. A supplemental test for tuberculosis 
in cervids.
    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 on 
captive cervids.
    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 Sec.  
77.37.

[[Page 234]]

    Negative. Showing no response to the SCT test or the CCT test, 
classified by the testing laboratory as ``avian'' or ``negative'' on the 
BTB 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 (CCT) test; and
    (3) The blood tuberculosis (BTB) 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 Sec.  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 the SCT test or 
the CCT test, or is classified by the testing laboratory as ``M. bovis 
positive'' on the BTB 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 the SCT test or 
the CCT test, or that is classified by the testing laboratory as 
equivocal on the BTB 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.



Sec.  77.21  Applicability of this subpart.

    All references in this subpart to the tuberculosis status of States 
and zones pertain to such status for captive cervids.

[[Page 235]]



Sec.  77.22  Accredited-free States or zones.

    (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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0146)



Sec.  77.23  Interstate movement from accredited-free States and zones.

    Notwithstanding any other provisions of this part, captive cervids 
that originate in an accredited-free State or zone may be moved 
interstate without restriction.



Sec.  77.24  Modified accredited advanced States or zones.

    (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 Sec.  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

[[Page 236]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0146)



Sec.  77.25  Interstate movement from modified accredited advanced 
States and zones.

    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 under one of the following 
conditions:
    (a) The captive cervids are moved directly to slaughter at an 
approved slaughtering establishment.
    (b) The captive cervids are from an accredited herd, qualified herd, 
or monitored herd; are officially identified; and are accompanied by a 
certificate 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.
    (c) The captive cervids are officially identified and are 
accompanied by a certificate stating that they were negative to an 
official tuberculin test conducted within 90 days prior to the date of 
movement.

(Approved by the Office of Management and Budget under control number 
0579-0146)



Sec.  77.26  Modified accredited States or zones.

    (a) States listed in paragraph (b) of this section must submit to 
APHIS \1\ by October 23, 2001 data demonstrating that the State complies 
with the UMR or the State will be redesignated as nonaccredited. If a 
State does submit surveillance data by October 23, 2001 that meets the 
UMR standards, and that APHIS believes qualifies the State for a 
classification other than modified accredited, APHIS will initiate 
rulemaking to change the State's classification.
---------------------------------------------------------------------------

    \1\ Send the information to National Animal Health Programs, 
Veterinary Services, APHIS, 4700 River Road, Unit 42, Riverdale, 
Maryland 20737-1231.
---------------------------------------------------------------------------

    (b) The following are modified accredited States: Alabama, Alaska, 
Arizona, Arkansas, California, Colorado,

[[Page 237]]

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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0146)



Sec.  77.27  Interstate movement from modified accredited States and zones.

    Except for captive cervids from a qualified herd or monitored herd, 
as provided in Sec. Sec.  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 under one of the following conditions:
    (a) The captive cervids are moved directly to slaughter at an 
approved slaughtering establishment.
    (b) The captive cervids are from an accredited herd and are 
accompanied by a certificate stating that the accredited herd completed 
the testing necessary for accredited status with

[[Page 238]]

negative results within 24 months prior to the date of movement.
    (c) The captive cervids are sexually intact animals; are not from an 
accredited herd; are officially identified; and are accompanied by a 
certificate 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.

(Approved by the Office of Management and Budget under control number 
0579-0146)



Sec.  77.28  Accreditation preparatory States or zones.

    (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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0146)



Sec.  77.29  Interstate movement from accreditation preparatory States 
and zones.

    Except for captive cervids from a qualified herd or monitored herd, 
as provided in Sec. Sec.  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,

[[Page 239]]

may be moved interstate only under one of the following conditions:
    (a) The captive cervids are moved directly to slaughter at an 
approved slaughtering establishment.
    (b) The captive cervids are from an accredited herd; are officially 
identified; and are accompanied by a certificate 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.
    (c) The captive cervids are sexually intact animals; are not from an 
accredited herd; are officially identified; and are accompanied by a 
certificate 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.

(Approved by the Office of Management and Budget under control number 
0579-0146)



Sec.  77.30  Nonaccredited States or zones.

    (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.



Sec.  77.31  Interstate movement from nonaccredited States and zones.

    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 an approved slaughtering establishment.



Sec.  77.32  General restrictions.

    (a) Except for movement from accredited-free States and zones in 
accordance with Sec.  77.23, movement from accredited herds in 
accordance with Sec.  77.35, and movement to slaughter in accordance 
with Sec. Sec.  77.25(a), 77.27(a), 77.29(a), and 77.31(d), 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 Sec.  7.40.
    (c) Except for captive cervids moving interstate under permit 
directly to slaughter or necropsy under Sec.  77.40, each captive cervid 
or shipment of captive cervids to be moved interstate must be 
accompanied by a certificate 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.



Sec.  77.33  Testing procedures for tuberculosis in captive cervids.

    (a) Approved testers. Except as explained in paragraphs (a)(1) and 
(a)(2) of this section, official tuberculosis tests may only be given by 
a veterinarian employed by the State in which

[[Page 240]]

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 Sec.  77.34(a)(2) and Sec.  77.39(e) and (f).
    (2) Any accredited veterinarian may conduct the BTB 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) The following laboratory is approved to perform the BTB test: 
Texas Veterinary Medical Center laboratory at Texas A&M University in 
College Station, TX.
    (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) BTB test. Copies of the BTB test results must be submitted by 
the testing laboratory to the person, firm, or corporation responsible 
for the management of the herd, cooperating State and Federal animal 
health officials of the State in which the captive cervid is tested, and 
the testing veterinarian. The report must include the following 
information for all BTB 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; the test interpretation, 
and a summary of supporting data. Full supporting data must be submitted 
by the testing laboratory on a case-by-case basis at the request of 
cooperating State and Federal animal health officials.
    (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 Sec.  77.34(a).
    (2) Interpretation of a CCT test will be in accordance with the 
classification requirements described in Sec.  77.34(b).
    (3) Interpretation of a BTB test will be in accordance with the 
patented standards for the BTB test \2\ and the classification 
requirements described in Sec.  77.34(c).
---------------------------------------------------------------------------

    \2\ The patented standards for the BTB test may be obtained from the 
Texas Veterinary Medial Center, College of Veterinary Medicine, Texas 
A&M University, College Station, TX, or from the Deer Research 
Laboratory, Department of Microbiology, University of Otago, P.O. Box 
56, Dunedin, New Zealand.
---------------------------------------------------------------------------

    (f) Captive cervids eligible for testing. Except as provided in 
Sec.  77.35(a)(1) and Sec.  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.



Sec.  77.34  Official tuberculosis tests.

    (a) Single cervical tuberculin (SCT) test. (1) The SCT test is the 
primary test to 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 either 
the CCT test or the BTB

[[Page 241]]

test and is either found negative for tuberculosis or is classified as a 
reactor, unless, with the 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 the DTE determines, based 
on epidemiological evidence, that the captive cervid should be 
classified as a reactor.
    (2) The SCT test is the primary test to 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 captive 
cervids 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 the DTE 
determines that the captive cervid should be classified as a suspect 
because of possible exposure to a tuberculous animal.
    (b) Comparative cervical tuberculin (CCT) test. (1) The CCT test is 
a supplemental test that may only be used for retesting captive cervids 
classified as suspects. 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 the DTE. The CCT test may not 
be used as a primary test for herds of unknown tuberculous status.
    (2) 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.
    (3) 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:
    (i) 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
    (ii) It has a response to the bovine PPD tuberculin that is equal to 
or greater than 1mm and equal to or less than 2mm and that is equal to 
or greater than the response to the avian PPD tuberculin.
    (4) A captive cervid tested with the CCT test must be classified as 
a reactor if:
    (i) 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
    (ii) It has been classified as a suspect on two successive CCT 
tests.
    (iii) Any exceptions to reactor classification under the conditions 
in paragraph (b)(4)(i) and (b)(4)(ii) of this section must be justified 
by the testing veterinarian in writing and have the concurrence of the 
DTE.
    (c) Blood tuberculosis (BTB) test. (1) The BTB test is a 
supplemental test that may be used in place of the CCT test for 
retesting captive cervids classified as suspects.
    (2) Except as provided in Sec.  77.39(e), any captive cervid 
classified by the testing laboratory as ``equivocal'' will be classified 
as a suspect.
    (3) Any captive cervid classified by the testing laboratory as ``M. 
bovis positive'' will be classified as a reactor.
    (4) Any captive cervid classified by the testing laboratory as 
``avian'' or ``negative'' will be considered negative for tuberculosis.
    (5) The owner of the captive cervid tested is responsible for the 
cost of the BTB test.



Sec.  77.35  Interstate movement from accredited herds.

    (a) Qualifications. To be recognized as an accredited herd:
    (1) All captive cervids in the herd eligible for testing in 
accordance with Sec.  77.33(f) must have tested negative to at least 
three 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

[[Page 242]]

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 Sec.  77.23 with regard 
to captive cervids that originate in an accredited-free State or zone, 
and except as provided in Sec.  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 accompanied by a certificate, as provided in Sec.  
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 certificate.
    (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 21-27 months from the anniversary date of the third 
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 21-27 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 second year). Accredited herd status is valid for 24 
months (730 days) from the anniversary date of the accrediting test. If 
the herd is tested between 24 and 27 months

[[Page 243]]

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.



Sec.  77.36  Interstate movement from qualified herds.

    (a) Qualifications. To be recognized as a qualified herd:
    (1) All captive cervids in the herd eligible for testing in 
accordance with Sec.  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 Sec.  77.23 with regard 
to captive cervids that originate in an accredited-free State or zone, 
and except as provided in Sec.  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 accompanied by a certificate, as provided 
in Sec.  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 certificate 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 certificate.
    (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 the certificate 
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, and are accompanied by a certificate 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

[[Page 244]]

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.



Sec.  77.37  Interstate movement from monitored herds.

    (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.\3\ A maximum number 
of 178 captive cervids must be slaughter inspected or tested for 
interstate movement over a 3-year period to meet this requirement.
---------------------------------------------------------------------------

    \3\ A chart showing the number of captive cervids that must be 
slaughter inspected or tested for interstate movement, depending on the 
size of a herd, to meet this requirement may be obtained from the 
National Animal Health Programs staff, Veterinary Services, APHIS, 4700 
River Road Unit 43, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (b) Movement allowed. Except as provided in Sec.  77.23 with regard 
to captive cervids that originate in an accredited-free State or zone, 
and except as provided in Sec.  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 accompanied by a certificate, as provided 
in Sec.  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 certificate 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

[[Page 245]]

captive cervids in the group may be moved under one certificate.
    (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 the certificate 
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.



Sec.  77.38  Interstate movement from herds that are not accredited, 
qualified, or monitored.

    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.

[[Page 246]]



Sec.  77.39  Other interstate movements.

    (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 or the BTB 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) The sample for the first BTB test may not be taken until at 
least 12 days after the injection for the SCT test. It is recommended 
that the sample be taken within 30 days following the injection for the 
SCT test.
    (ii) A captive cervid classified as a suspect on the first CCT test 
or the first BTB 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; or
    (B) A suspect on the first BTB test is tested with a second BTB test 
and is found negative for tuberculosis. It is recommended that the 
captive cervid be tested with the second BTB test within 60 days 
following the injection for the SCT test.
    (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 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 Sec.  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.

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    (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 the DTE 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 the DTE, 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. The BTB test may be used simultaneously with the SCT test as an 
additional diagnostic test. Any exposed captive cervid that responds to 
the SCT test or tests ``M. bovis positive'' or ``equivocal'' on the BTB 
test must be classified as a reactor and must be slaughter inspected or 
necropsied. Any exposed captive cervid that tests negative to the SCT 
test or tests ``avian'' or ``negative'' on the BTB 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 the DTE.
    (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 must be retested with the 
SCT 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.

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    (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 test must be classified as reactors. If 
none respond to the SCT test, the herd may be released from quarantine 
and will return to the herd classification status in effect before the 
herd was quarantined, unless the DTE judges 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 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.



Sec.  77.40  Procedures for and interstate movement to necropsy and 
slaughter.

    (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 an approved slaughtering establishment, as defined 
in Sec.  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

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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.



Sec.  77.41  Cleaning and disinfection of premises, conveyances, and 
materials.

    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.



PART 78_BRUCELLOSIS--Table of Contents




                      Subpart A_General Provisions

Sec.
78.1 Definitions.
78.2 Handling of certificates, permits, and ``S'' brand permits for 
          interstate movement of animals.
78.3 Handling in transit of cattle and bison moved interstate.
78.4 [Reserved]

   Subpart B_Restrictions on Interstate Movement of Cattle Because of 
                               Brucellosis

78.5 General restrictions.
78.6 Steers and spayed heifers.
78.7 Brucellosis reactor cattle.
78.8 Brucellosis exposed cattle.
78.9 Cattle from herds not known to be affected.
78.10 Official vaccination of cattle moving into and out of Class B and 
          Class C States or areas.
78.11 Cattle moved to a specifically approved stockyard not in 
          accordance with this part.
78.12 Cattle from quarantined areas.
78.13 Other movements.

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78.14 Rodeo bulls.
78.15-78.19 [Reserved]

   Subpart C_Restrictions on Interstate Movement of Bison Because of 
                               Brucellosis

78.20 General restrictions.
78.21 Bison steers and spayed heifers.
78.22 Brucellosis reactor bison.
78.23 Brucellosis exposed bison.
78.24 Bison from herds not known to be affected.
78.25 Other movements.
78.26-78.29 [Reserved]

   Subpart D_Restrictions on Interstate Movement of Swine Because of 
                               Brucellosis

78.30 General restrictions.
78.31 Brucellosis reactor swine.
78.32 Brucellosis exposed swine.
78.33 Sows and boars.
78.34 Other movements.
78.35-78.39 [Reserved]

               Subpart E_Designation of Brucellosis Areas

78.40 Designation of States/areas.
78.41 State/area classification.
78.42 Quarantined areas.
78.43 Validated brucellosis-free States.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 51 FR 32580, Sept. 12, 1986, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  78.1  Definitions.

    The following terms are defined in this section:

Accredited veterinarian
Administrator
Animals
Animal and Plant Health Inspection Service
APHIS representative
Approved brucella vaccine
Approved individual herd plan
Approved intermediate handling facility
Area
``B'' branded
Boar
Brucellosis
Brucellosis exposed
Brucellosis negative
Brucellosis reactor
Brucellosis ring test
Brucellosis suspect
Certificate
Certified brucellosis-free herd
Class A State or area
Class B State or area
Class C State or area
Class Free State or area
Complete herd test (CHT)
Confirmatory test
Dairy cattle
Designated epidemiologist
Directly
Epidemiologist
Epidemiology
Farm of origin
Feral swine
Finished fed cattle
Herd
Herd blood test
Herd known to be affected
Herd not known to be affected
Herd of origin of swine
Interstate
Market cattle identification test cattle
Market swine test (MST) reactor
Market swine test swine
Monitored-negative feral swine population
Moved
Moved (movement) in interstate commerce
Official adult vaccinate
Official brand inspection certificate
Official brand recording agency
Official calfhood vaccinate
Official eartag
Official seal
Official swine tattoo
Official test
Official vaccinate
Official vaccination eartag
Originate
Parturient
Permit
Permit for entry
Person
Postparturient
Purebred registry association
Qualified herd
Quarantined area
Quarantined feedlot
Quarantined pasture
Recognized slaughtering establishment
``S'' branded
``S'' brand permit
Sow
Specifically approved stockyard
State
State animal health official
State representative
Successfully closed case
Swine brucellosis
Test-eligible cattle and bison
United States Department of Agriculture backtag
Validated brucellosis-free herd
Validated brucellosis-free State
Veterinarian in Charge
Whole herd vaccination


As used in this part, the following terms shall have the meanings set 
forth in this section.
    Accredited veterinarian. A veterinarian approved by the 
Administrator

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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.
    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 
Sec.  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 1 year; (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 Sec.  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

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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.
    Certificate. An official document issued by an APHIS representative, 
state representative, or accredited veterinarian at the point of origin 
of an interstate movement of animals.
    (a) The certificate must show the official eartag number, individual 
animal register breed association registration tattoo, individual animal 
registered breed association registration brand, individual animal 
registered breed association registration number, or similar individual 
identification of each animal to be moved; 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. 
Ownership brands may be used in place of individual animal 
identification on certificates for cattle moved interstate when no 
official test for brucellosis is required under this part, provided the 
ownership brands are registered with the official brand recording 
agency. Except as provided in paragraphs (b) and (c) of this definition, 
all of the information required by this paragraph must be typed or 
written on the certificate.
    (b) 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 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 
prepared the document and the date the document was signed.
    (c) As an alternative to typing or writing ownership brands on a 
certificate, 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 stabled to the original and each copy of the certificate;
    (2) Each copy of the official brand inspection certificate must show 
the ownership brand of each animal to be moved with the certificate, but 
any

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other ownership brands, and any unused space for recording ownership 
brands, must be crossed out in ink;
    (3) The following information must be 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 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.
    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. Either of the following two methods may be used 
to qualify a herd:
    (1) In the case of dairy cattle, by conducting a minimum of four 
consecutive negative brucellosis ring tests 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
    (2) By conducting at least two consecutive negative herd blood tests 
not less than 10 months nor more than 14 months apart.
    (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. 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. 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 field strain 
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 Sec.  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

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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 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 are 
moved into a herd known to be affected and all herds which have received 
cattle 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 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 Sec.  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

[[Page 255]]

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 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 are 
moved into a herd known to be affected and all herds which have received 
cattle 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 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.

[[Page 256]]

    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 Sec.  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 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 are 
moved into a herd known to be affected and all herds which have received 
cattle 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 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

[[Page 257]]

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. Any 
reclassification will be made in accordance with Sec.  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 known foci of 
brucellosis in any species of domestic livestock are left uncontrolled. 
The following are the standards to attain and maintain Class Free 
status.
    (a) Surveillance--(1) 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.
    (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 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:
    (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:

[[Page 258]]

    (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 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; (ii) Epidemiologically 
traced herds. All herds from which cattle are moved into a herd known to 
be affected and all herds which have received cattle 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. (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. All 
cattle herds in the State or area must remain free of field strain 
Brucella abortus for 12 consecutive months. States or areas 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 field strain Brucella abortus of 0.0 percent or 0 herds 
per 1,000.
    (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.
    (4) Retaining Class Free status. (i) If a single herd in a Class 
Free State is found to be affected with brucellosis, the State may 
retain its Class Free status if it meets the conditions of this 
paragraph. A State may retain its status in this manner only once during 
any 2-year period. The following conditions must be satisfied within 60 
days of the date an animal in the herd is determined to be infected:
    (A) The affected herd must be immediately quarantined, tested for 
brucellosis, and depopulated; and
    (B) An epidemiological investigation must be performed and the 
investigation must confirm that brucellosis has not spread from the 
affected 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.
    (ii) 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 paragraph (b)(4)(i) have been 
satisfied and that the State is in compliance with all other applicable 
provisions.
    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

[[Page 259]]

tube test, the Rivanol test, the complement fixation test (CF), the 
particle concentration fluorescence immunoassay (PCFIA), the semen 
plasma test, and the standard plate test.
    Dairy cattle. A bovine animal of a recognized dairy breed.
    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. Without unloading en route if moved in a means of 
conveyance, or without stopping if moved in any other manner.
    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.
    Herd blood test. (a) Cattle and bison. A blood test for brucellosis 
conducted in a herd on all cattle or bison which are
    (1) 6 months of age or over and not official vaccinates, except 
steers and spayed heifers;
    (2) Official calfhood vaccinates of any age which are parturient or 
postparturient;
    (3) Official calfhood vaccinates of beef breeds or bison with the 
first pair of permanent incisors fully erupted (2 years of age or over); 
and
    (4) Official calfhood vaccinates of dairy breeds with partial 
eruption of the first pair of permanent incisors (20 months of age or 
over).
    (b) [Reserved]
    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.
    Market cattle identification test cattle. Cows and bulls 2 years 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 shall be identified by an official eartag and/or United 
States Department of Agriculture backtag prior to or at the first 
market, stockyard,

[[Page 260]]

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.
    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.
    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.
    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 eartag approved by APHIS as being 
tamper-resistant and providing unique identification for each animal. An 
official eartag may conform to the alpha-numeric National Uniform 
Eartagging System, or it may bear a valid premises identification number 
that is used in conjunction with the producer's livestock production 
numbering system to

[[Page 261]]

provide a unique identification number.
    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[reg] 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[reg] 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.


[[Page 262]]


    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.

[[Page 263]]

    (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[reg]) 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[reg] 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,

[[Page 264]]

Veterinary Services, Operational Support, 4700 River Road Unit 33, 
Riverdale, Maryland 20737-1231, or at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
    (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  Suspect.
 to .60.
.30 or less............................  Positive.
------------------------------------------------------------------------

    (11) D-Tec[reg] 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) x 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  Suspect.
 equal to 70 percent.
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) 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[reg] 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.


[[Page 265]]

    (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.
    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 penned in a specifically approved stockyard with cattle 
from a lower class State or area, in violation of the requirements set 
forth in Sec.  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

[[Page 266]]

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.\1\ A confined area under State quarantine 
approved jointly by the State animal health official and the 
Veterinarian in Charge. Approval will be granted only after a State 
representative or APHIS representative inspects the confined 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 cattle and bison, and that there is no possibility of 
brucellosis being mechanically transmitted from the confined area. The 
quarantined feedlot shall be maintained for feeding cattle and bison for 
slaughter, with no provisions for pasturing or grazing. All cattle and 
bison in a quarantined feedlot, except steers and spayed heifers, shall 
be treated as brucellosis exposed.
---------------------------------------------------------------------------

    \1\ A list of quarantined feedlots in any State may be obtained from 
the State animal health official, a State representative, or an APHIS 
representative.
---------------------------------------------------------------------------

    (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

[[Page 267]]

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.\2\ 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.
---------------------------------------------------------------------------

    \2\ A list of recognized slaughtering establishments in any State 
may be obtained from an APHIS representative, the State animal health 
official, or a State representative.
---------------------------------------------------------------------------

    Rodeo bulls. Male cattle kept solely for performance at rodeos.
    ``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

[[Page 268]]

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.\3\ Premises where cattle or bison 
are assembled for sale or sale purposes and which meet the standards set 
forth in Sec.  71.20 of this chapter and are approved by the 
Administrator.
---------------------------------------------------------------------------

    \3\ Notices containing lists of specifically approved stockyards are 
published in the Federal Register. Lists of specifically approved 
stockyards also may be obtained from the State animal health official, 
State representatives, or APHIS representatives.
---------------------------------------------------------------------------

    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 Department of Agriculture backtag. A backtag issued by 
APHIS that conforms to the eight-character alpha-numeric National

[[Page 269]]

Backtagging System, and 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 unforseen 
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 Sec.  
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

[[Page 270]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[51 FR 32580, Sept. 12, 1986]

    Editorial Note: For Federal Register citations affecting Sec.  78.1, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



Sec.  78.2  Handling of certificates, permits, and ``S'' brand permits 
for interstate movement of animals.

    (a) Any certificate, 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, or accredited 
veterinarian issuing a certificate or permit required for the interstate 
movement of animals under this part, except for permits for entry and 
``S'' brand permits, shall forward a copy thereof as follows:
    (1) A copy of each certificate shall be forwarded to the State 
animal health official of the State of destination, or to the State 
animal health official of the State of origin for forwarding to the 
State of destination; or
    (2) A copy of each permit shall be forwarded to the State animal 
health official of the State of destination.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[51 FR 32580, Sept. 12, 1986, as amended at 56 FR 54533, Oct. 22, 1991; 
56 FR 58639, Nov. 21, 1991]



Sec.  78.3  Handling in transit of cattle and bison moved interstate.

    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 
Sec. Sec.  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 Sec. Sec.  71.4, 71.7, 71.10, and 
71.11 of this chapter.



Sec.  78.4  [Reserved]



   Subpart B_Restrictions on Interstate Movement of Cattle Because of 
                               Brucellosis



Sec.  78.5  General restrictions.

    Cattle may not be moved interstate except in compliance with this 
subpart.



Sec.  78.6  Steers and spayed heifers.

    Steers and spayed heifers may be moved interstate without 
restriction under this subpart.



Sec.  78.7  Brucellosis reactor cattle.

    (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

[[Page 271]]

    (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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[51 FR 32580, Sept. 12, 1986, as amended at 59 FR 67133, Dec. 29, 1994; 
60 FR 48367, Sept. 19, 1995]



Sec.  78.8  Brucellosis exposed cattle.

    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.

The official seal numbers must be recorded on the accompanying permit or 
``S'' brand permit.
    (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

[[Page 272]]

    (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.

The official seal numbers must be recorded on the accompanying permit or 
``S'' brand permit.
    (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 Sec.  78.10 and as follows:

[[Page 273]]

    (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 Sec.  
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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[51 FR 32580, Sept. 12, 1986, as amended at 54 FR 1925, Jan. 18, 1989; 
56 FR 54533, 54534, Oct. 22, 1991; 56 FR 65782, Dec. 18, 1991; 59 FR 
67133, Dec. 29, 1994; 60 FR 48367, Sept. 19, 1995]



Sec.  78.9  Cattle from herds not known to be affected.

    Male cattle which are not test eligible and are from herds not known 
to be affected may be moved interstate without further restriction. 
Female cattle which are not test eligible and are from herds not known 
to be affected may be moved interstate only in accordance with Sec.  
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 Sec.  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 from a farm of origin or 
returned interstate to a farm of origin in the course

[[Page 274]]

of normal ranching operations, without change of ownership, directly to 
or from another premises owned, leased, or rented by the same 
individual; or
    (iii) Such cattle are moved interstate accompanied by a certificate 
which states, in addition to the items specified in Sec.  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 a certificate which states, in addition to 
the items specified in Sec.  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 a 
certificate which states, in addition to the items specified in Sec.  
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 from a farm of origin or 
returned interstate to a farm of origin in the course of normal ranching 
operations, without change of ownership, directly to or

[[Page 275]]

from another premises owned, leased, or rented by the same individual.
    (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 
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 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 a 
certificate or ``S'' brand permit which states, in addition to the items 
specified in Sec.  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.

The official seal numbers must be recorded on the accompanying ``S'' 
brand permit.
    (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 Sec.  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 a certificate or ``S'' 
brand permit which states, in addition to the items specified in Sec.  
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

[[Page 276]]

    (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.

The official seal numbers must be recorded on the accompanying ``S'' 
brand permit.
    (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 Sec.  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 a certificate which states, in 
addition to the items specified in Sec.  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 a certificate which states, in addition to 
the items specified in Sec.  78.1, that the cattle originated in a 
certified brucellosis-free herd; or

[[Page 277]]

    (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 a certificate which states, in addition to 
the items specified in Sec.  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 from a farm of origin or 
returned interstate to a farm of origin in the course of normal ranching 
operations, without change of ownership, directly to or from another 
premises owned, leased or rented by the same individual, 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 
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 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 a certificate or 
``S'' brand permit which states, in addition to the items specified in 
Sec.  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.

The official seal numbers must be recorded on the accompanying ``S'' 
brand permit.
    (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

[[Page 278]]

Sec.  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 a certificate or ``S'' 
brand permit which states, in addition to the items specified in Sec.  
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.

The official seal numbers must be recorded on the accompanying ``S'' 
brand permit.
    (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 Sec.  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

[[Page 279]]

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 a certificate which states, in 
addition to the items specified in Sec.  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 a certificate which states, in addition to the 
items specified in Sec.  78.1 of this part, that the cattle originated 
in a certified brucellosis-free herd.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[51 FR 32580, Sept. 12, 1986, as amended at 54 FR 1925, Jan. 18, 1989; 
56 FR 54533, 54534, Oct. 22, 1991; 56 FR 58638, Nov. 21, 1991; 59 FR 
67133, Dec. 29, 1994; 60 FR 48368, Sept. 19, 1995]



Sec.  78.10  Official vaccination of cattle moving into and out of 
Class B and Class C States or areas.

    (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 \4\ unless they are moved 
interstate 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, or directly to an approved intermediate 
handling facility and then directly to a quarantined feedlot and then 
directly to a recognized slaughtering establishment. Female cattle 
eligible for official calfhood vaccination and required by this 
paragraph to be officially vaccinated may be moved interstate from a 
farm of origin directly to a specifically approved stockyard and be 
officially vaccinated upon arrival at the specifically approved 
stockyard.
---------------------------------------------------------------------------

    \4\ Female cattle imported into the United States may be exempted 
from the vaccination requirements of this paragraph with the concurrence 
of the State animal health official of the State of destination. This 
concurrence is required prior to the importation of the cattle into the 
United States.
---------------------------------------------------------------------------

    (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 \4\ unless they are moved interstate directly to a recognized 
slaughtering establishiment, 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. Female cattle eligible for 
official calfhood vaccination and required by this paragraph to be 
officially vaccinated may be moved interstate from a farm of origin 
directly to a specifically approved stockyard and be officially 
vaccinated upon arrival at the specifically approved stockyard.
    (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 \4\ inder Sec.  78.9(d)(3) of this part.

[[Page 280]]

Female cattle from a certified brucellosis-free herd that are eligible 
for official calfhood vaccination and required by this paragraph to be 
officially vaccinated may be moved interstate from a farm of origin 
directly to a specifically approved stockyard and be officially 
vaccinated upon arrival at the specifically approved stockyard.

[51 FR 32580, Sept. 12, 1986, as amended at 54 FR 1926, Jan. 18, 1989; 
56 FR 58638, Nov. 21, 1991]



Sec.  78.11  Cattle moved to a specifically approved stockyard not in 
accordance with this part.

    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.

The official seal numbers must be recorded on the ``S'' brand permit; or
    (d) Directly to a quarantined feedlot if such cattle are ``S'' 
branded and accompanied by an ``S'' brand permit.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[51 FR 32580, Sept. 12, 1986, as amended at 56 FR 54534, Oct. 22, 1991; 
56 FR 58638, 58639, Nov. 21, 1991]



Sec.  78.12  Cattle from quarantined areas.

    Not withstanding any provisions in the regulations to the contrary, 
cattle may be moved interstate from a quarantined area only in 
accordance with Sec.  78.10 and this section.
    (a) Steers and spayed heifers. Steers and spayed heifers may be 
moved interstate without restriction under this section.
    (b) Brucellosis reactor cattle. Brucellosis reactor cattle may be 
moved interstate in accordance with Sec.  78.7.
    (c) Brucellosis exposed cattle. Brucellosis exposed cattle may be 
moved interstate in accordance with Sec.  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 a certificate or ``S'' brand permit which states, in 
addition to the items specified in Sec.  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

[[Page 281]]

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 Sec.  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 
Sec.  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 Sec.  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 
a certificate which states, in addition to the items specified in Sec.  
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 Sec.  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 a certificate which 
states, in addition to the items specified in Sec.  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 Sec.  
78.8(a) or (b).\5\
---------------------------------------------------------------------------

    \5\A herd which is not qualified in a quarantined area may become a 
qualified herd upon compliance with the provisions set forth in Sec.  
78.1 in the definition of ``qualified herd.''

(Approved by the Office of Management and Budget under control number 
---------------------------------------------------------------------------
0579-0051)

[51 FR 32580, Sept. 12, 1986, as amended at 56 FR 58638, Nov. 21, 1991; 
59 FR 67133, Dec. 29, 1994]



Sec.  78.13  Other movements.

    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.

[51 FR 32580, Sept. 12, 1986, as amended at 56 FR 54534, Oct. 22, 1991]



Sec.  78.14  Rodeo bulls.

    (a) A rodeo bull that is test-eligible and that is from a herd not 
known to be affected may be moved interstate if:
    (1) The bull is 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 
a bull that is moved only between Class Free States;
    (2) The bull is identified with an official eartag;
    (3) There is no change of ownership since the date of the last 
official test;
    (4) A certificate accompanies each interstate movement of the bull; 
and

[[Page 282]]

    (5) A permit for entry is issued for each interstate movement of the 
bull.
    (b) A bull that would qualify as a rodeo bull, but that is used for 
breeding purposes during the 365 days following the date of being 
tested, may be moved interstate only if the bull meets the requirements 
for cattle in this subpart.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[56 FR 58639, Nov. 21, 1991, as amended at 67 FR 70310, Nov. 22, 2002]



Sec. Sec.  78.15-78.19  [Reserved]



   Subpart C_Restrictions on Interstate Movement of Bison Because of 
                               Brucellosis



Sec.  78.20  General restrictions.

    Bison may not be moved interstate except in compliance with this 
subpart.



Sec.  78.21  Bison steers and spayed heifers.

    Bison steers and spayed heifers may be moved interstate without 
restriction under this subpart.



Sec.  78.22  Brucellosis reactor bison.

    (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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[51 FR 32580, Sept. 12, 1986, as amended at 59 FR 67133, Dec. 29, 1994; 
60 FR 48368, Sept. 19, 1995]



Sec.  78.23  Brucellosis exposed bison.

    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

[[Page 283]]

    (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 restriction 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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[51 FR 32580, Sept. 12, 1986, as amended at 59 FR 67133, Dec. 29, 1994]



Sec.  78.24  Bison from herds not known to be affected.

    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 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 
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 Sec.  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 a certificate.
    (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 a certificate.
    (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 a certificate which states, in addition to the items specified in 
Sec.  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 a certificate 
which states, in addition to the items specified in Sec.  78.1, that the 
bison originated in a certified brucellosis-free herd.

(Approved by the Office of Management and Budget under control number 
0579-0047)

[51 FR 32580, Sept. 12, 1986, as amended at 56 FR 58639, Nov. 21, 1991]



Sec.  78.25  Other movements.

    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.

[51 FR 32580, Sept. 12, 1986, as amended at 56 FR 54534, Oct. 22, 1991]

[[Page 284]]



Sec. Sec.  78.26-78.29  [Reserved]



   Subpart D_Restrictions on Interstate Movement of Swine Because of 
                               Brucellosis



Sec.  78.30  General restrictions.

    (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.

[51 FR 32580, Sept. 12, 1986, as amended at 56 FR 54534, Oct. 22, 1991; 
59 FR 18952, Apr. 21, 1994]



Sec.  78.31  Brucellosis reactor swine.

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[51 FR 32580, Sept. 12, 1986, as amended at 59 FR 67133, Dec. 29, 1994]



Sec.  78.32  Brucellosis exposed swine.

    (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

[[Page 285]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[59 FR 12533, Mar. 17, 1994, as amended at 59 FR 67133, Dec. 29, 1994]



Sec.  78.33  Sows and boars.

    (a) Sows and boars may be moved in interstate commerce for slaughter 
or for sale for slaughter if they are identified in accordance with 
Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  71.19 of this chapter.

[62 FR 27936, May 22, 1997]



Sec.  78.34  Other movements.

    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.

[51 FR 32580, Sept. 12, 1986, as amended at 56 FR 54534, Oct. 22, 1991]



Sec. Sec.  78.35-78.39  [Reserved]



               Subpart E_Designation of Brucellosis Areas



Sec.  78.40  Designation of States/areas.

    The Administrator may amend Sec. Sec.  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 Sec.  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 Sec.  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 Sec.  78.1. In the case 
of any reclassification to a lower class, reclassification as a 
quarantined

[[Page 286]]

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.

[51 FR 32580, Sept. 12, 1986, as amended at 53 FR 2222, Jan. 27, 1988; 
56 FR 54533, Oct. 22, 1991; 56 FR 55803, Oct. 30, 1991]



Sec.  78.41  State/area classification.

    (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, 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, Utah, Vermont, Virgin 
Islands, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
    (b) Class A. Missouri and Texas.
    (c) Class B. None.

[51 FR 32580, Sept. 12, 1986]

    Editorial Note: For Federal Register citations affecting Sec.  
78.41, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  78.42  Quarantined areas.

    None.



Sec.  78.43  Validated brucellosis-free States.

    Alabama, Alaska, Arizona, California, Colorado, Connecticut, 
Delaware, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, 
Kentucky, 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, Utah, Vermont, Virgin Islands, Virginia, Washington, West 
Virginia, Wisconsin, Wyoming.

[53 FR 4382, Feb. 16, 1988; 53 FR 21979, June 13, 1988, as amended at 53 
FR 24930, July 1, 1988; 53 FR 44180, Nov. 2, 1988; 55 FR 420, Jan. 5, 
1990; 55 FR 7883, Mar. 6, 1990; 55 FR 41995, Oct. 17, 1990; 55 FR 42354, 
Oct. 19, 1990; 56 FR 2127, Jan. 22, 1991; 56 FR 46109, Sept. 10, 1991; 
58 FR 11365, Feb. 25, 1993; 58 FR 28343, May 13, 1993; 58 FR 68506, Dec. 
28, 1993; 60 FR 67321, Dec. 29, 1995; 63 FR 34267, June 24, 1998; 63 FR 
44777, Aug. 21, 1998; 63 FR 53782, Oct. 7, 1998]



PART 79_SCRAPIE IN SHEEP AND GOATS--Table of Contents




Sec.
79.1 Definitions.
79.2 Identification of sheep and goats in interstate commerce.
79.3 General restrictions.
79.4 Designation of scrapie-positive animals, high-risk animals, exposed 
          animals, suspect animals, exposed flocks, infected flocks, 
          noncompliant flocks, and source flocks; notice to owners.
79.5 Issuance of certificates.
79.6 Standards for States to qualify as Consistent States.
79.7 Waiver of requirements for scrapie control pilot projects.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 66 FR 43990, Aug. 21, 2001, unless otherwise noted.



Sec.  79.1  Definitions.

    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.

[[Page 287]]

    Approved laboratory. A laboratory approved by the Administrator in 
accordance with Sec.  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 listed in Sec.  
151.9 of this chapter 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.
    Certificate. An official document issued in accordance with Sec.  
79.5 by an APHIS representative, State representative, or accredited 
veterinarian at the point of origin of an interstate movement of 
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 either:
    (i) Meets the requirements of Sec.  79.6; or
    (ii) Effectively enforces a State designed plan that the 
Administrator determines is at least as effective in controlling scrapie 
as the requirements of Sec.  79.6.
    (2) The Administrator has determined the following States to be 
Consistent 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, Rhode 
Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, 
Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
    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. (1) Any animal that has been in the same flock at 
the same time as a scrapie-positive female animal, excluding limited 
contacts; or

[[Page 288]]

    (2) Any animal born in a flock after a scrapie-positive animal was 
born into that flock or lambed in that flock, if born before that flock 
completes the requirements of a flock plan; or
    (3) Any animal that was commingled with a scrapie-positive female 
animal during or up to 30 days after she lambed, kidded, or aborted, or 
while a visible vaginal discharge was present, or that was commingled 
with any other scrapie-positive female animal for 24 hours or more, 
including during activities such as shows and sales or while in 
marketing channels; or
    (4) Any animal in a noncompliant flock.
    Exposed flock. Any flock in which a scrapie-positive animal was born 
or lambed. Any flock that currently contains a female high-risk, 
exposed, or suspect animal, or that once contained a female high-risk, 
exposed, or suspect animal that lambed in the flock and from which 
tissues were not submitted for official testing and found negative. A 
flock that has completed a post-exposure management and monitoring plan 
following the exposure will no longer be an exposed flock.
    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 Sec.  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 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 Sec.  54.8(a)(f) of this chapter.
    High-risk animal. A sexually intact animal, excluding male sheep 
that have tested RR at codon 171 and AA at codon 136 using an official 
genotype test, that is:
    (1) The progeny of a scrapie-positive dam; or
    (2) Born in the same flock during the same lambing season as progeny 
of a scrapie-positive dam, unless the progeny of the scrapie-positive 
dam are

[[Page 289]]

from separate contemporary lambing groups; or
    (3) Born in the same flock during the same lambing season that a 
scrapie-positive animal was born, or during any subsequent lambing 
season, if born before that flock completes the requirements of a flock 
plan; or
    (4) An exposed female sheep that has not tested QR, HR, or RR at 
codon 171 using an official genotype test.
    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 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.\1\
---------------------------------------------------------------------------

    \1\ The names and addresses of laboratories approved by the 
Administrator to conduct live-animal screening tests will be published 
in the Notices Section of the Federal Register. A list of approved 
laboratories is also available upon request from the Animal and Plant 
Health Inspection Service, Veterinary Services, National Animal Health 
Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235. 
State, Federal, and university laboratories will be approved by the 
Administrator when he or she determines that the laboratory: (a) Employs 
personnel trained by the National Veterinary Services Laboratories 
assigned to supervise the testing; (b) follows standard test protocols; 
(c) meets check test proficiency requirements; and (d) will report all 
test results to State and Federal animal health officials. Before the 
Administrator may withdraw approval of any laboratory for failure to 
meet any of these conditions, the Administrator will give written notice 
of the proposed withdrawal to the director of the laboratory, and will 
give the director an opportunity to respond. If there are conflicts as 
to any material fact, a hearing will be held to resolve the conflicts.
---------------------------------------------------------------------------

    Low-risk commercial sheep. Commercial whitefaced, whitefaced cross, 
or commercial hair sheep from a flock with no known risk factors for 
scrapie, including any exposure to female blackfaced sheep, that are 
identified with a legible permanent brand or earnotch pattern registered 
with an official brand registry and that are not scrapie-positive, 
suspect, high-risk, or exposed animals and are not animals from an 
infected, source, or exposed flock. 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 sheep may only exist in a State where scrapie has not 
been diagnosed in the previous 10 years in commercial whitefaced, 
whitefaced cross, or commercial hair sheep that were not commingled with 
female blackfaced sheep.
    Low-risk goat. A goat that is not a scrapie-positive, suspect, high-
risk, or

[[Page 290]]

exposed animal, that has not been commingled with sheep, and that is 
from:
    (1) A State in which scrapie has not been identified in a goat 
during the previous 10 years;
    (2) A State in which scrapie has been identified in a goat during 
the previous 10 years, but the scrapie-positive goat was not born in the 
State and resided in the State for less than 54 months and did not kid 
while in the State; or,
    (3) A State in which scrapie has been identified in a goat during 
the previous 10 years, and the scrapie-positive goat was commingled with 
sheep, but flock records allowed a complete epidemiologic investigation 
to be completed and all resulting infected, source, and exposed goat 
herds have completed flock plans and are in compliance with post-
exposure monitoring plans.
    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.
    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 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. An identification eartag approved by APHIS as being 
sufficiently tamper-resistant for the intended use and providing unique 
identification for each animal. An official eartag may conform to the 
alphanumeric National Uniform Eartagging system or another system 
approved by APHIS, or it may bear a premises identification number that 
either contains or is used in conjunction with the producer's livestock 
production numbering system to provide a unique identification number.
    Official genotype test. Any test to determine the genotype of a live 
or dead animal that is conducted at either an approved laboratory or at 
the National Veterinary Services Laboratories, when the animal is 
officially identified and the samples used for the test are collected 
and shipped to the laboratory by either an accredited veterinarian or a 
State or APHIS representative.
    Official identification. Identification mark or device approved by 
APHIS for use in the Scrapie Eradication Program. Examples are listed in 
Sec.  79.2(a)(2).
    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 statement. A written statement by the owner that includes the 
owner's name, signature, address, and phone number, date the animals 
left the flock of origin, the premises identification number assigned to 
the premises, the number of animals, the premises portion of the 
premises identification if premises identification is used, and a 
statement that the animals were either born or were used for breeding 
purposes on the premises to which the premises identification is 
assigned.
    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.

[[Page 291]]

    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.
    Premises identification. An APHIS approved eartag, backtag, or 
legible tattoo bearing the premises identification number, consisting of 
the State postal abbreviation or code followed by a unique alphanumeric 
number or name, assigned by a State or Federal animal health official to 
the premises of the flock of origin for the sheep or goats that, in the 
judgment of the State animal health official or area veterinarian in 
charge, is epidemiologically distinct from other premises, 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.
    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 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 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.\2\
---------------------------------------------------------------------------

    \2\ Individual copies of the SFCP standards may be obtained on the 
World Wide Web at URL http://www.aphis.usda.gov/vs, or from the Animal 
and Plant Health Inspection Service, National Animal Health Programs 
Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235.
---------------------------------------------------------------------------

    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 western 
blotting on CNS and/or peripheral tissue samples from a live or

[[Page 292]]

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 test method approved by the Administrator in 
accordance with Sec.  54.10 of this chapter.\3\
---------------------------------------------------------------------------

    \3\ The names and addresses of laboratories approved by the 
Administrator to conduct tests are published in the Notices Section of 
the Federal Register. A list of approved laboratories is also available 
upon request from the Animal and Plant Health Inspection Service, 
Veterinary Services, National Animal Health Programs Staff, 4700 River 
Road Unit 43, Riverdale, MD 20737-1235. State, Federal, and university 
laboratories will be approved by the Administrator when he or she 
determines that the laboratory: (a) Employs personnel trained by the 
National Veterinary Services Laboratories assigned to supervise the 
testing; (b) follows standard test protocols; (c) meets check test 
proficiency requirements; and (d) will report all test results to State 
and Federal animal health officials. Before the Administrator may 
withdraw approval of any laboratory for failure to meet any of these 
conditions, the Administrator must give written notice of the proposed 
withdrawal to the director of the laboratory and must give the director 
an opportunity to respond. If there are conflicts as to any material 
fact, a hearing will be held to resolve the conflict.
---------------------------------------------------------------------------

    Separate contemporary lambing groups. To be a separate contemporary 
lambing group, the group must be maintained separately such that the 
animals cannot come into physical contact with other lambs, kids, ewes 
or does or birth fluids or placenta from other ewes or does. This 
separate maintenance must preclude contact through a fence, during 
lambing and for 60 days following the date the last lamb or kid is born 
in a lambing season, and must preclude using the same lambing facility 
as other ewes or does, unless the lambing facility is cleaned and 
disinfected under supervision by an APHIS representative, State 
representative, or an accredited veterinarian between lambings in 
accordance with Sec.  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. The flock owner must maintain 
adequate records to document which animals were maintained in each 
contemporary lambing group and to document when cleaning and 
disinfection was performed and who supervised it.
    Slaughter channels. Animals in slaughter channels include any animal 
that is sold, transferred, or moved either directly to a slaughter 
facility, to an individual for custom slaughter, or for feeding for the 
express purpose of improving the animals' condition for movement to 
slaughter. Any sexually intact animal that is commingled with breeding 
animals or that has been bred is not in slaughter channels. When selling 
animals for slaughter, owners should note on the bill of sale that the 
animals are sold only for slaughter.
    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.

[[Page 293]]

    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 Sec.  79.4 if it is:
    (1) A sheep or goat that exhibits any of the following possible 
signs of scrapie and that has been determined to be suspicious for 
scrapie by an accredited veterinarian or a State or APHIS 
representative: Weight loss despite retention of appetite; behavioral 
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.
    (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 authorized to perform this 
function where animals 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 from which 
animals are moved only to another terminal feedlot or directly to 
slaughter; or
    (2) A pasture when approved by and maintained under the supervision 
of the State and in which only nonpregnant animals are permitted, 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.
    (3) Records of all animals entering and leaving a terminal feedlot 
must be maintained for 1 year after the animal leaves the feedlot and 
must include the person from whom the animals were acquired and the 
slaughtering facility in which they were slaughtered. Records must be 
made available for inspection 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.



Sec.  79.2  Identification of sheep and goats in interstate commerce.

    (a) No sheep or goat that is required to be individually identified 
or premises identified by Sec.  79.3 may be sold, transported, received 
for transportation, or offered for sale or transportation in interstate 
commerce unless each sheep or goat is identified in accordance with this 
section.
    (1) The sheep or goat must be identified to its flock of origin and, 
for an animal born after January 1, 2002, to its flock of birth, by the 
owner of the flock or his or her agent; at whichever of the following 
points in commerce comes first, Except that; animals born after January 
1, 2002, may be moved interstate direct to slaughter without 
identification to flock of birth until June 1, 2003, and animals that 
cannot be identified to their flock of origin because Consistent States 
have exempted them from flock of origin identification in intrastate 
commerce in accordance with Sec.  79.6(a)(10)(i) may be moved interstate 
with only individual animal identification traceable to the State of 
origin and to the owner of the animals at the time they were so 
identified:
    (i) The point of first commingling of the sheep or goats in 
interstate commerce with sheep or goats from any other flock of origin;

[[Page 294]]

    (ii) Upon unloading of the sheep or goats in interstate commerce at 
any livestock market, except a market described in paragraph (a)(1)(iii) 
of this section;
    (iii) Upon leaving a livestock market that has been approved in 
accordance with this chapter to handle sheep and goats in interstate 
commerce and that has agreed to act as an agent for the owner to apply 
official identification to the animals. In such cases the animals must 
be:
    (A) Moved to the market and maintained until officially identified 
in distinguishable groups identifiable to their flocks of origin and 
when required their flock of birth by means of partitions or other such 
maintenance; and,
    (B) Accompanied by an owner statement that contains the information 
needed to officially identify the animals to their flock of origin and, 
when required, their flock of birth;
    (iv) Upon transfer of ownership of the sheep or goats in interstate 
commerce;
    (v) In the case of animals shipped directly to slaughter at a 
slaughter plant that has agreed to act as an agent for the owner to 
apply official identification to the animals, upon arrival of the sheep 
or goats in interstate commerce at the slaughter plant. In such cases 
the animals must be:
    (A) Moved to the slaughter plant and maintained until officially 
identified in distinguishable groups identifiable to their flocks of 
origin and when required their flock of birth by means of partitions or 
other such maintenance; and,
    (B) Accompanied by an owner statement that contains the information 
needed to officially identify the animals to their flock of origin and, 
when required, their flock of birth. If the slaughter plant has agreed 
to allow APHIS to conduct slaughter sampling, animals need not be 
identified if they arrive at the plant on days that an APHIS designated 
sampler is not available at the plant to collect samples; or
    (vi) Prior to moving a sheep or goat across a State line, unless the 
animals are moving to an approved livestock market in accordance with 
paragraph (a)(1)(iii) of this section or to an approved slaughter plant 
in accordance with paragraph (a)(1)(v) of this section.
    (2) The sheep or goats must be identified by one of the following 
means of identification, and must remain so identified until they reach 
their final destination:
    (i) Electronic implants for animals required to be identified by the 
SFCP, when used in a flock participating in the SFCP and when 
accompanied by a certificate or owner statement that includes the 
electronic implant numbers and the name of the chip manufacturer;
    (ii) Official eartags, including tags approved for use in the SFCP 
or APHIS-approved premises identification number eartags when combined 
with a unique animal identification number;
    (iii) United States Department of Agriculture backtags or official 
premises identification backtags that include a unique animal 
identification number, when used on sheep or goats moving directly to 
slaughter and when applied within 3 inches of the poll on the dorsal 
surface of the head or neck;
    (iv) Legible official registry tattoos that have been recorded in 
the book of record of a sheep or goat registry association when the 
animal is accompanied by either a registration certificate or a 
certificate of veterinary inspection. These tattoos may also be used as 
premises identification if they contain a unique premises prefix that 
has been linked in the National Scrapie Database with the assigned 
premises identification number of the flock of origin;
    (v) Premises identification eartags or tattoos, if the premises 
identification method includes a unique animal number or is combined 
with a flock eartag that has a unique animal number and the animal is 
accompanied by an owner statement; or
    (vi) Premises identification when premises identification is allowed 
by Sec.  79.3 and the animal is accompanied by an owner statement.
    (3) The owner of the flock of origin is responsible for the 
identification of animals required to be identified by this section. No 
person who buys or sells, for his or her own account or as

[[Page 295]]

the agent of the buyer or seller, transports, receives for 
transportation, offers for sale or transportation, or otherwise handles 
sheep or goats in interstate commerce shall receive or otherwise handle 
any animal in interstate commerce that has not been identified as 
required by this section. If an animal loses its identification to its 
flock of origin while in interstate commerce it is the responsibility of 
the person who has control or possession of the animal to identify the 
animal 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. If 
the flock of origin cannot be determined, all possible flocks of origin 
shall be listed on the record.
    (b) Serial numbers for use in official identification 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 or her place of business. Serial numbers of official 
eartags will be assigned to each accredited veterinarian or State or 
APHIS 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. The official 
responsible for issuing eartags in a State may assign serial numbers of 
official eartags to other responsible persons, such as 4-H leaders, if 
the State animal health official and the area veterinarian in charge 
agree that such assignments will improve scrapie control and eradication 
within the State. Persons assigned serial numbers may either directly 
apply eartags to animals, or may reassign eartag numbers to producers. 
If these persons reassign eartag numbers, they must maintain appropriate 
records that permit traceback of animals to their flock of origin, or 
flock of birth when required. Premises identification eartag, backtag, 
and tattoo numbers (series of alphanumeric USDA tags and backtags may be 
assigned as premises identification if they are linked to the premises 
in the National Scrapie Database) will be assigned to animal owners by 
the State animal health official or the area veterinarian in charge, 
whoever is responsible for assigning premises codes in that State. 
Persons assigned serial numbers of United States Department of 
Agriculture backtags, official sheep and goat tattoos, official eartags, 
and premises identification numbers must:
    (1) If the person assigned the numbers is a flock owner, so that the 
assigned numbers are directly linked to the flock of origin in the 
national scrapie database, record the following information on a 
document:
    (i) The premises identification number or serial numbers;
    (ii) The number of animals so identified;
    (iii) The date the animals were identified;
    (iv) For animals born after January 1, 2002, that were not born in 
the flock of origin and that are not identified to the previous flock of 
origin, the individual identification number applied and the name, 
street address, including the city and State, or the township, county, 
and State, and the telephone number, if the telephone number is 
available, of the flock of birth if known.
    (2) If the person assigned the numbers is a veterinarian, extension 
agent, auction market operator, dealer, or any person other than the 
owner of the flock of origin, record the following information on a 
document:
    (i) All serial numbers applied to a sheep or goat;
    (ii) Any other serial numbers and approved identification appearing 
on the sheep or goat;
    (iii) The street address, including the city and State, or the 
township, county, and State, of the premises where the approved means of 
identification was applied;
    (iv) The date the identification was applied;
    (v) The name, street address, including the city and State, or the 
township, county, and State, and the telephone number if the telephone 
number is available, of the owner of the flock of origin and, if 
different, the person who owns or possesses the sheep or goat, and

[[Page 296]]

    (vi) For animals born after January 1, 2002, that were not born in 
the flock of origin and that are not identified to the previous flock of 
origin, the individual identification number applied and the name, 
street address, including the city and State, or the township, county, 
and State, and the telephone number if the telephone number is 
available, of the flock of birth if known.
    (vii) The serial numbers, the manufacturer, and the type and color 
of all official tags received. Usually maintaining the tag invoice will 
meet this requirement.
    (3) Maintain these records for 5 years; and
    (4) 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 or the State, and presentation of his or her official 
credentials.
    (5) Any person who fails to comply with these requirements shall not 
be assigned serial numbers of United States Department of Agriculture 
backtags, official sheep and goat tattoos, official eartags, or premises 
identification numbers. If a person who is not in compliance with these 
requirements has already been assigned such serial numbers, the 
Administrator may withdraw the assignment by giving notice to such 
person. After such notice the person shall be subject to criminal and 
civil penalties if he continues to use those assigned serial numbers.
    (c) No person shall apply a premises identification number or a 
brand or earnotch pattern to an animal that did not originate on the 
premises 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 tags and backtags that have been assigned to 
a premises for use as premises identification and registration tattoos 
that contain prefixes that have been assigned to a premises for use as 
premises identification. This does not preclude the owner of a flock 
from using a premises identification number tag assigned to that flock 
on an animal owned by him that resides in that flock but that was born 
or previously resided on a different premises as long as the records 
required in paragraph (b)(1)(iv) of this section are maintained.
    (d) 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 
sheep or goats in interstate commerce must ensure that the animals are 
identified as required in this part and must keep records relating to 
the transfer of ownership, shipment, or handling of the sheep or goats, 
such as yarding receipts, sale tickets, invoices, and waybills.
    (1) If official individual animal identification is required, the 
records must include the number of sheep and/or goats; the breed or 
cross if known; the name, street address, including city and State, or 
the township, county, and State, and the telephone number if the 
telephone number is available, of the owner of the flock of origin and, 
if different, the person from whom the sheep or goats were purchased or 
otherwise obtained; and a copy of any documents required to accompany 
the animal including any certificate, owner statement, letter, or 
permit; and
    (i) For animals not in slaughter channels the records must include 
all serial numbers and other approved means of identification appearing 
on the sheep or goat. This requirement may usually be met by maintaining 
a copy of the certificate that accompanied the animals. The premises 
number may be recorded instead of the individual numbers in the case of 
animals identified with premises identification if:
    (A) The premises identification meets the requirements of paragraph 
(a)(2)(v) of this section for individual animal identification; or
    (B) The animals are allowed to move interstate with only premises 
identification in accordance with Sec.  79.3.
    (ii) For animals in slaughter channels that are identified with 
individual animal identification traceable to the flock of origin or 
that are identified to

[[Page 297]]

the flock of origin with official premises identification that meets the 
requirements for individual animal identification, no additional records 
are required;
    (iii) For animals in slaughter channels that are identified with 
individual animal identification traceable to a previous flock but not 
to the flock of origin, or that are identified with official premises 
identification that meets the requirements for individual animal 
identification that is traceable to a previous flock but not to the 
flock of origin, the records must include all serial numbers and other 
approved means of identification appearing on the sheep or goat;
    (iv) For animals that are not required to be identified until they 
reach their final destination, the records must include the final 
destination.
    (2) If official premises identification is required or allowed, the 
records must include:
    (i) The premises identification number(s) and the number of animals 
identified with each premises number;
    (ii) Copies of any required documents such as the brand inspection 
certificate, an owner's statement, an accredited veterinarian's 
statement, or a health certificate;
    (iii) The name, street address, including city and State, or the 
township, county, and State, and the telephone number if the telephone 
number is available, of the owner of the flock of origin and, if 
different, the person from whom the sheep or goats were purchased or 
otherwise obtained.
    (3) Each person required to keep records under this paragraph must 
maintain the records for at least 5 years after the person has sold or 
otherwise disposed of the sheep or goat 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 sheep 
or goat identified in the records. The person must 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 or the State, upon that 
employee's request and presentation of his or her official credentials.
    (e) No person may remove or tamper with any means of identification 
required to be on sheep or goats pursuant to this section while the 
animals are in interstate commerce, and, at the time of slaughter, 
animal identification must be maintained throughout postmortem 
inspection in accordance with regulations of the Food Safety and 
Inspection Service, U.S. Department of Agriculture, in chapter III of 
this title.
    (f) Requirements for approval of official premises and individual 
identification tags. (1) The Administrator may approve tag companies to 
produce official premises and/or individual identification tags for use 
on sheep or goats. Tags may be plastic or metal and must be an 
appropriate size for use in sheep and goats. Tags must be able to 
legibly accommodate the required alphanumeric sequences. Tags must 
resist removal and be difficult to place on another animal once removed, 
but need not be tamper-proof. Tags must be readily distinguishable as 
USDA official sheep and goat tags, must carry the alphanumeric 
sequences, symbols, or logos specified by APHIS, and must have a means 
of discouraging counterfeiting, such as use of a unique copywrited logo 
or trade mark. Tags for use only on animals in slaughter channels must 
be marked with the words ``Meat'' or ``For Slaughter Only,'' or else 
must be used in conjunction with an ear tattoo of the word ``Meat.''
    (2) Written requests for approval of official premises 
identification tags for sheep and goats should be sent to the Animal and 
Plant Health Inspection Service, Veterinary Services, National Animal 
Health Programs Staff, Attention: National Scrapie Program Coordinator, 
4700 River Road Unit 43, Riverdale, MD 20737-1235. The request must 
include:
    (i) Data supporting the durability of the tag and durability and 
legibility of the identification numbers and high retention rates of the 
tags in animals, preferably sheep and/or goats. Preference will be given 
to tags with high legibility and retention rates in sheep and goats that 
minimize injury to the ear.

[[Page 298]]

    (ii) A signed statement agreeing to:
    (A) Send official eartags only to a State or APHIS representative, 
to a flock owner at the address to which the premises number or tag 
sequence was assigned by a State or APHIS representative, or as directed 
by APHIS;
    (B) Provide a monthly report by State of all tags produced, 
including the tag sequences produced and the person's and address to 
which the tags were shipped; and
    (C) When required by APHIS, enter the sequences of tags shipped into 
the National Scrapie Database through a web page interface or other 
means specified by APHIS.
    (iii) Twenty-five sample tags. Additional tags must be submitted if 
requested by APHIS.
    (3) Approval to produce official premises and/or individual 
identification tags will be valid for 1 year and must be renewed 
annually. The Administrator may also grant approval to produce tags for 
periods of less than 1 year in cases where all of the submissions 
required by this section have not been received or evaluated but there 
is substantial evidence that the tags meet the requirements of this 
section. The Administrator may decline to renew a company's approval if 
the tags do not show adequate retention and durability in field use or 
if any of the requirements of this section are not met by the tag 
company. If a company's tags do not show adequate retention and 
durability in field use or if any of the requirements of this section 
are not met by the tag company, the approval may be withdrawn with 60 
days written notice. Any person who is approved to produce official 
premises or individual 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.
    (g) New types of identification. Written requests for approval of 
sheep or goat identification devices and markings not listed in 
paragraph (a)(2) of this section should be sent to the Animal and Plant 
Health Inspection Service, Veterinary Services, National Animal Health 
Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235. If 
the Administrator determines that the devices and markings will provide 
a means of tracing sheep and goats in interstate commerce, a proposal 
will be published in the Federal Register to add the devices and 
markings to the list of approved means of sheep and goat identification.

[66 FR 43990, Aug. 21, 2001, as amended at 68 FR 6343, Feb. 7, 2003]



Sec.  79.3  General restrictions.

    The following prohibitions and movement conditions apply to the 
interstate movement of sheep and goats, and no sheep or goat may move 
interstate except in compliance with them.

      Interstate Movement General Restrictions for Sheep and Goats
    Note: A CONSISTENT STATE is one whose intrastate identification,
 reporting, and movement restrictions for infected and source flocks and
   high-risk animals are consistent with the APHIS standards for State
                            scrapie programs.
------------------------------------------------------------------------
                                      Moved from          Moved from
   Type of interstate movement    INCONSISTENT state   CONSISTENT state
------------------------------------------------------------------------
(a) Sale or other movement of
 breeding animals, show animals
 or any other animal not
 specifically addressed in this
 chart. General Condition: No
 animal may be removed from
 slaughter channels in
 interstate commerce if it was
 sold at a slaughter-only
 auction, is identified with a
 tag or ear tattoo marked
 ``meat'' or ``slaughter only,''
 or was sold with a bill of sale
 marked for slaughter only, and
 other animals may be removed
 from slaughter channels in
 interstate commerce only if
 they are identified to their
 flock of birth.--

[[Page 299]]

 
    (1) High-risk, scrapie-       Prohibited \1\....  Prohibited \1\
     positive, or suspect
     animals, or animals from a
     noncompliant flock.
    (2) Non-high-risk animals     Prohibited \1\....  Prohibited,\1\
     from an infected or source                        except as allowed
     flock that are not scrapie-                       in an approved
     positive or suspect animals.                      scrapie control
                                                       pilot project
                                                       flock plan and
                                                       must meet the
                                                       requirements for
                                                       exposed animals.
    (3) Sexually intact exposed   Flock must be       Official
     animals that are not          enrolled in the     individual animal
     scrapie-positive, suspect,    Complete            identification
     or high-risk animals and      Monitored           and a permit.\2\
     are not animals from an       category of the     For any female
     infected or source flock.     Scrapie Flock       exposed sheep the
                                   Certification       results of an
                                   Program or          official genotype
                                   equivalent APHIS    test must be
                                   recognized          included on or
                                   program, have       attached to the
                                   official            permit and must
                                   individual animal   be QR or RR at
                                   identification,     codon 171. For
                                   and a permit.\2\    any female animal
                                   For any female      moving for
                                   exposed sheep the   exhibition, the
                                   results of an       permit must
                                   official genotype   include a
                                   test must be        statement by both
                                   included on or      the owner and an
                                   attached to the     accredited
                                   permit and must     veterinarian that
                                   be QR or RR at      the animal has
                                   codon 171. For      not lambed or
                                   any female animal   aborted within 30
                                   moving for          days of being
                                   exhibition, the     exhibited and is
                                   permit must         not due to lamb
                                   include a           within 30 days of
                                   statement by both   being exhibited
                                   the owner and the   and that there is
                                   accredited          no visible
                                   veterinarian that   vaginal
                                   the animal has      discharge. For
                                   not lambed or       any animal born
                                   aborted within 30   after 1-1-2002,
                                   days of being       the permit must
                                   exhibited and is    include the flock
                                   not due to lamb     of birth and the
                                   within 30 days of   flock of origin,
                                   being exhibited     if different.
                                   and that there is
                                   no visible
                                   vaginal
                                   discharge. For
                                   any animal born
                                   after 1-1-2002,
                                   the certificate
                                   must include the
                                   flock of birth
                                   and the flock of
                                   origin, if
                                   different.
(4)(i) Sexually intact sheep
 except as allowed in (a)(7).
    (ii) Sexually intact goats,   Flock must be       Official
     except for low-risk goats.    enrolled in the     individual animal
                                   Complete            identification
                                   Monitored           and a
                                   category of the     certificate. For
                                   Scrapie Flock       any animal born
                                   Certification       after 1-1-2002,
                                   Program or          the certificate
                                   equivalent APHIS-   must include the
                                   recognized          flock of birth
                                   program, have       and the flock of
                                   official            origin, if
                                   individual animal   different.
                                   identification,
                                   and a
                                   certificate. For
                                   any animal born
                                   after 1-1-2002,
                                   the certificate
                                   must include the
                                   flock of birth
                                   and the flock of
                                   origin, if
                                   different.
    (5) Sexually intact low-risk  Official            Official
     goats.                        individual animal   individual animal
                                   identification      identification
                                   and a               and a
                                   certificate. For    certificate. For
                                   any animal born     any animal born
                                   after 1-1-2002,     after 1-1-2002,
                                   the certificate     the certificate
                                   must include the    must include the
                                   flock of birth      flock of birth
                                   and the flock of    and the flock of
                                   origin, if          origin, if
                                   different.          different.
    (6) Castrated animals that    Official            None, except for
     are not scrapie-positive or   individual animal   exposed animals
     suspect animals.              identification      that must have
                                   and a certificate.  official
                                                       individual animal
                                                       identification.
    (7) Low-risk commercial       Official            (i) Official
     sheep.                        individual animal   premises
                                   identification      identification
                                   and a               that is a
                                   certificate, and    permanent brand
                                   the flock must be   or ear notch
                                   enrolled in the     pattern
                                   Complete            registered with
                                   Monitored           an official brand
                                   category of the     registry;
                                   Scrapie Flock      (ii) A brand
                                   Certification       inspection
                                   Program or an       certificate;
                                   equivalent APHIS-  (iii) An owner
                                   recognized          statement dated
                                   program. For any    within 30 days
                                   animal born after   stating that the
                                   1-1-2002, the       animals were born
                                   certificate must    in the flock,
                                   include the flock   that the flock
                                   of birth and the    does not contain
                                   flock of origin,    any animal
                                   if different.       exhibiting signs
                                                       of scrapie, that
                                                       to the best of
                                                       his or her
                                                       knowledge the
                                                       flock has no risk
                                                       factors for or
                                                       exposure to
                                                       scrapie, and that
                                                       the flock has
                                                       never contained:
                                                       (A) Any animal
                                                       diagnosed as
                                                       having scrapie;
                                                       (B) any female
                                                       blackfaced sheep;
                                                       or (C) any female
                                                       blackfaced cross
                                                       sheep that were
                                                       not born in the
                                                       flock; and

[[Page 300]]

 
                                                      (iv) An accredited
                                                       veterinarian's
                                                       statement issued
                                                       within 12 months
                                                       of the date of
                                                       movement
                                                       indicating that,
                                                       to the best of
                                                       his or her
                                                       knowledge, the
                                                       flock has no
                                                       known risk
                                                       factors for or
                                                       exposure to
                                                       scrapie, and that
                                                       he or she has
                                                       inspected the
                                                       flock and it does
                                                       not contain: (A)
                                                       Any animal
                                                       exhibiting signs
                                                       of scrapie; (B)
                                                       any female
                                                       blackfaced sheep;
                                                       or (C) any female
                                                       blackfaced cross
                                                       sheep that were
                                                       not born in the
                                                       flock. The
                                                       statements must
                                                       include the
                                                       owner's name,
                                                       address, and the
                                                       premises
                                                       identification
                                                       number and a
                                                       drawing of the
                                                       owner's
                                                       registered brand
                                                       or ear notch
                                                       pattern.
    (8) Commercial low-risk       Official            None.
     goats..                       individual animal
                                   identification
                                   and a
                                   certificate. For
                                   any animal born
                                   after 1-1-2002,
                                   the certificate
                                   must include the
                                   flock of birth
                                   and the flock of
                                   origin, if
                                   different.
(b) Sale or other movement
 directly to slaughter, through
 slaughter channels to
 slaughter, or to feedlots for
 later movement to slaughter of
 animals that are under 18
 months of age as evidenced by
 eruption of the second incisor,
 not pregnant, and have not
 lambed or kidded. General
 Condition: No animal may be
 removed from slaughter channels
 in interstate slaughter
 channels in interstate commerce
 if it was sold at a slaughter-
 only auction, is identified
 with a tag or ear tattoo marked
 ``meat'' or ``slaughter only,''
 or was sold with a bill of sale
 marked for slaughter only, and
 other animals may be removed
 from slaughter channels in
 interstate commerce only if
 they are identified to their
 flock of birth.--
    (1) Scrapie-positive or       Prohibited \1\....  Prohibited.\1\
     suspect animal.
    (2) Sexually intact high-     Official            Official
     risk animals and sexually     individual animal   individual animal
     intact animals from           identification      identification
     infected or source flocks     and a permit, or    and a permit, or
     that are not scrapie-         a permit and an     a permit and an
     positive or suspect animals.  indelible ``S''     indelible ``S''
                                   mark on the left    mark on the left
                                   jaw, or sealed      jaw, or sealed
                                   conveyance and a    conveyance and a
                                   permit. (Note:      permit. (Note:
                                   these animals may   these animals may
                                   only be permitted   only be permitted
                                   to slaughter or     to slaughter or
                                   to terminal         to terminal
                                   feedlots.\3\)       feedlots.\3\)
    (3) Exposed sexually intact   Official            Official
     animals that are not          individual animal   individual animal
     scrapie-positive, suspect,    identification      identification
     or high-risk. animals and     for any animal      for any animal
     that are not animals from     that is not         that is not
     an infected or source flock.  moving directly     moving direct to
                                   to slaughter or     slaughter or to a
                                   to a terminal       terminal
                                   feedlot.3, 4        feedlot.3, 4
                                   (Note: pregnant     (Note: Pregnant
                                   animals and         animals and
                                   animals with a      animals with a
                                   visible vaginal     visible vaginal
                                   discharge may       discharge may
                                   only be permitted   only be permitted
                                   to slaughter or     to slaughter or
                                   to terminal         to terminal
                                   feedlots.).         feedlots.)
    (4) Sexually intact sheep     Official premises   None.
     that are not scrapie-         identification or
     positive, suspect, high-      official
     risk, or exposed animals      individual animal
     and are not animals from an   identification
     infected or source flock.     for any animal
                                   that is not
                                   moving direct to
                                   slaughter or to a
                                   terminal
                                   feedlot.3
    (5) Sheep enrolled in the     None..............  None.
     selective monitored or
     complete monitored category
     of the SFCP that are not
     scrapie-positive, suspect,
     high-risk, or exposed
     animals.
    (6) Castrated animals that    None..............  None.
     are not scrapie-positive,
     or suspect animals.

[[Page 301]]

 
    (7) Sexually intact goats     None..............  None.
     that are not scrapie-
     positive, suspect, high-
     risk, or exposed animals
     and are not animals from an
     infected or source flock.
(c) Sale or other movement
 directly to slaughter, through
 slaughter channels to
 slaughter, or to feedlots for
 later movement to slaughter of
 animals that are over 18 months
 of age, as evidenced by
 eruption of the second incisor,
 or that are pregnant or that
 have lambed or kidded. General
 Condition: No animal may be
 removed from slaughter channels
 in interstate commerce if it
 was sold at a slaughter-only
 auction, is identified with a
 tag or ear tattoo marked
 ``meat'' or ``slaughter only,''
 or was sold with a bill of sale
 marked for slaughter only, and
 other animals may be removed
 from slaughter channels in
 interstate commerce only if
 they are identified to their
 flock of birth.--
    (1) Scrapie-positive or       Prohibited1.......  Prohibited.1
     suspect animal.
    (2) Sexually intact high-     Official            Official
     risk animals and sexually     individual animal   individual animal
     intact animals from an        identification      identification
     infected or source flock      and a permit, or    and a permit, or
     that are not scrapie-         a permit and an     a permit and an
     positive, or suspect          indelible ``S''     indelible ``S''
     animals.                      mark on the left    mark on the left
                                   jaw, or sealed      jaw, or sealed
                                   conveyance and a    conveyance and a
                                   permit. (Note:      permit. (Note:
                                   these animals may   These animals may
                                   only be permitted   only be permitted
                                   to slaughter or     to slaughter or
                                   to terminal         to terminal
                                   feedlots.3          feedlots.3
    (3) Sexually intact exposed   Official            Official
     animals that are not          individual animal   individual animal
     scrapie-positive, suspect,    identification      identification.
     or high-risk animals and      and a permit, or    (Note: pregnant
     are not animals from an       a permit and an     animals and
     infected or source flock.     indelible ``S''     animals with a
                                   mark on the left    visible vaginal
                                   jaw, or sealed      discharge may
                                   conveyance and a    only be moved
                                   permit when         directly to
                                   moving directly     slaughter or to
                                   to slaughter.       terminal
                                   (Note: pregnant     feedlots.3, 4
                                   animals and
                                   animals with a
                                   visible vaginal
                                   discharge may
                                   only be permitted
                                   to slaughter or
                                   to terminal
                                   feedlots.3, 4
    (4) Sheep over 18 months of   Official            Official
     age that are not scrapie-     individual animal   individual animal
     positive, suspect, sexually   identification      identification.\4
     intact high-risk, or          and a               \
     sexually intact exposed       certificate.\4\.
     animals and that are not
     sexually intact animals
     from an infected or source
     flock.
    (5) Low-risk commercial       Official            (i) Official
     sheep.                        individual animal   premises
                                   identification      identification
                                   and a certificate   that is a
                                   \4\.                permanent legible
                                                       brand or ear
                                                       notch pattern
                                                       registered with
                                                       an official brand
                                                       registry or, in
                                                       the case of
                                                       animals moving
                                                       directly to
                                                       slaughter, may be
                                                       a legible paint
                                                       brand registered
                                                       with an official
                                                       brand registry;
                                                      (ii) A brand
                                                       inspection
                                                       certificate;
                                                      (iii) An owner
                                                       statement dated
                                                       within 30 days of
                                                       the movement
                                                       stating that the
                                                       flock does not
                                                       contain any
                                                       animal exhibiting
                                                       signs of scrapie,
                                                       and that, to the
                                                       best of his or
                                                       her knowledge,
                                                       the flock has no
                                                       risk factors for
                                                       or exposure to
                                                       scrapie and has
                                                       never contained:
                                                       (A) Any animal
                                                       diagnosed as
                                                       having scrapie;
                                                       (B) any female
                                                       blackfaced sheep;
                                                       or (C) any female
                                                       blackfaced cross
                                                       sheep that was
                                                       not born in the
                                                       flock;

[[Page 302]]

 
                                                      (iv) An accredited
                                                       veterinarian's
                                                       statement issued
                                                       within 12 months
                                                       of the date of
                                                       movement
                                                       indicating that,
                                                       to the best of
                                                       his or her
                                                       knowledge, the
                                                       flock has no
                                                       known risk
                                                       factors for or
                                                       exposure to
                                                       scrapie, and that
                                                       he or she has
                                                       inspected the
                                                       flock and it does
                                                       not contain: (A)
                                                       Any animal
                                                       exhibiting signs
                                                       of scrapie; (B)
                                                       any female
                                                       blackfaced sheep;
                                                       or (C) any female
                                                       blackfaced cross
                                                       sheep that was
                                                       not born in the
                                                       flock. The
                                                       statements must
                                                       include the
                                                       owner's name,
                                                       address, and the
                                                       premises
                                                       identification
                                                       number and a
                                                       drawing of the
                                                       owner's
                                                       registered brand
                                                       or ear notch
                                                       pattern.\4\
    (6) Goats that are not        None..............  None.
     scrapie-positive, suspect,
     sexually intact high-risk,
     or sexually intact exposed
     animals and that are not
     sexually intact animals
     from an infected or source
     flock.
(d) Movement of animals for
 grazing or other management
 purposes without change of
 ownership.--
    (1) Scrapie-positive,         Prohibited \1\....  Prohibited.\1\
     suspect, or sexually intact
     high-risk animals.
    (2) Non-high-risk animals     Prohibited \1\....  Prohibited,\1\
     from an infected or source                        except as allowed
     flock.                                            in an approved
                                                       scrapie control
                                                       pilot project
                                                       flock plan and
                                                       must meet the
                                                       requirements for
                                                       exposed animals.
    (3) Sexually intact exposed   Official            Official
     animals that are not          individual animal   individual animal
     scrapie-positive, suspect,    identification      identification
     or high-risk animals and      and a permit.\2\    and a permit.\2\
     that are not animals from     For any female      For any female
     an infected or source flock.  exposed sheep the   exposed sheep the
                                   results of an       results of an
                                   official genotype   official genotype
                                   test must be        test must be
                                   included on or      included on or
                                   attached to the     attached to the
                                   permit and must     permit and must
                                   be QR or RR at      be QR or RR at
                                   codon 171.          codon 171.
    (4) Sexually intact sheep or  Official premises   None.
     sexually intact goats that    identification
     have been commingled with     and a
     sheep and that are not        certificate..
     scrapie-positive, suspect,
     high-risk, or exposed
     animals and are not animals
     from an infected or source
     flock.
    (5) Sexually intact goats     None..............  None.
     that have not been
     commingled with sheep and
     that are not scrapie-
     positive, suspect, high-
     risk, or exposed animals
     and are not animals from an
     infected or source flock.
    (6) Castrated animals that    None..............  None.
     are not scrapie-positive or
     suspect animals and are not
     an animal from an infected
     or source flock.
------------------------------------------------------------------------
\1\ Animals prohibited movement may be moved interstate only if they are
  moving interstate for destruction or research as approved by the
  Administrator.
\2\ A copy of the permit must be sent to the State veterinarian and the
  AVIC of the receiving State prior to movement of animals.
\3\ No exposed or high-risk animal from any State or any animal from an
  Inconsistent State shall be removed from slaughter channels once it
  has entered interstate commerce.
\4\ Official individual animal identification or official premises
  identification is not required for these slaughter animals if the
  animals are kept as a group on the same premises on which they were
  born or used for breeding purposes and are not commingled with animals
  from another premises at any time, including throughout the feeding,
  marketing, and slaughter process.


[[Page 303]]



Sec.  79.4  Designation of scrapie-positive animals, high-risk animals, 

exposed animals, suspect animals, exposed flocks, infected flocks, 
noncompliant flocks, and source flocks; notice to owners.

    (a) Designation. A designated scrapie epidemiologist will designate 
an animal to be a scrapie-positive animal, high-risk animal, exposed 
animal, or suspect animal after determining that the animal meets the 
criteria of the relevant definition in Sec.  79.1.
    (1) A State or APHIS veterinarian will designate an animal to be a 
suspect animal after determining that the animal meets the criteria of 
the relevant definition in Sec.  79.1.
    (2) A designated scrapie epidemiologist will designate a flock to be 
a source, infected, or exposed flock after reviewing sale, movement, and 
breeding records that indicate the flock meets the criteria of the 
relevant definition in Sec.  79.1.
    (i) A designated scrapie epidemiologist may conduct testing of 
animals if he or she determines such testing is needed to properly 
designate a flock to be a source, infected, or exposed flock. The 
designated scrapie epidemiologist will select animals for testing in a 
manner that will provide a 95 percent confidence of detecting scrapie at 
a prevalence of 1 percent or, when flock records are adequate and all 
exposed animals that lambed in the flock are available for testing, may 
limit the testing to all exposed and suspect animals. Flocks meeting the 
definition of infected or source flocks that are designated as exposed 
flocks must complete a post exposure monitoring and management plan. 
Testing may include live-animal testing using a live-animal official 
test, an official genotype test, the culling and postmortem examination 
and testing of genetically susceptible animals in the flock that cannot 
be evaluated by a live animal test, and postmortem examination and 
testing of animals found dead or cull animals at slaughter.
    (ii) If an owner does not make his or her animals available for 
testing within 60 days of notification or as mutually agreed or fails to 
submit required postmortem samples, the flock will be designated a 
source, infected, or exposed flock, whichever definition applies. Any 
flock that is pending designation must comply with the movement 
restrictions for infected flocks.
    (3) A designated scrapie epidemiologist will designate a flock to be 
a noncompliant flock after determining that the flock meets the 
definition of a noncompliant flock in Sec.  79.1.
    (b) Redesignation. (1) A designated scrapie epidemiologist may 
reclassify an animal designated a high-risk animal as an exposed animal 
after receiving negative results from an official test or in accordance 
with an approved Scrapie Control Pilot Project.
    (2) A State or APHIS veterinarian may remove the suspect animal 
designation from an animal that had clinical signs of scrapie and that 
did not test positive for scrapie or for the proteinase resistant 
protein associated with scrapie upon determination that it is alive and 
no longer exhibits such signs, or that the signs are not caused by 
scrapie.
    (3) A designated scrapie epidemiologist may remove the suspect 
animal designation from an animal that has tested positive for scrapie 
or for the proteinase resistant protein associated with scrapie on an 
unofficial test based on knowledge of the test used or based on an 
epidemiologic investigation which may include additional testing of the 
suspect animal and or animals that have been commingled with the suspect 
animal.
    (4) A designated scrapie epidemiologist may remove the suspect 
animal designation from an animal that tested positive on a live-animal 
screening test based on an epidemiologic investigation which includes 
additional official testing of the suspect animal and when appropriate, 
animals that have been commingled with the suspect animal.
    (5) A designated scrapie epidemiologist may remove the exposed flock 
designation after completing an epidemiologic investigation or upon 
completion of a post-exposure management and monitoring plan. As part of 
the epidemiologic investigation the designated scrapie epidemiologist 
may conduct testing of animals if he or she determines such testing is 
needed to properly redesignate the flock. The designated scrapie 
epidemiologist will

[[Page 304]]

select animals for testing in a manner that will provide a 95 percent 
confidence of detecting scrapie at a prevalence of 1 percent or, when 
flock records are adequate and all exposed animals that lambed in the 
flock are available for testing, may limit the testing to all exposed 
and suspect animals. Testing may include live-animal testing using a 
live-animal official test, an official genotype test, the culling and 
postmortem examination and testing of genetically susceptible animals in 
the flock that cannot be evaluated by a live animal test, and postmortem 
examination and testing of animals found dead or cull animals at 
slaughter. A designated scrapie epidemiologist shall redesignate an 
exposed flock as a noncompliant flock if the owner fails to make his 
animals available for testing within 60 days of notification or as 
mutually agreed or fails to submit required postmortem samples.
    (6) Based on an epidemiologic investigation and testing, a 
designated scrapie epidemiologist may redesignate an infected flock or 
source flock as an exposed flock. The designated scrapie epidemiologist 
may only use this option when the epidemiologic investigation reveals 
that the scrapie exposure was minor or could not be confirmed due to 
inadequate records. The designated scrapie epidemiologist will select 
animals for testing in a manner that will provide a 95 percent 
confidence of detecting scrapie at a prevalence of 1 percent or, when 
flock records are adequate and all exposed animals that lambed in the 
flock are available for testing, may limit the testing to all exposed 
and suspect animals. Testing may include live-animal testing using a 
live-animal official test, an official genotype test, the culling and 
postmortem examination and testing of genetically susceptible animals in 
the flock that cannot be evaluated by a live animal test, and postmortem 
examination and testing of animals found dead or cull animals at 
slaughter. Infected or source flocks that are redesignated as exposed 
flocks must complete a post exposure monitoring and management plan. If 
an owner does not make his or her animals available for testing within 
60 days of notification or as mutually agreed or fails to submit 
required postmortem samples, the flock designation will remain 
unchanged.
    (7) A designated scrapie epidemiologist may remove the noncompliant 
flock designation after reviewing any required testing of the flock and 
determining that the flock has complied with the required testing or no 
longer meets the definition of a noncompliant flock.
    (8) A designated scrapie epidemiologist may redesignate an exposed 
animal, exposed flock, or infected flock by removing that designation 
after completing an epidemiologic investigation and determining that the 
exposure was limited to a scrapie-positive male animal that was not born 
in the flock (the owner must have adequate records and animal 
identification to show that the scrapie-positive male animal was 
purchased).
    (c) Notice to owner. As soon as possible after making such a 
determination, a State or APHIS representative will attempt to notify 
the owner(s) of the flock(s) in writing that their flock contained or 
contains a scrapie-positive animal, a suspect animal, a high-risk animal 
or an exposed animal, or that the flock is an infected, source, exposed, 
or noncompliant flock or that the flock is pending designation as an 
infected, source, exposed, or noncompliant flock. The notice will 
include:
    (1) A description of the interstate movement restrictions and 
identification requirements;
    (2) Reporting requirements;
    (3) Sample submission requirements for suspect and high-risk animals 
contained in this part;
    (4) Options for controlling the spread of scrapie from, and 
eradicating 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; and
    (5) In the case of flocks that are pending designation the 
notification shall include the testing options available to them and the 
designation their flock will receive if they decline to test.

[[Page 305]]



Sec.  79.5  Issuance of certificates.

    (a) Certificates are required as specified by Sec.  79.3 for certain 
interstate movements of animals. A certificate must show the official 
ear tag number, individual animal registered breed association 
registration tattoo, individual animal registered breed association 
registration brand, individual animal registered breed association 
registration number, and any other official individual identification of 
each animal to be moved; provided that, in the case of animals 
identified with premises identification \4\ that is assigned to the 
flock of origin and that meets the requirements for individual animal 
identification, the premises number may be recorded instead of the 
individual identification numbers. 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. Certificates must indicate the flock of 
birth for any breeding sheep born after January 1, 2002, that are 
covered by the certificate. The certificate must include a statement by 
the issuing accredited or State or Federal veterinarian that the animals 
were not exhibiting clinical signs associated with scrapie at the time 
of examination and an owner statement indicating whether the animal is 
or is not a scrapie-positive, suspect, high-risk or exposed animal and 
whether it originated in an infected, source, exposed, or noncompliant 
flock. Except as provided in paragraphs (b) and (c) of this section, all 
of the information required by this paragraph must be typed or written 
on the certificate. Note that in accordance with Sec.  79.3(a), (b), and 
(c), scrapie-positive, suspect, and high-risk animals, some exposed 
animals, and animals that originated in an infected or source flock 
require permits rather than certificates.
---------------------------------------------------------------------------

    \4\ Ownership brands may be used on certificates for sheep and goats 
moved interstate when premises identification is required under this 
part, provided the ownership brands are legible and are registered with 
the official brand recording agency and the animals are accompanied by a 
brand inspection certificate.
---------------------------------------------------------------------------

    (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 
prepared the document and the date the document was signed.
    (c) Ownership brands documents attached to certificates. As an 
alternative to typing or writing ownership brands on a certificate, 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 certificate;
    (2) Each copy of the official brand inspection certificate must show 
the ownership brand of each animal to be moved with the certificate, 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 
certificate and must be circled or boxed, also in ink, so that no 
additional information can be added:

[[Page 306]]

    (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.



Sec.  79.6  Standards for States to qualify as Consistent States.

    (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 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 Sec.  79.4;
    (iv) Relieve infected and source flock movement restrictions only 
after completion of a flock plan created in accordance with Sec.  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 provided APHIS with a plan and timeline for complying with 
the

[[Page 307]]

following additional requirements, which must be met within 2 years of 
designation of the State as a Consistent State \5\:
---------------------------------------------------------------------------

    \5\ This provision would apply until January 1, 2003. Any State 
designated as a Consistent State after that date would have to meet all 
requirements prior to designation.
---------------------------------------------------------------------------

    (i) 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:
    (A) 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
    (B) 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.
    (C) 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.
    (ii) 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:
    (A) Premises information and assigned premises numbers and 
individual identification number sequences assigned for use as premises 
identification;
    (B) Individual animal information on all scrapie-positive, suspect, 
high-risk, and exposed animals in the State;
    (C) Individual animal information on all out-of-State animals to be 
traced; and
    (D) Accurate flock status data.
    (iii) 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.
    (iv) Effectively enforces movement restrictions on all scrapie-
positive, suspect, and high-risk animals throughout their lives unless 
they are moved in accordance with Sec.  79.3.
    (v) 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.
    (vi) 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 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.



Sec.  79.7  Waiver of requirements for scrapie control pilot projects.

    (a) The Administrator may waive the following requirements of this 
part for participants in a scrapie control pilot

[[Page 308]]

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]



PART 80_JOHNE'S DISEASE IN DOMESTIC ANIMALS--Table of Contents




Sec.
80.1 Definitions.
80.2 General restrictions.
80.3 Movement of domestic animals that are positive to an official 
          Johne's disease test.
80.4 Segregation of animals positive to an official Johne's disease test 
          during interstate movement.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 65 FR 18878, Apr. 10, 2000, unless otherwise noted.



Sec.  80.1  Definitions.

    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.
    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 Sec.  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 eartag approved by APHIS as being 
tamper-resistant and providing unique identification for each animal. An 
official eartag may conform to the alpha-numeric National Uniform 
Eartagging System, or it may bear a valid premises identification number 
that is used in conjunction with the producer's livestock production 
numbering system to provide a unique identification number.
    Official Johne's disease test. An organism detection test approved 
by the Administrator and conducted in a laboratory approved by the 
Administrator.\1\
    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. A unique number assigned by the 
State animal health official to a livestock production unit that is, in 
the judgment of the State animal health official or area veterinarian in 
charge,

[[Page 309]]

epidemiologically distinct from other livestock production units. A 
premises identification number shall consist of the State's two-letter 
postal abbreviation followed by the premises' assigned number. A 
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.
    Recognized slaughtering establishment. A slaughtering establishment 
\2\ operating under the Federal Meat Inspection Act (21 U.S.C. 601 et 
seq.) or a State inspected slaughtering establishment.
---------------------------------------------------------------------------

    \1\ A list of currently approved laboratories and the requirements 
for obtaining approval are available from the Diagnostic Bacteriology 
Laboratory, National Veterinary Services Laboratories, P.O. Box 844, 
Ames, Iowa 50010. the Administrator will approve laboratories to conduct 
an official Johne's disease test only after determining that the 
laboratory meets the check test proficiency requirements prescribed by 
the National Veterinary Services Laboratories. Approval will continue as 
long as such check test proficiency requirements are met on an annual 
basis.
    \2\ A list of recognized slaughtering establishments in any State 
may be obtained from an APHIS representative, the State animal health 
official, or a State representative.
---------------------------------------------------------------------------

    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.



Sec.  80.2  General restrictions.

    Domestic animals that are positive to an official Johne's disease 
test may not be moved interstate except in compliance with this part.



Sec.  80.3  Movement of domestic animals that are positive to an 
official Johne's disease test.

    (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 
Sec.  71.6 of this chapter. The facilities in which the animals were 
maintained must be cleaned and disinfected in accordance with Sec.  71.7 
of this chapter.



Sec.  80.4  Segregation of animals positive to an official Johne's 
disease test during interstate movement.

    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.



PART 82_EXOTIC NEWCASTLE DISEASE (END) AND CHLAMYDIOSIS--Table of Contents




                Subpart A_Exotic Newcastle Disease (END)

Sec.
82.1 Definitions.
82.2 Criteria for determining birds or poultry to be infected with, 
          exposed to, or free from END.
82.3 Quarantined areas.

[[Page 310]]

82.4 General provisions.
82.5 Interstate movement of live birds and live poultry from a 
          quarantined area.
82.6 Interstate movement of dead birds and dead poultry from a 
          quarantined area.
82.7 Interstate movement of manure and litter from a quarantined area.
82.8 Interstate movement of eggs, other than hatching eggs, from a 
          quarantined area.
82.9 Interstate movement of hatching eggs from a quarantined area.
82.10 Interstate movement of vehicles, cages, coops, containers, 
          troughs, and other equipment from a quarantined area.
82.11 Issuance of permits.
82.12 Other interstate movements and special permits.
82.13 Denial and withdrawal of permits and special permits.
82.14 Removal of quarantine.
82.15 Replacement birds and poultry.
82.16 Extraordinary emergencies: applicability of regulations.

                    Subpart B_Chlamydiosis in Poultry

82.19 Definitions.
82.20 General restrictions.
82.21 Vehicles, cages, coops, containers, troughs, and other equipment 
          used for infected poultry.
82.22 Cleaning and disinfecting premises.
82.23 Issuance of permits.
82.24 Other interstate movements and special permits.
82.25 Denial and withdrawal of permits and special permits.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 61 FR 56883, Nov. 5, 1996, unless otherwise noted.



                Subpart A_Exotic Newcastle Disease (END)



Sec.  82.1  Definitions.

    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.
    Dressed carcasses. Carcasses of birds or poultry that have been 
eviscerated, with heads and feet removed.
    END. Any velogenic Newcastle disease. END is an acute, rapidly 
spreading, and usually fatal viral disease of birds and poultry.
    Exposed. At risk of developing END because of association with birds 
or poultry infected with END, excrement from birds or poultry infected 
with END, or other material touched by birds or poultry infected with 
END, or because there is reason to believe that association has occurred 
with END or vectors of END, 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 END because of 
association with birds or poultry infected with END, excrement from 
birds or poultry infected with END, or other material touched by birds 
or poultry infected with END, or because there is reason to believe that 
association has occurred with END or vectors of END, 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.
    Official seal. A serially numbered metal or plastic strip, 
consisting of a

[[Page 311]]

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 bird. Any bird that is kept for personal pleasure and is not for 
sale.
    Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, 
partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys.
    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 [deg]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.



Sec.  82.2  Criteria for determining birds or poultry to be infected 
with, exposed to, or free from END.

    (a) The determination that birds or poultry are infected with END 
must be made by either a Federal veterinarian or a State 
veterinarian.\1\ They will base that determination on one or more of the 
following factors: clinical evidence (signs, post-mortem lesions, and 
history of the occurrence of END); diagnostic tests; \2\ or 
epidemiological evidence (evaluation of clinical evidence and the degree 
of risk posed by the potential spread of END based on population and 
exposure factors, including evaluation of whether the birds and poultry 
have had the opportunity to be in contact with birds or poultry infected 
with END or with excrement from birds or poultry infected with END, or 
if the birds and poultry have shared feed or water with birds or poultry 
infected with END).
---------------------------------------------------------------------------

    \1\ The location of Federal veterinarians and State veterinarians 
may be obtained by writing to Emergency Programs, Veterinary Services, 
Animal and Plant Health Inspection Service, 4700 River Road, Unit 41, 
Riverdale, MD 20737-1231, or by referring to the local telephone book.
    \2\ A copy of the protocols for END diagnostic tests may be obtained 
by writing to Emergency Programs, Veterinary Services, Animal and Plant 
Health Inspection Service, 4700 River Road Unit 41, Riverdale, MD 20737-
1231. The protocols are also found in ``Recommended Uniform Diagnostic 
Procedures,'' published by the Committee of the American Association of 
Veterinary Laboratory Diagnosticians.
---------------------------------------------------------------------------

    (b) The determination that birds or poultry are exposed to END 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 END, to excrement from birds or poultry 
infected with END, and to other material touched by birds or poultry 
infected with END; the number of birds or poultry infected with END to 
which the birds or poultry were exposed; the species involved; the 
virulence of the END

[[Page 312]]

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 
END, and to material touched by birds or poultry infected with END. 
Birds or poultry determined to be exposed to END will continue to be 
treated as exposed unless they are subsequently determined to be 
infected with END or until either a Federal veterinarian or a State 
veterinarian finds them to be free of END based on one or more of the 
---------------------------------------------------------------------------
factors listed in paragraph (a) of this section.

(Approved by the Office of Management and Budget under control number 
0579-0116)



Sec.  82.3  Quarantined areas.

    (a) Any area where birds or poultry infected with END 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 END. 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 END will 
remain designated as a quarantined area until all of the requirements of 
Sec.  82.14 have been met.
    (c) The following areas are quarantined because of END: There are no 
areas in the United States quarantined because of END.

[61 FR 56883, Nov. 5, 1996, as amended at 67 FR 70675, Nov. 26, 2002; 68 
FR 1517, Jan. 13, 2003; 68 FR 3376, Jan. 24, 2003; 68 FR 7413, Feb. 14, 
2003; 68 FR 18532, Apr. 16, 2003; 68 FR 26987, 26989, May 19, 2003; 68 
FR 34781, June 11, 2003; 68 FR 45744, Aug. 4, 2003; 68 FR 54800, Sept. 
19, 2003]



Sec.  82.4  General provisions.

    (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 END, or are from a flock of birds or 
poultry infected with END;
    (2) Litter used by or manure generated by birds or poultry, or a 
flock of birds or poultry, infected with END;
    (3) Any eggs from birds or poultry, or a flock of birds or poultry, 
infected with END;
    (4) Hatching eggs from flocks of birds or poultry exposed to END; 
and
    (5) Live birds or live poultry from flocks infected with or exposed 
to END.
    (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 END;
    (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 END;
    (3) Litter used by or manure generated by birds or poultry not known 
to be infected with END;
    (4) Eggs, other than hatching eggs, from birds or poultry from 
flocks not known to be infected with END;
    (5) Hatching eggs from birds or poultry not known to be infected 
with or exposed to END; 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.



Sec.  82.5  Interstate movement of live birds and live poultry from a 
quarantined area.

    (a) Pet birds. An individual may move his or her pet birds 
interstate from a quarantined area if the birds are not known to be 
infected with or exposed to END and:
    (1) The birds are accompanied by a permit obtained in accordance 
with Sec.  82.11;
    (2) Epidemiological evidence, as described in Sec.  82.2(a), 
indicates that the birds are not infected with any communicable disease;

[[Page 313]]

    (3) The birds 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;
    (4) The birds have been maintained apart from other birds and 
poultry in the quarantined area during the 90 days before interstate 
movement;
    (5) The birds have been under the ownership and control of the 
individual to whom the permit is issued for the 90 days before 
interstate movement;
    (6) The birds are moved interstate by the individual to whom the 
permit is issued;
    (7) The birds are caged while being moved interstate;
    (8) The individual to whom the permit is issued maintains ownership 
and control of the birds and maintains 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 
\3\ examines the birds and determines that the birds show no clinical 
signs of END. The examination will not be less than 30 days after the 
interstate movement;
---------------------------------------------------------------------------

    \3\ The location of Federal representatives and State 
representatives may be obtained by writing to Emergency Programs, 
Veterinary Services, Animal and Plant Health Inspection Service, 4700 
River Road Unit 41, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (9) The individual to whom the permit is issued allows Federal 
representatives and State representatives to examine the birds at any 
time until they are declared free of END by either a Federal 
veterinarian or a State veterinarian;
    (10) 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 \4\ in the State to which the birds are moved; and
---------------------------------------------------------------------------

    \4\ The location of the veterinarian in charge or the State animal 
health official may be obtained by writing to Emergency Programs, 
Veterinary Services, Animal and Plant Health Inspection Service, 4700 
River Road Unit 41, Riverdale, MD 203/737-1231, or by referring to the 
local telephone book.
---------------------------------------------------------------------------

    (11) 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 and poultry. Except as provided for pet birds in 
paragraph (a) of this section, a person may move live birds and live 
poultry that are not known to be infected with or exposed to END 
interstate from a quarantined area only if:
    (1) The birds and poultry are accompanied by a permit obtained in 
accordance with Sec.  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, the poultry are moved interstate to a recognized 
slaughtering establishment \5\ and are slaughtered within 24 hours of 
arrival at the recognized slaughtering establishment;
---------------------------------------------------------------------------

    \5\ A list of recognized slaughtering establishments in any State 
may be obtained from a Federal representative, the State animal health 
official, or a State representative.
---------------------------------------------------------------------------

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0116)

[[Page 314]]



Sec.  82.6  Interstate movement of dead birds and dead poultry from a 
quarantined area.

    (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 END 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 Sec.  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 Sec.  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 END; 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 END 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; \6\
---------------------------------------------------------------------------

    \6\ See footnote 5 to Sec.  82.5.
---------------------------------------------------------------------------

    (2) The dressed carcasses are accompanied by a permit obtained in 
accordance with Sec.  82.11;
    (3) The dressed carcasses are moved in a means of conveyance either 
under official seal or accompanied by a Federal representative;
    (4) The dressed carcasses are not unloaded until their arrival at 
the destination listed on the permit required by paragraph (b)(2) of 
this section;
    (5) The dressed carcasses are moved, without stopping, to the 
destination listed on the permit required by paragraph (b)(2) of this 
section, except for normal traffic conditions, such as traffic lights 
and stop signs; and
    (6) Copies of the permit accompanying the dressed carcasses 
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 dressed carcasses at 
the destination listed on the permit required by paragraph (b)(2) of 
this section.

(Approved by the Office of Management and Budget under control number 
0579-0116)



Sec.  82.7  Interstate movement of manure and litter from a quarantined 
area.

    Manure generated by and litter used by birds or poultry not known to 
be infected with END may be moved interstate from a quarantined area 
only if:
    (a) The manure and litter is accompanied by a permit obtained in 
accordance with Sec.  82.11;
    (b) The manure and litter has been heated throughout, in the 
quarantined area, to a temperature of not less than 175 [deg]F (79.4 
[deg]C), 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;
    (c) The declaration or affidavit required by Sec.  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

[[Page 315]]

    (d) 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.



Sec.  82.8  Interstate movement of eggs, other than hatching eggs, from 
a quarantined area.

    (a) Eggs, other than hatching eggs, from birds or poultry from 
flocks not known to be infected with END may be moved interstate from a 
quarantined area only if:
    (1) The eggs are accompanied by a permit obtained in accordance with 
Sec.  82.11;
    (2) The eggs have been cleaned and sanitized in accordance with 7 
CFR part 59;
    (3) The eggs are packed either in previously unused flats or cases 
or in used plastic flats or cases that were cleaned and 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.



Sec.  82.9  Interstate movement of hatching eggs from a quarantined area.

    Hatching eggs from birds or poultry not known to be infected with or 
exposed to END may be moved interstate from a quarantined area only if:
    (a) The hatching eggs are accompanied by a permit obtained in 
accordance with Sec.  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; and
    (c) 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 END.



Sec.  82.10  Interstate movement of vehicles, cages, coops, containers, 
troughs, and other equipment from a quarantined area.

    (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 Sec.  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,

[[Page 316]]

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 \7\ 
inspect the items after they have been cleaned;
---------------------------------------------------------------------------

    \7\ See footnote 3 to Sec.  82.5.
---------------------------------------------------------------------------

    (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 
END.
    (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 Sec.  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 \8\ for the 
State of destination within 72 hours of the arrival of the vehicles, 
cages, coops, containers, troughs, and other equipment at the 
destination listed on the permit.
---------------------------------------------------------------------------

    \8\ See footnote 4 of Sec.  82.5.

(Approved by the Office of Management and Budget under control number 
0579-0116)



Sec.  82.11  Issuance of permits.

    (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 Sec.  82.5 for live birds or 
live poultry, Sec.  82.6 for dead birds and dead poultry, Sec.  82.7 for 
litter or manure, Sec.  82.8 for eggs other than hatching eggs, Sec.  
82.9 for hatching eggs, or Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0116)



Sec.  82.12  Other interstate movements and special permits.

    (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 END. A special

[[Page 317]]

permit is required for the disposal of dead birds or dead poultry that 
are infected with END, or dead birds or dead poultry from flocks 
infected with END, or manure generated by or eggs from birds or poultry 
infected with END, 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 END. To apply for a special permit, contact the 
veterinarian in charge \9\ for the State in which the birds, poultry, or 
other items are located. The Administrator may, at his or her 
discretion, issue special permits if he or she determines that the 
activity authorized will not result in the interstate dissemination of 
END.
---------------------------------------------------------------------------

    \9\ See footnote 4 to Sec.  82.5.
---------------------------------------------------------------------------

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0116)



Sec.  82.13  Denial and withdrawal of permits and special permits.

    (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 END, 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 
\10\ and must state all of the facts and reasons upon which the

[[Page 318]]

person relies to show that the permit or special permit was wrongfully 
denied or withdrawn. The Administrator will grant or deny the appeal, in 
writing, explaining all of the reasons for the decision, as promptly as 
circumstances allow. In cases where there is a conflict as to any 
material fact, the person denied a permit or special permit, or from 
whom a permit or special permit is withdrawn, shall be given an 
opportunity for a hearing with respect to the merits of the validity of 
the denial or withdrawal in accordance with rules of practice adopted 
for the proceeding.
---------------------------------------------------------------------------

    \10\ Written appeals should be sent to the Administrator, c/o 
Emergency Programs, Veterinary Services, Animal and Plant Health 
Inspection Service, 4700 River Road, Riverdale, MD 20737-1231.

(Approved by the Office of Management and Budget under control number 
0579-0116)



Sec.  82.14  Removal of quarantine.

    An area will be removed from quarantine only when all of the 
following requirements have been met:
    (a) All birds and poultry exposed to END in the quarantined area 
have been found to be free of END;
    (b) All birds and poultry infected with END 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 END 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 END must be composted in the quarantined area. The birds 
and poultry must be composted according to the following instructions:
    (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 
[deg]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 
[deg]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 END 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

[[Page 319]]

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 END 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 according to the 
following method: 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 [deg]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 
[deg]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 END 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 END, 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 
END 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.

(Approved by the Office of Management and Budget under control number 
0579-0116)



Sec.  82.15  Replacement birds and poultry.

    Birds and poultry that have been destroyed because of a quarantine 
for

[[Page 320]]

END may not be replaced by birds or poultry moved interstate into the 
quarantined area until the Administrator decides that END has been 
eradicated and that replacement birds or poultry will not become 
infected with END.



Sec.  82.16  Extraordinary emergencies; applicability of regulations.

    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 END, 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.

[68 FR 1517, Jan. 13, 2003]



                    Subpart B_Chlamydiosis in Poultry



Sec.  82.19  Definitions.

    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.



Sec.  82.20  General restrictions.

    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.

[[Page 321]]



Sec.  82.21  Vehicles, cages, coops, containers, troughs, and other 
equipment used for infected poultry.

    (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,\1\ or an 
accredited veterinarian, inspect the items after they have been cleaned;
---------------------------------------------------------------------------

    \1\ See footnote 3 to Sec.  82.5.
---------------------------------------------------------------------------

    (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 Sec.  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 \2\ 
for the State of destination within 72 hours of the arrival of the 
vehicles, cages, coops, containers, troughs, and other equipment at the 
destination listed on the permit.
---------------------------------------------------------------------------

    \2\ See footnote 4 to Sec.  82.5.

(Approved by the Office of Management and Budget under control numbers 
0579-0116 and 0579-0032)



Sec.  82.22  Cleaning and disinfecting premises.

    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.

(Approved by the Office of Management and Budget under control numbers 
0579-0116 and 0579-0032)



Sec.  82.23  Issuance of permits.

    (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

[[Page 322]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0116)



Sec.  82.24  Other interstate movements and special permits.

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0116)



Sec.  82.25  Denial and withdrawal of permits and special permits.

    (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 
\3\ and must state all of the facts and reasons upon which the person 
relies to show that the permit or special permit was wrongfully denied 
or withdrawn. The Administrator

[[Page 323]]

will grant or deny the appeal, in writing, explaining all of the reasons 
for the decision, as promptly as circumstances allow. In cases where 
there is a conflict as to any material fact, the person denied a permit 
or special permit, or from whom a permit or special permit is withdrawn, 
shall be given an opportunity for a hearing with respect to the merits 
or validity of the denial or withdrawal in accordance with rules of 
practice adopted for the proceeding.
---------------------------------------------------------------------------

    \3\ See footnote 10 to Sec.  82.13.

(Approved by the Office of Management and Budget under control number 
0579-0116)



PART 85_PSEUDORABIES--Table of Contents




Sec.
85.1 Definitions.
85.2 Notice relating to the existence of the contagion of pseudorabies.
85.3 General restriction.
85.4 Interstate movement of livestock.
85.5 Interstate movement of infected swine or exposed swine.
85.6 Interstate movement of pseudorabies vaccinate swine, except swine 
          from qualified negative gene-altered vaccinated herds, not 
          known to be infected with or exposed to pseudorabies.
85.7 Interstate movement of swine not vaccinated for pseudorabies and 
          not known to be infected with or exposed to pseudorabies.
85.8 Interstate movement of swine from a qualified negative gene-altered 
          vaccinated herd.
85.9 Other interstate movements.
85.10 Interstate movement of swine semen and swine embryos for 
          insemination of or implantation into swine.
85.11 Permits and certificates.
85.12 Cleaning and disinfecting means of conveyance.
85.13 Cleaning and disinfecting livestock markets and other facilities.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 44 FR 10309, Feb. 16, 1979, unless otherwise noted.



Sec.  85.1  Definitions.

    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 Sevice. 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.\1\
---------------------------------------------------------------------------

    \1\ The names and addresses of laboratories approved by the 
Administrator to conduct approved differential pseudorabies tests are 
published in the Notices Section of the Federal Register. A list of 
approved laboratories is also available upon request from the Animal and 
Plant Health Inspection Service, Veterinary Services, Operational 
Support, 4700 River Road Unit 33, Riverdale, Maryland 20737-1231. State, 
Federal, and university laboratories will be approved by the 
Administrator when he or she determines that the laboratory: (a) Employs 
personnel trained at the National Veterinary Services Laboratories 
assigned to supervise the testing; (b) follows standard test protocols; 
(c) meets check test proficiency requirements; and (d) will report all 
test results to State and Federal animal health officials. Before the 
Administrator may withdraw approval of any laboratory for failure to 
meet any of these conditions, the Administrator must give written notice 
of the proposed withdrawal to the director of the laboratory, and must 
give the director an opportunity to respond. If there are conflicts as 
to any material fact, a hearing will be held to resolve the conflict.
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    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

[[Page 324]]

been approved by the Administrator under Sec.  71.20 of this chapter.\2, 
3\
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    \2\ Notices containing lists of such approved livestock markets are 
published in the Federal Register. Information concerning livestock 
markets can be obtained from the Veterinarian in Charge, Veterinary 
Services, Animal and Plant Health Inspection Service, United States 
Department of Agriculture for the State in question.
    \3\ Before the Administrator withdraws approval of any livestock 
market, the owner of such livestock market shall be given notice by the 
Administrator of the proposed withdrawal of approval and the reasons 
therefor and such owner shall have an opportunity to present his views 
thereon. In those instances where there are conflicts as to the facts, a 
hearing shall be held to resolve such conflicts.
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    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 a 
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.

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    (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 permises have shown clinical signs of pseudorabies 
after removal of the postive swine; or
    (2) All swine have been depopulated for 30 days and the herd 
premises have been cleaned and disinfected in accordance with Sec.  
85.13; or
    (3) In a herd of swine in which swine are positive to an official 
pseudorabies serologic test but no swine are postive 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\
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    \4\ The epidemiologist shall consider the following epidemiologic 
evidence to determine which swine in the herd, in addition to the 
titered swine, must be subjected to an official pseudorbies serologic 
test and found negative: (a) the percentage and number of titered swine 
in the herd; (b) the number of titered swine as compared to the number 
of swine tested; (c) the extent of the contact of members of the herd 
with the titered swine; (d) the prevalence of pseudorabies in the area; 
(e) the herd management practices; and (f) any other reliable 
epidemiologic evidence.
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    (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

[[Page 326]]

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.\5\ The following tests for the diagnosis of 
pseudorabies have been approved by the Administrator: 1. Microtitration 
Serum-Virus Neutralization Test; 2. Virus Isolation and Identification 
Test; 3. Fluorescent Antibody Tissue Section Test; 4. Enzyme-Linked 
Immunosorbent Assay (ELISA) Test, except for approved differential 
pseudorabies tests other than the glycoprotein I (gpI) ELISA test; 5. 
Latex Agglutination Test (LAT); and 6. Particle Concentration 
Fluorescence Immunoassay (PCFIA) Test, including the gpI PCFIA test.\6\ 
State, Federal, and University laboratories will be approved by the 
Administrator following the determination by him that the laboratory: 
(a) Has personnel trained at the Veterinary Services Diagnostic 
Laboratory, Ames, Iowa, assigned to supervise the test, (b) follows 
standard test protocol, (c) meets check test proficiency requirements, 
and (d) will report all test results to State and Federal animal health 
officials.\7\
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    \5\ Notices containing lists of laboratories approved for the 
purposes of the regulations in this part are published in the Federal 
Register Notices Section. The lists are also available upon request from 
the Animal and Plant Health Inspection Service, Veterinary Services, 
Operational Support, 4700 River Road Unit 33, Riverdale, Maryland 20737-
1231.
    \6\ Copies of the test protocols (Recommended Minimum Standards for 
Diagnostic Tests Employed in the Diagnosis of Pseudorabies (Aujeszky's 
Disease)) published as a Veterinary Services Notice, May 17, 1978, are 
available upon request from the Animal and Plant Health Inspection 
Service, Veterinary Services, Operational Support, 4700 River Road, Unit 
33, Riverdale, Maryland 20737-1231.
    \7\ Before the Administrator withdraws the approval of any 
laboratory, the Director of such laboratory shall be given a notice by 
the Administrator of the proposed disapproval and the reasons therefore 
and such Director shall have an opportunity to present his views 
thereon. In those instances where there are conflicts as to the facts, a 
hearing shall be held to resolve such conflicts.
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    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; \8\ and (c) reported as 
official vaccinates at the time of vaccination to the State animal 
health official.
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    \8\ The numbered pink eartags are available commercially. Should any 
problem arise regarding the availability of such eartags, contact the 
appropriate State animal health official.
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    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

[[Page 327]]

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.\1\
    (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 Sec.  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

[[Page 328]]

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

[[Page 329]]

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 Sec.  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.\1\
    (c) Qualified pseudorabies negative herd status is maintained by 
subjecting

[[Page 330]]

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 
Sec.  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.\9, 10\
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    \9\ Notices containing lists of slaughter markets approved for the 
purposes of the regulations in this part are published in the Federal 
Register. Information concerning slaughter markets can be obtained from 
the Veterinarian in Charge, Veterinary Services, Animal and Plant Health 
Inspection Service, U.S. Department of Agriculture, for the State in 
question.
    \10\ Before the Administrator withdraws approval of any slaughter 
market, the owner of such slaughter market shall be given notice by the 
Administrator of the proposed withdrawal of approval and the reasons 
therefore and such owner shall have an opportunity to present his views 
thereon. In those instances where there are conflicts as to the facts, a 
hearing shall be held to resolve such conflicts.

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[[Page 331]]

    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 pseudo rabies 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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0069)

[44 FR 10309, Feb. 16, 1979; 44 FR 12159, Mar. 6, 1979, as amended at 48 
FR 57472, Dec. 30, 1983; 50 FR 42145, Oct. 18, 1985; 50 FR 47350, Nov. 
15, 1985; 52 FR 45935, Dec. 3, 1987; 54 FR 21049, May 16, 1989; 55 FR 
19251, May 9, 1990; 55 FR 49592, Nov. 29, 1990; 58 FR 68507, Dec. 28, 
1993; 59 FR 67613, Dec. 30, 1994; 60 FR 26355, May 17, 1995; 62 FR 
27937, May 22, 1997; 63 FR 17316, Apr. 9, 1998; 66 FR 21063, Apr. 27, 
2001]



Sec.  85.2  Notice relating to the existence of the contagion of 
pseudorabies.

    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.



Sec.  85.3  General restriction.

    Livestock shall not be moved interstate except in compliance with 
the regulations in this part.



Sec.  85.4  Interstate movement of livestock.

    (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.

[44 FR 10309, Feb. 16, 1979, as amended at 50 FR 47352, Nov. 15, 1985]

[[Page 332]]



Sec.  85.5  Interstate movement of infected swine or exposed swine.

    Infected swine or exposed swine, other than swine described in Sec.  
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 con 
signee;
    (3) The permit, in addition to the information in Sec.  85.1, or the 
owner-shipper statement, in addition to the information in Sec.  85.1, 
lists the identification of the swine as required by Sec.  71.19 of this 
chapter; except if the swine are moved interstate and the indentity of 
the farm of origin of each swine is maintained, the permit or the owner-
shipper statement need not list the identification required by Sec.  
71.19 of this chapter, if such swine are identified to the farm of orgin 
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 Sec.  
85.1, states: (i) The present pseudorabies quarantine status of the farm 
of origin; (ii) the identification of the swine as required by Sec.  
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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[44 FR 10309, Feb. 16, 1979, as amended at 48 FR 57472, Dec. 30, 1983; 
50 FR 47352, Nov. 15, 1985; 53 FR 40387, Oct. 14, 1988; 59 FR 67133, 
Dec. 29, 1994]



Sec.  85.6  Interstate movement of pseudorabies vaccinate swine, except 

swine from qualified negative gene-altered vaccinated herds, not known 
to be infected with or exposed to pseudorabies.

    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.

[[Page 333]]

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 Sec.  85.1 
states: (i) The pseudorabies status of the herd; (ii) the identification 
of the swine required by Sec.  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 
Sec.  85.1, states:
    (i) The identification required by Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0051)

[44 FR 10309, Feb. 16, 1979, as amended at 48 FR 57472, Dec. 30, 1983; 
50 FR 47352, Nov. 15, 1985; 53 FR 40387, Oct. 14, 1988; 55 FR 19253, May 
9, 1990; 59 FR 67133, Dec. 29, 1994; 60 FR 26355, May 17, 1995; 63 FR 
17316, Apr. 9, 1998]



Sec.  85.7  Interstate movement of swine not vaccinated for pseudorabies 
and not known to be infected with or exposed to pseudorabies.

    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

[[Page 334]]

less restrictive than those in the definition of known infected herd in 
Sec.  85.1, and
    (i) Unless the swine are moving interstate in a swine production 
system in compliance with Sec.  71.19(h) 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 Sec.  71.19 of this 
chapter.
    (ii) Unless the swine are moving interstate in a swine production 
system in compliance with Sec.  71.19(h) 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 Sec.  
85.1, states the identification of the farm of origin of each swine 
being moved by a means of identification required by Sec.  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 Sec.  71.19(h) 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 
Sec.  85.1, states: (i) The identification required by Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0069)

[44 FR 10309, Feb. 16, 1979, as amended at 48 FR 57472, Dec. 30, 1983; 
50 FR 47352, Nov. 15, 1985; 53 FR 40387, Oct. 14, 1988; 66 FR 65604, 
Dec. 20, 2001]



Sec.  85.8  Interstate movement of swine from a qualified negative 
gene-altered vaccinated herd.

    Swine from a qualified negative gene-altered vaccinated herd, and 
not known to be infected with or exposed to pseudorabies, may be moved 
interestate 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 Sec.  71.19(h) of this chapter.
    (b) For all interstate movements other than those set forth in 
paragraph

[[Page 335]]

(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 Sec.  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 Sec.  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.

[55 FR 19253, May 9, 1990, as amended at 66 FR 65604, Dec. 20, 2001]



Sec.  85.9  Other interstate movements.

    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.

[44 FR 10309, Feb. 16, 1979, as amended at 54 FR 21049, May 16, 1989. 
Redesignated at 55 FR 19253, May 9, 1990]



Sec.  85.10  Interstate movement of swine semen and swine embryos for 
insemination of or implantation into swine.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0032)

[44 FR 10309, Feb. 16, 1979, as amended at 50 FR 47353, Nov. 15, 1985. 
Redesignated at 55 FR 19253, May 9, 1990; 59 FR 67133, Dec. 29, 1994]



Sec.  85.11  Permits and certificates.

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0069)

[44 FR 10309, Feb. 16, 1979, as amended at 48 FR 57472, Dec. 30, 1983. 
Redesignated at 55 FR 19253, May 9, 1990]



Sec.  85.12  Cleaning and disinfecting means of conveyance.

    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 Sec.  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.

[44 FR 10309, Feb. 16, 1979, as amended at 62 FR 27937, May 22, 1997]



Sec.  85.13  Cleaning and disinfecting livestock markets and other facilities.

    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 Sec.  71.7 of this chapter 
using one of the disinfectants registered under the

[[Page 336]]

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.

[44 FR 10309, Feb. 16, 1979, as amended at 62 FR 27937, May 22, 1997]



PART 88_COMMERCIAL TRANSPORTATION OF EQUINES FOR SLAUGHTER--Table of Contents




Sec.
88.1 Definitions.
88.2 General information.
88.3 Standards for conveyances.
88.4 Requirements for transport.
88.5 Requirements at a slaughtering facility.
88.6 Violations and penalties.

    Authority: 7 U.S.C. 1901, 7 CFR 2.22, 2.80, 371.4.

    Source: 66 FR 63615, Dec. 7, 2001, unless otherwise noted.



Sec.  88.1  Definitions.

    The following definitions apply to this part:
    APHIS. The Animal and Plant Health Inspection Service of the U.S. 
Department of Agriculture.
    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.
    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.
    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,\1\ which requires the 
information specified by Sec.  88.4(a)(3) of this part.
---------------------------------------------------------------------------

    \1\ Forms may be obtained from the National Animal Health Programs 
Staff, Veterinary Services, APHIS, 4700 River Road Unit 43, Riverdale, 
MD 20737-1231.
---------------------------------------------------------------------------

    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.
    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.



Sec.  88.2  General information.

    (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 to a slaughtering facility 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.



Sec.  88.3  Standards for conveyances.

    (a) The animal cargo space of conveyances used for the commercial 
transportation of equines to slaughtering facilities 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

[[Page 337]]

(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 in commercial transportation to slaughtering facilities 
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.



Sec.  88.4  Requirements for transport.

    (a) Prior to the commercial transportation of equines to a 
slaughtering facility, 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 \2\ to each equine in the shipment;
---------------------------------------------------------------------------

    \2\ USDA backtags are available at recognized slaughtering 
establishments and specifically approved stockyards and from State 
representatives and APHIS representatives. A list of recognized 
slaughtering establishments and specifically approved stockyards may be 
obtained as indicated in Sec.  78.1 of this chapter. The terms ``State 
representative'' and ``APHIS representative'' are defined in Sec.  78.1 
of this chapter.
---------------------------------------------------------------------------

    (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 the slaughtering facility 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 transit to the slaughtering facility, 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

[[Page 338]]

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 equine to the 
slaughtering facility.
    (c) Handling of all equines in commercial transportation to a 
slaughtering facility 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 in 
commercial transportation to a slaughtering facility 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 to 
a slaughtering facility, 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 to a 
slaughtering facility, 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.



Sec.  88.5  Requirements at a slaughtering facility.

    (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.



Sec.  88.6  Violations and penalties.

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0160.)

[[Page 339]]



PART 89_STATEMENT OF POLICY UNDER THE TWENTY-EIGHT HOUR LAW--Table of Contents




Sec.
89.1 Amount of feed.
89.2 Two or more feedings at same station.
89.3 Feeding, watering, and resting livestock in the car.
89.4 Watering.
89.5 Feeding pens.

    Authority: 49 U.S.C. 80502; 7 CFR 2.22, 2.80, and 371.4.

    Source: 28 FR 5967, June 13, 1963, unless otherwise noted.



Sec.  89.1  Amount of feed.

    (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:

------------------------------------------------------------------------
                                                        At second and
   Species and quantity of      At first feeding     subsequent feeding
          livestock                  station              stations
------------------------------------------------------------------------
Cattle and beef type or       200 lbs. of hay \1,   300 lbs. of hay. \1,
 range calves (for each car    2\.                   2\
 \1\).
Dairy calves (for each car    100 lbs. of hay \1,   150 lbs. of hay. \1,
 deck \1\).                    2\.                   2\
Horses and mules (for each    400 lbs. of hay \1,   400 lbs. of hay. \1,
 car \1\).                     2\.                   2\
Sheep and goats (for each     200 lbs. of hay \1,   300 lbs. of hay.\1,
 car deck \1\).                2\.                   2\
Lambs and kids (for each car  100 lbs. of hay \1,   150 lbs. of hay.\1,
 deck \1\).                    2\.                   2\
Swine (for each carload lot,
 in single or double deck
 car, the amount of shelled
 corn \2\ indicated):
  Lots of not more than       2 bushels...........  2 bushels.
   18,000 lbs.
  More than 18,000 lbs. but   2\1/2\ bushels......  2\1/2\ bushels.
   not more than 21,000 lbs.
  More than 21,000 lbs. but   3 bushels...........  3 bushels.
   not more than 24,000 lbs.
  More than 24,000 lbs. but   3\1/2\ bushels......  3\1/2\ bushels.
   not more than 27,000 lbs.
  More than 27,000 lbs. but   4 bushels...........  4 bushels.
   not more than 30,000 lbs.
  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, i.e., a load of livestock transported in a
  car 50 feet in length would require an additional 25 percent of feed
  or 2.5 percent for each additional foot of car over 40 feet.
\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.



Sec.  89.2  Two or more feedings at same station.

    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 Sec.  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.



Sec.  89.3  Feeding, watering, and resting livestock in the car.

    (a) Livestock should be unloaded into pens of the character 
described in Sec.  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

[[Page 340]]

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.



Sec.  89.4  Watering.

    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.



Sec.  89.5  Feeding pens.

    (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.

[[Page 341]]



SUBCHAPTER D_EXPORTATION AND IMPORTATION OF ANIMALS (INCLUDING POULTRY) 
                           AND ANIMAL PRODUCTS





PART 91_INSPECTION AND HANDLING OF LIVESTOCK FOR EXPORTATION--Table of Contents




                      Subpart A_General Provisions

Sec.
91.1 Definitions.
91.2 Animals to be handled in compliance with regulations.
91.3 General export requirements.
91.4 Other movements and conditions.

                 Subpart B_Diagnostic Tests, Treatments

91.5 Cattle.
91.6 Goats.
91.7 Captive cervids.
91.8 Sheep.
91.9 Swine.

    Subpart C_Ports of Embarkation, Facilities, Health Certification

91.14 Ports of embarkation and export inspection facilities.
91.15 Inspection of animals for export.
91.16 Certification of animals for export.

           Subpart D_Inspection of Vessels and Accommodations

91.17 Accommodations for humane treatment of animals on ocean vessels.
91.18 Cleaning and disinfection of transport carriers for export.
91.19 Inspection of ocean vessels prior to loading.
91.20 General construction.
91.21 Ventilation.
91.22 Protection from heat of boilers and engines.
91.23 Loading ramps and doors.
91.24 Attendants.
91.25 Space requirements for animals on ocean vessels.
91.26 Concrete flooring.
91.27 Troughs and hayracks.
91.28 Stanchions and rails.
91.29 Hatches.
91.30 Defective fittings.

             Subpart E_Cleaning and Disinfecting of Aircraft

91.41 Cleaning and disinfecting of aircraft.

    Authority: 7 U.S.C. 8301-8317; 19 U.S.C. 1644a(c); 21 U.S.C. 136, 
136a, and 618; 46 U.S.C. 3901 and 3902; 7 CFR 2.22, 2.80, and 371.4.

    Source: 42 FR 28990, June 7, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  91.1  Definitions.

    Whenever in the regulations in this part the following terms are 
used, they shall be construed as follows:
    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. Horses, cattle (including American bison), captive cervids, 
sheep, swine, and goats.
    APHIS representative. An individual employed by APHIS who is 
authorized to perform the function involved.
    Department. The United States Department of Agriculture.
    Horses. Horses, mules, and asses.
    Inspector. An inspector of the Animal and Plant Health Inspection 
Service.
    Miniature swine. Swine bred and raised as pets or for laboratory 
testing purposes that do not weigh more than 100 pounds at maturity.
    Official brucellosis vaccinate. A female bovine animal vaccinated 
against brucellosis in accordance with the provisions prescribed in the 
Recommended brucellosis Eradication Uniform Methods and Rules, chapter 
1, part I-H, I, and J. The provisions of the Uniform Methods and Rules 
are hereby incorporated by reference.

[[Page 342]]

    Origin health certificate. An official document issued by an APHIS 
representative or an accredited veterinarian at the point of origin of a 
shipment of animals to be moved under this part, which shows the 
identification tag, tattoo, or registration number or similar 
identification of each animal to be moved, the number, breed, sex, and 
approximate age of the animals covered by the document, the date and 
place of issuance, the points of origin and destination, the consignor, 
and the consignee, and which states that the animal or animals 
identified on the certificate meet the export health requirements.
    Premises of origin. The farm or other premises where the animals 
intended for export are being raised or assembled, or both, immediately 
before movement for export.
    Roofing paper. Any saturated roofing paper of a grade known to the 
trade as 30-pound roofing paper.
    State of origin. The State in which the premises of origin is 
located.
    Veterinary Services. The Veterinary Services, Animal and Plant 
Health Inspection Service of the Department.

[42 FR 28990, June 7, 1977, as amended at 53 FR 51746, Dec. 23, 1988; 57 
FR 23047, June 1, 1992; 57 FR 39353, Aug. 31, 1992; 63 FR 72129, Dec. 
31, 1998]



Sec.  91.2  Animals to be handled in compliance with regulations.

    No animals covered by the regulations in this part shall be exported 
to a foreign country except in compliance with the provisions in this 
part.



Sec.  91.3  General export requirements.

    (a) All animals intended for exportation to a foreign country, 
except by land to Mexico or Canada, must be accompanied from the State 
of origin of the export movement to the port of embarkation by an origin 
health certificate. All animals intended for exportation by land to 
Mexico or Canada must be accompanied from the State of origin of the 
export movement to the border of the United States by an origin health 
certificate. The origin health certificate must certify that the animals 
were inspected within the 30 days prior to the date of export, except as 
follows: When the Administrator allows sampling or testing to be done 
more than 30 days prior to the date of export, in accordance with 
paragraph (c) of this section, then the animals also may be inspected 
within that same time period, and the origin health certificate will 
remain valid for that time period. The origin health certificate must 
certify that the animals were found upon inspection to be healthy and 
free from evidence of communicable disease and exposure to communicable 
disease. The origin health certificate must be endorsed by an authorized 
APHIS veterinarian in the State of origin and must include any test 
results added by the authorized APHIS veterinarian pursuant to Sec.  
161.3(k) of this chapter (any added test results must be initialed by 
the authorized veterinarian). The origin health certificate must 
individually identify the animals in the shipment as to species, breed, 
sex, and age and, if applicable, must also show registration name and 
number, tattoo markings, or other natural or acquired markings. The 
origin health certificate must include all test results, certifications, 
or other statements required by the country of destination.
    (b) Inspection. All animals in each export shipment, except animals 
intended for export by land to Mexico or Canada, shall have been 
inspected, tested, or treated in the manner prescribed in this part 
prior to the movement of the export shipment to the export inspection 
facility. All animals in each export shipment intended for export by 
land to Mexico or Canada shall have been inspected, tested, or treated 
in the manner prescribed in this part prior to the movement of the 
animals from the State of origin. The Administrator may, upon request of 
the appropriate animal health official of the country of destination, 
waive the tuberculosis and brucellosis tests referred to in Sec. Sec.  
91.5(a) and (b), 91.6(a)(1) and (2), and 91.9(a) of this part when he 
finds such tests are not necessary to prevent the exportation of 
diseased animals from the United States.
    (c) Testing. All samples for tests required by Sec. Sec.  91.5 
through 91.13 for exportation of animals under this section shall be 
taken by an inspector or an accredited veterinarian in the State of

[[Page 343]]

origin of the export movement. The samples must be taken and tests must 
be made within the 30 days prior to the date of export, except that the 
Administrator may allow such sampling or testing to be conducted more 
than 30 days prior to the date of export if required or allowed by the 
receiving country, and the tuberculin test may be conducted within the 
90 days prior to the date of export. The test for brucellosis shall be 
conducted in a cooperating State-Federal laboratory \1\ in accordance 
with the Recommended Brucellosis Eradication Uniform Methods and Rules.
---------------------------------------------------------------------------

    \1\ A list of cooperating State-Federal laboratories may be obtained 
from the Administrator, Animal and Plant Health Inspection Service, 
Veterinary Services, National Center for Import-Export, 4700 River Road, 
Unit 38, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (d) Movement in cleaned and disinfected carriers or containers. The 
origin health certificate accompanying animals shall be accompanied by a 
statement from the issuing accredited veterinarian or inspector that the 
means of conveyance or container has been cleaned and disinfected since 
last used for animals with a disinfectant approved under Sec.  71.10 of 
this chapter, prior to loading, or that the carrier or container has not 
previously been used in transporting animals.
    (e) Clean and disinfected facilities for unloading animals. Animals 
intended for exportation to Mexico or Canada or enroute to a port of 
embarkation shall be unloaded only into a facility which shall have been 
cleaned and disinfected with a disinfectant approved under Sec.  71.10 
of this chapter, under the supervision of an inspector or an accredited 
veterinarian prior to such unloading. A statement certifying to such 
action shall be attached to the origin health certificate by the 
supervising inspector or accredited veterinarian.

(Approved by the Office of Management and Budget under control number 
0579-0020)

[42 FR 28990, June 7, 1977, as amended at 44 FR 28298, May 15, 1979. 
Redesignated and amended at 45 FR 86412, Dec. 31, 1980; 48 FR 57472, 
Dec. 30, 1983; 57 FR 23047, 23048, June 1, 1992; 59 FR 48994, Sept. 26, 
1994; 59 FR 67613, Dec. 30, 1994; 60 FR 4536, Jan. 24, 1995; 60 FR 9611, 
Feb. 21, 1995; 60 FR 13898, Mar. 15, 1995; 67 FR 11560, Mar. 15, 2002]



Sec.  91.4  Other movements and conditions.

    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 may prescribe in each specific case to prevent the 
spread of livestock diseases and to insure the humane treatment of the 
animals while in transit.

[43 FR 27171, June 23, 1978. Redesignated at 45 FR 86412, Dec. 31, 1980, 
and amended at 57 FR 23047, June 1, 1992]



                 Subpart B_Diagnostic Tests, Treatments

    Source: 45 FR 86412, Dec. 31, 1980, unless otherwise noted.



Sec.  91.5  Cattle.

    In order to be eligible for export, cattle shall be tested with 
results as specified in this section, and the origin health certificate 
shall specify the type of tests conducted, the dates of the tests, and 
the results of the tests.
    (a) Tuberculosis. All cattle over 1 month of age shall be negative 
to a caudal intradermal tuberculin test using 0.1 ml. of tuberculin with 
a reading obtained 72 hours (plus or minus six hours) after injection as 
prescribed in Veterinary Services Memorandum 552.15 ``Instructions and 
Procedures for Conducting Tuberculin Tests in Cattle,'' section VIII 
A.\2\
---------------------------------------------------------------------------

    \2\ Copies of this publication may be obtained from the Animal and 
Plant Health Inspection Service, Veterinary Services, National Center 
for Import-Export, 4700 River Road, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (1) Provided that, such tests are not required for any of the 
following:
    (i) Cattle exported directly to slaughter in a country that the 
Administrator has determined has an acceptable tuberculosis surveillance 
system at slaughter plants and that agrees to share any findings of 
tuberculosis in U.S. origin cattle with APHIS; or
    (ii) Cattle exported directly to slaughter from a State designated 
as an Accredited-Free State in 9 CFR 77.1.
    (2) The Administrator has determined that the following countries

[[Page 344]]

have an acceptable tuberculosis surveillance system at slaughter plants: 
Canada and Mexico.
    (b) Brucellosis. All cattle over 6 months of age shall be negative 
to a test for brucellosis conducted as prescribed in ``Standard 
Agglutination Test Procedures for the Diagnosis of Brucellosis'' \2\ or 
``Supplemental Test Procedures for the Diagnosis of Brucellosis.'' \2\
    (1) Provided that, such tests are not required for any of the 
following:
    (i) Official vaccinates of dairy breeds under 20 months of age;
    (ii) Official vaccinates of beef breeds under 24 months of age;
    (iii) Steers and spayed heifers;
    (iv) Cattle exported directly to slaughter in a country that the 
Administrator has determined has an acceptable brucellosis surveillance 
system at slaughter plants and that agrees to share any findings of 
brucellosis in U.S. origin cattle with APHIS; or
    (v) Cattle exported directly to slaughter from a State designated as 
a Class Free State in 9 CFR 78.41.
    (2) The Administrator has determined that the following country has 
an acceptable brucellosis surveillance system at slaughter plants: 
Canada.
    (c) Treatment for ectoparasites. All cattle, except those found free 
of ectoparasites or those intended for exportation for slaughter 
purposes to any foreign country, shall be treated for ectoparasites 
within 30 days preceding the date of export. Such treatment shall be 
made using a pesticide registered by the Environmental Protection Agency 
for use in treating animals infested with the ectoparasite involved in 
accordance with the label requirements. Treatment shall be personally 
supervised and certified on the origin health certificate by an 
accredited veterinarian who shall be ready to apply an antidote if 
adverse side effects occur following treatment.

(Approved by the Office of Management and Budget under control number 
0579-0020)

[45 FR 86412, Dec. 31, 1980, as amended at 48 FR 57472, Dec. 30, 1983; 
55 FR 12634, Apr. 5, 1990; 56 FR 366, Jan. 4, 1991; 57 FR 23047, June 1, 
1992; 59 FR 67614, Dec. 30, 1994; 60 FR 4536, Jan. 24, 1995; 60 FR 
13898, Mar. 15, 1995; 61 FR 6918, Feb. 23, 1996; 62 FR 3446, Jan. 23, 
1997]



Sec.  91.6  Goats.

    (a) In order to be eligible for export, goats shall be tested with 
results as specified in this section, and the origin health certificate 
for such animals shall specify the type of test conducted, the date of 
the tests, and the results of the tests.
    (1) Tuberculosis. All goats over 1 month of age shall be negative to 
a caudal intradermal tuberculin test using 0.1 ml. of tuberculin with a 
reading obtained 72 hours (plus or minus 6 hours) after injection as 
prescribed in Veterinary Services Memorandum 552.15.
    (2) Brucellosis. Dairy and breeding goats shall be negative to a 
plate or tube agglutination test for brucellosis as prescribed in 
``Standard Agglutination Test Procedures for the Diagnosis of 
Brucellosis.'' \2\
---------------------------------------------------------------------------

    \2\ See footnote 2 to Sec.  91.5.
---------------------------------------------------------------------------

    (3) No goat shall be exported if it is a scrapie-positive animal or 
an exposed animal, as defined in 9 CFR parts 54 and 79, or if it has 
ever been in an infected flock, source flock, or trace flock, as defined 
in 9 CFR parts 54 and 79; or if it is the progeny, parent, or sibling of 
any scrapie-positive animal.
    (4) Goats exported for immediate slaughter need not comply with the 
requirements of paragraphs (a)(1), (2), (3), and (5) of this section.
    (5) All goats intended for export shall be identified by eartags or 
tattoos approved by the Administrator, except that goats for export to 
Canada or Mexico for immediate slaughter may be identified by flock 
brands.

(Approved by the Office of Management and Budget under control number 
0579-0020)

[45 FR 86412, Dec. 31, 1980, as amended at 48 FR 57472, Dec. 30, 1983; 
57 FR 23048, June 1, 1992; 59 FR 48994, Sept. 26, 1994; 60 FR 4536, Jan. 
24, 1995]



Sec.  91.7  Captive cervids.

    To be eligible for export, a captive cervid must be accompanied by 
an origin health certificate stating that the captive cervid has tested 
negative to an official single cervical tuberculin test for 
tuberculosis, as described in part 77, subpart B, of this chapter,

[[Page 345]]

within 90 days prior to export. The origin health certificate must 
specify the date the test was conducted and the test results.

[63 FR 72129, Dec. 31, 1998]



Sec.  91.8  Sheep.

    (a) No sheep shall be exported if it is a scrapie-positive animal or 
an exposed animal, as defined in 9 CFR parts 54 and 79, or if it has 
ever been in an infected flock, source flock, or trace flock, as defined 
in 9 CFR parts 54 and 79; or if it is the progeny, parent, or sibling of 
any scrapie-positive animal.
    (1) Sheep exported for immediate slaughter need not comply with the 
requirements of paragraph (a)(2) of this section.
    (2) All sheep intended for export shall be identified by eartags or 
tattoos approved by the Administrator.\3\ except that sheep for export 
to Canada or Mexico for immediate slaughter may be identified by flock 
brands.
---------------------------------------------------------------------------

    \3\ Information concerning eartags or tattoos approved by the 
Administrator may be obtained, upon request, from the Animal and Plant 
Health Inspection Service, Veterinary Services, National Center for 
Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

(Approved by the Office of Management and Budget under control number 
---------------------------------------------------------------------------
0579-0020)

[45 FR 86412, Dec. 31, 1980, as amended at 57 FR 23047, 23048, June 1, 
1992; 59 FR 48994, Sept. 26, 1994; 59 FR 67133, Dec. 29, 1994; 59 FR 
67614, Dec. 30, 1994; 61 FR 6918, Feb. 23, 1996]



Sec.  91.9  Swine.

    (a) No swine shall be exported if they were fed garbage at any time. 
The swine shall be accompanied by a certification from the owner stating 
that they were not fed garbage, and that any additions to the herd made 
within the 30 days immediately preceding the export shipment, have been 
maintained isolated from the swine to be exported. All breeding swine 
shall be tested for and show negative test results to brucellosis by a 
test prescribed in ``Standard Agglutination Test Procedures for the 
Diagnosis of Brucellosis'' or ``Supplemental Test Procedures for the 
Diagnosis of Brucellosis''. The test results shall be classified 
negative in accordance with the provisions prescribed in the Recommended 
Brucellosis Eradication Uniform Methods and Rules, chapter 2, part II, 
G, 1, 2, and 3.
    (b) [Reserved]

(Approved by the Office of Management and Budget under control number 
0579-0020)

[45 FR 86412, Dec. 31, 1980, as amended at 59 FR 67133, Dec. 29, 1994]



    Subpart C_Ports of Embarkation, Facilities, Health Certification



Sec.  91.14  Ports of embarkation and export inspection facilities.

    (a) The following ports which have export inspection facilities 
which satisfy the requirements of paragraph (c) of this section are 
hereby designated as ports of embarkation. All animals, except animals 
being exported by land to Mexico or Canada, shall be exported through 
said ports or through ports designated in special cases under paragraph 
(b) of this section:
    (1) California.
    (i) Los Angeles--airport and ocean port.
    (A) Jet Pets, Inc., 9014 Pershing Drive, Plaza del Rey, CA 90291, 
(213) 823-8901.
    (B) Valley Livestock, 14380 South Euclid Avenue, Chino, CA 91710, 
(909) 597-1756.
    (ii) San Francisco--airport and ocean port.
    (A) Cow Palace, P.O. Box 34206, San Francisco, CA 94134, (415) 469-
6000.
    (B) Petair, 145 Bel Air Road, P.O. Box 2431, South San Francisco, CA 
94080, (415) 877-0200.
    (2) Florida.
    (i) Miami--airport and ocean port.
    (A) USDA Import-Export Center, 6300 NW. 36th Street, P.O. Box 
523054, Miami, FL 33152, (305) 526-2828.
    (ii) Tampa--ocean port.
    (A) Tampa Port Authority, 2703 E. 7th Avenue, Tampa, FL 33605, (813) 
248-1924.
    (3) Georgia.
    (i) Atlanta Hartsfield International Airport.
    (A) Atlanta Equine Complex, 1270 Woolman Place, Atlanta, GA 30354, 
(404) 767-1700.
    (B) Tumbleweed Farm (horses only), 1677 Buckner Road, Mableton, GA 
30059, (770) 948-3556.

[[Page 346]]

    (C) Southern Cross Ranch (horses only), 1670 Bethany Church Road, 
Madison, GA 30650, (706) 342-8027.
    (4) Hawaii.
    (i) Honolulu--airport and ocean port.
    (A) Hawaii State Quarantine Station, 99-762 Moanalua Road, Aiea, 
Hawaii 96701, (808) 487-5351.
    (5) Illinois.
    (i) Chicago--airport only.
    (A) C&R Midwest Quarantine Facilities, Ltd., Box 470, Route 31, 
Dundee, IL 60118, (312) 426-5009.
    (B) Knief Quarantine Facility, 11 N 470 Chapman Road, Box 305, 
Burlington, Illinois 60109, (312) 683-3873.
    (6) Kentucky.
    (i) Greater Cincinnati Airport, Covington; and Standiford Field 
Airport, Louisville--airport only.
    (A) Newton Paddocks (horses only), Barn No. 8, Newton Pike, 
Lexington, KY 40511, (606) 253-3456.
    (7) Louisiana.
    (i) New Iberia--airport only.
    (A) Acadiana Regional Airport, Star R-3, Box 390-H (ARA), New 
Iberia, LA 70560, (318) 365-7204.
    (8) Massachusetts. (i) Boston--airport only.
    (A) Logan International Airport (miniature swine only), East Boston, 
Massachusetts 02128, (617) 565-4649.
    (9) Minnesota.
    (i) Minneapolis/St. Paul--airport only.
    (A) American Livestock Export Company, 25789 Northfield Blvd., 
Hampton, MN 55031, (612) 831-3873.
    (B) Cannon Export Center, 2870 Rochester Blvd., Cannon Falls, MN 
55009, (507) 263-3064.
    (10) Missouri.
    (i) Kansas City--airport only.
    (A) KCI Multipurpose Export Facility, 12600 NW Prairie View Road, 
Kansas City, MO 64195, (314) 751-4338 (mailing address: P.O. Box 20462, 
Kansas City, MO 64195-0462).
    (11) New Jersey.
    (i) Elizabeth--ocean port.
    (A) Tolleshunt Horse Farm (horses only), 10 Island Road, Box 469, 
Whitehouse, NJ 08888-0469, (908) 534-7738.
    (B) The U.S. Equestrian Team's headquarters (horses only), 
Pottersville Road, Gladstone, NJ 07934, (908) 234-1251.
    (ii) Newark International Airport.
    (A) Tolleshunt Horse Farm (horses only), 10 Island Road, Box 469, 
Whitehouse, NJ 08888-0469, (908) 534-7738.
    (B) The U.S. Equestrian Team's headquarters (horses only), 
Pottersville Road, Gladstone, NJ 07934, (908) 234-1251.
    (iii) Salem--ocean port.
    (A) Mannington Meadows Farm (horses only), 60 Oechsle Road, 
Woodstown, NJ 08098, (609) 769-2009.
    (12) New York.
    (i) New York--airport and ocean port.
    (A) Tolleshunt Horse Farm (horses only), 10 Island Road, Box 469, 
Whitehouse, NJ 08888-0469, (908) 534-7738.
    (B) The U.S. Equestrian Team's headquarters (horses only), 
Pottersville Road, Gladstone, NJ 07934, (908) 234-1251.
    (C) Vetport, Inc., Bldg. 189, J.F. Kennedy International Airport 
(Cargo Area), Jamaica, NY 11430, (212) 656-6042.
    (13) Ohio.
    (i) Dayton International Airport.
    (A) Instone Air Services, Inc., (equines only), 1 Emory Plaza, 
Dayton International Airport, Vandalia, OH 45377, (970) 382-0002.
    (B) [Reserved]
    (ii) Wilmington--airport only.
    (A) Airborne Express Animal Export Facility, 145 Hunter Drive, 
Wilmington, OH 96701, (513) 382-5591.
    (B) [Reserved]
    (14) Pennsylvania.
    (i) Harrisburg--airport only.
    (A) Penn. Holstein Farm Export Inspection Facility, R.D. 1, 
Middletown, PA 17057, (717) 944-1374.
    (15) Puerto Rico.
    (i) San Juan--airport.
    (A) El Commandante Race Track (Horses Only), P.O. Box 1304, Rio 
Piedras, PR 00929, (809) 724-6060.
    (16) Texas.
    (i) Brownsville--airport, ocean port, and border port.
    (A) Texas Department of Agriculture, Livestock Inspection Facility, 
International Airport, Brownsville, TX 78520, (512) 546-5135.
    (ii) Dallas/Fort Worth International Airport.

[[Page 347]]

    (A) DFW Quarantine (horses only), 1010 A Chinn Chapel Road, 
Lewisville, TX 75067, (214) 317-6861.
    (B) [Reserved]
    (iii) Del Rio--border port.
    (A) Texas Department of Agriculture, Livestock Export Facility, Box 
1046, Del Rio, TX 78840, (512) 775-1518.
    (iv) Eagle Pass--border port.
    (A) Texas Department of Agriculture, Livestock Export Facility, Box 
1164, Eagle Pass, TX 78852, (512) 773-2359.
    (v) El Paso--border port.
    (A) Texas Department of Agriculture, Livestock Export Facility, 
10800 Socorro Drive, El Paso, TX 79927, (915) 543-7419.
    (vi) Houston--airport and ocean port.
    (A) Texas Department of Agriculture, Livestock Export Facility, Box 
60107, AMF, Houston, TX 77205, (713) 443-2447.
    (vii) Laredo--airport and border port.
    (A) El Primero Equine Export Facility (horses only), Route 7, Box 
305, Laredo, TX 78041, (512) 723-5436.
    (B) Texas Department of Agriculture, Livestock Export Facility, 
Route 1, Box 67-P, Laredo, TX 78040, (512) 722-6308.
    (17) Virginia.
    (i) Richmond--airport and ocean port.
    (A) American Marketing Services, Inc., 1301 Hermitage Road, 
Richmond, VA 23220, (804) 359-4433.
    (18) Washington.
    (i) Moses Lake--airport only.
    (A) Port of Moses Lake, Grant County Airport, Terminal Bldg., Moses 
Lake, WA 98837, (509) 762-5363.
    (ii) Seattle--airport and ocean port.
    (A) Stevedoring Service of America, 3415 11th Avenue SW., Seattle, 
WA 98134, (800) 422-3505.
    (iii) Olympia--ocean port.
    (A) Port of Olympia Animal Export Facility, 915 Washington Street 
NE., Olympia, Washington 98507-0827, (206) 586-6150.
    (iv) Tacoma--airport and ocean port.
    (A) Pacific Rim Livestock Quarantine, 17835 Highway 507 SE., Yelm, 
WA 98507, (206) 458-1762.
    (b) In special cases, other ports may be designated as ports of 
embarkation by the Administrator, with the concurrence of the Director 
of Customs, when the exporter can show to the satisfaction of the 
Administrator that the animals to be exported would suffer undue 
hardship if they are required to be moved to a port of embarkation 
listed in Sec.  91.14(a). Such ports shall be designated only if the 
inspection facilities are approved as meeting the requirements of 
paragraph (c) of this section.
    (c) Standards for export inspection facilities. Inspection 
facilities located at ports of embarkation designated under paragraph 
(a) of this section, and inspection facilities designated in special 
cases under paragraph (b) of this section, shall meet the following 
requirements:
    (1) Materials. Floors of pens, alleys, and chutes shall be made of 
impervious materials and finished so as to be skid-resistant. Impervious 
floors are those constructed of a material that resists the absorption 
of fluids. Such materials include concrete, asphalt, brick, metal, or 
other synthetic material that may be cleaned and disinfected. Fences, 
gates, and other parts of the facility shall be constructed of wood, 
metal, or other material that will securely restrain the animals in a 
safe and humane manner. The facility shall have a roof adequate to 
protect the animals from inclement weather over at least three-fourths 
of the pens and alleys and over all of the inspection area.
    (2) Size. The facility shall be large enough to accommodate all the 
animals in a single export shipment at one time. A minimum space twice 
the rate required per animal in Sec.  91.25(b) shall be provided for 
each animal. Facilities that inspect horses must have ceilings at least 
12 feet high in any areas where horses are inspected.
    (3) Inspection implements. The facility shall have a separate area 
available for inspection and identification of the animals. Pens and 
animal restraining devices shall be provided in this area which are 
sufficient for the inspection and identification of each animal. Pens or 
yards shall be provided for appropriate segregation, treatment, or both, 
of animals of questionable health status apart from animals qualified 
for exportation under this part.
    (4) Cleaning and disinfection. The facility and equipment shall be 
cleaned and disinfected with a disinfectant permitted under Sec.  71.10 
of this chapter

[[Page 348]]

under the supervision of a Federal inspector prior to entry of each 
export shipment into the export inspection facility. Personnel tending 
the animals shall, if they come in contact with animals outside of the 
facility, be required to change or sanitize their outer clothing and 
footwear. All facilities must have running water available to wash and 
disinfect the facilities. On and after March 23, 1995, facilities to be 
approved must have a drainage system; and, on and after March 23, 1997, 
every facility approved before March 23, 1995, must have a drainage 
system. The drainage system must control surface drainage into or from 
the facility in a manner that prevents any significant risk of livestock 
diseases being spread into or from the facility.
    (5) Feed and water. An ample supply of running, potable water shall 
be made available to the animals intended for export, and in cold 
weather such water shall be kept free of ice. Feed and feeding 
facilities appropriate for the animals intended for export shall be 
provided.
    (6) Access; approval of arrangements. Access to all parts of the 
facility shall be allowed to an inspector at all times, day or night, 
and the arrangement for handling the animals shall be subject to the 
approval of the inspector. Approval shall be granted by the inspector if 
he finds that such arrangements will not permit the dissemination of 
communicable diseases of livestock to the animals in the export 
shipment.
    (7) Testing and treatment. Testing and treatment of animals in 
export inspection facilities shall be performed by an accredited 
veterinarian under the supervision of an APHIS veterinarian. Tests 
related to APHIS animal disease programs shall be performed in 
accordance with the Recommended Brucellosis Eradication Uniform Methods 
and Rules.
    (8) Location. The arrangement and location of the facilities shall 
provide for the isolation of all animals in the facility from contact 
with any other animals. Isolation of separate export shipments in the 
facility shall be at the discretion of the inspector.
    (9) Disposal of animal wastes. The application for approval of an 
export inspection facility shall be accompanied by a certification from 
the authorities having jurisdiction over environmental affairs in the 
locality of the facility stating that the facility complies with the 
applicable State and local regulations or ordinances and the 
requirements, if any, of the United States Environmental Protection 
Agency, regarding disposal of animal wastes.
    (10) Lighting. The facility shall be equipped with artifical 
lighting to provide not less than 70 foot candle power in the inspection 
area and not less than 40 foot candle power in the remainder of the 
facility.
    (11) Office and rest room. A suitable office and adequate rest room 
facilities shall be provided at the export inspection facility site for 
use of the inspectors. The facility must have a working telephone.
    (12) Walkways. Facilities where horses are inspected must have 
walkways in front of horse stalls wide enough to allow APHIS personnel 
to safely remove horses from the stalls for inspection, if necessary.
    (d) Approval and denial, revocation, or suspension of approval. 
Approval of each export inspection facility for designation under 
paragraph (a) of this section and in special cases under paragraph (b) 
of this section, shall be obtained from the Administrator. Approval of 
an export inspection facility under paragraph (a) or (b) will be denied 
or revoked for failure to meet the standards in paragraph (c) of this 
section. A written notice at least 60 days prior to the date of any 
proposed revocation and a written notice of any proposed denial shall be 
given to the operator of the facility and he will be given an 
opportunity to present his views thereon. Such notice shall list in 
detail the deficiencies concerned. Pending a final determination, 
approval of any facility may be denied or suspended by the Administrator 
when he has reason to believe that the facility does not meet such 
standards. Approval of a port of embarkation in connection with the 
designation of an export inspection facility in a special case shall be 
limited to the special case for which the designation was made.

(Approved by the Office of Management and Budget under control number 
0579-0020)

[42 FR 28990, June 7, 1977]

[[Page 349]]


    Editorial Note: For Federal Register citations affecting Sec.  
91.14, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  91.15  Inspection of animals for export.

    (a) All animals offered for exportation to any foreign country, 
except by land to Mexico or Canada, shall be inspected within 24 hours 
of embarkation by an APHIS veterinarian at an export inspection facility 
at a port designated in Sec.  91.14(a), or at a port or inspection 
facility designated by the Administrator in a special case under Sec.  
91.14(b).
    (b) Such animals shall be held for a period of not less than 5 hours 
at the port of embarkation or export inspection facility during which 
time the animals shall be given a careful visual health inspection. 
Sorting, grouping, identification, or other handling of the animals by 
the exporter may be before or after this period of time. If individual 
clinical inspection of an animal is deemed necessary by an APHIS 
veterinarian for the purpose of determining its health status, such 
inspection may be made during this period of time or thereafter.
    (c) Feed and water. All animals shall be allowed a period of at 
least 5 hours for rest at the export inspection facility, with adequate 
feed and water available, before movement to an ocean vessel or aircraft 
for loading for export. (This may be the same period required by 
paragraph (b) for health inspection.) However, feed and water will not 
be required if the animals were transported to the export inspection 
facility in a carrier in which adequate feed and water were provided and 
if sufficient evidence is presented to an APHIS veterinarian that the 
animals, if under 30 days of age, will arrive in the country of 
destination within 24 hours after they were last fed and watered, in the 
United States, or in the case of other animals within 36 hours after 
they were last fed and watered in the United States

[42 FR 28990, June 7, 1977, as amended at 44 FR 28299, May 15, 1979. 
Redesignated at 45 FR 86413, Dec. 31, 1980, and amended at 57 FR 23048, 
June 1, 1992; 60 FR 4536, Jan. 24, 1995; 60 FR 9611, Feb. 21, 1995]



Sec.  91.16  Certification of animals for export.

    If, upon inspection by an APHIS veterinarian at the export 
inspection facility, the animals offered for export are found to be 
sound, healthy, and free from evidence of communicable disease or 
exposure thereto, an export certificate, VS Form 17-37, shall be issued 
by said APHIS veterinarian and shall contain a statement to that effect.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980, 
as amended at 57 FR 23047, 23048, June 1, 1992]



           Subpart D_Inspection of Vessels and Accommodations



Sec.  91.17  Accommodations for humane treatment of animals on ocean vessels.

    (a) The owner or operator of an ocean vessel carrying animals from 
the United States to a foreign country shall provide, for such animals, 
feed and water, space, ventilation, fittings, and other facilities 
aboard the carrier as set forth in this part. For animals embarked for a 
voyage which will be of more than 36 hours duration, there shall be 
provided to the satisfaction of the inspector sufficient amounts of 
suitable feed and fresh water, and proper accommodations shall be 
provided on board for storage and distribution of the water and feed. 
The feed shall not be exposed to the weather at sea. However, such feed 
and water shall not be required if it is determined by the APHIS 
veterinarian that the animals, if under 30 days of age will arrive in 
the country of destination within 24 hours after they were last fed and 
watered in the United States, or, in the case of other animals, within 
36 hours after they were last fed and watered in the United States.
    (b) Owners masters, or operators of such vessels shall not accept 
for transportation any animal that in the judgment of the APHIS 
veterinarian is in an unfit condition to withstand the rigors of such 
transportation. Further, no animal intended for export shall be placed 
aboard any ocean vessel, unless in the opinion of the inspector the 
loading arrangements, fittings, ventilation systems, and the 
arrangements

[[Page 350]]

provided by the vessel for their use reasonably assure arrival of a 
viable animal in the country of destination. Halters, ropes, or other 
suitable equipment provided for the handling and tying of horses shall 
be found to be satisfactory by the APHIS veterinarian to assure humane 
treatment of the animals.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980, 
as amended at 57 FR 23047, June 1, 1992]



Sec.  91.18  Cleaning and disinfection of transport carriers for export.

    All fittings, utensils and equipment, unless new, to be used in the 
loading, stowing, or other handling of animals aboard surface vessels 
under the provisions of this part, shall first be cleaned and 
disinfected under the supervision of an inspector before being used for, 
or in connection with, the transportation of animals from any United 
States port. Such disinfection of halters, ropes, and similar equipment 
used in handling and tying of animals shall be by immersion in an 
approved disinfectant. When the surface vessel has last been used to 
carry livestock to or from a foot-and-mouth disease infected country, 
the approved disinfectant shall be a freshly prepared solution of:
    (a) Sodium carbonate (4 percent) in the proportion of 1 pound to 3 
gallons of water.
    (b) 4 percent sodium carbonate plus 0.1 percent sodium silicate.
    (c) 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\1/2\-
ounce can to 5 gallons of water.\7\
---------------------------------------------------------------------------

    \7\Due to the extreme caustic nature of sodium hydroxide solution, 
precautionary measures such as the wearing of rubber gloves, boots, 
raincoat, and goggles should be observed. An acid solution such as 
vinegar shall be kept readily available in case any of the sodium 
hydroxide solution should come in contact with the body.

For carriers returning from other foreign countries, the approved 
disinfectant shall be a disinfectant permitted for use under Sec.  
---------------------------------------------------------------------------
71.10, part 71 of this chapter.

[42 FR 28990, June 7, 1977. Redesignated and amended at 45 FR 86413, 
Dec. 31, 1980; 53 FR 51746, Dec. 23, 1988]



Sec.  91.19  Inspection of ocean vessels prior to loading.

    It shall be the responsibility of the owners or the masters of an 
ocean vessel intended for use in exporting livestock to present the 
vessel to an inspector at a United States port of embarkation or at the 
descretion of the Administrator, upon request of the exporter, 
transporting company, or their agent, at a foreign port, for an 
inspection to determine if the fittings aboard the vessel are in 
compliance with the provisions of this part. A notarized statement from 
an engineering concern shall be required to certify to the rate of air 
exchange in each compartment. Such notarized statement shall be required 
upon first use of such vessel: Provided, That such notarized statement 
may again be required by the Administrator if substantive changes in 
fittings aboard the vessel have been made since the vessel was last 
certified.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980, 
and amended at 57 FR 23047, 23048, June 1, 1992]



Sec.  91.20  General construction.

    A variety of construction materials such as wood, metal plate, or 
pipe may be used for stalls, crates, or pens aboard ocean vessels. Pipe 
fittings have the advantage of smooth surfaces, easy maintenance, long 
range economy and spaces between pipe rails to allow for feeding, 
watering, cleaning and better ventilation. Material used for stalls, 
crates, or pens shall be properly formed, closely fitted, and rigidly 
secured in place. Special care shall be taken to design and finish all 
edges, welds, and hardware that are accessible to animals. A combination 
of wood and steel pipe or other steel profile construction may be 
accepted if the construction complies with the regulations in this part. 
Where the sides of pens are adjacent to the ship's sides which have 
steel casing, frames, stays or similar fittings, the carrier shall

[[Page 351]]

cover these profiles with wooden battens of at least 2 inch thick lumber 
or plywood of similar strength to prevent animals from injury.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980]



Sec.  91.21  Ventilation.

    Each underdeck compartment on which animals are being transported 
aboard an ocean vessel shall be equipped with a system of mechanical 
ventilation that will furnish a complete change of air in each 
compartment every 2 minutes when deck height\8\ is less than 8 feet and 
every 2\1/2\ minutes when the deck height\8\ exceeds 8 feet. Spare 
motors and fans shall be available on board, for replacement or repair 
of the ventilation system during the voyage. A spare motor and fan of an 
approved type in working order shall be aboard the vessel for each type 
of motor or fan used. Net pen space in any compartment shall not exceed 
80 percent of the deck area.
---------------------------------------------------------------------------

    \8\ Deck height is the height from the ceiling to the floor.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec 31, 1980]



Sec.  91.22  Protection from heat of boilers and engines.

    No animals shall be stowed along the alleyways leading to the engine 
or boiler rooms unless the sides of said engine or boiler rooms are 
covered by a tongue and groove tight sheathing producing a 3-inch-wide 
air space except that on ships powered with internal combustion engines 
this sheathing may not be required at the discretion of the inspector.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980]



Sec.  91.23  Loading ramps and doors.

    (a) Ramps connecting one deck of a ship to another shall have a 
clear width of 3 feet and a clear height of not less than 6 feet 6 
inches. The incline of the ramps shall not exceed 1:2 (26\1/2\[deg]) 
between the ramps and the horizontal plane. The ramps shall be fitted 
with footlocks of approximately 2x2 lumber and 
spaced no more than one foot apart. The ramps shall have side fencing 
not less than 5 feet in height. Side doors in ship's shell plating 
through which livestock are to be loaded shall have a height of not less 
than 6 feet for cattle and 6 feet 6 inches for horses.
    (b) Alleyways running fore and aft on the ocean vessel that are used 
for feeding, watering, and loading animals, including horses in box 
stalls, shall have a minimum width of 3 feet. However, for a distance 
not to exceed 8 feet at the end of alleyways in the bow and the stern of 
ship, and where obstructions of less than 3 feet in length occur, the 
width may be reduced to a minimum of 24 inches. A sufficient number of 
athwartship alleyways at least 24 inches in width shall be provided to 
afford ready access to scuppers and to ends of alleyways running fore 
and aft. However, on exposed decks where scuppers and the end of fore 
and aft alleyways are readily accessible athwartship alleyways are not 
required and if the alleyways are to be used for feeding or watering 
livestock, but not for loading or unloading of livestock, such alleyways 
shall have a minimum width of 28 inches.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980]



Sec.  91.24  Attendants.

    It shall be the responsibility of the captain of the ocean vessel to 
carry at least three men on board the vessel who are experienced in the 
handling of the kind/kinds of livestock to be carried, and a sufficient 
number of attendants, satisfactory to the inspector or the APHIS 
veterinarian at the port embarkation to insure proper care of the 
animals: Provided, however, That only one person experienced in the 
handling of the kind/kinds of livestock to be carried and a sufficient 
number of attendants, satisfactory to the APHIS veterinarian at the port 
of embarkation, to insure proper care of the animals must be carried on 
board the ocean vessel if less than 800 head of livestock are carried.

[42 FR 28990, June 7, 1977, as amended at 43 FR 27171, June 23, 1978. 
Redesignated at 45 FR 86413, Dec. 31, 1980, and amended at 57 FR 23047, 
June 1, 1992]

[[Page 352]]



Sec.  91.25  Space requirements for animals on ocean vessels.

    (a) General requirements. A general space requirement for any 
individual animal in stalls or crates on ocean vessels shall be six 
inches more in height, depth, and width than the measurements of the 
animal concerned. The number of animals in each stall, pen or other 
container, the cubic inches of air available for each animal, and the 
ventilation capability of the transporting carrier are other criteria 
used to determine final space requirements for each animal. Guidelines 
of space requirements for storage of animals in pens are listed in 
paragraphs (b) and (c) of this section. Final determination of space 
needed and manner of loading of animals for export shipment will be made 
by the inspector or the APHIS veterinarian at the port of embarkation, 
based upon the size and type of animals presented, weather, destination, 
route, and means of transportation employed for the export shipment.
    (b) Space guidelines:

------------------------------------------------------------------------
                                                               Space in
                                                             square feet
                                                             allowed per
                                                               animal--
------------------------------------------------------------------------
Animal weight, pounds:
  100......................................................          4.0
  150......................................................          5.0
  200......................................................          6.0
  250......................................................          6.9
  300......................................................          7.9
  350......................................................          8.9
  400......................................................          9.9
  450......................................................         10.9
  500......................................................         11.8
  550......................................................         12.5
  600......................................................         13.2
  650......................................................         13.9
  700......................................................         14.6
  750......................................................         15.3
  800......................................................         15.9
  850......................................................         16.6
  900......................................................         17.3
  950......................................................         17.8
  1,000....................................................         18.4
  1,050....................................................         18.9
  1,100....................................................         19.4
  1,150....................................................         19.9
  1,200....................................................         20.4
  1,250....................................................         21.0
  1,300....................................................         21.5
  1,350....................................................         22.0
  1,400....................................................         22.7
  1,450....................................................         23.3
  1,500....................................................         24.0
  1,550....................................................         24.6
  1,600....................................................         25.3
  1,650....................................................         25.9
  1.700....................................................         26.6
  1,750....................................................         27.2
  1,800....................................................         27.8
------------------------------------------------------------------------

    (c) Space guidelines for containers. Containers used aboard 
containerized ocean vessels measure 8 feet in width outside but vary 
from 7 feet 3 inches to 7 feet 9 inches in width inside and from 17 feet 
to 40 feet in length. For such containers the space requirements and 
minimum pen widths shown in the following charts shall be used whenever 
the length of the animal exceeds the width of the container. For ready 
measurement of dairy cattle only, the distance from the withers to the 
pin bone multiplied by 1.65 gives the approximate total length. Length 
of other cattle and large animals will require measurement of their 
total length. Other animals larger than those shown in the following 
charts shall be stowed subject to the approval of the inspector or the 
APHIS veterinarian at the port of embarkation. Maximum inside length of 
container pens shall be 12 feet 9 inches.

------------------------------------------------------------------------
                                  3 head                  4 head
             Square feet -----------------------------------------------
   Weight      per head     Square                  Square
                             feet        Width       feet        Width
------------------------------------------------------------------------
                 Containers 7[foot]9 in Width
------------------------------------------------------------------------
 
        800         18.5  ..........  ..........        74.0  9[foot]7 in Width
------------------------------------------------------------------------
 
        700         16.3  ..........  ..........        65.2  9[foot]9
Sec.  91.26  Concrete flooring.

    (a) Pens aboard an ocean vessel shall have a 3 inch concrete 
pavement, proportioned and mixed to give 2000 psi. compressive strength 
in 28 days. The pavement shall have a broom or rough finish. Steel angle 
bars may be used for footlocks if they are mounted into the flooring in 
such a way that, at the same time, the bars serve as gutterways. The 
angle bars shall not be less than 2 inches by 2 inches and \5/16\ inches 
in thickness, and spaced on 12 inch centers running for and aft on the 
vessel.
    (b)(1) Horses and cattle. Flooring shall be laid athwartship and 
secured by placing ends beneath the under side of foot and rump boards 
or under a 2x4 strip nailed along these boards. 
Floors may be either of two types, flush or raised. The flush type shall 
be constructed of not less than 1 thick lumber laid flat on 
the deck. The raised type shall be constructed of not less than 
2 thick lumber nailed to scantlings of at least 
2x3 dimensions laid 2 feet 6 inches apart. If 
desired, flooring may be laid in portable sections. Flooring will not be 
required on ships with wooden decks provided footlocks are secured to 
the decks. Cement or composite material diagonally scored one-half inch 
deep may be used on iron decks instead of wooden flooring if the 
footlocks are molded in the same and bolted to the deck.
    (2) Sheep, goats, and swine. Flooring for sheep, goats, and swine 
shall be the same as prescribed in this section for horses and cattle, 
except that the raised flooring need not be greater than 12 inch in 
thickness.
    (3) Drainage. Provisions shall be made for drainage of urine and 
surface water from all parts of the vessel used for carriage of animals 
including sufficient scuppers. A walkway shall provide easy access to 
the scuppers.
    (c)(1) Horses and cattle. In pens for horses or cattle, there shall 
be four footlocks of 1x4 lumber laid fore and aft 
with flat side down, and so placed as to provide in-between spaces of 
12, 14, 26, and 14 inches, beginning at inside of the footboard. 
Additional footlocks shall be added at 14 inch intervals in pens having 
a depth of 9 feet or more. They shall be well secured with nails of a 
length that will permit 1 inch clinch in 1 inch flooring and 2 inch 
penetration in 2 inch flooring.
    (2) Sheep, goats, and swine. Footlocks in pens for sheep, goats, and 
swine shall be of not less than 1x2 lumber, four 
to each pen, equally distributed and laid in the manner prescribed in 
paragraph (c)(1) of this section for horses and cattle.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980, 
and amended at 57 FR 23047, June 1, 1992]



Sec.  91.27  Troughs and hayracks.

    All stalls and pens aboard an ocean vessel shall be equipped with 
proper troughs for feeding and watering animals as provided in this 
section. Racks or nets furnished for feeding hay shall be of a type 
acceptable to the inspector. The feeding of hay to the animals on ocean 
vessels may be by means of dispensing the hay from racks or nets or by 
placing the hay on the floor of the pens in which the animals are 
confined.
    (a) Horses and cattle. Troughs may be constructed of metal or wood 
and may be either removable or fixed. The space between the first 
footlock and footboard may be utilized for feeding cattle, provided a 
2x4 piece of lumber is affixed along the top 
surface of said footlock so that it, together with the footboard and the 
battens, will form an enclosure. If wooden troughs are used for feeding, 
an adequate supply of buckets or other metal containers shall

[[Page 355]]

be provided for the proper watering of the animals.
    (b) Sheep, goats, and swine. Pens for these animals shall have feed 
troughs not less than 8 inches wide and shall be equipped with proper 
receptacles for watering. Pens for sheep and goats shall also have ample 
hayracks suitable for these animals.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980]



Sec.  91.28  Stanchions and rails.

    (a)(1) Pipes used for stanchions and rails for pens aboard an ocean 
vessel shall be made of zinc coated, galvanized, extra strong, medium 
carbon steel. Steel pipes or other steel profiles shall consist of not 
less than 4 pipes or profiles, the upper one to have 3 inch diameter and 
the others a diameter of not less than 2\1/2\ inches. Stanchions shall 
not be of less than 3\1/2\ inches diameter; shall not be of less than 
\5/16\ inch thickness and shall not be placed more than 8 feet apart 
center to center.
    (2) Threaded pipe connections shall not be used. All parts shall be 
cut from factory fabricated, seamless pipe.
    (3) Bolt and pin holes shall not be drilled to more than \1/32\ inch 
oversize. Holes shall be properly located and centered on pipe.
    (4) Pipe shall not be deformed or weakened by welding such items as 
reinforcing rods or hinges thereto. Welding shall be used for such 
attachment to be exposed in the finished work. Pins, plates, and parts 
other than pipe shall be made of galvanized steel. All areas where 
galvanizing of the steel has eroded or has been damaged shall be 
finished with a rust preventative.
    (5) Pipe rails shall be placed in proper alignment with tops of all 
gates at the same height.
    (b) All gates of animal pens aboard an ocean vessel shall have 
smooth finished surfaces and the pivot-pins shall have a minimum 
diameter of \3/4\ inch.
    (c) Animals may be carried on upper decks of an ocean vessel in 
space abutting the outside rails or bulwarks only if such rails or 
bulwarks are 3 feet or more in height from the deck and are of 
sufficient strength to hold the necessary fittings securely or if the 
space available is sufficient to permit securing the required fittings 
to provide the necessary strength. When animals are carried on upper 
decks, bulkheads shall be erected at all unprotected ends of stalls.
    (d)(1) Cattle and horses. Rail stanchions for pens aboard an ocean 
vessel for cattle or horses shall be constructed of not less that 
4 or 6 lumber set 5 feet apart on centers secured 
to the ship's rail or bulwark with \5/8\ inch or larger bolts or collars 
and with heels raced to the sheer streak or waterway. Inboard stanchions 
of 4x6 lumber shall be set in line with the rail 
stanchions and properly braced: Provided, however, That the method of 
securing and bracing of stanchions may be modified as approved by the 
underwriter of the cargo bureau, and the inspector. Information 
concerning the modifications shall be made available to APHIS, at its 
request. On open rail ships, spaces between the rails shall be blocked 
out to permit the affixing of outside planking. If supplementary 
stanchions are required for rump boards, these shall not be less than 
3x4 in size and shall be secured to beams and 
decks as outlined above. On upper deck fittings at ends of unprotected 
stalls, a stanchion not less than 3x4 in size 
shall be similarly spaced and secured to beams and decks and properly 
braced. Stanchions on underdecks shall be constructed, spaced, and 
secured in the same manner as upper deck fittings.
    (2) Sheep, goats, and swine. Stanchions for single or double tier 
pens for sheep, goats, and swine shall be constructed of not less 
3x4 lumber set at not greater distance than 5 feet 
on centers and secured as outlined in paragraph (d)(1).
    (e) For all animals, two beams of 2x6 lumber 
shall be bolted on each side of the stanchions using \5/8\ inch bolts, 
nuts, and washers. Beams shall extend from outside planking to at least 
2 feet beyond the line of the breast boards unless the beams butt on the 
ship's deck fittings. Two beams of 2x6 lumber 
shall be used to support the roof of single tier pens on exposed decks 
and the floor of double tier pens on all decks.
    (f) All pens for carrying animals on exposed decks aboard an ocean 
vessel shall be roofed with not less than 1

[[Page 356]]

inch thick, watertight lumber extending from outside planking to at 
least 2 feet beyond the line of breast boards: Provided, That, if tongue 
and grooved lumber is used, it must be caulked or covered so that it is 
watertight or if square edged lumber is used it shall be covered with a 
saturated roofing paper known to the trade as 30 pound roofing paper and 
shall be securely battened.
    (g) All pens for carrying animals on exposed decks shall be provided 
with outside planking of not less than 1\1/2\ inch tongue and groove 
lumber, laid fore and aft of ship, driven tightly together and securely 
nailed to backs of stanchions in a manner to cover all open spaces 
properly. However, during warm weather the top course planking may be 
left off in order to allow a free circulation of air. On vessels with 
closed bulwarks, the outside planking shall extend not less than 6 
inches below the upper edge of the bulwark.
    (h)(1) Horses. All stalls and pens for horses shall be equipped with 
breast boards of no less than 2x10 dressed lumber 
with the top edge placed 3 feet 10 inches from the floor and securely 
nailed to the stanchions. Where butting occurs, the joints are to be on 
the stanchions and shall be covered with metal plates 3 inches square or 
5 inches in diameter and not less than \1/4\ inch in thickness. A \5/8\ 
inch bolt shall then be passed through the plate, joint, and stanchion 
and securely fastened with a nut. All breast boards shall have 1 inch 
holes bored through them at proper distances for tying animals. An 
occassional pen shall be provided with a removable breast board in order 
that animals may be loaded into and removed from the stalls and pens. 
All stalls and pens shall be provided with foot boards of not less than 
2x10 lumber securely nailed or bolted to the 
stanchions. At the discretion of the inspector, small ponies, asses, 
small mules, mares with foal at foot, young unbroken horses or gentle 
horses of any size may be stowed loose in pens. In these cases, a 
sufficient number of finished 2x10 lumber shall be 
placed between the breast and foot boards to effectively contain the 
animals.
    (2) Cattle. All stalls and pens for cattle shall be provided with 
boards as required for horses in paragraph (a), except that the front or 
breast boards shall be constructed in sets of three or more boards of 
2x10 dressed lumber separated by 3 inch spacers 
and placed on the foot board so that the front of the pen extends 48 
inches or more in height from the floor. One or more of the breast 
boards may be left off if feed or water troughs are to be mounted 
externally.
    (3) Sheep, goats, and swine. Front boards in pens for sheep, goats, 
and swine shall be of not less than 1x6 pieces of 
lumber approximately spaced and extending to the proper height for these 
species of animals. Provision shall be made for removing a section of 
front boards to allow entry of animals into pens or removal therefrom 
and for feeding or watering.
    (i)(1) Horses and cattle. Rump boards in pens for horses or cattle 
shall form a solid wall at least 4 feet high for cattle and 4 feet 6 
inches high for horses and shall be of lumber not less than 1\1/2\ 
inches thick if tongued and grooved or 2 inches thick if square edged or 
of plywood of the same strength. Where the deck is clear of 
obstructions, rump boards may be set on the inside of the rail 
stanchions. When this is not possible, sections so affected may be 
brought forward to clear such obstructions and shall be fastened by 
stanchions provided for this purpose. On lower decks where the ship's 
construction so justifies, rump boards may be affixed to 
2x6 wooden pieces set the same as prescribed for 
stanchions. Rump boards may be formed by filling spaces between cargo 
battens. Rump boards in stalls or pens built alongside hatches need be 
carried down only to the coaming line.
    (2) Sheep, goats, and swine. Pens for sheep, goats, and swine on all 
exposed decks shall be provided with rump boards of the specified size 
built to a height of 2 feet 6 inches.
    (j)(1) Horses and cattle. Division boards in pens for horses and 
cattle shall be used to separate all stalls and pens and to close the 
sides thereof at the ends of rows. They shall be used in sets of four 
boards of 2x10 dressed lumber separated by 3 inch 
spacers, shall extend from the rump boards to the inboard stanchions, 
and shall be fitted into appropriate channels or

[[Page 357]]

slots at both ends in a manner that will permit their ready removal.
    (2) Sheep, goats, and swine. Division boards and those forming ends 
of pens for sheep, goats, and swine shall be the same as prescribed for 
rump boards for these animals in paragraph (i) of this section.

[45 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980, 
and amended at 57 FR 23047, June 1, 1992]



Sec.  91.29  Hatches.

    (a) Animals may be placed on hatches on exposed decks on an ocean 
vessel if the pens or stalls are securely lashed down.
    (b) Animals may be placed on hatches on underdecks on an ocean 
vessel provided the height requirements of Sec.  91.25 (e) and (f) are 
met and sufficient space shall be left clear on such hatches for 
passageway across ship.
    (c) On all hatches on which animals are carried and under which hay 
and feed or animals are stowed, sufficient space shall be left clear for 
the proper removal and handling of such hay and feed and animal 
carcasses. Such hatches shall be watertight.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980]



Sec.  91.30  Defective fittings.

    If previously used fittings aboard an ocean vessel are employed, any 
portion thereof found by the inspector to be worn, decayed, unsound, or 
otherwise defective shall be replaced.

[42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980]



             Subpart E_Cleaning and Disinfecting of Aircraft



Sec.  91.41  Cleaning and disinfecting of aircraft.

    Prior to loading of animals, the stowage area of aircraft to be used 
to export animals under the provisions of this part shall, under the 
supervision of an inspector, be cleaned and then disinfected using a 
freshly prepared solution of 4 percent sodium carbonate plus 0.1 percent 
sodium silicate. In addition, all loading ramps, fittings, and equipment 
to be used in loading the animals on the aircraft shall be cleaned and 
disinfected using an approved disinfectant listed in Sec.  71.10 of this 
chapter. The time at which the cleaning and disinfection is performed 
must be approved by the inspector, who will give approval only if he or 
she determines that the cleaning and disinfection will be effective up 
to the projected time of loading of animals. If the animals are not 
loaded by the projected time, the inspector shall determine whether 
further cleaning and disinfection are necessary. 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 inspector, do not 
contain materials that may contain animal disease pathogens such as 
garbage, soil, manure, plant materials, insects, waste paper, or debris. 
After cleaning and disinfection is performed, the inspector shall 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, the inspector 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 inspector 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 inspection of the stowage 
area for materials that may contain animal disease pathogens such as 
garbage, soil, manure, plant materials, insects, waste paper, or debris.

[53 FR 51747, Dec. 23, 1988]

[[Page 358]]



PART 92_IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: PROCEDURES FOR 
REQUESTING RECOGNITION OF REGIONS--Table of Contents




Sec.
92.1 Definitions.
92.2 Application for recognition of the animal health status of a 
          region.
92.3 Movement restrictions.

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 
U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    Source: 62 FR 56012, Oct. 28, 1997, unless otherwise noted.



Sec.  92.1  Definitions.

    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.
    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.
    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.
    European Union. The organization of Member States consisting of 
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, 
Luxembourg, the Netherlands, Portugal, Republic of Ireland, Spain, 
Sweden, and the United Kingdom (England, Scotland, Wales, the Isle of 
Man, and Northern Ireland).
    Import (imported, importation) into the United States. To bring into 
the territorial limits of the United States.
    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.
    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.
    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.
    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

[[Page 359]]

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.

[62 FR 56012, Oct. 28, 1997, as amended at 68 FR 16938, Apr. 7, 2003]



Sec.  92.2  Application for recognition of the animal health status of 
a region.

    (a) The representative of the national government(s) of any country 
or countries who has the authority to request such a change may request 
at any time that all or part of the country or countries be recognized 
as a region, be included within an adjacent previously recognized 
region, or be made part of a region larger than an individual country. 
Requests for recognition of a region must be sent to the Administrator, 
in accordance with paragraph (c) of this section.
    (b) Each request for approval to export a particular type of animal 
or animal product to the United States from a foreign region must be 
made to the Administrator, in accordance with paragraph (c) of this 
section, and must include, in English, the following information about 
the region:
    (1) The authority, organization, and infrastructure of the 
veterinary services organization in the region.
    (2) Disease status--i.e., is the restricted disease agent known to 
exist in the region? If ``yes,'' at what prevalence? If ``no,'' when was 
the most recent diagnosis?
    (3) The status of adjacent regions with respect to the agent.
    (4) The extent of an active disease control program, if any, if the 
agent is known to exist in the region.
    (5) The vaccination status of the region. When was the last 
vaccination? What is the extent of vaccination if it is currently used, 
and what vaccine is being used?
    (6) The degree to which the region is separated from adjacent 
regions of higher risk through physical or other barriers.
    (7) The extent to which movement of animals and animal products is 
controlled from regions of higher risk, and the level of biosecurity 
regarding such movements.
    (8) Livestock demographics and marketing practices in the region.
    (9) The type and extent of disease surveillance in the region--e.g., 
is it passive and/or active; what is the quantity and quality of 
sampling and testing?
    (10) Diagnostic laboratory capabilities.
    (11) Policies and infrastructure for animal disease control in the 
region--i.e., emergency response capacity.
    (c) Requests for recognition of a region or for approval to export 
animals or animal products to the United States from a region, including 
the information required by this section, must be sent to the 
Administrator, c/o National Center for Import and Export, VS, APHIS, 
4700 River Road Unit 38, Riverdale, MD 20737-1231. (Where possible, 
include a copy of the request and accompanying information on a 3.5-inch 
floppy disk in ASCII or a word processing format.)
    (d) The information submitted in accordance with paragraph (b) of 
this section will be made available to the public prior to initiation by 
APHIS of any rulemaking action on the request.
    (e) If, after review of the information submitted, APHIS believes 
the requested importation can be safely allowed, APHIS will publish a 
proposed rule in the Federal Register to allow the importation, and the 
conditions under which the importation would be allowed, along with a 
discussion of the basis for the proposal.
    (f) APHIS will provide a period of time during which the public may 
comment on the proposal. During the comment period, the public will have 
access to the information upon which APHIS based its analysis of the 
risk of such importation, as well as to its methodology in conducting 
the analysis. Once APHIS has reviewed all comments received, it will 
make a final decision on what conditions will be necessary to allow the 
importation in question, and will publish the conditions for import in 
the Federal Register.
    (g) If a region is granted animal health status under the provisions 
of

[[Page 360]]

this section, that region 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 to 
maintain its animal health status.

(Approved by the Office of Management and Budget under control number 
0579-0219)

[62 FR 56012, Oct. 28, 1997, as amended at 68 FR 50054, Aug. 20, 2003]



Sec.  92.3  Movement restrictions.

    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.

[68 FR 16938, Apr. 7, 2003]



 PART 93_IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND CERTAIN 
 
 ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS OF CONVEYANCE 
 AND SHIPPING CONTAINERS--Table of Contents




                             Subpart A_Birds

Sec.
93.100 Definitions.
93.101 General prohibitions; exceptions.
93.102 Ports designated for the importation of birds.
93.103 Import permits for birds; and reservation fees for space at 
          quarantine facilities maintained by APHIS.
93.104 Certificates for pet birds, commercial birds, zoological birds, 
          and research birds.
93.105 Inspection at the port of entry.
93.106 Quarantine requirements.

                                 Canada

93.107 Special provisions.

                            Subpart B_Poultry

93.200 Definitions.
93.201 General prohibitions; exceptions.
93.202 Inspection of certain aircraft and other means of conveyance and 
          shipping containers thereon; unloading, cleaning, and 
          disinfection requirements.
93.203 Ports designated for the importation of poultry.
93.204 Import permits for poultry and for poultry test specimens for 
          diagnostic purposes; and reservation fees for space at 
          quarantine facilities maintained by APHIS.
93.205 Certificate for poultry.
93.206 Declaration and other documents for poultry.
93.207 Inspection at the port of entry.
93.208 Articles accompanying poultry.
93.209 Quarantine requirements.
93.210 Poultry quarantine facilities.
93.211 Quarantine stations, visiting restricted; sales prohibited.
93.212 Manure from quarantined poultry.
93.213 Appearance of disease among poultry in quarantine.

                                 Canada

93.214 Import permit and declaration for poultry.
93.215 Special provisions.
93.216 Poultry from Canada.

                   Central America and the West Indies

93.217 Import permit and declaration for poultry.

                                 Mexico

93.218 Import permits and applications for inspection for poultry.
93.219 Declaration for poultry.
93.220 Inspection at port of entry.

                            Subpart C_Horses

93.300 Definitions.
93.301 General prohibitions; exceptions.
93.302 Inspection of certain aircraft and other means of conveyance and 
          shipping containers thereon; unloading, cleaning, and 
          disinfection requirements.
93.303 Ports designated for the importation of horses.
93.304 Import permits for horses from regions affected with CEM and for 
          horse specimens for diagnostic purposes; reservation fees for 
          space at quarantine facilities maintained by APHIS.
93.305 Declaration and other documents for horses.
93.306 Inspection at the port of entry.
93.307 Articles accompanying horses.
93.308 Quarantine requirements.
93.309 Horse quarantine facilities.
93.310 Quarantine stations, visiting restricted; sales prohibited.
93.311 Milk from quarantined horses.
93.312 Manure from quarantined horses.
93.313 Appearance of disease among horses in quarantine.

[[Page 361]]

93.314 Horses, certification, and accompanying equipment.

                                 Canada

93.315 Import permit and declaration for horses.
93.316 Horses from Canada for immediate slaughter.
93.317 Horses from Canada.
93.318 Special provisions.

                     Central America and West Indies

93.319 Import permit and declaration for horses.
93.320 Horses from Central America and the West Indies.

                                 Mexico

93.321 Import permits and applications for inspection for horses.
93.322 Declaration for horses.
93.323 Inspection.
93.324 Detention for quarantine.
93.325 Horses from Mexico.
93.326 Horses for immediate slaughter.

                           Subpart D_Ruminants

93.400 Definitions.
93.401 General prohibitions; exceptions.
93.402 Inspection of certain aircraft and other means of conveyance and 
          shipping containers thereon; unloading, cleaning, and 
          disinfection requirements.
93.403 Ports designated for the importation of ruminants.
93.404 Import permits for ruminants and for ruminant test specimens for 
          diagnostic purposes; and reservation fees for space at 
          quarantine facilities maintained by APHIS.
93.405 Certificates for ruminants.
93.406 Diagnostic tests.
93.407 Declaration and other documents for ruminants.
93.408 Inspection at the port of entry.
93.409 Articles accompanying ruminants.
93.410 Movement from conveyances to quarantine station.
93.411 Quarantine requirements.
93.412 Ruminant quarantine facilities.
93.413 Quarantine stations, visiting restricted; sales prohibited.
93.414 Milk from quarantined ruminants.
93.415 Manure from quarantined ruminants.
93.416 Appearance of disease among ruminants in quarantine.

                                 Canada

93.417 Import permit and declaration for ruminants.
93.418 Cattle from Canada.
93.419 Sheep and goats from Canada.
93.420 Ruminants from Canada for immediate slaughter.
93.421 Special provisions.

                     Central America and West Indies

93.422 Import permit and declaration for ruminants.
93.423 Ruminants from Central America and the West Indies.

                                 Mexico

93.424 Import permits and applications for inspection of ruminants.
93.425 Declaration for ruminants.
93.426 Inspection at port of entry.
93.427 Cattle from Mexico.
93.428 Sheep and goats and wild ruminants from Mexico.
93.429 Ruminants for immediate slaughter.
93.430-93.431 [Reserved]
93.432 Cattle from the Republic of Ireland.
93.433 [Reserved]
93.434 Standards for approval of privately operated quarantine 
          facilities for sheep or goats, and handling procedures for the 
          importation of sheep or goats.
93.435 Sheep and goats.

                             Subpart E_Swine

93.500 Definitions.
93.501 General prohibitions; exceptions.
93.502 Inspection of certain aircraft and other means of conveyance and 
          shipping containers thereon; unloading, cleaning, and 
          disinfection requirements.
93.503 Ports designated for the importation of swine.
93.504 Import permits for swine and for swine specimens for diagnostic 
          purposes; and reservation fees for space at quarantine 
          facilities maintained by APHIS.
93.505 Certificate for swine.
93.506 Declaration and other documents for swine.
93.507 Inspection at the port of entry.
93.508 Articles accompanying swine.
93.509 Movement from conveyances to quarantine station.
93.510 Quarantine requirements.
93.511 Swine quarantine facilities.
93.512 Quarantine stations, visiting restricted; sales prohibited.
93.513 Milk from quarantined swine.
93.514 Manure from quarantined swine.
93.515 Appearance of disease among swine in quarantine.

                                 Canada

93.516 Import permit and declaration for swine.
93.517 Swine from Canada.
93.518 Swine from Canada for immediate slaughter.
93.519 Special provisions.

                     Central America and West Indies

93.520 Import permit and declaration for swine.

[[Page 362]]

                                 Mexico

93.521 Declaration for swine.

                             Subpart F_Dogs

93.600 Importation of dogs.

                     Subpart G_Miscellaneous Animals

93.700 Definitions.
93.701 Prohibitions.
93.702 Restrictions.
93.703 Ports designated for importation.
93.704 Import permit.
93.705 Health certificate.
93.706 Notification of arrival.
93.707 Inspection at the port of first arrival.

       Subpart H_Elephants, Hippopotami, Rhinoceroses, and Tapirs

93.800 Definitions.
93.801 Prohibitions.
93.802 Import permit.
93.803 Health certificate.
93.804 Declaration upon arrival.
93.805 Ports of entry, inspection, and treatment.
93.806 Animals refused entry.
93.807 Other importations.

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 
U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    Source: 55 FR 31495, Aug. 2, 1990, unless otherwise noted. 
Redesignated at 62 FR 56012, Oct. 28, 1997.



                             Subpart A_Birds



Sec.  93.100  Definitions.

    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).
    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

[[Page 363]]

flock begin laying eggs until the ratites cease laying eggs.
    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.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 31865, July 12, 1991; 59 
FR 10732, Mar. 8, 1994; 59 FR 47068, Sept. 14, 1994. Redesignated and 
amended at 62 FR 56012, 56013, Oct. 28, 1997]



Sec.  93.101  General prohibitions; exceptions.

    (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;\1\ nor shall 
any such product or bird be handled or moved after physical entry into 
the United States before final release from quarantine orany other form 
of governmental detention except in compliance with such regulations; 
Provided, That the Administrator may upon request in specific cases 
permit products or birds 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.
---------------------------------------------------------------------------

    \1\ Importations of certain animals from various regions are 
absolutely prohibited under part 94 because of specified diseases.
---------------------------------------------------------------------------

    (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 
Sec. Sec.  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 Sec.  
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

[[Page 364]]

visit to the flock premises by an APHIS representative under Sec.  
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; \2\
---------------------------------------------------------------------------

    \2\ Copies should be mailed to the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (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 Sec.  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 Sec.  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

[[Page 365]]

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 Sec.  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 Sec. Sec.  93.103 or 93.203: Provided, That, 
such birds are found upon port of entry veterinary inspection under 
Sec.  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) Pet birds which originated in the United States and have not 
been outside the region for more than 60 days may be offered for entry 
under the provisions of Sec.  93.101(c)(1): Provided, That such 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 provided further, That 
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) Lots of pet birds of United States origin which have been 
outside the United States for more than 60 days which are found upon 
port of entry veterinary inspection to be free of poultry diseases, and 
that otherwise meet the requirements of paragraph (c)(2)(i) of this 
section, may be imported by the owner thereof if, the owner importing 
such 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 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
    (B) An agreement on VS Form 17-8, 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 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
    (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 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. 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)(3) of this section.
    (3) 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

[[Page 366]]

entry designated in Sec.  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 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 Sec.  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\3\ 
at the port where the birds are to be held for a minimum 30-day 
isolation in a biologically secure unit separate and apart from all 
other avian species, except, that birds arriving without an advanced 
reservation may be handled if an isolation unit is available, provided 
the reservation fee as required in Sec.  93.103(a)(3) is paid. Pet birds 
offered for entry at a port of entry that has not been designated in 
Sec.  93.102(a), or pet birds arriving without an advanced reservation 
at a port of entry designated in Sec.  93.102(a) but at which isolation 
units are not available, shall be refused entry at such port. However, 
such pet birds may be transported at the owner's expense to another port 
of entry designated in Sec.  93.102(a) if available quarantine space 
exists, if the reservation fee is paid and the birds are shipped to such 
other port under conditions deemed sufficient by the Administrator to 
prevent the spread of communicable diseases of poultry: Provided, That 
pet birds arriving with or without an advance reservation at the port of 
Hidalgo, Texas, will be transported at Department expense to the 
quarantine facility at Mission, Texas, if available quarantine space 
exists at that facility, until quarantine facilities are available at 
Hidalgo, Texas; and pet birds arriving with or without an approved 
reservation entered at the port of New York, New York, will be 
transported at Department expense to the quarantine facility at 
Newburgh, New York, if available quarantine space exists at the 
facility, until quarantine facilities are available at New York, New 
York. Following the isolation period, if such birds are found to be free 
from communicable diseases of poultry, the birds shall be returned at 
Department expense to the respective ports of Hidalgo, Texas, or New 
York, New York, as appropriate, for Agriculture release for entry 
through U.S. Customs.
---------------------------------------------------------------------------

    \3\ The names and addresses of the port veterinarians, as well as a 
fee schedule for quarantine charges, are available from the Animal and 
Plant Health Inspection Service, Veterinary Services, Operational 
Support, 4700 River Road Unit 33, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (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 Sec.  
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 Sec.  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

[[Page 367]]

of export from the region of origin, to communicable diseases of 
poultry, if an import permit \4\ has been obtained under Sec.  93.103 of 
this chapter and all conditions therein are observed; and if such birds 
are handled as follows:
---------------------------------------------------------------------------

    \4\ Such permit may be obtained from the Animal and Plant Health 
Inspection Service, Veterinary Services, Operational Support, 4700 River 
Road Unit 33, Riverdale, Maryland 20737-1231. Requests for approval of 
such facilities should also be made to the Deputy Administrator.
---------------------------------------------------------------------------

    (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 
Sec.  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\5\ in advance by the Administrator in accordance with paragraph 
(d)(3) of this section as adequate to prevent the spread within the 
United States of any livestock or poultry disease, and they are 
maintained there under continuous confinement until loaded aboard a 
means of conveyance for transportation from the United States and are 
maintained under continuous confinement aboard such means of conveyance 
until it leaves the United States; the import permit will specify any 
additional conditions necessary to assure that the transit of the 
poultry or birds through the United States can be made without 
endangering the livestock or poultry of the United States, and that 
Department inspectors may inspect the poultry or birds on board such 
means of conveyance or in such holding facility to ascertain whether the 
requirements of this paragraph are met, and dispose of them in 
accordance with the Animal Health Protection Act (7 U.S.C. 8301 et seq.) 
if such conditions are not met; and
---------------------------------------------------------------------------

    \5\ See footnote 4 in subpart A.
---------------------------------------------------------------------------

    (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 
Sec. Sec.  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 may be imported at any of the 
ports of entry listed in Sec.  93.102 or 93.203 if accompanied by an 
import permit as required by Sec.  93.103 and such birds are found upon 
port of entry veterinary inspection to be free of communicable diseases 
of poultry.
    (g) Any smuggled bird shall:
    (1) Be refused entry into the United States and be removed from the 
United States,\6\ or
---------------------------------------------------------------------------

    \6\ Birds that would require handfeeding will be refused entry.

---------------------------------------------------------------------------

[[Page 368]]

    (2) Be quarantined in a USDA-operated quarantine facility pending 
negative results to two consecutive tests for exotic Newcastle disease 
(END) \7\ administered not less than 30 days apart, with the first test 
administered within seven days after the bird enters the facility.
---------------------------------------------------------------------------

    \7\ Such tests are conducted according to the Protocol for END which 
is available upon request from the Administrator.
---------------------------------------------------------------------------

    (3) Tissue samples from any smuggled bird which has died prior to 
release from quarantine shall be submitted for END 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 END 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 END 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 END 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 END 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.

(Approved by the Office of Management and Budget under control number 
0579-0020)

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 31865, 31866, July 12, 
1991; 57 FR 28080, June 24, 1992; 59 FR 10732, Mar. 8, 1994; 59 FR 
36026, July 15, 1994; 59 FR 47068, Sept. 14, 1994; 59 FR 63881, Dec. 12, 
1994; 59 FR 67133, Dec. 29, 1994; 59 FR 67614, Dec. 30, 1994; 61 FR 
56890, Nov. 5, 1996; 61 FR 68125, Dec. 27, 1996. Redesignated and 
amended at 62 FR 56012-56014, Oct. 28, 1997; 67 FR 52394, Aug. 12, 2002; 
68 FR 6343, Feb. 7, 2003]



Sec.  93.102  Ports designated for the importation of birds.

    (a) Special ports for pet birds. The following ports are designated 
as ports of entry for pet birds imported under the provisions of Sec.  
93.101(c) and performing or theatrical birds imported under the 
provisions of Sec.  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 Sec.  93.105.

[[Page 369]]

    (d) Limited ports. The following ports are designated as ports of 
entry for pet birds imported under the provisions of Sec.  93.101(c)(1) 
or (2) and performing or theatrical birds imported under the provisions 
of Sec.  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.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 36026, July 15, 1994; 60 
FR 16045, Mar. 29, 1995; 60 FR 25120, May 11, 1995; 61 FR 68125, Dec. 
27, 1996. Redesignated and amended at 62 FR 56012, 56014, Oct. 28, 1997; 
65 FR 38178, June 20, 2000; 67 FR 6370, Feb. 12, 2002]



Sec.  93.103  Import permits for birds; and reservation fees for space 
at quarantine facilities maintained by APHIS.

    (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 Sec. Sec.  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 \8\ must include the following 
information:
---------------------------------------------------------------------------

    \8\ VS import permit application forms are available from local 
offices of Veterinary Services, which are listed in telephone 
directories, or from the Animal and Plant Health Inspection Service, 
Veterinary Services, National Center for Import-Export, 4700 River Road 
Unit 38, Riverdale, Maryland 20737-1231. For other permit requirements 
for birds, the regulations issued by the U.S. Department of the Interior 
(title 50, Code of Federal Regulations, parts 14 and 17) should be 
consulted.
---------------------------------------------------------------------------

    (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 Sec.  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:

I certify that the information provided herein is true and correct to 
the best of my knowledge and belief, and agree to comply with the 
applicable regulations in title 9, Code of Federal Regulations, 
Sec. Sec.  93.100 through 93.107;
    (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 Sec.  93.107, shall 
specify the number of ratites or

[[Page 370]]

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 Sec.  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 Sec.  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 Sec.  93.107, a permit to import ratites or

[[Page 371]]

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 Sec.  93.101(b)(3), indicates that the ratites and hatching eggs 
are not identified and marked as required under Sec.  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

[[Page 372]]

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 \9\ during regular business hours (8:00 a.m. 
to 4:30 p.m. Monday through Friday, excluding holidays) no later than 15 
days for birds prior to the beginning of the time of importation as 
specified in the import permit or as arranged with the veterinarian in 
charge of the quarantine facility if no import permit is required (the 
15 day period shall not include Saturdays, Sundays, or holidays), or
---------------------------------------------------------------------------

    \9\ The addresses of USDA quarantine facilities may be found in 
telephone directories listing the facilities or by contacting the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 
20737-1231.
---------------------------------------------------------------------------

    (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

[[Page 373]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 31866, July 12, 1991; 57 
FR 21725, May 22, 1992; 59 FR 10733, Mar. 8, 1994; 59 FR 47068, Sept. 
14, 1994; 59 FR 47235, Sept. 15, 1994; 59 FR 67614, Dec. 30, 1994; 61 FR 
68125, Dec. 27, 1996. Redesignated and amended at 56012, 56014, Oct. 28, 
1997; 65 FR 38178, June 20, 2000]



Sec.  93.104  Certificate for pet birds, commercial birds, zoological 
birds, and research birds.

    (a) General. All pet birds, except as provided for in Sec.  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.

[[Page 374]]

    (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, 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, chlamydiosis, or other communicable 
disease of poultry during the 90 days immediately preceding their 
exportation;
    (4) That the birds have not been vaccinated with Newcastle disease 
vaccine;
    (5) That 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
    (7) That the birds were placed into previously unused containers 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 Sec.  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, 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, chlamydiosis, or other 
communicable disease of pountry 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;
    (6) That 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;
    (8) That, except as provided in Sec.  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 previously unused containers 
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 Sec.  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 Sec.  
93.101(b)(3);
    (15) Except for ratites imported from Canada in accordance with 
Sec.  93.107, the number of ratite laying hens in the flock from which 
the ratites come;

[[Page 375]]

    (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 Sec.  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, 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, chlamydiosis, or other 
communicable disease of poultry during the 90 days immediately preceding 
the exportation of the hatching eggs;
    (5) That 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 previously unused 
containers 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 Sec.  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 
Sec.  93.101(b)(3);
    (11) Except for hatching eggs of ratites imported from Canada in 
accordance with Sec.  93.107, the number of ratite laying hens in the 
flock from which the hatching eggs come.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[56 FR 31866, July 12, 1991; 56 FR 41726, Aug. 22, 1991, as amended at 
57 FR 28080, June 24, 1992; 59 FR 10733, March 8, 1994; 59 FR 47235, 
Sept. 15, 1994; 61 FR 56891, Nov. 5, 1996; 61 FR 68126, Dec. 27, 1996. 
Redesignated and amended at 62 FR 56012, 56014, Oct. 28, 1997]



Sec.  93.105  Inspection at the port of entry.

    (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 Sec.  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 Sec.  
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 Sec.  93.102(a). Pet birds 
of Canadian origin and those birds meeting the provisions of Sec.  
93.101(c)(2) shall be subject to veterinary inspection at any of the 
ports of entry listed in Sec.  93.102 and 93.203.
    (c) Ratites, other than hatching eggs of ratites, imported from any 
part of

[[Page 376]]

the world must be inspected at the Customs port of entry by a veterinary 
inspector of APHIS and, except as provided in Sec.  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.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 31867, July 12, 1991; 57 
FR 21726, May 22, 1992; 59 FR 36026, July 15, 1994; 59 FR 47069, Sept. 
14, 1994; 61 FR 68126, Dec. 27, 1996. Redesignated and amended at 62 FR 
56012, 56014, Oct. 28, 1997; 65 FR 38178, June 20, 2000]



Sec.  93.106  Quarantine requirements.

    (a) Birds other than ratites and hatching eggs of ratites. Each lot 
of pet birds, except as provided for in Sec.  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 Sec.  
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 Sec.  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 Sec.  93.103 of this part.
    (2) Each lot of hatching eggs of ratites imported from any part of 
the

[[Page 377]]

world except as provided in Sec.  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 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 \10\ by an 
inspector until the inspector determines that the ratites are free of 
ectoparasites.
---------------------------------------------------------------------------

    \10\ APHIS will use an EPA registered dust formulation that contains 
5 percent carbaryl as the only active ingredient. The dust formulation 
will be used in accordance with all applicable directions, restrictions, 
and precautions on the label. Treated birds may not be slaughtered for 
food purposes.
---------------------------------------------------------------------------

    (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

[[Page 378]]

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 inchx1.5 
inches (2.54 cmx3.81 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 Sec.  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 Sec.  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

[[Page 379]]

(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 Sec.  
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

[[Page 380]]

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 Sec.  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.\11\
---------------------------------------------------------------------------

    \11\ A list of approved vaccines is available from the the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 
20737-1231.
---------------------------------------------------------------------------

    (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 frank or clinical Newcastle disease occurs 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 Sec.  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.

[[Page 381]]

    (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.

 Cooperative And Trust Fund Agreement between ------ (name of importer) 
and the United States Department of Agriculture, Animal and Plant Health 
                           Inspection Service.

    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

[[Page 382]]

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, Sec.  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 Sec.  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 exotic 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.

Written instructions shall be provided to the monitoring agency which 
shall require that upon activation of the alarm, the police and a 
representative of the Service designated by the Service shall be 
notified by the monitoring agency. Such instructions, as well as any 
changes in such instructions, shall be filed in writing with the 
Administrator. The Importer shall notify the Service whenever a break in 
security occurs or is suspected of occurring.
    (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 exotic 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, Sec.  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

[[Page 383]]

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 END 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 END, 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,\12\ which are attached hereto and 
made a part thereof.
---------------------------------------------------------------------------

    \12\ Import-Export Animals Staff, Veterinary Services, APHIS, USDA, 
will furnish each importer with copies of exhibits B and C prior to 
their signing the Cooperative and Trust Fund Agreement.
---------------------------------------------------------------------------

    (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.

Date____________________________________________________________________
________________________________________________________________________

Importer
Date____________________________________________________________________
________________________________________________________________________

Administrator, Animal and Plant Health Inspection Service, United States 
                        Department of Agriculture

    (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.

[[Page 384]]

    (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.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 31867, July 12, 1991; 56 
FR 41726, Aug. 22, 1991; 57 FR 21726, May 22, 1992; 58 FR 38957, July 
21, 1993; 59 FR 36026, July 15, 1994; 59 FR 47069, Sept. 14, 1994; 59 FR 
47235, Sept. 15, 1994; 59 FR 67614, Dec. 30, 1994; 61 FR 31392, June 20, 
1996; 61 FR 56891, Nov. 5, 1996. Redesignated and amended at 62 FR 
56012, 50614-56015, Oct. 28, 1997; 65 FR 38178, June 20, 2000; 68 FR 
6343, Feb. 7, 2003]

                               Canada \13\
---------------------------------------------------------------------------

    \13\ Importations from Canada shall be subject to Sec.  93.107, in 
addition to other sections in this part which are in terms applicable to 
such importations.
---------------------------------------------------------------------------



Sec.  93.107  Special provisions.

    (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 Sec.  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 Sec.  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 
Sec.  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 Sec.  
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 Sec.  93.105(a); and
    (3) If offered for entry at a Canadian land border port listed in 
Sec.  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.

[55 FR 31495, Aug. 2, 1990, as amended at 61 FR 68126, Dec. 27, 1996. 
Redesignated and amended at 56012, 56015, Oct. 28, 1997; 65 FR 38178, 
June 20, 2000; 67 FR 68022, Nov. 8, 2002]



                            Subpart B_Poultry



Sec.  93.200  Definitions.

    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.

[[Page 385]]

    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.
    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.
    Immediate slaughter. Consignment directly from the port of entry to 
a recognized slaughtering establishment \1\ and slaughter thereat within 
two weeks from the date of entry.
---------------------------------------------------------------------------

    \1\ The name of recognized slaughtering establishments approved 
under this part may be obtained from the Area Veterinarian in Charge, 
Veterinary Services, for the State of destination of the shipment.
---------------------------------------------------------------------------

    Inspector. An employee of the Animal and Plant Health Inspection 
Service authorized to perform duties required under this subpart.
    Operator. For the purpose of Sec.  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).
    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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56015, Oct. 28, 1997]



Sec.  93.201  General prohibitions; exceptions.

    (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; \2\ nor shall 
any such poultry or 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, the Administrator may upon request in 
specific cases permit poultry or 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.
---------------------------------------------------------------------------

    \2\ Importations of certain animals from various regions are 
absolutely prohibited under part 94 because of specific diseases.
---------------------------------------------------------------------------

    (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 \3\ has 
been obtained under Sec.  93.204 of

[[Page 386]]

this chapter and all conditions therein are observed; and if such 
poultry are handled as follows:
---------------------------------------------------------------------------

    \3\ Such permit may be obtained from the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. 
Requests for approval of such facilities should also be made to the 
Deputy Administrator.
---------------------------------------------------------------------------

    (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 
Sec.  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 \4\ in advance by the Administrator in accordance with 
paragraph (b)(3) of this section as adequate to prevent the spread 
within the United States of any livestock or poultry disease, and they 
are maintained there under continuous confinement until loaded aboard a 
means of conveyance for transportation from the United States and are 
maintained under continuous confinement aboard such means of conveyance 
until it leaves the United States; the import permit will specify any 
additional conditions necessary to assure that the transit of the 
poultry through the United States can be made without endangering the 
livestock or poultry of the United States, and that Department 
inspectors may inspect the poultry on board such means of conveyance or 
in such holding facility to ascertain whether the requirements of this 
paragraph are met, and dispose of them in accordance with the Animal 
Health Protection Act (7 U.S.C. 8301 et seq.) if such conditions are not 
met; and
---------------------------------------------------------------------------

    \4\ See footnote 3 in subpart B.
---------------------------------------------------------------------------

    (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 may be imported at any of the 
ports of entry listed in Sec.  93.203 if accompanied by an import permit 
as required by Sec.  93.204 and such poultry are found upon port of 
entry veterinary inspection to be free of communicable diseases of 
poultry.
    (d) The provisions in this part relating to poultry shall not be 
applicable to performing or theatrical poultry.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 56012, 56015, 
Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]



Sec.  93.202  Inspection of certain aircraft and other means of 

conveyance and shipping containers thereon; unloading, cleaning, 
and disinfection requirements.

    (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

[[Page 387]]

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.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67614, Dec. 30, 1994. 
Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997; 68 FR 
6344, Feb. 7, 2003]



Sec.  93.203  Ports designated for the importation of poultry.

    (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

[[Page 388]]

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.

[55 FR 31495, Aug. 2, 1990, as amended at 58 FR 37642, July 13, 1993; 60 
FR 16045, Mar. 29, 1995; 60 FR 25120, May 11, 1995. Redesignated at 
56012, Oct. 28, 1997, as amended at 65 FR 38178, June 20, 2000; 67 FR 
6370, Feb. 12, 2002; 67 FR 68022, Nov. 8, 2002]



Sec.  93.204  Import permits for poultry and for poultry test specimens 

for diagnostic purposes; and reservation fees for space at quarantine 
facilities maintained by APHIS.

    (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 Sec. Sec.  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

[[Page 389]]

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 \5\ during regular business hours (8:00 a.m. 
to 4:30 p.m., Monday through Friday, excluding holidays) no later than 
15 days prior to the beginning of the time of importation as specified 
in the import permit or as arranged with the veterinarian in charge of 
the quarantine facility if no import permit is required (the 15 day 
period shall not include Saturdays, Sundays, or holidays), or
---------------------------------------------------------------------------

    \5\ The addresses of USDA quarantine facilities may be found in 
telephone directories listing the facilities or by contacting the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 
20737-1231.
---------------------------------------------------------------------------

    (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

[[Page 390]]

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.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67614, Dec. 30, 1994. 
Redesignated and amended at 56012, 56015, Oct. 28, 1997]



Sec.  93.205  Certificate for poultry.

    All poultry, except eggs for hatching, offered for importation from 
any region of the world 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 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, and that, as 
far as it has been possible to determine, they were not exposed to any 
such disease common to poultry during the 90 days immediately preceding 
the date of such movement and that these premises are not located in any 
area under quarantine during the preceding 90 days. Certificates for 
such poultry shall also state that the poultry have been kept

[[Page 391]]

in the region from which they are offered for importation for at least 
90 days immediately preceding the date of movement therefrom or since 
hatched and that, as far as it has been possible to determine, no case 
of European fowl pest (fowl plague) or Newcastle disease occurred on the 
premises where such poultry were kept, or on adjoining premises, during 
that 90-day period. All eggs for hatching offered for importation from 
any part of the world, 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 the flock or flocks of origin were 
found upon inspection to be free from evidence of communicable diseases 
of poultry, that no Newcastle disease has occurred on the premises of 
origin or on adjoining premises during the 90 days immediately preceding 
the date of movement of the eggs from such region, and that as far as it 
has been possible to determine such flock or flocks were not exposed to 
such disease during the preceding 90 days.

[55 FR 31495, Aug. 2, 1992, as amended at 57 FR 28080, June 24, 1992. 
Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997]



Sec.  93.206  Declaration and other documents for poultry.

    (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.



Sec.  93.207  Inspection at the port of entry.

    Inspection shall be made at the port of entry of all poultry 
imported from any part of the world except as provided in Sec. Sec.  
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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 56012, 56015, 
Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]



Sec.  93.208  Articles accompanying poultry.

    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.



Sec.  93.209  Quarantine requirements.

    (a) Poultry, other than eggs for hatching, imported, except as 
provided in Sec.  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

[[Page 392]]

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 Sec.  94.6(a)(2) of this chapter as free of exotic 
Newcastle disease, 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.

[55 FR 31495, Aug. 2, 1990, as amended at 61 FR 56891, Nov. 5, 1996. 
Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997]



Sec.  93.210  Poultry quarantine facilities.

    (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

[[Page 393]]

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.



Sec.  93.211  Quarantine stations, visiting restricted; sales prohibited.

    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.



Sec.  93.212  Manure from quarantined poultry.

    No manure shall be removed from the quarantine premises until the 
release of the poultry producing same.



Sec.  93.213  Appearance of disease among poultry in quarantine.

    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.

                               Canada \6\



Sec.  93.214  Import permit and declaration for poultry.

    (a) For poultry intended for importation from Canada, the importer 
shall first apply for and obtain from APHIS an import permit as provided 
in Sec.  93.204: Provided, That an import permit is not required for 
poultry if offered for entry at a land border port designated in Sec.  
93.203(b).
---------------------------------------------------------------------------

    \6\ Importations from Canada shall be subject to Sec. Sec.  93.214 
to 93.216, inclusive, in addition to other sections in this part which 
are in terms applicable to such importations.
---------------------------------------------------------------------------

    (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 Sec.  93.206.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56015, Oct. 28, 1997]



Sec.  93.215  Special provisions.

    (a) In-bond shipments from Canada. (1) Poultry from Canada 
transported in-bond through the United States for immediate export shall 
be inspected at

[[Page 394]]

the border port of entry and, when accompanied by an import permit 
obtained under Sec.  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 Sec.  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 paper containing the information 
shall be attached to 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.

(Approved by the Office of Management and Budget under control number 
0579-0020)

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67133, Dec. 29, 1994. 
Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997]



Sec.  93.216  Poultry from Canada.

    Poultry imported from Canada is not required to meet the 
requirements of Sec.  93.209 but shall meet all other requirements of 
this part applicable to poultry or to animals generally.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56015, Oct. 28, 1997]

                 Central America and the West Indies \7\



Sec.  93.217  Import permit and declaration for poultry.

    (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 Sec.  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.
---------------------------------------------------------------------------

    \7\ Importations from regions of Central America and the West Indies 
shall be subject to Sec.  93.217, in addition to other sections in this 
part, which are in terms applicable to such importations.
---------------------------------------------------------------------------

    (b) For all poultry offered for importation from regions of Central 
America or of the West Indies, the importer or

[[Page 395]]

his or her agent shall present two copies of a declaration as provided 
in Sec.  93.206.
    (c) All poultry offered for importation from regions of Central 
America and the West Indies shall also meet the additional requirements 
in Sec. Sec.  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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56015, Oct. 28, 1997]

                               Mexico \8\



Sec.  93.218  Import permits and applications for inspection for poultry.

    (a) For poultry intended for importation from Mexico, the importer 
shall first apply for and obtain from APHIS an import permit as provided 
in Sec.  93.204.
---------------------------------------------------------------------------

    \8\ Importations from Mexico shall be subject to Sec. Sec.  93.218 
to 93.220 inclusive, in addition to other sections in this part which 
are in terms applicable for such importations.
---------------------------------------------------------------------------

    (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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56016, Oct. 28, 1997]



Sec.  93.219  Declaration for 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 Sec.  93.206.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56016, Oct. 28, 1997]



Sec.  93.220  Inspection at port of entry.

    (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 Sec.  93.203.

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 12190, Apr. 9, 1992. 
Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997]



                            Subpart C_Horses



Sec.  93.300  Definitions.

    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.

[[Page 396]]

    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 \1\ and slaughter thereat within 
two weeks from the date of entry.
---------------------------------------------------------------------------

    \1\ The name of recognized slaughtering establishments approved 
under this part may be obtained from the Area Veterinarian in Charge, 
Veterinary Services, for the State of destination of the shipment.
---------------------------------------------------------------------------

    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.
    Operator. For the purposes of Sec.  93.308, any person operating an 
approved quarantine 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.
    Recognized slaughtering establishment.\2\ An establishment where 
slaughtering operations are regularly carried on under federal or state 
inspection and which has been approved by the Animal and Plant Health 
Inspection Service to receive animals for slaughter under this part.
---------------------------------------------------------------------------

    \2\ See footnote 1 to subpart C.
---------------------------------------------------------------------------

    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.
    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.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 15489, Apr. 17, 1991; 61 
FR 52239, Oct. 7, 1996. Redesignated and amended at 62 FR 56012, 56016, 
Oct. 28, 1997]



Sec.  93.301  General prohibitions; exceptions.

    (a) 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

[[Page 397]]

part and part 94 of this subchapter; \3\ nor shall any such horse or 
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, 
the Administrator may upon request in specific cases permit horses 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.
---------------------------------------------------------------------------

    \3\ Importations of certain animals from various regions are 
absolutely prohibited under part 94 because of specific diseases.
---------------------------------------------------------------------------

    (b) 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 \4\ has been obtained under Sec.  93.304 of 
this chapter and all conditions therein are observed; and if such horses 
are handled as follows:
---------------------------------------------------------------------------

    \4\ Such permit may be obtained from the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (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 \5\ in advance by the Administrator in accordance with 
paragraph (b)(3) of this section as adequate to prevent the spread 
within the United States of any livestock or poultry disease, and they 
are maintained there under continuous confinement until loaded aboard a 
means of conveyance for transportation from the United States and are 
maintained under continuous confinement aboard such means of conveyance 
until it leaves the United States; the import permit will specify any 
additional conditions necessary to assure that the transit of the horses 
through the United States can be made without endangering the livestock 
or poultry of the United States, and that Department inspectors may 
inspect the horses on board such means of conveyance or in such holding 
facility to ascertain whether the requirements of this paragraph are 
met, and dispose of them in accordance with the Animal Health Protection 
Act (7 U.S.C. 8301 et seq.) if such conditions are not met; and
---------------------------------------------------------------------------

    \5\ See footnote 4 to subpart C.
---------------------------------------------------------------------------

    (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

[[Page 398]]

from any of the following listed regions and the importation of all 
horses that have been in any listed region within the 12 months 
immediately preceding their being offered for entry into the United 
States is prohibited, either because contagious equine metritis (CEM) 
exists in the listed region or because the listed region trades horses 
freely with a region in which CEM exists without testing for CEM: 
Austria, Belgium, Bosnia and Herzegovina, Croatia, Czech Republic, 
Denmark, Finland, France, Germany, Guinea-Bissau, Ireland, Italy, Japan, 
the Member States of the European Union, The Netherlands, Norway, 
Slovakia, Slovenia, Sweden, Switzerland, The Former Yugoslav Republic of 
Macedonia, the United Kingdom (England, Northern Ireland, Scotland, 
Wales, and the Isle of Man), and the nonrecognized areas of the former 
Yugoslavia (Montenegro and Serbia).
    Note: Montenegro and Serbia have asserted the formation of a joint 
independent State entitled ``The Federal Republic of Yugoslavia,'' but 
this entity has not been formally recognized by the United States.
    (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 whose age is certified on the import 
health certificate required under Sec.  93.314(a);
    (iv) Horses imported in accordance with conditions prescribed by the 
Administrator as provided in Sec.  93.301(a);
    (v) Spanish Pure Breed horses imported for permanent entry from 
Spain or thoroughbred horses imported for permanent entry from France, 
Germany, Ireland, or the United Kingdom 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) of this section; and
    (viii) Horses temporarily exported from the United States or from 
another region not known to be affected with CEM to a region listed in 
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, Ireland, and the United Kingdom. (1) Spanish Pure 
Breed horses from Spain and thoroughbred horses from France, Germany, 
Ireland, and the United Kingdom 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 Sec.  93.304;
    (ii) Each horse is accompanied at the time of importation by an 
import health certificate issued in accordance with Sec.  93.314(a). In 
addition to the information required by Sec.  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 \6\ and certified by the breed association to be current, 
true, and factual for the following information:
---------------------------------------------------------------------------

    \6\ The following breed associations and their record systems have 
been approved by the Department: Jefatura de Cria Caballar Registro 
Matricula for Spain; Weatherby's Ltd. for the United Kingdom and 
Ireland; Haras du Pain for France; and Direktorium f[uuml]r 
Vollblutzucht und Rennen e.v. for Germany.
---------------------------------------------------------------------------

    (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;

[[Page 399]]

    (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 sets of 
specimens collected on 3 separate occasions within a 7-day period from 
the mucosal surfaces of the clitoral fossa and the clitoral sinuses of 
any female horses and from the surfaces of the prepuce, the urethral 
sinus, 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 days 1, 4, and 7 of the 7-day period, 
and the last of these sets of specimens must be collected within 30 days 
of 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 Sec.  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 Sec.  
93.308, be consigned to an approved State listed in paragraph (h)(6) or 
(h)(7) 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 in 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 Sec.  93.304. The import permit 
must indicate that, after completion of the Federal quarantine required 
in Sec.  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 Sec.  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 specimens must be collected from the 
prepuce, urethral sinus, and fossa glandis, including the diverticulum 
of

[[Page 400]]

the fossa glandis; for mares, the specimens must be collected from the 
mucosal surfaces of the clitoral fossa and the clitoral sinuses. 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 Sec.  93.308. Upon completion of the Federal quarantine, stallions 
must be sent to an approved State listed in paragraph (h)(6) of this 
section, and mares must be sent to an approved State listed in paragraph 
(h)(7) of this section.
    (ii) 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.
    (iii) 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 paragraph (i) of this section to 
conduct CEM cultures and tests.
    (iv) 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, and the fossa glandis, including the 
diverticulum of the fossa glandis, of the stallion 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.\7\ The treatment shall be 
performed by an accredited veterinarian and monitored by a State or 
Federal veterinarian.
---------------------------------------------------------------------------

    \7\ A list of ointments effective against the CEM organism may be 
obtained from the National Center for Import and Export, Import/Export 
Animals, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (B) Each mare to which the stallion has been test bred shall be 
cultured for CEM from sets of specimens that are collected from the 
mucosal surfaces of the clitoral fossa and clitoral sinuses on the 
third, sixth, and ninth days

[[Page 401]]

after the breeding, with negative results. A complement fixation test 
for CEM must be done with negative results on the fifteenth 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.'' The marking shall be 
permanently applied by an inspector, a State inspector, or an accredited 
veterinarian who shall use a hot iron, freezemarking, or a lip tattoo. 
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. For culture, sets of specimens shall be collected on 
the first, fourth, and seventh days of a 7-day period from the mucosal 
surfaces of the clitoral fossa and clitoral sinuses.
    (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, sets of specimens shall be collected from the 
mare on three separate occasions within a 7-day period. On days 1, 4, 
and 7, an accredited veterinarian shall collect specimens from the 
mucosal surfaces of the clitoral fossa and clitoral sinuses and shall 
submit each set of specimens to the National Veterinary Services 
Laboratories, Ames, IA, or to a laboratory approved by the Administrator 
in accordance with paragraph (i) of this section 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.\8\
---------------------------------------------------------------------------

    \8\ Recommended protocols for the flushing of sinuses may be 
obtained from the National Center for Import and Export, Import/Export 
Animals, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (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.\9\
---------------------------------------------------------------------------

    \9\ A list of ointments effective against the CEM organism may be 
obtained from the National Center for Import and Export, Import/Export 
Animals, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (iv) A mare may be released from State quarantine only if all 
cultures

[[Page 402]]

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. Horses over 731 
days of age may be imported into the United States for no more than 90 
days to compete in specified events if the following conditions are met:
    (1) The horse may remain in the United States for not more than 90 
days following the horse's arrival in the United States, except as 
provided in paragraph (f)(6) of this section and, while in the United 
States, the horse must be moved according to the itinerary and methods 
of transport specified in the import permit provided for in Sec.  93.304 
of this part;
    (2) While the horse is in the United States, the following 
conditions must be met:
    (i) Except when in transit, the horse must be kept on a premises 
that has been approved, orally or in writing, by an APHIS 
representative. If the approval is oral, it will be confirmed in writing 
by the Administrator as soon as circumstances permit. To receive 
approval, the premises:
    (A) Must not be a breeding premises; and
    (B) Must be or contain a building in which the horse can be kept in 
a stall that is separated from other stalls containing horses, 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 m) high.
    (ii) While at the premises at which the horse competes, the horse 
must be monitored by an accredited veterinarian or APHIS representative 
to ensure that the provisions of paragraphs (f)(2)(i), (f)(2)(iv), and 
(f)(2)(v) 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 for the event be 
conducted by APHIS representatives to ensure compliance.
    (iii) 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 
at the horse's destination, except in situations where the horse's life 
is in danger.
    (iv) Except when actually competing or being exercised, the horse 
must be kept in a stall that is separated from other stalls containing 
horses, 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 
m) high.
    (v) The horse may not be used for breeding purposes (including 
artificial insemination), may not have any other sexual contact with 
other horses, and may not undergo any genital examinations.
    (vi) 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 Sec. Sec.  71.7 through 71.12 of this chapter, 
before any other horse is transported in the vehicle.
    (vii) The cleaning and disinfection specified in paragraph 
(f)(2)(vi) 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.

[[Page 403]]

    (viii) The owner or importer of the horse must comply with any other 
provisions of this part applicable to him or her.
    (3) 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 should be sent to the Administrator, c/o Import-
Export Animals Staff, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 
20737-1231. 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. If more than one application for an 
import permit is received, APHIS personnel will be assigned in the order 
that the applications that otherwise meet the requirements of this 
section are received.
    (4) The Administrator may cancel, orally or in writing, the import 
permit provided for under Sec.  93.304 of this part whenever the 
Administrator finds that the owner or importer of the horse has not 
complied with the provisions of paragraphs (f)(1) through (f)(3) 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.
    (5) 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 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 
according to the import permit. The stall in which the horse is kept 
must be separated from other stalls containing horses, either by an 
empty stall, by an open area across which horses cannot touch each 
other, or a by solid wall that is at least 8 feet (2.4 m) 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.
    (6) Stallions or mares over 731 days of age that are imported for no 
more than 90 days in accordance with paragraphs (f)(1) through (f)(3) 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 Sec.  93.304 of this part, the horse's owner or 
importer applies for and receives a new import permit that specifies 
that the stallion or mare

[[Page 404]]

will be moved to an approved State listed in paragraph (h)(6) or (h)(7) 
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.
    (7) All costs and charges associated with the supervision and 
maintenance of a horse imported under paragraphs (f)(1) through (f)(3) 
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.
    (8) 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 paragraphs (f)(1) 
through (f)(3) of this section, 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, to conduct the 
monitoring required by paragraph (f)(2)(ii) of this section, and to 
supervise the cleaning and disinfection required by paragraph (f)(2)(vi) 
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 
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 and the APHIS office or facility;
    (vi) Number of trips between the premises at which the horse 
competes 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.
    (9) If a trust fund agreement with APHIS has been executed by the 
owner or importer of a horse in accordance with paragraph (f)(8) 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)(2) 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

[[Page 405]]

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 according to the import permit. The stall in which 
the horse is kept must be separated from other stalls containing horses 
either by an empty stall, an open area across which horses cannot touch 
each other, or a solid wall that is at least 8 feet (2.4 m) 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 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. 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 has been 
temporarily exported for not more than 60 days from the United States to 
a CEM-affected region listed in paragraph (c)(1) of this section, or if 
a horse has been temporarily exported for not more than 60 days from 
another region not known to be affected with CEM to a CEM-affected 
region during the 12 months preceding its exportation to the United 
States, the horse may be eligible for return or 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 Sec.  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 the horse was not bred to or bred by any animal, nor did 
it have 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 Sec.  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 (a) through (c) 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 Sec.  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 in 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

[[Page 406]]

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 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.
    (5) 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.
    (6) The following States have been approved to receive stallions 
over 731 days of age imported under paragraph (e) of this section:

The State of Alabama
The State of California
The State of Colorado
The State of Florida
The State of Georgia
The State of Kentucky
The State of Louisiana
The State of Maryland
The State of Montana
The State of New Hampshire
The State of New Jersey
The State of New York
The State of North Carolina
The State of Ohio
The State of Oklahoma
The State of Oregon
The State of Rhode Island
The State of South Carolina
The State of Tennessee
The State of Virginia
The State of Wisconsin

    (7) The following States have been approved to receive mares over 
731 days of age imported under paragraph (e) of this section:

The State of Alabama
The State of California
The State of Colorado
The State of Florida
The State of Georgia
The State of Kentucky
The State of Louisiana
The State of Maryland
The State of Montana
The State of Hew Hampshire
The State of New Jersey
The State of New York
The State of North Carolina
The State of Ohio
The State of Oklahoma
The State of Oregon
The State of Rhode Island
The State of South Carolina
The State of Tennessee
The State of Virginia
The State of Wisconsin

    (i) Approval of laboratories. (1) The Administrator will approve a 
laboratory to conduct CEM cultures and tests only after consulting with 
the State animal health official in the State in which the laboratory is 
located and after determining that the laboratory:
    (i) Has technical personnel assigned to conduct the CEM culturing 
and testing who possess the following minimum qualifications:
    (A) A bachelor's degree in microbiology;
    (B) A minimum of 2 years experience working in a bacteriology 
laboratory; and
    (C) Experience working with the CEM organism, including knowledge of 
the specific media requirements, atmospheric requirements, and 
procedures for the isolation and identification of the CEM organism.\10\
---------------------------------------------------------------------------

    \10\ When training regarding CEM culturing and testing is necessary, 
it may be obtained at the National Veterinary Services Laboratories, 
Ames, IA 50010.

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[[Page 407]]

    (ii) Follows standard test protocols that will reliably and 
consistently provide for the isolation and identification of the CEM 
organism; \11\ and
---------------------------------------------------------------------------

    \11\ Standard test protocols recommended by the National Veterinary 
Services Laboratories and a list of approved laboratories can be 
obtained from the National Veterinary Services Laboratories, Ames, IA 
50010.
---------------------------------------------------------------------------

    (iii) Reports all official test results to the State animal health 
official and the Veterinarian in Charge.
    (2) To retain approval, the laboratory must meet the requirements 
prescribed in paragraph (i)(1) of this section, and shall test with the 
CEM organism each lot of media it prepares to ensure that the media will 
support growth of the laboratory's reference culture. Media that will 
not support growth of the reference culture must be discarded.
    (3) The Administrator may deny or withdraw approval of any 
laboratory to conduct CEM culturing or testing upon a determination that 
the laboratory does not meet the criteria for approval or maintenance of 
approval under paragraphs (i)(1) and (i)(2) of this section.
    (i) In the case of a denial of approval, the operator of the 
laboratory will be informed of the reasons for denial and, upon request, 
will be afforded an opportunity for a hearing with respect to the merits 
or validity of the denial in accordance with rules of practice that will 
be adopted for the hearing.
    (ii) In the case of a withdrawal of approval, before such action is 
taken, the operator of the laboratory will be informed of the reasons 
for the proposed withdrawal and, upon request, will be afforded an 
opportunity for a hearing with respect to the merits or validity of the 
proposed withdrawal in accordance with rules of practice that will be 
adopted for the hearing. However, the withdrawal will become effective 
pending a final determination in the hearing when the Administrator 
determines that such action is necessary to protect the public health, 
interest, or safety. The withdrawal will be effective upon oral or 
written notification, whichever is earlier, to the operator of the 
laboratory. In the event of oral notification, written confirmation will 
be given as promptly as circumstances allow. The withdrawal will 
continue in effect pending completion of the hearing and any judicial 
review of the hearing, unless otherwise ordered by the Administrator.
    (iii) Approval for a laboratory to conduct CEM culturing or testing 
will be automatically withdrawn by the Administrator when the operator 
of the approved laboratory notifies the National Veterinary Services 
Laboratories, Ames, IA 50010, in writing, that the laboratory no longer 
conducts CEM culturing and testing.
    (j) Examination and treatment for screwworm. Horses from Angola, 
Argentina, Bahrain, Bangladesh, Benin, Bolivia, Botswana, Brazil, 
Brunei, Burkina Faso, Burundi, Cambodia, Cameroon, Central African 
Republic, China, Columbia, Congo, Dominican Republic, Ecuador, 
Equatorial Guinea, French Guiana, Gabon, Gambia, Ghana, Guinea, Guinea-
Bissau, Guyana, Haiti, India, Indonesia, Iraq, Isla de Pascua (Easter 
Island, part of Chile), Ivory Coast, Jamaica, Kenya, Kuwait, Laos, 
Lesotho, Liberia, Macau, Malawi, Malaysia, Mali, Mauritania, Mozambique, 
Myanmar, Namibia, Nigeria, Oman, Pacific Islands (Palau), Panama, Papua 
New Guinea, Paracel Islands, Paraguay, Peru, Philippines, Qatar, Rwanda, 
Saudi Arabia, Senegal, Sierra Leone, Singapore, South Africa, Spratly 
Islands, Sri Lanka, Surinam, Swaziland, Taiwan, Tanzania, Thailand, 
Togo, Trinidad and Tobago, Uganda, United Arab Emirates, Uruguay, 
Venezuela, Vietnam, Zaire, Zambia, Zimbabwe, or any other region of the 
world where screwworm is considered to exist may be imported into the 
United States only if they meet the following requirements and all other 
applicable requirements of this part:
    (1) 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.
    (2) 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.

[[Page 408]]

    (3) 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.
    (4) 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 (j)(1) and (j)(3) of this section.
    (5) Horses must be quarantined upon arrival in the United States at 
an APHIS animal import center for at least 7 days.
    (6) Horses must be examined for screwworm by a veterinarian within 
24 hours after arrival at an APHIS animal import center in the United 
States. The examining veterinarian must examine horses, including their 
external genitalia, to determine whether the horse is infested with 
screwworm.
    (7) 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.

(Approved by the Office of Management and Budget under control numbers 
0579-0040 and 0579-0165)

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 15849-15852, Apr. 17, 
1991; 56 FR 66781, Dec. 26, 1991; 57 FR 5931, Feb. 18, 1992; 57 FR 
28080, June 24, 1992; 59 FR 24888, May 13, 1994; 59 FR 67133, Dec. 29, 
1994; 59 FR 67614, Dec. 30, 1994; 61 FR 52239, Oct. 7, 1996. 
Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997; 63 FR 
6064, Feb. 6, 1998; 63 FR 40008, July 27, 1998; 65 FR 46860, Aug. 1, 
2000; 65 FR 67622, Nov. 13, 2000; 65 FR 69238, Nov. 16, 2000; 65 FR 
78899, Dec. 18, 2000; 65 FR 81727, Dec. 27, 2000; 66 FR 55071, Nov. 1, 
2001; 67 FR 11565, Mar. 15, 2002; 68 FR 6344, Feb. 7, 2003; 68 FR 7414, 
Feb. 14, 2003]



Sec.  93.302  Inspection of certain aircraft and other means of 

conveyance and shipping containers thereon; unloading, cleaning, 
and disinfection requirements.

    (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

[[Page 409]]

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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56016, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]



Sec.  93.303  Ports designated for the importation of horses.

    (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 these stations, 
except as provided in paragraphs (b), (c), (d), (e), and (f) of this 
section, Sec. Sec.  93.308(a), (b) and (c) and 93.317: Los Angeles, 
California; Miami, Florida; and Newburgh, New York.
    (b) Canadian border ports. (1) The following land border ports are 
designated as having the necessary inspection facilities for the entry 
of horses 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.
    (2) International Falls, Minnesota, is designated as a port of entry 
for horses from Canada.
    (c) Mexican border ports. The following land border ports are 
designated for the entry of horses 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, Columbus, and Santa Teresa, New Mexico.
    (d) Limited ports. The following 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: 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; Dayton, 
Ohio; Portland, Oregon; San Juan, Puerto Rico; Memphis, Tennessee (no 
live animals); Galveston and Houston, Texas; and Seattle, Spokane, and 
Tacoma, Washington.
    (e) Ports and quarantine facilities provided by the importer for 
horses. Horses, except horses from or which have transited any region in 
which African horsesickness is declared to exist,\12\ may be entered 
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 U.S. Customs Service and quarantined at quarantine 
facilities provided by the importer provided that applicable provisions 
of Sec. Sec.  93.301(c), 93.304(a), 93.306, 93.308(a), (b) and (c), and 
93.314 are met.
---------------------------------------------------------------------------

    \12\ Information as to the regions where African horsesickness is 
declared to exist may be obtained from the Administrator.
---------------------------------------------------------------------------

    (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.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 15489, Apr. 17, 1991; 57 
FR 37690, Aug. 20, 1992; 58 FR 45237, Aug. 27, 1993; 60 FR 16045, Mar. 
29, 1995; 60 FR 25120, May 11, 1995; 61 FR 52239, Oct. 7, 1996; 62 FR 
27938, May 22, 1997. Redesignated and amended at 62 FR 56012, Oct. 28, 
1997; 64 FR 23179, Apr. 30, 1999; 65 FR 38178, June 20, 2000; 67 FR 
68022, Nov. 8, 2002]



Sec.  93.304  Import permits for horses from regions affected with 

CEM and for horse specimens for diagnostic purposes; reservation 
fees for space at quarantine facilities maintained by APHIS.

    (a) Application for permit; reservation required. (1)(i) For horses 
from regions listed in Sec.  93.301(c)(1) of the regulations, horses 
intended for quarantine at a

[[Page 410]]

quarantine facility provided by the importer, and horse test specimens 
for diagnostic screening purposes, intended for importation from any 
part of the world, except as otherwise provided for in Sec. Sec.  
93.315, 93.319, and 93.321, 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. Notice 
of any such requirements will be given to the applicant in each case.
    (ii) Horses intended for importation under Sec.  93.301(f) of this 
part must meet the permit requirements of paragraph (a)(1)(i) of this 
section. Additionally, for horses intended for importation under Sec.  
93.301(f) 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) Approval of an application for a permit to import a horse 
under Sec.  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 Sec.  93.301(c)(1) of the regulations, horses intended for quarantine 
at a quarantine facility provided by the importer, 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

[[Page 411]]

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            25 percent of the reservation fee.
 reservation date.
15-29 days before the scheduled reservation     50 percent of the reservation fee.
 date.
Less than 15 days before the scheduled          100 percent of the reservation fee.
 reservation date.
----------------------------------------------------------------------------------------------------------------

    (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;

[[Page 412]]

    (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.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 15489, 15492, Apr. 2, 
1991; 56 FR 15489, 15492, Apr. 17, 1991; 56 FR 63627, Dec. 5, 1991; 56 
FR 66781, Dec. 26, 1991; 57 FR 27901, June 23, 1992; 59 FR 31924, June 
21, 1994; 59 FR 52237, Oct. 17, 1994; 60 FR 49752, Sept. 27, 1995; 61 FR 
1699, Jan. 23, 1996; 61 FR 52239, 52245, Oct. 7, 1996. Redesignated and 
amended at 62 FR 56012, 56016, Oct. 28, 1997; 67 FR 72830, Dec. 9, 2002]



Sec.  93.305  Declaration and other documents for horses.

    (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.



Sec.  93.306  Inspection at the port of entry.

    Inspection shall be made at the port of entry of all horses imported 
from any part of the world except as provided in Sec. Sec.  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 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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56016, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]



Sec.  93.307  Articles accompanying horses.

    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 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.



Sec.  93.308  Quarantine requirements.

    (a) Except as provided in this section and in Sec.  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 Sec. Sec.  
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 Sec. Sec.  93.317 and 93.324, and except 
with respect to horses from Argentina, Bermuda, and the British Virgin 
Islands, horses intended for importation from the Western Hemisphere 
shall be quarantined at a port designated in Sec.  93.303 for not less 
than 7 days to be evaluated for signs of Venezuelan equine 
encephalomyelitis.
    (2) Horses intended for importation from regions APHIS considers to 
be affected with African horse sickness may enter the United States only 
at the

[[Page 413]]

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. APHIS considers the 
following regions to be affected with African horse sickness: Oman, 
Saudi Arabia, the Yemen Arab Republic, and all the regions on the 
continent of Africa except Morocco.
    (3) 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.\14\ 
However, horses imported from Australia and New Zealand are exempt from 
testing for dourine and glanders. In addition, all horses must undergo 
any other tests, inspections, disinfections, and precautionary 
treatments that may be required by the Administrator to determine their 
freedom from communicable diseases.
---------------------------------------------------------------------------

    \14\ Because the official tests for dourine and glanders are 
performed only at the National Veterinary Services Laboratories in Ames, 
IA, the protocols for those tests have not been published and are, 
therefore, not available; however, copies of ``Protocol for the 
Complement-Fixation Test for Equine Piroplasmosis'' and ``Protocol for 
the Immunno-Diffusion (Coggins) Test For Equine Infectious Anemia'' may 
be obtained from the Animal and Plant Health Inspection Service, 
Veterinary Services, National Center for Import-Export, 4700 River Road 
Unit 38, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (4) 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 
unforseen 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) Special provisions. Horses presented for entry into the United 
States as provided in Sec.  93.303(e) of this part shall be quarantined 
in facilities provided by the importer and approved by the 
Administrator. Requests for approval and plans for proposed facilities 
shall be submitted no less than 15 days before the proposed date of 
entry of horses into the quarantine facility to the Animal and Plant 
Health Inspection Service, Veterinary Services, National Center for 
Import-Export, 4700 River Road, Unit 38, Riverdale, Maryland 20737-1231. 
Before the facility is approved, an inspection of the facility shall be 
made by a Veterinary Medical Officer of APHIS, to determine whether it 
complies with the standards set forth in paragraph (c) of this section: 
Provided, however, That approval of any quarantine facility and use of 
such facility shall be contingent upon a determination made by the 
Administrator that adequate personnel are available to provide services 
required by the facility. Approval of any facility may be refused and 
approval of any approved quarantine facility may be withdrawn at any 
time by the Administrator, upon his or her determination that any 
requirement of this section is not being met. Before such action is 
taken, the operator of the facility shall be informed of the reasons for 
the proposed action by the Administrator and afforded an opportunity to 
present his or her views thereon. If there is a conflict as to any 
material fact, a hearing shall

[[Page 414]]

be held to resolve such conflict. The cost of the facility and all 
maintenance and operation costs of such facility shall be borne by the 
importer.
    (c) Standards and handling procedures for approval of quarantine 
facilities provided by the importer. To qualify for designation as an 
approved quarantine facility provided by the importer for horses, the 
facility shall be maintained and operated in accordance with the 
following standards:
    (1) Supervision of the facility. The facility shall be under the 
general supervision of an APHIS veterinarian. Inspection and quarantine 
services shall be arranged by the importer of his or her agent with the 
Veterinarian in Charge, Veterinary Services, APHIS, USDA, for the State 
in which the approved facility is located,\15\ no less than 7 days 
before the proposed date of entry of the horses into the quarantine 
facility.
---------------------------------------------------------------------------

    \15\ The name and address of the Veterinarian in Charge of any State 
are available from the Animal and Plant Health Inspection Service, 
Veterinary Services, National Center for Import-Export, 4700 River Road 
Unit 38, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (2) Physical requirements for facilities--(i) Location. The facility 
shall be located and constructed to prevent horses from having physical 
contact with animals outside the facility.
    (ii) Construction. (A) The facility shall be constructed only with 
materials that can withstand repeated cleaning and disinfection in 
accordance with Sec. Sec.  71.7 and 71.10 of subchapter C of this title. 
(All walls, floors and ceilings shall be constructed of solid impervious 
material.)
    (B) Doors, windows, and other openings of the facility shall be 
provided with double screens which will prevent insects from entering 
the facility.
    (3) Sanitation and security. (i) The importer shall arrange for a 
supply of water adequate to clean and disinfect the facility in 
accordance with Sec. Sec.  71.7 and 71.10 of subchapter C of this title.
    (ii) All feed and bedding used for horses in approved quarantine 
facilities shall originate from an area not under quarantine because of 
cattle fever ticks (see Sec. Sec.  72.3 and 72.5 of subchapter C of this 
title) and shall be stored within the facility.
    (iii) Upon the death or destruction of any horse, the importer shall 
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 which are refused entry into 
the United States shall be either by incineration or in a public sewer 
system which 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.
    (iv) The facility shall be maintained and operated in accordance 
with any additional requirements the Administrator deems appropriate to 
prevent the dissemination of any communicable disease.
    (v) The facility shall comply with all applicable local, State and 
Federal requirements for environmental quality.
    (4) Operational procedures--(i) Personnel. (A) Access to the 
facility shall be granted only to persons working at the facility or to 
persons specifically granted such access by the supervising APHIS 
veterinarian.
    (B) The importer shall provide attendants for the care and feeding 
of horses while in the quarantine facility.
    (C) Persons working in the quarantine facility shall not come in 
contact with any horses outside the quarantine facility during the 
quarantine period for any horses in such quarantine facility.
    (ii) Handling of horses in quarantine. Horses offered for 
importation into the United States which are quarantined in an approved 
quarantine facility provided by the importer shall be handled in 
accordance with Sec.  93.308(a) while in quarantine.

[55 FR 31495, Aug. 2, 1990]

    Editorial Note: For Federal Register citations affecting Sec.  
93.308, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  93.309  Horse quarantine facilities.

    (a) Privately operated quarantine facilities. The importer, or his 
or her agent, of horses subject to quarantine under

[[Page 415]]

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

[[Page 416]]

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.



Sec.  93.310  Quarantine stations, visiting restricted; sales prohibited.

    Visitors shall not be admitted to the quarantine enclosure during 
any time that horses 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 horses 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 horses may be admitted upon written 
permission from the said inspector. No exhibition or sale shall be 
allowed within the quarantine grounds.



Sec.  93.311  Milk from quarantined horses.

    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.



Sec.  93.312  Manure from quarantined horses.

    No manure shall be removed from the quarantine premises until the 
release of the horses producing same.



Sec.  93.313  Appearance of disease among horses in quarantine.

    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.



Sec.  93.314  Horses, certification, and accompanying equipment.

    (a) Horses offered for importation from any part of the world 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, showing that:
    (1) The horses described in the certificate have been in said region 
during the 60 days preceding exportation;
    (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

[[Page 417]]

with all other applicable requirements of this part;
    (4) 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
    (5) That, except as provided in Sec.  93.301(g):
    (i) The horses have not been in any region listed in Sec.  
93.301(c)(1) 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 Sec.  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.

[61 FR 52245, Oct. 7, 1996. Redesignated and amended at 62 FR 56012, 
56017, Oct. 28, 1997; 63 FR 53783, Oct. 7, 1998]

                               Canada \16\
---------------------------------------------------------------------------

    \16\ Importations from Canada shall be subject to Sec. Sec.  93.315, 
93.316, 93.317 and 93.318, in addition to other sections in this part 
which are in terms applicable to such importations.
---------------------------------------------------------------------------



Sec.  93.315  Import permit and declaration for horses.

    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 Sec.  93.305.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56017, Oct. 28, 1997]



Sec.  93.316  Horses from Canada for immediate slaughter.

    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 Sec.  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.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 28216, June 1, 1994. 
Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997]



Sec.  93.317  Horses from Canada.

    (a) Except as provided in paragraph (c) of this section, horses from 
Canada shall be inspected as provided in Sec.  93.306; shall be 
accompanied by a certificate as required by Sec.  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; Except, that horses accompanying their dams 
which were foaled after their dam was so tested negative

[[Page 418]]

need not be so tested; and shall otherwise be handled as provided in 
Sec.  93.314: Provided, however, That certificates required for horses 
from Canada may be either issued or endorsed by a salaried veterinarian 
of the Canadian Government: And provided, further, That 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) 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.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 33863, July 24, 1991. 
Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997]



Sec.  93.318  Special provisions.

    (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 Sec.  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 
Sec.  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 Sec.  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

[[Page 419]]

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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56017, Oct. 28, 1997]

                Central America and the West Indies \17\
---------------------------------------------------------------------------

    \17\ Importations from regions of Central America and the West 
Indies shall be subject to Sec. Sec.  93.319 and 93.320, in addition to 
other sections in this subpart, which are in terms applicable to such 
importations.
---------------------------------------------------------------------------



Sec.  93.319  Import permit and declaration for horses.

    For all horses 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 Sec.  93.305.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56017, Oct. 28, 1997]



Sec.  93.320  Horses from Central America and the West Indies.

    Horses from Central America and the West Indies shall be inspected 
as provided in Sec.  93.306; shall be accompanied by a certificate and 
otherwise handled as provided in Sec.  93.314; and shall be quarantined 
and tested as provided in Sec.  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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56017, Oct. 28, 1997]

                               Mexico \18\
---------------------------------------------------------------------------

    \18\ Importations from Mexico shall be subject to Sec. Sec.  93.321 
to 93.326 inclusive, in addition to other sections in this subpart which 
are in terms applicable for such importations.
---------------------------------------------------------------------------



Sec.  93.321  Import permits and applications for inspection for horses.

    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.



Sec.  93.322  Declaration for horses.

    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 Sec.  93.305.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56017, Oct. 28, 1997]



Sec.  93.323  Inspection.

    (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 Sec.  
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.

[[Page 420]]

    (b) Horses covered by paragraph (a) of this section shall be 
imported through facilities described in Sec.  93.324, which are 
equipped with facilities necessary for proper chute inspection, dipping, 
and testing, as provided in this part.

[55 FR 31495, Aug. 2, 1990, as amended at 58 FR 45238, Aug. 27, 1993. 
Redesignated at 62 FR 56012, 56017, Oct. 28, 1997]



Sec.  93.324  Detention for quarantine.

    Horses intended for importation from Mexico shall be quarantined 
until they qualify for release from such quarantine, either at an APHIS 
facility designated in Sec.  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,\19\ and such other tests that 
may be required by the Administrator to determine their freedom from 
other communicable diseases. Such horses shall also be subjected to such 
other inspections and disinfections deemed necessary by the 
Administrator, and they shall be released from quarantine only if found 
to be free from any communicable disease upon inspection.
---------------------------------------------------------------------------

    \19\ In view of the fact that official test for dourine and glanders 
are run exclusively at the National Veterinary Services Laboratory, 
Ames, Iowa, protocols for these tests have not been published and are 
therefore not available; copies of ``Protocol for the Complement-
Fixation Test for Equine Piroplasmosis'' and ``Protocol for the Immuno-
Diffusion (Coggins) Test for Equine Infectious Anemia'' may be obtained 
from the Animal and Plant Health Inspection Service, Veterinary 
Services, National Center for Import-Export, 4700 River Road Unit 38, 
Riverdale, Maryland 20737-1231.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 15489, Apr. 17, 1991; 58 
FR 45238, Aug. 27, 1993; 59 FR 67614, Dec. 30, 1994; 60 FR 5128, Jan. 
26, 1995; 61 FR 39853, July 31, 1996; 61 FR 52246, Oct. 7, 1996. 
Redesignated at 62 FR 56012, 56017, Oct. 28, 1997, as amended at 63 FR 
3640, Jan. 26, 1998]



Sec.  93.325  Horses from Mexico.

    Horses offered for entry from Mexico shall be inspected as provided 
in Sec. Sec.  93.306 and 93.323; shall be accompanied by a certificate 
and otherwise handled as provided in Sec.  93.314; and shall be 
quarantined and tested as provided in Sec.  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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56017, Oct. 28, 1997]



Sec.  93.326  Horses for immediate slaughter.

    Horses may be imported from Mexico, subject to the applicable 
provisions of Sec. Sec.  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 Goverment 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 Sec.  
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.

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 28080, June 24, 1992; 58 
FR 45238, Aug. 27, 1993; 60 FR 5128, Jan. 26, 1995; 61 FR 39853, July 
31, 1996. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 
63 FR 3640, Jan. 26, 1998]

[[Page 421]]



                           Subpart D_Ruminants

    Source: 55 FR 31495, Aug. 2, 1990, unless otherwise noted. 
Redesignated at 62 FR 56012, Oct. 28, 1997.



Sec.  93.400  Definitions.

    Wherever in this subpart the following terms are used, unless the 
context otherwise requires, they shall be construed, respectively, to 
mean:
    Accredited herd. An accredited herd is one that has passed at least 
two consecutive annual official tuberculin tests and has no evidence of 
bovine tuberculosis. All animals in a herd must be free from 
tuberculosis.
    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.
    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.
    Brucellosis certified-free province or territory of Canada. A 
province or territory of Canada in which all herds of cattle are 
brucellosis certified free. The brucellosis certified free provinces and 
territories of Canada are Alberta, British Columbia, Manitoba, New 
Brunswick, Newfoundland (including Labrador), Northwest Territories, 
Nova Scotia, Ontario, Quebec, Prince Edward Island, Saskatchewan, and 
Yukon Territory.
    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).
    Fever tick. Boophilus annulatus, including, but not limited to, the 
varieties Americana and Australia.
    Flock. A herd.
    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. The herd within which an individual animal was born 
and raised and that was maintained on common ground for at least 4 
months. For a group of one or more animals to qualify as a herd of 
origin for the purposes of Sec.  93.406, animals may be added to the 
herd during or after the 4-month qualifying period only if they:
    (1) Originated from a tuberculosis-free herd; or
    (2) Originated from an accredited herd or originated from a herd of 
origin that tested negative to a whole herd test, and the individual 
cattle to be added to the herd also tested negative to any additional 
individual tests for tuberculosis required by the Administrator.
    Immediate slaughter. Consignment directly from the port of entry to 
a recognized slaughtering establishment \1\ and slaughter thereat within 
two weeks from the date of entry.
---------------------------------------------------------------------------

    \1\ The name of recognized slaughtering establishments approved 
under this part may be obtained from the Area Veterinarian in Charge, 
Veterinary Services, for the State of destination of the shipment.
---------------------------------------------------------------------------

    Inspector. An employee of the Animal and Plant Health Inspection 
Service

[[Page 422]]

authorized to perform duties required under this subpart.
    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.
    Official tuberculin test. A test for bovine tuberculosis that is 
approved by the Administrator as equivalent to the international 
standard test described in the Manual of Standards for Diagnostic Tests 
and Vaccines, Office International des Episodes, and that is 
administered and reported by a full-time salaried veterinary officer of 
the national government of the region of origin, or administered and 
reported 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.
    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.
    Recognized slaughtering establishment.\2\ An establishment where 
slaughtering operations are regularly carried on under federal or state 
inspection and which has been approved by the Animal and Plant Health 
Inspection Service to receive animals for slaughter under this part.
---------------------------------------------------------------------------

    \2\ The names of recognized slaughtering establishments approved 
under this Part may be obtained from the Area Veterinarian in Charge, 
Veterinary Services, for the State of destination of the shipment.
---------------------------------------------------------------------------

    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.
    Tuberculosis-free herd. A herd which is not known to be infected 
with bovine tuberculosis (M. bovis) and which is certified by the 
Canadian Government as a tuberculosis-free herd.
    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. An official tuberculin test of all cattle in a herd 
of origin that are 6 months of age or older, and of all cattle in the 
herd of origin that are less than 6 months of age and were not born into 
the herd of origin, except those cattle that are less than 6 months of 
age and:
    (1) Were born in and originated from a tuberculosis-free herd; or
    (2) Were born in and originated from an accredited herd or 
originated from a herd of origin that has tested negative to a whole 
herd test, and the individual cattle have tested negative to any 
additional individual tests for tuberculosis required by the 
Administrator.
    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.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 366, Jan. 4, 1991; 58 FR 
68509, Dec. 28, 1993; 60 FR 13900, Mar. 15, 1995; 61 FR 17237, Apr. 19, 
1996. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 66 
FR 20189, Apr. 20, 2001; 68 FR 35533, June 16, 2003]

[[Page 423]]



Sec.  93.401  General prohibitions; exceptions.

    (a) 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;\3\ nor shall 
any such ruminant or 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. Notwithstanding any other provision of this subpart, the 
importation of any ruminant that has been in a region listed in Sec.  
94.18(a)(1) or (a)(2) of this subchapter is prohibited. Provided, 
however, the Administrator may upon request in specific cases permit 
ruminants or 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.
---------------------------------------------------------------------------

    \3\ Importations of certain animals from various regions are 
absolutely prohibited under part 94 because of specified diseases.
---------------------------------------------------------------------------

    (b) 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 \4\ has been obtained under Sec.  93.404 of this chapter 
and all conditions therein are observed; and if such ruminants are 
handled as follows:
---------------------------------------------------------------------------

    \4\ Such permit may be obtained from the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. 
Requests for approval of such facilities should also be made to the 
Administrator.
---------------------------------------------------------------------------

    (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 \5\ in advance by the Administrator in accordance 
with paragraph (b)(3) of this section as adequate to prevent the spread 
within the United States of any livestock disease, and they are 
maintained there under continuous confinement until loaded aboard a 
means of conveyance for transportation from the United States and are 
maintained under continuous confinement aboard such means of conveyance 
until it leaves the United States; the import permit will specify any 
additional conditions necessary to assure that the transit of the 
ruminants through the United States can be made without endangering the 
livestock or poultry of the United States, and that Department 
inspectors may inspect the ruminants on board such means of conveyance 
or in such holding facility to ascertain whether the requirements of 
this paragraph are met, and dispose of them in accordance with the 
Animal Health Protection Act (7 U.S.C. 8301 et seq.) if such conditions 
are not met; and
---------------------------------------------------------------------------

    \5\ See footnote 4 to subpart D.
---------------------------------------------------------------------------

    (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

[[Page 424]]

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.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67614, Dec. 30, 1994. 
Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 68 FR 
6344, Feb. 7, 2003; 68 FR 31940, May 29, 2003]



Sec.  93.402  Inspection of certain aircraft and other means of 

conveyance and shipping containers thereon; unloading, cleaning, 
and disinfection requirements.

    (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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56017, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]



Sec.  93.403  Ports designated for the importation of ruminants.

    (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

[[Page 425]]

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 operated quarantine facilities for sheep. 
Sheep may be entered 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 U.S. Customs Service and 
quarantined at privately operated quarantine facilities provided the 
applicable provisions of Sec. Sec.  93.401, 93.404(a), 93.407, 93.408, 
93.433, and 93.434 are met.

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 2010, Jan. 17, 1992; 58 
FR 38283, July 16, 1993; 60 FR 16045, Mar. 29, 1995; 60 FR 25120, May 
11, 1995. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 
64 FR 23179, Apr. 30, 1999; 65 FR 38178, June 20, 2000; 67 FR 68022, 
Nov. 8, 2002]



Sec.  93.404  Import permits for ruminants and for ruminant test 

specimens for diagnostic purposes; and reservation fees for space 
at quarantine facilities maintained by APHIS.

    (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 Sec. Sec.  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 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) An application for permit to import will be denied for domestic 
ruminants from any region designated in Sec.  94.1 of this chapter as a 
region

[[Page 426]]

where rinderpest or foot-and-mouth disease exists.
    (3) 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.
    (4)(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 \6\ during regular business hours (8:00 a.m. 
to 4:30 p.m. Monday through Friday, excluding holidays) no later than 15 
days for ruminants prior to the beginning of the time of importation as 
specified in the import permit or as arranged with the veterinarian in 
charge of the quarantine facility if no import permit is required (the 
15 days period shall not include Saturdays, Sundays, or holidays), or
---------------------------------------------------------------------------

    \6\ The addresses of USDA quarantine facilities may be found in 
telephone directories listing the facilities or by contacting the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 
20737-1231.
---------------------------------------------------------------------------

    (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

[[Page 427]]

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)(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. 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 or 
rinderpest 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 or rinderpest exist.
    (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

[[Page 428]]

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:

Agreement for the Importation, Quarantine and Exhibition of Certain Wild 
                        Ruminants and Wild Swine

    --------, 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 or rinderpest 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, rinderpest, 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 
rinderpest or 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

[[Page 429]]

importation without showing clinical evidence of foot-and-foot mouth 
disease, rinderpest, 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, rinderpest, 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.

________________________________________________________________________
(Signature of importer)
    Subscribed and sworn to before me this ---- day of ----, ----.
________________________________________________________________________
(Title or designation)

________________________________________________________________________
(Name of zoological park)

 By_____________________________________________________________________
(Signature of officer of zoological park)

________________________________________________________________________
(Title of officer)
    Subscribed and sworn to before me this ---- day of ----,----
________________________________________________________________________
(Title or designation)

(Approved by the Office of Management and Budget under control numbers 
0579-0040 and 0579-0224)

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 28216, June 1, 1994; 59 
FR 31924, June 21, 1994; 59 FR 67615, Dec. 30, 1994; 62 FR 23637, May 1, 
1997. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997; 65 
FR 38178, June 20, 2000; 68 FR 6344, Feb. 7, 2003; 68 FR 35533, June 16, 
2003]



Sec.  93.405  Certificate for ruminants.

    (a) All ruminants intended for importation from any part of the 
world, except as provided in Sec. Sec.  93.418(a), 93.419(a), 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, rinderpest, 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 Angola, Argentina, Bahrain, 
Bangladesh, Benin, Bolivia, Botswana, Brazil, Brunei, Burkina Faso, 
Burundi, Cambodia, Cameroon, Central African Republic, China, Columbia, 
Congo, Dominican Republic, Ecuador, Equatorial Guinea, French Guiana, 
Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Guyana, Haiti, India, 
Indonesia, Iraq, Isla de Pascua (Easter Island, part of Chile), Ivory 
Coast, Jamaica, Kenya, Kuwait, Laos, Lesotho, Liberia, Macau, Malawi, 
Malaysia, Mali, Mauritania, Mozambique, Myanmar, Namibia, Nigeria, Oman, 
Pacific Islands (Palau), Panama, Papua New Guinea, Paracel Islands, 
Paraguay, Peru, Philippines, Qatar, Rwanda, Saudi Arabia, Senegal, 
Sierra Leone, Singapore, South Africa, Spratly Islands, Sri Lanka, 
Surinam, Swaziland, Taiwan, Tanzania, Thailand, Togo, Trinidad and 
Tobago, Uganda, United Arab Emirates, Uruguay, Venezuela, Vietnam, 
Zaire, Zambia, Zimbabwe, or any other region of the world where 
screwworm is considered to exist, the ruminants may be

[[Page 430]]

imported into the United States only if they meet the following 
requirements and all other applicable requirements of this part:
    (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) Goats. (1) In addition to the statements required by paragraph 
(a) of this section, the certificate accompanying goats intended for 
importation from any part of the world must state:
    (i) That none of the goats in the herd from which the goats will be 
imported is the progeny of a sire or dam that has been affected with 
scrapie or that has produced offspring that have been affected with 
scrapie;
    (ii) That none of the female goats in the herd from which the goats 
will be imported has been impregnated, during the 5 years immediately 
preceding shipment of the goats to the United States, with germ plasm 
from a herd known to be infected with scrapie;
    (iii) That the veterinarian issuing the certificate has inspected 
the goats in the herd from which the animals will be imported and found 
the herd to be free of any evidence of infectious or contagious disease; 
and
    (iv) That as far as it is possible for the veterinarian who inspects 
the animals to determine, none of the goats in the herd from which the 
animals will be imported has been exposed to any infectious or 
contagious disease during the 60 days immediately preceding shipment to 
the United States.
    (2) In addition, the certificate accompanying goats intended for 
importation from any part of the world except Australia, Canada, and New 
Zealand must state:
    (i) That the goats have not been in any herd nor had contact with 
sheep or goats that have been in any flock or herd where scrapie has 
been diagnosed or suspected during the 5 years immediately prior to 
shipment; and
    (ii) That the goats have not had any contact with sheep during the 5 
years immediately prior to shipment; provided that, this statement is 
not required if the goats are imported in accordance with Sec.  
93.435(a) into a herd in the United States that participates in the 
Voluntary Scrapie Flock Certification Program.
    (c) Sheep. (1) In addition to the statements required by paragraph 
(a) of this section, the certificate accompanying sheep intended for 
importation from any part of the world must state:
    (i) That none of the sheep in the flock from which the sheep will be 
imported is the progeny of a sire or dam that has been affected with 
scrapie or that has produced offspring that have been affected with 
scrapie;
    (ii) That none of the female sheep in the flock from which the sheep 
will be imported has been impregnated, during the 5 years immediately 
preceding shipment of the sheep to the United States, with germ plasm 
from a flock known to be infected with scrapie;
    (iii) That the veterinarian issuing the certificate has inspected 
the sheep in the flock from which the animals will be imported and found 
the flock to be free of any evidence of infectious or contagious 
disease; and
    (iv) That as far as it is possible for the veterinarian who inspects 
the animals to determine, none of the sheep in the flock from which the 
animals will be imported has been exposed to any

[[Page 431]]

infectious or contagious disease during the 60 days immediately 
preceding shipment to the United States.
    (2) In addition, the certificate accompanying sheep intended for 
importation from any part of the world except Australia, Canada, and New 
Zealand must state that the sheep have not been in any flock nor had 
contact with sheep or goats that have been in any flock or herd where 
scrapie has been diagnosed or suspected during the 5 years immediately 
prior to shipment.
    (3) In addition, the certificate accompanying sheep intended for 
importation from Australia, Canada, and New Zealand must state that none 
of the female sheep in the flock from which the sheep will be imported 
has been impregnated, during the 5 years immediately preceding shipment 
of the sheep to the United States, with germ plasm from a region other 
than Australia, Canada, New Zealand, or the United States, or from a 
flock of unknown scrapie status; provided that, this statement is not 
required if the sheep are imported in accordance with Sec.  93.435(a) 
into a flock in the United States that participates in the Voluntary 
Scrapie Flock Certification Program.
    (d) If ruminants are unaccompanied by the certificate as required by 
paragraphs (a), (b), and (c) 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.

(Approved by the Office of Management and Budget under control numbers 
0579-0040 and 0579-0165)

[55 FR 31495, Aug. 2, 1990, as amended at 55 FR 39606, Sept. 28, 1990; 
57 FR 28080, June 24, 1992; 59 FR 52241, Oct. 17, 1994; 61 FR 17237, 
Apr. 19, 1996. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 
1997; 65 FR 67623, Nov. 13, 2000; 67 FR 11565, Mar. 15, 2002; 68 FR 
6344, Feb. 7, 2003]



Sec.  93.406  Diagnostic tests.

    (a) Tuberculosis and brucellosis tests of cattle. Except as provided 
in Sec. Sec.  93.418, 93.427(d), and 93.432, all cattle imported from 
any part of the world, except for immediate slaughter, must be 
accompanied by a certificate of a salaried veterinary officer of the 
national government of the region of origin, or if exported from Mexico, 
must 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:
    (1) Brucellosis. The cattle have been tested for brucellosis with 
negative results within 30 days prior to the date of their exportation 
to the United States; Provided, that the brucellosis test will not be 
required for steers, spayed heifers, or any cattle less than 6 months 
old. The certificate must give the dates and places of testing, names of 
the consignor and consignee, and a description of the cattle, with 
breed, ages, and markings; and
    (2) Tuberculosis. (i) For steers and spayed heifers, the cattle 
originated from a herd of origin that tested negative to a whole herd 
test for tuberculosis within 1 year prior to the date of exportation to 
the United States, and the animals each tested negative to an additional 
official tuberculin test conducted within 60 days prior to the date of 
exportation to the United States, and any individual cattle that had 
been added to the herd tested negative to any individual tests for 
tuberculosis required by the Administrator; or
    (ii) For sexually intact cattle that are from an accredited herd, 
the herd was certified as an accredited herd for tuberculosis within 1 
year prior to the date of exportation to the United States; or
    (iii) For sexually intact cattle that are not from an accredited 
herd, the cattle originated from a herd of origin that tested negative 
to a whole herd test for tuberculosis within 1 year prior to the date of 
exportation to the United States, and the animals each tested negative 
to one additional official tuberculin test conducted no more than 6 
months and no less than 60 days prior to the date of exportation to the

[[Page 432]]

United States, and any individual cattle that had been added to the herd 
tested negative to any individual tests for tuberculosis required by the 
Administrator, except that the additional test is not required if the 
animals are exported within 6 months of when the herd of origin tested 
negative to a whole herd test.
    (b) Tuberculosis and brucellosis tests of goats. Except as provided 
in Sec. Sec.  93.419 and 93.428(b), 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) Further tests during quarantine. Ruminants that have been tested 
as prescribed in paragraphs (a) and (b) of this section and that are 
subject to quarantine at the port of entry, as provided in Sec.  93.411 
or Sec.  93.427, must be retested during the last 10 days of the 
quarantine period under the supervision of a veterinary inspector by one 
or more of the methods approved by the Administrator, except that cattle 
tested in accordance with paragraph (a)(2)(i) of this section are not 
required to be retested for tuberculosis.

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 28080, June 24, 1992; 58 
FR 68509, Dec. 28, 1993. Redesignated and amended at 62 FR 56012, 56018, 
Oct. 28, 1997; 66 FR 20190, Apr. 20, 2001; 68 FR 35533, June 16, 2003]



Sec.  93.407  Declaration and other documents for ruminants.

    (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.



Sec.  93.408  Inspection at the port of entry.

    Inspection shall be made at the port of entry of all ruminants 
imported from any part of the world except as provided in Sec. Sec.  
93.421 and 93.426. 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 
Sec. Sec.  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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56018, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]

[[Page 433]]



Sec.  93.409  Articles accompanying ruminants.

    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.



Sec.  93.410  Movement from conveyances to quarantine station.

    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.



Sec.  93.411  Quarantine requirements.

    (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.

[61 FR 17238, Apr. 19, 1996. Redesignated at 62 FR 56012, Oct. 28, 1997]



Sec.  93.412  Ruminant quarantine facilities.

    (a) Privately operated quarantine facilities. 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 
privately operated quarantine facility and for the care, feed, and 
handling of the ruminants 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 
ruminants and must be approved by the Administrator prior to the 
issuance of any import permit. The facilities occupied by ruminants 
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 ruminants, 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 ruminants 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 ruminants shall be made by certified check or 
U.S. money order

[[Page 434]]

prior to release of the ruminants. If such payment is not made, the 
ruminants 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 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) 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.



Sec.  93.413  Quarantine stations, visiting restricted; sales prohibited.

    Visitors shall not be admitted to the quarantine enclosure during 
any time that ruminants 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 ruminants 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 ruminants may be 
admitted upon written permission from the said inspector. No exhibition 
or sale shall be allowed within the quarantine grounds.



Sec.  93.414  Milk from quarantined ruminants.

    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 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

[[Page 435]]

be removed from the quarantine premises except in compliance with all 
State and local regulations.



Sec.  93.415  Manure from quarantined ruminants.

    No manure shall be removed from the quarantine premises until the 
release of the ruminants producing same.



Sec.  93.416  Appearance of disease among ruminants in quarantine.

    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.

                               Canada \7\
---------------------------------------------------------------------------

    \7\ Importations from Canada shall be subject to Sec. Sec.  93.417 
to 93.421, inclusive, in addition to other sections in this part which 
are in terms applicable to such importations.
---------------------------------------------------------------------------



Sec.  93.417  Import permit and declaration for ruminants.

    (a) For ruminants intended for importation from Canada, the importer 
shall first apply for and obtain from APHIS an import permit as provided 
in Sec.  93.404: Provided, That an import permit is not required for 
ruminants offered for entry at a land border port designated in Sec.  
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 Sec.  93.407.

[55 FR 31495, Aug. 2, 1990, as amended at 60 FR 13900, Mar. 15, 1995. 
Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997]



Sec.  93.418  Cattle from Canada.

    (a) Health certificates. Except for cattle imported for immediate 
slaughter in accordance with Sec.  93.420, cattle intended for 
importation from Canada shall be accompanied by a certificate issued in 
accordance with Sec.  93.405(a). The certificate shall state that the 
cattle have been inspected and 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) Tuberculin-test certificates. (1) Cattle from Canada from a herd 
in which any cattle have been determined to have tuberculosis shall not 
be imported into the United States.
    (2) Except for cattle prohibited from importation under paragraph 
(b)(1) of this section, cattle from Canada may be imported into the 
United States if:
    (i) The cattle are imported for slaughter in accordance with Sec.  
93.420 of this part; or
    (ii) The cattle are accompanied by a certificate issued or endorsed 
by a salaried veterinarian of the Canadian Government showing:
    (A) That the cattle are from a tuberculosis-free herd; or
    (B) The date and place the cattle were last tested for tuberculosis; 
that the cattle were found negative for tuberculosis on such test; and 
that such test was performed within 60 days preceding the arrival of the 
cattle at the port of entry; or
    (C) That the cattle are at least five days but not more than four 
weeks of age and, therefore, exempt from the tuberculosis testing 
requirement; or
    (D) For a calf imported with its dam, the date and place the calf's 
dam was last tested for tuberculosis; that the dam was found negative 
for tuberculosis on such test; that such test was performed within 60 
days preceding the arrival of the calf and dam at the port

[[Page 436]]

of entry; and that the calf was born after such test was performed.
    (c) Brucellosis test or vaccination certificates. (1) Cattle from 
Canada from a herd in which any cattle have been determined to have 
brucellosis may not be imported into the United States;
    (2) Except for cattle prohibited from importation into the United 
States under paragraph (c)(1) of this section, cattle 6 months of age or 
older from Canada may be imported into the United States if the 
following conditions are met:
    (i) The cattle are imported for slaughter in accordance with Sec.  
92.420;
    (ii) The cattle are steers; or
    (iii) The cattle are accompanied by a certificate issued or endorsed 
by a salaried veterinarian of the Canadian government showing:
    (A) That the cattle are from a brucellosis certified-free herd, 
province, or territory; or
    (B) The date and place the cattle were last tested for brucellosis; 
that the cattle were found negative for brucellosis on such test; and 
that such test was performed within 30 days preceding the arrival of the 
cattle at the port of entry; or
    (C) That the female cattle under 18 months of age were vaccinated 
against brucellosis in accordance with Canadian regulations.
    (d) The certificates prescribed in paragraphs (b) and (c) of this 
section shall state:
    (1) The names of the consignor and the consignee;
    (2) A description of the cattle to be imported, including the breed, 
ages, markings, and tattoo and eartag numbers of each animal;
    (3) The dates and places of each test required by paragraphs (b) and 
(c) of this section; and
    (4) The date of vaccination, dosage of vaccine used, and the age of 
each animal on the date of vaccination for each vaccination conducted in 
accordance with paragraph (c)(2)(ii)(C) of this section.

[55 FR 31495, Aug. 2, 1990, as amended at 55 FR 49990, Dec. 4, 1990; 58 
FR 37641, July 13, 1993; 59 FR 28216, June 1, 1994; 61 FR 17238, Apr. 
19, 1996. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997]



Sec.  93.419  Sheep and goats from Canada.

    (a) Except for sheep and goats imported for immediate slaughter in 
accordance with Sec.  93.420, sheep and goats intended for importation 
from Canada shall be accompanied by a certificate issued in accordance 
with Sec.  93.405.
    (b) If sheep or goats are unaccompanied by the certificate required 
by paragraph (a) 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 and shall be 
handled or quarantined, or otherwise disposed of as the Administrator 
may direct.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 28216, June 1, 1994; 61 
FR 17239, Apr. 19, 1996. Redesignated and amended at 62 FR 56012, 56018, 
Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]



Sec.  93.420  Ruminants from Canada for immediate slaughter.

    Any ruminant 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 2 weeks from the date of 
entry. Such ruminants shall be inspected at the port of entry and 
otherwise handled in accordance with Sec.  93.408.

[59 FR 28216, June 1, 1994. Redesignated and amended at 62 FR 56012, 
56018, Oct. 28, 1997]



Sec.  93.421  Special provisions.

    (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 Sec.  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 Sec.  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

[[Page 437]]

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 paper containing information 
shall be attached to 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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56018, Oct. 28, 1997]

                   Central America and West Indies \8\



Sec.  93.422  Import permit and declaration for ruminants.

    (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 Sec.  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 Sec.  93.423.
---------------------------------------------------------------------------

    \8\ Importations from regions of Central America and the West Indies 
shall be subject to Sec. Sec.  93.422 and 93.423, in addition to other 
sections in this part, which are in terms applicable to such 
importations.
---------------------------------------------------------------------------

    (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 Sec.  93.407.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56019, Oct. 28, 1997]



Sec.  93.423  Ruminants from Central America and the West Indies.

    (a) 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 Sec.  
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

[[Page 438]]

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 Sec.  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 Sec.  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 Sec.  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 splenetic, 
southern, or tick fever, 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.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[55 FR 31495, Aug. 2, 1990, as amended at 61 FR 17239, Apr. 19, 1996. 
Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997; 68 FR 
6344, Feb. 7, 2003]

                               Mexico \9\



Sec.  93.424  Import permits and applications for inspection of ruminants.

    (a) For ruminants intended for importation from Mexico, the importer 
shall first apply for and obtain from APHIS an import permit as provided 
in Sec.  93.404: Provided, That an import permit is not required for a 
ruminant offered for entry at a land border port designated in Sec.  
93.403(c), if such animal is:
---------------------------------------------------------------------------

    \9\ Importations from Mexico shall be subject to Sec. Sec.  93.424 
to 93.429, inclusive, in addition to other sections in this part which 
are in terms applicable for such importations.
---------------------------------------------------------------------------

    (1) A wether; or
    (2) A sheep or goat imported for immediate slaughter.
    (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 mutually satisfactory arrangements for the 
orderly inspection of the animals. For

[[Page 439]]

all cattle, except those entering pursuant to the third proviso in Sec.  
93.427(d), and except for steers, an official record of negative 
brucellosis test conducted on the herd of origin as required in Sec.  
93.427(d) shall be presented to the veterinary inspector at the port of 
entry when application is made for inspection. 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.

[55 FR 31495, Aug. 2, 1990, as amended at 60 FR 13898, 13900, Mar. 15, 
1995. Redesignated and amended at 56012, 56019, Oct. 28, 1997; 68 FR 
35534, June 16, 2003]



Sec.  93.425  Declaration for ruminants.

    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 Sec.  93.407.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56019, Oct. 28, 1997]



Sec.  93.426  Inspection at port of entry.

    (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 Sec.  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 Sec.  93.403, which are equipped 
with facilities necessary for proper chute inspection, dipping, and 
testing, as provided in this part.

[55 FR 31495, Aug. 2, 1990, as amended at 60 FR 13898, Mar. 15, 1995. 
Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997; 68 FR 
6344, Feb. 7, 2003]



Sec.  93.427  Cattle from Mexico.

    (a) Cattle and other ruminants imported 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.
    (b) Fever ticks. (1) Except as provided in paragraph (b)(2) of this 
section, all cattle intended for importation from Mexico, for purposes 
other than immediate slaughter, shall be accompanied by a certificate 
issued in accordance with Sec.  93.405(a), and showing that the 
veterinarian issuing the certificate inspected the cattle at the time of 
movement to the port of entry and found them free from any evidence of 
communicable disease and that, as far as it has been possible to 
determine, they have not been exposed to any such disease, including 
splenetic, southern or tick fever, during the preceding 60 days and, if 
shipped by rail or truck, the certificate shall further specify that the 
cattle were loaded into clean and disinfected cars or trucks for 
transportation direct to the port of entry. They shall also be 
accompanied by a certificate of the importer, or his or her agent 
supervising the shipment, stating that while en route to the port of 
entry they have not been trailed or driven through any district or area 
infested with fever ticks. Notwithstanding such certificates, such 
cattle shall be detained as provided in paragraph (a) of this section 
and shall be dipped at least once, under the supervision of an 
inspector, in one of the permitted dips listed in Sec.  72.13(b) of this

[[Page 440]]

chapter. The selection of the permitted dip to be used will be made by 
the port veterinarian in each case. The owner or his or her agent shall 
first execute an application for inspection and dipping as provided in 
paragraph (b)(2)(iii) of this section.
    (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 State of Texas, except into 
areas quarantined because of said disease or tick infestation as 
specified in Sec.  72.5 of this chapter, either at one of the land 
border ports in Texas listed in Sec.  93.403(c) of this part, or at the 
port of Santa Teresa, NM, provided that the following conditions are 
strictly observed and complied with:
    (i) The cattle shall be accompanied by a certificate issued in 
accordance with Sec.  93.405(a), and showing that the veterinarian 
issuing the certificate has inspected the cattle and found them free 
from fever ticks and any evidence of communicable disease, and that, as 
far as it has been possible to determine, they have not been exposed to 
any such disease, except splenetic, southern, or tick fever, during the 
60 days immediately preceding their movement to the port of entry.
    (ii) The cattle shall be shown by a certificate issued in accordance 
with Sec.  93.405(a) to have been dipped in a tickicidal dip within 7 to 
12 days before being offered for entry.
    (iii) The importer, or his or her duly authorized agent, shall first 
execute and deliver to an inspector at the port of entry an application 
for inspection and supervised dipping wherein he or she shall agree to 
waive all claims against the United States for any loss or damage to the 
cattle occasioned by or resulting from dipping, 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 importer which may come into contact with the cattle so 
dipped.
    (iv) The cattle when offered for entry shall receive a chute 
inspection by an inspector. If found free from ticks they shall be given 
one dipping in one of the permitted dips listed in Sec.  72.13(b) of 
this chapter under the supervision of an inspector 7 to 14 days after 
the dipping required by paragraph (b)(2)(ii) of this section. The 
selection of the permitted dip to be used will be made by the port 
veterinarian in each case. If found to be infested with fever ticks, the 
entire lot of cattle shall be rejected and will not be again inspected 
for entry until 10 to 14 days after they have again been dipped in the 
manner provided by paragraph (b)(2)(ii) of this section.
    (v) The conditions at the port of entry shall be such that the 
subsequent movement of the cattle can be made without exposure to fever 
ticks.
    (c) Tuberculosis. (1) Each steer 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 is imported for 
slaughter in accordance with Sec.  93.429. Each spayed heifer imported 
into the United States from Mexico shall be identified with a distinct, 
permanent, and legible ``Mx'' mark applied with a freeze 
brand, hot iron, or other method prior to arrival at a port of entry, 
unless the spayed heifer is imported for slaughter in accordance with 
Sec.  93.429. The ``M'' or ``Mx'' mark shall be not less than 
2 inches nor more than 3 inches high, and shall be applied to each 
animal's right hip, high on the tailhead (over the junction of the 
sacral and first coccygeal vertebrae).
    (2) Cattle from a herd or herds in which one or more reactors to the 
tuberculin test have been disclosed shall not be eligible for 
importation until the herd to which the animals in the lot belong 
achieve accredited herd status as defined in Sec.  93.400, and provided 
that the animals offered for entry have met the other applicable 
requirements of this section.
    (3) All sexually intact cattle accompanied by the certificate 
required by Sec.  93.405(a) will be detained at the port of entry under 
the supervision of the port veterinarian until tested for tuberculosis 
with negative results: Provided, That if any reactor is disclosed in any 
lot when so tested at the port of entry, the entire lot will be refused 
entry and the entire lot or any portion of it will

[[Page 441]]

not be eligible for importation until the herd to which the animals in 
the lot belong achieve accredited herd status as defined in Sec.  
93.400, and provided that the animals offered for entry have met the 
other applicable requirements of this section.
    (4) The importation of Holstein steers and Holstein spayed heifers 
from Mexico is prohibited.
    (d) Brucellosis. All cattle offered for importation into the United 
States from Mexico shall be individually identified with a numbered, 
blue metal eartag issued by the Mexican Ministry of Agriculture and 
Water Resources (SARH); and except in the case of steers, shall be 
eligible for entry into the United States only if, in addition to 
complying with other applicable provisions of this part, they:
    (1) Are accompanied by a certificate issued in accordance with Sec.  
93.405(a) stating:
    (i) That such cattle originated in a herd in which all cattle 
(except calves under 6 months of age and steers) were tested for 
brucellosis not less than 30 days nor more than 90 days prior to the 
date of certification and were found to be negative;
    (ii) The date and place such herd was tested; and
    (iii) That the cattle in the herd have been isolated from all other 
cattle from the time the herd was tested negative for brucellosis to the 
date of the offer of the cattle for entry into the United States; and
    (2) Except for calves under 6 months of age, are subjected to an 
additional test for brucellosis at the port of entry and found negative 
to such test: Provided, That if any reactor is disclosed in any lot when 
so tested at the port of entry, the entire lot shall be refused entry 
and the entire lot or any portion thereof may not be reoffered for entry 
until retested and recertified in accordance with paragraphs (d)(1) and 
(2) of this section or any cattle found to be negative to such test and 
any calves under 6 months of age in such lot may enter if consigned and 
moved under U.S. Department of Agriculture seal and without diversion to 
recognized slaughtering establishment as defined in Sec.  78.1 of this 
chapter for immediate slaughter, or if consigned and moved under U.S. 
Department of Agriculture seal and without diversion to a quarantined 
feedlot, as defined in Sec.  78.1 of this chapter and thereafter handled 
in accordance with the provisions of Sec.  78.12 of this chapter: 
Provided, further, That if any suspect but no reactor is disclosed in 
any lot when so tested at the port of entry, any cattle found to be 
negative to such test and any calves under 6 months of age in such lot 
may enter without further restriction under this paragraph (d): And 
provided further, That any cattle other than cattle which are classified 
as a reactor or suspect to a test for brucellosis may enter the United 
States from Mexico without the certificate or any test otherwise 
required by this paragraph, if they are individually identified with a 
numbered, blue metal eartag issued by the Mexican Ministry of 
Agriculture and Water Resources (SARH) and are consigned and moved to a 
slaughtering establishment for immediate slaughter, or to a quarantined 
feedlot, in accordance with the first proviso in this paragraph and 
otherwise comply with the applicable provisions of this part.

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 2010, Jan. 17, 1992; 57 
FR 28080, 28081, June 24, 1992; 58 FR 68509, Dec. 28, 1993; 59 FR 24886, 
May 13, 1994; 59 FR 65897, Dec. 22, 1994; 60 FR 13898, Mar. 15, 1995; 61 
FR 17239, Apr. 19, 1996. Redesignated and amended at 62 FR 56012, 56019, 
Oct. 28, 1997; 62 FR 64266, Dec. 5, 1997; 66 FR 20190, Apr. 20, 2001]



Sec.  93.428  Sheep and goats and wild ruminants from Mexico.

    (a) Sheep and goats intended for importation from Mexico shall be 
accompanied by a certificate issued in accordance with Sec.  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 Sec.  
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

[[Page 442]]

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 Sec.  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 
Sec.  93.426.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 367, Jan. 4, 1991; 57 FR 
28081, June 24, 1992; 61 FR 17239, Apr. 19, 1996. Redesignated and 
amended at 62 FR 56012, 56019, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]



Sec.  93.429  Ruminants for immediate slaughter.

    Ruminants, other than sheep and goats, may be imported from Mexico, 
subject to the applicable provisions of Sec. Sec.  93.424, 93.425, 
93.426, and 93.427(b)(2) for immediate slaughter if accompanied by a 
certificate issued in accordance with Sec.  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.

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 28081, June 24, 1992; 61 
FR 17239, Apr. 19, 1996. Redesignated and amended at 62 FR 56012, 56019, 
Oct. 28, 1997]



Sec.  93.430-93.431  [Reserved]



Sec.  93.432  Cattle from the Republic of Ireland.

    (a) All cattle to be imported from the Republic of Ireland shall be 
accompanied by a certificate issued or endorsed by a salaried 
veterinarian of the Republic of Ireland showing that the cattle 
originated from a herd which is officially certified by the Republic of 
Ireland as a brucellosis qualified for export herd and that the cattle 
meet the requirements in Sec.  93.432(c).
    (b) A brucellosis qualified for export herd is a herd in which all 
of the cattle have been maintained as a herd unit for at least two years 
prior to importation and all of the test eligible cattle in the herd 
(i.e., cattle over 6 months of age, except steers and spayed heifers) 
have been tested annually for brucellosis and found negative in 
accordance with Republic of Ireland requirements for at least two years 
prior to importation. The most recent negative herd test must have been 
conducted within 12 months of the date of importation. In addition:
    (1) Such herd unit may include cattle which were born and raised 
within such herd unit during the two year period, or cattle which were 
moved directly to the herd from another herd unit of like status; or
    (2) Such herd unit may include other cattle (except brucellosis 
reactors, suspects and animals listed in Sec.  93.432(c)(1)) if:
    (i) Such other cattle have been tested for brucellosis and found 
negative within 30 days prior to entry into the herd unit and all 
eligible cattle in the herd unit have been tested for brucellosis and 
found negative not less than

[[Page 443]]

90 days following the date when the last of the other cattle had been 
added to the herd unit; or
    (ii) All eligible cattle in the herd unit have been tested negative 
for brucellosis no less than 180 days nor more than 12 months (365 days) 
following the date when the last of the other cattle had been added to 
the herd unit.
    (c) The certificate accompanying cattle offered for importation from 
the Republic of Ireland shall show that the cattle are from a 
brucellosis qualified for export herd and that they meet the following 
requirements:
    (1) The cattle to be exported were not born to or nursed by 
brucellosis reactors and they were not born in a herd at the time the 
herd was under quarantine due to brucella infection.
    (2) The cattle were placed in an isolation facility approved by a 
full-time, salaried, Government of Ireland veterinary official, on 
separate premises a minimum of 500 yards from other livestock not 
destined for export to the United States for at least 60 days prior to 
export.
    (3) The cattle were negative to the following tests conducted not 
less than 60 nor more than 120 days from the date of export and a second 
set of tests conducted within 30 days of the date of export;
    (i) Plate or Tube agglutination test conducted in dilutions to 
detect reactions at 30, 60, 120, and 240 International Units per 
milliliter (IU/ml);
    (ii) Brucellosis card test (Rose Bengal test);
    (iii) Complement Fixation (CF) test conducted in dilutions to detect 
prozone reactions, when present.
    (4) Cattle are eligible for entry only if classified as negative at 
30 IU to the Plate or Tube agglutination test, negative to the 
brucellosis card test and negative to the CF test as performed and 
interpreted by standard methods at the Republic of Ireland Brucellosis 
Diagnostic Laboratory. Any animal exhibiting a prozone serological 
reaction is ineligible for export to the United States.
    (5) Cattle showing a serological titer more than 60 IU to the Plate 
or Tube agglutination test, or a reaction to the Brucellosis card test 
(Rose Bengal) or CF test that would be interpreted to be an infected 
animal (reactor) under the Republic of Ireland brucellosis control 
program. Animals from that herd of origin and all other cattle having 
the opportunity for contact with the reactor animal shall not be 
eligible for export to the United States. Brucellosis bacteriologically 
positive animals, if known, regardless of serologic reactions, are not 
eligible for importation nor are any animals in contact with such 
animals.
    (6) The cattle were moved directly to the port of export from the 
isolation facility without contact with any other cattle which are not 
qualified for export to the United States.
    (d) The certificate accompanying the cattle offered for importation 
must also show the dates and places of testing, names of the consignor 
and consignee, and descriptions of the cattle, including breed, ages, 
markings, and tattoo and eartag numbers.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56019, Oct. 28, 1997]



Sec.  93.433  [Reserved]



Sec.  93.434  Standards for approval of privately operated quarantine 

facilities for sheep or goats, and handling procedures for the 
importation of sheep or goats.

    (a) Cooperative agreement. No facility shall operate as a privately 
operated quarantine facility for sheep or goats unless it is operated in 
accordance with a cooperative agreement executed by the operator or 
other designated representative of the facility and by the 
Administrator, and unless such cooperative agreement includes all the 
requirements of this section and includes a requirement that the cost of 
the facility and all costs associated with the maintenance and operation 
of the facility shall be borne by the operator in accordance with the 
provisions of Sec.  93.412 of this part.
    (b) Approval of facilities. To qualify for designation as an 
approved privately operated quarantine facility \15\

[[Page 444]]

and to retain such approval, the facility and its maintenance and 
operation must meet the minimum requirements of this section. Approval 
of any quarantine facility shall be contingent upon a determination by 
the Administrator that adequate personnel are available to provide 
services required by the facility if approved. The cost of the facility 
and all costs associated with the maintenance and operation of the 
facility shall be borne by the operator in accordance with the 
provisions of Sec.  93.412 of this part.
---------------------------------------------------------------------------

    \15\ Information as to the identity of such facilities may be 
obtained from the Administrator, Animal and Plant Health Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250.
---------------------------------------------------------------------------

    (1) Supervision of the facility. The facility shall be maintained 
under the supervision of an APHIS veterinarian.
    (2) Physical plant requirements. The facility shall comply with the 
following requirements:
    (i) Location. The quarantine facility shall:
    (A) Be located at one of the ports listed in Sec.  93.403(g) of this 
part;
    (B) Be located within the immediate area of the port of entry to 
minimize the possibility of introduction and dissemination of diseases 
by the imported sheep or goats while in transit from the point of entry 
to the quarantine facility; and
    (C) Be located at least one-half mile from any livestock.
    (ii) Construction. The quarantine facility building shall:
    (A) Be constructed so that the surfaces of the floors and the 
surfaces of that part of the walls with which the sheep or goats, their 
excrement, or discharges have contact are constructed of materials that 
are substantially impervious to moisture and that can withstand 
continued cleaning and disinfection;
    (B) Be constructed so that the ceiling and that part of the walls 
with which the sheep or goats, their excrement, or discharges do not 
have contact can withstand cleaning and disinfection between shipments;
    (C) Be constructed with each entryway equipped with a series of two 
solid doors, and with other openings covered with screening 16 mesh or 
finer, unless the Administrator specifically approves other types of 
doors and openings as adequate to prevent the entry of insects;
    (D) Be constructed so that different lots of sheep or goats in the 
facility at the same time are separated by physical barriers in such a 
manner that sheep or goats in a given lot do not have physical contact 
with sheep or goats in another lot, or with their excrement, or 
discharges (for the purposes of this section a ``lot'' shall mean a 
group of sheep or goats that have been held on a premises with 
opportunity for commingling (physical contact with other sheep or goats 
in the group or with their excrement or discharges) at any time since 30 
days prior to export to the United States);
    (E) Have a ventilation capacity sufficient to control moisture and 
odor at levels that are not injurious to the health of the sheep or 
goats in quarantine;
    (F) Have a separate, controlled, forced air ventilation system for 
each lot of sheep or goats that is housed in the facility if the 
facility is approved to handle more than one lot of sheep or goats at a 
time;
    (G) Have a separate feed storage area, if feed is stored in the 
facility;
    (H) Have office space for recordkeeping available for use by APHIS 
personnel;
    (I) Have a necropsy area with facilities adequate for specimen 
preparation and equipped with a refrigerator-freezer for storing 
specimens for laboratory examination;
    (J) Have a separate area for washing clothes and equipment used in 
the facility;
    (K) Have a shower at the entrance to the sheep- or goat-holding area 
and the necropsy area and a clothes storage and change area at each end 
of the shower area; and
    (L) Have a storage area for equipment necessary for quarantine 
operations.
    (iii) Sanitation and security. Arrangements shall exist for:
    (A) Equipment and supplies necessary to maintain the facility in a 
clean and sanitary condition, including insect and pest control 
equipment and supplies;
    (B) Separately maintained equipment and supplies for each lot of 
animals;

[[Page 445]]

    (C) A supply of potable water adequate to meet all watering and 
cleaning needs;
    (D) Power cleaning and disinfecting equipment with adequate capacity 
to disinfect the facility and equipment;
    (E) Sufficient stocks of a disinfectant authorized in Sec.  71.10 of 
this chapter;
    (F) Disposal of wastes by burial, incineration or in a public sewer 
system in compliance with all applicable environmental quality control 
standards;
    (G) Upon the death or destruction of any sheep or goat, disposal of 
the carcass, in conformance with all applicable environmental quality 
control standards, by incineration, by burial, or by storing the sheep 
or goat carcasses in the facility in a freezer at a temperature below 20 
degrees Fahrenheit and upon release of the lot of sheep or goats from 
the facility, disposing of any carcasses by grinding and then heating 
them for at least one hour at a temperature of not less than 265 degrees 
Fahrenheit;
    (H) Control of surface drainage into or from the facility in a 
manner adequate to prevent any significant risk of livestock diseases 
being spread into or from the facility;
    (I) Protective clothing and footwear adequate in quantity to ensure 
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;
    (J) A receptacle for soiled and contaminated clothing in the clothes 
change area located nearest the entrance to the sheep- or goat-holding 
area;
    (K) A security system which prevents persons not authorized entry to 
the facility and animals outside the facility from having contact with 
sheep or goats in quarantine. Such a system shall include a daily log to 
record the entry and exit of all persons entering the facility; and
    (L) Feed and bedding for sheep or goats in quarantine must originate 
in an area not under quarantine because of cattle fever ticks (see part 
72 of this chapter) and must be stored in the facility in a manner which 
adequately protects these supplies against infestation by vermin and 
against spoilage.
    (3) Operating procedures. To retain designation as an approved 
quarantine facility, 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 APHIS veterinarian.
    (A) All personnel granted access to the sheep- or goat-holding area 
shall:
    (1) Wear clean protective clothing and footwear upon entering the 
sheep- or goat-holding area;
    (2) Change protective clothing and footwear when they become soiled 
or contaminated;
    (3) Shower when entering and leaving the sheep- or goat-holding 
area;
    (4) Shower when leaving the necropsy area after conducting a 
necropsy; and
    (5) Be prohibited from having contact with any sheep other than the 
lot of sheep or goats to which the person is assigned and be prohibited 
from having contact with ruminants or swine outside the quarantine 
facility.
    (B) The operator of the facility shall handle soiled and 
contaminated clothing worn within the quarantine facility in a manner 
approved by the APHIS veterinarian as adequate to preclude transmission 
of any animal disease agent from the facility.
    (ii) Any other person who enters the sheep- or goat-holding area, in 
addition to those persons granted access in paragraph (b)(3)(i) of this 
section, shall be prohibited from having contact with other lots of 
sheep or goats within the facility and with ruminants and swine outside 
the facility for a period of time determined by the supervising 
veterinarian as necessary to prevent a risk of spreading communicable 
livestock diseases.
    (iii) Any vehicle entering the quarantine facility building to 
deliver feed shall be cleaned and disinfected under the supervision of 
an inspector with a disinfectant authorized in Sec.  71.10 of the 
regulations immediately before entering and before leaving the facility.
    (iv) Handling of the sheep or goats in quarantine. The sheep or 
goats in the quarantine facility shall be handled in compliance with the 
following requirements:

[[Page 446]]

    (A) Each lot of sheep or goats to be quarantined shall be placed in 
the facility on an ``all-in, all-out'' basis. No sheep or goat shall be 
taken out of the lot while it is in quarantine except for diagnostic 
purposes and no sheep shall be added to a lot while the lot is in 
quarantine.
    (B) The portion of the quarantine facility from which a lot of sheep 
or goats has been released shall be thoroughly cleaned and disinfected 
under supervision of an inspector with a disinfectant authorized in 
Sec.  71.10 of this chapter, before a new lot is placed in that portion 
of the facility.
    (v) Records. It shall be the responsibility of the supervisory 
veterinarian to maintain a current daily log for each lot of sheep or 
goats, recording such information as the individual identification of 
the sheep or goats, source or origin of the sheep or goats in the lot, 
total number of sheep or goats in the lot when imported, number of dead 
or injured sheep or goats when the lot arrived, the date the lot was 
placed into the facility, the general condition of the sheep or goats 
each day, record of any medication administered to the sheep or goats, 
number of deaths each day in the lot during the quarantine period, 
necropsy results, laboratory findings on sheep or goats that died during 
the quarantine period, date of prescribed tests and results, Department 
import permit numbers of each lot, the date the lot was removed from the 
facility, and any other observations pertinent to the general health of 
the sheep or goats in the lot. The operator of the facility shall hold 
the log for 12 months following the date of release of the sheep or 
goats from quarantine and shall make it available to APHIS personnel 
upon request.
    (4) Environmental requirements. It shall be the responsibility of 
the operator of the facility to provide a certification executed by an 
appropriate government official indicating compliance with the 
applicable laws for environmental protection.
    (5) Additional requirements. 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 sheep or goats in such facility will be 
adequate to enable determination of their health status, prevent spread 
of disease among sheep or goats in quarantine, and prevent escape of 
animal disease agents from the facility.
    (c) Request for approval. Requests for approval of a privately 
operated quarantine facility shall be made by writing to the Animal and 
Plant Health Inspection Service, Veterinary Services, National Center 
for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-
1231. The request should include the full name and mailing address of 
the applicant and the location and street address of the facility for 
which approval is sought. Requests for approval and plans for proposed 
facilities shall be submitted no less than 90 days before the proposed 
date of entry of the first lot of sheep or goats into the quarantine 
facility.
    (d) Withdrawal or denial of approval. (1) Approval of any facility 
may be refused and approval of any approved quarantine facility may be 
withdrawn at any time by the Administrator, for any of the reasons 
provided in paragraph (d)(2) of this section. Before such action is 
taken, the operator of the facility will be informed of the reasons for 
the proposed action. If there is a conflict as to any material fact, the 
operator, 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. 
However, such 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 to 
the operator of the facility as promptly as circumstances allow. This 
withdrawal shall continue in effect pending the completion of the 
proceeding and any

[[Page 447]]

judicial review, unless otherwise ordered by the Administrator. In 
addition to withdrawal or denial of approval when the requirements for 
approval are not complied with, approval will be automatically withdrawn 
by the Administrator 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.\16\
---------------------------------------------------------------------------

    \16\ The name and address of the Veterinarian in Charge of any State 
are available from the Animal and Plant Health Inspection Service, 
Veterinary Services, National Center for Import-Export, 4700 River Road 
Unit 38, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (2) Except as provided in paragraph (d)(4) of this section, the 
approval of a privately operated quarantine facility for sheep or goats 
may be denied or withdrawn if:
    (i) Any requirement of this section is not complied with; or
    (ii) The operator or a person responsibly connected with the 
business of the quarantine facility is or has been convicted of any 
crime under any law regarding the importation or quarantine of any 
animal or bird; or
    (iii) 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 integrity needed for the conduct of operations 
affecting the importation of animals; or
    (iv) The approved quarantine facility has not been used to 
quarantine sheep or goats for a period of one year.
    (3) For the purposes of this section, a person shall be 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 
an employee in a managerial or executive capacity.
    (4) The denial or withdrawal referred to in paragraph (d)(2) of this 
section shall not be solely based upon the convictions of those persons 
responsibly connected with an approved privately operated quarantine 
facility for sheep or goats if, after issuance of a complaint and upon 
receipt of notification from the Administrator of the denial or 
withdrawal, the operator of the approved quarantine facility enters into 
a consent agreement with the Administrator, in which it is agreed that 
the responsibly connected person identified in the notification shall 
not ever be associated with the approved quarantine facility and the 
operator complies with the provisions of the agreement. Violation of the 
consent agreement shall constitute independent grounds for withdrawal of 
approval of an approved quarantine facility.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67615, Dec. 30, 1994; 60 
FR 13898, Mar. 15, 1995; 61 FR 17239, Apr. 19, 1996. Redesignated and 
amended at 62 FR 56012, 56019, Oct. 28, 1997]



Sec.  93.435  Sheep and goats.

    (a) Except as provided in paragraph (b) of this section, all sheep 
and goats imported into the United States must be placed in a flock or 
herd in the United States that participates in the Voluntary Scrapie 
Flock Certification Program (see 9 CFR part 54, subpart B) and:
    (1) The flock or herd qualifies as a ``Certified'' flock or herd; or
    (2) The flock or herd owner has agreed, in writing, to maintain the 
flock or herd in compliance with all requirements of the Voluntary 
Scrapie Flock Certification Program until the flock or herd qualifies as 
a ``Certified'' flock or herd.
    (b) The following sheep and goats are not subject to paragraph (a) 
of this section:
    (1) Goats intended for importation from Australia, Canada, or New 
Zealand;
    (2) Goats intended for importation from any region other than 
Australia, Canada, or New Zealand, provided that such goats have not had 
any contact with sheep during the 5 years immediately prior to shipment, 
in accordance with Sec.  93.405(b)(2)(ii);
    (3) Sheep intended for importation from Australia, Canada, or New 
Zealand, provided that none of the female sheep in the flock from which 
the sheep will be imported has been impregnated,

[[Page 448]]

during the 5 years immediately preceding shipment of the sheep to the 
United States, with germ plasm from a region other than Australia, 
Canada, New Zealand, or the United States, in accordance with Sec.  
93.405(c)(3);
    (4) Wethers;
    (5) Sheep or goats imported for immediate slaughter; and
    (6) Wild sheep or goats imported for exhibition purposes to an 
approved zoological park in accordance with Sec.  93.404(c).
    (c) Sheep or goats may be imported under paragraph (a) of this 
section only if the importer provides the Voluntary Scrapie Flock 
Certification Program identification number of the receiving flock or 
herd as part of the application for an import permit.
    (d) Sheep and goats may be imported under paragraph (a)(1) of this 
section only if they come from a flock or herd in the region of origin 
that participates in a program determined by the Administrator to be 
equivalent to the Voluntary Scrapie Flock Certification Program, and the 
flock or herd has been determined by the Administrator to be at a level 
equivalent to ``Certified'' in the Voluntary Scrapie Flock Certification 
Program.
    (e) Sheep and goats may be imported under paragraph (a)(2) of this 
section only if they are placed in a Certifiable Class C flock or herd 
participating in the Voluntary Scrapie Flock Certification Program; 
except, that if the sheep and goats come from a flock or herd in the 
region of origin that participates in a program determined by the 
Administrator to be equivalent to the Voluntary Scrapie Flock 
Certification Program, then the sheep and goats may be placed in a herd 
or flock in the United States which would be classified at a level 
equivalent to or lower (i.e., at a greater risk) than the certification 
level, as determined by the Administrator, of the flock or herd from 
which the sheep or goats are to be imported.
    (f) Sheep and goats imported under paragraph (a)(2) of this section 
must be monitored for scrapie disease until the flock or herd qualifies 
as a ``Certified'' flock or herd.
    (g) Except for imported sheep and goats placed in Certifiable Class 
C flocks or herds, the certificate accompanying sheep or goats imported 
under paragraph (a) of this section must contain the following 
statement: ``The animals identified on this certificate have been 
monitored by a salaried veterinary officer of [name of country of 
origin], for [number of months], in the same source flock or herd which 
had been determined by the Administrator, APHIS, prior to the 
exportation of these animals to the United States, to be equivalent to 
[certification level] of the Voluntary Scrapie Flock Certification 
Program authorized under 9 CFR part 54, subpart B.''
    (1) The Administrator will determine, based upon information 
supplied by the importer, whether the flock or herd from which the 
animals are to be imported participates in a program in the country of 
origin that is equivalent to the Voluntary Scrapie Flock Certification 
Program, and if so, at what level the source flock or herd should be 
classified.
    (2) In order for the Administrator to make a determination, the 
importer must supply the following information with the application for 
an import permit no less than 1 month prior to the anticipated date of 
importation:
    (i) The name, title, and address of a knowledgeable official in the 
veterinary services of the region of origin;
    (ii) The details of scrapie control programs in the region of 
origin, including information on disease surveillance and border control 
activities and the length of time such activities have been in effect;
    (iii) Any available information concerning additions, within the 5 
years immediately preceding shipment to the United States, to the flock 
or herd from which the sheep and goats will be imported;
    (iv) Any available data concerning disease incidence, within the 5 
years immediately preceding shipment to the United States, in the flock 
or herd from which the sheep or goats are to be imported, including, but 
not limited to, the results of diagnostic tests, especially 
histopathology tests, conducted on any animals in the flock or herd;
    (v) Information concerning the health, within the 5 years 
immediately preceding shipment to the United

[[Page 449]]

States, of other ruminants, flocks, and herds with which the imported 
sheep and goats, and with which animals in the sheep or goats' flock or 
herd might have had physical contact, and a description of the type and 
frequency of such physical contact; and
    (vi) Any other information requested by the Administrator in 
specific cases as needed to make a determination.

(Approved by the Office of Management and Budget under control numbers 
0579-0040 and 0579-0101)

[61 FR 17240, Apr. 19, 1996. Redesignated and amended at 62 FR 56012, 
56019, Oct. 28, 1997]



                             Subpart E_Swine



Sec.  93.500  Definitions.

    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 \1\ and slaughter thereat within 
two weeksfrom the date of entry.
---------------------------------------------------------------------------

    \1\ The name of recognized slaughtering establishments approved 
under this part may be obtained from the Area Veterinarian in Charge, 
Veterinary Services, for the State of destination of the shipment.
---------------------------------------------------------------------------

    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.
    Recognized slaughtering establishment. \2\ An establishment where 
slaughtering operations are regularly carried on under federal or state 
inspection and which has been approved by the Animal and Plant Health 
Inspection Service to receive animals for slaughter under this part.
---------------------------------------------------------------------------

    \2\ The name of recognized slaughtering establishments approved 
under this part may be obtained from the Area Veterinarian in Charge, 
Veterinary Services, for the State of destination of the shipment.
---------------------------------------------------------------------------

    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

[[Page 450]]

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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56020, Oct. 28, 1997]



Sec.  93.501  General prohibitions; exceptions.

    (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;\3\ nor shall 
any such swine or 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, the Administrator may upon request in specific cases 
permit swine or 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.
---------------------------------------------------------------------------

    \3\ Importations of certain animals from various countries are 
absolutely prohibited under part 94 because of specified diseases.
---------------------------------------------------------------------------

    (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 \4\ has been 
obtained under Sec.  93.504 of this Chapter and all conditions therein 
are observed; and if such swine are handled as follows:
---------------------------------------------------------------------------

    \4\ Such permit may be obtained from the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. 
Requests for approval of such facilities should also be made to the 
Administrator.
---------------------------------------------------------------------------

    (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 \5\ in advance by the Administrator in accordance with 
paragraph (d)(3) of this section as adequate to prevent the spread 
within the United States of any livestock or poultry disease, and they 
are maintained there under continuous confinement until loaded aboard a 
means of conveyance for transportation from the United States and are 
maintained under continuous confinement aboard such means of conveyance 
until it leaves the United States; the import permit will specify any 
additional conditions necessary to assure that the transit of the swine 
through the United States can be made without endangering the livestock 
or poultry of the United States, and that Department inspectors may 
inspect the swine on board such means of conveyance or in such holding 
facility to ascertain whether the requirements of this paragraph are 
met, and dispose of them in accordance with the Animal Health Protection 
Act (7 U.S.C. 8301 et seq.) if such conditions are not met; and
---------------------------------------------------------------------------

    \5\ See footnote 4 to subpart E.
---------------------------------------------------------------------------

    (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.

[[Page 451]]

    (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.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67615, Dec. 30, 1994. 
Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 FR 
6344, Feb. 7, 2003]



Sec.  93.502  Inspection of certain aircraft and other means of 

conveyance and shipping containers thereon; unloading, cleaning, 
and disinfection requirements.

    (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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56020, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]



Sec.  93.503  Ports designated for the importation of swine.

    (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

[[Page 452]]

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.

[55 FR 31495, Aug. 2, 1990, as amended at 58 FR 38283, July 16, 1993; 60 
FR 16045, Mar. 29, 1995; 60 FR 25120, May 11, 1995. Redesignated at 62 
FR 56012, Oct. 28, 1997, as amended at 64 FR 23179, Apr. 30, 1999; 65 FR 
38178, June 20, 2000; 67 FR 68022, Nov. 8, 2002]



Sec.  93.504  Import permits for swine and for swine specimens for 

diagnostic purposes; and reservation fees for space at quarantine 
facilities maintained by APHIS.

    (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 Sec. Sec.  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 Sec.  94.1 of this chapter as a 
region where rinderpest or 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

[[Page 453]]

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 \6\ during regular business hours (8:00 a.m. 
to 4:30 p.m. Monday through Friday, excluding holidays) no later than 15 
days prior to the beginning of the time of importation as specified in 
the import permit or as arranged with the veterinarian in charge of the 
quarantine facility if no import permit is required (the 15 day period 
shall not include Saturdays, Sundays, or holidays), or
---------------------------------------------------------------------------

    \6\ The addresses of USDA quarantine facilities may be found in 
telephone directories listing the facilities or by contacting the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 
20737-1231.
---------------------------------------------------------------------------

    (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

[[Page 454]]

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 or 
rinderpest 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 or rinderpest exist.
    (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

[[Page 455]]

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:

Agreement for the Importation, Quarantine and Exhibition of Certain Wild 
                        Ruminants and Wild Swine

    --------, 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 or rinderpest 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, rinderpest, 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 
rinderpest or 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, 
rinderpest, 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, rinderpest, or other communicable disease that is exotic to the 
United States or for which

[[Page 456]]

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.

________________________________________________________________________
(Signature of importer)
    Subscribed and sworn to before me this ---- day of ----, ----
________________________________________________________________________
(Title or designation)

________________________________________________________________________
(Name of zoological park)

 By_____________________________________________________________________
(Signature of officer of zoological park)

________________________________________________________________________
(Title of officer)
    Subscribed and sworn to before me this ---- day of ----,----

________________________________________________________________________
(Title or designation)

(Approved by the Office of Management and Budget under control number 
0579-0040)

[55 FR 31495, Aug. 2, 1990 as amended at 59 FR 28216, June 1, 1994; 59 
FR 31924, June 21, 1994; 59 FR 67615, Dec. 30, 1994; 62 FR 23638, May 1, 
1997. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 
FR 6344, Feb. 7, 2003]



Sec.  93.505  Certificate for swine.

    (a) All swine offered for importation from any part of the world 
except as provided in Sec.  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, rinderpest, 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 classical swine fever, 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.
    (b) Swine from Angola, Argentina, Bahrain, Bangladesh, Benin, 
Bolivia, Botswana, Brazil, Brunei, Burkina Faso, Burundi, Cambodia, 
Cameroon, Central African Republic, China, Columbia, Congo, Dominican 
Republic, Ecuador, Equatorial Guinea, French Guiana, Gabon, Gambia, 
Ghana, Guinea, Guinea-Bissau, Guyana, Haiti, India, Indonesia, Iraq, 
Isla de Pascua (Easter Island, part of Chile), Ivory Coast, Jamaica, 
Kenya, Kuwait, Laos, Lesotho, Liberia, Macau, Malawi, Malaysia, Mali, 
Mauritania, Mozambique, Myanmar, Namibia, Nigeria, Oman, Pacific Islands 
(Palau), Panama, Papua New Guinea, Paracel Islands, Paraguay, Peru, 
Philippines, Qatar, Rwanda, Saudi Arabia, Senegal, Sierra Leone, 
Singapore, South Africa, Spratly Islands, Sri Lanka, Surinam, Swaziland, 
Taiwan, Tanzania, Thailand, Togo, Trinidad and Tobago, Uganda, United 
Arab Emirates, Uruguay, Venezuela, Vietnam, Zaire, Zambia, Zimbabwe, or 
any other region of the world where screwworm is considered to exist may 
only be imported into the United States if they meet the following 
requirements and all other applicable requirements of this part:
    (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

[[Page 457]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0165)

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 28081, June 24, 1992. 
Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 65 FR 
67623, Nov. 13, 2000; 67 FR 11565, Mar. 15, 2002; 68 FR 6344, Feb. 7, 
2003; 68 FR 16938, Apr. 7, 2003]



Sec.  93.506  Declaration and other documents for swine.

    (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.



Sec.  93.507  Inspection at the port of entry.

    Inspection shall be made at the port of entry of all swine imported 
from any part of the world except as provided in Sec.  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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56020, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]



Sec.  93.508  Articles accompanying swine.

    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.



Sec.  93.509  Movement from conveyances to quarantine station.

    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

[[Page 458]]

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.



Sec.  93.510  Quarantine requirements.

    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.



Sec.  93.511  Swine quarantine facilities.

    (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

[[Page 459]]

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.



Sec.  93.512  Quarantine stations, visiting restricted; sales prohibited.

    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.



Sec.  93.513  Milk from quarantined swine.

    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.



Sec.  93.514  Manure from quarantined swine.

    No manure shall be removed from the quarantine premises until the 
release of the swine producing same.



Sec.  93.515  Appearance of disease among swine in quarantine.

    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.

                               Canada \7\



Sec.  93.516  Import permit and declaration for swine.

    (a) For swine intended for importation from Canada, the importer 
shall first apply for and obtain from APHIS an import permit as provided 
in Sec.  93.504: Provided, That an import permit is not required for 
swine offered for entry at a land border port designated in Sec.  
93.503(b) if such swine:
---------------------------------------------------------------------------

    \7\ Importations from Canada shall be subject to Sec. Sec.  93.516 
to 93.519, inclusive, in addition to other sections in this part which 
are in terms applicable to such importations.

---------------------------------------------------------------------------

[[Page 460]]

    (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 Sec.  93.506.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56020, Oct. 28, 1997]



Sec.  93.517  Swine from Canada.

    (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 Sec. Sec.  
93.507, 93.516, and 93.518.

[55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56020, Oct. 28, 1997; 68 FR 16938, Apr. 7, 2003]



Sec.  93.518  Swine from Canada for immediate slaughter.

    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.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 28216, June 1, 1994. 
Redesignated at 62 FR 56012, Oct. 28, 1997]



Sec.  93.519  Special provisions.

    (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 Sec.  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 Sec.  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 paper containing the information 
shall be attached to 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

[[Page 461]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0020)

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67133, Dec. 29, 1994. 
Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997]

                   Central America and West Indies \8\



Sec.  93.520  Import permit and declaration for swine.

    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 Sec.  93.506.
---------------------------------------------------------------------------

    \8\ Importations from regions of Central America and the West Indies 
shall be subject to Sec.  93.520, in addition to other sections in this 
part, which are in terms applicable to such importations.

[55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56020, Oct. 28, 1997]

                               Mexico \9\



Sec.  93.521  Declaration for swine.

    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 Sec.  93.506.
---------------------------------------------------------------------------

    \9\ Importations from Mexico shall be subject to Sec.  93.521, in 
addition to other sections in this subpart, which are in terms 
applicable to such importations.

[55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56020, Oct. 28, 1997]



                             Subpart F_Dogs



Sec.  93.600  Importation of dogs.

    (a) All dogs. Dogs from Angola, Argentina, Bahrain, Bangladesh, 
Benin, Bolivia, Botswana, Brazil, Brunei, Burkina Faso, Burundi, 
Cambodia, Cameroon, Central African Republic, China, Columbia, Congo, 
Dominican Republic, Ecuador, Equatorial Guinea, French Guiana, Gabon, 
Gambia, Ghana, Guinea, Guinea-Bissau, Guyana, Haiti, India, Indonesia, 
Iraq, Isla de Pascua (Easter Island, part of Chile), Ivory Coast, 
Jamaica, Kenya, Kuwait, Laos, Lesotho, Liberia, Macau, Malawi, Malaysia, 
Mali, Mauritania, Mozambique, Myanmar, Namibia, Nigeria, Oman, Pacific 
Islands (Palau), Panama, Papua New Guinea, Paracel Islands, Paraguay, 
Peru, Philippines, Qatar, Rwanda, Saudi Arabia, Senegal, Sierra Leone, 
Singapore, South Africa, Spratly Islands, Sri Lanka, Surinam, Swaziland, 
Taiwan, Tanzania, Thailand, Togo, Trinidad and Tobago, Uganda, United 
Arab Emirates, Uruguay, Venezuela, Vietnam, Zaire, Zambia, Zimbabwe, or 
any other region of the world where screwworm is considered to exist may 
only be imported into the United States if they meet the following 
requirements and all other applicable requirements of this part:
    (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

[[Page 462]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0165)

[65 FR 67623, Nov. 13, 2000, as amended at 67 FR 11565, Mar. 15, 2002]



                     Subpart G_Miscellaneous Animals

    Source: 60 FR 55181, unless otherwise noted. Redesignated at 62 FR 
56012, Oct. 28, 1997.



Sec.  93.700  Definitions.

    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.

[55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56020, Oct. 28, 1997]



Sec.  93.701  Prohibitions.

    (a) No person may import a hedgehog or tenrec into the United States 
from any region designated in Sec.  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.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 56012, 56021, 
Oct. 28, 1997; 65 FR 15218, Mar. 22, 2000]



Sec.  93.702  Restrictions.

    Hedgehogs and tenrecs not specifically prohibited from being 
imported under Sec.  93.701 may be imported into the United States only 
in accordance with the regulations in this subpart.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56021, Oct. 28, 1997]



Sec.  93.703  Ports designated for importation.

    (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:

[[Page 463]]

    (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.

[60 FR 55181, Oct. 30, 1995. Redesignated at 62 FR 56012, Oct. 28, 1997, 
as amended at 65 38178, June 20, 2000; 67 FR 68022, Nov. 8, 2002]



Sec.  93.704  Import permit.

    (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 complete and submit one copy of an application 
(VS Form 17-129) for an import permit to the Import-Export Animals 
Staff, National Center for Import-Export, Veterinary Services, Animal 
and Plant Health Inspection Service, United States Department of 
Agriculture, 4700 River Road Unit 39, Riverdale, Maryland 20737-1231. 
This staff will supply application forms for import permits upon 
request. 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

[[Page 464]]

United States only if all other applicable requirements of this subpart 
have been met.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56021, Oct. 28, 1997]



Sec.  93.705  Health certificate.

    (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]

(Approved by the Office of Management and Budget under control number 
0579-0040)

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56021, Oct. 28, 1997]



Sec.  93.706  Notification of arrival.

    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.



Sec.  93.707  Inspection at the port of first arrival.

    (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.

[[Page 465]]



       Subpart H_Elephants, Hippopotami, Rhinoceroses, and Tapirs



Sec.  93.800  Definitions.

    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.

[52 FR 29502, Aug. 10, 1987, as amended at 57 FR 23048, 23049, June 1, 
1992. Redesignated and amended at 62 FR 56012, 56021, Oct. 28, 1997]



Sec.  93.801  Prohibitions.

    Elephants, hippopotami, rhinoceroses, or tapirs shall not be 
imported or entered into the United States unless in accordance with 
this part.

[52 FR 29502, Aug. 10, 1987. Redesignated at 62 FR 56012, Oct. 28, 1997]



Sec.  93.802  Import permit.

    (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 must be submitted to the 
Animal and Plant Health Inspection Service, Veterinary Services, 
National Center for Import-Export, 4700 River Road Unit 38, Riverdale, 
Maryland 20737-1231.

[[Page 466]]

pplication forms for import permits 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 
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 Sec.  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.

[52 FR 29502, Aug. 10, 1987, as amended at 57 FR 23049, June 1, 1992; 59 
FR 67615, Dec. 30, 1994. Redesignated at 62 FR 56012, Oct. 28, 1997]



Sec.  93.803  Health certificate.

    (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, National Center for Import-Export, 4700 River Road

[[Page 467]]

Unit 38, Riverdale, Maryland 20737-1231; and
    (5) The name and address of the consignor and consignee.

[52 FR 29502, Aug. 10, 1987; 52 FR 35350, Sept. 18, 1987, as amended at 
57 FR 23049, June 1, 1992; 59 FR 67615, Dec. 30, 1994. Redesignated and 
amended at 62 FR 56012, 56021, Oct. 28, 1997]



Sec.  93.804  Declaration upon arrival.

    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 the Animal and 
Plant Health Inspection Service, Veterinary Services, National Center 
for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-
1231.) It 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.

[52 FR 29502, Aug. 10, 1987; 52 FR 35350, Sept. 18, 1987, as amended at 
57 FR 23049, June 1, 1992; 59 FR 67615, Dec. 30, 1994. Redesignated and 
amended at 62 FR 56012, 56021, Oct. 28, 1997]



Sec.  93.805  Ports of entry, inspection, and treatment.\1\
---------------------------------------------------------------------------

    \1\ Importers must also meet all requirements of the U.S. Department 
of the Interior regulations relevant to the importation of elephants, 
hippopotami, rhinoceroses, and tapirs, including regulations concerning 
ports of entry.
---------------------------------------------------------------------------

    (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 Sec.  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:

[[Page 468]]

    (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 interefere 
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 Sec.  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 Sec.  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 Sec.  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 
Sec.  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 Sec.  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 Sec.  71.10 of this 
chapter and then treated with a permitted dip listed in Sec.  72.13(b) 
of this chapter.

[52 FR 29502, Aug. 10, 1987, as amended at 57 FR 23049, June 1, 1992. 
Redesignated at 62 FR 56012, Oct. 28, 1997; 65 FR 38178, June 20, 2000]



Sec.  93.806  Animals refused entry.

    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.

[52 FR 29502, Aug. 10, 1987, as amended at 57 FR 23049, June 1, 1992. 
Redesignated at 62 FR 56012, Oct. 28, 1997]



Sec.  93.807  Other importations.

    (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:

[[Page 469]]

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0020)

[52 FR 29502, Aug. 10, 1987; 52 FR 35350, Sept. 18, 1987, as amended at 
57 FR 23049, June 1, 1992; 59 FR 67133, Dec. 29, 1994. Redesignated at 
62 FR 56012, Oct. 28, 1997, as amended at 64 FR 23179, April 30, 1999]



PART 94_RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL PLAGUE), 

EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, 
AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED 
IMPORTATIONS--Table of Contents



Sec.
94.0 Definitions.
94.1 Regions where rinderpest or foot-and-mouth disease exists; 
          importations prohibited.
94.1a Criteria for determining the separate status of a territory or 
          possession as to rinderpest and foot-and-mouth disease.
94.2 Fresh (chilled or frozen) products (other than meat), and milk and 
          milk products of ruminants and swine.
94.3 Organs, glands, extracts, or secretions of ruminants or swine.
94.4 Cured or cooked meat from regions where rinderpest or foot-and-
          mouth disease exists.
94.5 Regulation of certain garbage.
94.6 Carcasses, parts or products of carcasses, and eggs (other than 
          hatching eggs) of poultry, game birds, or other birds; 
          importations from regions where exotic Newcastle disease is 
          considered to exist.
94.7 Disposal of animals, meats, and other articles ineligible for 
          importation.
94.8 Pork and pork products from regions where African swine fever 
          exists or is reasonably believed to exist.
94.9 Pork and pork products from regions where classical swine fever 
          exists.
94.10 Swine from regions where classical swine fever exists.
94.11 Restrictions on importation of meat and other animal products from 
          specified regions.
94.12 Pork and pork products from regions where swine vesicular disease 
          exists.
94.13 Restrictions on importation of pork or pork products from 
          specified regions.
94.14 Swine from regions where swine vesicular disease exists; 
          importations prohibited.
94.15 Animal products and materials; movement and handling.
94.16 Milk and milk products.
94.17 Dry-cured pork products from regions where foot-and-mouth disease, 
          rinderpest, African swine fever, classical swine fever, or 
          swine vesicular disease exists.
94.18 Restrictions on importation of meat and edible products from 
          ruminants due to bovine spongiform encephalopathy.
94.19 Gelatin derived from horses or swine, or from ruminants that have 
          not been in any region where bovine spongiform encephalopathy 
          exists.
94.20 Importation of pork and pork products from Sonora and Yucatan, 
          Mexico.
94.21 Restrictions on importation of beef from Uruguay.
94.22 Importation of poultry meat and other poultry products from 
          Sinaloa and Sonora, Mexico.
94.23 Restrictions on the importation of swine, pork, and pork products 
          from parts of the European Union.
94.24 Restrictions on the importation of live swine, pork, or pork 
          products from Baja California, Baja California Sur, Chihuahua, 
          and Sinaloa.

    Authority: 7 U.S.C. 450, 7701-7772, and 8301-8317; 21 U.S.C. 136 and 
136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and 
371.4.



Sec.  94.0  Definitions.

    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

[[Page 470]]

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. An individual employed by Animal and Plant 
Health Inspection Service, United States Department of Agriculture, who 
is authorized to perform the function involved.
    Authorized inspector. Any employee of the Animal and Plant Health 
Inspection Service, United States Department of Agriculture, or any 
other individual who is authorized by the Administrator to enforce this 
part.
    Birds. All members of the class Aves (other than poultry or game 
birds).
    Cervid. All species of deer, elk, and moose.
    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.
    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 Sec.  94.1(c) and Sec.  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).
    Exotic Newcastle disease (END). Any velogenic Newcastle disease. 
Exotic Newcastle disease is an acute, rapidly spreading, and usually 
fatal viral disease of birds and poultry.
    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.
    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).
    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.
    Operator. The operator responsible for the day-to-day operations of 
a facility.
    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.
    Poultry. Chickens, turkeys, swans, partridges, guinea fowl, pea 
fowl; nonmigratory ducks, geese, pigeons, and

[[Page 471]]

doves; commercial, domestic, or pen-raised grouse, pheasants, and quail.
    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.
    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.
    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. The several states, 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, except as provided in Sec.  94.5 of this part.
    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.

[52 FR 33801, Sept. 8, 1987, as amended at 53 FR 48520, Dec. 1, 1988; 54 
FR 7393, Feb. 21, 1989; 54 FR 14794, Apr. 13, 1989; 54 FR 31504, July 
31, 1989; 55 FR 38982, Sept. 24, 1990; 57 FR 43886, Sept. 23, 1992; 59 
FR 13185, Mar. 21, 1994; 61 FR 56891, Nov. 5, 1996; 62 FR 56021, Oct. 
28, 1997; 67 FR 31937, May 13, 2002; 68 FR 36900, June 20, 2003]



Sec.  94.1  Regions where rinderpest or foot-and-mouth disease exists; 
importations prohibited.

    (a) Notice is hereby given that, in accordance with the Animal 
Health Protection Act (7 U.S.C. 8301 et seq.), it has been determined, 
and official notice has been given to the Secretary of the Treasury 
that:
    (1) Rinderpest or foot-and-mouth disease exists in all regions of 
the world, except those listed in paragraph (a)(2) or (a)(3) of this 
section;
    (2) The following regions are declared to be free of both rinderpest 
and foot-and-mouth disease: Australia, Austria, The Bahamas, Barbados, 
Belgium, Bermuda, British Honduras (Belize), Canada, Channel Islands, 
Chile, Costa Rica, Czech Republic, Denmark, Dominican Republic, El 
Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Greenland, 
Guatemala, Haiti, Honduras, Hungary, Iceland, Ireland, Italy, Jamaica, 
Japan, Luxembourg, Mexico, The Netherlands, New Caledonia, New Zealand, 
Nicaragua, Norway, Panama, Papua New Guinea, Poland, Portugal, Spain, 
Territory of St. Pierre and Miquelon, Sweden, Switzerland, Trinidad and 
Tobago, Trust Territory of the Pacific Islands, and the United Kingdom.
    (3) The following regions are declared to be free of rinderpest: The 
Republic of South Africa.
    (b) The importation of any ruminant or swine or any fresh (chilled 
or frozen)

[[Page 472]]

meat of any ruminant or swine \1\ that originates in any region where 
rinderpest or foot-and-mouth disease exists, as designated in paragraph 
(a) of this section, or that enters a port in or otherwise transits a 
region in which rinderpest or foot-and-mouth disease exists, is 
prohibited:
    (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 rinderpest or foot-and-mouth disease 
exists; and
    (3) Except as provided in Sec.  94.4 of this part for cooked or 
cured meat from regions where rinderpest or foot-and-mouth disease 
exists.
    (4) Except as provided in Sec.  94.21 for fresh (chilled or frozen) 
beef from Uruguay.
---------------------------------------------------------------------------

    \1\ Importation of animals and meat includes bringing the animals or 
meat within the territorial limits of the United States on a means of 
conveyance for use as sea stores or for other purposes.
---------------------------------------------------------------------------

    (c) The importation of any used farm equipment that originates in 
any region where rinderpest or 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 and rinderpest, as designated in 
paragraph (a)(2) of this section, and fresh (chilled or frozen) beef 
exported from Uruguay in accordance with Sec.  94.21, which during 
shipment to the United States enters a port or otherwise transits a 
region where rinderpest or 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 Sec.  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

[[Page 473]]

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.

(Approved by the Office of Management and Budget under control numbers 
0579-0015 and 0579-0195)

[30 FR 12118, Sept. 23, 1965]

    Editorial Note: For Federal Register citations affecting Sec.  94.1, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



Sec.  94.1a  Criteria for determining the separate status of a territory 
or possession as to rinderpest and foot-and-mouth disease.

    (a) The Secretary of Agriculture will make a determination as to 
whether a territory or possession may be deemed separate from the mother 
region, in which rinderpest or foot-and-mouth disease has been 
determined to exist only if:
    (1) The official authority of that territory or possession, having 
responsibility for animal health matters, has declared such territory or 
possession free of rinderpest and foot-and-mouth disease;
    (2) The territory or possession is geographically separate from the 
mother region and has full autonomy from the mother region in all animal 
health matters, including import and export;
    (3) The territory or possession has a veterinary service which is 
capable of speedily detecting rinderpest or foot-and-mouth disease and 
which is comprised of veterinarians who:
    (i) Are employed as officials of the government of the territory or 
possession,
    (ii) Are graduates of a recognized school of veterinary medicine, 
and
    (iii) Are assigned in sufficient numbers and are so distributed, 
with respect to the livestock population, to be able to promptly 
recognize the existence of rinderpest and foot-and-mouth disease;
    (4) A laboratory capable of diagnosing rinderpest and foot-and-mouth 
disease is available to the veterinary service of the territory or 
possession;
    (5) Vaccinations for foot-and-mouth disease or rinderpest are not 
permitted in the territory or possession;
    (6) The reporting of rinderpest or foot-and-mouth disease to the 
veterinary authorities of the territory or possession is required by 
anyone who has notice of the existence of these diseases;
    (7) Laws and regulations are in effect and are administered in such 
manner as to insure against the introduction of foot-and-mouth disease 
or rinderpest through the importation of animals, meat, and animal 
products from regions, including the mother region, declared by the 
United States Secretary of Agriculture to be regions where foot-and-
mouth disease or rinderpest exist;
    (8) Animals introduced into the territory or possession from 
rinderpest or foot-and-mouth disease infected regions, including the 
mother region, are imported through a quarantine station and under 
conditions acceptable to the Secretary of Agriculture of the United 
States, and such conditions include, but are not restricted to:
    (i) Tests deemed necessary for the detection of rinderpest and foot-
and-mouth disease,
    (ii) Quarantine deemed necessary for the detection of rinderpest and 
foot-and-mouth disease, and
    (iii) Opportunity for observation by a United States Department of 
Agriculture veterinarian during all phases of the import procedures;
    (b) An on-site inspection by a veterinary representative of the 
United States Department of Agriculture to determine whether the 
criteria in this

[[Page 474]]

section are met shall be made of the territory or possession before any 
final determination is made as to its status.

[39 FR 13069, Apr. 11, 1974, as amended at 62 FR 56021, Oct. 28, 1997; 
68 FR 6345, Feb. 7, 2003]



Sec.  94.2  Fresh (chilled or frozen) products (other than meat), and 
milk and milk products of ruminants and swine.

    (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 
Sec.  94.1(a) as a region infected with rinderpest or foot-and-mouth 
disease is prohibited, except as provided in Sec.  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 
Sec.  94.1(a) as a region infected with rinderpest or foot-and-mouth 
disease is prohibited, except as provided in Sec.  94.16.

[40 FR 44123, Sept. 25, 1975, as amended at 62 FR 56022, Oct. 28, 1997]



Sec.  94.3  Organs, glands, extracts, or secretions of ruminants or swine.

    The importation of fresh (chilled or frozen) organs, glands, 
extracts, or secretions derived from ruminants or swine, originating in 
any region where rinderpest or foot-and-mouth disease exists, as 
designated in Sec.  94.1, except for pharmaceutical or biological 
purposes under conditions prescribed by the Administrator in each 
instance, is prohibited.

[28 FR 5980, June 13, 1963, as amended at 53 FR 48520, Dec. 1, 1988; 62 
FR 56022, Oct. 28, 1997; 63 FR 67574, Dec. 8, 1998]



Sec.  94.4  Cured or cooked meat from regions where rinderpest or 
foot-and-mouth disease exists.

    (a) The importation of cured meats derived from ruminants or swine, 
originating in any region where rinderpest or foot-and-mouth disease 
exists, as designated in Sec.  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 
Sec.  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 rinderpest or foot-and-mouth disease 
exists, as designated in Sec.  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

[[Page 475]]

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 Sec.  318.300(d) of 
this chapter, 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 [deg]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 [deg]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 [deg]C (175 
[deg]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 Sec.  
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

[[Page 476]]

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 Sec.  94.4 (b)(4) or (b)(5) 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) 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 Sec.  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, Sec.  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)(8)(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----------.''
    (9) The meat is inspected by an FSIS inspector at a port of arrival 
in a defrost facility approved by the Administrator \2\ and the meat is 
found to be thoroughly cooked.
---------------------------------------------------------------------------

    \2\ The names and addresses of approved defrost facilities and 
conditions for approval may be obtained from the Administrator, Animal 
and Plant Health Inspection Service, United States Department of 
Agriculture, Washington, DC 20250.
---------------------------------------------------------------------------

    (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.\3\
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    \3\ Conditions for the approval of any defrost facility by the Food 
Safety and Inspection Service, United States Department of Agriculture, 
may be obtained from the Import Inspection Division, International 
Programs, Food Safety and Inspection Service, United States Department 
of Agriculture, Washington, DC 20250.
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    (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.

[[Page 477]]

    (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 rinderpest or 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 Sec.  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 Sec.  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,

[[Page 478]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5980, June 13, 1963, as amended at 52 FR 33801, Sept. 8, 1987; 53 
FR 48520, Dec. 1, 1988; 54 FR 7393, Feb. 21, 1989; 59 FR 13186, Mar. 21, 
1994; 59 FR 67134, Dec. 29, 1994; 62 FR 42900, Aug. 11, 1997; 62 FR 
46180, Sept. 2, 1997; 62 FR 56022, Oct. 28, 1997; 63 FR 67575, Dec. 8, 
1998; 66 FR 29899, June 4, 2001; 68 FR 6345, Feb. 7, 2003; 68 FR 15936, 
Apr. 2, 2003]



Sec.  94.5  Regulation of certain garbage.

    (a) Garbage. For purposes of this part, garbage means all waste 
material 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 
on board any means of conveyance, and including 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 means of 
conveyance. For purposes of this subpart, garbage also means meals and 
other food that were available for consumption by passengers and crew on 
an aircraft but were not consumed.
    Note: Not all garbage is regulated for the purposes of this part. 
Garbage regulated for the purposes of this part is defined as 
``regulated garbage'' in paragraphs (b) and (c) of this section.
    (b) Garbage regulated because of movements outside the United States 
or Canada. For purposes of this part, 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:
    (1) Exception 1. Garbage on or removed from a means of conveyance 
other than an aircraft is exempt from requirements under paragraph (b) 
of this section if the following conditions are met when the garbage is 
on or removed from the means of conveyance:
    (i) The means of conveyance is accompanied by a certificate from an 
inspector stating the following:
    (A) That the means of conveyance had first been cleared of all 
garbage and of the following: All meats and meat products, whatever the 
region of origin, except meats that are shelf-stable; all fresh and 
condensed milk and cream from regions designated in 9 CFR 94.1 as those 
in which foot-and-mouth disease exists; all fresh fruits and vegetables; 
and all eggs; and the items 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 paragraph 
(f)(1) of this section.
    (B) That the means of conveyance had been cleaned and disinfected in 
the presence of the inspector; and
    (ii) Since being cleaned and disinfected, the means of conveyance 
has not been in a non-Canadian foreign port.
    (2) Exception 2. Garbage on or removed from an aircraft is exempt 
from requirements under paragraph (b) of this section if the following 
two conditions are met:

[[Page 479]]

    (i) The aircraft had been cleared of all garbage and all stores; and 
the items 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 paragraph (f)(1) of this section.
    (ii) After the garbage and stores referred to in paragraph (b)(2)(i) 
of this section were removed, the aircraft has not been in a non-
Canadian foreign port.
    (c) Garbage regulated because of certain movements to or from 
Hawaii, territories, or possessions. For purposes of this part, garbage 
on or removed from a means of conveyance is regulated garbage, if the 
means of conveyance has moved during the previous one-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:
    (1) Exception 1. Garbage on or removed from a means of conveyance 
other than an aircraft is exempt from requirements under paragraph (c) 
of this section if the following two conditions are met when the garbage 
is on or removed from the means of conveyance:
    (i) The means of conveyance is accompanied by a certificate from an 
inspector, stating that the means of conveyance has been cleared of all 
garbage and all fresh fruits and vegetables; and the items 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 paragraph (f)(1) of this section.
    (ii) After being cleared of the garbage and stores referred to in 
paragraph (c)(1)(i) 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.
    (2) Exception 2. Garbage on or removed from an aircraft is exempt 
from requirements under paragraph (c) of this section if the following 
two conditions are met when the garbage is on or removed from the means 
of conveyance:
    (i) The aircraft had been cleared of all garbage and all fresh 
fruits and vegetables; and the items 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 paragraph 
(f)(1) of this section.
    (ii) After the garbage and stores referred to in paragraph (c)(2)(i) 
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.
    (d) Garbage that is commingled with regulated garbage is also 
regulated garbage.
    (e) Restrictions on regulated garbage. (1) Regulated garbage shall 
not be on or removed from a means of conveyance, or be disposed of, 
unless in accordance with the provisions of this part.
    (2) To prevent the dissemination of plant pests and livestock or 
poultry diseases, regulated garbage is subject to general surveillance 
for compliance with this section by Animal and Plant Health Inspection 
Service inspectors and to disposal measures authorized by sections 414, 
421, and 434 of the Plant Protection Act (7 U.S.C. 7714, 7731, and 7754) 
the Animal Health Protection Act (7 U.S.C. 8301 et seq.).
    (f)(1) All regulated garbage must be contained in tight, leak-proof 
covered 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,

[[Page 480]]

leak-proof receptacles under the direction of an Animal and Plant Health 
Inspection Service inspector to an approved facility for incineration, 
sterilization, or grinding into an approved sewage system, under 
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 
complying with the applicable laws for environmental protection and as 
adequate to prevent the dissemination into or within the United States 
of plant pests and livestock or poultry diseases. 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.
    (2) 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 shall be endorsed by the operator of the facility 
or sewage system. 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 therefor and an opportunity to show cause why the 
approval should be reinstated.
    (g) APHIS will cooperate with other Federal, State, and local 
agencies responsible for enforcing other statutes and regulations 
governing disposal of 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 Environmental 
Protection Agency and other Federal, State, and local agencies also 
having jurisdiction over such regulated garbage.
    (h)(1) Shelf-stable means 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 [deg]F 
or 10 [deg]C).
    (2) Sterilization means cooking regulated garbage at 212 [deg]F. for 
30 minutes and disposal of the residue by burying in a landfill, except 
that the burial provisions do not apply to materials extracted from the 
residue after cooking and determined by the Administrator to be 
unsuitable for use as food or as soil additives.
    (3) Incineration means to reduce the regulated garbage to ash by 
burning.
    (4) Approved sewage system means 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 it is certified by an

[[Page 481]]

appropriate government official as currently complying with the 
applicable laws for environmental protection.
    (5) Approved facility means 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.
    (6) Carrier means the principal operator of a means of conveyance.
    (7) United States means the States, District of Columbia, Guam, the 
Northern Mariana Islands, Puerto Rico, and the Virgin Islands of the 
United States.
    (8) Territories or possessions means Guam, the Northern Mariana 
Islands, Puerto Rico, and the Virgin Islands of the United States.
    (9) Continental United States means the 49 States located on the 
continent of North America and the District of Columbia.
    (10) Person means any individual, corporation, company, association, 
firm, partnership, society, or joint stock company.
    (i) Compliance agreement and cancellation.(1) Any person engaged in 
the business of handling or disposing of regulated garbage 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, shall comply with the following conditions and 
any supplemental conditions which shall be listed in the compliance 
agreement, as deemed by the Administrator to be necessary to prevent the 
dissemination into or within the United States of plant pests and 
livestock or poultry diseases:
    (i) Comply with the provisions of 9 CFR 94.5;
    (ii) Allow APHIS inspectors access to all records maintained by the 
person regarding handling or disposal of regulated garbage, and to all 
areas where handling or disposal of regulated garbage occurs;
    (iii) Remove regulated garbage from a means of conveyance only in 
tight, leak-proof receptacles;
    (iv) Move the receptacles of regulated garbage only to a facility 
approved in accordance with Sec.  94.5(f)(2); and
    (v) At the approved facility, dispose of the regulated garbage only 
through incineration, sterilization, grinding into a sewage system 
approved in accordance with Sec.  94.5(f)(2), or in any other 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 requirements set forth in this 
section are not met, after notice of, and the reasons for, the proposed 
denial of the approval, and an opportunity to demonstrate or achieve 
compliance with such requirements, has been afforded to the compliance 
agreement applicant.
    (4) Any compliance agreement may be cancelled in writing by the 
Administrator whenever it is found that the person who has entered into 
the compliance agreement has failed to comply with this section. Any 
person whose compliance agreement has been cancelled 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 cancelled. 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 
conflicts 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 cancelled, regulated 
garbage

[[Page 482]]

may continue to be unloaded from a means of conveyance and disposed of 
at an approved facility in accordance with Sec.  94.5(f)(1).

(Approved by the Office of Management and Budget under control numbers 
0579-0015 and 0579-0054)

[39 FR 32323, Sept. 6, 1974, as amended at 43 FR 39956, Sept. 8, 1978; 
45 FR 80269, Dec. 4, 1980; 48 FR 57472, Dec. 30, 1983; 53 FR 22129, June 
14, 1988; 53 FR 48520, Dec. 1, 1988; 53 FR 49977, Dec. 13, 1988; 53 FR 
52576, Dec. 28, 1988; 58 FR 66248, Dec. 20, 1993; 59 FR 67134, Dec. 29, 
1994; 62 FR 19903, Apr. 24, 1997; 62 FR 56022, Oct. 28, 1997; 66 FR 
21063, Apr. 27, 2001; 68 FR 6345, Feb. 7, 2003]



Sec.  94.6  Carcasses, parts or products of carcasses, and eggs 

(other than hatching eggs) of poultry, game birds, or other birds; 
importations from regions where exotic Newcastle disease is 
considered to exist.

    (a) Regions where Exotic Newcastle disease (END) is considered to 
exist. (1) Exotic Newcastle disease (END) is considered to exist in all 
regions of the world except those listed in paragraph (a)(2) of this 
section.
    (2) The following regions are considered to be free of Exotic 
Newcastle disease (END): Australia, Canada, Chile, Costa Rica, Fiji, 
Finland, France, Great Britain (England, Scotland, Wales, and the Isle 
of Man), Greece, Iceland, Luxembourg, New Zealand, Republic of Ireland, 
Spain, Sweden, and Switzerland.
    (b) Carcasses, and parts or products of carcasses, from regions 
where END is considered to exist. Carcasses, and parts or products of 
carcasses, of poultry, game birds, or other birds may be imported only 
in accordance with this section if they: are of poultry, game birds, or 
other birds that were raised or slaughtered in any region where END is 
considered to exist (see paragraph (a) of this section); are imported 
from any region where END is considered to exist; or are moved into or 
through any region where END is considered to exist at any time before 
importation or during shipment to the United States.
    (1) Carcasses of game birds may be imported if eviscerated, with 
heads and feet removed. Viscera, heads, and feet removed from game birds 
are ineligible for entry into the United States.
    (2) Carcasses, or parts or products of carcasses, of poultry, game 
birds, and other birds 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 END into the United 
States, and which is approved by the Administrator. \4\
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    \4\ The names and addresses of approved establishments may be 
obtained from, and requests for approval may be made to, the Animal and 
Plant Health Inspection Service, Veterinary Services, National Center 
for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-
1231.
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    (3) Carcasses, or parts or products of carcasses, of poultry, game 
birds, and other birds, may be imported if packed in hermetically sealed 
containers and if cooked by a commercial method after such packing to 
produce articles which are shelf stable without refrigeration.
    (4) Carcasses, or parts or products of carcasses, of poultry, game 
birds, and other birds may be imported if thoroughly cooked, and if, 
upon inspection by a representative of the United States Department of 
Agriculture at the port of arrival, the carcasses or parts or products 
thereof have a thoroughly cooked appearance throughout.
    (5) Poultry carcasses or parts or products of poultry carcasses that 
originated in a region considered to be free of END and are processed 
(cut, packaged, and/or cooked) in a region where END is considered to 
exist may be imported under the following conditions:
    (i) Shipment to approved establishments. (A) The poultry carcasses 
or parts or products of poultry carcasses must be shipped from the END-
free region where they originated 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 products' region of origin, the processing 
establishment to which the poultry carcasses or parts or

[[Page 483]]

products of poultry carcasses are consigned, and the numbers of the 
seals applied to the shipping containers.
    (B) the poultry carcasses or parts or products of poultry carcasses 
may be removed from containers at the processing establishment in the 
region where END 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. The official must attest to this 
fact by signing the certificate accompanying the shipment.
    (ii) Handling of poultry carcasses or parts or products of poultry 
carcasses. Establishments \5\ in regions where END is considered to 
exist that process poultry carcasses or parts or products of poultry 
carcasses for export to the United States:
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    \5\ As a condition of entry into the United States, poultry or 
poultry products must also meet all of the requirements of the Poultry 
Products Inspection Act (21 U.S.C. 451 et seq.) and regulations 
thereunder (9 CFR part 381), including requirements that the poultry or 
poultry products be prepared only in approved establishments.
---------------------------------------------------------------------------

    (A) May not receive or handle any live poultry.
    (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 poultry carcasses or parts or products of poultry 
carcasses that originate in both END-free regions and regions where END 
is considered to exist, provided that:
    (1) All areas, utensils, and equipment likely to contact the poultry 
carcasses or parts or products of poultry carcasses to be processed, 
including skimming, deboning, cutting, and packing areas, are cleaned 
and disinfected between processing poultry from regions where END is 
considered to exist and poultry carcasses or parts or products of 
poultry carcasses from END-free regions.
    (2) Poultry carcasses or parts or products of poultry carcasses 
intended for export to the United States are not handled, cut, or 
otherwise processed at the same time as any poultry not eligible for 
export to the United States.
    (3) Poultry carcasses or parts or products of poultry carcasses 
intended for export to the United States are packed in clean new 
packaging that is clearly distinguishable from that containing any 
poultry not eligible for export to the United States.
    (4) Poultry carcasses or parts or products of poultry carcasses 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 carcasses and parts or 
products of poultry carcasses 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 poultry was 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) Carcasses or parts or products of carcasses, of poultry, game 
birds, and other birds that do not otherwise qualify for importation 
under paragraphs (b)(1) through (b)(5) of this section may be imported 
only if the importer applies to, and is granted a permit by, the 
Administrator, authorizing such importation. Permission will be given

[[Page 484]]

only when the Administrator determines that such importation will not 
constitute a risk of introduction or dissemination of END 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 END is 
considered to exist. Eggs (other than hatching eggs \6\) from poultry, 
game birds, or other birds may be imported only in accordance with this 
section if they: Are laid by poultry, game birds, or other birds that 
are raised in any region where END is considered to exist (see paragraph 
(a) of this section); are imported from any region where END is 
considered to exist; or are moved into or through any region where END 
is considered to exist at any time before importation or during shipment 
to the United States.
---------------------------------------------------------------------------

    \6\ The requirements for importing hatching eggs are contained in 
part 93 of this chapter.
---------------------------------------------------------------------------

    (1) With a certificate. The eggs may be imported if they are 
accompanied by a certificate signed by a salaried veterinarian of the 
national government of the region of origin 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) No more than 90 days before the certificate was signed, a 
salaried veterinary officer of the national government of the region of 
origin 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 who signed the 
certificate.
    (ix) And, if the eggs were laid in any region where END is 
considered to exist (see paragraph (a) of this section):
    (A) No END 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 END 
during the 90 days before the certificate was signed.
    (C) The eggs are from a flock of origin found free of END in one of 
the following ways:
    (1) Sentinel birds \7\ were present in the flock of origin for at 
least 60 days before the certificate was signed. There was at least 1 
sentinel bird per 1,000 poultry, with at least 30 sentinel birds per 
house. The sentinel birds remained free of clinical and immunological 
evidence of END as demonstrated by negative hemagglutination inhibition 
tests conducted on blood samples drawn at 10-day intervals by a salaried 
veterinary officer of the national government of the region of origin. 
The tests were conducted in a laboratory located in the region of 
origin, and the laboratory was approved to conduct the tests by the 
national government of that region or;
---------------------------------------------------------------------------

    \7\ For information on sources of sentinel birds, contact the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Animal Health Policy Programs, 4700 River Road Unit 33, Riverdale, 
Maryland 20737-1231.
---------------------------------------------------------------------------

    (2) Once every week, beginning at least 60 days before the 
certificate was signed, a salaried veterinary officer of the national 
government of the region of origin collected carcasses of all poultry 
that died during that week, and the

[[Page 485]]

carcasses were examined for END using the embryonated egg inoculation 
technique. Once a month, beginning at least 60 days before the 
certificate was signed, a salaried veterinary officer of the national 
government of the region of origin collected tracheal and cloacal swabs 
from not less than 10 percent of the poultry in the flock, and the swabs 
were tested for END. All examinations and tests were conducted in a 
laboratory located in the region of origin, and the laboratory was 
approved to conduct the tests and examinations by the national 
government of that region. All results were negative for END.
    (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 END 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 END 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 END 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 END 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 END into the United States.
    (d) To apply for a permit, contact the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[39 FR 39546, Nov. 8, 1974; 39 FR 41242, Nov. 26, 1974]

    Editorial Note: For Federal Register citations affecting Sec.  94.6, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



Sec.  94.7  Disposal of animals, meats, and other articles ineligible 
for importation.

    (a) Ruminants and swine, and fresh (chilled or frozen) meats, 
prohibited importation under Sec. Sec.  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 Sec. Sec.  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 Sec. Sec.  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

[[Page 486]]

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 Sec. Sec.  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.

[68 FR 6345, Feb. 7, 2003]



Sec.  94.8  Pork and pork products from regions where African swine 
fever exists or is reasonably believed to exist.

    African swine fever exists or the Administrator has reason to 
believe that African swine fever exists \8\ in: All the countries of 
Africa, Brazil, Cuba, Haiti, Malta, and the Island of Sardinia, Italy.
---------------------------------------------------------------------------

    \8\ The Administrator bases the reason to believe African swine 
fever exists in a region the following factors: (1) 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 
(2) 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 (3) 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 (4) 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, (5) Any other fact or circumstance found to exist 
which constitutes a risk of introduction of African swine fever into the 
United States.
---------------------------------------------------------------------------

    (a) 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 (a)(4).
    (ii) Was heated by other than a flash-heating method to an internal 
temperature of at least 69 [deg]C. (156 [deg]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.

[[Page 487]]

    (4) The processing establishment \9\ in a region listed in this 
section must comply with the following requirements:
---------------------------------------------------------------------------

    \9\ As a condition of entry into the United States, pork or pork 
products must also meet all of the requirements of the Federal Meat 
Inspection Act (21 U.S.C. 601 et seq.) and regulations thereunder (9 
CFR, chapter III, part 327), including requirements that the pork or 
pork products be prepared only in approved establishments.
---------------------------------------------------------------------------

    (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.
    (b) Pork or pork products consigned from the port of arrival to an 
approved establishment under the provisions of paragraph (a)(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.
    (c) 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5980, June 13, 1963]

    Editorial Note: For Federal Register citations affecting Sec.  94.8, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



Sec.  94.9  Pork and pork products from regions where classical swine 
fever exists.

    (a) Classical swine fever is known to exist in all regions of the 
world except Australia; Canada; Denmark; England; Fiji; Finland; 
Iceland; Isle of Man; the Mexican States of Baja California, Baja 
California Sur, Chihuahua, and Sinaloa; New Zealand; Northern Ireland; 
Norway; the Republic of Ireland; Scotland; Sweden; Trust Territory of 
the Pacific Islands; Wales; and a single region in the European Union 
consisting of Austria, Belgium, Germany (except for the Kreis Uckermark 
in the Land of Brandenburg; the Kreis Oldenberg, the Kreis Soltau-
Fallingbostel, and the Kreis Vechta in the Land of Lower Saxony; the 
Kreis Heinsberg and the Kreis Warendorf in the Land of Northrhine-
Westphalia; the Kreis Bernkastel-Wittlich, the Kreis Bitburg-Prm, the 
Kreis Donnersbergkreis, the Kreis Rhein-Hunsrche, the Kreis Sdliche 
Weinstrasse, and the Kreis Trier-Saarburg in the Land of Rhineland 
Palatinate; and the Kreis Altmarkkreis in the Land of Saxony-Anhalt); 
Greece; Italy (except for the Regions of Emilia-Romagna, Piemonte, and 
Sardegna); the Netherlands; and Portugal.\10\
---------------------------------------------------------------------------

    \10\ See also other provisions of this part and parts 93, 95, and 96 
of this chapter and part 327 of this title for other prohibitions and 
restrictions upon importation of swine and swine products.
---------------------------------------------------------------------------

    (b) No 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:

[[Page 488]]

    (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 [deg]C. (156 [deg]F.) 
throughout; or
    (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 in 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 (b)(3) of this section also 
states that: The container seals specified in paragraph 
(b)(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 in paragraph (a) of this section as 
free of classical swine fever and processes all such pork or pork 
products in accordance with paragraph (b)(1)(i), (ii), or (iii) of this 
section.
    (2) Articles under paragraph (b)(1)(ii) or (iii) 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 Sec.  327.2 of this title; and,
    (3) In addition to the foreign meat inspection certificate required 
by Sec.  327.4 of this title, pork and pork products prepared under 
paragraph (b)(1)(ii) or (iii) of this section shall be accompanied by a 
certificate that states that the provisions of paragraph (b)(1)(ii) or 
(iii) 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 
Sec.  327.4 of this title.\11\ 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.
---------------------------------------------------------------------------

    \11\ The certification required may be placed on the foreign meat 
inspection certificate prescribed by Sec.  327.4 of this title or may be 
contained in a separate document.
---------------------------------------------------------------------------

    (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.
    (c) Thoroughly cured and fully dried pork and pork products from 
regions where both classical swine fever and

[[Page 489]]

swine vesicular disease are known or considered to exist need not comply 
with paragraph (b)(1)(iii) of this section if they are in compliance 
with the provisions of Sec.  94.12(b)(1)((iii) of this part.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[37 FR 21149, Oct. 6, 1972]

    Editorial Note: For Federal Register citations affecting Sec.  94.9, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



Sec.  94.10  Swine from regions where classical swine fever exists.

    (a) Classical swine fever is known to exist in all regions of the 
world except Australia; Canada; Denmark; England; Fiji; Finland; 
Iceland; Isle of Man; the Mexican States of Baja California, Baja 
California Sur, Chihuahua, and Sinaloa; New Zealand; Northern Ireland; 
Norway; the Republic of Ireland; Scotland; Sweden; Trust Territory of 
the Pacific Islands; Wales; and a single region in the European Union 
consisting of Austria, Belgium, Germany (except for the Kreis Uckermark 
in the Land of Brandenburg; the Kreis Oldenberg, the Kreis Soltau-
Fallingbostel, and the Kreis Vechta in the Land of Lower Saxony; the 
Kreis Heinsberg and the Kreis Warendorf in the Land of Northrhine-
Westphalia; the Kreis Bernkastel-Wittlich, the Kreis Bitburg-Prm, the 
Kreis Donnersbergkreis, the Kreis Rhein-Hunsrche, the Kreis Sdliche 
Weinstrasse, and the Kreis Trier-Saarburg in the Land of Rhineland 
Palatinate; and the Kreis Altmarkkreis in the Land of Saxony-Anhalt); 
Greece; Italy (except for the Regions of Emilia-Romagna, Piemonte, and 
Sardegna); the Netherlands; and Portugal. 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 (b) of this section.
    (b) Wild swine may be allowed importation into the United States by 
the Administrator upon request in specific cases under Sec.  93.504(c) 
or Sec.  93.501 of this chapter.

[54 FR 7394, Feb. 21, 1989, as amended at 54 FR 13053, Mar. 30, 1989; 55 
FR 31558, Aug. 2, 1990; 58 FR 11367, Feb. 25, 1993; 61 FR 40293, Aug. 2, 
1996; 62 FR 8868, Feb. 27, 1997; 62 FR 28620, May 27, 1997; 62 FR 43925, 
Aug. 18, 1997; 62 FR 56022, Oct. 28, 1997; 65 FR 56775, Sept. 20, 2000; 
68 FR 16939, Apr. 7, 2003; 68 FR 47841, Aug. 12, 2003; 68 FR 59531, Oct. 
16, 2003]



Sec.  94.11  Restrictions on importation of meat and other animal 
products from specified regions.

    (a) Austria, The Bahamas, Belgium, Channel Islands, Chile, Czech 
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, 
Ireland, Italy, Japan, Luxembourg, The Netherlands, Norway, Papua New 
Guinea, Poland, Portugal, Spain, Sweden, Switzerland, and the United 
Kingdom, which are declared in Sec.  94.1(a)(2) to be free of rinderpest 
and foot-and-mouth disease, supplement their national meat supply by the 
importation of fresh (chilled or frozen) meat of ruminants or swine from 
regions that are designated in Sec.  94.1(a) to be infected with 
rinderpest or foot-and-mouth disease; or have a common land border with 
regions designated as infected with rinderpest or foot-and-mouth 
disease; or import ruminants or swine from regions designated as 
infected with rinderpest or foot-and-mouth disease under conditions less 
restrictive than would be acceptable for importation into the United 
States. Thus, even though this Department has declared such regions to 
be free of rinderpest and foot-and-mouth disease, 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 infected region, 
resulting in an undue risk of introducing rinderpest or foot-and-mouth 
disease into the United States. Therefore, meat of ruminants or swine, 
and other animal products, and ship stores, airplane meals, and baggage 
containing such meat or animal products originating in the free regions 
listed in this section shall not be imported into the United States 
unless the following requirements in addition to other applicable 
requirements of chapter III of this title are met. However, meat and

[[Page 490]]

meat products which meet the requirements of Sec.  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 96 of this chapter.
    (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 Sec.  327.2, chapter III of this title, issued thereunder, and shall 
be accompanied by a Department-approved meat inspection certificate 
prescribed in Sec.  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 regions designated in paragraph (a) 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 listed in Sec.  94.1(a) as a region 
infected with rinderpest or foot-and-mouth disease;
    (2) The slaughtering establishment is not permitted to receive meat 
or other animal products derived from ruminants or swine which 
originated in such a rinderpest or foot-and-mouth disease infected 
region, or meat or other animal products from a rinderpest and foot-and-
mouth disease free region transported through a rinderpest or foot-and-
mouth disease infected 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 in Sec.  
94.1(a)(2) as free of rinderpest and foot-and-mouth disease and the meat 
or other animal product has never been in any region in which rinderpest 
or 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[38 FR 2752, Jan. 30, 1973]

    Editorial Note: For Federal Register citations affecting Sec.  
94.11, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  94.12  Pork and pork products from regions where swine vesicular 
disease exists.

    (a) Swine vesicular disease is considered to exist in all regions of 
the world except Australia, Austria, the Bahamas, Belgium, Bulgaria, 
Canada, Central American countries, Chile, Denmark, Dominican Republic, 
Fiji, Finland, France, Germany, Greece, Greenland, Haiti, Hungary, 
Iceland, Luxembourg, Mexico, the Netherlands, New Zealand, Norway, 
Panama, Portugal, Republic of Ireland, Romania, Spain, Sweden, 
Switzerland, Trust Territories of the Pacific, the United Kingdom

[[Page 491]]

(England, Scotland, Wales, the Isle of Man, and Northern Ireland), 
Yugoslavia, and the Regions in Italy of Friuli, Liguria, Marche, and 
Valle d'Aosta.
    (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 [deg]C. (156 [deg]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,\12\ for heating to an internal temperature of 166 [deg]F. 
During movement from the port of entry to the meat processing 
establishment, the pork or pork products must be moved under Department 
seals or seals of the the U.S. Customs Service, and shall be otherwise 
handled as the Administrator may direct in order to guard against the 
introduction and dissemination of swine vesicular disease. Seals applied 
under this section may not be broken except by persons authorized by the 
Administrator to do so.
---------------------------------------------------------------------------

    \12\ The names and addresses of approved establishments may be 
obtained from, and request for approval of any establishment may be made 
to, the Animal and Plant Health Inspection Service, Veterinary Services, 
National Center for Import-Export, 4700 River Road Unit 38, Riverdale, 
Maryland 20737-1231. Establishments will be approved only if the 
Administrator determines that the imported articles will be so handled 
at the establishment as to prevent the introduction and dissemination of 
livestock or poultry diseases into the United States. Approval of any 
establishment may be refused or withdrawn only after the operator 
thereof has been given notice of the proposed action and has had an 
opportunity to present his views thereon.
---------------------------------------------------------------------------

    (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 infected 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 in 
paragraph (a) 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 
infected region by a

[[Page 492]]

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 in paragraph (a) 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 [deg]C. (149 [deg]F.) throughout. The oven temperature 
started at a minimum of 62 [deg]C. (143.6 [deg]F.) and reached at least 
85 [deg]C. (185 [deg]F.).
    (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 Sec.  327.2 in chapter III of this 
title.
    (3) In addition to the foreign meat inspection certificate required 
in Sec.  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 Sec.  327.4 of this title.\13\ 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.
---------------------------------------------------------------------------

    \13\ See footnote 10 in Sec.  94.9 of this part.
---------------------------------------------------------------------------

    (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 Sec.  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 Sec.  94.12 
or Sec.  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

[[Page 493]]

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 [deg]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 Sec.  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.

(Approved by the Office of Management and Budget under control numbers 
0579-0015 and 0579-0214)

[38 FR 20610, Aug. 2, 1973]

    Editorial Note: For Federal Register citations affecting Sec.  
94.12, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.

[[Page 494]]



Sec.  94.13  Restrictions on importation of pork or pork products 
from specified regions.

    Austria, the Bahamas, Belgium, Bulgaria, Chile, Denmark, France, 
Germany, Hungary, Luxembourg, the Netherlands, Portugal, Republic of 
Ireland, Spain, Switzerland, the United Kingdom (England, Scotland, 
Wales, the Isle of Man, and Northern Ireland), Yugoslavia, and the 
Regions in Italy of Friuli, Liguria, Marche, and Valle d'Aosta are 
declared free of swine vesicular disease in Sec.  94.12(a) of this part. 
These regions either 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, 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 produced in such regions 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. Therefore, pork 
or pork products and ship's stores, airplane meals, and baggage 
containing such pork, other than those articles regulated under part 95 
or part 96 of this chapter, produced in such regions shall not be 
brought into the United States unless the following requirements are met 
in addition to other applicable requirements of part 327 of this title:
    (a) All such pork or pork products, except those treated in 
accordance with Sec.  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 Sec.  327.2 of this 
title and shall be accompanied by the foreign meat inspection 
certificate required by Sec.  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.
    (b) Unless such pork or pork products are treated according to one 
of the procedures described in Sec.  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, or have ever been in a region listed in 
Sec.  94.12(a) as a region in which swine vesicular disease is 
considered to exist;
    (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 
in Sec.  94.12 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[38 FR 20611, Aug. 2, 1973]

    Editorial Note: For Federal Register citations affecting Sec.  
94.13, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  94.14  Swine from regions where swine vesicular disease exists; 
importations prohibited.

    (a) Swine vesicular disease is known to exist in all regions of the 
world except those listed in Sec.  94.12(a) of this

[[Page 495]]

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 Sec.  93.501 or 
Sec.  93.504(c) of this chapter.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[54 FR 7395, Feb. 21, 1989, as amended at 55 FR 31558, Aug. 2, 1990; 59 
FR 67134, Dec. 29, 1994; 62 FR 56023, Oct. 28, 1997]



Sec.  94.15  Animal products and materials; movement and handling.

    (a) Any animal product or material which would be eligible for entry 
into the United States, as specified in the regulations in this part, 
may transit through the United States for immediate export if the 
following conditions are met:
    (1) Notification of the transiting of such animal product or 
material must be made by the importer to the Plant Protection and 
Quarantine Officer at the United States port of arrival prior to such 
transiting, and
    (2) The animal product or material transited shall be contained in a 
sealed, leakproof carrier or container which shall remain sealed while 
aboard the transporting carrier or other means of conveyance, or if the 
container or carrier in which such animal product or material is 
transported is offloaded in the United States for reshipment, it shall 
remain sealed at all times.
    (b) 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 
are met:
    (1) The person desiring to move the pork and pork products through 
the United States obtains a United States Veterinary Permit for 
Importation and Transportation of Controlled Materials and Organisms and 
Vectors (VS Form 16-6). (An application for the permit may be obtained 
from the Animal and Plant Health Inspection Service, Veterinary 
Services, National Center for Import-Export, 4700 River Road Unit 38, 
Riverdale, Maryland 20737-1231.)
    (2) The pork or pork products are packaged at a Tipo 
Inspecci[oacute]n 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 Plant Protection and Quarantine Officer 
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 transit the United States under 
Customs bond and are 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.).
    (c) 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

[[Page 496]]

the United States via land ports for immediate export if the following 
conditions are met:
    (1) The person desiring to move the poultry carcasses, parts, or 
products through the United States obtains a United States Veterinary 
Permit for Importation and Transportation of Controlled Materials and 
Organisms and Vectors (VS Form 16-6). An application for the permit may 
be obtained from the Animal and Plant Health Inspection Service, 
Veterinary Services, National Center for Import-Export, 4700 River Road 
Unit 38, Riverdale, Maryland 20737-1231.
    (2) The poultry carcasses, parts, or products are packaged at a Tipo 
Inspeccio[oacute]n 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 across Mexico and the 
United States.
    (3) The person moving the poultry carcasses, parts, or products 
through the United States notifies, in writing, the Plant Protection and 
Quarantine Officer at the U.S. 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 transit the United 
States under U.S. Customs bond and are 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.).
    (d) Meat and other products of ruminants or swine from regions 
listed in Sec.  94.11(a) and pork and pork products from regions listed 
in Sec.  94.13 that do not meet the requirements of Sec.  94.11(b) or 
Sec.  94.13(a) may transit through the United States for immediate 
export, provided the provisions of paragraph (a) of this section are 
met, and provided all other applicable provisions of this part are met.
    (e) Any meat or other animal products not otherwise eligible for 
entry into the United States, as provided in this part and part 95 of 
this chapter, may transit the United States for immediate export if the 
following conditions are met:
    (1) Notification of the transiting of such meat or other animal 
product is made by the importer to the Plant Protection and Quarantine 
officer at the United States port of arrival prior to such transiting;
    (2) The meat or other animal product is contained in a sealed, 
leakproof carrier or container, which remains sealed while aboard the 
transporting carrier or other means of conveyance, or, if the container 
or carrier in which the meat or other animal product is transported is 
offloaded in the United States for reshipment, it remains sealed at all 
times;
    (3) Such transit is limited to the maritime or airport port of 
arrival only, with no overland movement outside the airport terminal 
area or dock area of the maritime port; and
    (4) The meat or other animal product is not held or stored for more 
than 72 hours at the maritime or airport port of arrival.

(Approved by the Office of Management and Budget under control numbers 
0579-0040 and 0579-0145)

[43 FR 4595, Feb. 3, 1978, as amended at 57 FR 23928, June 5, 1992; 57 
FR 43886, Sept. 23, 1992; 59 FR 67616, Dec. 30, 1994; 60 FR 57315, Nov. 
15, 1995; 61 FR 32647, June 25, 1996; 62 FR 24804, May 7, 1997; 62 FR 
56023, Oct. 28, 1997; 65 FR 37270, June 14, 2000; 65 FR 50605, Aug. 21, 
2000; 68 FR 6345, Feb. 7, 2003]

[[Page 497]]



Sec.  94.16  Milk and milk products.

    (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 designated in Sec.  94.1(a) as a region infected with rinderpest 
or foot-and-mouth disease 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\14\ for further processing in a manner 
approved by the Administrator, as adequate to prevent the introduction 
or dissemination of livestock diseases into the United States. However, 
in specific cases, upon request by the importer to the Administrator, 
and approval by the Administrator, they may be stored for a temporary 
period in an approved warehouse\14\ under the supervision of an 
inspector of the Animal and Plant Health Inspection Service pending 
movement to an approved establishment. Such products shall be 
transported from the United States port of first arrival to an approved 
establishment\14\ or an approved warehouse,\14\ and from an approved 
warehouse\14\ to an approved establishment\14\ only under Department 
seals or seals of the U.S. Customs Service. Such seals shall be broken 
only by such an inspector or other person authorized to do so by the 
Administrator. Such products shall not be removed from the approved 
warehouse\14\ or approved establishment\14\ except upon special 
permission by the Administrator, and upon compliance with all the 
conditions and requirements specified by him for such movement in each 
specific case.
---------------------------------------------------------------------------

    \14\ The names and addresses of approved establishments or 
warehouses or information as to approved manner of processing, and 
request for approval of any such establishment, warehouse, or manner of 
processing may be made to the Animal and Plant Health Inspection 
Service, Veterinary Services, National Center for Import-Export, 4700 
River Road Unit 38, Riverdale, Maryland 20737-1231. Any establishment or 
warehouse will be approved for the purpose of this section only if the 
operator has provided the Administrator, with satisfactory evidence that 
the establishment or warehouse has the equipment, facilities, and 
capability to store, handle and process the imported dry milk or dry 
milk product subject to Sec.  94.16(b)(2) in a manner which will prevent 
the introduction or dissemination of livestock diseases into the United 
States. Similarly, processing methods will be approved only if the 
Administrator determines they are adequate to prevent the introduction 
or dissemination of such diseases into the United States. Approval of 
any establishment or warehouse or processing method may be refused or 
withdrawn by the Administrator only after the operator thereof has been 
given notice of the proposed action and has had an opportunity to 
present his views thereon, and upon a determination by the Administrator 
that the conditions for approval are not met. Approval of an 
establishment or warehouse may also be withdrawn after such notice and 
opportunity if the Administrator determines that such imported dry milk 
or milk products have been stored, handled, or processed by the operator 
thereof other than at an approved establishment or warehouse or other 
than in an approved manner.
---------------------------------------------------------------------------

    (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,

[[Page 498]]

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 in Sec.  94.1(a)(2) as free of rinderpest and foot-and-mouth 
disease but which have entered a port or otherwise transited any region 
designated in Sec.  94.1(a)(1) as a region infected with rinderpest or 
foot-and-mouth disease shall 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 in Sec.  94.1(a)(2) as free of rinderpest and 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 in Sec.  94.1(a)(2), or that the milk product was 
processed in a region listed in Sec.  94.1(a)(2) from milk produced in a 
region listed in Sec.  94.1(a)(2). 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 Sec.  94.16(c), the milk or milk 
product has never been in any region in which rinderpest or foot-and-
mouth disease exists. Milk or milk products from a region listed in 
Sec.  94.1(a)(2) that were processed in whole or in part from milk or 
milk products from a region not listed in Sec.  94.1(a)(2) may be 
imported into the United States in accordance with Sec.  94.16(b)(3).

(Approved by the Office of Management and Budget under control number 
0579-0015)

[40 FR 44123, Sept. 25, 1975, as amended at 48 FR 57472, Dec. 30, 1983; 
50 FR 20390, May 16, 1985; 50 FR 24187, June 10, 1985; 53 FR 22129, June 
14, 1988; 53 FR 48520, Dec. 1, 1988; 54 FR 7395, Feb. 21, 1989; 55 FR 
38982, Sept. 24, 1990; 59 FR 67616, Dec. 30, 1994; 60 FR 15858, Mar. 28, 
1995; 62 FR 46181, Sept. 2, 1997; 62 FR 56023, Oct. 28, 1997; 64 FR 
38550, July 19, 1999]

[[Page 499]]



Sec.  94.17  Dry-cured pork products from regions where foot-and-mouth 

disease, rinderpest, African swine fever, classical swine fever, or 
swine vesicular disease exists.

    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, rinderpest, 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, rinderpest, 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;\15\
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    \15\ As a condition of entry into the United States, pork and pork 
products must also meet all of the requirements of the Federal Meat 
Inspection Act (21 U.S.C. 601 et seq.) and regulations thereunder (9 
CFR, chapter III), including requirements that the pork or pork products 
be prepared only in approved establishments.
---------------------------------------------------------------------------

    (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 [deg]C (168.8 [deg]F), which may have been placed over the 
meat during curing, the dry-

[[Page 500]]

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[deg]-3[deg]C. (32[deg]-
34.7[deg]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[deg]-4[deg]C. 
(32[deg]-39.2[deg]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[deg]-4[deg]C. (32[deg]-39.2[deg]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[deg]-
6[deg]C. (33.8[deg]-42.8[deg]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[deg]-23[deg]C. (59[deg]-73.4[deg]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[deg]-20[deg]C. (59[deg]-68[deg]F.) and at a relative 
humidity of 65-80 percent at the beginning and increased by 5 percent 
every 2\1/2\ months until a relative humidity of 85 percent was reached.
    (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 [deg]C to 13 [deg]C (53.6 [deg]F to 55.4 [deg]F) for 
the first 24 hours, then at 13 [deg]C to 14 [deg]C (55.4 [deg]F to 57.2 
[deg]F) until the internal temperature of the ham reached 3 [deg]C to 4 
[deg]C (37.4 [deg]F to 39.2 [deg]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 [deg]C to 4 [deg]C (32 [deg]F to 39.2 [deg]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 [deg]C to 6 [deg]C (32 [deg]F to 42.8 [deg]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 [deg]C to 16 [deg]C (42.8 [deg]F to 60.8 
[deg]F), maintained for a minimum of 45 days;
    (B) A temperature of 16 [deg]C to 24 [deg]C (60.8 [deg]F to 75.2 
[deg]F), maintained for a minimum of 35 days;
    (C) A temperature of 24 [deg]C to 34 [deg]C (75.2 [deg]F to 93.2 
[deg]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 [deg]C to 20 [deg]C (53.6 
[deg]F to 68 [deg]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 [deg]C to 6.5 [deg]C (41.9 [deg]F to 43.7 [deg]F) for 
the first 24 hours, then at 9.5 [deg]C to 10.5 [deg]C (49.1 [deg]F to 
50.9 [deg]F) until the internal temperature of the ham reached 3 [deg]C 
to

[[Page 501]]

4 [deg]C (37.4 [deg]F to 39.2 [deg]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 [deg]C to 4 [deg]C (32 [deg]F to 39.2 [deg]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 [deg]C to 6 [deg]C (32 [deg]F to 42.8 [deg]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 [deg]C to 16 [deg]C (42.8 [deg]F to 60.8 [deg]F) and relative humidity 
of 60 to 80 percent for a minimum of 90 days.
    (vi) The temperature was raised to 16 [deg]C to 26 [deg]C (60.8 
[deg]F to 78.8 [deg]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 [deg]C to 22 [deg]C (53.6 
[deg]F to 71.6 [deg]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 [deg]C to 13 [deg]C (53.6 [deg]F to 55.4 [deg]F), with 
the relative humidity between 75 and 85 percent, for approximately 24 
hours, until the internal temperature reached 3 [deg]C to 4 [deg]C (37.4 
[deg]F to 39.2 [deg]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 [deg]C to 4 [deg]C (32 [deg]F to 39.2 
[deg]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 [deg]C to 6 [deg]C (32 [deg]F to 42.8 [deg]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 [deg]C to 16 [deg]C (42.8 [deg]F to 60.8 [deg]F) and a 
relative humidity of 60 to 80 percent for a minimum of 90 days.
    (vi) The temperature was raised to 16 [deg]C to 26 [deg]C (60.8 
[deg]F to 78.8 [deg]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 [deg]C to 22 [deg]C 
(53.6 [deg]F to 71.6 [deg]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 [deg]C to 12 [deg]C (51.8 [deg]F to 53.6 
[deg]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 [deg]C to 4 [deg]C (37.4 [deg]F to 39.2 
[deg]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 [deg]C to 4 [deg]C (37.4 [deg]F to 39.2 [deg]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.

[[Page 502]]

    (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 [deg]C to 6 [deg]C (35.6 [deg]F to 42.8 
[deg]F), maintained for a minimum of 20 days;
    (B) A temperature of 6 [deg]C to 15 [deg]C (42.8 [deg]F to 59.0 
[deg]F), maintained for a minimum of 20 days;
    (C) A temperature of 15 [deg]C to 25 [deg]C (59.0 [deg]F to 77.0 
[deg]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 [deg]C to 5 [deg]C (32.0 [deg]F 
to 41.0 [deg]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

[[Page 503]]

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 been determined by the 
Administrator, to be free of rinderpest, and which has through its 
veterinary services submitted 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

[[Page 504]]

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 \16\ must be inspected, prior to slicing and packaging any 
hams, pork shoulders, or pork loins in accordance with this paragraph, 
by an APHIS representative and determined by the Administrator to be 
capable of meeting the provisions of this paragraph.
---------------------------------------------------------------------------

    \16\ See footnote 15 in Sec.  94.17(e) of this part.
---------------------------------------------------------------------------

    (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

[[Page 505]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[52 FR 11625, Apr. 10, 1987, as amended at 53 FR 48520, Dec. 1, 1988; 54 
FR 7395, Feb. 21, 1989, 59 FR 55024, Nov. 3, 1994; 59 FR 67134, Dec. 29, 
1994; 62 FR 46181, Sept. 2, 1997; 62 FR 56023, Oct. 28, 1997; 62 FR 
61004, Nov. 14, 1997; 64 FR 38550, July 19, 1999; 68 FR 16939, Apr. 7, 
2003]



Sec.  94.18  Restrictions on importation of meat and edible products 
from ruminants due to bovine spongiform encephalopathy.

    (a)(1) Bovine spongiform encephalopathy exists in the following 
regions: Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, 
France, Germany, Greece, the Republic of Ireland, Israel, Italy, Japan, 
Liechtenstein, Luxembourg, Oman, The Netherlands, Poland, Portugal, 
Slovakia, Slovenia, Spain, Switzerland, and the United Kingdom.
    (2) The following regions, because of import requirements less 
restrictive than those that would be acceptable for import into the 
United States and/or because of inadequate surveillance, present an 
undue risk of introducing bovine spongiform encephalopathy into the 
United States: Albania, Andorra, Bosnia-Herzegovina, Bulgaria, Croatia, 
the Federal Republic of Yugoslavia, Hungary, the Former Yugoslav 
Republic of Macedonia, Monaco, Norway, Romania, San Marino, and Sweden.
    (3) A region may request at any time that the Administrator consider 
its removal from a list set forth in paragraphs (a)(1) or (a)(2) of this 
section by following the procedures set forth in Sec. Sec.  92.2(b) (1) 
through (4), 92.2(b) (5) through (11), and 92.2(c) of this chapter.
    (b) Except as provided in paragraph (d) of this section, the 
importation of fresh (chilled or frozen) meat, meat products, and edible 
products other than meat (excluding gelatin, milk, and milk products), 
from ruminants that have been in any of the countries listed in 
paragraph (a) of this section is prohibited.
    (c) Gelatin. The importation of gelatin derived from ruminants that 
have been in any region listed in paragraph

[[Page 506]]

(a) of this section is prohibited unless the following conditions have 
been met:
    (1) The gelatin must be imported for use in human food, human 
pharmaceutical products, photography, or some other use that will not 
result in the gelatin coming in contact with ruminants in the United 
States.
    (2) The person importing the gelatin 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.\17\
---------------------------------------------------------------------------

    \17\ VS form 16-3 may be obtained from the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (3) The permit application must state the intended use of the 
gelatin and the name and address of the consignee in the United States.
    (d) Transit shipment of articles. Fresh (chilled or frozen) meat, 
and edible products other than meat, that are prohibited importation 
into the United States in accordance with this section may transit the 
United States for immediate export if the following conditions are met:
    (1) The person moving the articles 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.\18\
---------------------------------------------------------------------------

    \18\ VS form 16-3 may be obtained from the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (2) The articles must be sealed in leakproof containers bearing 
serial numbers during transit. Each container must remain sealed during 
the entire time that it is in the United States.
    (3) The person moving the articles shall notify, in writing, the 
Plant Protection and Quarantine Officer at both the place in the United 
States where the articles will arrive and the port of export prior to 
such transit. The notification must include the:
    (i) United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors permit 
number;
    (ii) Times and dates of arrival in the United States;
    (iii) Times and dates of exportation from the United States;
    (iv) Mode of transportation; and
    (v) Serial numbers of the sealed containers.
    (4) The articles must transit the United States in Customs bond.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[56 FR 63868, Dec. 6, 1991, as amended at 58 FR 65104, Dec. 13, 1993; 59 
FR 24638, May 12, 1994; 59 FR 67616, Dec. 30, 1994; 62 FR 18264, Apr. 
15, 1997; 62 FR 46181, Sept. 2, 1997; 62 FR 56023, Oct. 28, 1997; 62 FR 
61434, Nov. 18, 1997; 62 FR 66000, Dec. 17, 1997; 63 FR 408, Jan. 6, 
1998; 63 FR 4347, Jan. 28, 1998; 63 FR 71210, Dec. 24, 1998; 64 FR 
38550, July 19, 1999; 65 FR 51519, Aug. 24, 2000; 66 FR 22426, May 4, 
2001; 66 FR 29900, June 4, 2001; 66 FR 42600, Aug. 14, 2001; 66 FR 
52484, Oct. 16, 2001; 66 FR 54643, Oct. 30, 2001; 66 FR 62914, Dec. 4, 
2001; 67 FR 4878, Feb. 1, 2002; 67 FR 12832, 12834, Mar. 20, 2002; 67 FR 
44018, July 1, 2002; 67 FR 47244, July 18, 2002; 68 FR 31940, May 29, 
2003]



Sec.  94.19  Gelatin derived from horses or swine, or from ruminants 
that have not been in any region where bovine spongiform encephalopathy exists.

    Gelatin derived from horses or swine, or from ruminants that have 
not been in any region listed in Sec.  94.18(a) of this part, 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 and, if the 
gelatin is derived from ruminants, certify that the gelatin is not 
derived from ruminants that have been in any region listed in Sec.  
94.18(a).

(Approved by the Office of Management and Budget under control number 
0579-0015)

[58 FR 50251, Sept. 27, 1993, as amended at 59 FR 67134, Dec. 29, 1994; 
62 FR 56023, Oct. 28, 1997]

[[Page 507]]



Sec.  94.20  Importation of pork and pork products from Sonora and 
Yucatan, Mexico.

    Notwithstanding any other provisions of this part, pork and pork 
products from the States of Sonora and Yucatan, Mexico, may be imported 
into the United States under the following conditions:
    (a) The pork or pork product is from swine that were born and raised 
in Sonora or Yucatan and slaughtered in Sonora or Yucatan at a federally 
inspected slaughter plant that is under the direct supervision of a 
full-time salaried veterinarian of the Government of Mexico and that is 
approved to export pork products to the United States in accordance with 
Sec.  327.2 of this title.
    (b) If processed, the pork or pork product was processed in either 
Sonora or Yucatan 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 pork or pork product has not been in contact with pork or 
pork products from any State in Mexico other than Sonora or Yucatan or 
from any other region not listed in Sec.  94.9(a) as a region where 
classical swine fever is not known to exist.
    (d) The foreign meat inspection certificate accompanying the pork or 
pork product (required by Sec.  327.4 of this title) includes a 
statement certifying that the requirements in paragraphs (a), (b) (if 
applicable), and (c) of this section have been met and, if applicable, a 
list of the numbers of the seals required by paragraph (e)(1) of this 
section.
    (e) The shipment of pork or pork products has not been in any State 
in Mexico other than Sonora or Yucatan or in any other region not listed 
in Sec.  94.9(a) as a region where classical swine fever is not known to 
exist en route to the United States, unless:
    (1) The pork or pork product arrives at the U.S. port of entry in 
shipping containers bearing intact, serially numbered seals that were 
applied at the federally inspected slaughter or processing plant in 
either Sonora or Yucatan 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 pork or pork product arrives 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 pork or 
pork product containers were opened and resealed en route by an 
appropriate official of the Government of Mexico and the pork or pork 
product was not contaminated or exposed to contamination during movement 
from Sonora or Yucatan to the United States.

(Approved by the Office of Management and Budget under control number 
0579-0138)

[65 FR 1536, Jan. 11, 2000, as amended at 68 FR 16939, Apr. 7, 2003]



Sec.  94.21  Restrictions on importation of beef from Uruguay.

    Notwithstanding any other provisions of this part, fresh (chilled or 
frozen) beef from Uruguay may be exported to the United States under the 
following conditions:
    (a) The meat is beef from bovines that have been born, raised, and 
slaughtered in Uruguay.
    (b) Foot-and-mouth disease has not been diagnosed in Uruguay within 
the previous 12 months.
    (c) The beef came from bovines that originated from premises where 
foot-and-mouth disease has not been present during the lifetime of any 
bovines slaughtered for the export of beef to the United States.
    (d) The beef came from bovines that were moved directly from the 
premises of origin to the slaughtering establishment without any contact 
with other animals.
    (e) The beef came from bovines 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 beef consists only of bovine parts that are, by standard 
practice, part of the animal's carcass that is placed in a chiller for 
maturation after

[[Page 508]]

slaughter. Bovine parts that may not be imported include all parts of 
bovine heads, feet, hump, hooves, and internal organs.
    (g) All bone and visually identifiable blood clots and lymphoid 
tissue have been removed from the beef.
    (h) The beef has not been in contact with meat from regions other 
than those listed in Sec.  94.1(a)(2).
    (i) The beef came from bovine carcasses that were allowed to 
maturate at 40 to 50[deg] F (4 to 10[deg] C) for a minimum of 36 hours 
after slaughter and that reached a pH of 5.8 or less 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 5.8 or less may be allowed to maturate an 
additional 24 hours and be retested, and, if the carcass still has not 
reached a pH of 5.8 or less after 60 hours, the meat from the carcass 
may not be exported to the United States.
    (j) An authorized veterinary official of the Government of Uruguay 
certifies on the foreign meat inspection certificate that the above 
conditions have been met.
    (k) The establishment in which the bovines are slaughtered allows 
periodic on-site evaluation and subsequent inspection of its facilities, 
records, and operations by an APHIS representative.

[68 FR 31949, May 29, 2003]



Sec.  94.22  Importation of poultry meat and other poultry products 
from Sinaloa and Sonora, Mexico.

    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 Sec.  94.6 as 
a region where exotic 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 Sec.  94.6 as a region where exotic 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

[[Page 509]]

during movement from Sinaloa or Sonora to the United States.

[65 FR 15526, Mar. 23, 2000]



Sec.  94.23  Restrictions on the importation of swine, pork, and pork 
products from parts of the European Union.

    In addition to meeting all other applicable provisions of this part, 
live swine, pork, and pork products imported from the region of the 
European Union consisting of Austria, Belgium, Germany (except for the 
Kreis Uckermark in the Land of Brandenburg; the Kreis Oldenberg, the 
Kreis Soltau-Fallingbostel, and the Kreis Vechta in the Land of Lower 
Saxony; the Kreis Heinsberg and the Kreis Warendorf in the Land of 
Northrhine-Westphalia; the Kreis Bernkastel-Wittlich, the Kreis Bitburg-
Prm, the Kreis Donnersbergkreis, the Kreis Rhein-Hunsrche, the Kreis 
Sdliche Weinstrasse, and the Kreis Trier-Saarburg in the Land of 
Rhineland Palatinate; and the Kreis Altmarkkreis in the Land of Saxony-
Anhalt), Greece, Italy (except for the Regions of Emilia-Romagna, 
Piemonte, and Sardegna), the Netherlands, and Portugal must meet the 
following conditions:
    (a) Pork and pork products. (1) The pork or pork products must not 
have been commingled with pork or pork products derived from swine that 
have been in any region when the region was classified in Sec.  94.10(a) 
as one in which classical swine fever is known to exist;
    (2) The swine from which the pork or pork products were derived must 
not have lived in a region when the region was classified in Sec.  
94.10(a) as one in which classical swine fever is known to exist, and 
must not have transited such a region unless moved directly through the 
region in a sealed means of conveyance with the seal determined to be 
intact upon arrival at the point of destination; and
    (3) The pork and pork products 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 by Sec.  327.4 of this title, stating that the provisions of 
paragraphs (a)(1) and (a)(2) of this section have been met.\19\
---------------------------------------------------------------------------

    \19\ The certification required may be placed on the foreign meat 
inspection certificate required by Sec.  327.4 of this title or may be 
contained in a separate document.
---------------------------------------------------------------------------

    (b) Live swine. (1) The swine must be breeding swine and must not 
have lived in a region when the region was classified in Sec.  94.10(a) 
as one in which classical swine fever is known to exist, and must not 
have transited such a region unless moved directly through the region in 
a sealed means of conveyance with the seal determined to be intact upon 
arrival at the point of destination;
    (2) The swine must never have been commingled with swine that were 
in a region at a time when the region was classified in Sec.  94.10(a) 
as one in which classical swine fever is known to exist;
    (3) No equipment or materials used in transporting the swine may 
have previously been used for transporting swine that do not meet the 
requirements of this section, unless the equipment or materials have 
first been cleaned and disinfected; and
    (4) The swine must be accompanied by a certificate issued by a 
salaried veterinary officer of the national government of the country of 
origin, stating that the provisions of paragraphs (b)(1) through (b)(3) 
of this section have been met.\20\
---------------------------------------------------------------------------

    \20\ The certification required may be placed on the certificate 
required by Sec.  93.505(a) of this chapter or may be contained in a 
separate document.
---------------------------------------------------------------------------

    (c) The certificates required by paragraphs (a)(3) and (b)(4) of 
this section must be presented by the importer to the appropriate 
Customs and Border Protection officer at the port of arrival, upon 
arrival of the swine, pork, or pork products at the port, for the use of 
the veterinary inspector at the port of entry.


(Approved by the Office of Management and Budget under control number 
0579-0218)

[68 FR 16939, Apr. 7, 2003]

[[Page 510]]



Sec.  94.24  Restrictions on the importation of live swine, pork, or 

pork products from Baja California, Baja California Sur, Chihuahua, 
and Sinaloa.

    The Mexican States of Baja California, Baja California Sur, 
Chihuahua, and Sinaloa, which are declared to be free of classical swine 
fever (CSF) in Sec. Sec.  94.9 and 94.10, supplement their pork supplies 
with fresh (chilled or frozen) pork imported from regions designated in 
Sec. Sec.  94.9 and 94.10 as being affected by CSF, 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, there exists a possibility 
that live swine, pork, or pork products from the CSF-free regions listed 
in this section 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. Therefore, live swine, pork, or 
pork products and shipstores, airplane meals, and baggage containing 
pork or pork products, other than those articles regulated under part 95 
or part 96 of this chapter, originating in the CSF-free regions listed 
in this section shall not be brought into the United States unless the 
following requirements are met in addition to other applicable 
requirements of parts 93 and 327 of this title:
    (a) Live swine. The swine must be accompanied by a certification 
issued by a full-time salaried veterinary officer of the Government of 
Mexico. 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 designated in Sec. Sec.  94.9 and 
94.10 as free of classical swine fever at the time the swine were in the 
region and must state that:
    (1) The swine have not lived in a region designated in Sec. Sec.  
94.9 and 94.10 as affected with classical swine fever.
    (2) The swine have never been commingled with swine that have been 
in a region that is designated in Sec. Sec.  94.9 and 94.10 as affected 
with classical swine fever;
    (3) The swine have not transited through a region designated in 
Sec. Sec.  94.9 and 94.10 as affected with classical swine fever 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 Sec.  93.502 of this 
subchapter.
    (b) 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 Government of Mexico. 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 designated in Sec. Sec.  94.9 and 94.10 as 
free of classical swine fever 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 designated in Sec. Sec.  94.9 and 94.10 as free 
of classical swine fever 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 Government of Mexico 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 Sec.  327.2 of this title;
    (2) The pork or pork products have never been commingled with pork 
or pork products that have been in a region that is designated in 
Sec. Sec.  94.9 and 94.10 as affected with classical swine fever;
    (3) The pork or pork products have not transited through a region 
designated in Sec. Sec.  94.9 and 94.10 as affected with classical swine 
fever 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

[[Page 511]]

    (4) If processed, the pork or pork products were processed in a 
region designated in Sec. Sec.  94.9 and 94.10 as free of classical 
swine fever in a federally inspected processing plant that is under the 
direct supervision of a full-time salaried veterinary official of the 
Government of Mexico.

(Approved by the Office of Management and Budget under control number 
0579-0230)

[68 FR 47841, Aug. 12, 2003]



PART 95_SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), AND 
HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES--Table of Contents




Sec.
95.1 Definitions.
95.2 Region of origin.
95.3 Byproducts from diseased animals prohibited.
95.4 Restrictions on the importation of processed animal protein, offal, 
          tankage, fat, glands, certain tallow other than tallow 
          derivatives, and serum due to bovine spongiform 
          encephalopathy.
95.5 Untanned hides and skins; requirements for unrestricted entry.
95.6 Untanned hides and skins; importations permitted subject to 
          restrictions.
95.7 Wool, hair, and bristles; requirements for unrestricted entry.
95.8 Wool, hair, and bristles; importations permitted subject to 
          restrictions.
95.9 Glue stock; requirements for unre stricted entry.
95.10 Glue stock; importations permitted subject to restrictions.
95.11 Bones, horns, and hoofs for trophies or museums; disinfected 
          hoofs.
95.12 Bones, horns, and hoofs; importations permitted subject to 
          restrictions.
95.13 Bone meal for use as fertilizer or as feed for domestic animals; 
          requirements for entry.
95.14 Blood meal, tankage, meat meal, and similar products, for use as 
          fertilizer or animal feed; requirements for entry.
95.15 Blood meal, blood albumin, intestines, and other animal byproducts 
          for industrial use; requirements for unre stricted entry.
95.16 Blood meal, blood albumin, intestines, and other animal byproducts 
          for industrial use; importations permitted subject to 
          restrictions.
95.17 Glands, organs, ox gall, and like materials; requirements for 
          unrestricted entry.
95.18 Glands, organs, ox gall, and like materials; importations 
          permitted subject to restrictions.
95.19 Animal stomachs.
95.20 Animal manure.
95.21 Hay and straw; requirements for unrestricted entry.
95.22 Hay and straw; importations permitted subject to restrictions.
95.23 Previously used meat covers; importations permitted subject to 
          restrictions.
95.24 Methods for disinfection of hides, skins, and other materials.
95.25 Transportation of restricted import products; placarding cars and 
          marking billing; unloading enroute.
95.26 Railroad cars, trucks, boats, aircraft and other means of 
          conveyance, equipment or containers, yards, and premises; 
          cleaning and disinfection.
95.27 Regulations applicable to products from Territorial possessions.
95.28 Hay or straw and similar material from tick-infested areas.
95.29 Certification for certain materials.

    Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 
9701; 7 CFR 2.22, 2.80, and 371.4.

    Source: 28 FR 5981, June 13, 1963, unless otherwise noted.



Sec.  95.1  Definitions.

    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 contagions of foot-and-mouth disease and rinderpest.
    Approved establishment means an establishment approved by Veterinary 
Services for the receipt and handling of restricted import animal 
byproducts.

[[Page 512]]

    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.
    Blood meal means dried blood of animals.
    Bone meal means ground animal bones and hoof meal and horn meal.
    Department means the United States Department of Agriculture.
    Deputy Administrator of Veterinary Services means the Deputy 
Administrator of Veterinary Services.
    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.
    Inspector means an inspector of Veterinary Services.
    Meat meal or tankage means the rendered and dried carcasses or parts 
of the carcasses of animals.
    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.
    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.

[28 FR 5981, June 13, 1963, as amended at 56 FR 19796, Apr. 30, 1991; 56 
FR 63869, Dec. 6, 1991; 62 FR 56024, Oct. 28, 1997; 66 FR 42600, Aug. 
14, 2001]



Sec.  95.2  Region of origin.

    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.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997]



Sec.  95.3  Byproducts from diseased animals prohibited.

    The importation of any animal byproduct taken or removed from an 
animal affected with anthrax, foot-and-mouth disease, or rinderpest is 
prohibited.



Sec.  95.4  Restrictions on the importation of processed animal 

protein, offal, tankage, fat, glands, certain tallow other than 
tallow derivatives, and serum due to bovine spongiform encephalopathy.

    (a) Except as provided in paragraphs (c) through (f) of this 
section, the importation of the following is prohibited:
    (1) Any of the materials listed in paragraphs (a)(1)(i) through 
(a)(1)(iv) of this section that have been derived from animals that have 
been in any region listed in Sec.  94.18(a) of this chapter:
    (i) Processed animal protein, tankage, offal, and tallow other than 
tallow derivatives, unless, in the opinion of the Administrator, the 
tallow cannot be used in feed, regardless of the animal species from 
which the material was derived;

[[Page 513]]

    (ii) Glands and unprocessed fat tissue derived from ruminants;
    (iii) Processed fats and oils, and derivatives of processed animal 
protein, tankage, and offal, regardless of the animal species from which 
the material was derived; and
    (iv) Derivatives of glands from ruminants.
    (2) Any of the materials listed in paragraphs (a)(2)(i) through 
(a)(2)(iv) of this section that have been stored, rendered, or otherwise 
processed in a region listed in Sec.  94.18(a) of this chapter, or that 
have otherwise been associated with a facility in a region listed in 
Sec.  94.18(a) of this chapter or with any material listed in paragraph 
(a)(1) through (a)(3) of this section:
    (i) Processed animal protein, tankage, offal, and tallow other than 
tallow derivatives, unless, in the opinion of the Administrator, the 
tallow cannot be used in feed, regardless of the animal species from 
which the material was derived;
    (ii) Glands and unprocessed fat tissue derived from ruminants;
    (iii) Processed fats and oils, and derivatives of processed animal 
protein, tankage, and offal, regardless of the animal species from which 
the material was derived; and
    (iv) Derivatives of glands from ruminants.
    (3) Products containing any of the items listed in paragraphs (a)(1) 
and (a)(2) of this section.
    (b) Except as provided in paragraphs (d) and (f) of this section, 
the importation of serum from ruminants that have been in any region 
listed in Sec.  94.18(a) of this chapter is prohibited, except that 
serum from ruminants may be imported for scientific, educational, or 
research purposes if the Administrator determines that the importation 
can be made under conditions that will prevent the introduction of 
bovine spongiform encephalopathy into the United States. Serum from 
ruminants imported in accordance with this paragraph must be accompanied 
by a permit issued by APHIS in accordance with Sec.  104.4 of this 
chapter, and must be moved and handled as specified on the permit.
    (c) Materials that are otherwise prohibited importation into the 
United States under paragraph (a) of this section may be imported into 
the United States if the following conditions are met prior to 
importation:
    (1) The material is derived from a nonruminant species, or from a 
ruminant species if the ruminants have never been in any region listed 
in Sec.  94.18(a) of this chapter.
    (2) All steps of processing and storing the material are carried out 
in a foreign facility that has not been used for the processing and 
storage of materials derived from ruminants that have been in any region 
listed in Sec.  94.18(a) of this chapter.
    (3) 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.
    (4) If the facility processes or handles any material derived from 
mammals, 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.
    (5) The facility allows periodic APHIS inspection of its facilities, 
records, and operations.
    (6) 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 region of export 
certifying that the

[[Page 514]]

conditions of paragraphs (c)(1) through (c)(3) of this section have been 
met.
    (7) 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. (VS Form 16-3 may be 
obtained from APHIS, Veterinary Services, National Center for Import-
Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or 
electronically at http://www.aphis.usda.gov/ncie.)
    (d) The importation of serum albumin, serocolostrum, amniotic 
liquids or extracts, and placental liquids derived from ruminants that 
have been in any region listed in Sec.  94.18(a) of this chapter, and of 
collagen and collagen products that meet any of the conditions listed in 
paragraphs (a)(1) through (a)(3) of this section, is prohibited unless 
the following conditions have been met:
    (1) The article is imported for use as an ingredient in cosmetics;
    (2) The person importing the article has obtained 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 (VS Form 16-3 may be obtained from APHIS, Veterinary Services, 
National Center for Import-Export, 4700 River Road Unit 38, Riverdale, 
MD 20737-1231, or electronically at http://www.aphis.usda.gov/ncie.); 
and
    (3) The permit application states the intended use of the article 
and the name and address of the consignee in the United States.
    (e) Insulin otherwise prohibited from importation into the United 
States under paragraph (a) of this section is not prohibited from 
importation under that paragraph 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 by filing a permit application on VS 
form 16-3. (VS Form 16-3 may be obtained from APHIS, Veterinary 
Services, National Center for Import-Export, 4700 River Road Unit 38, 
Riverdale, MD 20737-1231, or electronically at http://
www.aphis.usda.gov/ncie.

    Note: 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.)

    (f) Articles that are prohibited importation into the United States 
in accordance with this section may transit the United States for 
immediate export if the following conditions are met:
    (1) The person moving the articles has 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. (VS Form 16-3 may be obtained from APHIS, 
Veterinary Services, National Center for Import-Export, 4700 River Road 
Unit 38, Riverdale, MD 20737-1231, or electronically at http://
www.aphis.usda.gov/ncie.)
    (2) The articles are sealed in leakproof containers bearing serial 
numbers during transit. Each container remains sealed during the entire 
time that it is in the United States.
    (3) The person moving the articles notifies, in writing, the Plant 
Protection and Quarantine Officer at both the place in the United States 
where the articles will arrive and the port of export prior to such 
transit. The notification includes the:
    (i) United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors permit 
number;
    (ii) Times and dates of arrival in the United States;
    (iii) Times and dates of exportation from the United States;
    (iv) Mode of transportation; and
    (v) Serial numbers of the sealed containers.
    (4) The articles transit the United States in Customs bond.

(Approved by the Office of Management and Budget under control numbers 
0579-0015 and 0579-0183)

[66 FR 42600, Aug. 14, 2001]

[[Page 515]]



Sec.  95.5  Untanned hides and skins; requirements for unrestricted entry.

    Untanned hides and/or skins of cattle, buffalo, sheep, goats, other 
ruminants, and swine which do not meet the conditions of requirements 
specified in any one of paragraphs (a) to (e) of this section shall not 
be imported except subject to handling and treatment in accordance with 
Sec.  95.6 after arrival at the port of entry:
    (a) Hides or skins originating in and shipped directly from a region 
not declared by the Secretary of Agriculture to be infected with foot-
and-mouth disease or rinderpest may be imported without further 
restriction.
    (b) Hides or skins 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 be hard dried hides or 
skins.
    (c) Abattoir hides or skins taken from animals slaughtered under 
national government inspection in a region\1\ and in an abattoir in 
which is maintained an inspection service determined by the Secretary of 
Agriculture to be adequate to assure that they have been removed from 
animals found at time of slaughter to be free from anthrax, foot-and-
mouth disease, and rinderpest, and to assure further the identity of 
such materials until loaded upon the transporting vessel, may be 
imported without other restriction if accompanied by a certificate 
bearing the seal of the proper department of such national government 
and signed by an official veterinary inspector of such region showing 
that the therein described hides or skins were taken from animals 
slaughtered in such specified abattoir and found free from anthrax, 
foot-and-mouth disease, and rinderpest.
---------------------------------------------------------------------------

    \1\ Names of regions of this character will be furnished upon 
request to the Animal and Plant Health Inspection Service, Veterinary 
Services, National Center for Import-Export, 4700 River Road Unit 38, 
Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (d) Hides or skins may be imported without other restriction if 
shown upon inspection by an inspector, or by certificate of the shipper 
or importer satisfactory to said inspector, to 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.
    (e) Hides or skins may be imported without other restriction if 
shown upon inspection by an inspector, or by certificate of the shipper 
or importer satisfactory to said inspector, to have been treated with 
lime in such manner and for such period as to have become dehaired and 
to have reached the stage of preparation for immediate manufacture into 
products ordinarily made from rawhide.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended at 48 FR 57472, Dec. 30, 1983; 62 
FR 56024, Oct. 28, 1997]



Sec.  95.6  Untanned hides and skins; importations permitted subject 
to restrictions.

    Hides or skins offered for importation which do not meet the 
conditions or requirements of Sec.  95.5 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 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 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

[[Page 516]]

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 and rinderpest. 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 from the port of arrival to the said establishment.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994]



Sec.  95.7  Wool, hair, and bristles; requirements for unrestricted entry.

    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 Sec.  95.8 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 or rinderpest.
    (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\1\ and in an abattoir in which is maintained an 
inspection service determined by the Secretary of Agriculture to be 
adequate to assure that such materials have been removed from animals 
found at time of slaughter to be free from anthrax, foot-and-mouth 
disease, and rinderpest, and to assure further the identity of such 
materials until loaded upon the transporting vessel, may be imported 
without other restriction if accompanied by a certificate bearing the 
seal of the proper department of said national government and signed by 
an official veterinary inspector of such region showing that the therein 
described wool, hair, or bristles were taken from animals slaughtered in 
such specified abattoir and found free from anthrax, foot-and-mouth 
disease, and rinderpest.
---------------------------------------------------------------------------

    \1\ See footnote 1 to Sec.  95.5.
---------------------------------------------------------------------------

    (d) Wool, hair, or bristles which have been scoured, thoroughly 
washed, or dyed may be imported without other restriction.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended at 48 FR 57472, Dec. 30, 1983; 62 
FR 56024, Oct. 28, 1997]



Sec.  95.8  Wool, hair, and bristles; importations permitted subject 
to restrictions.

    Wool, hair, or bristles offered for importation which do not meet 
the conditions or requirements of Sec.  95.7 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

[[Page 517]]

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 and rinderpest. 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994]



Sec.  95.9  Glue stock; requirements for unre stricted entry.

    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 
Sec.  95.10 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 or rinderpest 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\1\ and in an abattoir 
in which is maintained an inspection service determined by the Secretary 
of Agriculture to be adequate to assure that such materials have been 
removed from animals found at time of slaughter to be free from anthrax, 
foot-and-mouth disease, and rinderpest, and to assure further the 
identity of such materials until loaded upon the transporting vessel, 
may be imported without other restriction if accompanied by a 
certificate bearing the seal of the proper department of said national 
government and signed by an official veterinary inspector of such region 
showing that the therein described glue stock was taken from animals 
slaughtered in such specified abattoir and found free from anthrax foot-
and-mouth disease, and rinderpest.
---------------------------------------------------------------------------

    \1\ See footnote 1 to Sec.  95.5.

(Approved by the Office of Management and Budget under control number 
---------------------------------------------------------------------------
0579-0015)

[28 FR 5981, June 13, 1963, as amended at 48 FR 57472, Dec. 30, 1983; 62 
FR 56024, Oct. 28, 1997]



Sec.  95.10  Glue stock; importations permitted subject to restrictions.

    Glue stock offered for importation which does not meet the 
conditions or requirements of Sec.  95.9 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

[[Page 518]]

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 and rinderpest. 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994]



Sec.  95.11  Bones, horns, and hoofs for trophies or museums; disinfected 
hoofs.

    (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[deg]F (82.2[deg]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.

[28 FR 5981, June 13, 1963, as amended at 59 FR 9400, Feb. 28, 1994; 62 
FR 56024, Oct. 28, 1997]



Sec.  95.12  Bones, horns, and hoofs; importations permitted subject 
to restrictions.

    Bones, horns, and hoofs offered for importation which do not meet 
the conditions or requirements of Sec.  95.11 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

[[Page 519]]

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, and rinderpest, 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994]



Sec.  95.13  Bone meal for use as fertilizer or as feed for domestic 
animals; requirements for entry.

    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 [deg]Fahrenheit (121 [deg]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.



Sec.  95.14  Blood meal, tankage, meat meal, and similar products, 
for use as fertilizer or animal feed; requirements 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 Sec.  95.16, 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 rinderpest; 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.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997]



Sec.  95.15  Blood meal, blood albumin, intestines, and other animal 
byproducts for industrial use; requirements for unre stricted entry.

    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 Sec.  95.16, 
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 or rinderpest.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994; 62 
FR 56024, Oct. 28, 1997]



Sec.  95.16  Blood meal, blood albumin, intestines, and other animal 
byproducts for industrial use; importations permitted subject to restrictions.

    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 Sec.  95.15 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

[[Page 520]]

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 and rinderpest. 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994]



Sec.  95.17  Glands, organs, ox gall, and like materials; requirements 
for unrestricted entry.

    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 Sec.  95.18, 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 or rinderpest.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997]



Sec.  95.18  Glands, organs, ox gall, and like materials; importations 
permitted subject to restrictions.

    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 Sec.  95.17 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994]



Sec.  95.19  Animal stomachs.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994]



Sec.  95.20  Animal manure.

    Manure of horses, cattle, sheep, other ruminants, and swine shall 
not be imported except upon permission from the Deputy Administrator, 
Veterinary

[[Page 521]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994]



Sec.  95.21  Hay and straw; requirements for unrestricted entry.

    Except as provided in Sec.  95.28, hay or straw shall not be 
imported except subject to handling and treatment in accordance with 
Sec.  95.22 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 or 
rinderpest.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997]



Sec.  95.22  Hay and straw; importations permitted subject to restrictions.

    Except as provided in Sec.  95.28, hay or straw which does not meet 
the conditions or requirements of Sec.  95.21 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.



Sec.  95.23  Previously used meat covers; importations permitted subject 
to restrictions.

    Cloth or burlap which has been used to cover fresh or frozen meats 
originating in any region designated in Sec.  94.1 of this subchapter as 
a region in which rinderpest or 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 rinderpest, 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994; 62 
FR 56024, Oct. 28, 1997]



Sec.  95.24  Methods for disinfection of hides, skins, and other 
materials.

    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.

[[Page 522]]



Sec.  95.25  Transportation of restricted import products; placarding 
cars and marking billing; unloading enroute.

    (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\1/2\ by 6 inches in size, on which shall be printed with 
permanent black ink and in boldface letters not less than 1\1/2\ inches 
in height the words ``Restricted import product.'' These placards shall 
also bear the words ``Clean and disinfect this car or truck.'' Each of 
the waybills, conductors' manifests, memoranda, and bills of lading 
pertaining to such shipments shall have the words ``Restricted import 
product, clean and disinfect car or truck,'' plainly written or stamped 
upon its face. If for any reason the placards required by this section 
have not been affixed to each car, or the billing has not been marked by 
the initial or the connecting carrier, or the placards have been 
removed, destroyed, or rendered illegible, the placards shall be 
immediately affixed or replaced and the billing marked by the initial or 
connecting carrier, the intention being that the billing accompanying 
the shipment shall be marked and each car, truck or other vehicle 
placarded as specified in this section from the time such shipment 
leaves the port of entry until it is unloaded at final destination and 
the cars, trucks or other vehicles are cleaned and disinfected as 
required by Sec.  95.26.
    (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 Sec.  95.26, 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5981, June 13, 1963, as amended at 48 FR 57472, Dec. 30, 1983]



Sec.  95.26  Railroad cars, trucks, boats, aircraft and other means of 

conveyance, equipment or containers, yards, and premises; cleaning and 
disinfection.

    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

[[Page 523]]

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 and rinderpest 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\1/2\-
ounce can to 5 gallons of water.\2\
---------------------------------------------------------------------------

    \2\ Due to the extreme caustic nature of sodium hydroxide solution, 
precautionary measures such as the wearing of rubber gloves, boots, 
raincoat and goggles should be observed. An acid solution such as 
vinegar shall be kept readily available in case any of the sodium 
hydroxide solution should come in contact with the body.
---------------------------------------------------------------------------

    (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 rinder-pest or foot-and-
mouth disease and tick infestation; or other disinfect ants or 
treatments approved by the Deputy Administrator, Veterinary Services.

[28 FR 5981, June 13, 1963, as amended at 32 FR 19157, Dec. 20, 1967]



Sec.  95.27  Regulations applicable to products from Territorial 
possessions.

    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.



Sec.  95.28  Hay or straw and similar material from tick-infested 
areas.

    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

[[Page 524]]

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 Sec.  95.26(d).



Sec.  95.29  Certification for certain materials.

    (a) In addition to meeting any other certification or permit 
requirements of this chapter, the following articles may be imported 
into the United States from any region not listed in Sec.  94.18(a) only 
if they are accompanied by a certificate, as described in paragraph (b) 
of this section:
    (1) Processed animal protein, tankage, offal, and tallow other than 
tallow derivatives, unless, in the opinion of the Administrator, the 
tallow cannot be used in feed, regardless of the animal species from 
which the material is derived;
    (2) Glands and unprocessed fat tissue derived from ruminants;
    (3) Processed fats and oils, and derivatives of processed animal 
protein, tankage, and offal, regardless of the animal species from which 
the material is derived;
    (4) Derivatives of glands from ruminants; and
    (5) Any product containing any of the materials listed in paragraphs 
(a)(1) through (a)(4) of this section.
    (b) The certificate required by paragraph (a) of this section must 
be an original official certificate, signed by a full-time, salaried 
veterinarian of the agency responsible for animal health in the 
exporting region, that states the following:
    (1) The animal species from which the material was derived;
    (2) The region in which any facility where the material was 
processed is located;
    (3) That the material was derived only from animals that have never 
been in any region listed in Sec.  94.18(a) of this chapter, with the 
regions listed in Sec.  94.18(a) specifically named;
    (4) That the material did not originate in, and was never stored in, 
rendered or processed in, or otherwise associated with a facility in a 
region listed in Sec.  94.18(a); and
    (5) The material was never associated with any of the materials 
listed in paragraph (a) of this section that have been in a region 
listed in Sec.  94.18(a).
    (c) The certification required by paragraph (a) of this section must 
clearly correspond to the shipment by means of an invoice number, 
shipping marks, lot number, or other method of identification.

(Approved by the Office of Management and Budget under control number 
0579-0183)

[66 FR 42601, Aug. 14, 2001]



PART 96_RESTRICTION OF IMPORTATIONS OF FOREIGN ANIMAL CASINGS OFFERED 
FOR ENTRY INTO THE UNITED STATES--Table of Contents




Sec.
96.1 Definitions.
96.2 Prohibition of casings due to African swine fever and bovine 
          spongiform encephalopathy.
96.3 Certificate for animal casings.
96.4 Uncertified animal casings; disposition.
96.5 Instructions regarding handling certified animal casings.
96.6 Certified foreign animal casings arriving at seaboard or border 
          port.
96.7 Dried bladders, weasands, and casings.
96.8 Uncertified casings; disinfection at seaboard port.
96.9 Casings admitted on disinfection; sealing; transfer and 
          disinfection.
96.10 Uncertified casings; transportation for disinfection; original 
          shipping containers; disposition of salt.
96.11 Disinfecting plant and equipment for uncertified casings.
96.12 Uncertified casings not disinfected in 30 days; disposition.
96.13 Uncertified casings; disinfection with hydrochloric acid.
96.14 Uncertified casings; disinfection with saturated brine solution.

    Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 
2.80, and 371.4.

    Source: 28 FR 5986, June 13, 1963, unless otherwise noted.



Sec.  96.1  Definitions.

    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

[[Page 525]]

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.
    Department. 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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[57 FR 28082, June 24, 1992, as amended at 57 FR 29785, July 7, 1992; 59 
FR 67134, Dec. 29, 1994; 62 FR 56024, Oct. 28, 1997]



Sec.  96.2  Prohibition of casings due to African swine fever and bovine 
spongiform encephalopathy.

    (a) Swine casings. The importation of swine casings that originated 
in or were processed in a region where African swine fever exists, as 
listed in Sec.  94.8 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 in Sec.  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 in Sec.  94.8 
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 \1\ in a region listed in Sec.  94.8 of 
this subchapter. The processing establishment does not receive or 
process any live swine and uses only pork and pork products that 
originate in a region not listed in Sec.  94.8 of this subchapter and 
that are shipped to the processing establishment in accordance with 
paragraphs (a)(2) through (a)(4) of this section.
---------------------------------------------------------------------------

    \1\ As a condition of entry into the United States, pork or pork 
products must also meet all of the requirements of the Federal Meat 
Inspection Act (21 U.S.C. 601 et seq.) and regulations under the Act (9 
CFR, chapter III, part 327), including requirements that the pork or 
pork products be prepared only in approved establishments.
---------------------------------------------------------------------------

    (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

[[Page 526]]

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) Bovine or other ruminant casings. The importation of casings, 
except stomachs, from bovines and other ruminants that originated in or 
were processed in any region listed in Sec.  94.18(a) of this subchapter 
is prohibited.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[65 FR 1307, Jan. 10, 2000]



Sec.  96.3  Certificate for animal casings.

    (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:

             foreign official certificate for animal casings

Place (City) -------------------- (Region) -------- (Date) --------


[[Page 527]]


    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.

Kind of casings_________________________________________________________
Number of packages______________________________________________________
Weight__________________________________________________________________

Identification marks on the packages____________________________________
Consignor_______________________________________________________________
                                                               (Address)
Consignee_______________________________________________________________
                                                           (Destination)
Shipping marks__________________________________________________________
Signature:______________________________________________________________
Official issuing the certificate. (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.)
Official title:_________________________________________________________
Signature:______________________________________________________________
Official issuing the certificate. (Veterinarian salaried by the national 
government of the region in which the animals were slaughtered and the 
casings were collected.)
Official title:_________________________________________________________

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5986, June 13, 1963, as amended at 48 FR 57472, Dec. 30, 1983. 
Redesignated and amended at 57 FR 28082, June 24, 1992. Redesignated at 
58 FR 47031, Sept. 7, 1993, as amended at 62 FR 56024, Oct. 28, 1997]



Sec.  96.4  Uncertified animal casings; disposition.

    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 Sec. Sec.  96.5 through 96.16.

[28 FR 5986, June 13, 1963. Redesignated and amended at 57 FR 28082, 
28083, June 24, 1992; 57 FR 29785, July 7, 1992. Redesignated and 
amended at 58 FR 47031, Sept. 7, 1993]



Sec.  96.5  Instructions regarding handling certified animal casings.

    (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.

[28 FR 5986, June 13, 1963. Redesignated and amended at 57 FR 28082, 
28083, June 24, 1992; 57 FR 29785, July 7, 1992. Redesignated at 58 FR 
47031, Sept. 7, 1993]

[[Page 528]]



Sec.  96.6  Certified foreign animal casings arriving at seaboard or 
border port.

    (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.

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. 
Redesignated at 58 FR 47031, Sept. 7, 1993]



Sec.  96.7  Dried bladders, weasands, and 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.

[28 FR 5986, June 13, 1963. Redesignated at 58 FR 47031, Sept. 7, 1993]



Sec.  96.8  Uncertified casings; disinfection at seaboard port.

    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.

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. 
Redesignated at 58 FR 47031, Sept. 7, 1993]



Sec.  96.9  Casings admitted on disinfection; sealing; transfer and 
disinfection.

    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 ``insp'd & p's'd'' and the establishment number have been 
removed.
    (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.

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. 
Redesignated at 58 FR 47031, Sept. 7, 1993]



Sec.  96.10  Uncertified casings; transportation for disinfection; 
original shipping containers; disposition of salt.

    (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

[[Page 529]]

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\1/2\-
ounce can to 5 gallons of water.\2\
---------------------------------------------------------------------------

    \2\ Due to the extreme caustic nature of sodium hydroxide solution, 
and of sodium carbonate solution to a lesser degree, precautionary 
measures such as the wearing of rubber gloves, boots, raincoat and 
goggles should be observed. An acid solution such as vinegar shall be 
kept readily available in case any of the sodium hydroxide solution 
should come in contact with the body.
---------------------------------------------------------------------------

    (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\3/4\ gallons of C. P. hydrochloric acid 
containing not less than 35 percent actual HCl; mix thoroughly and allow 
the solution to stand for at least thirty minutes. The finished solution 
must contain not less than 1 percent actual hydrochloric acid. (This 
solution may be utilized in the disinfection of casings as prescribed in 
Sec.  96.13.)
    (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.

[28 FR 5986, June 13, 1963, as amended at 32 FR 19158, Dec. 20, 1967; 57 
FR 29785, July 7, 1992. Redesignated and amended at 58 FR 47031, Sept. 
7, 1993; 62 FR 56024, Oct. 28, 1997; 65 FR 1307, Jan. 10, 2000]



Sec.  96.11  Disinfecting plant and equipment for uncertified casings.

    Uncertified foreign animal casings shall be disinfected only at a 
plant whose sanitation and disinfecting equipment have been approved by 
an APHIS inspector.

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. 
Redesignated at 58 FR 47031, Sept. 7, 1993]



Sec.  96.12  Uncertified casings not disinfected in 30 days; disposition.

    Foreign animal casings offered for importation without certification 
shall be disinfected as prescribed in Sec.  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.

[28 FR 5986, June 13, 1963. Redesignated and amended at 58 FR 47031, 
Sept. 7, 1993]

[[Page 530]]



Sec.  96.13  Uncertified casings; disinfection with hydrochloric acid.

    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\3/4\ gallons 
(10.35 liters) C. P. hydrochloric acid containing not less than 35 
percent actual HCl and mix throughly. The finished solution must contain 
not less than 1 percent actual hydrochloric acid.
    (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 resist ant 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\1/2\ pounds of sodium bicarbonate 
in each 100 gallons of water. 100 gallons of this solution is sufficient 
for 175 pounds of casings. Keep the casings in this solution for 30 
minutes, moving them about frequently and vigorously so as to insure 
complete contact of the solution with the casings. After this 
neutralization, remove the casings from the sodium bicarbonate solution 
and wash them to remove the excess of bicarbonate.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. 
Redesignated at 58 FR 47031, Sept. 7, 1993, as amended at 59 FR 67134, 
Dec. 29, 1994]



Sec.  96.14  Uncertified casings; disinfection with saturated brine solution.

    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 [deg]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 
[deg]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 unsat isfactory 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

[[Page 531]]

the bottom of the volume of casings being disinfected.

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. 
Redesignated at 58 FR 47031, Sept. 7, 1993]



PART 97_OVERTIME SERVICES RELATING TO IMPORTS AND EXPORTS--Table of Contents




Sec.
97.1 Overtime work at laboratories, border ports, ocean ports, and 
          airports.
97.2 Administrative instructions prescribing commuted traveltime.

    Authority: 7 U.S.C. 8301-8317; 49 U.S.C. 80503; 7 CFR 2.22, 2.80, 
and 371.4.



Sec.  97.1  Overtime work at laboratories, border ports, ocean ports, and airports.\1\
---------------------------------------------------------------------------

    \1\ For designated ports of entry for certain animals, animal semen, 
poultry, and hatching eggs see 9 CFR Sec. Sec.  93.102, 93.203, 93.303, 
93.403, 93.503, 93.703, and 93.805 and for designated ports of entry for 
certain purebred animals see 9 CFR Sec. Sec.  151.1 through 151.3.
---------------------------------------------------------------------------

    (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 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 or holiday or overtime service request the Animal and 
Plant Health Inspection Service 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), and (a)(3) of 
this section:

 Overtime for Inspection, Laboratory Testing, Certification, or Quarantine of Animals, Animal Products or Other
                                              Regulated Commodities
----------------------------------------------------------------------------------------------------------------
                                                               Overtime rates (per hour)
Outside the employee's normal tour of --------------------------------------------------------------------------
                 duty                   Oct. 1, 2003-Sept. 30,   Oct. 1, 2004-Sept. 30,
                                                 2004                     2005            Beginning Oct. 1, 2005
----------------------------------------------------------------------------------------------------------------
Monday through Saturday and holidays.                   $48.00                   $49.00                   $51.00
Sundays..............................                    63.00                    65.00                    67.00
----------------------------------------------------------------------------------------------------------------

    (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 Customs Service, Immigration and 
Naturalization Service, 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\
----------------------------------------------------------------------------------------------------------------
                                                               Overtime rates (per hour)
Outside the employee's normal tour of --------------------------------------------------------------------------
                 duty                   Oct. 1, 2003-Sept. 30,   Oct. 1, 2004-Sept. 30,
                                                 2004                     2005            Beginning Oct. 1, 2005
----------------------------------------------------------------------------------------------------------------
Monday through Saturday and holidays.                   $39.00                   $40.00                   $41.00

[[Page 532]]

 
Sundays..............................                    51.00                    53.00                   55.00
----------------------------------------------------------------------------------------------------------------
\1\ These charges exclude administrative overhead costs.

    (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 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--     2-hour     Commuted \2\
                                 no minimum     guarantee    traveltime
                                                 charge     (CTT) charge
------------------------------------------------------------------------
      Charges for Inspection Within Metropolitan Area of Employee's
                              Headquarters
------------------------------------------------------------------------
Work beginning before daily
 tour begins:
    8 to 59 minutes...........  Yes.........  No..........  None.
    60 to 119 minutes.........  ............  Yes.........  \1/2\ CTT.
    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.........  \1/2\ CTT.
    61 minutes or more........  ............  Yes.........  Full CTT.
-------------------------------
 Charges for Inspection Services Performed Outside Metropolitan Area of
                         Employee's Headquarters
------------------------------------------------------------------------
Work beginning before daily
 tour begins:
    8 to 59 minutes...........  Yes.........  No..........  \1/2\ CTT.
    60 minutes or more........  ............  Yes.........  Full CTT.
Work beginning after daily
 tour ends:
    Direct continuations......  Yes.........  No..........  \1/2\ CTT.
    2-59 minutes..............  No..........  Yes.........  \1/2\ CTT.
    60 minutes or more........  No..........  Yes.........  Full CTT.
-------------------------------
    Charges for Call Out Inspection Service on Holiday or Nonworkday
------------------------------------------------------------------------
 
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 \1/2\ of the full CTT period.

    (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

[[Page 533]]

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 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 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 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 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.
    (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 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 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 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 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 more than 90 days delinquent. Services will be denied 
until the delinquent debt is paid.

[38 FR 28814, Oct. 17, 1973, as amended at 42 FR 1455, Jan. 7, 1977; 49 
FR 1176, Jan. 10, 1984; 49 FR 12191, Mar. 29, 1984; 50 FR 723, Jan. 7, 
1985; 52 FR 16823, May 6, 1987; 53 FR 52992, Dec. 30, 1988; 54 FR 13516, 
Apr. 4, 1989; 55 FR 3198, Jan. 31, 1990; 55 FR 41059, Oct. 9, 1990; 56 
FR 1082, Jan. 11, 1991; 58 FR 32434, June 10, 1993; 62 FR 56025, Oct. 
28, 1997; 67 FR 48523, July 25, 2002; 68 FR 51882, Aug. 29, 2003]



Sec.  97.2  Administrative instructions prescribing commuted traveltime.

    Each period of overtime and holiday duty as prescribed in Sec.  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]
------------------------------------------------------------------------
                                                       Metropolitan Area
        Location covered              Served from    -------------------
                                                       Within    Outside
------------------------------------------------------------------------
Alaska:
  Anchorage.....................  ..................         1  ........
   Do...........................  Palmer............  ........         3

[[Page 534]]

 
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     San Bernardino....  ........         5
   International Airport.
   Do...........................  Los Angeles.......         2  ........
  Los Angeles Harbor, San Pedro,  Los Angeles.......  ........         2
   including Long Beach,
   Wilmington, and Terminal
   Island.
  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,        ..................         2  ........
   Alameda, Richmond, Pittsburg,
   and other ports in San
   Francisco and San Pablo Bay
   areas.
  San Louis Obispo..............  San Pedro.........  ........         6
  San Ysidro....................  ..................         1  ........
  Stockton......................  San Francisco.....  ........         4
Colorado:
  Stapleton International         Arvada............         1  ........
   Airport, Denver.
   Do...........................  Aurora............  ........         2
Connecticut:
  Bradley International Airport.  Westerly, RI......  ........         5
   Do...........................  Willington........  ........         1
  Bradley International Airport,  Ashford...........  ........         1
   Windsor Locks.
   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,       ..................         2  ........
   Barber's Point Naval Air
   Station, Honolulu
   International Airport, West
   Loch, Middle Loch, East Loch,
   Pearl City and Waipahu.
Idaho:
  Boise.........................  Caldwell or         ........         2
                                   Middleton.
  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

[[Page 535]]

 
   Do...........................  Louisville........         1  ........
Louisiana:
  Acadian Regional Airport, New   Abbeville.........  ........         2
   Iberia.
  Any point below Chalmette and   Baton Rouge.......  ........         4
   on the East Bank, Belle
   Chasse, LA, and points to and
   including Port Sulphur on the
   west bank.
  Any point on the Mississippi    ......do..........  ........         2
   River above the St. Charles-
   Jefferson Parish boundary to
   and including Gramercy.
  Morgan City...................  ......do..........  ........         5
  New Orleans including Orleans   ......do..........  ........         4
   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.
  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\1/2\
  Juarez........................  El Paso, TX.......  ........         1
  Nuevo Laredo..................  Laredo, TX........  ........    1\1/2\
  Ojinaga.......................  Presidio, TX......  ........         1
  Piedras Negras................  Eagle Pass, TX....  ........         1
  Reynosa (Pharr International    Hidalgo, TX.......  ........         1
   Bridge).
  San Jeronimo..................  El Paso, TX.......  ........         2
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            ..................         2  ........
   International Airport.
   Do...........................  Rochester.........  ........         3
   Do...........................  Princeton.........  ........         3
  Noyes.........................  Pembina...........  ........         1
Missouri:
  Kansas City International       Jefferson.........  ........         6
   Airport.
  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/                  1  ........
                                   Sweetgrass.
  Sweetgrass....................  ..................         1  ........
Nebraska:
  Lincoln Airport...............  ..................         1  ........

[[Page 536]]

 
New Jersey:
  Newark International Airport..  Hightstown........         2  ........
   Do...........................  Mount Holly.......         3  ........
   Do...........................  Princeton.........         2  ........
  Port of Salem.................  Hightstown........    3\1/2\  ........
   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,   ........         2
                                   VT.
   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   Greenville........  ........         2
   Airport.
   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       ........         6
                                   Antonio.
  Brownsville and Brownsville     Harlingen and San   ........         1
   International Airport.          Benito.
   Do...........................  McAllen or          ........         3
                                   Edinburg.
   Do...........................  Weslaco...........  ........         2
  Dallas-Fort Worth               Ft. Worth or               1         2
   International Airport.          Dallas.
  Del Rio.......................  ..................         1  ........
   Do...........................  Eagle Pass........  ........         3
   Do...........................  Edinburg, McAllen   ........         6
                                   or Mission.
   Do...........................  Laredo or San       ........         5
                                   Antonio.
  Eagle Pass....................  ..................         1  ........
   Do...........................  Del Rio...........  ........         3
   Do...........................  Edinburgh, McAllen  ........         6
                                   or Mission.
   Do...........................  Laredo or San       ........         5
                                   Antonio.
  El Paso.......................  ..................         1  ........
   Do...........................  Hatchita or         ........         6
                                   Deming, NM.
   Do...........................  Las Cruces, NM....  ........         3
  Forney........................  Corsicana.........  ........         3
   Do...........................  Ft. Worth.........  ........         3
   Do...........................  Tyler.............  ........         3
  Harlingen.....................  Edinburg, McAllen   ........         2
                                   or Mission.
   Do...........................  Weslaco...........  ........         1
  Hidalgo.......................  Brownsville.......  ........         3
   Do...........................  Edinburg, Mission   ........         1
                                   and McAllen.
   Do...........................  Harlingen.........  ........         2
   Do...........................  Lyford............  ........         2
   Do...........................  Rio Grande City...  ........         2
  Houston (including Houston      ..................         2  ........
   Intercontinental Airport).
  Laredo........................  ..................         1  ........
   Do...........................  Brownsville or San  ........         6
                                   Antonio.
   Do...........................  Eagle Pass........  ........         5
   Do...........................  McAllen, Edinburg   ........         6
                                   or Mission.
  Presidio......................  ..................         1  ........

[[Page 537]]

 
   Do...........................  El Paso...........  ........         6
Utah:
  Salt Lake City................  Murray and Ogden..         2  ........
Vermont:
  Burlington International        Burlington........         1  ........
   Airport.
   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
------------------------------------------------------------------------


[39 FR 41356, Nov. 27, 1974]

    Editorial Note: For Federal Register citations affecting Sec.  97.2, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



PART 98_IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN--Table of Contents




Sec.
98.1 Prohibition.

Subpart A_Ruminant and Swine Embryos from Regions Free of Rinderpest and 
         Foot-and-Mouth Disease; and Embryos of Horses and Asses

98.2 Definitions.
98.3 General conditions.
98.4 Import permit.
98.5 Health certificate.
98.6 Ports of entry.
98.7 Declaration upon arrival.
98.8 Inspection.
98.9 Embryos refused entry.
98.10 Other importations.
98.10a Embryos from sheep in regions other than Australia, Canada, and 
          New Zealand.

 Subpart B_Ruminant and Swine Embryos from Regions Where Rinderpest or 
                      Foot-and-Mouth Disease Exists

98.11 Definitions.
98.12 General prohibitions.
98.13 Import permit.
98.14 Health certificate.
98.15 Health requirements.
98.16 The embryo collection unit.
98.17 Procedures.
98.18 Shipment of embryos to the United States.
98.19 Arrival and inspection at the port of entry.
98.20 Embryos refused entry.
98.21 Embryos from sheep in regions other than Australia, Canada, and 
          New Zealand.

                     Subpart C_Certain Animal Semen

98.30 Definitions.
98.31 General prohibitions; exceptions.
98.32 Inspection of certain aircraft and other means of conveyance and 
          shipping containers thereon; unloading, cleaning, and 
          disinfection requirements.
98.33 Ports designated for the importation of certain animal semen.
98.34 Import permits for poultry semen and animal semen.
98.35 Declaration, health certificate, and other documents for animal 
          semen.
98.36 Animal semen from Canada.

[[Page 538]]

98.37 Semen from sheep in regions other than Australia, Canada, and New 
          Zealand.
98.38 Restrictions on the importation of swine semen from parts of the 
          European Union.

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 
U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.



Sec.  98.1  Prohibition.

    An embryo shall not be imported or entered into the United States 
unless in accordance with the provisions of this part.

[50 FR 43563, Oct. 25, 1985. Redesignated at 56 FR 58808, Oct. 30, 1991]



Subpart A_Ruminant and Swine Embryos from Regions Free of Rinderpest and 
         Foot-and-Mouth Disease; and Embryos of Horses and Asses



Sec.  98.2  Definitions.

    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.
    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.

[50 FR 43563, Oct. 25, 1985. Redesignated and amended at 56 FR 55808, 
Oct. 30, 1991; 57 FR 29194, July 1, 1992; 61 FR 17241, Apr. 19, 1996; 62 
FR 56025, Oct. 28, 1997]



Sec.  98.3  General conditions.

    Except as provided in subpart B of this part, an animal embryo shall 
not

[[Page 539]]

be imported into the United States unless it is from a region listed in 
Sec.  94.1(a)(2) of this chapter as being free of rinderpest and 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;
    (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 92 of this chapter for a health certificate required as a condition 
of importation into the United States;
    (f) There is no basis for denying an import permit for the donor 
sire or donor dam under Sec.  93.304(a)(2) for horses, Sec.  
93.404(a)(2) or (3) for ruminants, and Sec.  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.

[50 FR 43563, Oct. 25, 1985, as amended at 55 FR 31558, Aug. 2, 1990; 56 
FR 55809, Oct. 30, 1991; 57 FR 29194, July 1, 1992; 62 FR 56025, Oct. 
28, 1997]



Sec.  98.4  Import permit.

    (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, 
National Center for Import-Export, 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) After receipt and review of the application by APHIS, an import 
permit indicating the applicable conditions under this subpart for 
importation into

[[Page 540]]

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.

[50 FR 43563, Oct. 25, 1985, as amended at 56 FR 55809, Oct. 30, 1991; 
57 FR 29194, July 1, 1992; 59 FR 67616, Dec. 30, 1994; 62 FR 56025, Oct. 
28, 1997]



Sec.  98.5  Health certificate.

    (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 Sec.  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) The certificate accompanying sheep or goat embryos intended for 
importation from any part of the world shall, in addition to the 
statements required by paragraph (a) 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.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[50 FR 43563, Oct. 25, 1985, as amended at 56 FR 55809, Oct. 30, 1991; 
61 FR 15183, Apr. 5, 1996; 61 FR 17241, Apr. 19, 1996; 62 FR 56025, Oct. 
28, 1997]



Sec.  98.6  Ports of entry.

    An embryo shall not be imported into the United States unless at a 
port of entry listed in Sec.  93.303 for horses, Sec.  93.403 for 
ruminants, or Sec.  93.503 for swine of this chapter.

[50 FR 43563, Oct. 25, 1985, as amended at 55 FR 31558, Aug. 2, 1990; 62 
FR 56025, Oct. 28, 1997]



Sec.  98.7  Declaration upon arrival.

    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

[[Page 541]]

    (i) The name and address of the person to whom the embryo will be 
delivered.

[50 FR 43563, Oct. 25, 1985, as amended at 57 FR 29194, July 1, 1992; 62 
FR 56025, Oct. 28, 1997]



Sec.  98.8  Inspection.

    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.

[50 FR 43563, Oct. 25, 1985, as amended at 56 FR 55809, Oct. 30, 1991]



Sec.  98.9  Embryos refused entry.

    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.

[50 FR 43563, Oct. 25, 1985, as amended at 56 FR 55809, Oct. 30, 1991; 
57 FR 29194, July 1, 1992]



Sec.  98.10  Other importations.

    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.

[50 FR 43563, Oct. 25, 1985, as amended at 57 FR 29194, July 1, 1992]



Sec.  98.10a  Embryos from sheep in regions other than Australia, 
Canada, and New Zealand.

    (a) 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 one of 
the following conditions:
    (1) The embryos are transferred to females in a flock in the United 
States that participates in the Voluntary Scrapie Flock Certification 
Program (see 9 CFR part 54, subpart B) and qualifies as a ``Certified'' 
flock; or
    (2) The embryos are transferred to females in a flock in the United 
States that participates in the Voluntary Scrapie Flock Certification 
Program (see 9 CFR part 54, subpart B) and the flock owner has agreed, 
in writing, to maintain the flock, and all first generation progeny 
resulting from embryos imported in accordance with this section, in 
compliance with all requirements of the Voluntary Scrapie Flock 
Certification Program until the flock, including all first generation 
progeny resulting from embryos imported in accordance with this section, 
qualifies as a ``Certified'' flock.
    (b) Sheep embryos may be imported under paragraph (a) of this 
section only if the importer provides the Voluntary Scrapie Flock 
Certification Program identification number of the receiving flock as 
part of the application for an import permit.
    (c) Sheep embryos may be imported under paragraph (a)(1) of this 
section only if they are the progeny of a dam and sire that are part of 
flocks in the region of origin that participate in a program determined 
by the Administrator to be equivalent to the Voluntary Scrapie Flock 
Certification Program, and the flocks have been determined by the 
Administrator to be at a level equivalent to ``Certified'' in the 
Voluntary Scrapie Flock Certification Program.
    (d) Sheep embryos may be imported under paragraph (a)(2) of this 
section only if they are transferred to animals in a Certifiable Class C 
flock participating in the Voluntary Scrapie Flock Certification 
Program; except, that if the embryos are the progeny of a dam

[[Page 542]]

and sire whose flock in the region of origin participates in a program 
determined by the Administrator to be equivalent to the Voluntary 
Scrapie Flock Certification Program, then the embryos may be placed in a 
flock in the United States which would be classified at a level 
equivalent to or lower (i.e., at a greater risk) than the certification 
level, as determined by the Administrator, of either the flock of the 
dam or the flock of the sire, whichever one presents the greater risk.
    (e) The flock to which the sheep embryos are transferred pursuant to 
paragraph (a)(2) of this section must be monitored for scrapie disease 
until the flock, and all first generation progeny resulting from the 
embryos imported in accordance with this section, qualifies as a 
``Certified'' flock.
    (f) Except for sheep embryos being placed in Certifiable Class C 
flocks, the certificate accompanying sheep embryos imported under 
paragraph (a) of this section must contain the following statement: 
``The embryos identified on this certificate are the progeny of a dam 
and sire that have been monitored by a salaried veterinary officer of 
[name of region of origin], for [number of months], in the same source 
flock which had been determined by the Administrator, APHIS, prior to 
the exportation of these embryos to the United States, to be equivalent 
to [certification level (of dam or sire) presenting greater risk] of the 
Voluntary Scrapie Flock Certification Program authorized under 9 CFR 
part 54, subpart B.''
    (1) The Administrator will determine, based upon information 
supplied by the importer, whether the flock of the embryos' dam and sire 
participates in a program in the region of origin that is equivalent to 
the Voluntary Scrapie Flock Certification Program, and if so, at what 
level the source flock would be classified.
    (2) In order for the Administrator to make a determination, the 
importer must supply the following information with the application for 
an import permit, no less than 1 month prior to the anticipated date of 
importation:
    (i) The name, title, and address of a knowledgeable official in the 
veterinary services of the region of origin;
    (ii) The details of scrapie control programs in the region of 
origin, including information on disease surveillance and border control 
activities and the length of time such activities have been in effect;
    (iii) Any available information concerning additions, within the 5 
years immediately preceding collection of the embryos, to the flock of 
the embryos' sire and dam;
    (iv) Any available data concerning disease incidence, within the 5 
years immediately preceding collection of the embryos, in the flock of 
the embryos' sire and dam, including, but not limited to, the results of 
diagnostic tests, especially histopathology tests, conducted on any 
animals in the flock;
    (v) Information concerning the health, within the 5 years 
immediately preceding collection of the embryos, of other ruminants, 
flocks, and herds with which the embryos' sire and dam and the flock of 
the embryos' sire and dam might have had physical contact, and a 
description of the type and frequency of the physical contact; and
    (vi) Any other information requested by the Administrator in 
specific cases as needed to make a determination.
    (g) All first generation progeny resulting from embryos imported 
under this section are subject to the requirements of 9 CFR part 54 and 
all other applicable regulations.

(Approved by the Office of Management and Budget under control numbers 
0579-0040 and 0579-0101)

[61 FR 17241, Apr. 19, 1996, as amended at 62 FR 56025, Oct. 28, 1997]



 Subpart B_Ruminant and Swine Embryos From Regions Where Rinderpest or 
                      Foot-and-Mouth Disease Exists

    Source: 56 FR 55809, Oct. 30, 1991, unless otherwise noted.



Sec.  98.11  Definitions.

    Animal and Plant Health Inspection Service. The Animal and Plant 
Health Inspection Service of the United States Department of 
Agriculture.
    Collection of embryos. Embryos removed from a single donor dam in 
one operation.

[[Page 543]]

    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 Sec.  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.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 
FR 56025, Oct. 28, 1997]



Sec.  98.12  General prohibitions.

    (a) Ruminant and swine embryos may not be imported from regions 
where rinderpest or 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.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 
FR 56025, Oct. 28, 1997]



Sec.  98.13  Import permit.

    (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 or rinderpest 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, 
National Center for Import-Export, 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;

[[Page 544]]

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[56 FR 55809, Oct. 30, 1991, as amended at 59 FR 67616, Dec. 30, 1994; 
61 FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997]



Sec.  98.14  Health certificate.

    (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 vetrinarian 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.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 61 
FR 17242, Apr. 19, 1996; 62 FR 56025, Oct. 28, 1997]



Sec.  98.15  Health requirements.

    Ruminant and swine embryos may be imported from a region where 
rinderpest or 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, and 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: Bovine spongiform encephalopathy, contagious bovine

[[Page 545]]

pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest, 
or vesicular stomatitis; or
    (ii) Swine: African swine fever, foot-and-mouth disease, classical 
swine fever, pseudorabies, rinderpest, 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: Bovine spongiform encephalopathy, contagious bovine 
pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest, 
or vesicular stomatitis; or
    (ii) Swine: African swine fever, foot-and-mouth disease, classical 
swine fever, pseudorabies, rinderpest, swine vesicular disease, or 
vesicular stomatitis.
    (3) During the 60 days before embryo collection, the donor dam did 
not receive a vaccination for either rinderpest or 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 Sec.  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, 
rinderpest, or vesicular stomatitis; or
    (B) Swine: African swine fever, classical swine fever, pseudorabies, 
rinderpest, 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: Bovine spongiform encephalopathy, brucellosis, 
contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley 
fever, rinderpest, tuberculosis, and vesicular stomatitis; or
    (B) Swine: African swine fever, brucellosis, foot-and-mouth disease, 
classical swine fever, pseudorabies, rinderpest, 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: Bovine spongiform encephalopathy, brucellosis, 
contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley 
fever, rinderpest, tuberculosis, and vesicular stomatitis; or

[[Page 546]]

    (B) Swine: African swine fever, brucellosis, foot-and-mouth disease, 
classical swine fever, pseudorabies, rinderpest, 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.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 
FR 56025, Oct. 28, 1997; 68 FR 16940, Apr. 7, 2003]



Sec.  98.16  The embryo collection unit.

    Ruminant and swine embryos may be imported into the United States 
from a region where rinderpest or 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

[[Page 547]]

constructed of materials that can withstand repeated cleaning and 
disinfection.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15184, Apr. 5, 1996; 62 
FR 56025, Oct. 28, 1997]



Sec.  98.17  Procedures.

    (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 Sec.  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 Sec.  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

[[Page 548]]

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 Sec.  
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 50x 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

[[Page 549]]

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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15184, Apr. 5, 1996; 62 
FR 56026, Oct. 28, 1997]



Sec.  98.18  Shipment of embryos to the United States.

    (a) Release from the embryo collection unit. Except as provided in 
Sec.  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 Sec.  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.

[56 FR 55809, Oct. 30, 1991, as amended at 62 FR 56026, Oct. 28, 1997]



Sec.  98.19  Arrival and inspection at the port of entry.

    (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.



Sec.  98.20  Embryos refused entry.

    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.



Sec.  98.21  Embryos from sheep in regions other than Australia, 
Canada, and New Zealand.

    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 Sec.  
98.10a.

(Approved by the Office of Management and Budget under control numbers 
0579-0040 and 0579-0101)

[61 FR 17242, Apr. 19, 1996]



                     Subpart C_Certain Animal Semen

    Source: 55 FR 31558, Aug. 2, 1990, unless otherwise noted.



Sec.  98.30  Definitions.

    Whenever in this subpart of the following terms are used, unless the 
context otherwise requires, they shall be construed, respectively, to 
mean:

[[Page 550]]

    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).
    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.
    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.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991; 
61 FR 17242, Apr. 19, 1996; 62 FR 56026, Oct. 28, 1997; 65 FR 56777, 
Sept. 20, 2000]



Sec.  98.31  General prohibitions; exceptions.

    (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.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, 
and amended at 58 FR 37643, July 13, 1993; 59 FR 26596, May 23, 1994; 62 
FR 56026, Oct. 28, 1997]



Sec.  98.32  Inspection of certain aircraft and other means of conveyance 

and shipping containers thereon; unloading, cleaning, and disinfection 
requirements.

    (a) Inspection: All aircraft and other means of conveyance 
(including shipping containers thereon) moving into

[[Page 551]]

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.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991; 
62 FR 56026, Oct. 28, 1997; 68 FR 6345, Feb. 7, 2003]



Sec.  98.33  Ports designated for the importation of certain animal semen.

    (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

[[Page 552]]

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.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, 
and amended at 58 FR 37643, July 13, 1993; 60 FR 16045, Mar. 29, 1995; 
60 FR 25120, May 11, 1995; 64 FR 23179, Apr. 30, 1999; 65 FR 38178, June 
20, 2000; 67 FR 68022, November 8, 2002]



Sec.  98.34  Import permits for poultry semen and animal semen.

    (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 Sec.  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 or rinderpest 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

[[Page 553]]

not handled as outlined in the application for the permit and as 
specified in the permit issued.
    (c) Animal semen from regions where rinderpest or foot-and-mouth 
disease exists. Importation of semen of ruminants or swine, originating 
in any region designated in paragraph (a) of Sec.  94.1 of this 
subchapter as a region where rinderpest or 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 rinderpest or 
foot-and-mouth disease; that the donor animal was never on a farm or 
other premise where rinderpest or foot-and-mouth disease then existed; 
that the donor animal has not been on a premise that had an animal that 
was susceptible to the virus of rinderpest or foot-and-mouth disease and 
that was exposed to either disease during the 12 months immediately 
prior to the date of inspection of the donor animal; that the donor 
animal, if a ruminant, has never been vaccinated against rinderpest; 
that the donor animal, if a swine, has never been vaccinated against 
rinderpest or 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 rinderpest or foot-and-mouth 
disease shall have been permitted to enter such farm or location and no 
other source of exposure to rinderpest or 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 rinderpest, 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

[[Page 554]]

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.'' \1\
---------------------------------------------------------------------------

    \1\ The test procedures for the virus infection associated (VIA) 
test, the virus isolation test, and the virus neutralization test are 
available from the Chief, Foreign Animal Disease Diagnostic Laboratory, 
National Veterinary Services Laboratories, P.O. Box 848, Greenport, NY 
11944.
---------------------------------------------------------------------------

    (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 rinderpest or 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 rinderpest or foot-
and-mouth disease. The semen collected at the approved isolation 
facility, other than the semen samples, may be held in the region of

[[Page 555]]

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 
rinderpest or 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, rinderpest, 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,\2\ in lieu of the

[[Page 556]]

tests required by paragraphs (c)(1)(iv) and (vi) of this section. If 
test samples from any donor boars are lost, damaged, or destroyed prior 
to testing, or if test results are inconclusive, the donor boars 
involved shall be subjected to retesting:
---------------------------------------------------------------------------

    \2\ Technical information on laboratory methods and procedures for 
these tests may be obtained from the Administrator, c/o Director, 
National Veterinary Services Laboratories, P.O. Box 844, Ames, IA 50010.
---------------------------------------------------------------------------

    (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.

All samples of the above tests, except as noted for FMD, SVD, and TB, 
will be submitted to laboratories designated by the OVO of the PRC. At 
least 21 days after the final collection of semen for exportation, the 
donor animals will be retested for the diseases listed above, with the 
exception of tuberculosis and Japanese encephalitis. In addition, 
aliquots of each ejaculate of semen collected shall be submitted to 
FADDL for pathogen isolation tests for FMD, brucellosis, swine vesicular 
disease, classical swine fever, Japanese encephalitis, and pseudorabies.
    (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.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, 
and amended at 58 FR 37644, July 13, 1993; 59 FR 26596, May 23, 1994; 62 
FR 56026, Oct. 28, 1997; 68 FR 16940, Apr. 7, 2003]



Sec.  98.35  Declaration, health certificate, and other documents for 
animal semen.

    (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

[[Page 557]]

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 certificate accompanying sheep or goat semen intended for 
importation from any part of the world shall, in addition to the 
statements required by paragraph (d) of this section, state that:
    (1) The semen donor has 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 semen;
    (2) The semen donor showed no evidence of scrapie at the time the 
semen was collected; and
    (3) The parents of the semen donor are not, nor were not, affected 
with scrapie.
    (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.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, 
as amended at 58 FR 37644, July 13, 1993; 61 FR 15184, Apr. 5, 1996; 61 
FR 17242, Apr. 19, 1996; 62 FR 56026, Oct. 28, 1997; 65 FR 56777, Sept. 
20, 2000]

[[Page 558]]



Sec.  98.36  Animal semen from Canada.

    (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 Sec.  Sec.   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    See paragraph (b) of this section.
 equine, sheep, or goat semen.
------------------------------------------------------------------------

    (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  The donor animal was      The donor animal was     The importer or his
 in Sec.   98.33(b) of this part.      born in Canada or the     legally imported into    agent, in accordance
                                       United States and has     Canada, released to      with Sec.   98.35 of
                                       never been in a region    move freely in Canada,   this part, must
                                       other than Canada or      and has been released    present:
                                       the United States.        in Canada for no less   (i) Two copies of a
                                                                 than 60 days.            declaration; and
                                                                                         (ii) A health
                                                                                          certificate.
-------------------------------------
(2) Canadian land border port listed  The donor animal does                              The importer or his
 in Sec.   98.33(b) of this part.      not meet the special                               agent, in accordance
                                       conditions listed above                            with Sec.  Sec.
                                       in paragraph (b)(1) of                             98.34 and 98.35 of
                                       this table.                                        this part, must
                                                                                          present:
                                                                                         (i) An import permit;
                                                                                         (ii) Two copies of a
                                                                                          declaration; and
                                                                                         (iii) A health
                                                                                          certificate.

[[Page 559]]

 
(3) Port not listed in Sec.                                                              The importer or his
 98.33(b) of this part.                                                                   agent, in accordance
                                                                                          with Sec.  Sec.
                                                                                          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.
----------------------------------------------------------------------------------------------------------------


[65 FR 56778, Sept. 20, 2000]



Sec.  98.37  Semen from sheep in regions other than Australia, Canada, 
and New Zealand.

    (a) Except for semen from sheep in Australia, Canada, or New 
Zealand, semen from sheep may only be imported into the United States if 
it complies with all applicable provisions of this subpart and one of 
the following conditions:
    (1) The semen is transferred to females in a flock in the United 
States that participates in the Voluntary Scrapie Flock Certification 
Program (see 9 CFR part 54, subpart B) and qualifies as a ``Certified'' 
flock; or
    (2) The semen is transferred to females in a flock in the United 
States that participates in the Voluntary Scrapie Flock Certification 
Program (see 9 CFR part 54, subpart B), and the flock owner has agreed, 
in writing, to maintain the flock, and all first generation progeny 
resulting from semen imported in accordance with this section, in 
compliance with all requirements of the Voluntary Scrapie Flock 
Certification Program until the flock, including all first generation 
progeny resulting from semen imported in accordance with this section, 
qualifies as a ``Certified'' flock.
    (b) Sheep semen may be imported under paragraph (a) of this section 
only if the importer provides the Voluntary Scrapie Flock Certification 
Program identification number of the receiving flock as part of the 
application for an import permit.
    (c) Sheep semen may be imported under paragraph (a)(1) of this 
section only if it comes from a donor animal in a flock in the region of 
origin that participates in a program determined by the Administrator to 
be equivalent to the Voluntary Scrapie Flock Certification Program, and 
the flock has been determined by the Administrator to be at a level 
equivalent to ``Certified'' in the Voluntary Scrapie Flock Certification 
Program.
    (d) Sheep semen may be imported under paragraph (a)(2) of this 
section only if it is transferred to animals in a Certifiable Class C 
flock participating in the Voluntary Scrapie Flock Certification 
Program; except, that if the semen comes from a donor animal whose flock 
in the region of origin participates in a program determined by the 
Administrator to be equivalent to the Voluntary Scrapie Flock 
Certification Program, then the semen may be used in a flock in the 
United States which would be classified at a level equivalent to or 
lower (i.e., at greater risk) than the certification level, as 
determined by the Administrator, of the flock of the donor animal.
    (e) The flock to which the sheep semen is transferred pursuant to 
paragraph (a)(2) of this section must be

[[Page 560]]

monitored for scrapie disease until the flock, and all first generation 
progeny resulting from the semen imported in accordance with this 
section, qualifies as a ``Certified'' flock.
    (f) Except for sheep semen being placed in Certifiable Class C 
flocks, the certificate accompanying the sheep semen imported under 
paragraph (a) of this section must contain the following statement: 
``The semen identified on this certificate has been collected from a 
sire that has been monitored by a salaried veterinary officer of [name 
of region of origin], for [number of months], in the same source flock 
which had been determined by the Administrator, APHIS, prior to the 
exportation of the semen to the United States, to be equivalent to 
[certification level] of the Voluntary Scrapie Flock Certification 
Program authorized under 9 CFR part 54, subpart B.''
    (1) The Administrator will determine, based upon information 
supplied by the importer, whether the donor animal's flock participates 
in a program in the region of origin that is equivalent to the Voluntary 
Scrapie Flock Certification Program, and if so, at what level the source 
flock would be classified.
    (2) In order for the Administrator to make a determination, the 
importer must supply the following information with the application for 
an import permit, no less than 1 month prior to the anticipated date of 
importation:
    (i) The name, title, and address of a knowledgeable official in the 
veterinary services of the region of origin;
    (ii) The details of scrapie control programs in the region of 
origin, including information on disease surveillance and border control 
activities and the length of time these activities have been in effect;
    (iii) Any available information concerning additions, within the 5 
years immediately preceding collection of the semen, to the flock of the 
semen donor;
    (iv) Any available data concerning disease incidence, within the 5 
years immediately preceding collection of the semen in the donor 
animal's flock, including, but not limited to, the results of diagnostic 
tests, especially histopathology tests, conducted on any animals in the 
flock;
    (v) Information concerning the health, within the 5 years 
immediately preceding collection of the semen, of other ruminants, 
flocks, and herds with which the donor animal and the donor animal's 
flock might have had physical contact, and a description of the type and 
frequency of the physical contact; and
    (vi) Any other information requested by the Administrator in 
specific cases as needed to make a determination.
    (g) All first generation progeny resulting from semen imported under 
this section are subject to the requirements of 9 CFR part 54 and all 
other applicable regulations.

(Approved by the Office of Management and Budget under control numbers 
0579-0040 and 0579-0101)

[61 FR 17242, Apr. 19, 1996, as amended at 62 FR 56026, Oct. 28, 1997; 
64 FR 23179, April 30, 1999]



Sec.  98.38  Restrictions on the importation of swine semen from parts 
of the European Union.

    In addition to meeting all other applicable provisions of this part, 
swine semen imported from the region of the European Union consisting of 
Austria, Belgium, Germany (except for the Kreis Uckermark in the Land of 
Brandenburg; the Kreis Oldenberg, the Kreis Soltau-Fallingbostel, and 
the Kreis Vechta in the Land of Lower Saxony; the Kreis Heinsberg and 
the Kreis Warendorf in the Land of Northrhine-Westphalia; the Kreis 
Bernkastel-Wittlich, the Kreis Bitburg-Prm, the Kreis Donnersbergkreis, 
the Kreis Rhein-Hunsrche, the Kreis Sdliche Weinstrasse, and the Kreis 
Trier-Saarburg in the Land of Rhineland Palatinate; and the Kreis 
Altmarkkreis in the Land of Saxony-Anhalt); Greece, Italy (except for 
the Regions of Emilia-Romagna, Piemonte, and Sardegna), the Netherlands, 
and Portugal must meet the following conditions:
    (a) The semen must come only from a semen collection center approved 
for export by the veterinary services of the national government of the 
country of origin;
    (b) The donor boar must not have lived in a region when the region 
was

[[Page 561]]

classified in Sec.  94.10(a) as one in which classical swine fever is 
known to exist, and must not have transited such a region unless moved 
directly through the region in a sealed means of conveyance with the 
seal determined to be intact upon arrival at the point of destination;
    (c) The donor boar must never have been commingled with swine that 
have been in a region when the region was classified in Sec.  94.10(a) 
as one in which classical swine fever is known to exist;
    (d) The donor boar must be held in isolation for at least 30 days 
prior to entering the semen collection center;
    (e) No more than 30 days prior to being held in isolation as 
required by paragraph (d) of this section, the donor boar must be tested 
with negative results with a classical swine fever test approved by the 
Office International des Epizooties;
    (f) 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 has first been 
cleaned and disinfected;
    (g) The donor boar must be observed at the semen collection center 
by the center veterinarian, and exhibit no clinical signs of classical 
swine fever;
    (h) Before the semen is exported to the United States, the donor 
boar must be held at the semen collection center for at least 40 days 
following collection of the semen, and, along with all other swine at 
the semen collection center, exhibit no clinical signs of classical 
swine fever; and
    (i) The semen must be accompanied to the United States by a 
certificate issued by a salaried veterinary officer of the national 
government of the country of origin, stating that the provisions of 
paragraphs (a) through (h) of this section have been met.\3\
---------------------------------------------------------------------------

    \3\ The certification required may be placed on the certificate 
required under Sec.  98.35(c) or may be contained in a separate 
document.

(Approved by the Office of Management and Budget under control number 
---------------------------------------------------------------------------
0579-0218)

[68 FR 16940, Apr. 7, 2003]



PART 99_RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER CERTAIN ACTS--Table of Contents




                            Subpart A_General

Sec.
99.1 Scope and applicability of rules of practice.

                Subpart B_Supplemental Rules of Practice

99.10 Stipulations.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 48 FR 30095, June 30, 1983, unless otherwise noted. 
Redesignated at 52 FR 29502, Aug. 10, 1987.



                            Subpart A_General



Sec.  99.1  Scope and applicability of rules of practice.

    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:

Act of May 29, 1884, commonly known as the Animal Industry Act, section 
7, as amended (21 U.S.C. 117),
Act of August 30, 1890, section 6, as amended (21 U.S.C. 104),
Act of February 2, 1903, commonly known as the Cattle Contagious 
Diseases Act of 1903, section 3, as amended (21 U.S.C. 122),
Act of July 2, 1962, section 6(a), as amended (21 U.S.C. 134e),
Act of May 6, 1970, section 2, as amended (21 U.S.C. 135a).
The Animal Health Protection Act, section 10414 (7 U.S.C. 8313)


In addition, the Supplemental Rules of Practice set forth in subpart B 
of this part shall be applicable to such proceedings.

[48 FR 30095, June 30, 1983. Redesignated at 52 FR 29502, Aug. 10, 1987, 
as amended at 68 FR 6345, Feb. 7, 2003]



                Subpart B_Supplemental Rules of Practice



Sec.  99.10  Stipulations.

    (a) At any time prior to the issuance of a complaint seeking a civil 
penalty

[[Page 562]]

under any of the Acts listed in Sec.  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.

[48 FR 30095, June 30, 1983. Redesignated and amended at 52 FR 29502, 
Aug. 10, 1987]

[[Page 563]]



SUBCHAPTER E_VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS 
                               AND VECTORS





PART 101_DEFINITIONS--Table of Contents




Sec.
101.1 Applicability.
101.2 Administrative terminology.
101.3 Biological products and related terms.
101.4 Labeling terminology.
101.5 Testing terminology.
101.6 Cell cultures.
101.7 Seed organisms.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Source: 38 FR 8426, Apr. 2, 1973, unless otherwise noted.



Sec.  101.1  Applicability.

    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.



Sec.  101.2  Administrative terminology.

    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.
    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

[[Page 564]]

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

[[Page 565]]

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).

[38 FR 8426, Apr. 2, 1973; 38 FR 9221, Apr. 12, 1973, as amended at 40 
FR 46093, Oct. 6, 1975; 41 FR 44358, Oct. 8, 1976; 49 FR 22624, May 31, 
1984; 52 FR 30131, Aug. 13, 1987; 56 FR 66782, 66783, Dec. 26, 1991; 57 
FR 38756, Aug. 27, 1992; 62 FR 31328, June 9, 1997; 64 FR 43044, Aug. 9, 
1999]



Sec.  101.3  Biological products and related terms.

    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.

[[Page 566]]

    (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.

[38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 50 
FR 24903, June 14, 1985; 56 FR 66782, Dec. 26, 1991; 60 FR 14354, Mar. 
17, 1995]



Sec.  101.4  Labeling terminology.

    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.

[38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 56 
FR 66782, Dec. 26, 1991; 61 FR 29464, June 11, 1996]



Sec.  101.5  Testing terminology.

    Terms used when evaluating biological products shall mean:

[[Page 567]]

    (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) No test. A test which produces inconclusive or invalid results 
and therefore, cannot be used to evaluate a biological product.
    (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

[[Page 568]]

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.

[38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 41 
FR 6751, Feb. 13, 1976; 43 FR 3701, Jan. 27, 1978; 56 FR 66782, 66783 
Dec. 26, 1991; 62 FR 19037, Apr. 18, 1997]



Sec.  101.6  Cell cultures.

    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.

[38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 49 
FR 22624, May 31, 1984]



Sec.  101.7  Seed organisms.

    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.

[49 FR 22625, May 31, 1984]



PART 102_LICENSES FOR BIOLOGICAL PRODUCTS--Table of Contents




Sec.
102.1 Licenses issued by the Administrator.
102.2 Licenses required.
102.3 License applications.
102.4 U.S. Veterinary Biologics Establishment License.
102.5 U.S. Veterinary Biological Product License.
102.6 Conditional licenses.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.



Sec.  102.1  Licenses issued by the Administrator.

    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.

[60 FR 48021, Sept. 18, 1995]

[[Page 569]]



Sec.  102.2  Licenses required.

    (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.

[52 FR 11026, Apr. 7, 1987, as amended at 56 FR 66783, Dec. 26, 1991; 61 
FR 52873, Oct. 9, 1996]



Sec.  102.3  License applications.

    (a) U.S. Veterinary Biologics Establishment License. (1) The 
operator of each establishment of the kind specified in Sec.  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 four copies of an Outline of Production prepared in 
accordance with Sec. Sec.  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 Sec.  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 
Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 37763, Oct. 24, 1974, as amended at 48 FR 57472, Dec. 30, 1983; 
49 FR 21043, May 18, 1984; 50 FR 50763, Dec. 12, 1985; 56 FR 66783, Dec. 
26, 1991]



Sec.  102.4  U.S. Veterinary Biologics Establishment License.

    (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:

[[Page 570]]

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 37762, Oct. 24, 1974; 39 FR 38364, Nov. 1, 1974, as amended at 41 
FR 44359, Oct. 8, 1976; 48 FR 57472, Dec. 30, 1983; 52 FR 11026, Apr. 7, 
1987; 52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991; 60 FR 
48021, Sept. 18, 1995; 61 FR 52873, Oct. 9, 1996; 62 FR 13294, Mar. 20, 
1997]



Sec.  102.5  U.S. Veterinary Biological 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.

[[Page 571]]

    (4) The date of issuance.
    (5) Any restrictions designated by the Administrator under paragraph 
(e) of this section.
    (6) When necessary to comply with Sec.  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 Sec. Sec.  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, Licensing and Policy Development, 510 
South 17th Street, Suite 104, Ames, IA 50010-8197. 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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 37763, Oct. 24, 1974, as amended at 48 FR 57472, Dec. 30, 1983; 
50 FR 50764, Dec. 12, 1985; 52 FR 11026, Apr. 7, 1987; 56 FR 66783, Dec. 
26, 1991; 57 FR 38760, Aug. 27, 1992; 59 FR 67616, Dec. 30, 1994; 62 FR 
13294, Mar. 20, 1997; 64 FR 43044, Aug. 9, 1999]



Sec.  102.6  Conditional licenses.

    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 Sec.  
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.

[52 FR 11026, Apr. 7, 1987, as amended at 60 FR 48021; Sept. 18, 1995]

[[Page 572]]



PART 103_EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF 
BIOLOGICAL PRODUCTS PRIOR TO LICENSING--Table of Contents




Sec.
103.1 Preparation of experimental biological products.
103.2 Disposition of animals administered experimental biological 
          products or live organisms.
103.3 Shipment of experimental biological products.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.



Sec.  103.1  Preparation of experimental biological products.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[30 FR 11848, Sept. 16, 1965, as amended at 48 FR 57473, Dec. 30, 1983; 
56 FR 66783, Dec. 26, 1991]



Sec.  103.2  Disposition of animals administered experimental biological 
products or live organisms.

    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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0059)

[30 FR 11848, Sept. 16, 1965, as amended at 48 FR 57473, Dec. 30, 1983; 
56 FR 66783, Dec. 26, 1991; 66 FR 21063, Apr. 27, 2001]



Sec.  103.3  Shipment of experimental biological products.

    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

[[Page 573]]

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) Three copies of labels or label sketches which show the name or 
identification of the product and bear a statement, ``Notice! For 
Experimental Use Only--Not For Sale,'' or equivalent. 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.

[26 FR 7726, Aug. 18, 1961, as amended at 30 FR 11848, Sept. 16, 1965; 
52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991]



PART 104_PERMITS FOR BIOLOGICAL PRODUCTS--Table of Contents




Sec.
104.1 Permit required.
104.2 Permit authorized.
104.3 Permit application.
104.4 Products for research and evaluation.
104.5 Products for distribution and sale.
104.6 Products for transit shipment only.
104.7 Product permit.
104.8 Illegal shipments.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Source: 38 FR 32916, Nov. 29, 1973, unless otherwise noted.



Sec.  104.1  Permit required.

    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

[[Page 574]]

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.

[38 FR 32916, Nov. 29, 1973, as amended at 56 FR 66783, Dec. 26, 1991; 
56 FR 66783, Dec. 26, 1991]



Sec.  104.2  Permit authorized.

    (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, rinderpest, fowl pest (fowl plague), 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 Sec.  104.4(d).

[38 FR 32916, Nov. 29, 1973, as amended at 56 FR 66783, Dec. 26, 1991; 
56 FR 66783, Dec. 26, 1991]



Sec.  104.3  Permit application.

    (a) Each person desiring to import a biological product shall make 
written application to Animal and Plant Health Inspection Service for a 
permit. Blank forms of application shall be furnished upon request.
    (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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[38 FR 32916, Nov. 29, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 
56 FR 66783, Dec. 26, 1991]



Sec.  104.4  Products for research and evaluation.

    (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 
Sec.  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 Sec.  
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

[[Page 575]]

vitro Research and Evaluation tests: Provided, That, the importation of 
such product will not endanger the livestock or poultry of this country.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[38 FR 32916, Nov. 29, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 
52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991]



Sec.  104.5  Products for distribution and sale.

    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) Three 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. Four 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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[38 FR 32916, Nov. 29, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 
49 FR 21044, May 18, 1984; 56 FR 66783, Dec. 26, 1991]

[[Page 576]]



Sec.  104.6  Products for transit shipment only.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[38 FR 32916, Nov. 29, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 
56 FR 66784, Dec. 26, 1991; 61 FR 52873, Oct. 9, 1996]



Sec.  104.7  Product permit.

    (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.

[38 FR 32916, Nov. 29, 1973, as amended at 56 FR 66783, Dec. 26, 1991; 
62 FR 13294, Mar. 20, 1997]



Sec.  104.8  Illegal shipments.

    (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.



PART 105_SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL LICENSES 
OR PERMITS--Table of Contents




Sec.
105.1 Suspension or revocation.
105.2 Notification of infractions.
105.3 Notices re: worthless, contaminated, dangerous, or harmful 
          biological products.
105.4 Termination of licenses and permits for inactivity.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.



Sec.  105.1  Suspension or revocation.

    (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;

[[Page 577]]

    (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.

[38 FR 23512, Aug. 31, 1973, as amended at 41 FR 44359, Oct. 8, 1976; 61 
FR 52874, Oct. 9, 1996; 64 FR 43044, Aug. 9, 1999]



Sec.  105.2  Notification of infractions.

    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 Sec.  105.1(b).

[42 FR 31430, June 21, 1977, as amended at 56 FR 66783, Dec. 26, 1991]



Sec.  105.3  Notices re: worthless, contaminated, dangerous, or harmful 
biological products.

    (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.

[38 FR 23512, Aug. 31, 1973, as amended at 56 FR 66783, Dec. 26, 1991]



Sec.  105.4  Termination of licenses and permits for inactivity.

    (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 Sec.  116.8.

[61 FR 52874, Oct. 9, 1996]



PART 106_EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS 
OR UNDER DEPARTMENT CONTROL OR SUPERVISION--Table of Contents




    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

[[Page 578]]



Sec.  106.1  Biological products; exemption.

    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.

[45 FR 65184, Oct. 2, 1980, as amended at 56 FR 66783, Dec. 26, 1991]



PART 107_EXEMPTIONS FROM PREPARATION PURSUANT TO AN UNSUSPENDED AND 
UNREVOKED LICENSE--Table of Contents




Sec.
107.1 Veterinary practitioners and animal owners.
107.2 Products under State license.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.



Sec.  107.1  Veterinary practitioners and animal owners.

    Products prepared as provided in paragraphs (a) and (b) of this 
section and establishments 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 establishments 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) 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.

[52 FR 30131, Aug. 13, 1987, as amended at 56 FR 66783, Dec. 26, 1991]



Sec.  107.2  Products under State 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

[[Page 579]]

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.

[52 FR 30131, Aug. 13, 1987, as amended at 56 FR 66783, Dec. 26, 1991]



PART 108_FACILITY REQUIREMENTS FOR LICENSED ESTABLISHMENTS--Table of Contents




Sec.
108.1 Applicability.
108.2 Plot plans, blueprints, and legends required.
108.3 Preparation of plot plans.
108.4 Preparation of blueprints.
108.5 Preparation of legends.
108.6 Revision of plot plans, blueprints, and legends.
108.7 Filing of plot plans, blueprints, and legends.
108.8 Construction of buildings.
108.9 Dressing rooms and other facilities.
108.10 Outer premises and stables.
108.11 Water quality requirements.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Source: 39 FR 16854, May 10, 1974, unless otherwise noted.



Sec.  108.1  Applicability.

    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.

[39 FR 16854, May 10, 1974, as amended at 56 FR 66783, Dec. 26, 1991]



Sec.  108.2  Plot plans, blueprints, and legends required.

    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.



Sec.  108.3  Preparation of plot plans.

    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

[[Page 580]]

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.



Sec.  108.4  Preparation of blueprints.

    (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.



Sec.  108.5  Preparation of legends.

    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.

[[Page 581]]

    (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.

[39 FR 16854, May 10, 1974, as amended at 40 FR 51413, Nov. 5, 1975; 50 
FR 50764, Dec. 12, 1985]



Sec.  108.6  Revision of plot plans, blueprints, and legends.

    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.

[39 FR 16854, May 10, 1974, as amended at 56 FR 66783, Dec. 26, 1991]



Sec.  108.7  Filing of plot plans, blueprints, and legends.

    Three 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.

[39 FR 16854, May 10, 1974, as amended at 56 FR 66783, Dec. 26, 1991]



Sec.  108.8  Construction of buildings.

    (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.



Sec.  108.9  Dressing rooms and other facilities.

    Each licensed establishment shall have dressing rooms, toilet 
facilities,

[[Page 582]]

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.



Sec.  108.10  Outer premises and stables.

    (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.



Sec.  108.11  Water quality requirements.

    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.

[39 FR 16854, May 10, 1974, as amended at 56 FR 66783, Dec. 26, 1991]



PART 109_STERILIZATION AND PASTEURIZATION AT LICENSED ESTABLISHMENTS--Table of Contents




Sec.
109.1 Equipment and the like.
109.2 Sterilizers.
109.3 Pasteurizers.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.



Sec.  109.1  Equipment and the like.

    (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 [deg]C. for not less than one-half hour, or by dry heat at 
a temperature of at least 160 [deg]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.

[23 FR 10051, Dec. 23, 1958, as amended at 34 FR 18119, Nov. 11, 1969; 
56 FR 66783, Dec. 26, 1991]



Sec.  109.2  Sterilizers.

    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.

[35 FR 16039, Oct. 13, 1970, as amended at 56 FR 66783, Dec. 26, 1991]

[[Page 583]]



Sec.  109.3  Pasteurizers.

    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 [deg]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.

[35 FR 16039, Oct. 13, 1970, as amended at 56 FR 66783, Dec. 26, 1991]



PART 112_PACKAGING AND LABELING--Table of Contents




Sec.
112.1 General.
112.2 Final container label, carton label, and enclosure.
112.3 Diluent labels.
112.4 Subsidiaries, divisions, distributors, and permittees.
112.5 Review and approval of labeling.
112.6 Packaging biological products.
112.7 Special additional requirements.
112.8 For export only.
112.9 Biological products imported for research and evaluation.
112.10 Special packaging and labeling.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Source: 38 FR 12094, May 9, 1973, unless otherwise noted.



Sec.  112.1  General.

    (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 Sec.  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.

[38 FR 12094, May 9, 1973, as amended at 59 FR 43445, Aug. 24, 1994]



Sec.  112.2  Final container label, carton label, and enclosure.

    (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 principal part of the true name of the biological product 
which

[[Page 584]]

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 a carton label and enclosures;
    (2) If the biological product is prepared in the United States, the 
name and address of the producer (licensee or subsidiary) or if the 
biological product is prepared in a foreign country, the name and 
address of the permittee and of the foreign producer.
    (3) The license or permit number assigned by the Department which 
shall be shown only in one of the following forms respectively: ``U.S. 
Veterinary License No. ------,'' or ``U.S. Vet. License No. ------,'' or 
``U.S. Vet Lic. No. ------,'' or ``U.S. Veterinary Permit No. ------,'' 
or ``U.S. Permit No. ------.''
    (4) Storage temperature recommendation for the biological product 
stated as not over 45 [deg]F. or stated as not over 7 [deg]C. or stated 
as not over 45 [deg]F. or 7 [deg]C.
    (5) Full instructions for the proper use of the product, including 
vaccination schedules, warnings, cautions, and the like: 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;
    (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) If the biological product contains viable or dangerous organisms 
or viruses, a warning to ``Burn this container and all unused 
contents,'' except that in the case of a small one-dose container, the 
statement ``Burn this container'' or ``Burn this vial'' may be used.
    (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;
    (10) In the case of a product which contains an antibiotic added 
during the production process, the statement ``Contains ------ as a 
preservative,'' or an equivalent statement indicating the antibiotic 
added shall appear on cartons and enclosures if used: Provided, That if 
cartons are not used, such information shall 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.
    (b) Labels may also include any other statement which is not false 
or misleading and may include factual statements regarding variable 
response of

[[Page 585]]

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 veterinary use only'' or an equivalent 
statement may appear on the carton labels and enclosures for a product 
if such statement is being used to indicate that the product is 
recommended specifically for animals, and not for humans.
    (e) When label requirements of a foreign country conflict with the 
requirements as prescribed in this part, special labels may be approved 
for use on biological products to be exported to such country. 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 thereto, such certification may be made by Animal and Plant 
Health Inspection Service upon request of the licensee.
    (f) 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 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 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 for approval.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[38 FR 12094, May 9, 1973, as amended at 39 FR 16856, May 10, 1974; 41 
FR 44359, Oct. 8, 1976; 42 FR 11825, Mar. 1, 1977; 42 FR 29854, June 10, 
1977; 42 FR 41850, Aug. 19, 1977; 48 FR 57473, Dec. 30, 1983; 56 FR 
66784, Dec. 26, 1991]



Sec.  112.3  Diluent labels.

    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, ``Burn this container and all unused 
contents,'' except that, in the case of a small one-dose container, the 
statement ``Burn this container'' or ``Burn this vial'' may be used.

[[Page 586]]

    (g) The establishment license number or the permit number, as the 
case may be, in one of the forms provided in Sec.  112.2(a)(3).

[38 FR 12094, May 9, 1973; 38 FR 13476, May 22, 1973, and amended at 39 
FR 16856, May 10, 1974]



Sec.  112.4  Subsidiaries, divisions, distributors, and permittees.

    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 Sec.  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 
Sec.  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 Sec.  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.

[50 FR 46417, Nov. 8, 1985, as amended at 59 FR 43445, Aug. 24, 1994]



Sec.  112.5  Review and approval of labeling.

    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 (c) of this section and under the 
master label system provided in paragraph (d) of this section.
    (a) Transmittal forms, furnished by Animal and Plant Health 
Inspection Service upon request, 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) 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.

[[Page 587]]

    (c)(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 Sec.  112.5(d) 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) Change in the color of label print, provided that such change 
does 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 or changing label control numbers of bar codes; and
    (vi) Revising or updating logos.
    (d) 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 Sec.  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 Sec.  
112.5(d)(1)(iii): 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 three 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. Two copies of each 
finished label will be retained by APHIS. One copy will be stamped and 
returned to the licensee. Labels to which exceptions are taken shall be 
marked as sketches and handled under Sec.  112.5(d)(1)(i).
    (iv) For finished master labels, submit for each product three 
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 sizes of 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. Two copies of 
each finished master label will be retained by APHIS. One copy will be 
stamped and returned to the licensee. Master labels to which exceptions 
are taken will be marked as sketches and handled under Sec.  
112.5(d)(1)(ii).
    (2) Mounting:

[[Page 588]]

    (i) Each label or sketch shall be securely fastened to a separate 
sheet of heavy bond paper (8\1/2\ x 11) in such a 
manner that all information is available for review.
    (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: The reason for and 
information relevant to the submission shall be stated in the lower left 
hand corner as:
    (i) Master label dose sizes approved for code ------------.
    (ii) Replacement for label, master label, and/or sketch No. --------
----.
    (iii) Reference to label or master label No. ------------.
    (iv) Addition to label No. ------------.
    (v) License Application Pending ------------.
    (vi) Foreign Language copy of Label No. ------------.
    (e) Special requirements for foreign language labels:
    (1) If true, a statement that the label is a direct translation from 
a corresponding approved domestic label.
    (2) If the foreign language label is not a direct translation of an 
approved domestic label, an English version shall be submitted with an 
explanation for the difference in texts.
    (3) 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.
    (f) 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.
    (g) 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 Sec.  112.5(c).

(Approved by the Office of Management and Budget under control number 
0579-0013)

[38 FR 12094, May 9, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 49 
FR 21044, May 18, 1984; 56 FR 66783, Dec. 26, 1991; 59 FR 43445, Aug. 
24, 1994; 61 FR 29464, June 11, 1996; 61 FR 33175, June 26, 1996; 64 FR 
43044, Aug. 9, 1999]

[[Page 589]]



Sec.  112.6  Packaging biological products.

    (a) Each multiple-dose final container of a biological product which 
requires a diluent for administration shall be packaged in an individual 
carton with a container of the proper volume of diluent for that dose as 
specified in the filed Outline of Production. Each multiple-dose final 
container of a product which does not require a diluent for 
administration need not be packaged in an individual carton unless the 
final container labeling does not contain all information required by 
the regulations. Such information must be included in or on a carton. 
Exceptions are provided in paragraphs (c) and (d) of this section and 
Sec.  112.8.
    (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 Sec.  107.1.
    (f) Labels which are affixed to or included with a biological 
product shall not be removed or altered in any manner.

[47 FR 8761, Mar. 2, 1982, as amended at 48 FR 12691, Mar. 28, 1983; 59 
FR 43445, Aug. 24, 1994; 64 FR 43044, Aug. 9, 1999]



Sec.  112.7  Special additional requirements.

    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.

[[Page 590]]

    (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 Sec.  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 Sec.  113.312, 
paragraph (b) or (c), or both.
    (e) In the case of bovine rhinotracheitis 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.
    (f) Unless otherwise authorized in a filed Outline of Production, 
labels for inactivated bacterial products shall contain an unqualified 
recommendation for a repeat dose to accomplish primary immunization to 
be given at an appropriate time interval: Provided, That, repeat dose 
recommendations prescribed in paragraphs (f)(1) through (3) of this 
section are required for products containing the fractions listed.
    (1) Clostridium haemolyticum. ``Repeat the dose every 5 or 6 months 
in animals subject to reexposure.''
    (2) Erysipelothrix rhusiopathiae. ``Swine: For breeding animals, 
repeat after 21 days and annually. Turkeys: Repeat dose every 3 
months.''
    (3) Clostridium botulinum Type C. ``Revaccinate breeders 1 month 
before breeding.''
    (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) Unless otherwise authorized in an Outline of Production filed 
subsequent to the effective date of these amendments, 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 of any age with 
one dose except that if the animal is less than 12 weeks of age, a 
second dose should be given at 12 to 16 weeks of age. Annual 
revaccination with a single dose is recommended.
    (2) Modified live virus vaccines. Vaccinate healthy cats of any age 
with one dose except that if the animal is less than 12 weeks of age, a 
second dose

[[Page 591]]

should be given at 12 to 16 weeks of age. Annual revaccination with a 
single dose is recommended. Do not vaccinate pregnant cats.
    (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 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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[38 FR 12094, May 9, 1973]

    Editorial Note: For Federal Register citations affecting Sec.  
112.7, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  112.8  For export only.

    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 Sec.  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.

[38 FR 12094, May 9, 1973, as amended at 39 FR 19202, May 31, 1974; 40 
FR 46093, Oct. 6, 1975; 43 FR 11145, Mar. 17, 1978; 56 FR 66784, Dec. 
26, 1991]



Sec.  112.9  Biological products imported for research and evaluation.

    A biological product imported for research and evaluation under a 
permit issued in accordance with Sec.  104.4, with the exception of 
products imported under Sec.  104.4(d), shall be labeled as provided in 
this section.

[[Page 592]]

    (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 Sec.  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.

[50 FR 46417, Nov. 8, 1985, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  112.10  Special packaging and labeling.

    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.



PART 113_STANDARD REQUIREMENTS--Table of Contents




                              Applicability

Sec.
113.1 Compliance.
113.2 Testing aids.
113.3 Sampling of biological products.
113.4 Exemptions to tests.
113.5 General testing.
113.6 Animal and Plant Health Inspection Service testing.
113.7 Multiple fractions.
113.8 In vitro tests for serial release.
113.9 New potency test.
113.10 Testing of bulk material for export or for further manufacture.

                           Standard Procedures

113.25 Culture media for detection of bacteria and fungi.
113.26 Detection of viable bacteria and fungi except in live vaccine.
113.27 Detection of extraneous viable bacteria and fungi in live 
          vaccines.
113.28 Detection of mycoplasma contamination.
113.29 Determination of moisture content in desiccated biological 
          products.
113.30 Detection of Salmonella contamination.
113.31 Detection of avian lymphoid leukosis.
113.32 Detection of Brucella contamination.
113.33 Mouse safety tests.
113.34 Detection of hemagglutinating viruses.
113.35 Detection of viricidal activity.
113.36 Detection of pathogens by the chicken inoculation test.
113.37 Detection of pathogens by the chicken embryo inoculation test.
113.38 Guinea pig safety test.
113.39 Cat safety tests.
113.40 Dog safety tests.
113.41 Calf safety test.
113.42 Detection of lymphocytic choriomeningitis contamination.
113.43 Detection of chlamydial agents.
113.44 Swine safety test.
113.45 Sheep safety test.
113.46 Detection of cytopathogenic and/or hemadsorbing agents.
113.47 Detection of extraneous viruses by the fluorescent antibody 
          technique.

                         Ingredient Requirements

113.50 Ingredients of biological products.
113.51 Requirements for primary cells used for production of biologics.
113.52 Requirements for cell lines used for production of biologics.
113.53 Requirements for ingredients of animal origin used for production 
          of biologics.
113.54 Sterile diluent.
113.55 Detection of extraneous agents in Master Seed Virus.

                         Live Bacterial Vaccines

113.64 General requirements for live bacterial vaccines.
113.65 Brucella Abortus Vaccine.
113.66 Anthrax Spore Vaccine--Nonencapsulated.
113.67 Erysipelothrix Rhusiopathiae Vaccine.
113.68 Pasteurella Haemolytica Vaccine, Bovine.
113.69 Pasteurella Multocida Vaccine, Bovine.
113.70 Pasteurella Multocida Vaccine, Avian Isolate.
113.71 Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia.

                     Inactivated Bacterial Products

113.100 General requirements for inactivated bacterial products.
113.101 Leptospira Pomona Bacterin.
113.102 Leptospira Icterohaemorrhagiae Bacterin.
113.103 Leptospira Canicola Bacterin.
113.104 Leptospira Grippotyphosa Bacterin.
113.105 Leptospira Hardjo Bacterin.
113.106 Clostridium Chauvoei Bacterin.
113.107 Clostridium Haemolyticum Bacterin.
113.108 Clostridium Novyi Bacterin-Toxoid.

[[Page 593]]

113.109 Clostridium Sordellii Bacterin-Toxoid.
113.110 Clostridium Botulinum Type C Bacterin-Toxoid.
113.111 Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.
113.112 Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid.
113.113 Autogenous biologics.
113.114 Tetanus Toxoid.
113.115 Staphylococcus Aureus Bacterin-Toxoid.
113.116 Pasteurella Multocida Bacterin, Avian Isolate, Type 4.
113.117 Pasteurella Multocida Bacterin, Avian Isolate, Type 1.
113.118 Pasteurella Multocida Bacterin, Avian Isolate, Type 3.
113.119 Erysipelothrix Rhusiopathiae Bacterin.
113.120 Salmonella Typhimurium Bacterin.
113.121 Pasteurella Multocida Bacterin.
113.122 Salmonella Choleraesuis Bacterin.
113.123 Salmonella Dublin Bacterin.

                          Killed Virus Vaccines

113.200 General requirements for killed virus vaccines.
113.201 Canine Distemper Vaccine, Killed Virus.
113.202 Canine Hepatitis and Canine Adenovirus Type 2 Vaccine, Killed 
          Virus.
113.203 Feline Panleukopenia Vaccine, Killed Virus.
113.204 Mink Enteritis Vaccine, Killed Virus.
113.205 Newcastle Disease Vaccine, Killed Virus.
113.206 Wart Vaccine, Killed Virus.
113.207 Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, 
          Killed Virus.
113.208 Avian Encephalomyelitis Vaccine, Killed Virus.
113.209 Rabies Vaccine, Killed Virus.
113.210 Feline Calicivirus Vaccine, Killed Virus.
113.211 Feline Rhinotracheitis Vaccine, Killed Virus.
113.212 Bursal Disease Vaccine, Killed Virus.
113.213 Pseudorabies Vaccine, Killed Virus.
113.214 Parvovirus Vaccine, Killed Virus (Canine).
113.215 Bovine Virus Diarrhea Vaccine, Killed Virus.
113.216 Bovine Rhinotracheitis Vaccine, Killed Virus.

                           Live Virus Vaccines

113.300 General requirements for live virus vaccines.
113.301 Ovine Ecthyma Vaccine.
113.302 Distemper Vaccine--Mink.
113.303 Bluetongue Vaccine.
113.304 Feline Panleukopenia Vaccine.
113.305 Canine Hepatitis and Canine Adenovirus Type 2 Vaccine.
113.306 Canine Distemper Vaccine.
113.308 Encephalomyelitis Vaccine, Venezuelan.
113.309 Bovine Parainfluenza3 Vaccine.
113.310 Bovine Rhinotracheitis Vaccine.
113.311 Bovine Virus Diarrhea Vaccine.
113.312 Rabies Vaccine, Live Virus.
113.313 Measles Vaccine.
113.314 Feline Calicivirus Vaccine.
113.315 Feline Rhinotracheitis Vaccine.
113.316 Canine Parainfluenza Vaccine.
113.317 Parvovirus Vaccine (Canine).
113.318 Pseudorabies Vaccine.
113.319-113.324 [Reserved]
113.325 Avian Encephalomyelitis Vaccine.
113.326 Avian Pox Vaccine.
113.327 Bronchitis Vaccine.
113.328 Fowl Laryngotracheitis Vaccine.
113.329 Newcastle Disease Vaccine.
113.330 Marek's Disease Vaccines.
113.331 Bursal Disease Vaccine.
113.332 Tenosynovitis Vaccine.

                        Diagnostics and Reagents

113.400-113.405 [Reserved]
113.406 Tuberculin, Intradermic.
113.407 Pullorum antigen.
113.408 Avian mycoplasma antigen.
113.409 Tuberculin--PPD Bovis, Intradermic.

                            Antibody Products

113.450 General requirements for antibody products.
113.451 Tetanus Antitoxin.
113.452 Erysipelothrix Rhusiopathiae Antibody.
113.453 [Reserved]
113.454 Clostridium Perfringens Type C Antitoxin.
113.455 Clostridium Perfringens Type D Antitoxin.
113.456-113.498 [Reserved]
113.499 Products for treatment of failure of passive transfer.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Source: 34 FR 18004, Nov. 7, 1969, unless otherwise noted.

                              Applicability



Sec.  113.1  Compliance.

    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.



Sec.  113.2  Testing aids.

    To better ensure consistent and reproducible test results when 
Standard

[[Page 594]]

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.

[39 FR 21041, June 18, 1974, as amended at 40 FR 758, Jan. 3, 1975; 50 
FR 21799, May 29, 1985; 56 FR 66784, Dec. 26, 1991]



Sec.  113.3  Sampling of biological products.

    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:

[[Page 595]]

    (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

[[Page 596]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[38 FR 29886, Oct. 30, 1973, as amended at 40 FR 758, Jan. 3, 1975; 40 
FR 49768, Oct. 24, 1975; 41 FR 56627, Dec. 29, 1976; 48 FR 9506, Mar. 7, 
1983; 48 FR 57473, Dec. 30, 1983; 50 FR 21799, May 29, 1985; 56 FR 
66784, Dec. 26, 1991; 60 FR 14356, Mar. 17, 1995; 67 FR 15713, Apr. 3, 
2002]



Sec.  113.4  Exemptions to tests.

    (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.

[38 FR 29887, Oct. 30, 1973, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  113.5  General testing.

    (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

[[Page 597]]

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.
    (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.

(Approved by the Office of Management and Budget under control number 
0579-0059)

[34 FR 18004, Nov. 4, 1969, as amended at 39 FR 25463, July 11, 1974; 40 
FR 45420, Oct. 2, 1975; 40 FR 46093, Oct. 6, 1975; 41 FR 6751, Feb. 13, 
1976; 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991]



Sec.  113.6  Animal and Plant Health Inspection Service testing.

    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.

[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 45420, Oct. 2, 1975; 40 
FR 53378, Nov. 18, 1975; 41 FR 6751, Feb. 13, 1976; 56 FR 66784, Dec. 
26, 1991]



Sec.  113.7  Multiple fractions.

    (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 Sec.  113.100 are complied 
with.
    (e) Virus titrations for a multivirus product shall be conducted by 
methods which will quantitate each virus.

[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 46093, Oct. 6, 1975; 56 
FR 66785, Dec. 26, 1991]



Sec.  113.8  In vitro tests for serial release.

    (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 Sec. Sec.  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:

[[Page 598]]

    (i) Potency for live products may be determined by log10 
virus titer or determining the live bacterial count based on the 
protective dose used in the Master Seed immunogenicity test plus an 
adequate overage for adverse conditions and test error; and
    (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\0.7\ or 
greater, the initial titer may be considered a result of test system 
error and the serial or subserial considered satisfactory for virus 
titer.
    (ii) If the difference between the average titer obtained in the 
retests and the titer obtained in the initial test is less than 10\0.7\, 
a new average shall be determined using the titers obtained in all 
tests. If the new average is below the required minimum, the serial or 
subserial is unsatisfactory.
    (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 
log10 virus titer or organism count, an appropriate 
difference between the average potency value obtained in the retests and 
the potency value obtained in the initial test shall be established for 
use in paragraphs (b)(3) and (b)(4) of this section to evaluate such 
products and shall be specified in the product Standard Requirement or 
filed Outline of Production.
    (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.\1\ Firms currently using 
immunoassays which do not satisfy this requirement shall have 2 years 
from the effective date of the final rule

[[Page 599]]

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 method for evaluating relative antigen content, Supplemental 
Assay Method 318, and relative potency calculation software are 
available from the United States Department of Agriculture, Animal and 
Plant Health Inspection Service, Veterinary Services, National 
Veterinary Services Laboratories, Center for Veterinary Biologics--
Laboratory, 1800 Dayton Road, P. O. Box 844, Ames, Iowa 50010.
---------------------------------------------------------------------------

    (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

[[Page 600]]

in paragraphs (c)(4) (i) and (ii) and (c)(5) (i) and (ii) of this 
section, and confirmatory testing by APHIS.
    (d) Repeat immunogenicity tests. (1) The accuracy of the protective 
dose established for live products in the Master Seed immunogenicity 
test and defined as live virus titer or live bacterial count shall be 
confirmed in 3 years in a manner acceptable to APHIS, unless use of the 
lot of Master Seed previously tested is discontinued.
    (2) 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
------------------------------------------------------------------------
                                 Number   Failures for     Failures for
             Stage                 of     satisfactory    unsatisfactory
                                animals      serials         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

[[Page 601]]

reevaluation of the product is made and the problem is resolved.

[49 FR 22625, May 31, 1984, as amended at 56 FR 66784, 66786, Dec. 26, 
1991; 62 FR 19038, Apr. 18, 1997]



Sec.  113.9  New potency test.

    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 Sec.  113.4.

[40 FR 14084, Mar. 28, 1975, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  113.10  Testing of bulk material for export or for further manufacture.

    When a product is prepared in a licensed establishment for export in 
large multiple-dose containers as provided in Sec.  112.8(d) or (e) of 
this subchapter or for further manufacturing purposes as provided in 
Sec.  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.

[49 FR 45846, Nov. 21, 1984]

                           Standard Procedures



Sec.  113.25  Culture media for detection of bacteria and fungi.

    (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 Sec. Sec.  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.

[35 FR 16039, Oct. 13, 1970, as amended at 37 FR 2430, Feb. 1, 1972; 41 
FR 27715, July 6, 1976; 56 FR 66784, Dec. 26, 1991]

[[Page 602]]



Sec.  113.26  Detection of viable bacteria and fungi except in live vaccine.

    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 
Sec.  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 
[deg]to 35 [deg]C. to test for bacteria and 14 days at 20 [deg]to 25 
[deg]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.

[35 FR 16039, Oct. 13, 1970, as amended at 37 FR 2430, Feb. 1, 1972; 39 
FR 21042, June 18, 1974; 40 FR 758, Jan. 3, 1975; 40 FR 14084, Mar. 28, 
1975; 56 FR 66784, Dec. 26, 1991]



Sec.  113.27  Detection of extraneous viable bacteria and fungi in 
live vaccines.

    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

[[Page 603]]

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 Sec.  113.25(d) indicates the need for a 
greater dilution of the product. Incubation shall be at 30 [deg]to 35 
[deg]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 Sec.  113.25(d) indicates the need 
for a greater dilution of the product. Incubation shall be at 20 [deg]to 
25 [deg]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 Sec.  113.25(d) indicates the 
need for a greater dilution of the product. Incubation shall be at 30 
[deg]to 35 [deg]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 Sec.  113.25(d) indicates the need 
for a greater dilution of the product. Incubation shall be at 20 [deg]to 
25 [deg]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

[[Page 604]]

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 [deg]to 35 
[deg]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 [deg]to 25 
[deg]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 [deg]to 
35 [deg]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 [deg]to 
25 [deg]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.

[[Page 605]]

    (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 
[deg]to 35 [deg]for 7 days and the other plate shall be incubated at 20 
[deg]to 25 [deg]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.

[48 FR 28430, June 22, 1983, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  113.28  Detection of mycoplasma contamination.

    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 [deg]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 [deg]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:

126 ml of inactivated horse serum
21 ml of DPN-Cysteine solution
525,000 units of Penicillin.
Dispense 10 ml aliquots into 60x15 mm disposable culture dishes or petri 
dishes.

    (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

[[Page 606]]

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 [deg]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 
CO2 atmosphere at 33 [deg]to 37 [deg]C for 10-14 days and 
examined with a stereoscopic microscope at 35x to 100x or with a regular 
microscope at 100x.
    (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.

[38 FR 29887, Oct. 30, 1973, as amended at 41 FR 6752, Feb. 13, 1976; 41 
FR 32882, Aug. 6, 1976]



Sec.  113.29  Determination of moisture content in desiccated biological 
products.

    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 [deg]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

[[Page 607]]

oven. Set the vacuum to < 2.5 kPa and the temperature to 60 3 [deg]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:

(B-C)/(B-A) x (100) = Percentage of residual moisture, where:
A = tare weight of weighing bottle
B-A = weight of sample before drying
B-C = weight of sample after drying

    (7) The results are considered satisfactory if the percentage of 
residual moisture is less than or equal to the manufacturer's 
specification.

[68 FR 57608, Oct. 6, 2003]



Sec.  113.30  Detection of Salmonella contamination.

    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 [deg]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.

[38 FR 29888, Oct. 30, 1973]



Sec.  113.31  Detection of avian lymphoid leukosis.

    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

[[Page 608]]

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 [deg]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 [deg]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.

[38 FR 29888, Oct. 30, 1973, as amended at 38 FR 32917, Nov. 29, 1973; 
39 FR 21042, June 18, 1974; 56 FR 66784, Dec. 26, 1991]



Sec.  113.32  Detection of Brucella contamination.

    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 CO2 atmosphere at a 
temperature of 35-37 [deg]C for at least 7 days.
    (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.

[38 FR 29888, Oct. 30, 1973]



Sec.  113.33  Mouse safety tests.

    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. Eight mice shall be inoculated intracerebrally with 0.03 ml and 
eight mice shall be inoculated intraperitoneally with 0.5 ml. Both 
groups shall be observed for 7 days.

[[Page 609]]

    (2) If unfavorable reactions attributable to the product occur in 
two or more mice in either group during the observation period, the 
serial or subserial is unsatisfactory. If unfavorable reactions which 
are not attributable to the product occur in two or more mice in either 
group, the test shall be declared inconclusive 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 inconclusive and may be 
repeated: Provided, That, if the test is not repeated, the serial or 
subserial shall be declared unsatisfactory.

[38 FR 34727, Dec. 18, 1973, as amended at 39 FR 16857, May 10, 1974]



Sec.  113.34  Detection of hemagglutinating viruses.

    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.

[38 FR 29889, Oct. 30, 1973]



Sec.  113.35  Detection of viricidal activity.

    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

[[Page 610]]

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 [deg]to 25 
[deg]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 log10 below the titer of 
the vaccine virus(es) rehydrated with sterile purified water, the 
product is unsatisfactory for use as diluent.
    (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 Sec.  112.7(g).

[44 FR 25412, May 1, 1979, as amended at 56 FR 66784, Dec. 26, 1991; 64 
FR 43044, Aug. 9, 1999]



Sec.  113.36  Detection of pathogens by the chicken inoculation test.

    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\2\). Twenty birds may be used for each route or 
combination of routes.
    (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 
inconclusive and may be repeated: Provided, That, if the test is not 
repeated, the serial of subserial tested shall be considered 
unsatisfactory.

[38 FR 29889, Oct. 30, 1973, as amended at 39 FR 21042, June 18, 1974; 
43 FR 7610, Feb. 24, 1978]



Sec.  113.37  Detection of pathogens by the chicken embryo inoculation 
test.

    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.

[[Page 611]]

    (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.

[38 FR 29889, Oct. 30, 1973, as amended at 39 FR 21042, June 18, 1974]



Sec.  113.38  Guinea pig safety test.

    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 
inconclusive and may be repeated: Provided, That, if the test is not 
repeated, the serial or subserial shall be declared unsatisfactory.

[39 FR 16857, May 10, 1974; 39 FR 20368, June 10, 1974]



Sec.  113.39  Cat safety tests.

    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

[[Page 612]]

not attributable to the Master Seed Virus, the test shall be declared 
inconclusive 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 inconclusive and repeated: Provided, That, if 
not repeated, the serial shall be unsatisfactory.

[44 FR 58898, Oct. 12, 1979, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  113.40  Dog safety tests.

    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 
inconclusive 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 inconclusive and may be repeated: 
Provided, That, if the test is not repeated, the serial shall be 
considered unsatisfactory.

[60 FR 14358, Mar. 17, 1995]



Sec.  113.41  Calf safety test.

    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 
inconclusive and may be repeated: Provided, That, if the test is not 
repeated, the serial or subserial shall be declared unsatisfactory.

[39 FR 27428, July 29, 1974]



Sec.  113.42  Detection of lymphocytic choriomeningitis contamination.

    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.

[[Page 613]]

    (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.

[42 FR 6794, Feb. 4, 1977]



Sec.  113.43  Detection of chlamydial agents.

    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.

[44 FR 58899, Oct. 12, 1979]



Sec.  113.44  Swine safety test.

    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 
inconclusive and may be repeated; Provided, That, if the test is not 
repeated, the serial or subserial shall be declared unsatisfactory.

[48 FR 33476, July 22, 1983]



Sec.  113.45  Sheep safety test.

    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 
inconclusive and may be repeated; Provided, That, if the test is not 
repeated, the serial or subserial shall be declared unsatisfactory.

[48 FR 33476, July 22, 1983]

[[Page 614]]



Sec.  113.46  Detection of cytopathogenic and/or hemadsorbing agents.

    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\2\ and at least 7 days from the last subculture shall be 
tested as provided in this paragraph.
    (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\2\ and at least 7 days from the last subculture shall be 
tested as provided in this paragraph.
    (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[deg] 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 [deg]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.

[50 FR 441, Jan. 4, 1985, as amended at 58 FR 50252, Sept. 27, 1993]



Sec.  113.47  Detection of extraneous viruses by the fluorescent 
antibody technique.

    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 
FAID50 of the specific virus being tested for as positive 
controls.
    (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 
Sec. Sec.  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\2\.
    (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.

[[Page 615]]

    (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 inconclusive 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 inconclusive, 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.

[60 FR 24548, May 9, 1995]

                         Ingredient Requirements



Sec.  113.50  Ingredients of biological products.

    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.

[38 FR 29889, Oct. 30, 1973]



Sec.  113.51  Requirements for primary cells used for production of 
biologics.

    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

[[Page 616]]

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 Sec.  113.28. The sample for testing shall consist of 
at least 75 cm\2\ of actively growing cells or the equivalent in harvest 
fluids; Provided, That all sources of cells in the batch of primary 
cells are represented.
    (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 Sec.  113.26 or Sec.  113.27 (whichever is 
applicable).
    (c) A monolayer at least 75 cm\2\ from each batch of primary cells 
or each subculture of primary cells used to prepare a biological product 
shall be shown free of extraneous agents as prescribed in this 
paragraph.
    (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\2\. The last subculture shall meet the minimum area 
requirement specified in Sec. Sec.  113.46 and 113.47.
    (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\. The last subculture shall meet the minimum area 
requirement specified in Sec. Sec.  113.46 and 113.47.
    (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 Sec.  
113.46;
    (ii) Extraneous viruses by the fluorescent antibody technique as 
prescribed in Sec.  113.47.

[50 FR 442, Jan. 4, 1985, as amended at 60 FR 24549, May 9, 1995]



Sec.  113.52  Requirements for cell lines used for production of biologics.

    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

[[Page 617]]

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\ 
shall be grown to at least 80 percent confluency.
    (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 Sec.  113.28. The sample for testing shall consist of 
at least 75 cm\2\ of actively growing cells or the equivalent, in 
harvest fluids. The cells shall represent all sources of cells in the 
batch.
    (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 
Sec.  113.26 or Sec.  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\2\ from each MCS shall be shown free 
of extraneous agents as prescribed in this paragraph.
    (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\2\. The last subculture shall meet 
the minimum area requirement specified in Sec. Sec.  113.46 and 113.47 
and paragraph (f) of this section.
    (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 Sec.  
113.46; and
    (ii) Extraneous agents by the fluorescent antibody technique as 
prescribed in Sec.  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\2\ shall also be shown free of extraneous agents as prescribed in 
this paragraph.
    (1) Alternately freeze and thaw the monolayer(s) three times. 
Centrifuge the disrupted cells at no greater than 2,000xg for no more 
than 15 minutes to

[[Page 618]]

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\2\) 
of:
    (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\2\. 
The last subculture shall meet the minimum area requirement specified in 
Sec. Sec.  113.46 and 113.47.
    (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 Sec.  
113.46; and
    (ii) Extraneous viruses by the fluorescent antibody technique as 
prescribed in Sec.  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.

[50 FR 442, Jan. 4, 1985; 50 FR 3316, Jan. 24, 1985, as amended at 56 FR 
66784, Dec. 26, 1991; 60 FR 24549, May 9, 1995]



Sec.  113.53  Requirements for ingredients of animal origin used for 
production of biologics.

    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 Sec.  
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 Sec.  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;

[[Page 619]]

    (1) Monolayers at least 75 cm\2\ of Vero (African green monkey 
kidney) cell line and of primary cells or a cell line of the same 
species of origin as the ingredient shall be used in the test. Cell 
lines used shall have been found satisfactory when tested as prescribed 
in Sec.  113.52 and primary cells used shall have been found 
satisfactory when tested as prescribed in Sec.  113.51.
    (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\2\ test 
monolayers. The ingredient shall also be used in the growth medium when 
monolayers are subcultured. If the ingredient being tested is cytotoxic 
when tested in this manner, other procedures may be used if approved by 
APHIS.
    (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\2\. The last subculture shall meet 
the minimum area requirements specified in Sec. Sec.  113.46 and 113.47.
    (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 Sec.  
113.46; and
    (ii) Extraneous viruses by the fluorescent antibody technique as 
prescribed in Sec.  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 80,000xg, the pellet material shall be 
reconstituted in distilled water and inoculated into a flask containing 
75 cm\2\ of a 30 to 50 percent confluent monolayer culture of primary 
porcine cells or a porcine cell line of proven equal PPV susceptibility. 
An additional flask of cells shall be held as a negative control.
    (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 Sec.  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.

[50 FR 442, Jan. 4, 1985; 50 FR 3316, Jan. 24, 1985, as amended at 56 FR 
66784, Dec. 26, 1991; 60 FR 24549, May 9, 1995]



Sec.  113.54  Sterile diluent.

    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 Sec.  113.26. 
Any serial found to be unsatisfactory shall not be released.

[39 FR 27428, July 29, 1974, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  113.55  Detection of extraneous agents in Master Seed Virus.

    Unless otherwise prescribed in a Standard Requirement or in a filed 
Outline of Production, each Master

[[Page 620]]

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\2\ in area) of:
    (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 Sec.  113.52 and primary cells used shall have been found 
satisfactory when tested as prescribed in Sec.  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\2\. The last subculture shall meet the minimum 
area requirement specified in Sec. Sec.  113.46 and 113.47.
    (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 Sec.  
113.46;
    (2) Extraneous agents by the fluorescent antibody technique as 
prescribed in Sec.  113.47.

[50 FR 444, Jan. 4, 1985, as amended at 56 FR 66784, Dec. 26, 1991]

                         Live Bacterial Vaccines



Sec.  113.64  General requirements for live bacterial vaccines.

    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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  113.45.
    (iv) Live bacterial vaccine recommended for use in swine shall be 
tested as provided in Sec.  113.44.

[[Page 621]]

    (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 Sec.  113.50. Ingredients of animal 
origin shall meet the applicable requirements provided in Sec.  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 Sec.  113.29.

[48 FR 33476, July 22, 1983, as amended at 54 FR 19352, May 5, 1989; 56 
FR 66784, Dec. 26, 1991; 68 FR 57608, Oct. 6, 2003]



Sec.  113.65  Brucella Abortus Vaccine.

    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 [deg] 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

[[Page 622]]

rays pass through the plate at a 45 [deg]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 [deg] 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 [deg] 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.

[39 FR 16857, May 10, 1974. Redesignated at 39 FR 25463, July 11, 1974, 
and amended at 40 FR 758, Jan. 3, 1975; 50 FR 23794, Jan. 6, 1985]



Sec.  113.66  Anthrax Spore Vaccine--Nonencapsulated.

    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

[[Page 623]]

first through the fifth passage from the Master Seed.
    (a) The Master Seed shall meet the applicable general requirements 
prescribed in Sec.  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 
LD50 of a virulent suspension of Bacillus anthracis furnished 
or approved by Animal and Plant Health Inspection Service and observed 
for 10 days.
    (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) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot previously tested is discontinued. The vaccinates 
and controls must meet the criteria prescribed in paragraphs (b)(4) and 
(b)(5) of this section.
    (7) 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 [deg]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.

[50 FR 23794, June 6, 1985, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  113.67  Erysipelothrix Rhusiopathiae Vaccine.

    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 Sec.  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.

[[Page 624]]

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 [deg] F or higher on at least 2 
consecutive days, the test shall be considered inconclusive: 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 [deg] 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) The Master Seed shall be retested for immunogenicity in 3 years. 
Only five vaccinates and five controls need to be used in the retest: 
Provided, That at least four of five vaccinates and four of the five 
controls shall meet the criteria prescribed in paragraphs (b)(5) and 
(b)(6) of this section.
    (8) 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 Sec.  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 Sec.  113.33(b) and in swine as prescribed in Sec.  
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.

[50 FR 23795, June 6, 1985, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  113.68  Pasteurella Haemolytica Vaccine, Bovine.

    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

[[Page 625]]

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 Sec.  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) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot previously tested is discontinued. Only five 
vaccinates and five controls need to be used in the retest: Provided, 
that, at least four of five vaccinates and four of five controls shall 
meet the criteria prescribed in paragraphs (b)(4) and (b)(5) of this 
section.
    (7) 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 Sec. Sec.  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 
Sec. Sec.  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

[[Page 626]]

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.

[55 FR 35559, Aug. 31, 1990]



Sec.  113.69  Pasteurella Multocida Vaccine, Bovine.

    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 Sec.  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) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot previously tested is discontinued. Only five 
vaccinates and five controls need to be used in the retest: Provided, 
that, at least four of five vaccinates and four of five controls shall 
meet the criteria prescribed in paragraphs (b)(4) and (b)(5) of this 
section.
    (7) 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 Sec. Sec.  113.8 
and 113.64 and the requirements in this paragraph. Any serial or 
subserial found unsatisfactory

[[Page 627]]

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 
Sec. Sec.  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.

[55 FR 35560, Aug. 31, 1990]



Sec.  113.70  Pasteurella Multocida Vaccine, Avian Isolate.

    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 Sec.  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.
    (5) The Master Seed shall be retested for immunogenicity in 3 years 
and shall meet the criteria prescribed in paragraph (b)(4) of this 
section.
    (c) Test requirements for release. Each serial and subserial shall 
meet the applicable requirements in Sec. Sec.  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.

[[Page 628]]

    (iii) If unfavorable reactions occur which are not attributable to 
the test vaccine, the test is inconclusive 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.

[55 FR 35560, Aug. 31, 1990, as amended at 59 FR 19633, Apr. 25, 1994; 
64 FR 43044, Aug. 9, 1999]



Sec.  113.71  Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live 
Chlamydia.

    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 Sec.  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 Sec.  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 inconclusive 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) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot previously tested is discontinued. Either 10 
vaccinates and 6 controls or 5 vaccinates and 3 controls shall be used 
in the retest.
    (i) If less than five of six or three of three of the controls in 
the retest show clinical signs of feline pneumonitis infection other 
than fever, the test is inconclusive and may be repeated.

[[Page 629]]

    (ii) A significant difference in clinical signs shall be 
demonstrated between vaccinates and controls in a valid test as 
prescribed in paragraph (c)(3)(ii) of this section.
    (5) 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 Sec.  
113.300(a)(3)(ii), each serial and subserial shall meet the requirements 
prescribed in Sec.  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 Sec.  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.

[55 FR 35561, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991]

                     Inactivated Bacterial Products



Sec.  113.100  General requirements for inactivated bacterial products.

    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 Sec.  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 Sec.  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 Sec.  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 Sec.  
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

[[Page 630]]

final product shall meet the requirements provided in Sec.  113.50. 
Ingredients of animal origin shall meet the applicable requirements 
provided in Sec.  113.53.
    (e) Only serials tested for viricidal activity in accordance with 
the test provided in Sec.  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.\2\ Firms currently using tests for residual free 
formaldehyde content other than the ferric chloride test have until July 
14, 2004 to update their Outline of Production to be in compliance with 
this requirement.
---------------------------------------------------------------------------

    \2\ The procedures for performing the ferric chloride test for 
residual free formaldehyde may be obtained from USDA, APHIS, Center for 
Veterinary Biologics-Laboratory, 1800 Dayton Road, P.O. Box 844, Ames, 
IA 50010.
---------------------------------------------------------------------------

    (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).

[39 FR 16862, May 10, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 60 FR 14355, Mar. 17, 1995; 68 FR 35283, June 13, 2003]



Sec.  113.101  Leptospira Pomona Bacterin.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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 LD50 as determined by titration.
    (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 total    Cumulative total
                                       Number of       Cumulative number   dead hamsters for   dead hamsters for
              Stage                   vaccinates         of vaccinates       satisfactory       unsatisfactory
                                                                                serial              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.

[39 FR 16862, May 10, 1974, as amended at 40 FR 20067, May 8, 1975; 45 
FR 40100, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66785, Dec. 26, 1991]

[[Page 631]]



Sec.  113.102  Leptospira Icterohaemorrhagiae Bacterin.

    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 
Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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 LD50 as determined by titration.
    (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:

----------------------------------------------------------------------------------------------------------------
                                                                           Cumulative total    Cumulative total
                                       Number of       Cumulative number   dead hamsters for   dead hamsters for
              Stage                   vaccinates         of vaccinates       satisfactory       unsatisfactory
                                                                                serial              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.

[39 FR 16862, May 10, 1974, as amended at 45 FR 40100, June 13, 1980. 
Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, 
Dec. 26, 1991]



Sec.  113.103  Leptospira Canicola Bacterin.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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.

[[Page 632]]

    (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 LD50 as determined by titration.
    (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:

----------------------------------------------------------------------------------------------------------------
                                                                           Cumulative total    Cumulative total
                                       Number of       Cumulative number   dead hamsters for   dead hamsters for
              Stage                   vaccinates         of vaccinates       satisfactory       unsatisfactory
                                                                                serial              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.

[39 FR 16862, May 10, 1974, as amended at 45 FR 40100, June 13, 1980. 
Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, 
Dec. 26, 1991]



Sec.  113.104  Leptospira Grippotyphosa Bacterin.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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 LD50 as determined by titration.
    (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
----------------------------------------------------------------------------------------------------------------
                                                                   Dead hamsters for        Dead hamsters for
                Stage                    Number of vaccinates          acceptance               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.

[40 FR 17003, Apr. 16, 1975, as amended at 40 FR 23989, June 4, 1975; 45 
FR 40100, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66785, Dec. 26, 1991]

[[Page 633]]



Sec.  113.105  Leptospira Hardjo Bacterin.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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.

[40 FR 17003, Apr. 16, 1975, as amended at 40 FR 20067, May 8, 1975. 
Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, 
Dec. 26, 1991]



Sec.  113.106  Clostridium Chauvoei Bacterin.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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 LD50 of challenge material. This dose shall 
be determined by statistical analysis of results of titrations of the 
challenge material. The vaccinates and controls shall be observed for 3 
days postchallenge and all deaths recorded.
    (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:

----------------------------------------------------------------------------------------------------------------
                                                                                               Cumulative total
                                                                           Cumulative total    number of deaths
              Stage                    Number of       Cumulative number   number of deaths         for an
                                      vaccinates         of vaccinates    for a satisfactory    unsatisfactory
                                                                                 test                test
----------------------------------------------------------------------------------------------------------------
1...............................  8.................  8.................  1 or less.........  3 or more.
2...............................  8.................  16................  4 or less.........  5 or more.
----------------------------------------------------------------------------------------------------------------


The second stage shall be required only when exactly two animals die in 
the first stage. The second stage shall be conducted in a manner 
identical to the first stage.

[39 FR 16862, May 10, 1974, as amended at 45 FR 40100, June 13, 1980. 
Redesignated at 55 FR 35562, Aug. 31, 1990 and amended at 56 FR 66784, 
66785, Dec. 26, 1991]



Sec.  113.107  Clostridium Haemolyticum Bacterin.

    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 Sec.  113.100 and 
shall be tested for purity,

[[Page 634]]

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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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 LD50 of challenge material. This dose shall 
be determined by statistical analysis of results of titrations of the 
challenge material. The vaccinates and controls shall be observed for 3 
days postchallenge and all deaths recorded.
    (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:

----------------------------------------------------------------------------------------------------------------
                                                                                               Cumulative total
                                                                           Cumulative total    number of deaths
              Stage                    Number of       Cumulative number   number of deaths         for an
                                      vaccinates         of vaccinates    for a satisfactory    unsatisfactory
                                                                                 test                test
----------------------------------------------------------------------------------------------------------------
1...............................  8.................  8.................  1 or less.........  3 or more.
2...............................  8.................  16................  4 or less.........  5 or more.
----------------------------------------------------------------------------------------------------------------


The second stage shall be required only when exactly two animals die in 
the first stage. The second stage shall be conducted in a manner 
identical to the first stage.

[39 FR 16862, May 10, 1974, as amended at 40 FR 20067, May 8, 1975; 45 
FR 40100, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66785, Dec. 26, 1991]



Sec.  113.108  Clostridium Novyi Bacterin-Toxoid.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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

[[Page 635]]

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 [deg]C for 25 
minutes; and storing at 4 [deg]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 inconclusive 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 
inconclusive 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.

[39 FR 16862, May 10, 1974, as amended at 45 FR 40101, June 13, 1980. 
Redesignated at 55 FR 35562, Aug. 31, 1990; 56 FR 37825, Aug. 9, 1991, 
as amended at 56 FR 66784, 66785, Dec. 26, 1991]



Sec.  113.109  Clostridium Sordellii Bacterin-Toxoid.

    Clostridium Sordellii Bacterin-Toxoid shall be produced from a 
culture of Clostridium sordellii which has been inactivated and is 
nontoxic. Each serial

[[Page 636]]

of biological product containing Clostridium sordellii fraction shall 
meet the applicable requirements in Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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 [deg]C for 25 
minutes; and storing at 4 [deg]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 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.

[[Page 637]]

    (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 inconclusive 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 
inconclusive 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.

[39 FR 16862, May 10, 1974, as amended at 42 FR 61247, Dec. 2, 1977; 45 
FR 40101, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990; 56 
FR 37826, Aug. 9, 1991; 56 FR 66784, 66785, Dec. 26, 1991]



Sec.  113.110  Clostridium Botulinum Type C Bacterin-Toxoid.

    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 
Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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\4.0\ mouse MLD dose. The titration technique 
shall include inoculation of the mice intraperitoneally.
    (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.

[39 FR 16862, May 10, 1974, as amended at 40 FR 759, Jan. 3, 1975. 
Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, 
Dec. 26, 1991]



Sec.  113.111  Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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.

[[Page 638]]

    (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 L0 and L+ doses of 
Standard Toxin according to their definitions.
    (ii) L0 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 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 [deg]F for 25 
minutes; and storing at 4 [deg]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 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 
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 L0 
doses per ml and make a second dilution of Standard Toxin to contain 10 
L+ doses per ml.
    (iii) Combine 10 International Units of Standard Antitoxin with 10 
L0 doses of diluted Standard Toxin and combine 10 
International Units of Standard Antitoxin with 10 L+ doses of 
diluted Standard Toxin.
    (iv) Combine 1 ml of undiluted serum with 10 L0 doses of 
diluted Standard Toxin.
    (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 L0 doses of Standard Toxin 
die, the results of the test are inconclusive 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 mixture of 
10 International Units of Standard Antitoxin and 10 L+ doses 
of Standard Toxin die, the results of the test are inconclusive 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 serum with 10 
L0 doses of

[[Page 639]]

Standard Toxin die, the serum is considered to contain less than 10 
International Units per ml. and the serial is unsatisfactory

[39 FR 16862, May 10, 1974, as amended at 40 FR 759, Jan. 3, 1975; 40 FR 
41088, Sept. 5, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66785, Dec. 26, 1991; 62 FR 31330, June 9, 1997]



Sec.  113.112  Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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 L0 and L+ doses of 
Standard Toxin according to their definitions.
    (ii) L0 dose. The largest quantity of toxin which can be 
mixed with one-tenth 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-tenth unit of Standard Antitoxin and cause death in at 
least 80 percent of injected mice.
    (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 [deg]F for 25 
minutes; and storing at 4 [deg]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 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 
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 Lo 
doses per ml and make a second dilution of Standard Toxin to contain 10 
L+ doses per ml.
    (iii) Combine 1 International Unit of Standard Antitoxin with 10 
Lo doses of diluted Standard Toxin and Combine 1 
International Unit of Standard Antitoxin with 10 L+ doses of 
diluted Standard Toxin.
    (iv) Dilute 1 ml of serum with 1 ml of diluent (1:2) and combine 1 
ml of this

[[Page 640]]

solution with 10 Lo doses of diluted Standard Toxin.
    (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 Lo doses of Standard Toxin die, 
the results of the test are inconclusive 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 mixture of 
1 International Unit of Standard Antitoxin and 10 L+ doses of 
Standard Toxin die, the results of the test are inconclusive 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 serum with 10 
Lo doses of Standard Toxin die, the serum is considered to 
contain less than 2 International Units per ml, and the serial is 
unsatisfactory.

[39 FR 16865, May 10, 1974; 39 FR 20783, June 14, 1974. Redesignated at 
39 FR 25463, July 11, 1974, and amended at 40 FR 759, Jan. 3, 1975; 40 
FR 41088, Sept. 5, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66785, Dec. 26, 1991; 62 FR 31331, June 9, 1997]



Sec.  113.113  Autogenous biologics.

    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, 510 South 17th Street, Suite 104, Ames, IA 50010-8197) 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

[[Page 641]]

involvement of the adjacent herd(s) with the disease observed.

The applicant shall give notice to the State Veterinarian or other 
appropriate State Official in writing when an autogenous biologic is to 
be used in adjacent herds.
    (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, 
510 South 17th Street, Suite 104, Ames, IA 50010-8197) 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.

In addition, an applicant for authorization under this paragraph (a)(3) 
shall provide written approval from the State Veterinarian or other 
appropriate State Official in the State in which the autogenous biologic 
is to be used in nonadjacent herds.
    (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 Sec.  113.26, and for safety as 
prescribed in Sec.  113.33(b) or Sec.  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 Sec.  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

[[Page 642]]

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, 510 South 17th Street, Suite 104, Ames, IA 50010-8197) 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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  
113.33 (b) or Sec.  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, Licensing and Policy Development, 510 South 17th 
Street, Suite 104, Ames, IA 50010-8197 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

[[Page 643]]

for such fraction(s) that has been shown to be antigenic or immunogenic 
in accordance with paragraph (c)(2)(iv)(A) of this section.

[57 FR 38756, Aug. 27, 1992, as amended at 59 FR 67616, Dec. 30, 1994; 
64 FR 43044, Aug. 9, 1999; 67 FR 15714, Apr. 3, 2002]



Sec.  113.114  Tetanus Toxoid.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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.

[39 FR 16862, May 10, 1974, as amended at 46 FR 23224, Apr. 24, 1981; 50 
FR 24905, June 14, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 37827, Aug. 9, 1991; 56 FR 66785, Dec. 26, 1991]



Sec.  113.115  Staphylococcus Aureus Bacterin-Toxoid.

    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 Sec.  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 
Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product shall be tested for safety as provided in Sec.  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

[[Page 644]]

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 [deg]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 [deg]C water bath for 1 hour. 
Refrigerate at 5 [deg]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.

[39 FR 16862, May 10, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66785, Dec. 26, 1991]



Sec.  113.116  Pasteurella Multocida Bacterin, Avian Isolate, Type 4.

    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 Sec.  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 inconclusive 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.

[[Page 645]]

    (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 inconclusive and may be repeated if the validity 
requirement is not met, but the serial is unsatisfactory if the test is 
not repeated.

----------------------------------------------------------------------------------------------------------------
                                                                  Cummulative total number of dead vaccinates
                                        Number of  Cumulative                      for------
                Stage                  vaccinates   number of --------------------------------------------------
                                                   vaccinates     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.

[47 FR 5795, Feb. 4, 1982; 47 FR 6817, Feb. 17, 1982, as amended at 52 
FR 9117, Mar. 23, 1987. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66785, Dec. 26, 1991]



Sec.  113.117  Pasteurella Multocida Bacterin, Avian Isolate, Type 1.

    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 Sec.  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 Sec.  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 inconclusive 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

[[Page 646]]

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 inconclusive and may be repeated if the validity 
requirements are not met, but the serial is unsatisfactory if the test 
is not repeated.

----------------------------------------------------------------------------------------------------------------
                                                                  Cummulative total number of dead vaccinates
                                        Number of  Cumulative                      for------
                Stage                  vaccinates   number of --------------------------------------------------
                                                   vaccinates     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.

[39 FR 16866, May 10, 1974; 39 FR 20368, June 10, 1974, as amended at 40 
FR 759, Jan. 3, 1975; 40 FR 23989, June 4, 1975; 47 FR 5195, Feb. 4, 
1982; 52 FR 9118, Mar. 23, 1987. Redesignated at 55 FR 35562, Aug. 31, 
1990, as amended at 56 FR 66785, Dec. 26, 1991]



Sec.  113.118  Pasteurella Multocida Bacterin, Avian Isolate, Type 3.

    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 Sec.  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 Sec.  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 inconclusive 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.

[[Page 647]]

    (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 inconclusive and may be repeated if the validity 
requirements are not met, but the serial is unsatisfactory if the test 
is not repeated.

----------------------------------------------------------------------------------------------------------------
                                                                  Cummulative total number of dead vaccinates
                                        Number of  Cumulative                      for------
                Stage                  vaccinates   number of --------------------------------------------------
                                                   vaccinates     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.

[39 FR 16862, May 10, 1974, as amended at 40 FR 759, Jan. 3, 1975; 47 FR 
5196, Feb. 4, 1982; 52 FR 9118, Mar. 23, 1987. Redesignated at 55 FR 
35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]



Sec.  113.119  Erysipelothrix Rhusiopathiae Bacterin.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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 \1/10\ 
of the least dose recommended on the label for swine. Such swine dose 
shall not be less than 1 ml.
    (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 LD50 of a suitable culture of Erysipelothrix 
rhusiopathiae shall be used. All survivors in each group of mice shall 
be recorded 10 days postchallenge.
    (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:

[[Page 648]]

[GRAPHIC] [TIFF OMITTED] TC14NO91.016

    (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.

[39 FR 16862, May 10, 1974, as amended at 40 FR 759, Jan. 3, 1975; 40 FR 
20067, May 8, 1975; 40 FR 51414, Nov. 5, 1975; 44 FR 71408, Dec. 11, 
1979; 50 FR 23795, June 6, 1985; 51 FR 23731, July 1, 1986. Redesignated 
at 55 FR 35562, Aug. 31, 1990; 56 FR 66558, Dec. 24, 1991; 56 FR 66784, 
66785, Dec. 26, 1991]



Sec.  113.120  Salmonella Typhimurium Bacterin.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
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 1/20 of the least 
dose recommended on the label for other animals which shall not be less 
than 2 ml.
    (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

[[Page 649]]

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 LD50 as determined by 
titration, of a suitable culture of Salmonella typhimurium. All 
survivors in each group of mice shall be recorded 14 days postchallenge.
    (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:
[GRAPHIC] [TIFF OMITTED] TC14NO91.017

    (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.

[40 FR 17003, Apr. 16, 1975, as amended at 42 FR 59487, Nov. 18, 1977; 
48 FR 31008, July 6, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66784, 66785, Dec. 26, 1991]



Sec.  113.121  Pasteurella Multocida Bacterin.

    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 Sec.  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 Sec.  113.26.
    (b) Safety test. Bulk or final container samples of completed 
product from each serial shall be tested for safety as provided in Sec.  
113.33(b). The subcutaneous route is to be used.

[[Page 650]]

    (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 1/20 of the least 
dose recommended on the label for other animals which shall not be less 
than 2 ml.
    (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 LD50,, as determined by 
titration, of a suitable culture of Pasteurella multocida. All survivors 
in each group of mice shall be recorded 10 days postchallenge.
    (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:
[GRAPHIC] [TIFF OMITTED] TC14NO91.018

    (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

[[Page 651]]

this section, the serial is unsatisfactory.

[40 FR 17004, Apr. 16, 1975, as amended at 42 FR 59487, Nov. 18, 1977; 
48 FR 31008, July 6, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66784, 66785, Dec. 26, 1991]



Sec.  113.122  Salmonella Choleraesuis Bacterin.

    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).

The subcutaneous route shall be used when the product is in combination 
with Pasteurella Multocida Bacterin.
    (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 \1/20\ of the 
least dose recommended on the label for other animals which shall not be 
less than 2 ml.
    (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 LD50 as determined by 
titration of a suitable culture of Salmonella choleraesuis. All 
survivors in each group of mice shall be recorded 14 days postchallenge.
    (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:
[GRAPHIC] [TIFF OMITTED] TC14NO91.019

    (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.

[[Page 652]]

    (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.

[43 FR 25077, June 9, 1978, as amended at 48 FR 31008, July 6, 1983. 
Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, 
Dec. 26, 1991]



Sec.  113.123  Salmonella Dublin Bacterin.

    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 \1/20\ of the 
least dose recommended on the label for other animals which shall not be 
less than 2 ml.
    (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 LD50 as determined by 
titration of a suitable culture of Salmonella dublin. All survivors in 
each group of mice shall be recorded 14 days postchallenge.
    (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:
[GRAPHIC] [TIFF OMITTED] TC14NO91.020

    (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

[[Page 653]]

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.

[43 FR 25077, June 9, 1978, as amended at 48 FR 31009, July 6, 1983. 
Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, 
Dec. 26, 1991]

                          Killed Virus Vaccines



Sec.  113.200  General requirements for killed virus vaccines.

    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 
Sec.  113.51 and cell lines shall meet the requirements in Sec.  113.52.
    (c) Purity tests--(1) Bacteria and fungi. Final container samples of 
completed product from each serial shall be tested as prescribed in 
Sec.  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 Sec.  113.30; and
    (ii) Lymphoid leukosis virus contamination as prescribed in Sec.  
113.31; and
    (iii) Hemagglutinating viruses as prescribed in Sec.  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 Sec.  
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 
Sec.  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 
Sec.  113.38 and for safety in mice as prescribed in Sec.  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 Sec.  113.35 and found 
satisfactory by such test shall be packaged as diluent for desiccated 
fractions in combination packages.

[[Page 654]]

    (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.\3\ Firms 
currently using tests for residual free formaldehyde content other than 
the ferric chloride test have until July 14, 2004 to update their 
Outline of Production to be in compliance with this requirement.
---------------------------------------------------------------------------

    \3\ The procedures for performing the ferric chloride test for 
residual free formaldehyde may be obtained from USDA, APHIS, Center for 
Veterinary Biologics-Laboratory, 1800 Dayton Road, P.O. Box 844, Ames, 
IA 50010.

[39 FR 27428, July 29, 1974, as amended at 40 FR 23989, June 4, 1975; 43 
FR 49528, Oct. 24, 1978. Redesignated at 55 FR 35562, Aug. 31, 1990; 68 
FR 35283, June 13, 2003]



Sec.  113.201  Canine Distemper Vaccine, Killed Virus.

    Canine Distemper 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 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 Sec.  113.200.
    (b) The immunogenicity of vaccine prepared from the Master Seed 
Virus in accordance with the Outline of Production shall be established. 
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.
    (1) Twenty-five canine distemper 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 distemper to determine susceptibility. A constant virus-varying 
serum neutralization test in cell culture using 50 to 300 
TCID50 of virus shall be used. Dogs shall be considered 
susceptible if there is no neutralization at a 1:2 final serum dilution.
    (i) The 20 dogs used as vaccinates shall be injected with one dose 
of vaccine by the method recommended on the label. If a second dose is 
recommended, the second dose shall be administered at the time specified 
on the label.
    (ii) At least 14 days after the last inoculation, the vaccinates and 
controls shall each be challenged intracerebrally with canine distemper 
virus furnished or approved by the Animal and Plant Health Inspection 
Service and observed each day for 21 days.
    (iii) 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 inconclusive and may be repeated.
    (iv) If at least 19 of the 20 vaccinated do not survive without 
showing clinical signs of canine distemper during the observation 
period, the Master Seed Virus is unsatisfactory.
    (c) Test requirements for release. Each serial shall meet the 
applicable general requirements prescribed in Sec.  113.200 and the 
special requirements for safety and potency provided in this section.
    (1) Safety test. The vaccinates used in the potency test in 
paragraph (c)(2) of this section shall be observed each day during the 
postvaccination observation 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 inconclusive and may be repeated: Provided, That, if the 
test is not repeated, the serial is unsatisfactory.
    (2) Potency test--serum neutralization test. Bulk or final container 
samples of completed product shall be tested for potency using five 
susceptible dogs (four vaccinates and one control) as the test animals. 
Blood samples drawn from each dog shall be individually tested for 
neutralizing antibody against canine distemper virus to determine 
susceptibility.
    (i) A constant virus-varying serum neutralization test in tissue 
culture using 50 to 300 TCID50 of virus shall be used. Dogs 
shall be considered susceptible if there is no neutralization at a 1:2 
final serum dilution.

[[Page 655]]

    (ii) Vaccination. Each of the four vaccinates shall be injected as 
recommended on the label. If two doses are recommended, the second dose 
shall be administered at the time specified on the label. The dogs shall 
be observed each day for at least 14 days after the last inoculation.
    (iii) Serology. At the end of the post vaccination observation 
period, a second blood sample shall be obtained from each of the five 
dogs and the serums shall be individually tested for neutralizing 
antibody against canine distemper virus in the same manner used to 
determine susceptibility.
    (iv) Interpretation of the serum neutralization test. If the control 
has not remained seronegative at 1:2, the test is inconclusive and may 
be repeated. If at least three of the four vaccinates in a valid test 
have not developed titers based upon a final serum dilution of at least 
1:50 and the remaining vaccinate has not developed a titer of at least 
1:25, the serial is unsatisfactory except as provided in paragraphs 
(c)(2)(v) and (vi) of this section.
    (v) Virus challenge test. If the results of a valid serum 
neutralization test are unsatisfactory, the vaccinates and the control 
may be challenged intracerebrally with a virulent canine distemper virus 
furnished or approved by the Animal and Plant Health Inspection Service 
and each animal observed each day for an additional 21 days.
    (vi) Interpretation of the virus challenge test. For a serial to be 
satisfactory, all vaccinates must remain free from clinical signs of 
canine distemper while the control must die of canine distemper. If the 
control does not die of canine distemper, the test is inconclusive and 
may be repeated except, that if any of the vaccinates show signs or dies 
of canine distemper, the serial is unsatisfactory.

[60 FR 14359, Mar. 17, 1995]



Sec.  113.202  Canine Hepatitis and Canine Adenovirus Type 2 Vaccine, 
Killed Virus.

    Canine Hepatitis and Canine Adenovirus Type 2 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 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 Sec.  113.200.
    (b) Each lot of Master Seed Virus used for vaccine production shall 
be tested for immunogenicity by one or both of the following methods. 
Vaccine used for these tests shall be at the highest passage from the 
Master Seed and prepared at the minimum preinactivation titer specified 
in the Outline of Production.
    (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 
TCID50 of canine adenovirus.
    (i) The 20 dogs to be used as vaccinates shall be injected with one 
dose of vaccine and the remaining five dogs held as controls. If a 
second dose is recommended, the second dose shall be administered at the 
time specified on the label.
    (ii) Not less than 14 days after the last inoculation, each 
vaccinate and control shall 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.
    (iii) If at least four of the five controls do not show severe 
clinical signs of infectious canine hepatitis, the test is inconclusive 
and may be repeated.
    (iv) 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

[[Page 656]]

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 
TCID50 of canine adenovirus.
    (i) The 20 dogs to be used as vaccinates shall be injected with one 
dose of vaccine and the remaining 10 dogs held as controls. If a second 
dose is recommended, the second dose shall be administered at the time 
specified on the label.
    (ii) Not less than 14 days after the last inoculation, 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.
    (iii) If at least 6 of 10 controls do not show clinical signs of 
canine adenovirus type 2 infection other than fever, the test is 
inconclusive and may be repeated.
    (iv) 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.
    (c) Test requirements for release. Each serial shall meet the 
applicable general requirements prescribed in Sec.  113.200, the special 
requirements for safety provided in this section, and the applicable 
potency tests provided in this section.
    (1) Safety test. The vaccinates used in the potency test in 
paragraph (c)(2) and/or (c)(3) of this section shall be observed each 
day during the postvaccination observation 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 inconclusive and may be 
repeated: Provided, That, if not repeated, the serial is unsatisfactory.
    (2) Potency test for canine hepatitis--serum neutralization test. 
Bulk or final container samples of completed product shall be tested for 
potency using at least five susceptible dogs (four vaccinates and one 
control) as the test animals. Blood samples drawn from each dog shall be 
individually tested for neutralizing antibody against canine adenovirus 
to determine susceptibility.
    (i) A constant virus-varying serum neutralization test in tissue 
culture using 50 to 300 TCID50 of virus shall be used. Dogs 
shall be considered susceptible if there is no neutralization at a 1:2 
final serum dilution.
    (ii) Vaccination. Each of the vaccinates shall be injected as 
recommended on the label. If two doses are recommended, the second dose 
shall be administered at the time specified on the label. The dogs shall 
be observed each day for at least 14 days after the last inoculation.
    (iii) Serology. At the end of the postvaccination observation 
period, a second blood sample shall be obtained from each of the dogs 
and the serums shall be individually tested for neutralizing antibody 
against canine adenovirus in the same manner used to determine 
susceptibility.
    (iv) Interpretation of the serum neutralization test. If the 
control(s) has not remained seronegative at 1:2, the test is 
inconclusive and may be repeated. If at least 75 percent of the 
vaccinates in a valid test have not developed titers based upon final 
serum dilution of at least 1:10 and the remaining vaccinate(s) has not 
developed a titer of at least 1:2, the serial is unsatisfactory except 
as provided in paragraphs (c)(2)(v) and (vi) of this section.
    (v) Virus challenge test. If the results of a valid serum 
neutralization test are unsatisfactory, the vaccinates and the 
control(s) may be challenged intravenously with a virulent canine 
hepatitis virus furnished or approved by the Animal and Plant Health 
Inspection Service and each animal observed each day for an additional 
14 days.
    (vi) Interpretation of the virus challenge test. For a serial to be 
satisfactory, all vaccinates must remain free of clinical signs of 
canine hepatitis while the control(s) must show severe

[[Page 657]]

clinical signs of canine hepatitis. If the control(s) does not show 
severe clinical signs of canine hepatitis, the test is inconclusive and 
may be repeated: Provided, That, if any of the vaccinates show signs or 
die of canine hepatitis, the serial is unsatisfactory.
    (3) Potency test for canine adenovirus type 2. Bulk or final 
container samples of completed product shall be tested for potency using 
eight susceptible dogs (five vaccinates and three controls) as the test 
animals. Blood samples drawn from each dog shall be individually tested 
for neutralizing antibody against canine adenovirus to determine 
susceptibility.
    (i) A constant virus-varying serum neutralization test in tissue 
culture using 50 to 300 TCID50 of virus shall be used. Dogs 
shall be considered susceptible if there is no neutralization at a 1:2 
final serum dilution.
    (ii) Vaccination. Each of the five vaccinates shall be injected as 
recommended on the label. If two doses are recommended, the second dose 
shall be administered at the time specified on the label. The dogs shall 
be observed each day for at least 14 days after the last inoculation.
    (iii) Not less than 14 days after the last inoculation, 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.
    (iv) If at least two of three controls do not show clinical signs of 
canine adenovirus type 2 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 the Animal and Plant Health Inspection Service and 
prescribed in the Outline of Production, the serial is unsatisfactory.

[60 FR 14359, Mar. 17, 1995]



Sec.  113.203  Feline Panleukopenia Vaccine, Killed Virus.

    Feline Panleukopenia 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. The 
Master Seed shall meet the applicable requirements prescribed in Sec.  
113.200. Each serial shall meet the applicable general requirements 
prescribed in Sec.  113.200 and the special requirements for safety and 
potency provided in this section.
    (a) Safety test. The vaccinates used in the potency test in 
paragraph (b) of this section shall be observed each day during the 
postvaccination observation 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 inconclusive and may be repeated: Provided, That, if not 
repeated, the serial is unsatisfactory.
    (b) Potency test--serum-neutralization test. Bulk or final container 
samples of completed product shall be tested for potency using five 
susceptible cats (four vaccinates and one control) as the test animals. 
Blood samples drawn from each cat shall be individually tested for 
neutralizing antibody against feline panleukopenia virus to determine 
susceptibility.
    (1) A constant virus-varying serum neutralization test in tissue 
culture using 100 to 300 TCID50 of virus shall be used. Cats 
shall be considered susceptible if there is no neutralization at a 1:2 
final serum dilution.
    (2) Vaccination. Each of the four vaccinates shall be injected as 
recommended on the label. If two doses are recommended, the second dose 
shall be given 7 to 10 days after the first dose and the cats observed 
each day for 14 to 21 days.
    (3) Serology. At the end of the postvaccination observation period, 
a second blood sample shall be obtained from each of the five cats and 
the serums shall be individually tested for neutralizing antibody 
against feline

[[Page 658]]

panleukopenia virus in the same manner used to determine susceptibility.
    (4) Interpretation of the SN test. (i) If the control has not 
remained sero negative at 1:2, the test is inconclusive and may be 
repeated.
    (ii) If at least 3 of the 4 vaccinates in a valid test have not 
developed titers based upon final serum dilution of at least 1:8, and 
the remaining vaccinate has not developed a titer of at least 1:4, the 
serial is unsatisfactory except as provided in paragraphs (b)(5) and (6) 
of this section.
    (5) Virus-challenge test. If the results of a valid SN test are 
unsatisfactory, the vaccinates and the control may be challenged with a 
virulent feline panleukopenia virus furnished by Veterinary Services and 
each animal observed each day for an additional 14 days.
    (6) Interpretation of the virus-challenge test. If the control does 
not show clinical signs of feline panleukopenia, the test is 
inconclusive and may be repeated except, that if any of the vaccinates 
show such signs, the serial is unsatisfactory. Clinical signs of feline 
panleukopenia shall include a pronounced leukopenia wherein the white 
blood 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.

[39 FR 27428, July 29, 1974, as amended at 40 FR 759, Jan. 3, 1975; 43 
FR 41186, Sept. 15, 1978; 43 FR 50162, Oct. 27, 1978; 50 FR 23796, June 
6, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 
66786, Dec. 26, 1991]



Sec.  113.204  Mink Enteritis Vaccine, Killed Virus.

    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 Sec.  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 inconclusive 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 inconclusive 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.

[39 FR 27428, July 29, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66786, Dec. 26, 1991; 60 FR 14361, Mar. 17, 1995]



Sec.  113.205  Newcastle Disease Vaccine, Killed Virus.

    Newcastle Disease Vaccine (Killed Virus) shall be prepared from 
virus-

[[Page 659]]

bearing tissues or fluids obtained from embryonated chicken eggs or cell 
cultures. With the exception of Sec.  113.200(c)(2)(iii), each serial 
shall meet the applicable general requirements prescribed in Sec.  
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 
inconclusive 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 inconclusive and may be 
repeated. If at least 90 percent of the vaccinates do not remain normal, 
the serial is unsatisfactory.

[39 FR 27428, July 29, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66786, Dec. 26, 1991]



Sec.  113.206  Wart Vaccine, Killed Virus.

    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 Sec.  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 Sec. Sec.  
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 Sec.  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 Sec.  
112.7(i).

[40 FR 14084, Mar. 28, 1975, as amended at 40 FR 23989, June 4, 1975; 40 
FR 30803, July 23, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66786, Dec. 26, 1991]



Sec.  113.207  Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, 
Killed Virus.

    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 Sec.  113.200, except 
those in Sec.  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,

[[Page 660]]

the serial is unsatisfactory. If unfavorable reactions not attributable 
to the product occur, the test is inconclusive 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 inconclusive 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.
----------------------------------------------------------------------------------------------------------------


[39 FR 44714, Dec. 27, 1974, as amended at 40 FR 14084, Mar. 28, 1975; 
42 FR 45284, Sept. 9, 1977. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66786, Dec. 26, 1991; 61 FR 67930, Dec. 26, 1996]



Sec.  113.208  Avian Encephalomyelitis Vaccine, Killed Virus.

    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 
Sec.  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

[[Page 661]]

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 inconclusive 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 
inconclusive 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 inconclusive and may be 
repeated.
    (3) If at least 80 percent of the vaccinates do not remain normal, 
the serial is unsatisfactory.

[39 FR 12958, Dec. 27, 1974, as amended at 40 FR 41088, Sept. 5, 1975. 
Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, 
Dec. 26, 1991]



Sec.  113.209  Rabies Vaccine, Killed Virus.

    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 Sec.  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 Sec.  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 Sec.  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

[[Page 662]]

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 1800 Dayton Avenue, P.O. Box 844, Ames, IA 50010; 
phone (515) 239-8331; fax (515) 239-8673. 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, 
Licensing and Policy Development, 4700 River Road, Riverdale, MD, or at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC.
    (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.\1\
    (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 Sec.  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.

[[Page 663]]

    (d) Test requirements for release: Each serial and each subserial 
shall meet the general requirements prescribed in Sec.  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 Sec.  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 Sec.  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.

[39 FR 44715, Dec. 27, 1974, as amended at 42 FR 6794, Feb. 4, 1977; 43 
FR 49528, Oct. 24, 1978; 50 FR 20090, May 14, 1985. Redesignated at 55 
FR 35562, Aug. 31, 1990; 56 FR 66784, 66786, Dec. 26, 1991; 61 FR 31823, 
June 21, 1996; 64 FR 45420, Aug. 20, 1999]



Sec.  113.210  Feline Calicivirus Vaccine, Killed Virus.

    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 Sec.  113.200.
    (b) The Master Seed shall be tested for chlamydial agents as 
prescribed in Sec.  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 Sec.  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.

[[Page 664]]

    (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.

[50 FR 433, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.211  Feline Rhinotracheitis Vaccine, Killed Virus.

    Feline Rhinotracheitis 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 Sec.  113.200.
    (b) The Master Seed shall be tested for chlamydial agents as 
prescribed in Sec.  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 Sec.  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 test. Vaccinates used in the potency test in paragraphs 
(d)(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 inconclusive and may be repeated. If the test is not 
repeated, the serial is unsatisfactory.
    (2) Potency test. Bulk or final container samples of completed 
product shall be tested for potency as follows:
    (i) Eight feline rhinotracheitis 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 rhinotracheitis 
virus. 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 rhinotracheitis virus antibody at the 1:2 final dilution in 
a 50 percent plaque

[[Page 665]]

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 rhinotracheitis virus 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 noted and recorded each day.
    (iv) If three of three controls do not show clinical signs of feline 
rhinotracheitis virus 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.

[50 FR 433, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.212  Bursal Disease Vaccine, Killed Virus.

    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 Sec.  113.200.
    (b) Each lot of Master Seed shall be tested for pathogens by the 
chicken embryo inoculation test prescribed in Sec.  113.37, except that, 
if the test is inconclusive because of a vaccine virus override, the 
chicken inoculation test prescribed in Sec.  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 Sec.  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 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 
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

[[Page 666]]

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:

----------------------------------------------------------------------------------------------------------------
                                                    Cumulative      Cumulative total number of failures for--
                 Stage                   Number of   number of -------------------------------------------------
                                        vaccinates  vaccinates    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.

[50 FR 434, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.213  Pseudorabies Vaccine, Killed Virus.

    Pseudorabies 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 Sec.  113.200.
    (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 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 Sec.  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 neurological 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 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 tested for potency as follows:
    (i) Ten pseudorabies susceptible pigs (five vaccinates and five 
controls) shall be used as test animals. The animals shall be at the 
minimal age recommended for vaccination. Blood samples shall be drawn 
and individual serum samples inactivated and tested for neutralizing 
antibody.
    (ii) A constant virus-varying serum neutralization test in cell 
culture using 50 to 300 TCID50 of virus shall be used. Pigs 
shall be considered susceptible if there is no neutralization at 1:2 
final serum dilution. Other tests of equal sensitivity acceptable to 
Animal and Plant Health Inspection Service may be used.
    (iii) The five pigs 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 after the interval 
recommended on the label.
    (iv) Fourteen days or more after vaccination, blood samples shall be 
drawn

[[Page 667]]

and individual serum samples inactivated and tested for pseudorabies 
virus neutralizing antibody by the method used to determine 
susceptibility.
    (v) Test interpretation. If the controls have not remained 
seronegative at 1:2, the test is inconclusive and may be repeated. If at 
least four of the five vaccinates in a valid test have not developed 
titers of at least 1:8, and the remaining vaccinate has not developed a 
titer of at least 1:4, 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 pseudorabies virus furnished or approved by 
Animal and Plant Health Inspection Service. The animals shall be 
observed each day for 14 days postchallenge. If four of five controls do 
not develop central nervous system signs or die, the test is 
inconclusive and may be repeated. In a valid test, if two or more of the 
vaccinates develop clinical signs or die, the serial is unsatisfactory.

[50 FR 434, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.214  Parvovirus Vaccine, Killed Virus (Canine).

    Parvovirus Vaccine, Killed Virus, 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 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 Sec.  113.200.
    (b) The immunogenicity of vaccine prepared in accordance with the 
Outline of Production shall be established as follows:
    (1) Twenty-five 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.

A constant virus-varying serum neutralization test in cell culture using 
50 to 300 TCID50 of virus shall be used. Dogs shall be 
considered susceptible if there is no neutralization at a 1:2 final 
serum dilution. Other tests of equal sensitivity acceptable to Animal 
and Plant Health Inspection Service may be used.
    (2) A viral hemagglutination test or another test acceptable to 
Animal and Plant Health Inspection Service shall be used to measure the 
antigenic content of vaccine produced at the highest passage from the 
Master Seed before the immunogenicity test is conducted. The 20 dogs 
used as vaccinates shall be injected with a predetermined dose of 
vaccine by the method recommended on the label. To confirm the dosage 
calculations, five replicate tests shall be conducted on a sample of the 
vaccine used. If two doses are used, five replicate confirming tests 
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 vaccine shall be evaluated on the 
following criteria of infection: temperature =103.4 [deg] 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 inconclusive and may be repeated.
    (ii) If at least 19 of the 20 vaccinates do not survive the 
observation period without showing any more than one criterion of 
infection described in subparagraph (3)(i), of this section, the Master 
Seed is unsatisfactory.

[[Page 668]]

    (4) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot previously tested is discontinued. Only five 
susceptible dogs (four vaccinates and one control) need to be used in 
the retest. Susceptibility shall be determined in the manner provided in 
paragraph (b)(1) of this section.
    (i) Each vaccinate shall be injected with a predetermined quantity 
of vaccine virus as provided in paragraph (b)(2) of this section.
    (ii) Fourteen to 21 days after the last vaccination, a second serum 
sample shall be drawn from each dog and tested for neutralizing antibody 
to canine parvovirus in the same manner used to determine 
susceptibility.
    (iii) If the control has not remained seronegative at 1:2, the test 
is inconclusive and may be repeated.
    (iv) If three of the four vaccinates in a valid test do not develop 
titers based upon final serum dilution of at least 1:16, and the 
remaining vaccinate does not develop a titer of at least 1:8, the Master 
Seed is unsatisfactory, except as provided in subparagraph (4)(v) of 
this section.
    (v) If the results of a valid SN test are unsatisfactory, the 
vaccinates and the control may be challenged as provided in paragraph 
(b)(3) of this section. If at least three of the four criteria of 
infection are not shown, the test is inconclusive and may be repeated, 
except that if any of the vaccinates show more than one criterion of 
infection, 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 requirements prescribed in Sec.  113.200 and in this paragraph. 
Any serial or subserial found unsatisfactory by a prescribed test shall 
not be released.
    (1) Potency. Bulk or final container samples of completed product 
shall be tested for antigenic content using the method used in paragraph 
(b)(2) of this section. To be eligible for release, each serial and each 
subserial shall have an antigenic content sufficiently greater than that 
used in the immunogenicity test to assure that, when tested at any time 
within the expiration period, each serial and subserial shall have an 
antigenic content equal to the amount used in such immunogenicity test.
    (2) Virus identity. Bulk or final container samples shall be tested 
for virus identity by conducting a hemagglutination test using duplicate 
samples and pretreating one with specific canine parvovirus antibody. If 
there is not at least an eightfold reduction in hemagglutinating 
activity, the hemagglutination is considered to be nonspecific and the 
serial is unsatisfactory.

[50 FR 435, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.215  Bovine Virus Diarrhea Vaccine, Killed Virus.

    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 Sec.  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 Sec.  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

[[Page 669]]

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 inconclusive 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 [deg]F and 
develop respiratory or clinical signs of bovine virus diarrhea, the test 
is inconclusive and may be repeated one time. If two or more vaccinates 
show a temperature of 104.0 [deg]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.

[55 FR 35562, Aug. 31, 1990]



Sec.  113.216  Bovine Rhinotracheitis Vaccine, Killed Virus.

    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 Sec.  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 Sec.  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

[[Page 670]]

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 inconclusive 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 
[deg]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[deg]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.

[55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991]

                           Live Virus Vaccines



Sec.  113.300  General requirements for live virus vaccines.

    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 Sec.  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 Sec.  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 Sec.  113.30; and
    (ii) Lymphoid leukosis virus contamination as prescribed in Sec.  
113.31; and
    (iii) Hemagglutinating viruses as prescribed in Sec.  113.34.
    (4) Extraneous viruses. Each lot of Master Seed Virus used to 
prepare live

[[Page 671]]

virus vaccine recommended for animals other than poultry shall meet the 
requirements for extraneous viruses as prescribed in Sec.  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 Sec. Sec.  113.39, 
113.40, 113.41, 113.44, and 113.45 or in a filed Outline of Production. 
The mouse safety test prescribed in Sec.  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 
ID50 of vaccine virus shall be neutralized by the antiserum.
    (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 Sec.  113.51, cell lines shall meet 
the requirements prescribed in Sec.  113.52, and ingredients of animal 
origin shall meet the applicable requirements in Sec.  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 Sec.  113.29.

[39 FR 27430, July 29, 1974, as amended at 43 FR 49528, Oct. 24, 1978; 
50 FR 1042, Jan. 9, 1985; 54 FR 19352, May 5, 1989. Redesignated at 55 
FR 35562, Aug. 31, 1990; 60 FR 24549, May 9, 1995; 68 FR 57608, Oct. 6, 
2003]



Sec.  113.301  Ovine Ecthyma Vaccine.

    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 Sec. Sec.  
113.27 and 113.300(a), (b), and (c). Each serial shall meet the moisture 
requirements in Sec.  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 
Sec.  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 
inconclusive and may be repeated.
    (4) If the vaccinates do not show a typical immune reaction, the 
serial is

[[Page 672]]

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.

[39 FR 27430, July 29, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66786, Dec. 26, 1991]



Sec.  113.302  Distemper Vaccine--Mink.

    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 Sec.  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 Sec.  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 ID50 of 
canine distemper virus. Other means of insuring susceptibility may be 
used if prior approval from Animal and Plant Health Inspection Service 
is received.
    (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 inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only five 
vaccinates and five controls need to be used in the retest; Provided, 
That five of the five vaccinates and at least four of the controls shall 
meet the criteria prescribed in paragraph (c)(3) of this section.
    (5) 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 Sec.  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

[[Page 673]]

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 
inconclusive 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\0.7\ greater than that 
used in such immunogenicity test when tested by the method used in 
paragraph (c)(2) of this section.

[40 FR 53000, Nov. 14, 1975, as amended at 48 FR 33471, July 22, 1983. 
Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 
66786, Dec. 26, 1991]



Sec.  113.303  Bluetongue Vaccine.

    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 Sec.  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 TCID50 
of bluetongue virus or another method acceptable to Animal and Plant 
Health Inspection Service.
    (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 TCID50 of bluetongue virus.
    (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 [deg] F or higher over the 
prechallenge mean temperature, the test shall be considered inconclusive 
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 [deg] F or higher 
than

[[Page 674]]

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.
    (6) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only five 
vaccinates and five controls need be used in the retest: Provided, That 
five of five vaccinates and at least four of the five controls shall 
meet the criteria prescribed in paragraphs (c)(4) of this section.
    (d) Test requirements for release. Each serial and subserial shall 
meet the applicable general requirements prescribed in Sec.  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 Sec.  113.33(a) 
and the lamb safety test prescribed in Sec.  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\0.7\ greater than that used in such immunogenicity 
test.

[50 FR 23796, June 6, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.304  Feline Panleukopenia Vaccine.

    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 Sec.  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 Sec.  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 TCID50 of virus shall be used.
    (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

[[Page 675]]

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 
inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Ten 
susceptible cats (8 vaccinates and 2 controls) shall be used in the 
retest. Susceptibility shall be determined in the manner provided in 
paragraph (c)(1) of this section.
    (i) Each vaccinate shall be injected with a predetermined quantity 
of vaccine virus as provided in paragraph (c)(2) of this section.
    (ii) Fourteen to twenty-one days postvaccination, a second serum 
sample shall be drawn from each cat and tested for neutralizing antibody 
to feline panleukopenia virus in the same manner used to determine 
susceptibility.
    (iii) If the two controls have not remained seronegative at 1:2, the 
test is inconclusive and may be repeated.
    (iv) If at least 6 of the 8 vaccinates in a valid test do not 
develop titers based upon final serum dilution of at least 1:8, and the 
remaining vaccinates do not develop titers of at least 1:4, the Master 
Seed Virus is unsatisfactory except as provided in paragraph (c)(4)(v) 
of this section.
    (v) If the results of a valid SN test are unsatisfactory, the 
vaccinates and the controls may be challenged as provided in paragraph 
(c)(3) of this section. If 100 percent of the controls do not show 
clinical signs of feline panleukopenia, the test is inconclusive and may 
be repeated except, that, if any of the vaccinates show such signs, 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) Test requirements for release. Each serial and subserial shall 
meet the requirements prescribed in Sec.  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 Sec.  113.33(a) 
and the cat safety test prescribed in Sec.  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 inconclusive 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\0.7\ greater than that used in

[[Page 676]]

such immunogenicity test but not less than 10 \2.5\ TCID50 
per dose.

[39 FR 44716, Dec. 27, 1974, as amended at 40 FR 53378, Nov. 18, 1975; 
43 FR 25078, June 9, 1978; 43 FR 41186, Sept. 15, 1978; 44 FR 58900, 
Oct. 12, 1979; 48 FR 33471, July 22, 1983. Redesignated at 55 FR 35562, 
Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.305  Canine Hepatitis and Canine Adenovirus Type 2 Vaccine.

    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 Sec.  113.300 except that the dog safety test prescribed 
in Sec.  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 
TCID50 of canine adenovirus.
    (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 inconclusive 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.
    (iii) The Master Seed Virus shall be retested for immunogenicity for 
canine hepatitis in 3 years unless use of the lot previously tested is 
discontinued. Ten susceptible dogs (8 vaccinates and 2 controls) shall 
be used in the retest. Susceptibility shall be determined in the manner 
provided in paragraph (b)(1) of this section.
    (A) Each vaccinate shall be injected with a predetermined quantity 
of vaccine virus as provided in paragraph (b)(1)(i) of this section.
    (B) At least 14 days postvaccination, a second serum sample shall be 
drawn from each dog and tested for neutralizing antibody to canine 
adenovirus in the same manner used to determine susceptibility.
    (C) If the two controls have not remained seronegative at 1:2, the 
test is inconclusive and may be repeated.
    (D) If at least six of the eight vaccinates in a valid test do not 
develop titers of at least 1:10 based upon final serum dilution, the 
Master Seed Virus is unsatisfactory except as provided in paragraph 
(b)(1)(iii)(E) of this section.
    (E) If the results of a valid serum neutralization test are 
unsatisfactory, the vaccinates and the controls may be challenged as 
provided in paragraph (b)(1)(ii) of this section. A Master Seed is 
satisfactory if all vaccinates remain free of clinical signs of canine 
hepatitis, while both controls develop severe clinical signs of canine 
hepatitis. If both controls do not show severe clinical signs of canine 
hepatitis, the test is inconclusive and may be repeated: Provided, That, 
if any of the vaccinates show such signs, the Master Seed Virus is 
unsatisfactory.
    (2) Immunogenicity for canine adenovirus Type 2. Thirty canine

[[Page 677]]

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 TCID50 of canine adenovirus.
    (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 
inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 
3 years unless use of the lot previously tested is discontinued. Either 
10 vaccinates and 6 controls or 5 vaccinates and 3 controls shall be 
used in the retest.
    (A) If less than 4 of 6 or 2 of 3 of the controls show clinical 
signs of canine adenovirus type 2 other than fever, the test is 
inconclusive and may be repeated.
    (B) A significant difference in clinical signs shall be demonstrated 
between vaccinates and controls in a valid test as prescribed in 
paragraph (b)(2)(ii)(B) of this section.
    (iv) 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 Sec.  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\0.7\ greater than 
that used in such immunogenicity test(s) but not less than 10\2.5\ 
TCID50 dose. If both immunogenicity tests in paragraph (b) of 
this section are conducted and a different amount of virus is used in 
each test, the virus titer requirements shall be based on the higher of 
the two amounts.
    (2) [Reserved]

[60 FR 14361, Mar. 17, 1995]



Sec.  113.306  Canine Distemper Vaccine.

    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 Sec.  113.300 and

[[Page 678]]

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 
Sec.  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 TCID50 of canine distemper virus.
    (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 inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Ten 
susceptible dogs (8 vaccinates and 2 controls) shall be used in the 
retest. Susceptibility shall be determined in the manner provided in 
paragraph (b)(1) of this section.
    (i) Each vaccinate shall be injected with a predetermined quantity 
of vaccine virus as provided in paragraph (b)(2) of this section.
    (ii) At least 14 days postvaccination, a second serum sample shall 
be drawn from each dog and tested for neutralizing antibody to canine 
distemper virus in the same manner used to determine susceptibility.
    (iii) If the two controls have not remained seronegative at 1:2, the 
test is inconclusive and may be repeated.
    (iv) If at least 6 of the 8 vaccinates in a valid test do not 
develop titers of at least 1:50 based upon final serum dilution, the 
Master Seed Virus is unsatisfactory, except as provided in paragraph 
(b)(4)(v) of this section.
    (v) If the results of a valid serum neutralization test are 
unsatisfactory, the vaccinates and the controls may be challenged as 
provided in paragraph (b)(3) of this section. A Master Seed is 
satisfactory if all vaccinates remain free of clinical signs of canine 
distemper, while the two controls die with clinical signs of canine 
distemper. If the two controls do not die with clinical signs of canine 
distemper, the test is inconclusive and may be repeated: Provided, That, 
if any of the vaccinates show such signs, the Master Seed Virus is 
unsatisfactory.
    (5) 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 Sec.  
113.300(a)(3)(ii), each serial and subserial shall meet the requirements 
prescribed in Sec.  113.300 and in this paragraph. Final container 
samples of

[[Page 679]]

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 Sec.  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\0.7\ greater than that used in such immunogenicity 
test but not less than 10\2.5\ TCID50 per dose.

[60 FR 14362, Mar. 17, 1995]



Sec.  113.308  Encephalomyelitis Vaccine, Venezuelan.

    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 Sec.  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 
TCID50 of Venezuelan equine encephalomyelitis virus.
    (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) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot is discontinued. Only five vaccinates and two 
controls need to be used in the retest: Provided, That five of five 
vaccinates and the two controls shall meet the criteria in paragraph 
(b)(4) of this section.
    (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 Sec.  113.300 and 
special requirements in this paragraph. Any serial or subserial found 
unsatisfactory by a prescribed test shall not be released.

[[Page 680]]

    (1) Safety test. The mouse safety test prescribed in Sec.  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\0.7\ greater than that used in the immunogenicity test, but not less 
than 10\2.5\ TCID50 per dose.

[50 FR 23797, June 6, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.309  Bovine Parainfluenza3 Vaccine.

    Bovine Parainfluenza3 Vaccine shall be produced 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 Sec.  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 
TCID50 of bovine parainfluenza3 virus; and
    (ii) Shall be negative to bovine parainfluenza3 virus 
isolation attempts from the nasal specimens on the day of injection.
    (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 
PI3 virus isolation. On the same day, all vaccinates and 
controls shall be given acceptable challenge PI3 virus 
titrating at least 10\7.0\ TCID50 per ml and the animals 
observed for 14 days. Two ml of the challenge virus shall be instilled 
in each nostril or shall be inhaled as an aerosol suspension. Upon 
request, challenge virus and instructions shall be furnished by Animal 
and Plant Health Inspection Service.
    (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 PI3 susceptible cells for a total of at 
least 14 days.

[[Page 681]]

    (ii) Two to four weeks post-vaccination, at least 19 of the 20 
vaccinates shall have PI3 neutralizing antibody titers of at 
least 1:4 and all five controls shall be negative at 1:2 dilution. None 
of the post-vaccination serums collected from the vaccinates on day 6 
2 days shall reveal serum neutralization antibody 
titers of 1:32 or greater based upon final dilution.
    (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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only five 
vaccinates and five controls need to be used in the retest; Provided, 
That five of five vaccinates and at least four of the controls shall 
meet the criteria prescribed in paragraph (c)(6) of this section.
    (10) 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 Sec.  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 
Sec.  113.32 shall be conducted on each batch of primary cells intended 
for production use.
    (2) Safety test. The mouse safety test prescribed in Sec.  113.33(a) 
and the calf safety test prescribed in Sec.  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\0.7\ greater than that used in the 
immunogenicity test but not less than 10\2.5\ TCID50 per 
dose.

[39 FR 44719, Dec. 27, 1974, as amended at 40 FR 41089, Sept. 5, 1975; 
43 FR 49529, Oct. 24, 1978; 48 FR 33472, July 22, 1983. Redesignated at 
55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 
1991; 60 FR 14357, Mar. 17, 1995]



Sec.  113.310  Bovine Rhinotracheitis Vaccine.

    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 Sec.  113.300.

[[Page 682]]

    (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 
TCID50 bovine rhinotracheitis virus. Results shall be used in 
making a determination as prescribed in paragraph (c)(6) of this 
section.
    (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 [deg]F. or higher post-challenge, the test shall be considered 
inconclusive 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 [deg]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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only five 
vaccinates and five controls need to be used in the retest; Provided, 
That five of five vaccinates and at least four of the five controls 
shall meet the criteria prescribed in paragraphs (c)(5) and (6) of this 
section.
    (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 Sec.  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 
Sec.  113.32 shall be conducted on each batch of primary cells intended 
for production use.
    (2) Safety test. The mouse safety test prescribed in Sec.  113.33(a) 
and the calf safety test prescribed in Sec.  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

[[Page 683]]

any time within the expiration period, each serial and subserial shall 
have a virus titer of 10\0.7\ greater than that used in the 
immunogenicity test but not less than 10\2.5\ TCID50 per 
dose.

[39 FR 44720, Dec. 27, 1974, as amended at 40 FR 20067, May 8, 1975; 40 
FR 23989, June 4, 1975; 40 FR 41089, Sept. 5, 1975; 43 FR 49529, Oct. 
24, 1978; 48 FR 33472, July 22, 1983. Redesignated at 55 FR 35562, Aug. 
31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.311  Bovine Virus Diarrhea Vaccine.

    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 Sec.  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 TCID50 of bovine virus diarrhea virus.
    (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 
TCID50 of bovine virus diarrhea virus. The white cell count 
for all vaccinates and controls shall be established at least 3 days 
just before challenge. Results shall be used in making a determination 
as prescribed in paragraph (c)(5) of this section.
    (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 inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only five 
vaccinates and five controls need to be used in the retest; Provided, 
That five of five vaccinates and at least four of the five controls 
shall meet the criteria prescribed in paragraphs (c)(4) and (c)(5) of 
this section.
    (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

[[Page 684]]

prescribed in Sec.  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 
Sec.  113.32 shall be conducted on each batch of primary cells intended 
for production use.
    (2) Safety test. The mouse safety test prescribed in Sec.  113.33(a) 
and the calf safety test prescribed in Sec.  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\0.7\ greater than that used in the 
immunogenicity test but not less than 10\2.5\ TCID 50 per 
dose.

[39 FR 44721, Dec. 27, 1974, as amended at 40 FR 20067, May 8, 1975; 40 
FR 41089, Sept. 5, 1975; 43 FR 49529, Oct. 24, 1978; 48 FR 33472, July 
22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 
FR 66784, 66786, Dec. 26, 1991]



Sec.  113.312  Rabies Vaccine, Live Virus.

    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 Sec.  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 
Sec.  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 Sec.  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 [deg]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.

------------------------------------------------------------------------
                                       Days after
        Route of injection              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

[[Page 685]]

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 Sec.  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

[[Page 686]]

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) The Master Seed Virus shall be retested for immunogenicity in 3 
years and each 5 years thereafter unless use of the lot previously 
tested is discontinued. Only five vaccinates and five controls need to 
be used in the retest and the retest may be limited to serological 
response at 1 year after vaccination of the vaccinates if such response 
is equal to or greater than that in the original immunogenicity test and 
all controls remain negative. If the SN response is not satisfactory, 
the vaccinates and controls may be challenged. To be satisfactory, at 
least 4 of the 5 controls shall die of rabies and 5 of the 5 vaccinates 
remain well for a period of 90 days.
    (6) The repeat immunogenicity tests may be terminated after 90 day 
SN tests if at least 10 vaccinates and at least 5 controls of each 
species are used and the test dose of vaccine contains the minimum 
acceptable virus titer throughout dating.
    (i) If the 10 vaccinates have SN titers equal to or greater than the 
90 day SN titers of the vaccinates in the initial immunogenicity test, 
the Master Seed Virus is satisfactory.
    (ii) If the 10 vaccinates do not have acceptable SN titers, each 
vaccinate and each control shall be challenged at 1 year with virulent 
rabies street virus and observed for 90 days.
    (iii) If at least 80 percent of the controls do not show signs of 
rabies during the observation period, the test is invalid and shall be 
repeated.
    (iv) If more than 10 percent of the vaccinates show signs of rabies, 
the Master Seed Virus is unsatisfactory.
    (7) 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 Sec.  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 Sec.  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 Sec.  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

[[Page 687]]

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 LD50 titer calculated by the 
Reed and Muench Method.
    (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\3.0\ LD50 per 0.03 ml.
    (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 LD50 titer calculated by the 
Reed and Muench Method; and
    (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\3.0\ LD50 per 0.02 ml.

[39 FR 44721, Dec. 27, 1974, as amended at 40 FR 20067, May 8, 1975; 42 
FR 6795, Feb. 4, 1977; 43 FR 49529, Oct. 24, 1978; 50 FR 20090, May 14, 
1985; 50 FR 23797, June 6, 1985. Redesignated at 55 FR 35562, Aug. 31, 
1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 61 FR 31823, June 
21, 1996]



Sec.  113.313  Measles Vaccine.

    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 Sec.  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 
ID50 of measles virus.
    (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

[[Page 688]]

dilution in varying serum-constant virus neutralization test using less 
than 500 ID50 of canine distemper virus.
    (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 [deg]F. or higher and at 
least 15 percent weight loss, the test is inconclusive and may be 
repeated.
    (ii) If at least 19 of the 20 vaccinates do not survive without 
showing a temperature of 104.0 [deg]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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only five 
vaccinates and five controls need to be used in the retest; Provided, 
That five of five vaccinates and at least four of the controls shall 
meet the criteria prescribed in this section.
    (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 general requirements prescribed in Sec.  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 Sec.  113.40 and 
the mouse safety test prescribed in Sec.  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\0.7\ greater than that used in the 
immunogenicity test but not less than 10\2.5\ ID50 per dose.

[40 FR 53001, Nov. 14, 1975, as amended at 43 FR 49529, Oct. 24, 1978; 
48 FR 33472, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.314  Feline Calicivirus Vaccine.

    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 Sec.  113.300.
    (b) The Master Seed Virus shall be tested for chlamydial agents as 
prescribed in Sec.  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

[[Page 689]]

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 TCID50 or plaque forming units of 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.
    (i) If less than 8 of 10 controls show clinical signs of feline 
calicivirus infection other than fever, the test is inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Either 10 
vaccinates and 6 controls or 5 vaccinates and 3 controls shall be used 
in the retest.
    (i) If less than 5 of 6 or 3 of 3 of the controls in the retest show 
clinical signs of feline calicivirus infection other than fever, the 
test is inconclusive and may be repeated.
    (ii) A significant difference in clinical signs shall be 
demonstrated between vaccinates and controls in a valid test as 
prescribed in paragraph (c)(3)(ii) of this section.
    (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) Test requirements for release. Each serial and subserial shall 
meet the requirements prescribed in Sec.  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 Sec.  113.33(a) 
and the cat safety test prescribed in Sec.  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\0.7\ greater than that used in the 
immunogenicity test but not less than 10\2.5\ TCID50 or 
plaque forming units per dose.

[44 FR 58899, Oct. 12, 1979; 44 FR 63083, Nov. 2, 1979, as amended at 48 
FR 33472, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.315  Feline Rhinotracheitis Vaccine.

    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 Sec.  113.300.
    (b) The Master Seed Virus shall be tested for chlamydial agents as 
prescribed in Sec.  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

[[Page 690]]

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 TCID50 or plaque forming units of virulent 
feline rhinotracheitis virus furnished or approved by Animal and Plant 
Health Inspection Service and observed each day for 14 days post-
challenge. The rectal temperature of each animal shall be taken and the 
presence of respiratory or other clinical signs of feline 
rhinotracheitis noted and recorded each day.
    (i) If less than 8 of 10 controls show clinical signs of feline 
rhinotracheitis infection other than fever, the test is inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Either 10 
vaccinates and 6 controls or 5 vaccinates and 3 controls shall be used 
in the retest.
    (i) If less than 5 of 6 or 3 of 3 of the controls in the retest show 
clinical signs of feline rhinotracheitis infection other than fever, the 
test is inconclusive and may be repeated.
    (ii) A significant difference in clinical signs shall be 
demonstrated between vaccinates and controls in a valid test as 
prescribed in paragraph (c)(3)(ii) of this section.
    (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) Test requirements for release. Each serial and subserial shall 
meet the requirements prescribed in Sec.  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 Sec.  113.33(a) 
and the cat safety test prescribed in Sec.  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\0.7\ greater than that used in the 
immunogenicity test but not less than 10\2.5\ TCID50 or 
plaque forming units per dose.

[44 FR 58899, Oct. 12, 1979, as amended at 48 FR 33472, July 22, 1983. 
Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 
66786, Dec. 26, 1991]

[[Page 691]]



Sec.  113.316  Canine Parainfluenza Vaccine.

    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 Sec.  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 TCID50 of canine 
parainfluenza virus.
    (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 
inconclusive 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) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot previously tested is discontinued. Only five 
vaccinates and five controls need to be used in the retest: Provided, 
That five of five vaccinates and five of five controls shall meet the 
criteria prescribed in paragraph (b)(4) of this section.
    (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 Sec.  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

[[Page 692]]

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\0.7\ greater than that used in the 
immunogenicity test but not less than 10\2.5\ TCID50 per 
dose.
    (2) [Reserved]

[50 FR 436, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.317  Parvovirus Vaccine (Canine).

    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 Sec.  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 TCID50 of canine parvovirus.
    (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 [deg] 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 inconclusive 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) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot previously tested is discontinued. Five 
susceptible dogs (four vaccinates and one control) may be used in the 
retest. Susceptibility shall be determined in the manner provided in 
paragraph (c)(1) of this section.
    (i) Each vaccinate shall be administered a predetermined quantity of 
vaccine virus as provided in paragraph (c)(2) of this section.
    (ii) Fourteen to 21 days after the last vaccination, a second serum 
sample shall be drawn from each dog and tested for neutralizing antibody 
to canine

[[Page 693]]

parvovirus in the same manner used to determine susceptibility.
    (iii) If the control has not remained seronegative at 1:2, the test 
is inconclusive and may be repeated.
    (iv) If three of the four vaccinates in a valid test do not develop 
titers of at least 1:16 final serum dilution, and the remaining 
vaccinate does not develop a titer of at least 1:8, the Master Seed is 
unsatisfactory, except as provided in paragraph (c)(4)(v) of this 
section.
    (v) If the results of a valid SN test are unsatisfactory, the 
vaccinates and the control may be challenged as provided in paragraph 
(c)(3) of this section. If at least three of the four criteria of 
infection are not shown in the control dog, the test is inconclusive and 
may be repeated, except that if any of the vaccinates show more than one 
criterion of infection, 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 Sec.  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\0.7\ greater than that used in the immunogenicity test, but not less 
than 10\2.5\ ID50 per dose.

[50 FR 436, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.318  Pseudorabies Vaccine.

    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 Sec.  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 
TCID50 pseudorabies virus.
    (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 inconclusive 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) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot is discontinued. Only five vaccinates and five 
controls need to be

[[Page 694]]

used in the retest. Susceptibility and age requirements shall be as 
provided in paragraph (b)(1) of this section.
    (ii) Fourteen to 28 days postvaccination, a blood sample shall be 
taken from each pig and the serum inactivated and tested for 
neutralizing antibody to pseudorabies virus by the same method used to 
determine susceptibility.
    (iii) If the five controls have not remained seronegative at 1:2, 
the test is inconclusive and may be repeated.
    (iv) If at least four of the five vaccinates in a valid test have 
not developed titers of 1:8 final serum dilution or greater and the 
remaining vaccinate a titer of 1:4 or greater, the Master Seed is 
unsatisfactory, except as provided in paragraph (b)(4)(v).
    (v) If the results of a valid neutralization test are 
unsatisfactory, the vaccinates and controls may be challenged as 
provided in paragraph (b)(3) of this section. If at least four of five 
controls do not develop severe central nervous system signs or die, the 
test is inconclusive and may be repeated. If all five of the vaccinates 
in a valid test do not remain free of signs of pseudorabies, 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 Sec.  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.\0.7\ greater than that used in the immunogenicity test, but not less 
than 10\2.5\ TCID50 per dose.

[50 FR 437, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec. Sec.  113.319-113.324  [Reserved]



Sec.  113.325  Avian Encephalomyelitis Vaccine.

    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 Sec.  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 Sec.  113.37, except 
that, if the test is inconclusive 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 Sec.  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

[[Page 695]]

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 EID50 by the Spearman-Karber or Reed-
Muench method.
    (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 inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only one 
method of administration recommended on the label need be used in the 
retest. The vaccinates and the controls shall meet the criteria 
prescribed in paragraph (c)(4) of this section.
    (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 Sec.  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 Sec.  
113.37, except that, if the test is inconclusive because of a vaccine 
virus override, the chicken inoculation test prescribed in Sec.  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 inconclusive 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\0.7\ greater than that used in such 
immunogenicity test but not less than 10\.5\ EID50 per dose.

[39 FR 44723, Dec. 27, 1974, as amended at 40 FR 18405, Apr. 28, 1975; 
40 FR 41089, Sept. 5, 1975; 42 FR 43617, Aug. 30, 1977; 48 FR 33473, 
July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 
56 FR 66784, 66786, Dec. 26, 1991]

[[Page 696]]



Sec.  113.326  Avian Pox Vaccine.

    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 Sec.  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 Sec.  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 EID50 by the Spearman-Karber or Reed-
Muench method.
    (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 inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only one 
method of administration recommended on the label need be used in the 
retest. The vaccinates and the controls shall meet the criteria 
prescribed in paragraph (c)(4) of this section.
    (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 requirements in Sec.  113.36, in Sec.  
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.

[[Page 697]]

    (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
----------------------------------------------------------------------------------------------------------------
                                                                      Failures for             Failures for
                Stage                      Number of birds        satisfactory serials    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 inconclusive 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 inconclusive 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\0.7\ greater than that used in such 
immunogenicity test but not less than 10\2.0\ EID50 per dose.

[39 FR 44724, Dec. 27, 1974, as amended at 40 FR 18406, Apr. 28, 1975; 
40 FR 41089, Sept. 5, 1975; 44 FR 33051, June 8, 1979; 48 FR 33473, July 
22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 
FR 66784, 66786, Dec. 26, 1991]



Sec.  113.327  Bronchitis Vaccine.

    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 Sec.  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 Sec.  113.37, except 
that, if the test is inconclusive 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 Sec.  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

[[Page 698]]

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 
embyros 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 EID50 by the Spearman-Karber or Reed-
Muench method.
    (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\4.0\ EID50 per ml.
    (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 [deg]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 
inconclusive. 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 inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only one 
method of administration recommended on the label need be used in the 
retest. The vaccinates and the controls shall meet the criteria 
prescribed in paragraph (c)(3) of this section.
    (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 Sec.  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 Sec.  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 Sec.  
113.37, except that, if the test is inconclusive because of a vaccine 
virus override, the chicken inoculation test prescribed in Sec.  113.36 
may be conducted and the vaccine judged accordingly.

[[Page 699]]

    (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
----------------------------------------------------------------------------------------------------------------
                                                                      Failures for             Failures for
                Stage                     Number of chickens      satisfactory serials    unsatisfactory serials
----------------------------------------------------------------------------------------------------------------
1....................................  25.....................  2 or less..............  4 or more.
2....................................  50.....................  5 or less..............  6 or more.
----------------------------------------------------------------------------------------------------------------


If unfavorable reactions occur which are not attributable to the 
product, the test shall be declared inconclusive 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 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 Sec.  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\0.7\ greater than that used in such immunogenicity test but not less 
than 10\2.0\ EID50 per dose.

[39 FR 44724, Dec. 27, 1974, as amended at 40 FR 18406, Apr. 28, 1975; 
40 FR 41089, Sept. 5, 1975; 42 FR 43617, Aug. 30, 1977; 48 FR 33473, 
July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 
56 FR 66784, 66786, Dec. 26, 1991; 64 FR 43045, Aug. 9, 1999]



Sec.  113.328  Fowl Laryngotracheitis Vaccine.

    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 Sec.  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 Sec.  113.37, except 
that, if the test is inconclusive because of 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 Sec.  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

[[Page 700]]

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 EID50 by the Spearman-Karber or Reed-
Muench method.
    (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 inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only one 
method of administration recommended on the label need be used in the 
retest. The vaccinates and the controls shall meet the criteria 
prescribed in paragraphs (c)(4) and (5) of this section.
    (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) 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 Sec.  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 Sec.  
113.37, except that, if the test is inconclusive because of a vaccine 
virus override, the chicken inoculation test prescribed in Sec.  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

[[Page 701]]

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
----------------------------------------------------------------------------------------------------------------
                                                                      Failures for             Failures for
                Stage                     Number of chickens      satisfactory serials    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 inconclusive 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\0.7\ greater than 
that used in such immunogenicity test but not less than 10\2.5\ 
EID50 per dose for chicken embryo origin vaccine and 10\2.0\ 
EID50 or 10\2.5\ TCID50 per dose for tissue 
culture origin vaccine.

[39 FR 44726, Dec. 27, 1974, as amended at 40 FR 18407, Apr. 28, 1975; 
40 FR 41089, Sept. 5, 1975; 41 FR 44359, Oct. 8, 1976; 42 FR 43617, Aug. 
30, 1977; 48 FR 33473, July 22, 1983. Redesignated at 55 FR 35562, Aug. 
31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.329  Newcastle Disease Vaccine.

    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 Sec.  113.300, except Sec.  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 Sec.  113.37, except 
that, if the test is inconclusive 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 Sec.  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

[[Page 702]]

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 EID50 by the Spearman-Karber or Reed-
Muench method.
    (3) Twenty to twenty-eight days postvaccination, all vaccinates and 
controls shall be challenged intramuscularly with at least 10\4.0\ 
EID50 of virus per chicken and observed each day for 14 days. 
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 clinical 
signs of Newcastle disease during the observation period, the test is 
inconclusive 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) The Master Seed Virus shall be retested for immunogenicity in 3 
years unless use of the lot previously tested is discontinued. Only one 
method of administration recommended on the label need be used in the 
retest. The vaccinates and the controls shall meet the criteria 
prescribed in paragraph (c)(4) of this section.
    (6) A strain identity test acceptable to Animal and Plant Health 
Inspection Service shall be conducted.
    (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) 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 Sec.  113.300, 
except Sec.  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 Sec.  
113.37, except that, if the test is inconclusive because of a vaccine 
virus override, the chicken inoculation test prescribed in Sec.  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
----------------------------------------------------------------------------------------------------------------
                                                                      Failures for             Failures for
                Stage                     Number of chickens      satisfactory serials    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 inconclusive 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

[[Page 703]]

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\0.7\ greater 
than that used in the immunogenicity test but not less than 10\5.5\ 
EID50 per dose.

[39 FR 44727, Dec. 27, 1974, as amended at 40 FR 18407, Apr. 28, 1975; 
40 FR 23721, June 2, 1975; 40 FR 41090, Sept. 5, 1975; 42 FR 43618, Aug. 
30, 1977; 48 FR 33473, July 22, 1983. Redesignated at 55 FR 35562, Aug. 
31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991]



Sec.  113.330  Marek's Disease Vaccines.

    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 Sec.  113.300, and the requirements prescribed in this 
section. The identity test required in Sec.  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 Sec.  113.37, except that, 
if the test is inconclusive because of a vaccine virus override, the 
chicken inoculation test prescribed in Sec.  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 
inconclusive 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 inconclusive. 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,

[[Page 704]]

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 Sec.  113.300. The 
identity test required in Sec.  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 
Sec.  113.37 shall be conducted, except that, if the test is 
inconclusive because of a vaccine virus override, the chicken 
inoculation test prescribed in Sec.  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 inconclusive.
    (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

[[Page 705]]

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[deg]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[deg]C to 
4[deg]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.

[61 FR 33841, July 1, 1996]



Sec.  113.331  Bursal Disease Vaccine.

    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 Sec.  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 Sec.  113.37, except 
that, if the test is inconclusive because of a vaccine virus override, 
the chicken inoculation test prescribed in Sec.  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\2.0\ EID50 of a virulent bursal 
disease virus by eye-drop, isolated, and used as positive controls. The 
remaining controls shall be used as negative controls.
    (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 inconclusive 
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 inconclusive 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\2.0\ EID50 of a virulent bursal 
disease virus by eye-drop, isolated, and used as positive controls. 
Also, each of 20 additional chickens of the same source and hatch shall 
be isolated and held as negative controls.
    (i) Three or four days postvaccination, 10 of the vaccinates,

[[Page 706]]

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 
inconclusive 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 inconclusive 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 inconclusive and may be repeated.
    (4) The Master Seed Virus shall be retested for immunogenicity in 3 
years from the original testing unless use of the lot previously tested 
is discontinued. Only one method of administration recommended on the 
label need be used in the retest. The vaccinates and the controls shall 
meet the criteria prescribed in paragraph (c)(3) of this section.
    (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 Sec.  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 Sec.  113.37, except that, if the test is inconclusive 
because of a vaccine virus override, the chicken inoculation test 
prescribed in Sec.  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

[[Page 707]]

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 inconclusive 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\0.7\ times greater than that used in such 
immunogenicity test, but not less than 10\2.0\ titration units (PFU or 
ID50's) per dose.

[44 FR 60263, Oct. 19, 1979, as amended at 44 FR 67087, Nov. 23, 1979; 
48 FR 33473, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66784, 66786, Dec. 26, 1991; 64 FR 43045, Aug. 9, 
1999]



Sec.  113.332  Tenosynovitis Vaccine.

    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 Sec.  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 Sec.  
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 Sec.  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

[[Page 708]]

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 inconclusive 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 inconclusive 
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) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot is discontinued. Only one method of administration 
recommended on the label need be used in the retest. The vaccinates and 
controls shall meet the criteria prescribed in paragraph (c)(3) of this 
section.
    (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 Sec.  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 Sec.  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

[[Page 709]]

not attributable to the product, the test is inconclusive 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 
\0.7\ times greater than that used in the immunogenicity test, but not 
less than 10 \2.0\ titration units (PFU or ID 50) per dose.
    (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.

[50 FR 438, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as 
amended at 56 FR 66784, 66786, Dec. 26, 1991; 64 FR 43045, Aug. 9, 1999]

                        Diagnostics and Reagents



Sec. Sec.  113.400-113.405  [Reserved]



Sec.  113.406  Tuberculin, Intradermic.

    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 Sec.  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 inconclusive 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

[[Page 710]]

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.

[39 FR 16857, May 10, 1974. Redesignated at 39 FR 25463, July 11, 1974. 
Redesignated at 55 FR 35561, Aug. 31, 1990, as amended at 56 FR 66784, 
Dec. 26, 1991



Sec.  113.407  Pullorum antigen.

    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 Sec.  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.

[[Page 711]]

    (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.

[39 FR 16857, May 10, 1974. Redesignated at 39 FR 25463, July 11, 1974, 
and amended at 40 FR 760, Jan. 3, 1975. Redesignated at 55 FR 35561, 
Aug. 31, 1990]



Sec.  113.408  Avian mycoplasma antigen.

    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 1,000xg in a refrigerated centrifuge at 20 [deg]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

[[Page 712]]

Gallisepticum Antigen shall be 6.00.2. The pH of 
Mycoplasma Synoviae Antigen and Mycoplasma Meleagridis Antigen shall be 
7.00.2.
    (e) Purity requirements. The antigen shall be tested for viable 
bacteria and fungi as prescribed in Sec.  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.

[48 FR 33474, July 22, 1983. Redesignated at 55 FR 35561, Aug. 31, 1990, 
as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  113.409  Tuberculin--PPD Bovis, Intradermic.

    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 Sec.  113.26.
    (b) Safety test. Final container samples of completed product from 
each serial shall be tested for safety as prescribed in Sec.  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.

[[Page 713]]

    (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

[[Page 714]]

plus or minus 0.04 percent. A direct titration with a standardized 
bromide-bromate solution shall be conducted.

[41 FR 8471, Feb. 27, 1976, as amended at 41 FR 21760, May 28, 1976; 41 
FR 32883, Aug. 6, 1976. Redesignated at 55 FR 35561, Aug. 31, 1990, as 
amended at 56 FR 66784, Dec. 26, 1991]

                            Antibody Products



Sec.  113.450  General requirements for antibody products.

    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.

[[Page 715]]

    (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

[[Page 716]]

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[deg] C for 60 minutes, and blood derivatives of bovine, porcine, or 
other origin shall be heated at 58.0-59.0[deg] 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[deg] C for 
15 seconds or 89[deg] 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[deg] 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[deg] 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 Sec.  113.64.
    (ii) Viral Master Seeds shall be tested for purity and identity as 
prescribed for live virus vaccines in Sec.  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 Sec.  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 100x15 mm petri dish and 10-15 ml of violet red bile 
agar at 45-50[deg] 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[deg] 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 inconclusive 
and may be repeated. If characteristic growth is observed on any of the 
10 plates containing samples of the serial, one

[[Page 717]]

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 100x15 mm petri dish and 10-15 ml of brilliant green 
agar at 45-50[deg] 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[deg] 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 inconclusive 
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 100x15 mm petri dish and 10-15 ml of appropriately 
acidified potato dextrose agar at 45-50[deg] 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[deg] 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 inconclusive 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 100x15 mm petri dish and 10-15 ml of tryptone 
glucose extract agar at 45-50[deg] 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[deg] 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 inconclusive 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 Sec.  113.33(b). Dried product shall be 
reconstituted as indicated on the label and 0.5 ml injected per mouse.

[61 FR 51774, Oct. 4, 1996]



Sec.  113.451  Tetanus Antitoxin.

    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

[[Page 718]]

Sec.  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[deg] to 25 [deg] 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[deg] to 25 [deg] 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[deg] to 25 [deg] 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

[[Page 719]]

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.

[39 FR 16859, May 10, 1974. Redesignated at 39 FR 25463, July 11, 1974, 
and amended at 40 FR 760, Jan. 3, 1975; 40 FR 41996, Sept. 10, 1975; 43 
FR 1479, Jan. 10, 1978; 50 FR 24905, June 14, 1985. Redesignated at 55 
FR 35561, Aug. 31, 1990; 61 FR 51776, Oct. 4, 1996; 64 FR 43045, Aug. 9, 
1999]



Sec.  113.452  Erysipelothrix Rhusiopathiae Antibody.

    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 Sec.  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:

------------------------------------------------------------------------
                                    Cumulative total   Cumulative total
                       Cumulative   number of deaths   number of deaths
 Stage    Number of     number of         for a             for an
         vaccinates    vaccinates     satisfactory      unsatisfactory
                                          test               test
------------------------------------------------------------------------
     1           40            40   6 or less         11 or more.
     2           40            80   12 or less        13 or more.
------------------------------------------------------------------------


[39 FR 16859, May 10, 1974. Redesignated at 39 FR 25463, July 11, 1974, 
as amended at 40 FR 20067, May 8, 1975; 40 FR 23989, June 4, 1975. 
Redesignated at 55 FR 35561, Aug. 31, 1990; 61 FR 51776, Oct. 4, 1996; 
64 FR 43045, Aug. 9, 1999]



Sec.  113.453  [Reserved]



Sec.  113.454  Clostridium Perfringens Type C Antitoxin.

    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 Sec.  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 L0 and L+ doses of 
Standard Toxin according to their definitions.

[[Page 720]]

    (ii) L0dose. 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 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 [deg]F. for 25 
minutes; and storing at 4 [deg]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 L0 
doses per ml and make a second dilution of Standard Toxin to contain 10 
L+ doses per ml.
    (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 L0 doses.
    (iv) Combine 10 International Units of Standard Antitoxin with 10 
L0 doses of diluted Standard Toxin and combine 10 
International Units of Standard Antitoxin with 10 L+ doses of 
diluted Standard Toxin.
    (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 L0 
doses of Standard Toxin die, the results of the test are inconclusive 
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 10 International Units of Standard Antitoxin and 10 L+ 
doses of Standard Toxin die, the results of the test are inconclusive 
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 Clostridium 
Perfringens Type C Antitoxin diluted 1:50 and 10 L0 doses of 
Standard Toxin die, the antitoxin is considered to contain less than 500 
International Unit per ml and the serial is unsatisfactory.

[39 FR 16859, May 10, 1974. Redesignated at 39 FR 25463, July 11, 1974. 
Redesignated at 55 FR 35561, Aug. 31, 1990, as amended at 56 FR 66784, 
Dec. 26, 1991; 61 FR 51777, Oct. 4, 1996]



Sec.  113.455  Clostridium Perfringens Type D Antitoxin.

    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 Sec.  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 L0 and L+ doses of 
Standard Toxin according to their definitions.

[[Page 721]]

    (ii) L0dose. The largest quantity of toxin which can be 
mixed with one-tenth 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-tenth unit of Standard Antitoxin and cause death in at 
least 80 percent of injected mice.
    (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 [deg]F. for 25 
minutes; and storing at 4 [deg]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 L0 
doses per ml and make a second dilution of Standard Toxin to contain 10 
L+ doses per ml.
    (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 L0 doses.
    (iv) Combine 1 International Unit of Standard Antitoxin with 10 
L0 doses of Standard Toxin and combine 1 International Unit 
of Standard Antitoxin with 10 L+ doses of Standard Toxin.
    (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 L0 doses 
of Standard Toxin die, the results of the test are inconclusive 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 mixture of 
1 International Unit of Standard Antitoxin and 10 L+ doses of 
Standard Toxin die, the results of the test are inconclusive 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 Clostridium 
Perfringens Type D Antitoxin diluted 1:34 and 10 L0 doses of 
Standard Toxin die, the antitoxin is considered to contain less than 34 
International Units per ml and the serial is unsatisfactory.

[39 FR 16859, May 10, 1974. Redesignated at 39 FR 25463, July 11, 1974, 
as amended at 40 FR 760, Jan. 3, 1975. Redesignated at 55 FR 35561, Aug. 
31, 1990, as amended at 56 FR 66784, Dec. 26, 1991; 61 FR 51777, Oct. 4, 
1996]



Sec. Sec.  113.456-113.498  [Reserved]



Sec.  113.499  Products for treatment of failure of passive transfer.

    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 Sec.  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

[[Page 722]]

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.

[61 FR 51777, Oct. 4, 1996]



PART 114_PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS--Table of Contents




Sec.
114.1 Applicability.
114.2 Products not prepared under license.
114.3 Separation of establishments.
114.4 Identification of biological products.
114.5 Micro-organisms used as seed.
114.6 Mixing biological products.
114.7 Personnel at licensed establishments.
114.8 Outline of Production required.
114.9 Outline of Production guidelines.
114.10 Antibiotics as preservatives.
114.11 Storage and handling.
114.12 Expiration date required.
114.13 Expiration date determination.
114.14 Extension of expiration date for a serial or subserial.
114.15 Disposal of unsatisfactory products and byproducts.
114.16 Producing subsidiaries.
114.17 Rebottling of biological products.
114.18 Reprocessing of biological products.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Source: 39 FR 16869, May 10, 1974, unless otherwise noted.



Sec.  114.1  Applicability.

    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

[[Page 723]]

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.

[52 FR 11026, Apr. 7, 1987, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  114.2  Products not prepared under license.

    (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 Sec.  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 Sec.  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 Sec. Sec.  116.1 and 116.2 of this subchapter and shall include all 
products licensed by the State or USDA.
    (4) Reports prescribed in Sec.  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

[[Page 724]]

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.

`` ---------- Autogenous Bacterin''

 (State)

or ---------- Autogenous Vaccine''.

 (State)

[39 FR 16869, May 10, 1974, as amended at 60 FR 48021, Sept. 21, 1995]



Sec.  114.3  Separation of establishments.

    (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 Sec.  
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 Sec.  113.5 or Sec.  113.10 and to the requirements for 
identification specified in Sec.  114.4.

[39 FR 16869, May 10, 1974, as amended at 40 FR 46093, Oct. 6, 1975; 49 
FR 45846, Nov. 21, 1984; 56 FR 66784, Dec. 26, 1991]



Sec.  114.4  Identification of biological products.

    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 Sec.  114.15.



Sec.  114.5  Micro-organisms used as seed.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0059)

[39 FR 16869, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 
FR 66784, Dec. 26, 1991]



Sec.  114.6  Mixing biological products.

    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.



Sec.  114.7  Personnel at licensed establishments.

    (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

[[Page 725]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16869, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 
FR 66784, Dec. 26, 1991]



Sec.  114.8  Outline of Production required.

    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 Sec.  114.8(f).
    (a) The Outline of Production shall be prepared as prescribed in 
Sec.  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) The original and two copies shall be retained by Animal and 
Plant Health Inspection Service and the remaining copies returned.
    (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 Sec.  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

[[Page 726]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16869, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 
FR 66784, Dec. 26, 1991]



Sec.  114.9  Outline of Production guidelines.

    Each Outline of Production shall be prepared in accordance with the 
applicable directions provided in this section.
    (a) General requirements. (1) The original and not more than four 
copies of each Outline of Production or special outline or revised pages 
of either shall be prepared on heavy paper (8.5 x 
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\1/2\ 
inch margin shall be left at the top of the first page and a 2 inch 
margin at the bottom of each page for the Animal and Plant Health 
Inspection Service stamp.
    (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 the original and one copy 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. Blank forms shall be available upon request to Animal and 
Plant Health Inspection Service.
    (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:

Outline Guide for Production of Antiserum and Antitoxin and Normal Serum

License No. Name of Product Date

    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

[[Page 727]]

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:

      Outline Guide for Vaccines, Bacterins, Antigens, and Toxoids

License No. Name of Product Date

    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

[[Page 728]]

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:

                  Outline Guide for Allergenic Extracts

License No. Name of Product Date

    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:

                 Outline Guide for Diagnostic Test Kits

License No. Name of product Date

                              Introduction

    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.

[[Page 729]]

    6. General description of test interpretations and their 
limitations, including followup tests.

                         I. Antibody Components

    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.

                         II. Antigen Preparation

    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.

                  III. Preparation of Standard Reagents

    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.

                     IV. Preparation of the Product

    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.

[[Page 730]]

    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.

                               V. Testing

    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.

                        VI. Postpreparatory Steps

    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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16869, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 
FR 20124, May 2, 1991; 56 FR 66784, Dec. 26, 1991]



Sec.  114.10  Antibiotics as preservatives.

    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.

[39 FR 16869, May 10, 1974, as amended at 56 FR 66784, Dec. 26, 1991



Sec.  114.11  Storage and handling.

    Biological products at licensed establishments shall be protected at 
all times against improper storage and handling. Completed product shall 
be kept under refrigeration at 35 [deg]to 45 [deg]F. (2 [deg]to 7 
[deg]C.) unless the inherent nature of the product makes storage at a 
different temperature advisable, in which

[[Page 731]]

case, the proper storage temperature shall be specified in the filed 
Outline of Production. All biological products to be shipped or 
delivered shall be securely packed.



Sec.  114.12  Expiration date required.

    Each serial or subserial of biological product prepared in a 
licensed establishment shall be given an expiration date determined in 
accordance with the requirements provided in Sec.  114.13 or Sec.  
114.14. A licensed biological product shall be considered worthless 
under the Virus-Serum-Toxin Act subsequent to the expiration date 
appearing on the label.

[41 FR 44687, Oct. 12, 1976]



Sec.  114.13  Expiration date determination.

    Unless otherwise provided for in a Standard Requirement of filed 
Outline of Production, the expiration date for each product shall be 
computed from the date of the initiation of the potency test. Prior to 
licensure, stability of each fraction shall be determined by methods 
acceptable to Animal and Plant Health Inspection Service. Expiration 
dates based on this stability data shall be confirmed as follows:
    (a) Products consisting of viable organisms. Each serial shall be 
tested for potency at release and at the approximate expiration date 
until a statistically valid stability record has been established.
    (b) Nonviable biological products. Each serial presented in support 
of licensure shall be tested for potency at release and at or after the 
dating requested.
    (c) Subsequent changes in the dating period for a product may be 
granted, based on statistically valid data submitted to support a 
revision of the Outline of Production.

[50 FR 24903, June 14, 1985, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  114.14  Extension of expiration date for a serial or subserial.

    (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 Sec.  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 
Sec.  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]

[50 FR 24903, June 14, 1985, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  114.15  Disposal of unsatisfactory products and byproducts.

    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.

[41 FR 44687, Oct. 12, 1976, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  114.16  Producing subsidiaries.

    A serial or subserial of a biological product may be produced 
jointly by a

[[Page 732]]

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.

[40 FR 46093, Oct. 6, 1975]



Sec.  114.17  Rebottling of biological products.

    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.

[39 FR 16869, May 10, 1974, as amended at 56 FR 66784, Dec. 26, 1991



Sec.  114.18  Reprocessing of biological products.

    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.

[50 FR 24904, June 15, 1985, as amended at 56 FR 66784, Dec. 26, 1991]



PART 115_INSPECTIONS--Table of Contents




Sec.
115.1 Inspections of establishments.
115.2 Inspections of biological products.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.



Sec.  115.1  Inspections of establishments.

    (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.

[52 FR 30134, Aug. 13, 1987]

[[Page 733]]



Sec.  115.2  Inspections of biological products.

    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 thereof to the manufacturer or importer and to any 
jobbers, wholesalers, dealers or other persons known to have any of such 
product in their possession, and may proceed against such product 
pursuant to the provisions of part 118 of this subchapter. 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.

[52 FR 30134, Aug. 13, 1987]



PART 116_RECORDS AND REPORTS--Table of Contents




Sec.
116.1 Applicability and general considerations.
116.2 Inventory and disposition records.
116.3 Label records.
116.4 Sterilization and pasteurization records.
116.5 Reports.
116.6 Animal records.
116.7 Test records.
116.8 Completion and retention of records.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.



Sec.  116.1  Applicability and general considerations.

    (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) required by this part 
shall be completed by the licensee or the foreign manufacturer, as the 
case may be, before any portion of a serial of any product shall be 
marketed in the United States or exported.
    (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, 510 South 17th Street, Suite 104, 
Ames, IA 50010-8197; by electronic mail to [email protected]; by fax to (515) 
232-7120; or by telephone to (515) 232-5785.
    (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

[[Page 734]]

inspection of the records by APHIS inspectors, or foreign inspectors 
acting on behalf of APHIS.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16872, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 61 
FR 52874, Oct. 9, 1996; 64 FR 43045, Aug. 9, 1999; 66 FR 21064, Apr. 27, 
2001]



Sec.  116.2  Inventory and disposition records.

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16872, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 
FR 66784, Dec. 26, 1991; 61 FR 52874, Oct. 9, 1996; 66 FR 21064, Apr. 
27, 2001]



Sec.  116.3  Label records.

    (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 include the disposition of such labels including those not 
used in labeling a product.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16872, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 61 
FR 52874, Oct. 9, 1996; 66 FR 21064, Apr. 27, 2001]



Sec.  116.4  Sterilization and pasteurization records.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16872, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 61 
FR 52874, Oct. 9, 1996; 66 FR 21064, Apr. 27, 2001]



Sec.  116.5  Reports.

    (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, 510 South 17th Street, Suite 104, 
Ames, IA 50010-8197; by electronic mail to [email protected]; by fax to (515) 
232-7120; or by telephone to (515) 232-5785.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[61 FR 52874, Oct. 9, 1996, as amended at 64 FR 43045, Aug. 9, 1999]



Sec.  116.6  Animal records.

    Complete records shall be kept for all animals at a licensed 
establishment. Results of tests performed, antigens or

[[Page 735]]

treatment administered, maintenance and production records, disposition 
records, necropsy records, if any, and all other pertinent records shall 
be included.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16872, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 61 
FR 52874, Oct. 9, 1996; 66 FR 21064, Apr. 27, 2001]



Sec.  116.7  Test records.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16872, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 
FR 66784, Dec. 26, 1991; 61 FR 52874, Oct. 9, 1996]



Sec.  116.8  Completion and retention of records.

    All records (other than disposition records) required by this part 
shall 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 shall be retained at the licensed 
or foreign establishment or permittee's place of business for a period 
of two years after the expiration date of a product, or for such longer 
period as may be required by the Administrator.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[61 FR 52874, Oct. 9, 1996]



PART 117_ANIMALS AT LICENSED ESTABLISHMENTS--Table of Contents




Sec.
117.1 Applicability.
117.2 Animal facilities.
117.3 Admittance of animals.
117.4 Test animals.
117.5 Segregation of animals.
117.6 Removal of animals.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Source: 38 FR 15499, June 13, 1973, unless otherwise noted.



Sec.  117.1  Applicability.

    (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.

[38 FR 15499, June 13, 1973, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  117.2  Animal facilities.

    Animal facilities shall comply with the requirements provided in 
part 108 of this chapter.



Sec.  117.3  Admittance of animals.

    (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

[[Page 736]]

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.

[38 FR 15499, June 13, 1973, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  117.4  Test animals.

    (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.

[38 FR 15499, June 13, 1973, as amended at 60 FR 43356, Aug. 21, 1995]



Sec.  117.5  Segregation of animals.

    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.



Sec.  117.6  Removal of 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

[[Page 737]]

    (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.

[38 FR 15499, June 13, 1973, as amended at 56 FR 66784, Dec. 26, 1991]



PART 118_DETENTION; SEIZURE AND CONDEMNATION--Table of Contents




Sec.
118.1 Administrative detention.
118.2 Method of detention; Notifications.
118.3 Movement of detained biological products; Termination of 
          detention.
118.4 Seizure and condemnation.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Source: 52 FR 30135, Aug. 13, 1987, unless otherwise noted.



Sec.  118.1  Administrative detention.

    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 Sec.  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.

[52 FR 30135, Aug. 13, 1987, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  118.2  Method of detention; Notifications.

    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.

[52 FR 30135, Aug. 13, 1987, as amended at 56 FR 66784, Dec. 26, 1991]

[[Page 738]]



Sec.  118.3  Movement of detained biological products; Termination of 
detention.

    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.

[52 FR 30135, Aug. 13, 1987, as amended at 56 FR 66784, Dec. 26, 1991]



Sec.  118.4  Seizure and condemnation.

    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.

[52 FR 30135, Aug. 13, 1987, as amended at 56 FR 66784, Dec. 26, 1991]



PART 121_POSSESSION, USE, AND TRANSFER OF BIOLOGICAL AGENTS AND 
TOXINS--Table of Contents




Sec.
121.0 Effective and applicability dates.
121.1 Definitions.
121.2 Purpose and scope.
121.3 List of biological agents and toxins.
121.4 Exemptions for overlap agents or toxins.
121.5 Exemptions for animal agents and toxins.
121.6 Registration; who must register.
121.7 Registration; general provisions.
121.8 Denial, revocation, or suspension of registration.
121.9 Registration; how to register.
121.10 Responsibilities of the responsible official.
121.11 Restricting access to biological agents and toxins.
121.12 Biosafety and security plan.
121.13 Training.
121.14 Transfer of biological agents and toxins.
121.15 Records.
121.16 Inspections.

[[Page 739]]

121.17 Notification in the event of theft, loss, or release of a 
          biological agent or toxin.
121.18 Administrative review.

    Authority: Secs. 211-213, Title II, Pub. L. 107-188, 116 Stat. 647 
(7 U.S.C. 8401).

    Source: 67 FR 76931, Dec. 13, 2002, unless otherwise noted.



Sec.  121.0  Effective and applicability dates.

    (a) The regulations in this part are effective on February 11, 2003. 
On and after that date, any person possessing, using, or transferring 
any agent or toxin listed in Sec.  121.3 must be in compliance with the 
provisions of this part. However, so as not to disrupt research or 
educational projects involving listed agents or toxins that were 
underway as of the effective date of this part, any person possessing 
such agents or toxins as of the effective date (current possessors) will 
be afforded additional time to reach full compliance with this part. Any 
provision not specifically cited in paragraphs (a)(1) through (a)(6) of 
this section will be applicable as of February 11, 2003. In addition, 
any person who does not possess listed agents or toxins by the effective 
date of this part, but who wishes to initiate a research or educational 
project prior to November 12, 2003, must be in compliance with the 
provisions of this part that are applicable for current possessors at 
the time of application, as provided in paragraphs (a)(1) through (a)(5) 
of this section.
    (1) During the period from February 11, 2003, to November 12, 2003, 
biological agents or toxins listed in Sec.  121.3 may only be 
transferred to an individual or entity that is not registered under this 
part if:
    (i) The individual or entity is registered by CDC for that specific 
overlap agent or toxin in accordance with 42 CFR part 72; or
    (ii) The individual or entity has been issued a permit by the 
Administrator under part 122 of this subchapter to import or move 
interstate that specific agent or toxin. If an individual or entity has 
not been issued a permit under part 122 of this subchapter, the 
individual or entity may apply for a permit. To receive an agent or 
toxin, an individual or entity will also be required to submit APHIS 
Form 2041, in accordance with Sec.  121.14(c). Because USDA permits do 
not cover intrastate movement, unless registered by CDC under 42 CFR 
part 72, an individual or entity may not receive a listed agent or toxin 
that is being moved intrastate until that individual or entity is 
registered in accordance with this part.
    (2) By March 12, 2003, the responsible official must submit the 
registration application package as required in Sec.  121.9. In 
addition, the responsible official must submit to the Attorney General 
the names and identifying information for the responsible official; 
alternate responsible official, where applicable; entity; and, where 
applicable, the individual who owns or controls the entity.
    (3) By April 11, 2003, the responsible official must submit to the 
Attorney General the names and identifying information for all 
individuals whom the responsible official has identified as having a 
legitimate need to handle or use listed agents or toxins, and who have 
the appropriate training and skills to handle such agents or toxins, as 
required in Sec.  121.11.
    (4) By June 12, 2003, the responsible official must submit the 
security section of the Biosafety and Security Plan required in Sec.  
121.12 to APHIS or, for overlap agents or toxins, to APHIS or CDC.
    (5) By September 12, 2003, the responsible official must implement 
the security section of the Biosafety and Security Plan, as required in 
Sec.  121.12, and provide security training in accordance with 9 CFR 
121.13.
    (6) By November 12, 2003, the registration application process must 
be complete and the entity in full compliance with the regulations in 
this part, except as otherwise provided in paragraphs (b) and (c) of 
this section.
    (b) Provisional registration. (1) Notwithstanding the provisions in 
paragraph (a) of this section, APHIS may issue a provisional 
registration certificate to current possessors if, as of November 12, 
2003:
    (i) The Attorney General has received all of the information, 
including fingerprint cards, required by the Attorney General to conduct 
a security risk assessment of the entity, including any

[[Page 740]]

individual who owns or controls the entity; and
    (ii) The entity otherwise meets all of the requirements of this 
part.
    (2) Notwithstanding the provisions in paragraph (a) of this section, 
APHIS may issue a provisional registration certificate to individuals 
and entities that did not possess listed biological agents or toxins as 
of February 11, 2003, if, as of November 12, 2003:
    (i) The Attorney General has received all of the information, 
including fingerprint cards, required by the Attorney General to conduct 
a security risk assessment of the entity, including any individual who 
owns or controls the entity;
    (ii) The entity otherwise meets all of the requirements of this 
part; and
    (iii) The Administrator finds that circumstances warrant such action 
in the interest of the health of plants or plant products or national 
security.
    (3) A provisional registration certificate will be effective until 
APHIS either issues a certificate of registration or suspends or revokes 
the provisional registration.
    (c) Notwithstanding the provisions in paragraph (a) of this section, 
APHIS may issue a provisional grant of access for individuals identified 
by an entity as having a legitimate need to handle or use agents or 
toxins listed in Sec.  121.3 if, as of November 12, 2003, the Attorney 
General has received all of the information, including fingerprint 
cards, required by the Attorney General to conduct a security risk 
assessment of that individual. A provisional grant of access will be 
effective until APHIS grants or denies access to biological agents or 
toxins listed in Sec.  121.3.

[68 FR 62220, Nov. 3, 2003]



Sec.  121.1  Definitions.

    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.
    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, rickettsiae, 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 United States Department of Health 
and Human Services.
    Clinical laboratory. A laboratory facility that receives patients 
and collects specimens for processing or shipping to another laboratory.
    Diagnostic laboratory. A laboratory facility that receives specimens 
for the purpose of determining the identities of pests, pathogens, 
contaminants, or causes of disease.
    Entity. Any government agency (Federal, State, or local), academic 
institution, corporation, company, partnership, society, association, 
firm, sole proprietorship, or other legal entity.
    Import. To move into, or the act of movement into, the territorial 
limits of the United States.
    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.
    Overlap agent or toxin. Any microorganism (including, but not 
limited to, bacteria, viruses, fungi, rickettsiae, or protozoa) or toxin 
that poses a risk to both human and animal health and that is listed in 
Sec.  121.3(b).
    Permit. A written authorization by the Administrator to import or 
move interstate biological agents or toxins, under conditions prescribed 
by the Administrator.
    Proficiency testing. A sponsored, time-limited analytical trial 
whereby one or more analytes, previously confirmed by

[[Page 741]]

the sponsor, are submitted to the testing laboratory for analysis and 
where final results are graded, scores are recorded and provided to 
participants, and scores for participants are evaluated for acceptance.
    Responsible official. The individual designated by an entity to act 
on its behalf. This individual must have the authority and control to 
ensure compliance with the regulations in this part.
    Specimen. A sample of material collected for use in testing, such as 
tissues, gastrointestinal contents, feces, bodily fluids (blood, serum, 
etc.), soil, water, feed or feed ingredients, swabs, cultures, and 
suspensions.
    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.
    Toxin. The toxic material or product of plants, animals, 
microorganisms (including, but not limited to, bacteria, viruses, fungi, 
rickettsiae, 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 United States Department of Agriculture.



Sec.  121.2  Purpose and scope.

    (a) This part sets forth the requirements for possession, use, and 
transfer of biological agents or toxins that have been determined to 
have the potential to pose a severe threat to both human and animal 
health, to animal health, or to animal products. The purpose of this 
part is to ensure the safe handling of such agents or toxins, and to 
protect against the use of such agents or toxins in domestic or 
international terrorism or for any other criminal purpose.
    (b) Accordingly, this part provides that any individual or entity 
that possesses, uses, or transfers any agent or toxin listed in Sec.  
121.3 must register in accordance with Sec.  121.7. To register, each 
entity must designate an individual who has the authority and control to 
ensure compliance with the regulations to be the responsible official. 
The responsible official must complete and submit the registration 
application package to APHIS or, for overlap agents or toxins, to APHIS 
or CDC. As part of registration, the responsible official, the entity, 
and, where applicable, the individual who owns or controls such entity 
will be subject to a security risk assessment by the Attorney General.
    (c) The responsible official is responsible for ensuring compliance 
with the safety procedures in this part, including implementing the 
Biosafety and Security Plan in accordance with Sec.  121.12, providing 
the proper training to individuals who handle or use agents or toxins 
listed in Sec.  121.3, and providing proper laboratory facilities to 
contain and dispose of such agents or toxins. In addition, the 
responsible official is responsible for ensuring compliance with the 
safeguard and security measures in this part, including restricting 
access to only those individuals who have a legitimate need to handle or 
use agents or toxins and who have been approved in accordance with Sec.  
121.11, and transferring such agents or toxins only to registered 
individuals or entities in accordance with Sec.  121.13.



Sec.  121.3  List of biological agents and toxins.

    (a) Except as provided in paragraphs (f) and (g) 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 
both human and animal health, to animal health, or to animal products.
    (b) Overlap agents and toxins.

Bacillus anthracis
Botulinum neurotoxins
Botulinum neurotoxin producing species of Clostridium
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia mallei

[[Page 742]]

Burkholderia pseudomallei
Clostridium botulinum
Clostridium perfringens epsilon toxin
Coccidioides immitis
Coxiella burnetii
Eastern equine encephalitis virus
Francisella tularensis
Hendra virus
Nipah virus
Rift Valley fever virus
Shigatoxin
Staphylococcal enterotoxins
T-2 toxin
Venezuelan equine encephalitis virus

    (c) Genetic elements, recombinant nucleic acids, and recombinant 
organisms of overlap agents or toxins:
    (1) Biological agent viral nucleic acids (synthetic or naturally 
derived, contiguous or fragmented, in host chromosomes or in expression 
vectors) that can encode infectious and/or replication competent forms 
of any of the biological agent viruses.
    (2) Nucleic acids (synthetic or naturally derived) that encode for 
the functional form(s) of any of the toxins listed in paragraph (b) of 
this section, if the nucleic acids:
    (i) Are in a vector or host chromosome;
    (ii) Can be expressed in vivo or in vitro; or
    (iii) Are in a vector or host chromosome and can be expressed in 
vivo or in vitro.
    (3) Viruses, bacteria, fungi, and toxins listed in paragraph (b) of 
this section that have been genetically modified.
    (d) Animal agents and toxins.

African horse sickness virus
African swine fever virus
Akabane virus
Avian influenza virus (highly pathogenic)
Bluetongue virus (exotic)
Bovine spongiform encephalopathy agent
Camel pox virus
Classical swine fever virus
Cowdria ruminantium (Heartwater)
Foot-and-mouth disease virus
Goat pox virus
Japanese encephalitis virus
Lumpy skin disease virus
Malignant catarrhal fever virus (exotic)
Menangle virus
Mycoplasma capricolum/M. F38/M. mycoides capri (contagious caprine 
pleuropneumonia)
Mycoplasma mycoides mycoides (contagious bovine pleuropneumonia)
Newcastle disease virus (VVND)
Peste des petits ruminants virus
Rinderpest virus
Sheep pox virus
Swine vesicular disease virus
Vesicular stomatitis virus (exotic)

    (e) The Administrator has determined that it would be impractical to 
regulate a biological agent or toxin that is in its naturally occurring 
environment. Therefore, any biological agent or toxin listed in this 
section that is in its naturally occurring environment will not be 
subject to the requirements of this part, provided that the biological 
agent or toxin has not been intentionally introduced, cultivated, 
collected, or otherwise extracted from its natural source.
    (f) The Administrator has determined that biological agents or 
toxins that meet any of the following criteria do not have the potential 
to pose a severe threat to both human and animal health, or to animal 
health or animal products. Therefore, an individual or entity that only 
possesses, uses, or transfers an agent or toxin that meets any of the 
following criteria will not be subject to the requirements of this part:
    (1) Nonviable agents or fixed tissues that are, bear, or contain 
agents or toxins listed in this section.\1\
---------------------------------------------------------------------------

    \1\ However, the importation and interstate movement of these 
genetic elements or subunits of listed agents or toxins are still 
subject to the permit requirements under part 122 of this subchapter.
---------------------------------------------------------------------------

    (2) Genetic elements or subunits of agents or toxins listed in 
paragraph (d) of this section, if the genetic elements or subunits are 
not capable of causing disease.\2\
---------------------------------------------------------------------------

    \2\ See footnote 1.
---------------------------------------------------------------------------

    (3) Overlap toxins under the control of a principal investigator (or 
equivalent), if the total aggregate amount does not, at any time, exceed 
the following amounts: 0.5 mg of Botulinum neurotoxins (types A-G), 100 
mg of Clostridium perfringens epsilon toxin, 100 mg of Shigatoxin, 5 mg 
of Staphylococcal enterotoxins, and 1,000 mg of T-2 toxin.
    (g) Attenuated strains. Attenuated strains of biological agents 
listed in this section may not have the potential to pose a severe 
threat to both human and animal health, to animal health, or

[[Page 743]]

to animal products. Thus, an individual or entity may request review by 
the Administrator to determine whether a specific attenuated strain 
poses a severe threat to both human and animal health, or to animal 
health or animal products. For overlap agents, an individual or entity 
may request review by APHIS or CDC.
    (1) If APHIS or CDC determines that a specific attenuated strain 
does not pose a severe threat to human and animal health, or to animal 
health or animal products, an individual or entity will not be subject 
to the requirements of this part. This determination will be limited to 
the specific attenuated strain and to the specific activities involving 
that attenuated strain.
    (2) An individual or entity may request a review by writing to the 
Administrator or, for overlap agents, by writing to the Administrator or 
CDC.\3\
---------------------------------------------------------------------------

    \3\ A request to review an attenuated strain may be mailed to 
National Center for Import and Export, VS, APHIS, 4700 River Road Unit 
40, Riverdale, MD 20737-1231; or faxed to (301) 734-3652. For overlap 
agents, a request for review may be mailed to the above address or to 
Select Agent Program, Centers for Disease Control and Prevention, 1600 
Clifton Road, NE, Mail Stop E 79, Atlanta, GA 30333; or faxed to (404) 
498-2265.
---------------------------------------------------------------------------

    (3) If it is determined that a specific attenuated strain does not 
pose a severe threat, APHIS or CDC will notify the applicant and publish 
a notice in the Federal Register.
    (4) An individual or entity may request reconsideration of an 
adverse decision in writing to the Administrator. The request for 
reconsideration must state all of the facts and reasons upon which the 
individual or entity relies upon 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. If there is a conflict as to any material fact, the 
individual or entity may request a hearing to resolve the conflict.



Sec.  121.4  Exemptions for overlap agents or toxins.

    (a) Clinical or diagnostic laboratories and other entities 
possessing, using, or transferring overlap agents or toxins that are 
contained in specimens presented for diagnosis or verification will be 
exempt from the requirements of this part, provided that:
    (1) The identification of such agents or toxins is immediately 
reported to APHIS or CDC, and to other appropriate authorities when 
required by Federal, State, or local law; and
    (2) Within 7 days after identification, the agents or toxins are 
transferred or inactivated, and APHIS Form 2040 is submitted to APHIS or 
CDC.\4\ During agricultural emergencies or outbreaks, or in endemic 
areas, the Administrator may require less frequent reporting. A copy of 
the completed form must be maintained for 3 years.
---------------------------------------------------------------------------

    \4\ A clinical or diagnostic laboratory, or other entity, may 
immediately notify APHIS by faxing (301) 734-3652. APHIS Form 2040 may 
be obtained by calling APHIS at (301) 734-3277 or by calling CDC at 
(404) 498-2265. The form is also available on the Internet at http://
www.aphis.usda.gov/vs/ncie.bta.html or http://www.cdc.gov/od/ohs/
lrsat.htm. The completed form may be mailed or faxed to APHIS or CDC, as 
provided in footnote 3.
---------------------------------------------------------------------------

    (b) Clinical or diagnostic laboratories and other entities 
possessing, using, or transferring overlap agents or toxins that are 
contained in specimens presented for proficiency testing will be exempt 
from the requirements of this part, provided that:
    (1) The identification of such agents or toxins, and their 
derivatives, is immediately reported to the APHIS or CDC, and to other 
appropriate authorities when required by Federal, State, or local law; 
and
    (2) Within 90 days of receipt, the agents or toxins are transferred 
or inactivated, and APHIS Form 2040 is submitted to APHIS or CDC. 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 or plant 
health, or animal or plant products, an individual or entity possessing, 
using, or transferring products that are, bear, or contain overlap 
agents or toxins will be exempt from the requirements of this part if 
the products have been cleared, approved, licensed, or registered 
pursuant to:

[[Page 744]]

    (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) An individual or entity possessing, using, or transferring 
investigational products that are, bear, or contain overlap agents or 
toxins may be exempt from the requirements of this part 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 or plant health, and animal or plant 
products.
    (1) An individual or entity possessing, using, or transferring such 
investigational products may apply for an exemption from the 
requirements of this part by submitting APHIS Form 2042 to APHIS or CDC.
    (2) For investigational products authorized under any of the Federal 
laws specified in paragraph (c) of this section, the Administrator shall 
make a determination regarding an exemption within 14 days after receipt 
of the application and notification that the investigation has been 
authorized under a Federal law.
    (e) The Administrator may exempt an individual or entity from the 
requirements of this part, in whole or in part, for 30 days if it is 
necessary to respond to a domestic or foreign agricultural emergency 
involving an overlap agent or toxin. 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 
of this part, in whole or in part, for 30 days if the Secretary of 
Health and Human Services has granted an exemption for a public health 
emergency involving an overlap agent or toxin. The Administrator may 
extend the exemption once for an additional 30 days.



Sec.  121.5  Exemptions for animal agents and toxins.

    (a) Diagnostic laboratories and other entities possessing, using, or 
transferring agents or toxins that are contained in specimens presented 
for diagnosis or verification will be exempt from the requirements of 
this part, provided that:
    (1) The identification of such agents or toxins is immediately 
reported to the Administrator and to other appropriate authorities when 
required by Federal, State, or local law; and
    (2) Within 7 days after identification, the agents or toxins are 
transferred or inactivated, and APHIS Form 2040 is submitted to the 
Administrator.\5\ During agricultural emergencies or outbreaks, or in 
endemic areas, the Administrator may require less frequent reporting. A 
copy of the completed form must be maintained for 3 years.
---------------------------------------------------------------------------

    \5\ A diagnostic laboratory or other entity must immediately notify 
APHIS by faxing (301) 734-3652. APHIS Form 2040 may be obtained by 
calling (301) 734-3277. The form is also available on the Internet at 
http://www.aphis.usda.gov/vs/ncie.bta.html. The completed form may be 
mailed to National Center for Import and Export, VS, APHIS, 4700 River 
Road Unit 40, Riverdale, MD 20737-1231; or faxed to (301) 734-3652.
---------------------------------------------------------------------------

    (b) Diagnostic laboratories and other entities possessing, using, or 
transferring agents or toxins that are contained in specimens presented 
for proficiency testing will be exempt from the requirements of this 
part, provided that:
    (1) The identification of such agents or toxins, and their 
derivatives, is immediately reported to the Administrator, and to other 
appropriate authorities when required by Federal, State, or local law; 
and
    (2) Within 90 days of receipt, the agent or toxins are transferred 
or inactivated, and APHIS Form 2040 is submitted to the Administrator. A 
copy of the completed form must be maintained for 3 years.
    (c) An individual or entity receiving diagnostic reagents and 
vaccines that are, bear, or contain listed agents or toxins, also known 
as high consequence livestock pathogens or toxins, that are produced at 
USDA diagnostic facilities

[[Page 745]]

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, an 
individual or entity possessing, using, or transferring products that 
are, bear, or contain listed 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) An individual or entity possessing, using, or transferring 
experimental products that are, bear, or contain listed agents or toxins 
may be exempt from the requirements of this part 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 or plant health, and animal or plant 
products. An individual or entity possessing, using, or transferring 
such experimental products may apply for an exemption from the 
requirements of this part by submitting APHIS Form 2042 to APHIS.
    (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 and animal 
products. An individual or entity that possesses, uses, or transfers 
agents or toxins 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. If there is a conflict as to any 
material fact, the individual or entity may request a hearing to resolve 
the conflict.\6\
---------------------------------------------------------------------------

    \6\ A request for exemption may be mailed to National Center for 
Import and Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 
20737-1231; or faxed to (301) 734-3652.
---------------------------------------------------------------------------



Sec.  121.6  Registration; who must register.

    (a) Unless exempted under Sec. Sec.  121.4 or 121.5, any individual 
or entity that possesses, uses, or transfers any agent or toxin listed 
in Sec.  121.3 must register with APHIS or, for overlap agents or 
toxins, APHIS or CDC.
    (b) Each entity must designate an individual to be its responsible 
official. The responsible official must have the authority and control 
to ensure compliance with the regulations. The responsible official must 
complete and sign the registration application package, and will be the 
individual contacted by APHIS or CDC if any questions arise concerning 
the application or subsequent compliance with the regulations in this 
part. As part of registration, the responsible official and the entity 
will be subject to a security risk assessment by the Attorney General. 
While most registrants are likely to be entities, in the event that an 
individual applies for and is granted a certificate of registration, 
APHIS will consider the individual to be the responsible official.
    (c) An entity may designate one or more individuals to be an 
alternate responsible official, who may act for the responsible official 
when he/she is unavailable. These individuals must have the authority 
and control to ensure compliance with the regulations when acting as the 
responsible official. These individuals will also be subject to a 
security risk assessment by the Attorney General as part of 
registration.

[[Page 746]]



Sec.  121.7  Registration; general provisions.

    (a) Unless exempted under Sec. Sec.  121.4 or 121.5, an individual 
or entity shall not possess, use, or transfer any agent or toxin listed 
in Sec.  121.3 without a certificate of registration issued by APHIS or 
CDC.
    (b) A certificate of registration may be issued upon:
    (1) Approval of the responsible official; the alternate responsible 
official, where applicable; the entity; and, where applicable, the 
individual who owns or controls the entity following a security risk 
assessment by the Attorney General; \7\ and
---------------------------------------------------------------------------

    \7\ The security risk assessment of the entity and the individual 
who owns or controls such entity may be waived for Federal, State, or 
local governmental agencies.
---------------------------------------------------------------------------

    (2) Approval of the biosafety, containment, and security of the 
entity. The entity's biosafety, containment, and security procedures 
must be commensurate with the risk of the agent or toxin, given its 
intended use. APHIS or CDC will review the Biosafety and Security Plan, 
and may inspect and evaluate the premises and records to determine 
compliance with the regulations and the biosafety, containment, and 
security requirements; and
    (3) A determination by the Administrator that the individual or 
entity seeking to register has a lawful purpose to possess, use, or 
transfer such agents or toxins.
    (c) For overlap agents, APHIS and CDC will review applications for 
registration and amendments to a certificate of registration, and a 
certificate of registration or amendment to a certificate of 
registration will only be issued if APHIS and CDC concur.
    (d) A certificate of registration will be valid for only the 
specific agents or toxins listed in the certificate and specific 
activities and locations. A certificate of registration may cover more 
than one listed agent or toxin, and it may be amended to cover 
additional listed agents or toxins.
    (e) A certificate of registration may be amended to reflect changed 
circumstances (e.g., replacement of the responsible official, changes in 
ownership or control of the entity,\8\ changes in the activities 
involving the agent or toxin). The responsible official must immediately 
notify the agency that issued the certificate of registration, either 
APHIS or CDC, of such changes in circumstances that occur after 
submission of the application for registration or after receipt of a 
certificate of registration.
---------------------------------------------------------------------------

    \8\ Any change in ownership or control of an entity will require a 
security risk assessment for the new individual(s) who owns or controls 
the entity.
---------------------------------------------------------------------------

    (f) If a responsible official wishes to discontinue possessing, 
using, or transferring a particular agent or toxin, the responsible 
official may inactivate the agent or toxin or he/she may transfer the 
agent or toxin to a registered individual or entity in accordance with 
Sec.  121.13. The responsible official must notify APHIS or, for overlap 
agents or toxins, APHIS or CDC, 5 business days prior to the planned 
inactivation so that we may have the opportunity to observe the 
inactivation of the agents or toxins. APHIS or CDC will notify the 
responsible official if we wish to observe the inactivation of the 
agents or toxins.
    (g) A certificate of registration will be valid for a maximum of 3 
years.



Sec.  121.8  Denial, revocation, or suspension of registration.

    (a) APHIS may deny an application for registration or revoke 
registration if:
    (1) The Attorney General identifies the responsible official, 
entity, or individual who owns or controls the entity as within any of 
the categories described in 18 U.S.C. 175b; or
    (2) The Attorney General identifies the responsible official, 
entity, or individual who owns or controls the entity as 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

[[Page 747]]

    (iii) Being an agent of a foreign power as defined in 50 U.S.C. 
1801; or
    (3) The responsible official does not have a lawful purpose to 
possess, use, or transfer agents or toxins listed in Sec.  121.3; or
    (4) The responsible official is an individual who handles or uses 
agents or toxins listed in Sec.  121.3 and he/she does not have the 
necessary training or skills to handle such agents or toxins; or
    (5) The entity does not meet the biosafety, containment, and 
security requirements prescribed by the Administrator; \9\ or
---------------------------------------------------------------------------

    \9\ If registration is denied for this reason, we may provide 
technical assistance and guidance.
---------------------------------------------------------------------------

    (6) There are egregious or repeated violations of the biosafety, 
containment, or security requirements; or
    (7) The Administrator determines that such action is necessary to 
protect animal or plant health, and animal or plant products.
    (b) For overlap agents or toxins, APHIS or CDC shall deny an 
application for registration or revoke registration if the Attorney 
General identifies the responsible official, entity, or individual who 
owns or controls the entity as within any of the categories described in 
18 U.S.C. 175b. APHIS or CDC may also deny registration or revoke 
registration for the reasons set forth in paragraphs (a)(2) through 
(a)(7) of this section.
    (c) APHIS may summarily revoke or suspend registration for any of 
the reasons set forth in paragraphs (a) and (b) of this section.
    (d) APHIS will notify the responsible official in writing if an 
application for registration is denied or a certificate of registration 
is revoked or suspended. For overlap agents or toxins, APHIS or CDC will 
notify the responsible official in writing if an application for 
registration is denied or a certificate of registration is revoked or 
suspended.
    (e) Denial of an application for registration, revocation of 
registration, and suspension of registration may be appealed under Sec.  
121.17.



Sec.  121.9  Registration; how to register.

    (a) To apply for a certificate of registration, the responsible 
official must submit all of the information and documentation required 
in the registration application package to APHIS, including the name, 
source, and characterization data for each agent or toxin to be 
registered. For overlap agents or toxins, the responsible official must 
submit all of the information and documentation required in the 
registration package to either APHIS or CDC. The responsible official 
must submit the registration application package to APHIS in cases where 
he/she is seeking registration for both animal and overlap agents and 
toxins.
    (b) For animal agents and toxins, the registration application 
package may be obtained by calling (301) 734-3277 or faxing a request to 
(301) 734-3652. It is also available on the Internet at http://
www.aphis.usda.gov/vs/ncie.bta.html. The completed registration 
application package must be mailed to National Center for Import and 
Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-1231. 
Assistance in completing the registration application may be requested 
by calling (301) 734-3277.
    (c) For overlap agents and toxins, the registration application 
package may be obtained by contacting APHIS, as set forth in paragraph 
(b) of this section, or by calling CDC at (404) 498-2255; faxing a 
request to (404) 498-2265; or writing to Select Agent Program, Centers 
for Disease Control and Prevention, 1600 Clifton Road, NE, Mail Stop E 
79, Atlanta, GA 30333. It is also available on the Internet at http://
www.cdc.gov/od/ohs/lrsat.htm. The completed registration application 
package may be mailed to APHIS at the address provided in paragraph (b) 
of this section or to CDC's Select Agent Program at the address provided 
in this paragraph. Assistance in completing the registration application 
may be requested by calling APHIS or CDC at the telephone numbers 
provided in this section.

[[Page 748]]



Sec.  121.10  Responsibilities of the responsible official.

    (a) The responsible official is responsible for ensuring compliance 
with the regulations, including:
    (1) Developing and implementing a Biosafety and Security Plan in 
accordance with Sec.  121.12;
    (2) Allowing only approved individuals within the entity to have 
access to any agents or toxins listed in Sec.  121.3 in accordance with 
Sec.  121.11;
    (3) Providing appropriate training in biosafety, containment, and 
security procedures for all personnel in accordance with Sec.  121.13;
    (4) Transferring agents or toxins only to registered individuals or 
entities in accordance with Sec.  121.14;
    (5) Ensuring that all visitors are informed of and follow the 
entity's security requirements and procedures;
    (6) Notifying APHIS or, for overlap agents or toxins, APHIS or CDC, 
of changes in circumstances in accordance with Sec.  121.7;
    (7) Providing timely notice of any theft, loss, or release of a 
biological agent or toxin in accordance with Sec.  121.17;
    (8) Maintaining detailed records of information necessary to give a 
complete accounting of all of the activities related to agents or toxins 
listed in Sec.  121.3 in accordance with Sec.  121.15.
    (b) In addition to the requirements in paragraph (a) of this 
section, the responsible official for a diagnostic laboratory or other 
entities possessing, using, or transferring agents or toxins listed in 
Sec.  121.3 that are contained in specimens presented for diagnosis must 
immediately report the identification of such agents or toxins to the 
Administrator and to other appropriate authorities when required by 
Federal, State, or local law.\10\ During agricultural emergencies or 
outbreaks, or in endemic areas, the Administrator may require less 
frequent reporting.
---------------------------------------------------------------------------

    \10\ A diagnostic laboratory or other entity must immediately notify 
APHIS by faxing (301) 734-3652.
---------------------------------------------------------------------------

    (c) In addition to the requirements in paragraph (a) of this 
section, the responsible official must ensure that the following 
experiments are not conducted unless approved by the Administrator, 
after consultation with experts:
    (1) Experiments utilizing recombinant DNA that involve the 
deliberate transfer of a pathogenic trait or drug resistance trait to 
biological agents that are not known to acquire the trait naturally, if 
such acquisition could compromise the use of the drug to control disease 
agents in humans, veterinary medicine, or agriculture.
    (2) Experiments involving the deliberate formation of recombinant 
DNA containing genes for the biosynthesis of toxins lethal for 
vertebrates at an LD50<100 ng/kg body weight.



Sec.  121.11  Restricting access to biological agents and toxins.

    (a) An individual may not have access to biological agents or toxins 
listed in Sec.  121.3 unless approved by APHIS or CDC. APHIS will grant, 
limit, or deny access of individuals to listed agents or toxins. APHIS 
or CDC will grant, limit, or deny access of individuals to overlap 
agents or toxins.
    (b) The responsible official is responsible for ensuring that only 
approved individuals within the entity have access to any agents or 
toxins listed in Sec.  121.3. The responsible official must request such 
access for only those individuals who have a legitimate need to handle 
or use agents or toxins, and who have the appropriate training and 
skills to handle such agents or toxins.
    (c) The responsible official must provide appropriate training in 
biosafety, containment, and security procedures to all individuals with 
access to agents and toxins listed in Sec.  121.3.
    (d) For each individual identified by the responsible official as 
having a legitimate need to handle or use agents or toxins, the 
responsible official must submit that individual's name and identifying 
information to APHIS and the Attorney General. For overlap agents or 
toxins, the responsible official must submit this information to either 
APHIS or CDC and the Attorney General.
    (e) In addition, the responsible official must submit information 
about the individual's training and skills to APHIS or, for overlap 
agents or toxins, APHIS or CDC (e.g., curriculum vitae

[[Page 749]]

for principal investigators and researchers, and a description of 
training completed by support personnel).
    (f) APHIS may expedite the access approval process for individuals 
upon request by the responsible official and a showing of good cause 
(e.g., public health or agricultural emergencies, national security, 
impending expiration of a research grant, a short-term visit by a 
prominent researcher).
    (g) APHIS will notify the responsible official if an individual is 
granted full or limited access, or denied access to listed agents or 
toxins. APHIS will also notify the individual if he/she is denied access 
or granted only limited access. For overlap agents or toxins, APHIS or 
CDC will provide the necessary notification.
    (h) APHIS may deny or limit access of an individual to listed agents 
or toxins if:
    (1) The Attorney General identifies the individual as within any of 
the categories described in 18 U.S.C. 175b;
    (2) The Attorney General identifies the individual as 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;
    (3) The individual does not have a legitimate need to handle listed 
agents or toxins;
    (4) The individual does not have the necessary training or skills to 
handle listed agents or toxins;
    (5) The Administrator determines that such action is necessary to 
protect animal health or animal products.
    (i) For overlap agents or toxins, APHIS or CDC will deny an 
individual access to such agents or toxins if the Attorney General 
identifies the individual as within any of the categories described in 
18 U.S.C. 175b. APHIS or CDC may also deny or limit access of an 
individual for the reasons set forth in paragraphs (f)(2) through (f)(5) 
of this section.
    (j) An individual may appeal the Administrator's decision to deny or 
limit access under Sec.  121.17.
    (k) Access approval is valid for 5 years; thereafter, the 
responsible official shall request renewal of access approval every 5 
years for as long as the individual needs access to agents or toxins 
listed in Sec.  121.3.
    (l) The responsible official must immediately notify APHIS or, for 
overlap agents or toxins, APHIS or CDC, when an individual's access to 
agents or toxins listed in Sec.  121.3 is terminated by the entity and 
the reasons therefore.



Sec.  121.12  Biosafety and security plan.

    (a) As a condition of registration, the responsible official must 
develop and implement a Biosafety and Security Plan.\11\ The Biosafety 
and Security Plan must contain sufficient information and documentation 
to describe the biosafety and containment procedures, and the security 
systems and procedures. The plan must be commensurate with the risk of 
the agent or toxin, given its intended use.
---------------------------------------------------------------------------

    \11\ Technical assistance and guidance may be obtained by calling 
(301) 734-3277.
---------------------------------------------------------------------------

    (1) Biosafety and containment procedures.\12\ The biosafety and 
containment procedures must be sufficient to contain the agent or toxin 
(e.g., physical structure and features of the entity, and operational 
and procedural safeguards). At a minimum, the plan must address 
containment, personnel safety and health, and inventory control.
---------------------------------------------------------------------------

    \12\ For guidance on biosafety and containment procedures, see the 
CDC/NIH publication, ``Biosafety in Microbiological and Biomedical 
Laboratories'' (4th ed. 1999).
---------------------------------------------------------------------------

    (2) Security systems and procedures.\13\ The security systems and 
procedures

[[Page 750]]

must be designed according to a site-specific risk assessment and must 
provide graded protection in accordance with the threat posed by the 
agent or toxin.
---------------------------------------------------------------------------

    \13\ For guidance, see the USDA Departmental Manual No. 9610-001, 
``USDA Security Policies and Procedures for Biosafety Level-3 
Facilities'' (August 30, 2002). The manual may be obtained by calling 
(301) 734-3277. The manual is also available on the Internet at http://
www.usda.gov/ocio/directives/DM/DM9610-001.htm. See also Appendix F, 
``Biosafety in Microbiological and Biomedical Laboratories,'' in 
Morbidity and Mortality Weekly Report (2002). This document may be 
obtained by writing to Select Agent Program, Centers for Disease Control 
and Prevention, 1600 Clifton Road, NE, Mail Stop E 79, Atlanta, GA 
30333. It is also available on the Internet at http://www.cdc.gov/mmwr.
---------------------------------------------------------------------------

    (i) The site-specific risk assessment should involve a threat 
assessment and risk analysis in which threats are defined, 
vulnerabilities examined, and risks associated with those 
vulnerabilities are identified.
    (ii) The security systems and procedures must be tailored to address 
site-specific characteristics and requirements, ongoing programs, and 
operational needs and must mitigate the risks identified under paragraph 
(a)(2)(i) of this section.
    (iii) The plan must describe inventory control procedures, personnel 
suitability for those individuals with access to agents or toxins listed 
in Sec.  121.3, physical security, and cybersecurity. The plan must also 
contain provisions for routine cleaning, maintenance, and repairs; 
provisions for securing the area (e.g., card access, key pads, locks) 
and protocols for changing access numbers or locks following staff 
changes; procedures for loss or compromise of keys, passwords, 
combinations, etc.; procedures for reporting suspicious persons or 
activities, loss or theft of listed agents or toxins, release of listed 
agents or toxins, or alteration of inventory records; provisions for the 
control of access to containers where listed agents and toxins are 
stored; and procedures for reporting and removing unauthorized persons.
    (iv) With respect to areas containing listed agents or toxins, an 
entity or individual must adhere to the following security requirements 
or implement measures to achieve an equivalent or greater level of 
security as the provisions below:
    (A) Allow unescorted access only to approved individuals who are 
performing a specifically authorized function during hours required to 
perform that job;
    (B) Allow individuals not approved under Sec.  121.11 to conduct 
routine cleaning, maintenance, repairs, and other non-laboratory 
functions only when escorted and continually monitored by approved 
individuals;
    (C) Provide for the control of access to containers where listed 
agents and toxins are stored by requiring that such containers be locked 
when not in the direct view of an approved individual and by using other 
monitoring measures, as needed;
    (D) Require the inspection of all packages upon entry and exit;
    (E) Establish a protocol for intra-entity transfers, including 
provisions for ensuring that the packaging and movement, is conducted 
under the supervision of an approved individual;
    (F) Require that approved individuals do not share with any other 
person their unique means of accessing the area or listed agents or 
toxins; and
    (G) Require that approved individuals immediately report any of the 
following to the responsible official:
    (1) Any loss or compromise of keys, passwords, combinations, etc.;
    (2) Any suspicious persons or activities;
    (3) Any loss or theft of listed agents or toxins;
    (4) Any release of a listed agent or toxin; and
    (5) Any sign that inventory and use records for listed agents and 
toxins have been altered or otherwise compromised.
    (3) Incident response procedures.\14\ The Biosafety and Security 
Plan must also include incident response plans for containment breach, 
security breach, inventory violations, non-biological incidents such as 
workplace violence, and cybersecurity breach. The incident response 
plans must address personnel safety and health, containment, inventory 
control, and notification of managers and responders. The incident 
response plans must also address such events as bomb threats, severe 
weather (floods, hurricanes, tornadoes), earthquakes, power outages, and 
other natural disasters or emergencies.
---------------------------------------------------------------------------

    \14\ The requirements in this paragraph do not supercede or preempt 
the enforcement of emergency response requirements imposed by other 
statutes or regulations.
---------------------------------------------------------------------------

    (b) The Biosafety and Security Plan must be reviewed, performance 
tested,

[[Page 751]]

and updated annually. The plan must also be reviewed and revised, as 
necessary, after any incident.



Sec.  121.13  Training.

    (a) The responsible official must provide appropriate training in 
biosafety, containment, and security procedures to all individuals with 
access to agents and toxins listed in Sec.  121.3.
    (b) The responsible official must provide information and training 
to an individual at the time the individual is assigned to work with a 
listed agent or toxin. The responsible official must provide refresher 
training annually.



Sec.  121.14  Transfer of biological agents and toxins.

    Biological agents and toxins listed in Sec.  121.3 may only be 
transferred to individuals or entities registered to possess, use, or 
transfer that particular agent or toxin. However, the sender of an agent 
or toxin may be an individual or entity that has a certificate of 
registration for the agent or toxin, an individual or entity that is 
exempt from the requirements of this part, or an individual or entity 
located outside of the United States. Biological agents or toxins may 
only be transferred under the conditions of this section and must be 
authorized by APHIS or, for overlap agents or toxins, by APHIS or CDC, 
prior to the transfer.
    (a) Importation and interstate movement. In addition to the permit 
required under part 122 of this subchapter, biological agents or toxins 
listed in Sec.  121.3 may be imported or moved interstate only with the 
prior authorization of APHIS or, for overlap agents or toxins, APHIS or 
CDC. To obtain such authorization, the sender and the responsible 
official for the recipient must complete and submit APHIS Form 2041 to 
APHIS or CDC, in accordance with paragraph (c) of this section.
    (b) Intrastate movement. Biological agents or toxins listed in Sec.  
121.3 may be moved intrastate only with the prior authorization of APHIS 
or, for overlap agents or toxins, APHIS or CDC. To obtain such 
authorization, the sender and the responsible official for the recipient 
must complete and submit APHIS Form 2041 to APHIS or CDC, in accordance 
with paragraph (c) of this section.
    (c) APHIS Form 2041; process and procedures. (1) Prior to each 
transfer, the responsible official for the recipient and sender must 
complete APHIS Form 2041, and the sender must submit the form to APHIS 
or, for overlap agents or toxins, to APHIS or CDC.\15\
---------------------------------------------------------------------------

    \15\ APHIS Form 2041 may be obtained by calling APHIS at (301) 734-
3277 or by calling CDC at (404) 498-2265. The form is also available on 
the Internet at http://www.aphis.usda.gov/vs/ncie.bta.html or http://
www.cdc.gov/od/ohs/lrsat.htm. APHIS Form 2041 may be mailed to National 
Center for Import and Export, VS, APHIS, 4700 River Road Unit 40, 
Riverdale, MD 20737-1231; or faxed to (301) 734-3652. For overlap agents 
and toxins, it may be mailed to the above address or to Select Agent 
Program, Centers for Disease Control and Prevention, 1600 Clifton Road, 
NE, Mail Stop E 79, Atlanta, GA 30333; or faxed to (404) 498-2265.
---------------------------------------------------------------------------

    (2) APHIS or CDC will authorize the transfer based on a finding that 
the recipient has a certificate of registration covering the transfer of 
the listed agent or toxin.
    (3) The responsible official for the recipient must notify the 
agency authorizing the transfer (either APHIS or CDC) and the sender 
upon receipt of the agent or toxin by mailing or faxing a completed 
APHIS Form 2041 to APHIS or CDC within 2 business days.
    (4) The responsible official for the recipient must notify APHIS or 
CDC immediately if the agent or toxin has not been received within 48 
hours after the expected delivery or if the package containing the agent 
or toxin is leaking or has been damaged.
    (d) The sender must comply with all applicable laws governing 
packaging and shipping.



Sec.  121.15  Records.

    (a) The responsible official must maintain complete, up-to-date 
records of information necessary to give an accounting of all of the 
activities related to agents or toxins listed in Sec.  121.3. Such 
records must include the following:
    (1) The Biosafety and Security Plan;
    (2) A current list of all individuals with access to agents or 
toxins listed in Sec.  121.3;
    (3) Training records for individuals with access to such agents or 
toxins;

[[Page 752]]

    (4) Accurate and current inventory records (including source and 
characterization data);
    (5) Permits and transfer documents (APHIS Form 2041) issued by APHIS 
and CDC;
    (6) Security records (e.g., transactions from automated access 
control systems, testing and maintenance of security systems, visitor 
logs);
    (7) Biosafety, containment, and security incident reports.
    (b) The responsible official must maintain such records for 3 years.
    (c) All records must be produced upon request to APHIS or CDC 
inspectors, and appropriate Federal, State, or local law enforcement 
authorities.



Sec.  121.16  Inspections.

    (a) To ensure compliance with the regulations, any APHIS or CDC 
inspector must be allowed, without previous notification, to enter and 
inspect the entire premises, all materials and equipment, and all 
records required to be maintained by this part.
    (b) Prior to issuing a certificate of registration to an entity or 
individual, APHIS or CDC may inspect and evaluate the premises and 
records to ensure compliance with the regulations and the biosafety, 
containment, and security requirements.



Sec.  121.17  Notification in the event of theft, loss, or release 
of a biological agent or toxin.

    (a) The responsible official must orally notify APHIS and 
appropriate Federal, State, or local law enforcement agencies 
immediately upon discovery of the theft or loss of agents or toxins 
listed in Sec.  121.3. The oral notification must be followed by a 
written report (APHIS Form 2043) within 7 days.
    (b) The responsible official must orally notify APHIS immediately 
upon discovery that a release of an agent or toxin has occurred outside 
of the biocontainment area. The oral notification shall be followed by a 
written report (APHIS Form 2043) within 7 days. Upon notification and a 
finding that the release poses a threat to animal or plant health, or 
animal or plant products, APHIS will notify relevant Federal, State, and 
local authorities, and the public, if necessary. If the release involves 
an overlap agent or toxin, APHIS will also notify the Secretary of 
Health and Human Services.
    (c) The responsible official must orally notify APHIS of a theft, 
loss, or release of an agent or toxin by calling (866) 994-5698. A copy 
of APHIS Form 2043 may be obtained by writing to National Center for 
Import and Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 
20737-1231; or by calling (301) 734-3277. The form is also available on 
the Internet at http://www.aphis.usda.gov/vs/ncie.bta.html. APHIS Form 
2043 may be mailed to the same address or faxed to (301) 734-3652.



Sec.  121.18  Administrative review.

    An individual or entity may appeal a denial or revocation of 
registration under this part. An individual who has been denied access 
to listed agents or toxins or who has been granted only limited access 
to listed agents or toxins under this part may appeal that decision.\16\ 
The appeal must be in writing and submitted to the Administrator within 
30 days of the decision. The appeal must state all of the facts and 
reasons upon which the individual or entity disagrees with the decision. 
Where the denial or revocation of registration or the denial or 
limitation of an individual's access approval is based solely upon an 
identification by the Attorney General, APHIS will forward the request 
for review to the Attorney General. The Administrator's decision 
constitutes final agency action.
---------------------------------------------------------------------------

    \16\ An entity may not appeal the denial or limitation of an 
individual's access to listed agents or toxins.
---------------------------------------------------------------------------



PART 122_ORGANISMS AND VECTORS--Table of Contents




Sec.
122.1 Definitions.
122.2 Permits required.
122.3 Application for permits.
122.4 Suspension or revocation of permits.

    Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 151-158; 7 CFR 2.22, 2.80, 
and 371.4.



Sec.  122.1  Definitions.

    The following words, when used in the regulations in this part 122, 
shall be construed, respectively, to mean:

[[Page 753]]

    (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.

[31 FR 81, Jan. 5, 1966, as amended at 57 FR 30899, July 13, 1992]



Sec.  122.2  Permits required.

    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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[28 FR 7896, Aug. 2, 1963. Redesignated at 31 FR 81, Jan. 5, 1966 and 
amended at 48 FR 57473, Dec. 30, 1983; 57 FR 30899, July 13, 1992; 59 FR 
67134, Dec. 29, 1994]



Sec.  122.3  Application for permits.

    The Secretary may issue, at his discretion, a permit as specified in 
Sec.  122.2 when proper safeguards are set up as provided in Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[23 FR 10065, Dec. 23, 1958. Redesignated at 31 FR 81, Jan. 5, 1966 and 
amended at 48 FR 57473, Dec. 30, 1983; 59 FR 67134, Dec. 29, 1994]



Sec.  122.4  Suspension or revocation of permits.

    (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

[[Page 754]]

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.

[23 FR 10065, Dec. 23, 1958. Redesignated at 31 FR 81, Jan. 5, 1966, and 
amended at 57 FR 30899, July 13, 1992]



PART 123_RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE VIRUS-SERUM-TOXIN 
ACT--Table of Contents




    Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, 
and 371.4.



Sec.  123.1  Scope and applicability of rules of practice.

    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.

[42 FR 10960, Feb. 25, 1977]



PART 124_PATENT TERM RESTORATION--Table of Contents




                      Subpart A_General Provisions

Sec.
124.1 Scope.
124.2 Definitions.

                    Subpart B_Eligibility Assistance

124.10 APHIS liaison with PTO.

                   Subpart C_Regulatory Review Period

124.20 Patent term extension calculation.
124.21 Regulatory review period determination.
124.22 Revision of regulatory review period determination.
124.23 Final action on regulatory review period determination.

                    Subpart D_Due Diligence Petitions

124.30 Filing, format, and content of petitions.
124.31 Applicant response to petition.
124.32 APHIS action on petition.
124.33 Standard of due diligence.

                     Subpart E_Due Diligence Hearing

124.40 Request for hearing.
124.41 Notice of hearing.
124.42 Hearing procedure.
124.43 Administrative decision.

    Authority: 35 U.S.C. 156; 7 CFR 2.22, 2.80, and 371.4.

    Source: 58 FR 11369, Feb. 25, 1993, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  124.1  Scope.

    (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.

[58 FR 11369, Feb. 25, 1993, as amended at 64 FR 43045, Aug. 9, 1999]



Sec.  124.2  Definitions.

    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 Sec.  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).

[[Page 755]]

    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.

[58 FR 11369, Feb. 25, 1993, as amended at 68 FR 6346, Feb. 7, 2003]



                    Subpart B_Eligibility Assistance



Sec.  124.10  APHIS liaison with PTO.

    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.



                   Subpart C_Regulatory Review Period



Sec.  124.20  Patent term extension calculation.

    (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.



Sec.  124.21  Regulatory review period determination.

    (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

[[Page 756]]

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 Federal Register. The notice will include the 
following:
    (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.



Sec.  124.22  Revision of regulatory review period determination.

    (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 Federal Register. The request must be sent to the 
Director, Center for Veterinary Biologics, Licensing and Policy 
Development, 510 South 17th Street, Suite 104, Ames, IA 50010--8197. The 
request must specify the following:
    (1) The identity of the product;
    (2) The identity of the applicant for patent term restoration;
    (3) The docket number of the Federal Register notice announcing the 
regulatory review period determination; and
    (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 Federal Register, and include a statement giving the 
reasons for the revision. If comment is received, APHIS will make a 
final determination regarding the revision based on such comment and 
will then publish the revision in the Federal Register, giving reasons 
for its determination.

[59 FR 11369, Feb. 25, 1993, as amended at 59 FR 67617, Dec. 30, 1994; 
64 FR 43045, Aug. 9, 1999]



Sec.  124.23  Final action on regulatory review period determination.

    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 Sec.  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 Sec.  124.22 for revision of the regulatory 
review period determination;
    (c) A due diligence petition filed under Sec.  124.30; or
    (d) A request for a hearing filed under Sec.  124.40.

[58 FR 11369, Feb. 25, 1993; 58 FR 29028, May 18, 1993]



                    Subpart D_Due Diligence Petitions



Sec.  124.30  Filing, format, and content of petitions.

    (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 Sec.  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 Federal Register notice of the agency's regulatory review period 
determination. The petition must contain any additional information 
required by this subpart.
    (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.

[[Page 757]]

    (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.



Sec.  124.31  Applicant response to petition.

    (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.



Sec.  124.32  APHIS action on petition.

    (a) Within 90 days after APHIS receives a petition filed under Sec.  
124.30, the Under Secretary for Marketing and Regulatory Programs shall 
make a determination under paragraphs (b) or (c) of this section or 
under Sec.  124.33 whether the applicant acted with due diligence during 
the regulatory review period. APHIS will publish its determination in 
the Federal Register together with factual and legal basis for the 
determination, notify PTO of the determination in writing, and send 
copies of the determination to PTO, the applicant, and the petitioner.
    (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 Sec.  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.

[59 FR 11369, Feb. 25, 1993, as amended at 64 FR 43045, Aug. 9, 1999]



Sec.  124.33  Standard of due diligence.

    (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.



                     Subpart E_Due Diligence Hearing



Sec.  124.40  Request for hearing.

    (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 Sec.  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 Federal Register notice of 
APHIS's regulatory review period determination;
    (3) Be delivered to the Director, Center for Veterinary Biologics, 
Licensing and Policy Development, 510 South 17th Street, Suite 104, 
Ames, IA 50010--8197.

[[Page 758]]

    (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.

[58 FR 11369, Feb. 25, 1993, as amended at 59 FR 67617, Dec. 30, 1994; 
64 FR 43045, Aug. 9, 1999]



Sec.  124.41  Notice of hearing.

    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.



Sec.  124.42  Hearing procedure.

    (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 Sec.  124.33 will apply at the hearing. The party 
requesting the due diligence hearing will have the burden of proof at 
the hearing.



Sec.  124.43  Administrative decision.

    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 Sec.  124.32. APHIS will publish the 
due diligence redetermination in the Federal Register, notify PTO of the 
redetermination, and send copies of the notice to PTO and the requesting 
party, the applicant, and the petitioner.

[59 FR 11369, Feb. 25, 1993, as amended at 64 FR 43045, Aug. 9, 1999]

[[Page 759]]



                         SUBCHAPTER F_USER FEES





PART 130_USER FEES--Table of Contents




Sec.
130.1 Definitions.
130.2 User fees for individual animals and certain birds quarantined in 
          APHIS-owned or -operated quarantine facilities, including 
          APHIS Animal Import Centers; and fee for use of animal ramp.
130.3 User fees for exclusive use of space at APHIS Animal Import 
          Centers.
130.4 User fees for processing import permit applications.
130.5 User fees for services at privately owned permanent and temporary 
          import quarantine facilities.
130.6 User fees for inspection of live animals at land border ports 
          along the United States-Mexico border.
130.7 User fees for import or entry services for live animals at land 
          border ports along the United States-Canada border.
130.8 User fees for other services.
130.9 [Reserved]
130.10 User fees for pet birds.
130.11 User fees for inspecting and approving import/export facilities 
          and establishments.
130.12-130.13 [Reserved]
130.14 User fees for FADDL veterinary diagnostics.
130.15 User fees for veterinary diagnostic isolation and identification 
          tests performed at NVSL (excluding FADDL) or other authorized 
          site.
130.16 User fees for veterinary diagnostic serology tests performed at 
          NVSL (excluding FADDL) or at authorized sites.
130.17 User fees for other veterinary diagnostic laboratory tests 
          performed at NVSL (excluding FADDL) or at authorized sites.
130.18 User fees for veterinary diagnostic reagents produced at NVSL or 
          other authorized site (excluding FADDL).
130.19 User fees for other veterinary diagnostic services or materials 
          provided at NVSL (excluding FADDL).
130.20 User fees for endorsing export certificates.
130.21 [Reserved]
130.22 User fees for inspection services outside the United States.
130.23-130.48 [Reserved]
130.30 Hourly rate and minimum user fees.
130.49 Exemptions.
130.50 Payment of user fees.
130.51 Penalties for nonpayment or late payment.

    Authority: 5 U.S.C. 5542; 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 
and 136a; 31 U.S.C. 3701, 3716, 3717, 3719, and 3720A; 7 CFR 2.22, 2.80, 
and 371.4.

    Source: 57 FR 771, Jan. 9, 1992, unless otherwise noted.



Sec.  130.1  Definitions.

    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.\1\
---------------------------------------------------------------------------

    \1\ The addresses of Animal Import Centers may be obtained from the 
Animal and Plant Health Inspection Service, Veterinary Services, 
National Center for Import-Export, 4700 River Road, Unit 38, Riverdale, 
Maryland 20737-1231.
---------------------------------------------------------------------------

    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.
    Approved establishment. An establishment approved by the Animal and 
Plant Health Inspection Service for the receipt and handling of 
restricted import animal products or byproducts under 9 CFR chapter I, 
subchapter D.
    Biosecurity level three laboratory. A laboratory or production 
facility that works with foreign or domestic animal disease agents, 
organisms, or vectors that spread by aerosol route and that have serious 
or lethal effects, therefore requiring special biocontainment measures.
    Bird. Any member of the class aves, other than poultry.
    Breeding animal. Any animal imported into the United States for 
breeding purposes.
    Diagnostic reagent. Substances used in diagnostic tests to detect 
disease

[[Page 760]]

agents or antibodies by causing an identifiable reaction.
    Domestic animal. Any animal imported into the United States for any 
purpose other than exhibition in a zoo, park or other place maintained 
for the exhibition of live animals for recreational or educational 
purposes.
    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 9 
CFR part 93 for feeding.
    Game cock. Any chicken bred, trained, or imported for cock fighting.
    Germ plasm. Semen, embryos, or ova.
    Grade animal. Any unregistered animal.
    In-bond animal. Any animal imported into the United States under a 
United States Customs Service bond, as described in 19 CFR part 113.
    Load. Those animals, birds, or animal germ plasm, presented for 
importation into the United States in a single shipment, that originate 
from one address, are destined for one address, and require one entry 
permit or authorization.
    Miniature horse. Any horse which at maturity measures 34 inches high 
or less from the ground to the base of the last hair of the mane at the 
withers.
    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.
    Nonstandard care and handling. Nonstandard care and handling 
includes hand-feeding, more than one feeding per day, frequent 
observation, and any handling or observation that requires personnel to 
attend to the birds or poultry outside of normal business hours.\2\
---------------------------------------------------------------------------

    \2\ Normal business hours at the APHIS Animal Import Centers are: 7 
a.m. to 3:30 p.m., Miami, FL; and 8 a.m. to 4:30 p.m., Newburgh, NY.
---------------------------------------------------------------------------

    Nonstandard housing. Nonstandard housing is individual housing not 
normally available at an APHIS animal import center, any housing 
constructed or purchased at the request of the importer, any housing 
with blinds, dense foliage, or plants, and any housing where the 
temperature can be adjusted.
    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 9 CFR part 93 to quarantine animals or 
birds, except facilities operated by APHIS.
    Registered animal. Any animal recorded in the book of record of an 
animal registry association which issues certificates concerning the 
pedigree of animals.
    Slaughter animal. Any animal moving directly to slaughter.
    Standard feed. Seed, or dry feeds such as dog food or monkey 
biscuits, whether soaked in water or not.
    State animal health official. The State official responsible for 
livestock and poultry disease control and eradication programs.
    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.

[[Page 761]]

    Zoo animal. Any animal, including poultry, intended for exhibition 
in a zoo, park or other place maintained for the exhibition of live 
animals for recreational or educational purposes.\3\
---------------------------------------------------------------------------

    \3\ Regulations concerning approval of zoos and requirements for 
importing wild animals are found in part 93 of this chapter.
---------------------------------------------------------------------------

    Zoo bird. Any bird intended for exhibition in a zoo, park or other 
place maintained for the exhibition of live animals or birds for 
recreational or educational purposes.
    Zoo equine. Any equine intended for exhibition in a zoo, park or 
other place maintained for the exhibition of live animals for 
recreational or educational purposes.

[57 FR 771, Jan. 9, 1992, as amended at 58 FR 38957, July 21, 1993; 58 
FR 67654, Dec. 22, 1993; 59 FR 67617, Dec. 30, 1994; 61 FR 20432, May 7, 
1996; 62 FR 56026, Oct. 28, 1997; 63 FR 53788, Oct. 7, 1998; 63 FR 
64175, Nov. 19, 1998; 64 FR 67698, Dec. 3, 1999; 65 FR 38178, 38180, 
June 20, 2000; 68 FR 64507, Nov. 14, 2003]



Sec.  130.2  User fees for individual animals and certain birds 

quarantined in APHIS-owned or -operated quarantine facilities, 
including APHIS Animal Import Centers; and fee for use of animal 
ramp.

    (a) Standard requirements. User fees for each animal or bird 
receiving standard housing, care, feed, and handling while quarantined 
in an APHIS owned or operated animal import center or quarantine 
facility are listed in the following table. Each user fee listed in the 
table is assessed per animal or bird quarantined by APHIS. 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 Sec. Sec.  130.50 and 130.51.

------------------------------------------------------------------------
                                                        Daily user fee
                   Animal or bird                      Beginning Oct. 1,
                                                             2003
------------------------------------------------------------------------
Birds (excluding ratites and pet birds imported in
 accordance with Part 93 of this subchapter):
    0-250 grams.....................................               $1.75
    251-1,000 grams.................................                5.75
    Over 1,000 grams................................               13.00
Domestic or zoo animals (except equines, birds, and
 poultry):
    Bison, bulls, camels, cattle, or zoo animals....              102.00
    All others, including, but not limited to,                     27.00
     alpacas, llamas, goats, sheep, and swine.......
Equines (including zoo equines, but excluding
 miniature horses):
    1st through 3rd day (fee per day)...............              270.00
    4th through 7th day (fee per day)...............              195.00
    8th and subsequent days (fee per day)...........              166.00
Miniature horses....................................               61.00
Poultry (including zoo poultry):
    Doves, pigeons, quail...........................                3.50
    Chickens, ducks, grouse, guinea fowl, partridge,                6.25
     pea fowl, pheasants............................
    Large poultry and large waterfowl, including,                  15.00
     but not limited to game cocks, geese, swans,
     and turkeys....................................
Ratites:
    Chicks (less than 3 months old).................                9.25
    Juveniles (3 months through 10 months old)......               14.00
    Adults (11 months old and older)................               27.00
------------------------------------------------------------------------

    (b) Special requirements. User fees for birds or poultry, including 
zoo birds or poultry, receiving nonstandard housing, care, or handling 
to meet special requirements while quarantined in an APHIS owned or 
operated Animal Import Center or quarantine facility are listed in the 
following table. The user fees listed in the table are assessed for each 
bird or poultry 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. 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 Sec. Sec.  130.50 and 130.51.

[[Page 762]]



------------------------------------------------------------------------
                                                        Daily user fee
   Bird or poultry (nonstandard housing, care, or      Beginning Oct. 1,
                      handling)                              2003
------------------------------------------------------------------------
Birds 0-250 grams and doves, pigeons, and quail.....               $5.75
Birds 251-1,000 grams and poultry such as chickens,                13.00
 ducks, grouse, guinea fowl, partridge, pea fowl,
 and pheasants......................................
Birds over 1,000 grams and large poultry and large                 25.00
 waterfowl, including, but not limited to game
 cocks, geese, swans, and turkeys...................
------------------------------------------------------------------------

    (c) Feed. 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) Animal ramp. The user fee for the transport ramp used to move 
animals on or off aircraft at APHIS's Animal Import/Export and Plant 
Inspection Station at Miami International Airport is $151 per use. For 
labor services associated with the ramp, the hourly user fees in Sec.  
130.30 will apply.

(Approved by the Office of Management and Budget under control number 
0579-0094)

[63 FR 53788, Oct. 7, 1998, as amended at 65 FR 52005, Aug. 28, 2000; 68 
FR 51883, Aug. 29, 2003; 68 FR 62227, Nov. 3, 2003]



Sec.  130.3  User fees for exclusive use of space at APHIS Animal Import 
Centers.

    (a)(1) An importer may request to exclusively occupy a space at an 
APHIS animal import center. The user fees for spaces at APHIS animal 
import centers are listed in the following table. 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 Sec. Sec.  130.50 and 130.51.

------------------------------------------------------------------------
                                                       Monthly user fee
                Animal import center                   Beginning Oct. 1,
                                                             2003
------------------------------------------------------------------------
Newburgh, NY:
    Space A--5,396 sq. ft. (503.1 sq. m.)...........             $59,254
    Space B--8,903 sq. ft. (827.1 sq. m.)...........              97,764
    Space C--905 sq. ft. (84.1 sq. m.)..............               9,938
------------------------------------------------------------------------

    (2) 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. The 
person for whom the service is provided and the person requesting the 
service are jointly and severally liable for any additional charges.
    (3) Unless the importer cancels the reservation for exclusive use of 
space in time to receive a refund of the reservation fee in accordance 
with 9 CFR 93.103, 93.204, 93.304, 93.404, or 93.504, as appropriate, 
the 30-day user fee will be effective as of the first day for which the 
importer has reserved the space, regardless of whether the user occupies 
the space on that date or not.
    (b) Users must provide APHIS personnel at the Animal Import Center, 
at the time they make a reservation for quarantine space, with the 
following information:
    (1) Species of animals and birds to be quarantined;
    (2) Ages of animals and birds to be quarantined; and
    (3) Sizes of animals and birds to be quarantined.
    (c)(1) APHIS personnel at the Animal Importer Center will determine, 
based on the information provided by the importer under paragraph (b) of 
this section, and on routine husbandry needs, the maximum number of 
animals and birds permitted in the requested building.

[[Page 763]]

    (2) If the number of animals and birds requested by the importer can 
be housed in the space requested, as determined by APHIS personnel at 
the Animal Import Center, 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 pay for additional 
services on an hourly basis, or 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.
    (3) If the importer requests additional services, then the user fees 
for those services will be calculated at the hourly rate user fee listed 
in Sec.  130.30, for each employee required to perform the service.
    (d) The importer must provide feed, or pay for it on an actual cost 
basis, including cost of delivery to the Animal Import Center.

(Approved by the Office of Management and Budget under control numbers 
0579-0040 and 0579-0094)

[57 FR 771, Jan. 9, 1992, as amended at 58 FR 67654, Dec. 22, 1993; 61 
FR 20432, May 7, 1996; 62 FR 56026, Oct. 28, 1997; 63 FR 53789, Oct. 7, 
1998; 65 FR 52006, Aug. 28, 2000; 68 FR 51883, Aug. 29, 2003]



Sec.  130.4  User fees for processing import permit applications.

    User fees for processing applications for permits to import certain 
animals and animal products (using VS forms 16-3 and 17-129) are listed 
in the table in this section. 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 Sec. Sec.  
130.50 and 130.51. The table follows:

----------------------------------------------------------------------------------------------------------------
                                                                                                   User fee
                     Service                                         Unit                      Beginning Oct. 1,
                                                                                                     2003
----------------------------------------------------------------------------------------------------------------
1. Import compliance assistance:
    i. Simple (2 hours or less).................  Per release...............................              $70.00
    ii. Complicated (more than 2 hours).........  Per release...............................              180.00
2. Processing an application for a permit to
 import live animals, animal products or
 byproducts, organisms, vectors, or germ plasm
 (embryos or semen) or to transport organisms or
 vectors \1\
    i. Initial permit...........................  Per application...........................               94.00
    ii. Amended permit..........................  Per amended application...................               47.00
    iii. Renewed permit \2\.....................  Per application...........................               61.00
    3. Processing an application for a permit to  Per application...........................             322.00
     import fetal bovine serum when facility
     inspection is required.
----------------------------------------------------------------------------------------------------------------
\1\ Using Veterinary Services Form 16-3, ``Application for Permit to Import or Transport Controlled Material or
  Organisms or Vectors,'' or Form 17-129, ``Application for Import or In Transit Permit (Animals, Animal Semen,
  Animal Embryos, Birds, Poultry, or Hatching Eggs).''
\2\ Permits to import germ plasm and live animals are not renewable.


[66 FR 39631, Aug. 1, 2001, as amended at 68 FR 51883, Aug. 29, 2003]



Sec.  130.5  User fees for services at privately owned permanent and 
temporary import quarantine facilities.

    (a) User fees for each animal quarantined in a privately operated 
permanent or temporary import quarantine facility will be calculated at 
the hourly user fee rate listed in Sec.  130.30, 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 Sec. Sec.  
130.50 and 130.51.
    (b) [Reserved]

(Approved by the Office of Management and Budget under control number 
0579-0094)

[65 FR 52006, Aug. 28, 2000]



Sec.  130.6  User fees for inspection of live animals at land border ports 
along the United States-Mexico border.

    (a) User fees for live animals presented for importation into or 
entry into the United States through a land border port along the United 
States-Mexico border are listed in the following table. The minimum user 
fee for this service is listed in Sec.  130.30. The person for whom the 
service is provided

[[Page 764]]

and the person requesting the service are jointly and severally liable 
for payment of these user fees in accordance with Sec. Sec.  130.50 and 
130.51.

------------------------------------------------------------------------
                                                       Per head user fee
                 Type of live animal                   Beginning Oct. 1,
                                                             2003
------------------------------------------------------------------------
Any ruminants (including breeder ruminants) not                    $9.00
 covered below......................................
Feeder..............................................                2.50
Horses, other than slaughter........................               44.00
In-bond or in-transit...............................                5.75
Slaughter...........................................                3.75
------------------------------------------------------------------------

    (b) [Reserved]

(Approved by the Office of Management and Budget under control numbers 
0579-0055 and 0579-0094)

[65 FR 52006, Aug. 28, 2000, as amended at 68 FR 51884, Aug. 29, 2003]



Sec.  130.7  User fees for import or entry services for live animals at 
land border ports along the United States-Canada border.

    (a) User fees for live animals presented for importation into or 
entry into the United States through a land border port along the United 
States-Canada border are listed in the following table. The minimum user 
fee for this service is listed in Sec.  130.30. 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 
Sec. Sec.  130.50 and 130.51.

----------------------------------------------------------------------------------------------------------------
                                                                                                   User fee
               Type of live animal                                   Unit                      Beginning Oct. 1,
                                                                                                     2003
----------------------------------------------------------------------------------------------------------------
Animals being imported into the United States:
Breeding animals (Grade animals, except horses):
    Sheep and goats.............................  Per head..................................               $0.50
    Swine.......................................  Per head..................................                0.75
    All others..................................  Per head..................................                3.25
Feeder animals:
    Cattle (not including calves)...............  Per head..................................                1.50
    Sheep and calves............................  Per head..................................                0.50
    Swine.......................................  Per head..................................                0.25
Horses (including registered horses), other than  Per head..................................               29.00
 slaughter and in-transit.
Poultry (including eggs), imported for any        Per load..................................               50.00
 purpose.
Registered animals (except horses)..............  Per head..................................                6.00
Slaughter animals (except poultry)..............  Per load..................................               25.00
Animals transiting \1\ the United States:
    Cattle......................................  Per head..................................                1.50
    Sheep and goats.............................  Per head..................................                0.25
    Swine.......................................  Per head..................................                0.25
    Horses and all other animals................  Per head..................................               6.75
----------------------------------------------------------------------------------------------------------------
\1\ The user fee in this section will be charged for in-transit authorizations at the port where the
  authorization services are performed. For additional services provided by APHIS, at any port, the hourly user
  fee rate in Sec.   130.30 will apply.

    (b) [Reserved]

(Approved by the Office of Management and Budget under control numbers 
0579-0055 and 0579-0094)

[65 FR 52007, Aug. 28, 2000, as amended at 67 FR 48524, July 25, 2002; 
68 FR 51884, Aug. 29, 2003]



Sec.  130.8  User fees for other services.

    (a) User fees for other services that are not specifically addressed 
elsewhere in part 130 are listed in the following table. 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 Sec. Sec.  130.50 and 130.51.

----------------------------------------------------------------------------------------------------------------
                                                                                                   User fee
                     Service                                         Unit                      Beginning Oct. 1,
                                                                                                     2003
----------------------------------------------------------------------------------------------------------------
Germ plasm being exported: \1\
Embryo:
    Up to 5 donor pairs.........................  Per certificate...........................              $83.00
    Each additional group of donor pairs, up to   Per group of donor pairs..................               37.00
     5 pairs per group, on the same certificate.

[[Page 765]]

 
    Semen.......................................  Per certificate...........................               51.00
Release from export agricultural hold:
    Simple (2 hours or less)....................  Per release...............................               70.00
    Complicated (more than 2 hours).............  Per release...............................             180.00
----------------------------------------------------------------------------------------------------------------
\1\ This user fee includes a single inspection and resealing of the container at the APHIS employee's regular
  tour of duty station or at a limited port. For each subsequent inspection and resealing required, the hourly
  user fee in Sec.   130.30 will apply.

    (b) [Reserved]

(Approved by the Office of Management and Budget under control numbers 
0579-0015, 0579-0040, 0579-0055 and 0579-0094)

[65 FR 52007, Aug. 28, 2000, as amended at 66 FR 39632, Aug. 1, 2001; 68 
FR 51884, Aug. 29, 2003]



Sec.  130.9  [Reserved]



Sec.  130.10  User fees for pet birds.

    (a) User fees for pet birds of U.S. origin returning to the United 
States, except pet birds of U.S. origin returning from Canada, are as 
follows:

----------------------------------------------------------------------------------------------------------------
                                                                                                   User fee
                     Service                                         Unit                      Beginning Oct. 1,
                                                                                                     2003
----------------------------------------------------------------------------------------------------------------
(1) Which have been out of the United States 60   Per lot...................................             $108.00
 days or less.
(2) Which have been out of the United States      Per lot...................................              257.00
 more than 60 days.
----------------------------------------------------------------------------------------------------------------

    (b) User fees for each pet bird quarantined in an animal import 
center or other APHIS-owned or supervised quarantine facility are listed 
in the following table. These user fees include standard care, feed, and 
handling. 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 Sec. Sec.  130.50 and 130.51.

------------------------------------------------------------------------
                                               Daily user fee    Beginning
        Number of birds in isolette           Beginning Oct. 1,   Oct. 1,
                                                    2003            2003
--------------------------------------------------------------- -----------
1..........................................               $9.25
2..........................................               11.00
3..........................................               13.00
4..........................................               15.00
5 or more..................................               18.00
------------------------------------------------------------------------

    (c) 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.
    (d) If the importer requests additional services, then the user fees 
for those services will be calculated at the hourly rate user fee listed 
in Sec.  130.30, for each employee required to perform the service.

(Approved by the Office of Management and Budget under control number 
0579-0094)

[61 FR 20434, May 7, 1996; 61 FR 25513, May 21, 1996, as amended at 62 
FR 56026, Oct. 28, 1997; 63 FR 53791, Oct. 7, 1998; 64 FR 67700, Dec. 3, 
1999; 65 FR 52008, Aug. 28, 2000; 68 FR 51885, Aug. 29, 2003]



Sec.  130.11  User fees for inspecting and approving import/export 
facilities and establishments.

    (a) User fees for the inspection of various import and export 
facilities and establishments are listed in the following table. 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 Sec. Sec.  130.50 and 130.51.

----------------------------------------------------------------------------------------------------------------
                                                                                                   User fee
                     Service                                         Unit                     beginning  Oct. 1,
                                                                                                     2003
----------------------------------------------------------------------------------------------------------------
Embryo collection center inspection and approval  per year..................................             $380.00
 (all inspections required during the year for
 facility approval).
Inspection for approval of biosecurity level      per inspection............................              977.00
 three laboratories (all inspections related to
 approving the laboratory for handling one
 defined set of organisms or vectors).

[[Page 766]]

 
Inspection for approval of slaughter
 establishment:
    Initial approval (all inspections)..........  per year..................................              373.00
    Renewal (all inspections)...................  per year..................................              323.00
Inspection of approved establishments,
 warehouses, and facilities under 9 CFR parts 94
 through 96:
    Approval (compliance agreement) (all          per year..................................              398.00
     inspections for first year of 3-year
     approval).
    Renewed approval (all inspections for second  per year..................................              230.00
     and third years of 3-year approval).
----------------------------------------------------------------------------------------------------------------

    (b) [Reserved]

[65 FR 52008, Aug. 28, 2000, as amended at 68 FR 51885, Aug. 29, 2003; 
68 FR 64507, Nov. 14, 2003]



Sec. Sec.  130.12-130.13  [Reserved]



Sec.  130.14  User fees for FADDL veterinary diagnostics.

    (a) Diagnostic reagents. User fees for diagnostic reagents \4\ 
provided by FADDL are listed in the following table. 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 Sec. Sec.  130.50 and 130.51.
---------------------------------------------------------------------------

    \4\ Reagents provided by FADDL are for the diagnosis of animal 
diseases foreign to the United States. These reagents may be available 
to customers on the mainland after safety testing with permission from 
the Administrator. The customer may have to pay the cost for the safety 
test in addition to the reagent user fee. For more information on the 
specific reagents contact: Laboratory Chief, USDA, APHIS, VS, FADDL, 
Greenport, NY 11344; phone (516) 323-2500, FAX (516) 323-2798.

----------------------------------------------------------------------------------------------------------------
                        Reagent                            User fee                       Unit
----------------------------------------------------------------------------------------------------------------
Bovine antiserum, any agent...........................          $80.00  1 ml.
Caprine antiserum, any agent..........................           97.50  1 ml.
Cell culture antigen/microorganism....................           63.75  1 ml.
Equine antiserum, any agent...........................          100.50  1 ml.
Fluorescent antibody conjugate........................          120.25  1 ml.
Guinea pig antiserum, any agent.......................          104.50  1 ml.
Monoclonal antibody...................................          122.75  1 ml.
Ovine antiserum, any agent............................           94.25  1 ml.
Porcine antiserum, any agent..........................           81.25  1 ml.
Rabbit antiserum, any agent...........................           98.50  1 ml.
----------------------------------------------------------------------------------------------------------------

    (b) Veterinary diagnostics tests. User fees for veterinary 
diagnostic tests performed at FADDL are listed in the following table. 
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 Sec. Sec.  130.50 and 130.51.

----------------------------------------------------------------------------------------------------------------
                         Test                              User fee                       Unit
----------------------------------------------------------------------------------------------------------------
Agar gel immunodiffusion..............................          $14.75  Test.
Card..................................................            8.25  Test.
Complement fixation...................................           33.00  Test.
Direct immunofluorescent antibody.....................  11.  Test.
                                                                    00
Enzyme linked immunosorbent assay.....................  12.  Test.
                                                                    75
Fluorescent antibody neutralization (classical swine    96.  Test.
 fever).                                                            00
Hemagglutination inhibition...........................  27.  Test.
                                                                    75
Immunoperoxidase......................................  18.  Test.
                                                                    25
Indirect fluorescent antibody.........................  23.  Test.
                                                                    25
In-vitro safety.......................................  299  Test.
                                                                   .50
In-vivo safety........................................  434  Test.
                                                                  5.75
Latex agglutination...................................  11.  Test.
                                                                    00

[[Page 767]]

 
Tube agglutination....................................  14.  Test.
                                                                    00
Virus isolation (oesophageal/pharyngeal)..............  88.  Test.
                                                                    25
Virus isolation in embryonated eggs...................  176  Test.
                                                                   .00
Virus isolation, other................................  84.  Test.
                                                                    50
Virus neutralization..................................  25.  Test.
                                                                    75
----------------------------------------------------------------------------------------------------------------

    (c) Other veterinary diagnostic services. User fees for other 
veterinary diagnostic services performed at FADDL are listed in the 
following table. 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 Sec. Sec.  130.50 and 
130.51.

----------------------------------------------------------------------------------------------------------------
             Veterinary diagnostic service                 User fee                       Unit
----------------------------------------------------------------------------------------------------------------
Bacterial isolation...................................          $55.00  Test.
Hourly user fee services \1\..........................          220.00  Hour.
Hourly user fee services--Quarter hour................  55.  Quarter hour.
                                                                    00
Infected cells on chamber slides or plates............  31.  Slide.
                                                                    00
Reference animal tissues for immunohistochemistry.....  94.  Set.
                                                                    25
Sterilization by gamma radiation......................  530  Can.
                                                                   .00
Training (school or technical assistance).............  450  Per person per day.
                                                                   .00
Virus titration.......................................  55.  Test.
                                                                    00
----------------------------------------------------------------------------------------------------------------
\1\ For all veterinary diagnostic services for which there is no flat rate user fee, the hourly rate user fee
  will be calculated for the actual time required to provide the service.


(Approved by the Office of Management and Budget under control numbers 
0579-0055 and 0579-0094)

[63 FR 53791, Oct. 7, 1998, as amended at 64 FR 67700, Dec. 3, 1999; 68 
FR 16940, Apr. 7, 2003]



Sec.  130.15  User fees for veterinary diagnostic isolation and 

identification tests performed at NVSL (excluding FADDL) or other 
authorized site.

    (a) Bacteriology isolation and identification tests. User fees for 
bacteriology isolation and identification tests performed at NVSL 
(excluding FADDL) or other authorized sites are listed in the following 
table. 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 Sec. Sec.  130.50 and 130.51.

----------------------------------------------------------------------------------------------------------------
                         Test                              User fee                       Unit
----------------------------------------------------------------------------------------------------------------
Bacterial identification, automated...................          $16.00  Isolate.
Bacterial identification, non-automated...............  61.  Isolate.
                                                                    25
Bacterial isolation...................................  16.  Sample.
                                                                    00
Bacterial serotyping, all other.......................  30.  Isolate.
                                                                    75
Bacterial serotyping, Pasteurella multocida...........  7.5  Isolate.
                                                                     0
Bacterial serotyping, Salmonella......................  21.  Isolate.
                                                                    25
Bacterial toxin typing................................  91.  Isolate.
                                                                    50
Bacteriology requiring special characterization.......  27.  Test.
                                                                    00
DNA fingerprinting....................................           36.50  Test
DNA probe.............................................  29.  Test.
                                                                    50
Fluorescent antibody \1\..............................  9.7  Test.
                                                                     5
Leptospira culturing..................................  27.  Sample.
                                                                    00
Leptospira serotyping.................................  80.  Isolate.
                                                                    50
Mycobacterium avian serotyping........................  157  Isolate.
                                                                   .50
Mycobacterium identification (biochemical)............  63.  Isolate.
                                                                    25
Mycobacterium identification (gas chromatography).....  26.  Procedure.
                                                                    50
Mycobacterium isolation, animal inoculations..........  520  Submission.
                                                                   .50
Mycobacterium isolation, all other....................  105  Submission.
                                                                   .50
Mycobacterium paratuberculosis isolation..............  26.  Submission.
                                                                    50
Mycology culture identification.......................  52.  Isolate.
                                                                    75
Mycology/fungus culture or isolation..................  26.  Isolate.
                                                                    50
Mycoplasma isolation..................................  26.  Sample.
                                                                    25
Mycoplasma identification.............................  26.  Isolate.
                                                                    25
Phage typing, all other...............................  26.  Isolate.
                                                                    50
Phage typing, Salmonella enteritidis..................  10.  Isolate.
                                                                    75

[[Page 768]]

 
Plasmid typing........................................  26.  Isolate.
                                                                    50
Warburg...............................................  316  Isolate.
                                                                   .50
----------------------------------------------------------------------------------------------------------------
\1\ A discount will apply to all diagnostic, non-import related complement fixation, hemagglutination
  inhibition, fluorescent antibody, indirect fluorescent antibody, virus neutralization, and peroxidase linked
  antibody tests. This discount only applies to the 11th and subsequent tests on the same submission by the same
  submitter for the same test and antigen. The user fee for each discounted test will be 20 percent of the
  original user fee rounded up to the nearest quarter. This discount will apply for tests for all diseases
  except equine piroplasmosis, bovine piroplasmosis, dourine, and glanders.

    (b) Virology identification tests. User fees for virology 
identification tests performed at NVSL (excluding FADDL) or other 
authorized sites are listed in the following table. 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 Sec. Sec.  130.50 and 130.51.

----------------------------------------------------------------------------------------------------------------
                         Test                              User fee                       Unit
----------------------------------------------------------------------------------------------------------------
Fluorescent antibody tissue section...................          $18.25  Test.
Virus isolation for Newcastle disease virus...........           15.25  Test.
Virus isolation (except for Newcastle disease virus)..           31.50  Test.
----------------------------------------------------------------------------------------------------------------


(Approved by the Office of Management and Budget under control numbers 
0579-0055 and 0579-0094)

[63 FR 53792, Oct. 7, 1998]



Sec.  130.16  User fees for veterinary diagnostic serology tests performed 
at NVSL (excluding FADDL) or at authorized sites.

    (a) Bacteriology serology tests. User fees for bacteriology serology 
tests performed at NVSL (excluding FADDL) or other authorized sites are 
listed in the following table. 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 Sec. Sec.  
130.50 and 130.51.

----------------------------------------------------------------------------------------------------------------
                         Test                              User fee                       Unit
----------------------------------------------------------------------------------------------------------------
Brucella milk ELISA...................................          $15.75  Test.
Brucella ring (BRT)...................................           10.50  Test.
Brucella ring, Heat inactivated (HIRT)................           10.50  Test.
Brucella ring, Serial (Serial BRT)....................           15.75  Test.
Buffered acidified plate antigen presumptive..........            4.00  Test.
Card..................................................            2.00  Test.
Complement fixation \1\...............................            9.00  Test.
Enzyme linked immunosorbent assay for dourine,                    9.00  Test.
 glanders, or piroplasmosis.
Enzyme linked immunosorbent assay, all other..........            4.75  Test.
Indirect fluorescent antibody\1\......................            9.75  Test.
Mercaptoethanol.......................................            4.00  Test.
Microscopic agglutination--includes up to 5 serovars             11.00  Sample.
 \2\.
Mycology/fungus serology..............................           10.50  Test.
Particle concentration fluorescent immuno assay                  18.25  Test.
 (PCFIA).
Plate.................................................            4.00  Test.
Rapid automated presumptive...........................            4.25  Test.
Rivanol...............................................            4.00  Test.
Tube agglutination....................................            4.00  Test.
----------------------------------------------------------------------------------------------------------------
\1\ A discount will apply to all diagnostic, non-import related complement fixation, hemagglutination
  inhibition, fluorescent antibody, indirect fluorescent antibody, virus neutralization, and peroxidase linked
  antibody tests. This discount only applies to the 11th and subsequent tests on the same submission by the same
  submitter for the same test and antigen. The user fee for each discounted test will be 20 percent of the
  original user fee rounded up to the nearest quarter. This discount will apply for tests for all diseases
  except equine piroplasmosis, bovine piroplasmosis, dourine, and glanders.
\2\ The user fee for the sixth and subsequent serovar will be $2.00 each.

    (b) Virology serology tests. User fees for virology serology tests 
performed at NVSL (excluding FADDL) or at authorized sites are listed in 
the following table. The person for whom the service is provided and the 
person requesting the service are jointly and severally liable for 
payment of these

[[Page 769]]

user fees in accordance with Sec. Sec.  130.50 and 130.51.

----------------------------------------------------------------------------------------------------------------
                         Test                              User fee                       Unit
----------------------------------------------------------------------------------------------------------------
Agar gel immunodiffusion..............................           $5.00  Test.
Complement fixation \1\...............................            9.00  Test.
Enzyme linked immunosorbent assay.....................            4.75  Test.
Hemagglutination inhibition \1\.......................            7.50  Test.
Indirect fluorescent antibody \1\.....................            9.75  Test.
Latex agglutination...................................            5.00  Test.
Peroxidase linked antibody \1\........................            9.75  Test.
Plaque reduction neutralization.......................            7.75  Test.
Rabies fluorescent antibody neutralization............           26.50  Test.
Virus neutralization \1\..............................            7.75  Test.
----------------------------------------------------------------------------------------------------------------
\1\ A discount will apply to all diagnostic, non-import related complement fixation, hemagglutination
  inhibition, fluorescent antibody, indirect fluorescent antibody, virus neutralization, and peroxidase linked
  antibody tests. This discount only applies to the 11th and subsequent tests on the same submission by the same
  submitter for the same test and antigen. The user fee for each discounted test will be 20 percent of the
  original user fee rounded up to the nearest quarter. This discount will apply for tests for all diseases
  except equine piroplasmosis, bovine piroplasmosis, dourine, and glanders.


(Approved by the Office of Management and Budget under control numbers 
0579-0055 and 0579-0094)

[63 FR 53793, Oct. 7, 1998]



Sec.  130.17  User fees for other veterinary diagnostic laboratory tests 
performed at NVSL (excluding FADDL) or at authorized sites.

    (a) User fees for veterinary diagnostics tests performed at the 
Pathobiology Laboratory at NVSL (excluding FADDL) or at authorized sites 
are listed in the following table. 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 Sec. Sec.  
130.50 and 130.51.

----------------------------------------------------------------------------------------------------------------
                         Test                              User fee                       Unit
----------------------------------------------------------------------------------------------------------------
Aflatoxin quantitation................................          $20.50  Test.
Aflatoxin screen......................................           11.25  Test.
Agar gel immunodiffusion spp. identification..........            6.25  Test.
Antibiotic (bioautography) quantitation...............           25.00  Test.
Antibiotic (bioautography) screen.....................           50.00  Test.
Antibiotic inhibition.................................           25.25  Test.
Arsenic...............................................            6.75  Test.
Ergot alkaloid screen.................................           25.25  Test.
Ergot alkaloid confirmation...........................           33.00  Test.
Feed microscopy.......................................           25.25  Test.
Fumonisin only........................................           20.50  Test.
Gossypol..............................................           37.75  Test.
Mercury...............................................           56.00  Test.
Metals screen.........................................           29.75  Test.
Metals single element confirmation....................            6.75  Test.
Mycotoxin: aflatoxin-liver............................           82.25  Test.
Mycotoxin screen......................................           34.00  Test.
Nitrate/nitrite.......................................           25.00  Test.
Organic compound confirmation.........................           34.00  Test.
Organic compound screen...............................          114.75  Test.
Parasitology..........................................           19.25  Test.
Pesticide quantitation................................           52.25  Test.
Pesticide screen......................................           38.00  Test.
pH....................................................           10.00  Test.
Plate cylinder........................................           37.75  Test.
Selenium..............................................           33.25  Test.
Silicate/carbonate disinfectant.......................           25.00  Test.
Temperature disks.....................................           50.25  Test.
Toxicant quantitation, other..........................           42.25  Test.
Toxicant screen, other................................           25.00  Test.
Vomitoxin only........................................           20.75  Test.
Water activity........................................           12.50  Test.
Zearaleone quantitation...............................           20.50  Test.
Zearaleone screen.....................................           11.25  Test.
----------------------------------------------------------------------------------------------------------------


[[Page 770]]

    (b) [Reserved]

Approved by the Office of Management and Budget under control numbers 
0579-0055 and 0579-0094)

[63 FR 53793, Oct. 7, 1998]



Sec.  130.18  User fees for veterinary diagnostic reagents produced at 
NVSL or other authorized site (excluding FADDL).

    (a) Bacteriology reagents. User fees for bacteriology reagents 
produced by the Diagnostic Bacteriology Laboratory at NVSL (excluding 
FADDL) or other authorized site are listed in the following table. 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 Sec. Sec.  130.50 and 130.51.

----------------------------------------------------------------------------------------------------------------
                        Reagent                            User fee                       Unit
----------------------------------------------------------------------------------------------------------------
Anaplasma card test antigen...........................          $34.00  2 ml.
Anaplasma card test kit without antigen...............          105.50  Kit.
Anaplasma CF antigen..................................           17.00  2 ml.
Anaplasma stabilate...................................           67.25  4.5 ml.
Avian origin bacterial antiserums, mycoplasma.........           11.50  1 ml.
Avian origin bacterial antiserums, all other..........           17.75  1 ml.
Bacterial agglutinating antigens other than brucella             30.50  5 ml.
 and salmonella pullorum.
Bacterial conjugates..................................           36.00  1 ml.
Bacterial disease CF antigens, all other..............            8.50  1 ml.
Bacterial ELISA antigens..............................            9.50  1 ml.
Bacterial or protozoal antiserums, all other..........            7.25  1 ml.
Bacterial reagent culture \1\.........................           21.25  Culture.
Bacterial reference culture \2\.......................           63.25  Culture.
Bacteriophage reference culture.......................           63.25  Culture.
Bovine serum factor...................................            1.25  2 ml.
Brucella abortus CF antigen...........................           34.00  60 ml.
Brucella agglutination antigens, all other............           34.00  60 ml.
Brucella buffered plate antigen.......................           50.00  60 ml.
Brucella canis tube antigen...........................           30.50  25 ml.
Brucella card test antigen (packaged).................           19.50  Package.
Brucella card test kit without antigen................           70.25  Kit.
Brucella cells........................................            5.25  Gram.
Brucella cells, dried.................................            2.00  Pellet.
Brucella ring test antigen............................           72.75  60 ml.
Brucella rivanol solution.............................            8.75  60 ml.
Dourine CF antigen....................................           17.50  1 ml.
Dourine stabilate.....................................           34.75  4.5 ml.
Equine and bovine origin hemoparasitic antiserums.....           21.25  1 ml.
Equine negative control CF antigen....................          171.25  1 ml.
Equine origin glanders antiserum......................           18.25  1 ml.
Flazo-orange..........................................            6.25  3 ml.
Glanders CF antigen...................................           17.50  1 ml.
Hemoparasitic disease CF antigens, all other..........          158.25  1 ml.
Leptospira transport medium...........................            3.25  10 ml.
Monoclonal antibody...................................           37.50  1 ml.
Mycobacterium spp. old tuberculin.....................            3.75  1 ml.
Mycobacterium spp. PPD................................            3.25  1 ml.
Mycoplasma hemagglutination antigens..................          105.50  5 ml.
Negative control serums...............................            4.00  1 ml.
Other spp. antiserum, any.............................           32.75  1 ml.
Rabbit origin bacterial antiserum.....................           14.25  1 ml.
Salmonella pullorum microagglutination antigen........            6.25  5 ml.
Stabilates, all other.................................          258.25  4.5 ml.
----------------------------------------------------------------------------------------------------------------
\1\ A reagent culture is a bacterial culture that has been subcultured one or more times after being tested for
  purity and identity. It is intended for use as a reagent with a diagnostic test such as the leptospiral
  microagglutination test.
\2\ A reference culture is a bacterial culture that has been thoroughly tested for purity and identity. It
  should be suitable as a master seed for future cultures.

    (b) Virology reagents. User fees for virology reagents produced by 
the Diagnostic Virology Laboratory at NVSL (excluding FADDL) or at 
authorized sites are listed in the following table. 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 Sec. Sec.  130.50 and 130.51.

[[Page 771]]



----------------------------------------------------------------------------------------------------------------
                        Reagent                            User fee                       Unit
----------------------------------------------------------------------------------------------------------------
Antigen, except avian influenza and chlamydia psittaci          $41.50  2 ml.
 antigens, any.
Avian antiserum except avian influenza antiserum, any.           23.00  2 ml.
Avian influenza antigen, any..........................            9.25  2 ml.
Avian influenza antiserum, any........................           53.75  6 ml.
Bovine or ovine serum, any............................           88.00  2 ml.
Cell Culture..........................................           20.00  Flask.
Chlamydia psittaci spp. of origin monoclonal antibody            47.25  Panel.
 panel.
Conjugate, any........................................           20.25  1 ml.
Diluted positive control serum, any...................            6.75  2 ml.
Equine antiserum, any.................................           12.25  2 ml.
Classical swine fever tissue sets.....................           81.50  Tissue set.
Monoclonal antibody...................................           37.50  1 ml.
Other spp. antiserum, any.............................           32.75  1 ml.
Porcine antiserum, any................................           60.50  2 ml.
Positive control tissues, all.........................            4.25  2 cm\2\ section.
Rabbit origin antiserum...............................           14.25  1 ml.
Reference virus, any..................................           63.50  0.6 ml.
Viruses (except reference viruses), chlamydia psittaci            5.50  0.6 ml.
 agent, or chlamydia psittaci antigen, any.
----------------------------------------------------------------------------------------------------------------


(Approved by the Office of Management and Budget under control number 
0579-0094)

[63 FR 53794, Oct. 7, 1998, as amended at 68 FR 16940, Apr. 7, 2003]



Sec.  130.19  User fees for other veterinary diagnostic services or 
materials provided at NVSL (excluding FADDL).

    (a) User fees for other veterinary diagnostic services or materials 
available from NVSL (excluding FADDL) are listed in the following table. 
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 Sec. Sec.  130.50 and 130.51.

------------------------------------------------------------------------
                  Service                     User fee         Unit
------------------------------------------------------------------------
Antimicrobial susceptibility test.........       $30.50  Isolate.
Avian safety test.........................     2,701.75  Test.
Check tests, anaplasma complement fixation       132.00  Kit \1\.
Check tests, culture......................        88.00  Kit \1\.
Check tests, serology, all other..........       125.75  Kit \1\.
Fetal bovine serum safety test............       673.50  Verification.
Hourly user fee services: \2\.............
    Hour..................................        56.00  Hour.
    Quarter hour..........................        14.00  Quarter Hour.
    Minimum...............................        16.50  ...............
Manual, Brucellosis complement fixation...        13.00  1 copy.
Manual, Brucellosis culture...............        52.75  1 copy.
Manual, Tuberculosis culture (English or          79.25  1 copy.
 Spanish).
Manual, Veterinary mycology...............       105.50  1 copy.
Manual, Anaplasmosis, Johne's disease,            21.25  1 copy.
 mycoplasma hyopneumonia, piroplasmosis,
 dourine, or glanders.
Manuals or standard operating procedure           13.25  1 copy.
 (SOP), all other.
Manuals or SOP, per page..................         2.00  1 page.
Training (school or technical assistance).       120.00  Per person per
                                                          day.
------------------------------------------------------------------------
\1\ Any reagents required for the check test will be charged separately.
\2\ For veterinary diagnostic services for which there is no flat rate
  user fee the hourly rate user fee will be calculated for the actual
  time required to provide the service.

    (b) [Reserved]

(Approved by the Office of Management and Budget under control number 
0579-0094)

[63 FR 53795, Oct. 7, 1998]



Sec.  130.20  User fees for endorsing export certificates.

    (a) User fees for the endorsement of export health certificates that 
do not require the verification of tests or vaccinations are listed in 
the following

[[Page 772]]

table. The user fees apply to each export health certificate \5\ 
endorsed for the following types of animals, birds, or animal products, 
regardless of the number of animals, birds, or animal products covered 
by the certificate. 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 Sec. Sec.  130.50 and 
130.51.
---------------------------------------------------------------------------

    \5\ An export health certificate may need to be endorsed for an 
animal being exported from the United States if the country to which the 
animal is being shipped requires one. APHIS endorses export health 
certificates as a service.

------------------------------------------------------------------------
                                                           User fee
               Certificate categories                  Beginning Oct. 1,
                                                             2003
------------------------------------------------------------------------
Animal and nonanimal products.......................              $32.00
Hatching eggs.......................................               30.00
Poultry, including slaughter poultry................               30.00
Ruminants, except slaughter ruminants moving to                    33.00
 Canada or Mexico...................................
Slaughter animals (except poultry but including                    35.00
 ruminants) moving to Canada or Mexico..............
Other endorsements or certifications................               24.00
------------------------------------------------------------------------

    (b)(1) User fees for the endorsement of export health certificates 
that require the verification of tests or vaccinations are listed in the 
following table. The user fees apply to each export health certificate 
\5\ endorsed for animals and birds depending on the number of animals or 
birds covered by the certificate and the number of tests or vaccinations 
required. However, there will be a maximum user fee of 12 times the 
hourly rate user fee listed in Sec.  130.30(a) of this part for any 
single shipment. 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 the provisions in 
Sec. Sec.  130.50 and 130.51.
---------------------------------------------------------------------------

    \5\ An export health certificate may need to be endorsed for an 
animal being exported from the United States of the country to which the 
animal is being shipped requires one. APHIS endorses export health 
certificates as a service.

------------------------------------------------------------------------
                                                           User fee
    Number of tests or vaccinations and number of      Beginning Oct. 1,
         animals or birds on the certificate                 2003
------------------------------------------------------------------------
1-2 tests or vaccinations
Nonslaughter horses to Canada:
    First animal....................................              $38.00
    Each additional animal..........................                4.25
Other animals or birds:
    First animal....................................               76.00
    Each additional animal..........................                4.25
3-6 tests or vaccinations
    First animal....................................               94.00
    Each additional animal..........................                7.25
7 or more tests or vaccinations
    First animal....................................              109.00
    Each additional animal..........................                8.50
------------------------------------------------------------------------

    (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.
    (c) The user fees prescribed in this section will not apply to an 
export health certificate if the export health certificate is prepared 
for endorsement completely at the site of the inspection by an APHIS 
veterinarian in the course of performing inspection or supervision 
services for the animals listed on the certificate, and an APHIS user 
fee is

[[Page 773]]

payable under Sec.  130.30 of this part for the inspection or 
supervision services performed by the veterinarian.
    (d) 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.

(Approved by the Office of Management and Budget under control number 
0579-0055)

[57 FR 771, Jan. 9, 1992, as amended at 58 FR 38958, July 21, 1993. 
Redesignated at 58 FR 67655, Dec. 22, 1993, and amended at 58 FR 67656, 
Dec. 22, 1993; 61 FR 20434, 20436, May 7, 1996; 62 FR 61007, Nov. 14, 
1997; 63 FR 53796, Oct. 7, 1998; 64 FR 67700, Dec. 3, 1999; 65 FR 16124, 
Mar. 27, 2000; 65 FR 52009, Aug. 28, 2000; 67 FR 48524, July 25, 2002; 
68 FR 51886, Aug. 29, 2003]



Sec.  130.21  [Reserved]



Sec.  130.22  User fees for inspection services outside the United States.

    (a) 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 under this section.
    (b) Any person who wants APHIS to provide inspection services 
outside the United States must contact the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import-
Export, 4700 River Road, Unit 38, Riverdale, Maryland 20737-1231, to 
make an agreement.
    (c) All agreements must include the following:
    (1) Name, mailing address, and telephone number of either the person 
requesting the inspection services, or his or her agent;
    (2) Explanation of inspection services to be provided, including the 
regulations in title 9, Code of Federal Regulations which provide for 
the services;
    (3) Date(s) and time(s) the inspection services are to be provided;
    (4) Location (including street address) where inspection services 
are to be provided;
    (5) An estimate of the actual cost, as calculated by APHIS, to 
provide the described inspection services for 6 months;
    (6) A statement that APHIS agrees to provide the inspection 
services;
    (7) 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
    (8) 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.
    (d) APHIS will enter into an agreement only if qualified personnel 
can be made available to provide the inspection services.
    (e) An agreement can be terminated by either party on 30 days 
written notice.
    (f) 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.

[57 FR 771, Jan. 9, 1992. Redesignated at 58 FR 67655, Dec. 22, 1993; 59 
FR 67617, Dec. 30, 1994]



Sec. Sec.  130.23-130.29  [Reserved]



Sec.  130.30  Hourly rate and minimum user fees.

    (a) User fees for import- or export-related veterinary services 
listed in paragraphs (a)(1) through (a)(13) of this section, except 
those services covered by flat rate user fees elsewhere in this part, 
will be calculated at the hourly rate listed in the following table 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 
Sec. Sec.  130.50 and 130.51.

[[Page 774]]



------------------------------------------------------------------------
                                                           User fee
                                                       Beginning Oct. 1,
                                                             2003
------------------------------------------------------------------------
Hourly rate
    Per hour........................................              $84.00
    Per quarter hour................................               21.00
Per service minimum fee.............................               25.00
------------------------------------------------------------------------

    (1) Providing services to live animals for import or entry at 
airports, ocean ports, and rail ports.
    (2) Conducting inspections, including laboratory and facility 
inspections, required to obtain permits, either to import animal 
products, aquaculture products, organisms or vectors, or to maintain 
compliance with import permits.
    (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.
    (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) Providing other import-or export-related veterinary services 
for which there is no flat rate user fee specified elsewhere in this 
part.
    (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 listed in the following table for each 
employee needed to get the work done.

------------------------------------------------------------------------
                                                       Premium rate user
 Overtime rates (outside the employee's normal tour     fee  Beginning
                      of duty)                           Oct. 1, 2003
------------------------------------------------------------------------
Premium hourly rate Monday through Saturday and
 holidays:
    Per hour........................................             $100.00
    Per quarter hour................................               25.00
Premium hourly rate for Sundays:
    Per hour........................................              112.00
    Per quarter hour................................               28.00
------------------------------------------------------------------------


(Approved by the Office of Management and Budget under control numbers 
0579-0055 and 0579-0094)

[65 FR 52009, Aug. 28, 2000, as amended at 68 FR 51886, Aug. 29, 2003]



Sec. Sec.  130.31-130.48  [Reserved]



Sec.  130.49  Exemptions.

    (a) Veterinary diagnostics. User fees for veterinary diagnostic 
services, including, but not limited to, tests and diagnostic reagents 
specified in Sec. Sec.  130.14 through 130.19, are not charged 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]

[62 FR 61007, Nov. 14, 1997, as amended at 63 FR 53796, Oct. 7, 1998]



Sec.  130.50  Payment of user fees.

    (a) Who must pay APHIS user fees? Any person for whom a service is 
provided related to the importation,

[[Page 775]]

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 specified in Sec. Sec.  130.2 and 130.3 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 
paragraphs (b)(3) (i) or (ii), 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 the following table for each employee needed to 
get the work done:

                                      Overtime for Flat Rate User Fees 1, 2
----------------------------------------------------------------------------------------------------------------
                                                                           Overtime rates (per hour)
                                           Outside of the     --------------------------------------------------
                                       employee's normal tour   Oct. 1, 2003-    Oct. 1, 2004-   Beginning  Oct.
                                              of duty           Sept. 30, 2004   Sept. 30, 2005      1, 2005
----------------------------------------------------------------------------------------------------------------
Rate for inspection, testing,         Monday-Saturday and               $48.00           $49.00           $51.00
 certification or quarantine of        holidays.
 animals, animal products or other
 commodities.3.
                                      Sundays................            63.00            65.00            67.00
Rate for commercial airline           Monday-Saturday and                39.00            40.00            41.00
 inspection services.4.                holidays.
                                      Sundays................            51.00            53.00           55.00
----------------------------------------------------------------------------------------------------------------
\1\ 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 Sec.   97.1(b) of this
  chapter for specific information about commuted travel time.)
\3\ See Sec.   97.1(a) of this chapter or 7 CFR 354.3 for details.
\4\ See Sec.   97.1(a)(3) of this chapter for details.

    (ii) What amount do I pay if I receive an hourly rate user fee 
service? Instead of paying the normal hourly rate user fee under Sec.  
130.30(a), you pay the premium rate listed in Sec.  130.30(b) for each 
employee needed to get the work done.
    (c) When are APHIS user fees due?--(1) Animal and bird quarantine 
and related tests. User fees specified in Sec. Sec.  130.2, 130.3, 
130.5, 130.10, and tests specified in Sec. Sec.  130.14 through 130.19 
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. User fees for supervision and inspection services specified in 
Sec.  130.30 must be paid when billed, or, if covered by a compliance 
agreement signed in accordance with this chapter, must be paid when 
specified in the agreement.
    (3) Export health certificates. User fees for export health 
certificates specified in Sec.  130.20 must be paid prior to receipt of 
endorsed certificates unless APHIS determines that the user has 
established an acceptable credit history, at which time payment may, at 
the option of the user, be made when billed.
    (4) Veterinary diagnostics. User fees specified in Sec. Sec.  130.14 
through 130.19 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, unless APHIS determines 
that the user has established an acceptable

[[Page 776]]

credit history, at which time payment may, at the option of the user, be 
made when billed.
    (5) Other user fee services. User fees specified in Sec. Sec.  
130.6, 130.7, 130.8, and 130.30 must be paid when service is provided 
(for example when live animals are inspected when presented for 
importation at a port of entry), unless APHIS determines that the user 
has established an acceptable credit history, at which time payment may, 
at the option of the user, be made when billed.
    (d) What payment methods are acceptable? Payment must be for the 
exact amount due and may be paid by:
    (1) Cash, will be accepted only during normal business hours if 
payment is made at an APHIS office \7\ or an Animal Import Center;
---------------------------------------------------------------------------

    \7\ A list of APHIS offices and Animal Import Centers that accept 
cash or credit cards may be obtained from the Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import and 
Export, 4700 River Road Unit 38, Riverdale, MD 20738-1231.
---------------------------------------------------------------------------

    (2) 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, 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 (VISA\TM\ and MasterCard\TM\) if payment is made at 
an Animal Import Center or an APHIS office that is equipped to process 
credit cards.\7\

[63 FR 53796, Oct. 7, 1998, as amended at 64 FR 67700, Dec. 3, 1999; 65 
FR 52010, Aug. 28, 2000; 67 FR 48524, July 25, 2002; 68 FR 51887, Aug. 
29, 2003]



Sec.  130.51  Penalties for nonpayment or late payment.

    (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 chapter I of this title, 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;
    (ii) For billed fees, the user fee is unpaid 90 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.
    (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 specified 
in Sec.  130.2 or Sec.  130.3 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 in 
Sec.  130.20 is due for an export health certificate, APHIS will not 
release the certificate.

[[Page 777]]

    (3) Veterinary diagnostics. If an APHIS user fee specified in 
Sec. Sec.  130.14 through 130.19 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. If for unbilled user fees, the user fees 
are unpaid 30 days after the date the pertinent regulatory provisions 
indicates payment is due, or if billed, are unpaid 30 days after the 
date of the bill, APHIS will impose a late payment penalty and interest 
charges in accordance with 31 U.S.C. 3717.
    (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) 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, and may recover all expenses 
of handling the animals or birds from the proceeds of their sale or 
disposition.
    (2) 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 Sec.  130.50(a).

[63 FR 53797, Oct. 7, 1998, as amended at 68 FR 6346, Feb. 7, 2003]

[[Page 778]]



                    SUBCHAPTER G_POULTRY IMPROVEMENT





PART 145_NATIONAL POULTRY IMPROVEMENT PLAN--Table of Contents




                      Subpart A_General Provisions

Sec.
145.1 Definitions.
145.2 Administration.
145.3 Participation.
145.4 General provisions for all participants.
145.5 Specific provisions for participating flocks.
145.6 Specific provisions for participating hatcheries.
145.7 Specific provisions for participating dealers.
145.8 Terminology and classification; general.
145.9 Terminology and classification; hatcheries and dealers.
145.10 Terminology and classification; flocks, products, and States.
145.11 Supervision.
145.12 Inspections.
145.13 Debarment from participation.
145.14 Blood testing.

 Subpart B_Special Provisions for Egg Type Chicken Breeding Flocks and 
                                Products

145.21 Definitions.
145.22 Participation.
145.23 Terminology and classification; flocks and products.
145.24 Terminology and classification; States.

 Subpart C_Special Provisions for Meat Type Chicken Breeding Flocks and 
                                Products

145.31 Definitions.
145.32 Participation.
145.33 Terminology and classification; flocks and products.
145.34 Terminology and classification; States.

  Subpart D_Special Provisions for Turkey Breeding Flocks and Products

145.41 Definitions.
145.42 Participation.
145.43 Terminology and classification; flocks and products.
145.44 Terminology and classification; States.

Subpart E_Special Provisions for Waterfowl, Exhibition Poultry, and Game 
                    Bird Breeding Flocks and Products

145.51 Definitions.
145.52 Participation.
145.53 Terminology and classification; flocks and products.
145.54 Terminology and classification; States.

   Subpart F_Special Provisions for Ostrich, Emu, Rhea, and Cassowary 
                      Breeding Flocks and Products

145.61 Definitions.
145.62 Participation.
145.63 Terminology and classification; flocks and products.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 36 FR 23112, Dec. 3, 1971, unless otherwise noted. 
Redesignated at 44 FR 61586, Oct. 26, 1979.



                      Subpart A_General Provisions



Sec.  145.1  Definitions.

    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 Sec.  145.11(a) to 
perform functions under this part.
    Authorized laboratory. A laboratory designated by an Official State 
Agency, subject to review by the Service, to perform the blood testing 
and bacteriological examinations provided for in this part. The 
Service's review will include, but will not necessarily be limited to, 
checking records, laboratory protocol, check-test proficiency, periodic 
duplicate samples, and peer review. A satisfactory review will result

[[Page 779]]

in the authorized laboratory being recognized by the Service as a 
nationally approved laboratory qualified to perform the blood testing 
and bacteriological examinations provided for in this part.
    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 the program, conditions, criteria, or classifications with which 
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 
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.
    Hatchery. Hatchery equipment on one premises operated or controlled 
by any person for the production of baby poultry.
    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 hatching eggs used for the purpose of producing progeny 
for commercial egg or meat production or for other nonbreeding purposes.
    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,

[[Page 780]]

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 
Sec.  145.10 of this part.
    Public exhibition. A public show of poultry.
    Pullorum disease or pullorum. A disease of poultry caused by 
Salmonella pullorum.
    Reactor. A bird that has a positive reaction to a test, required or 
recommended in parts 145 or 147 of this chapter, for any poultry disease 
for which a program has been established under the Plan.
    Salmonella. Any bacteria belonging to the genus Salmonella, 
including the arizona group.
    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.
    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 Sec.  
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.

[36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973; 41 
FR 14256, Apr. 2, 1976; 41 FR 48723, Nov. 5, 1976. Redesignated at 44 FR 
61586, Oct. 26, 1979, and amended at 47 FR 21991, May 20, 1982; 49 FR 
19802, May 10, 1984; 50 FR 19898, May 13, 1985; 54 FR 23954, June 5, 
1989; 57 FR 57340, Dec. 4, 1992; 59 FR 12798, Mar. 18, 1994; 63 FR 
40009, July 27, 1998; 65 FR 8016, Feb. 17, 2000; 67 FR 8468, Feb. 25, 
2002]



Sec.  145.2  Administration.

    (a) The Department cooperates through a Memorandum of Understanding 
with Official State Agencies in the administration of the Plan.
    (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.

[[Page 781]]

    (d) The Official State Agency of any State may, except as limited by 
Sec.  145.3(d), 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 follow the laboratory protocols outlined in part 147 of this 
chapter when determining the status of a participating flock with 
respect to an official Plan classification.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 48 FR 57473, Dec. 30, 1983; 67 FR 8468, Feb. 25, 2002]



Sec.  145.3  Participation.

    (a) 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 Sec.  145.2. Affiliated flockowners 
may participate without signing an agreement with the Official State 
Agency.
    (b) Each participant shall comply with the Plan throughout the 
operating year of the Official State Agency, or until released by such 
Agency.
    (c) A participant in any State shall participate with all of his 
poultry hatching egg supply flocks and hatchery operations within such 
State. He 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, 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.
    (d) No person shall be compelled by the Official State Agency to 
qualify products for any of the other classifications described in Sec.  
145.10 as a condition of qualification for the U.S. Pullorum-Typhoid 
Clean classification.
    (e) Participation in the Plan shall entitle the participant to use 
the Plan emblem reproduced below:
[GRAPHIC] [TIFF OMITTED] TC10SE91.000


(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1500, Jan. 8, 1975. 
Redesignated at 44 FR 61586, Oct. 26, 1979 and amended at 48 FR 57473, 
Dec. 30, 1983; 57 FR 57341, Dec. 4, 1992; 63 FR 40010, July 27, 1998; 65 
FR 8016, Feb. 17, 2000]



Sec.  145.4  General provisions for all participants.

    (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

[[Page 782]]

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. 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.

(Approved by the Office of Management and Budget under control number 
0579-0057)

[36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973; 41 
FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, as 
amended at 47 FR 21991, May 20, 1982; 48 FR 57473, Dec. 30, 1983; 57 FR 
57341, Dec. 4, 1992]



Sec.  145.5  Specific provisions for participating flocks.

    (a) Poultry equipment, and poultry houses and the land in the 
immediate vicinity thereof, shall be kept in sanitary condition as 
recommended in Sec. Sec.  147.21 and 147.22 (a) and (e) of this chapter. 
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, or F 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.

[36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973. 
Redesignated at 44 FR 61586, Oct. 26, 1979, as amended at 63 FR 40010, 
July 27, 1998]



Sec.  145.6  Specific provisions for participating hatcheries.

    (a) Hatcheries must be kept in sanitary condition, acceptable to the 
Official State Agency. The procedures outlined in Sec. Sec.  147.22 
through 147.25 of this chapter 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 as outlined in 
Sec.  147.24 of this chapter.
    (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

[[Page 783]]

be cleaned and disinfected after each transfer. Cleaning and 
disinfection procedures should be as outlined in Sec.  147.24 of this 
chapter.
    (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 as outlined in Sec.  147.24 of this 
chapter.
    (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 as outlined in Sec.  147.24 of this 
chapter.
    (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 Sec.  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.

[36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 49 FR 19802, May 10, 1984; 65 FR 8016, Feb. 17, 2000; 67 
FR 8468, Feb. 25, 2002]



Sec.  145.7  Specific provisions for participating dealers.

    Dealers in poultry breeding stock, hatching eggs, or baby or started 
poultry shall comply with all provisions in this part which apply to 
their operations.



Sec.  145.8  Terminology and classification; general.

    (a) The official classification terms defined in Sec. Sec.  145.9 
and 145.10 and the various designs illustrative of the official 
classifications reproduced in Sec.  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.



Sec.  145.9  Terminology and classification; hatcheries and dealers.

    Participating hatcheries and dealers shall be designated as 
``National Plan Hatchery'' and ``National Plan Dealer'', respectively. 
All Official State

[[Page 784]]

Agencies shall be notified by the Service of additions, withdrawals, and 
changes in classification.

[36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 47 FR 21991, May 20, 1982]



Sec.  145.10  Terminology and classification; flocks, products, and States.

    Participating flocks, products produced from them, and States which 
have met the respective requirements specified in part 145 subpart B, C, 
D, E, or F may be designated by the following terms or illustrative 
designs:
    (a) [Reserved]
    (b) U.S. Pullorum-Typhoid Clean. (See Sec.  145.23(b), Sec.  
145.33(b), Sec.  145.43(b), Sec. sect; 145.53(b), and 145.63(a).)
[GRAPHIC] [TIFF OMITTED] TC10SE91.002

    (c) U.S. M. Gallisepticum Clean. (See Sec.  145.23(c), Sec.  
145.23(f), Sec.  145.33(c), Sec.  145.33(f), Sec.  145.43(c), and Sec.  
145.53(c).)
[GRAPHIC] [TIFF OMITTED] TC10SE91.003

    (d) U.S. Sanitation Monitored. (See Sec.  145.33(d).)
    [GRAPHIC] [TIFF OMITTED] TC10SE91.004
    
    (e) U.S. M. Synoviae Clean. (See Sec.  145.23(e), Sec.  145.23(g), 
Sec.  145.33(e), Sec.  145.33(g), Sec.  145.43(e), and Sec.  145.53(d)).
[GRAPHIC] [TIFF OMITTED] TC10SE91.005

    (f) U.S. M. Meleagridis Clean--(See Sec.  145.43(d)).
    [GRAPHIC] [TIFF OMITTED] TC10SE91.006
    
    (g) U.S. Pullorum-Typhoid Clean State. (See Sec.  145.24(a), Sec.  
145.34(a), Sec.  145.44(a), and Sec.  145.54(a).)

[[Page 785]]

[GRAPHIC] [TIFF OMITTED] TR21MR96.000

    (h) U.S. Pullorum-Typhoid Clean State, Turkeys. (See Sec.  
145.44(b).)
[GRAPHIC] [TIFF OMITTED] TR21MR96.001

    (i) U.S.M. Gallisepticum Clean State, Turkeys. (See Sec.  
145.44(c).)

[[Page 786]]

[GRAPHIC] [TIFF OMITTED] TC10SE91.009

    (j) U.S. M. Gallisepticum Clean State, Meat-Type Chickens. (See 
Sec.  145.34(b).)
[GRAPHIC] [TIFF OMITTED] TC10SE91.010

    (k) U.S. Sanitation Monitored, Turkeys. (See Sec.  145.43(f).)
    [GRAPHIC] [TIFF OMITTED] TC10SE91.011
    
                                Figure 12
    (l) [Reserved]
    (m) U.S. S. Enteritidis Clean. (See Sec.  145.23(d) and Sec.  
145.33(h).)
[GRAPHIC] [TIFF OMITTED] TR21MR96.002

    (n) U.S. M. Synoviae Clean State, Turkeys. (See Sec.  145.44(d).)

[[Page 787]]

[GRAPHIC] [TIFF OMITTED] TR21MR96.003

    (o) U.S. Salmonella Monitored. (See Sec.  145.33(i).)
    [GRAPHIC] [TIFF OMITTED] TR19AU97.000
    
    (p) U.S. M. Gallisepticum Monitored. (See Sec.  145.33(j).)
    [GRAPHIC] [TIFF OMITTED] TR19AU97.001
    
    (q) U.S. M. Synoviae Monitored. (See Sec.  145.33(k).)
    [GRAPHIC] [TIFF OMITTED] TR19AU97.002
    
    (r) U.S. Avian Influenza Clean. (See Sec. Sec.  145.23(h), 
145.33(l), and 145.53(e).)

[[Page 788]]

[GRAPHIC] [TIFF OMITTED] TR17FE00.013

    (s) U.S. M. Meleagridis Clean State, Turkeys. (See Sec.  145.44(e).)
    [GRAPHIC] [TIFF OMITTED] TR17FE00.008
    

[[Page 789]]


    (t) U.S. H5/H7 Avian Influenza Clean. (See Sec.  145.43(g).)
    [GRAPHIC] [TIFF OMITTED] TR14NO03.000
    

[38 FR 13706, May 24, 1973, as amended at 40 FR 1500, Jan. 8, 1975; 41 
FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and 
amended at 45 FR 10315, Feb. 15, 1980; 47 FR 21991, May 20, 1982; 50 FR 
19898, May 13, 1985; 54 FR 23955, June 5, 1989; 57 FR 57341, Dec. 4, 
1992; 59 FR 12798, Mar. 18, 1994; 61 FR 11517, Mar. 21, 1996; 62 FR 
44068, Aug. 19, 1997; 63 FR 40010, July 27, 1998; 65 FR 8016, Feb. 17, 
2000; 67 FR 8468, Feb. 25, 2002; 68 FR 64509, Nov. 14, 2003]



Sec.  145.11  Supervision.

    (a) The Official State Agency may designate qualified persons as 
Authorized Agents to do the sample collecting and blood testing provided 
for in Sec.  145.14 and the selecting required for the U.S. Approved 
classification provided for in Sec.  145.53(a).
    (b) The Official State Agency shall employ or authorize qualified 
persons as State Inspectors to perform or supervise the performance of 
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 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.

[36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973; 41 
FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979]



Sec.  145.12  Inspections.

    (a) Each participating hatchery shall be inspected 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 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.

[36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1501, Jan. 8, 1975. 
Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 54 FR 23955, 
June 5, 1989; 59 FR 12798, Mar. 18, 1994]



Sec.  145.13  Debarment from participation.

    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

[[Page 790]]

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.

[36 FR 23112, Dec. 3, 1971, as amended at 38 FR 3038, Feb. 1, 1973. 
Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 47 FR 21991, 
May 20, 1982; 67 FR 8468, Feb. 25, 2002]



Sec.  145.14  Blood testing.

    Poultry must be more than 4 months of age when blood tested for an 
official classification: Provided, That turkey candidates under subpart 
D of this part may be blood tested at more than 12 weeks of age; game 
bird candidates under subpart E of this part may be blood 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 blood tested when more than 12 months of 
age. Blood samples for official tests shall be drawn by an Authorized 
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 Agent or State Inspector. For Plan 
programs in which a representative sample may be tested in lieu of an 
entire flock, the minimum number tested shall be 30 birds per house, 
with at least 1 bird taken from each pen and unit in the house. The 
ratio of male to female birds in representative samples of birds from 
meat-type chicken, waterfowl, exhibition poultry, and game bird flocks 
must be the same as the ratio of male to female birds in the flock. In 
houses containing fewer than 30 birds, all birds in the house must be 
tested.
    (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. The 
procedures for conducting official blood tests are set forth in 
Sec. Sec.  147.1, 147.2, 147.3, and 147.5 of this chapter and referenced 
in footnote 3 of this section or in 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.\1\
---------------------------------------------------------------------------

    \1\ The criteria and procedures for Department approval of antigens 
and reagents may be obtained from the Animal and Plant Health Inspection 
Service, Veterinary Services, Center for Veterinary Biologics, 510 South 
17th Street, Suite 104, Ames, IA 50010-8197.
---------------------------------------------------------------------------

    (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 Sec. Sec.  145.23, 145.33, 
145.43, 145.53 and 145.63) the testing of a portion or sample of the 
birds may be used in lieu of testing each bird.

[[Page 791]]

    (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. The approved procedure for bacteriological 
examination is set forth in Sec.  147.11 of this chapter. 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 has no pullorum-typhoid reactors.
    (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 S. pullorum or S. 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 S. pullorum or S. gallinarum, \2\ the Official 
State Agency shall require:
---------------------------------------------------------------------------

    \2\ In making determinations of exposure, the State Inspector shall 
evaluate both evidence proving that exposure occurred and circumstances 
indicating a high probability of contacts with: infected wild birds; 
contaminated feed or waste; or birds, equipment, supplies, or persons 
from or exposed to flocks infected with S. pullorum or S. 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 S. 
pullorum or S. gallinarum occurred.\2\
    (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

[[Page 792]]

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 M. gallisepticum and M. synoviae: (1) The official blood 
tests for M. gallisepticum and M. synoviae shall be the serum plate 
agglutination test, the tube agglutination test, the hemagglutination 
inhibition (HI) test, the microhemagglutination inhibition test, the 
enzyme-linked immunosorbent assay (ELISA) test \3\ or a combination of 
two or more of these tests. The HI test, the microhemagglutination 
inhibition test, and the ELISA test shall be used to confirm the 
positive results of other serological tests. HI titers of 1:40 or less 
may be interpreted as equivocal, and final judgment may be based on 
further samplings and/or culture of reactors.
---------------------------------------------------------------------------

    \3\ Procedures for the enzyme-linked immunosorbent assay (ELISA) 
test are set forth in the following publications:
    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 tests shall be conducted using M. gallisepticum 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 criteria found in Sec.  147.6 of this chapter shall be used in 
determining the final status of the flock.
    (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.
    (c) For M. meleagridis. The official blood tests for M. meleagridis 
are specified in Sec.  145.43(d)(2).
    (d) For avian influenza. The official blood tests for avian 
influenza are the agar gel immunodiffusion (AGID) test

[[Page 793]]

and the enzyme-linked immunosorbent assay (ELISA).
    (1) The AGID test must be conducted on all ELISA-positive samples. 
Positive tests by AGID or ELISA must be further tested by Federal 
Reference Laboratories. Final judgment may be based upon further 
sampling or culture results.
    (2) The tests must be conducted using antigens or test kits approved 
by the Department and the Official State Agency and must be performed in 
accordance with the recommendations of the producer or manufacturer.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23112, Dec. 3, 1971]

    Editorial Note: For  Federal Register citations affecting Sec.  
145.14, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



 Subpart B_Special Provisions for Egg Type Chicken Breeding Flocks and 
                                Products



Sec.  145.21  Definitions.

    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.

[36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13707, May 24, 1973; 41 
FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and 
amended at 59 FR 12798, Mar. 18, 1994; 65 FR 8017, Feb. 17, 2000]



Sec.  145.22  Participation.

    Participating flocks of 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 Sec.  145.5(a).
    (b) Hatching eggs produced by primary breeding flocks shall be 
fumigated (see Sec.  147.25 of this chapter) 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 Sec.  145.10.

[36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1501, Jan. 8, 1975. 
Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19802, 
May 10, 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 8017, Feb. 17, 2000; 68 
FR 64510, Nov. 14, 2003]



Sec.  145.23  Terminology and classification; flocks and products.

    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 Sec.  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 Sec.  145.14 relating to the official blood test where 
applicable.)
    (1) It has been officially blood tested with no reactors.
    (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

[[Page 794]]

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 either no poultry or 
a flock not classified as U.S. Pullorum-Typhoid Clean were located the 
previous year; Provided, That an Authorized Agent must blood test up to 
300 birds per flock, as described in Sec.  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 Sec.  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 Sec.  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.

[[Page 795]]

    (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.
    (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 no reactors: Provided, That a bacteriological 
examination monitoring program acceptable to the Official State Agency 
and approved by the Service may be used in lieu of blood testing.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
compliance with the provisions of Sec.  147.26 of this chapter 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 Sec.  
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 
less 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; or
    (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 Sec.  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 Sec.  147.8 of this chapter.
    (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 chicks 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 chicks shall be boxed in clean boxes 
and delivered in trucks that have been cleaned and disinfected as 
described in Sec.  147.24(a) of this chapter.
    (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. 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 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 [deg] F., or 
above, or to a minimum

[[Page 796]]

temperature of 165 [deg] F. for at least 20 minutes, or to a minimum 
temperature of 184 [deg] 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 compliance with Sec. Sec.  147.21, 
147.24(a), and 147.26 of this chapter. Rodents and other pests should be 
effectively controlled;
    (v) Environmental samples shall be collected from the flock by an 
Authorized Agent, as described in Sec.  147.12 of this chapter, 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) If a Salmonella vaccine is used that causes positive reactions 
with pullorum-typhoid antigen, one of the following options must be 
utilized:
    (A) Administer the vaccine after the pullorum-typhoid testing is 
done as described in paragraph (d)(1)(vii) of this section.
    (B) If an injectable bacterin or live vaccine that does not spread 
is used, keep a sample of 350 birds unvaccinated and banded for 
identification until the flock reaches at least 4 months of age. 
Following negative serological and bacteriological examinations as 
described in paragraph (d)(1)(vii) of this section, vaccinate the 
banded, non-vaccinated birds.
    (vii) Blood samples from 300 non-vaccinated birds as described in 
paragraph (d)(1)(vi) of this section shall be tested 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. 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, as 
described in Sec.  147.11 of this chapter. Cultures from positive 
samples shall be serotyped.
    (viii) Hatching eggs are collected as quickly as possible and are 
handled as described in Sec.  147.22 of this chapter and are sanitized 
or fumigated (see Sec.  147.25 of this chapter).
    (ix) Hatching eggs produced by the flock are incubated in a hatchery 
that is in compliance with the recommendations in Sec. Sec.  147.23 and 
147.24(b) of this chapter, and sanitized either by a procedure approved 
by the Official State Agency or fumigated (see Sec.  147.25 of this 
chapter).
    (2) A flock shall not be eligible for this classification if 
Salmonella enteritidis ser 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, as described in Sec.  147.11(a) of this chapter, 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) A non-vaccinated flock shall be eligible for this classification 
if Salmonella enteritidis (S. enteritidis ser Enteritidis) is isolated 
from an environmental sample collected from the flock in accordance with 
paragraph (d)(1)(v) of this section: Provided, That testing is conducted 
in accordance with paragraph (d)(1)(vii) of this section each 30 days 
and no positive samples are found.
    (4) In order for a hatchery to sell products of this classification, 
all products handled shall meet the requirements of the classification.

[[Page 797]]

    (5) 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 compliance with 
the provisions of Sec.  147.26 of this chapter 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) It is a flock in which a minimum of 300 birds has been tested 
for M. synoviae as provided in Sec.  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 less 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; or
    (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 Sec.  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 Sec.  147.8 of this chapter.
    (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: 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 (e)(1)(i) or (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 Sec.  147.24(a) of this chapter.
    (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 compliance with the provisions of 
Sec.  147.26 of this chapter.
    (4) The flock's freedom from M. Gallisepticum is demonstrated by a 
negative blood test, as provided in Sec.  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 as 
described in Sec.  147.24(a) of this chapter.
    (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 compliance with the provisions of 
Sec.  147.26 of this chapter.
    (4) The flocks's freedom from M. synoviae is demonstrated by a 
negative blood test, as provided in Sec.  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 as 
described in Sec.  147.24(a) of this chapter.
    (h) U.S. Avian Influenza Clean. This program is intended to be the 
basis

[[Page 798]]

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 
serological 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 one of 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 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.
    (2) It is a multiplier breeding flock in which a minimum of 30 birds 
have been tested negative for antibodies 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 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 is tested within each 180-day period.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23112, Dec. 3, 1971]

    Editorial Note: For Federal Register citations affecting Sec.  
145.23, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  145.24  Terminology and classification; States.

    (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 
Sec.  145.23(b)(3)(i) through (vii), Sec.  145.33(b)(3)(i) through 
(vii), Sec.  145.43(b)(3)(i) through (vi), and Sec.  145.53(b)(3)(i) 
through (vii).
    (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.

[40 FR 1502, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 54 FR 23957, June 5, 1989; 67 FR 8469, Feb. 25, 2002]



 Subpart C_Special Provisions for Meat Type Chicken Breeding Flocks and 
                                Products



Sec.  145.31  Definitions.

    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.

[36 FR 23112, Dec. 3, 1971, as amended at 41 FR 48724, Nov. 5, 1976. 
Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 59 FR 12799, 
Mar. 18, 1994; 65 FR 8018, Feb. 17, 2000]

[[Page 799]]



Sec.  145.32  Participation.

    Participating flocks of 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 Sec.  145.5(a).
    (b) Hatching eggs produced by primary breeding flocks shall be 
fumigated (see Sec.  147.25 of this chapter) 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 Sec.  145.10.

[36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1502, Jan. 8, 1975; 41 
FR 48724, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and 
amended at 49 FR 19802, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 
8018, Feb. 17, 2000; 68 FR 64510, Nov. 14, 2003]



Sec.  145.33  Terminology and classification; flocks and products.

    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 Sec.  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 (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 Sec.  
145.14 relating to the official blood test where applicable.)
    (1) It has been officially blood tested with no reactors.
    (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 either no poultry or 
a flock not classified as U.S. Pullorum-Typhoid Clean were located the 
previous year; Provided, That an Authorized Agent must blood test up to 
300 birds per flock, as described in Sec.  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 Sec.  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-

[[Page 800]]

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 Sec.  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.
    (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 no reactors: Provided, That a bacteriological 
examination monitoring program acceptable to the Official State Agency 
and approved by the Service may be used in lieu of blood testing.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
compliance with the provisions of Sec.  147.26 of this chapter 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 Sec.  
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 
less than 150 birds may be tested at any one time, if all pens are 
equally represented and a total 150 birds is tested within each 90-day 
period; or
    (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 Sec. 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:

[[Page 801]]

    (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 Sec.  147.8 of this chapter.
    (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 (see Sec. Sec.  147.22, 147.23, and 
147.24) in a manner satisfactory to the Official State Agency: Provided, 
That U.S. M. Gallisepticum Clean chicks from primary breeding flocks 
must 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 chicks shall be boxed in clean boxes 
and delivered in trucks that have been cleaned and disinfected as 
described in Sec.  147.24(a) of this chapter.
    (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 Sec.  145.14(b), or by a polymerase chain reaction (PCR)-
based procedure approved by the Department. 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 Sec.  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 Sec.  145.33(d)(1) of this 
paragraph, are conducted;
    (ii) The flock is maintained in compliance with Sec. Sec.  147.21, 
147.24(a), and 147.26 of this chapter;
    (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 [deg] F. or above, or to a minimum temperature of 165 [deg] F. for 
at least 20 minutes, or to a minimum temperature of 184 [deg] 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 meeting the requirements 
of Sec. Sec.  147.23 and 147.24(b) of this chapter and sanitized or 
fumigated (see Sec.  147.25 of this chapter);

[[Page 802]]

    (vii) An Authorized Agent shall take environmental samples, as 
described in Sec.  147.12 of this chapter, from each flock at 4 months 
of age and every 90 days thereafter. An authorized laboratory for 
Salmonella shall examine the environmental samples bacteriologically;
    (viii) Owners of flocks found infected with a paratyphoid Salmonella 
may vaccinate these flocks with an autogenous bacterin with a 
potentiating agent.\4\
---------------------------------------------------------------------------

    \4\ Preparation and use of this type of vaccine may be regulated by 
State statutes.
---------------------------------------------------------------------------

    (2) The Official State Agency may use the procedures described in 
Sec.  147.14 of this chapter to monitor the effectiveness of the 
sanitation practices.
    (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 compliance 
with the provisions of Sec.  147.26 of this chapter 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) It is a flock in which a minimum of 300 birds has been tested 
for M. synoviae as provided in Sec.  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 less 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; or
    (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 Sec.  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 Sec.  147.8 of this chapter.
    (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: 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 (e)(1)(i) or (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 Sec.  147.24(a) of this chapter.
    (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 Sec.  145.14(b) or by a polymerase chain reaction (PCR)-
based procedure approved by the Department. 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 Sec.  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.

[[Page 803]]

    (3) The flock is maintained in compliance with the provisions of 
Sec.  147.26 of this chapter.
    (4) The flock's freedom from M. gallisepticum is demonstrated by a 
negative blood test, as provided in Sec.  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 as 
described in Sec.  147.24(a) of this chapter.
    (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 compliance with the provisions of 
Sec.  147.26 of this chapter.
    (4) The flock's freedom from M. synoviae is demonstrated by a 
negative blood test, as provided in Sec.  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 as 
described in Sec.  147.24(a) of this chapter.
    (h) U.S. S. Enteritidis Clean. This classification is intended for 
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 S. 
enteritidis at an authorized laboratory and any group D Salmonella 
samples have been serotyped:
    (A) A 25-gram sample of meconium from the chicks in the flock 
collected and cultured as described in Sec.  147.12(a)(5) of this 
chapter; or
    (B) A sample of chick papers collected and cultured as described in 
Sec.  147.12(c) of this chapter; or
    (C) A sample of 10 chicks that died within 7 days after hatching.
    (ii) All feed fed to the flock meets the following requirements:
    (A) Pelletized feed must have a minimum moisture content of 14.5 
percent and must have been heated throughout to a minimum temperature of 
190 [deg]F, or to a minimum temperature of 165 [deg]F for at least 20 
minutes, or to a minimum temperature of 184 [deg]F under 70 lb pressure 
during the manufacturing process;
    (B) Mash feed may contain animal protein if the finished feed is 
treated with a salmonella control product approved by the Food and Drug 
Administration.
    (C) All feed is stored and transported in such a manner as to 
prevent possible contamination.
    (iii) The flock is maintained in compliance with Sec. Sec.  147.21, 
147.24(a), and 147.26 of this chapter.
    (iv) Environmental samples, as described in Sec.  147.12 of this 
chapter, are collected from the flock by or under the supervision of an 
Authorized Agent when the flock reaches 4 months of age and every 30 
days thereafter. 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.
    (v) Blood samples from 300 birds from the flock are officially 
tested with pullorum antigen when the flock is at least 4 months of age. 
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 Sec. Sec.  147.10 
and 147.11 of this chapter. Cultures from group D positive samples shall 
be serotyped.
    (vi) Hatching eggs produced by the flock are collected as quickly as 
possible and are handled as described in Sec.  147.22 of this chapter.
    (vii) Hatching eggs produced by the flock are incubated in a 
hatchery that is in compliance with the recommendations in Sec. Sec.  
147.23 and 147.24(b) of this

[[Page 804]]

chapter, and the hatchery must have been sanitized either by a procedure 
approved by the Official State Agency or by fumigation.
    (2) If Salmonella enteritidis serotype Enteritidis (SE) is isolated 
from a specimen taken from a bird in the flock, except as provided in 
paragraph (h)(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 (h)(1)(iv) of this section, 25 
randomly selected live birds from the flock and/or 500 cloacal swabs 
collected in accordance with Sec.  147.12(a)(2) of this chapter must be 
bacteriologically examined for SE as described in Sec.  147.11 of this 
chapter. If only one 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. If no SE is recovered from any of the 
specimens in the second sample, the flock will be eligible for the 
classification and will remain eligible for this classification if the 
flock is tested in accordance with paragraph (h)(1)(v) of this section 
each 30 days and no positive samples are found.
    (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, or great-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 S. enteritidis as 
described in Sec.  147.12(a) of this chapter.
    (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, as described in Sec.  
147.11 of this chapter. Cultures from positive samples shall be 
serotyped.
    (D) Two consecutive environmental drag swabs taken at the clean 
premises collected as specified in Sec.  147.12(a) of this chapter 4 
weeks apart are negative for S. 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 
(h)(1)(v) of this section every 30 days and no positive samples are 
found and the flock meets the requirements set forth in Sec.  145.33(h).
    (i) 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:

[[Page 805]]

    (i) The flock shall originate from a source where sanitation and 
management practices, as outlined in Sec.  145.33(d)(1), are conducted;
    (ii) The flock is maintained in compliance with Sec. Sec.  147.21, 
147.24(a), and 147.26 of this chapter;
    (iii) If feed contains animal protein, 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 [deg]F or above, or to 
a minimum temperature of 165 [deg]F for at least 20 minutes, or to a 
minimum temperature of 184 [deg]F under 70 lb pressure during the 
manufacturing process;
    (iv) Feed shall be stored and transported in a manner to prevent 
possible contamination;
    (v) Chicks shall be hatched in a hatchery meeting the requirements 
of Sec. Sec.  147.23 and 147.24(b) of this chapter and sanitized or 
fumigated (see Sec.  147.25 of this chapter).
    (vi) 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;
    (vii) An Authorized Agent shall take environmental samples as 
described in Sec.  147.12 of this chapter from each flock at 4 months of 
age and every 30 days thereafter. An authorized laboratory for 
Salmonella shall examine the environmental samples bacteriologically;
    (viii) 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.
    (2) The Official State Agency may use the procedures described in 
Sec.  147.14 of this chapter to monitor the effectiveness of the egg 
sanitation practices.
    (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.
    (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 Sec.  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 paragraph (c)(1)(i) of this 
section 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 as 
described in Sec.  147.24(a) of this chapter.
    (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 Sec.  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

[[Page 806]]

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 paragraph (e)(1)(i) of this section 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 as 
described in Sec.  147.24(a) of this chapter.
    (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 primary breeding chickens 
through routine serological 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 one of 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 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.
    (2) It is a multiplier breeding flock in which a minimum of 30 birds 
have been tested negative for antibodies 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 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 is tested within each 180-day period.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23112, Dec. 3, 1971]

    Editorial Note: For Federal Register citations affecting Sec.  
145.33, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  145.34  Terminology and classification; States.

    (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 
Sec.  145.23(b)(3)(i) through (vii), Sec.  145.33(b)(3)(i) through 
(vii), Sec.  145.43(b)(3)(i) through (vi), and Sec.  145.53(b)(3)(i) 
through (vii).
    (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:

[[Page 807]]

    (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 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.

[40 FR 1503, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 50 FR 19899, May 13, 1985; 54 FR 23957, June 5, 1989; 67 
FR 8469, Feb. 25, 2002]



  Subpart D_Special Provisions for Turkey Breeding Flocks and Products



Sec.  145.41  Definitions.

    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.

[36 FR 23112, Dec. 3, 1971, as amended at 41 FR 48725, Nov. 5, 1976. 
Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 59 FR 12799, 
Mar. 18, 1994; 65 FR 8018, Feb. 17, 2000]



Sec.  145.42  Participation.

    (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 shall be fumigated (see Sec.  147.25 of this 
chapter) 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 Sec.  145.10.

[36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13707, May 24, 1973; 40 
FR 1503, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and 
amended at 49 FR 19802, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 
8018, Feb. 17, 2000; 68 FR 64511, Nov. 14, 2003]



Sec.  145.43  Terminology and classification; flocks and products.

    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 Sec.  145.10:
    (a) [Reserved]
    (b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from 
pullorum and typhoid has been demonstrated to

[[Page 808]]

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 Sec.  145.14 relating to the official 
blood test where applicable.)
    (1) It has been officially blood tested with no reactors.
    (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 either no poultry or 
a flock not classified as U.S. Pullorum-Typhoid Clean were located the 
previous year; Provided, That an Authorized Agent must blood test up to 
300 birds per flock, as described in Sec.  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 Sec.  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

[[Page 809]]

for reacting flocks as contained in Sec.  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 no reactors: Provided, That a bacteriological 
examination monitoring program acceptable to the Official State Agency 
and approved by the Service may be used in lieu of blood testing.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
accordance with the conditions and procedures described in Sec.  147.26 
of this chapter, and in which no reactors 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 Sec.  145.14(b): Provided, That to retain this classification, a 
minimum of 30 samples from male flocks and 60 samples from female flocks 
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 applicable conditions outlined in Sec.  147.26 of 
this chapter are being met. 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 shall be retested at 28-30 weeks of age and 
at 4-6 week intervals thereafter.
    (2) The official blood tests for M. meleagridis shall be the serum 
plate agglutination test, the tube agglutination test, or the 
microagglutination test. The hemagglutination inhibition (HI) test, 
microhemagglutination inhibition test, serum plate dilution test, 
microagglutination test and the enzyme-linked immunosorbent assay 
(ELISA) \5\ test may be used as supplemental tests to determine the 
status of the flock, in accordance with Sec.  147.6(b) of this chapter.
---------------------------------------------------------------------------

    \5\ See footnote 3 to Sec.  145.14(b)(1).
---------------------------------------------------------------------------

    (3) The tests shall be conducted using M. meleagridis antigens and 
the protocols for testing approved by the Department or the Official 
State Agency.

[[Page 810]]

    (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 block 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 Sec.  145.14(b): Provided, That to 
retain this classification a minimum of 30 samples from male flocks and 
60 samples from female flocks shall be retested at 28-30 weeks of age 
and at 4-6 week intervals thereafter.
    (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 Sec.  147.6 of this chapter will be 
used to determine the status of the flock.
    (3) Flocks located on premises which, during 3 consecutive years, 
have contained breeding flocks qualified as U.S. M. Synoviae Clean, as 
described in paragraph (e)(1) above, may qualify for this classification 
by a negative blood test of at least 100 birds from flocks of more than 
100 and each bird in flocks of 100 or less, when more than 12 weeks of 
age, and by testing a minimum of 30 samples from male flocks and 60 
samples from female flocks at 28-30 weeks of age and at 45 weeks of age.
    (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 as described in 
subpart C of part 147 of this chapter, and where the following 
monitoring, testing, and management practices are conducted:
    (1) Hatchery debris (dead germ hatching eggs, fluff, and meconium 
collected by sexors), a sample of the poults that died within 10 days 
after hatching, or both, from each 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, disinfected, and examined 
bacteriologically for the presence of Salmonella by an Authorized Agent, 
as described in Sec.  147.12 of this chapter.
    (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 [deg]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 [deg]F; or
    (C) The feed should be submitted to pressurization to the extent 
that the initial feed temperature rises to 235 [deg]F for 4 seconds; or

[[Page 811]]

    (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, as 
described in Sec.  147.12 of this chapter, from each flock at 12-20 
weeks of age and examined bacteriologically at an authorized laboratory 
for Salmonella.
    (5) Owners of flocks found infected with a paratyphoid Salmonella 
may vaccinate these flocks with an autogenous bacterin with a 
potentiating agent. \6\
---------------------------------------------------------------------------

    \6\ Preparation and use of this type of vaccine may be regulated by 
state statutes.
---------------------------------------------------------------------------

    (6) Environmental samples shall be taken by an Authorized Agent, as 
described in Sec.  147.12 of this chapter, 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.
    (7) Hatchery debris (dead germ hatching eggs, fluff, and meconium 
collected by sexors), a sample of the poults that died within 10 days 
after hatching, or both shall be cultured from poults produced from 
hatching eggs from each flock, 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 and H7 subtypes of avian 
influenza. It is intended to determine the presence of the H5 and H7 
subtypes of avian influenza in breeding turkeys through routine 
serological 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 
has been tested negative for antibodies to the H5 and H7 subtypes of 
avian influenza by the agar gel immunodiffusion test specified in Sec.  
147.9 of this chapter 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 are tested within each 90-day period.
    (2) It is a multiplier breeding flock in which a minimum of 30 birds 
has been tested negative for antibodies to the H5 and H7 subtypes of 
avian influenza by the agar gel immunodiffusion test specified in Sec.  
147.9 of this chapter 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) 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.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23112, Dec. 3, 1971]

    Editorial Note: For Federal Register citations affecting Sec.  
145.43, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.

[[Page 812]]



Sec.  145.44  Terminology and classification; States.

    (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 
Sec.  145.23(b)(3)(i) through (vii), Sec.  145.33(b)(3)(i) through 
(vii), Sec.  145.43(b)(3)(i) through (vi), and Sec.  145.53(b)(3)(i) 
through (vii).
    (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 
Sec.  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

[[Page 813]]

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

[[Page 814]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[40 FR 1503, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 45 FR 10316, Feb. 15, 1980; 48 FR 57473, Dec. 30, 1983; 
49 FR 19803, May 10, 1984; 54 FR 23957, June 5, 1989; 61 FR 11521, Mar. 
21, 1996; 65 FR 8018, Feb. 17, 2000; 67 FR 8469, Feb. 25, 2002]



Subpart E_Special Provisions for Waterfowl, Exhibition Poultry, and Game 
                    Bird Breeding Flocks and Products



Sec.  145.51  Definitions.

    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.
    Game birds. Domesticated fowl such as pheasants, partridge, quail, 
grouse, and guineas, but not doves and pigeons.
    Waterfowl. Domesticated fowl that normally swim, such as ducks and 
geese.

[36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 59 FR 12799, Mar. 18, 1994]



Sec.  145.52  Participation.

    Participating flocks of waterfowl, exhibition poultry, and game 
birds, 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 E.
    (a) Started poultry shall lose their identity under Plan terminology 
when not maintained by Plan participants under the conditions prescribed 
in Sec.  145.5(a).
    (b) Hatching eggs produced by primary breeding flocks shall be 
fumigated (see Sec.  147.25 of this chapter) or otherwise sanitized.
    (c) 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 printouts of 
computerized monthly shipping and receiving reports in lieu of VS Form 
9-3, ``Report of Sales of Hatching Eggs, Chicks, and Poults.''
    (d) 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 Sec.  145.10.

[36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 49 FR 19803, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 61 
FR 11521, Mar. 21, 1996; 65 FR 8019, Feb. 17, 2000]



Sec.  145.53  Terminology and classification; flocks and products.

    Participating flocks, and the eggs and baby 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 Sec.  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 Sec.  145.14 relating to the official blood test 
where applicable.):
    (1) It has been officially blood tested within the past 12 months 
with no reactors.
    (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;

[[Page 815]]

    (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 either no poultry or 
a flock not classified as U.S. Pullorum-Typhoid Clean were located the 
previous year; Provided, That an Authorized Agent must blood test up to 
300 birds per flock, as described in Sec.  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 Sec.  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 Sec.  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

[[Page 816]]

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 no reactors: 
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 waterfowl 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 three 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 
compliance with the provisions of Sec.  147 .26 of this chapter 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 Sec.  
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 from at least 5 percent of the birds in the flock, 
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 5 
percent 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 5 percent of the birds in the flock, but at least 30 birds, 
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 a 
random sample comprised of 50 percent of the birds in the flock, with a 
maximum of 200 birds and a minimum of 30 birds per flock, has been 
tested for M. gallisepticum as provided in Sec.  145.14(b) when more 
than 4 months of age or upon reaching sexual maturity: 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 from at least 2 percent of the birds in the flock, with a 
minimum of 30 birds per pen, 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 as 
described in Sec.  147.24(a) of this chapter.
    (d) U.S. M. Synoviae Clean. (1) A flock maintained in compliance 
with the provisions of Sec.  147.26 of this chapter 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 a minimum of 300 birds has been tested 
for M. synoviae as provided in Sec.  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

[[Page 817]]

days: And provided further, That a sample comprised of fewer than 150 
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 minimum 
of 150 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 
sample comprised of a minimum of 75 birds has been tested for M. 
synoviae as provided in Sec.  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, a sample of 50 birds 
shall be tested: Provided, That a sample of fewer than 50 birds may be 
tested at any one time, provided that a minimum of 30 birds per flock 
with a minimum of 15 birds per pen, whichever is greater, is tested each 
time and a total of at least 50 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 Sec.  147.8 of this chapter.
    (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 Sec.  147.24(a) of this chapter.
    (e) 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 waterfowl, exhibition 
poultry, and game bird breeding flocks through routine serological 
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 for antibodies to avian influenza by the agar 
gel immunodiffusion test specified in Sec.  147.9 of this chapter 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 are tested within each 90-day period.
    (2) It is a multiplier breeding flock in which a minimum of 30 birds 
has been tested negative for antibodies to avian influenza by the agar 
gel immunodiffusion test specified in Sec.  147.9 of this chapter 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 unvaccinated sentinel birds are tested within each 180-day 
period.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1503, Jan. 8, 1975; 41 
FR 48725, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and 
amended at 47 FR 21993, May 29, 1982; 48 FR 57473, Dec. 30, 1983; 50 FR 
19900, May 13, 1985; 54 FR 23956, 23957, June 5, 1989; 57 FR 57342, Dec. 
4, 1992; 59 FR 12799, Mar. 18, 1994; 62 FR 44070, Aug. 19, 1997; 63 FR 
3, Jan. 2, 1998; 65 FR 8019, Feb. 17, 2000; 67 FR 8469, Feb. 25, 2002; 
68 FR 64512, Nov. 14, 2003]



Sec.  145.54  Terminology and classification; States.

    (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

[[Page 818]]

Sec.  145.23(b)(3)(i) through (vii), Sec.  145.33(b)(3)(i) through 
(vii), Sec.  145.43(b)(3)(i) through (vi), and Sec.  145.53(b)(3)(i) 
through (vii).
    (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.

[40 FR 1504, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 54 FR 23957, June 5, 1989; 67 FR 8469, Feb. 25, 2002]



   Subpart F_Special Provisions for Ostrich, Emu, Rhea, and Cassowary 
                      Breeding Flocks and Products

    Source: 63 FR 40010, July 27, 1998, unless otherwise noted.



Sec.  145.61   Definitions.

    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.

[63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000]



Sec.  145.62  Participation.

    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 Sec.  145.5(a).
    (b) Hatching eggs produced by primary breeding flocks shall be 
fumigated or otherwise sanitized (see Sec.  147.22 of this chapter).
    (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 Sec.  145.10.

[63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000]



Sec.  145.63  Terminology and classification; flocks and products.

    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 Sec.  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 
Sec.  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 no reactors.
    (2) It is a multiplier or primary breeding flock in which a sample 
of each bird in flocks of 30 or fewer birds, a minimum of 30 birds from 
flocks up to 300 birds, or 10 percent of all birds from flocks exceeding 
300 birds has been officially tested for pullorum-typhoid within the 
past 12 months with no reactors: Provided, That a bacteriological 
examination monitoring program for ostriches, emus, rheas, or 
cassowaries acceptable to the Official State Agency and approved by the

[[Page 819]]

Service may be used in lieu of annual blood testing: And provided 
further, That when a flock is a multiplier 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.
    (b) [Reserved]

[63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000]

                           PART 146 [RESERVED]



PART 147_AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN--Table of Contents




                   Subpart A_Blood Testing Procedures

Sec.
147.1 The standard tube agglutination test.
147.2 The rapid serum test.
147.3 The stained-antigen, rapid, whole-blood test.
147.4 [Reserved]
147.5 The microagglutination test for pullorum-typhoid.
147.6 Procedure for determining the status of flocks reacting to tests 
          for Mycoplasma gallisepticum, Mycoplasma synoviae, and 
          Mycoplasma meleagridis.
147.7 Standard test procedures for mycoplasma.
147.8 Procedures for preparing egg yolk samples for diagnostic tests.
147.9 Standard test procedures for avian influenza.

             Subpart B_Bacteriological Examination Procedure

147.10 Laboratory procedure recommended for the bacteriological 
          examination of egg-type breeding flocks with salmonella 
          enteritidis positive environments.
147.11 Laboratory procedure recommended for the bacteriological 
          examination of salmonella.
147.12 Procedures for collection, isolation, and identification of 
          Salmonella from environmental samples, cloacal swabs, chick 
          box papers, and meconium samples.
147.13 Procedure for bacteriological culturing of eggshells for colon 
          bacilli organisms.
147.14 Procedures to determine status and effectiveness of sanitation 
          monitored program.
147.15 Laboratory procedure recommended for the bacteriological 
          examination of mycoplasma reactors.
147.16 Procedure for the evaluation of mycoplasma reactors by in vivo 
          bio-assay (enrichment).
147.17 Laboratory procedure recommended for the bacteriological 
          examination of cull chicks for salmonella.

                     Subpart C_Sanitation Procedures

147.21 Flock sanitation.
147.22 Hatching egg sanitation.
147.23 Hatchery sanitation.
147.24 Cleaning and disinfecting.
147.25 Fumigation.
147.26 Procedures for establishing isolation and maintaining sanitation 
          and good management practices for the control of Salmonella 
          and Mycoplasma infections.
147.27 Procedures recommended to prevent the spread of disease by 
          artificial insemination of turkeys.

Subpart D [Reserved]

   Subpart E_Procedure for Changing National Poultry Improvement Plan

147.41 Definitions.
147.42 General.
147.43 General Conference Committee.
147.44 Submitting, compiling, and distributing proposed changes.
147.45 Official delegates.
147.46 Committee consideration of proposed changes.
147.47 Conference consideration of proposed changes.
147.48 Approval of conference recommendations by the Department.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

    Source: 36 FR 23121, Dec. 3, 1971, unless otherwise noted. 
Redesignated at 44 FR 61586, Oct. 26, 1979.



                   Subpart A_Blood Testing Procedures



Sec.  147.1  The standard tube agglutination test.\1\
---------------------------------------------------------------------------

    \1\ The procedure described is a modification of the method reported 
in the Proceedings of the U.S. Live Stock Sanitary Association, November 
30 to December 2, 1932, pp. 487 to 491.
---------------------------------------------------------------------------

    (a) The blood samples should be collected and delivered as follows:

[[Page 820]]

    (1) The blood samples should be taken by properly qualified and 
authorized persons only, and in containers provided by the laboratory. 
The containers should be stout-walled test tubes, preferably \3/8\ by 3 
inches, without lip, or small well-selected medicine vials, which have 
been thoroughly cleaned and dried in a hot-air drying oven. If stoppers 
are used, they should be thoroughly cleaned and dried.
    (2) Sufficient blood should be procured by making a small incision 
in the large median wing vein with a small sharp lancet and allowing the 
blood to run into the tube, or by the use of a small syringe (with 20 or 
21 gage needle) which is properly cleansed between bleedings with 
physiological saline solution. To facilitate the separation of the 
serum, the tubes should be placed in a slanted position until the blood 
has solidified. After the blood has completely clotted, they should be 
packed and shipped by mail (special delivery), rapid express, or by 
messenger, to the laboratory. All labeling must be clear and permanent, 
and may be done with a suitable pencil on etched portions of the tube, 
or by means of fast-gum labels.
    (3) The blood samples must reach the laboratory in a fresh and 
unhemolyzed condition. Hemolyzed samples should be rejected. It is 
imperative, therefore, to cool the tubes immediately after slanting and 
clotting, and unless they reach the laboratory within a few hours, to 
pack them with ice in special containers, or use some other cooling 
system which will insure their preservation during transportation. In 
severe cold seasons, extreme precautions must be exercised to prevent 
freezing and consequent laking. The samples must be placed in cold (5 
[deg]to 10 [deg]C.) storage, immediately upon arrival at the laboratory.
    (b) The antigen shall consist of representative strains of S. 
pullorum which are of known antigenic composition, high agglutinability, 
but are not sensitive to negative and nonspecific sera. The stock 
cultures may be maintained satisfactorily by transferring to new sloped 
agar at least once a month and keeping at 18 [deg]to 25 [deg]C. (average 
room temperature) in a dark closet or chest, following incubation for 
from 24 to 36 hours at 37 [deg]C. The antigenic composition and purity 
of the stock cultures should be checked consistently.
    (c) A medium which has been used satisfactorily has the following 
composition:

Water.....................................  1,000 cc.
Difco beef extract........................  4 gm. (0.4 percent).
Difco Bacto-peptone.......................  10 gm. (1.0 percent).
Difco dry-granular agar...................  20 gm. (2.0 percent).
Reaction--pH 6.8 to 7.2.
 

    (d) Large 1-inch test tubes, Kolle flasks, or Blake bottles should 
be streaked liberally over the entire agar surface with inoculum from 
48-hour slant agar cultures prepared from the stock cultures of the 
selected strains. The antigen-growing tubes or bottles should be 
incubated 48 hours at 37 [deg]C., and the surface growth washed off with 
sufficient phenolized (0.5 percent) saline (0.85 percent) solution to 
make a heavy suspension. The suspension should be filtered free of 
clumps through a thin layer of absorbent cotton in a Buchner funnel with 
the aid of suction. The antigens of the separate strains should be 
combined in equal volume-density and stored in the refrigerator (5 
[deg]to 10 [deg]C.) in tightly stoppered bottles.
    (e) Thiosulfate-Glycerin (TG) medium may be used as an alternate 
medium for the preparation of tube agglutination antigen. The TG medium, 
formerly used for the preparation of stained, whole-blood antigen, is 
described in more detail in the article by A. D. MacDonald, Recent 
Developments in Pullorum Antigen for the Rapid, Whole-Blood Test, Report 
of the Conference of the National Poultry Improvement Plan, pages 122-
127, 1941. This medium provides a tube antigen of excellent specificity 
and greatly increases the yield of antigen from a given amount of 
medium. The TG medium has the following composition:

Beef infusion.............................  1,000 cc.
Difco Bacto-peptone.......................  20 gm. (2.0 percent).
Sodium thiosulfate........................  5 gm. (0.5 percent).
Ammonium chloride.........................  5 gm. (0.5 percent).
Glycerin, U.S.P. (95 percent).............  20 cc. (2.0 percent).
Difco dry-granular agar...................  30 gm. (3.0 percent).
Reaction--pH 6.8 to 7.2.
 


Large 1-inch test tubes, Kolle flasks, Blake bottles, or Erlenmeyer 
flasks

[[Page 821]]

should be seeded over the entire agar surface with inoculum from 24-hour 
beef infusion broth cultures prepared from the stock cultures of the 
selected strains. The antigen-growing tubes or bottles should be 
incubated 96 hours at 37 [deg]C., and the surface growth washed off with 
sufficient phenolized (0.5 percent) saline (0.85 percent) solution to 
make a heavy suspension. The suspension should be filtered free of 
clumps through a thin layer of absorbent cotton in a Buchner funnel with 
the aid of suction. The antigen then should be centrifuged. The mass of 
bacteria should be removed from the centrifuge tubes or bowl and 
resuspended in saline (0.85 percent) solution containing 0.5 percent 
phenol. After the bacterial mass has been uniformly suspended in the 
diluent, it should be again passed through a cotton pad in a Buchner 
funnel without the aid of suction. The antigens of the separate strains 
should be combined in equal volume-density and stored in the 
refrigerator (5 [deg]to 10 [deg]C.) in tightly stoppered bottles.
    (f) The diluted antigen to be used in the routine testing should be 
prepared from the stock antigen by dilution of the latter with 
physiological (0.85 percent) saline solution containing 0.25 percent of 
phenol to a turbidity corresponding to 0.75-1.00 on the McFarland 
nephelometer scale. The hydrogen-ion concentration of the diluted 
antigen should be corrected to pH 8.2 to 8.5 by the addition of dilute 
sodium hydroxide. New diluted antigen should be prepared each day and 
kept cold. The diluted antigen may be employed in 2 cc. quantities in 4 
by \1/2\-inch test tubes, or 1 cc. quantities in smaller tubes, in which 
the final serum-antigen mixtures are made and incubated. The 
distribution of the antigen in the tubes may be accomplished by the use 
of long burettes, or special filling devices made for the purpose.
    (g) The maximum serum dilution employed must not exceed 1:50 for 
chickens, nor 1:25 for turkeys. The available data indicate that 1:25 
dilution is the most efficient. In all official reports on the blood 
test, the serum dilutions shall be indicated. The sera should be 
introduced into the agglutination tubes in the desired amounts with 
well-cleaned serological pipettes or special serum-delivery devices 
which do not permit the mixing of different sera. The antigen and serum 
should be well mixed before incubation. The serum and antigen mixture 
must be incubated for at least 20 hours at 37 [deg]C.
    (h) The results shall be recorded as:

N, or - (negative) when the serum-antigen mixture remains uniformly 
turbid.
P, or + (positive) when there is a distinct clumping of the antigen, and 
the liquid between the agglutinated particles is clear.
S, or ? (suspicious) when the agglutination is only partial or 
incomplete.
M, or missing, when samples listed on the original record sheet are 
missing.
H, or hemolyzed, when blood samples are hemolyzed and cannot be tested.
B, or broken, when sample tubes are broken and no serum can be obtained.

(Some allowance must always be made for the difference in sensitiveness 
of different antigens and different set-ups, and therefore, a certain 
amount of independent, intelligent judgment must be exercised at all 
times. Also, the histories of the flocks require consideration. In 
flocks where individuals show a suspicious agglutination, it is 
desirable to examine representative birds bacteriologically to determine 
the presence or absence of S. pullorum.)

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23121, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
as amended at 59 FR 12799, Mar. 18, 1994]



Sec.  147.2  The rapid serum test.\2\
---------------------------------------------------------------------------

    \2\ The procedure described is a modification of the method reported 
by Runnels, Coon, Farley, and Thorpe, Amer. Vet. Med. Assoc. Jour. 70 
(N.S. 23): 660-662 (1927).
---------------------------------------------------------------------------

    (a) The procedure for the collection and delivery of blood samples 
in the rapid serum test is the same as that described in Sec.  147.1(a).
    (b) The selection and maintenance of suitable strains of S. pullorum 
and the composition of a satisfactory medium are described in Sec.  
147.1 (b) and (c).
    (c) Large 1-inch test tubes, Kolle flasks, or Blake bottles are 
streaked liberally from 48-hour slant-agar cultures prepared from stock 
cultures of the selected strains.
    (d) The antigen-growing tubes or bottles should be incubated 48 
hours at 37 [deg]C., and the surface growth washed off with a very 
slight amount of 12 percent solution of sodium chloride containing

[[Page 822]]

0.25 to 0.5 percent phenol, filtered through lightly packed sterile 
absorbent cotton placed in the apex of a sterile funnel.
    (e) The washings should be adjusted (using 12 percent sodium 
chloride containing 0.25 to 0.5 percent phenol) so that the turbidity is 
50 times greater than tube 0.75 of McFarland's nephelometer, or to a 
reading of 7 mm. by the Gates nephelometer.
    (f) The individual strain antigens should be tested with negative 
sera for their insensitivity and with positive sera for high 
agglutinability in comparison with known satisfactory antigen. The 
antigens of the separate strains should be combined in equal volume-
density and stored in the refrigerator (5 [deg]to 10 [deg]C.) in tightly 
stoppered bottles.
    (g) The tests should be conducted on a suitable, smooth plate. The 
serum-antigen dilution should be made so that the dilution will not 
exceed 1:50 when compared to the standard tube agglutination test. When 
testing turkey blood samples, it is desirable to use a serum-antigen 
dilution equivalent to the 1:25 in the tube method. The serum should be 
added to the antigen and mixed thoroughly by use of the tip of the serum 
pipette. Most strong positive reactions will be plainly evident within 
15 to 20 seconds. The final reading should be made at the end of 2 or 3 
minutes. Heating the plate at approximately 37 [deg]C. will hasten 
agglutination. Before reading, the plate should be rotated several 
times.
    (h) The results shall be recorded as described in Sec.  147.1(h).

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23121, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
as amended at 59 FR 12799, Mar. 18, 1994]



Sec.  147.3  The stained-antigen, rapid, whole-blood test.\3\
---------------------------------------------------------------------------

    \3\ The procedure described is a modification of the method reported 
by Schaffer, MacDonald, Hall, and Bunyea, Jour. Amer. Vet. Med. Assoc. 
79 (N. S. 32): 236-240 (1931).
---------------------------------------------------------------------------

    (a) The description of the preparation of antigen is not herein 
included because the antigen is a proprietary product produced only 
under license from the Secretary of Agriculture.
    (b) A loop for measuring the correct quantity of blood can usually 
be obtained from the manufacturer of the antigen. A satisfactory loop 
may be made from a piece of No. 20 gage nichrome wire, 2\1/2\ inches 
long, at the end of which is fashioned a loop three-sixteenths of an 
inch in diameter. Such a loop, when filled with blood so that the blood 
appears to bulge, delivers 0.02 cc. A medicine dropper whose tip is 
adjusted to deliver 0.05 cc. is used to measure the antigen. A glass 
plate about 15 inches square, providing space for 48 tests, has proved 
satisfactory for this work. The use of such a plate enables the tester 
to have a number of successive test mixtures under observation without 
holding up the work to wait for results before proceeding to the next 
bird.
    (c) A drop of antigen should be placed on the testing plate. A 
loopful of blood should be taken up from the wing vein. When submerged 
in the blood and then carefully withdrawn, the loop becomes properly 
filled. On looking down edgewise at the filled loop, one observes that 
the blood appears to bulge. The loopful of blood then should be stirred 
into the drop of antigen, and the mixture spread to a diameter of about 
1 inch. The loop then should be rinsed in clean water and dried by 
touching it to a piece of clean blotting paper, if necessary. The test 
plate should be rocked from side to side a few times to mix the antigen 
and blood thoroughly, and to facilitate agglutination. The antigen 
should be used according to the directions of the producer.
    (d) Various degrees of reaction are observed in this as in other 
agglutination tests. The greater the agglutinating ability of the blood, 
the more rapid the clumping and the larger the clumps. A positive 
reaction consists of a definite clumping of the antigen surrounded by 
clear spaces. Such reaction is easily distinguished against a white 
background. A somewhat weaker reaction consists of small but still 
clearly visible clumps of antigen surrounded by spaces only partially 
clear. Between this point and a negative or homogeneous smear, there 
sometimes occurs a very fine granulation barely visible

[[Page 823]]

to the naked eye; this should be disregarded in making a diagnosis. The 
very fine marginal clumping which may occur just before drying up is 
also regarded as negative. In a nonreactor, the smear remains 
homogeneous. (Allowance should be made for differences in the 
sensitiveness of different antigens and different set-ups, and 
therefore, a certain amount of independent, intelligent judgment must be 
exercised at all times. Also, the histories of the flocks require 
consideration. In flocks where individuals show a suspicious 
agglutination, it is desirable to examine representative birds 
bacteriologically to determine the presence or absence of S. pullorum.)

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23121, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
as amended at 59 FR 12799, Mar. 18, 1994]



Sec.  147.4  [Reserved]



Sec.  147.5  The microagglutination test for pullorum-typhoid.

    Routinely, the microagglutination test is applied as a single-
dilution test and only a single 18-24 hour reading is made.
    (a) The procedure for the collection and delivery of blood samples 
in the microagglutination test is the same as that described in Sec.  
147.1(a). A method that has proven advantageous is to transfer the serum 
samples from the blood clot to a microplate as described in ``Applied 
Microbiology,'' volume 24, No. 4, October 1972, pages 671-672. The 
dilutions are then performed according to paragraphs (d) or (e) of this 
section.
    (b) Stained microtest antigen for pullorum-typhoid is supplied as 
concentrated stock suspension and must be approved by the Department.\4\ 
Directions for diluting will be provided with the antigen. The stock as 
well as the diluted antigen prepared each day should be kept sealed in 
the dark at 5 [deg]to 10 [deg]C. when not in use.
---------------------------------------------------------------------------

    \4\ Information as to criteria and procedures for approval of 
concentrated stock suspension of stained microtest antigens may be 
obtained from the National Poultry Improvement Plan, Veterinary 
Services, APHIS, USDA, 1498 Klondike Road, Suite 200, Conyers, GA 30094.
---------------------------------------------------------------------------

    (c) Available data indicate that a 1:40 dilution for the 
microagglutination test is most efficient for the detection of pullorum-
typhoid agglutinins in both chickens and turkeys. In all official 
reports on the blood test, the serum dilutions shall be indicated.
    (d) The recommended procedure for the 1:40 dilution in the 
microagglutination test is as follows:
    (1) Add 100 microliters (0.10 cc.) of 0.85 percent physiological 
saline to each well of the microplate.
    (2) Using a microdiluter or a multimicrodiluter handle fitted with 
twelve 10 microliter microdiluters, transfer 5 microliters (0.005 cc.) 
of the serum sample from the collected specimen to the corresponding 
well of the microplate. This is accomplished by touching the surface of 
the serum sample with the microdiluter and then transferring and mixing 
with the diluent in the microplate well. The microdiluter is removed, 
blotted, touched to the surface of the distilled water wash, and again 
blotted. Other acceptable methods of serum delivery are described in 
``Applied Microbiology,'' volume 21, No. 3, March 1971, pages 394-399.
    (3) Dilute the microtest antigens with 0.50 percent phenolized 
saline and add 100 microliters (0.1 cc.) to each microplate well.
    (4) Seal each plate with a plastic sealer or place unsealed in a 
tight incubation box as described in ``Applied Microbiology,'' volume 
23, No. 5, May 1972, pages 931-937. Incubate at 37[deg]C. for 18-24 
hours.
    (5) Read the test results as described in paragraph (f) of this 
section.
    (e) The recommended procedure for a microagglutination test 
titration is as follows:
    (1) Add 50 microliters (0.05cc.) of 0.85 percent physiological 
saline to each well of the microplate.
    (2) To the wells representative of the lowest dilution in the 
titration, add an additional 50 microliters (0.05 cc.) of 0.85 percent 
physiological saline making a total of 100 microliters in these wells.
    (3) Transfer each serum sample as described in Sec.  147.5(d)(2) of 
this section to the first well containing 100 microliters

[[Page 824]]

(0.10cc.) in the titration, which represents the lowest dilution.
    (4) Make twofold serial dilutions of each serum by transferring 50 
microliters (0.05cc.) of diluted serum from one well to the next using 
twelve 50 microliter microdiluters fitted in a multimicrodiluter handle. 
When transfers have been made to all of the wells of the desired series, 
the 50 microliters remaining in the microdiluters are removed by 
blotting, touching the microdiluters to the surface of the distilled 
water wash, and blotting again.
    (5) Dilute the desired microtest antigen with 0.50 percent 
phenolized saline and add 50 microliters (0.05 cc.) to each microplate 
well.
    (6) Seal each plate with a plastic sealer or place the unsealed 
microplates in a tight incubation box and incubate at 37 [deg]C. for 18-
24 hours.
    (7) Read the test results as described in paragraph (f) of this 
section.
    (f) Read the test results with the aid of a reading mirror. Results 
are interpreted as follows:
    (1) N, or - (negative) when the microplate well has a large, 
distinct button of stained cells; or
    (2) P, or + (positive) when the microplate well reveals no antigen 
button; or
    (3) S, or ? (suspicious) when the microplate well has a small 
button. Suspicious reactions may tend to be more positive than negative 
[] or vice versa [[mnplus]] and can be so noted if 
desired.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[41 FR 48726, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 57 FR 57342, Dec. 4, 1992; 59 FR 12799, Mar. 18, 1994; 59 
FR 67617, Dec. 30, 1994; 61 FR 11521, Mar. 21, 1996; 63 FR 3, Jan. 2, 
1998; 67 FR 8469, Feb. 25, 2002]



Sec.  147.6  Procedure for determining the status of flocks reacting to 

tests for Mycoplasma gallisepticum, Mycoplasma synoviae, and Mycoplasma 
meleagridis.

    The macroagglutination tests for Mycoplasma antibodies, as described 
in ``Standard Methods for Testing Avian Sera for the Presence of 
Mycoplasma Gallisepticum Antibodies'' published by the Agricultural 
Research Service, USDA, March 1966, and the microagglutination tests, as 
reported in the Proceedings, Sixteenth Annual Meeting of the American 
Association of Veterinary Laboratory Diagnosticians, 1973, shall be the 
official tests. Procedures for isolation and identification of 
Mycoplasma may be found in Isolation and Identification of Avian 
Pathogens, published by the American Association of Avian Pathologists 
and Sec. Sec.  147.15 and 147.16.
    (a) The status of a flock for Mycoplasma shall be determined 
according to the following criteria:
    (1) If the tube agglutination or the serum plate test is negative, 
the flock qualifies.
    (2) If the tube agglutination or the serum plate test is positive, 
the hemaglutination inhibition (HI) test and/or the Serum Plate Dilution 
(SPD) test shall be conducted. Provided, that for egg-type and meat-type 
chicken and waterfowl, exhibition poultry, and game bird flocks, if more 
than 50 percent of the samples are positive for either Mycoplasma 
gallisepticum, M. synoviae, or both, the HI and/or the SPD test shall be 
conducted on 10 percent of the positive samples or 25 positive samples, 
whichever is greater. The results of the HI and/or SPD tests must be 
followed by the action prescribed in paragraphs (a)(3), (a)(4), and 
(a)(5) of this section.
    (3) If the tube agglutination or serum plate tests are positive and 
HI and/or the SPD tests are negative, the flock shall be retested in 
accordance with paragraph (a)(6) of this section.
    (4) If HI titers of 1:40 or SPD titers of 1:5 are found, the flock 
shall be considered suspicious and shall be retested in accordance with 
paragraph (a)(6) of this section.
    (5) If HI titers of 1:80, positive enzyme-labeled immunosorbent 
assay (ELISA) titers, or SPD titers of 1:10 or higher are found, the 
Official State Agency shall presume the flock to be infected. If the 
indicated titers are found, tracheal swabs from 30 randomly selected 
birds shall be taken promptly and cultured individually or a PCR-based 
procedure conducted on these specimens for Mycoplasma, and additional 
tests conducted in accordance with paragraph (a)(6) of this section 
before final determination of the flock status is made.

[[Page 825]]

    (6) Fourteen days after the previous bleeding date, all birds or a 
random sample comprised of 75 birds shall be tested by the serum plate 
or tube agglutination test. Tested birds shall be identified by numbered 
bands.
    (7) If the tube agglutination test or serum plate test is negative 
for the Mycoplasma for which the flock was tested, the flock qualifies.
    (8) If the tube agglutination or serum plate test is positive on the 
retest, the HI and/or SPD test shall be conducted on the reacting 
samples.
    (9) On the retest, if the tube agglutination or serum plate tests 
are positive at the same or higher rate and the HI or SPD tests are 
negative, the flock shall be considered suspicious and shall be retested 
in accordance with paragraph (a)(6) of this section.
    (10) On the retest if HI titers of 1:80 and/or SPD titers of 1:10 or 
higher are found, the flock shall be considered infected: Provided, 
That, at the discretion of the Official State Agency, additional tests 
may be conducted in accordance with paragraph (a)(6) of this section 
before final determination of the flock status is made.
    (11) If HI titers of 1:80 and/or SPD titers of 1:10 or higher are 
found on the second retest, the flock shall be considered infected for 
the Mycoplasma for which it was tested.
    (12) If the tube agglutination or serum plate tests are found on the 
second retest to be positive at the same or higher rate and the HI and/
or SPD tests are negative, the flock should be considered infected: 
Provided, That if the status of the flock is considered to be equivocal, 
the Official State Agency may examine reactors by the in vivo bio-assay, 
PCR-based procedures, and/or culture procedures before final 
determination of the flock status is made.
    (13) If the in vivo bio-assay, PCR-based procedures, and culture 
procedures are negative, the Official State Agency may qualify the flock 
for the classification for which it was tested.
    (14) If the in vivo bio-assay, PCR-based procedures, or culture 
procedures are positive, the flock will be considered infected. However, 
the following considerations may apply:
    (i) In PCR-positive flocks for which there are other negative 
mycoplasma test results, the flock's mycoplasma status should be 
confirmed through either seroconversion or culture isolation of the 
organism, or through both methods, before final determination of the 
flock's status is made.
    (ii) In flocks for which only the bio-assay is positive, additional 
in vivo bio-assay, PCR-based procedures, or cultural examinations may be 
conducted by the Official State Agency before final determination of the 
flock's status is made.
    (15) If the in vivo bio-assay, PCR-based procedures, or cultures are 
positive on retest, the flock shall be considered infected for the 
mycoplasma for which it was tested.
    (b) [Reserved]

[40 FR 1504, Jan. 8, 1975, as amended at 41 FR 48726, Nov. 5, 1976. 
Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 47 FR 21993, 
May 20, 1982; 50 FR 19900, May 13, 1985; 54 FR 23957, June 5, 1989; 59 
FR 12799, Mar. 18, 1994; 61 FR 11521, Mar. 21, 1996; 62 FR 44070, Aug. 
19, 1997; 63 FR 3, Jan. 2, 1998; 65 FR 8019, Feb. 17, 2000]



Sec.  147.7  Standard test procedures for mycoplasma.\5\

    The serum plate agglutination test, the tube agglutination test, and 
the enzyme-linked immunosorbent assay (ELISA) test should be considered 
basic screening tests for mycoplasma antibodies. The test selected will 
depend on preference, laboratory facilities, and availability of 
antigen. These three tests, though quite accurate, determine flock 
status rather than individual bird status, since occasional reactions 
are nonspecific. Under normal circumstances, the rate of such 
nonspecific reactions is low. Nonspecific reactions may occasionally be 
high, particularly after the use of erysipelas bacterin in turkeys and 
where mycoplasma antibodies are present for closely related mycoplasma 
other than

[[Page 826]]

for the species being tested. The hemagglutination inhibition (HI) test 
is too cumbersome for routine screening use. Positive reactions are 
extremely accurate however, and are useful in evaluating serum samples 
that react with the ELISA, plate, and/or tube antigens. The test should 
be conducted with 4 HA units. Titers of 1:80 or greater for both chicken 
and turkey sera are considered positive, while a 1:40 or 1:20 titer 
would be strongly suspicious and additional tests should be required.
---------------------------------------------------------------------------

    \5\ For additional information on mycoplasma test procedures, refer 
to the following references: Proc. 77th Annual Meeting, U.S. Animal 
Health Association, 1973; Isolation and Identification of Avian 
Pathogens, 3rd Edition; Methods for Examining Poultry Biologics and for 
Identifying and Quantifying Avian Pathogens, 1991.
---------------------------------------------------------------------------

    (a) Serum plate agglutination test. (1) The serum plate 
agglutination test for mycoplasma is conducted by contacting and mixing 
0.02 ml of test serum with 0.03 ml of serum plate antigen on a glass at 
room temperature. The standard procedure is:
    (i) Allow antigen and test serums to warm up to room temperature 
before use.
    (ii) Dispense test serums in 0.02 ml amounts with a pipette or 
standardized loop (rinsed between samples) to 1\1/2\ inch squares on a 
ruled glass plate. Limit the number of samples (no more than 25) to be 
set up at one time according to the speed of the operator. Serum should 
not dry out before being mixed with antigen.
    (iii) Dispense 0.03 ml of antigen beside the test serum on each 
square. Hold antigen dispensing bottle vertically.
    (iv) Mix the serum and antigen, using a multimixing device if large 
numbers are to be run at one time.
    (v) Rotate the plate for 5 seconds. At the end of the first minute, 
rotate the plate again for 5 seconds and read 55 seconds later.
    (2) A positive reaction is characterized by the formation of 
definite clumps, usually starting at the periphery of the mixture. Most 
samples that are highly positive will react well within the 2-minute 
test period. Reactions thereafter should be considered negative, 
although partial agglutination at 3 and 5 minutes may warrant further 
retesting. High-quality antigen contacted with negative serum will 
usually dry up on the plate without visible clumping. Whenever samples 
are run, the antigen should be tested against known positive and 
negative control serums. Standard reference antigens and negative and 
positive titered sera are available from the National Veterinary 
Services Laboratories (NVSL), P.O. Box 884, Ames, Iowa 50010.
    (3) Since it is difficult to measure uniform amounts of serum with a 
calibrated loop, this technique should not be used in conducting an 
official test.
    (b) Serum plate dilution test. (1) The serum plate dilution (SPD) 
test may be used to evaluate possible nonspecific reactions, gain 
additional information to evaluate positive plate tests occurring in an 
unexpected manner, and/or to evaluate the level of mycoplasma antibodies 
present in the serum sample. If sufficient serum is available, the 
following method would provide the dilutions required to conduct the 
test.
    (i) Rack three tubes and put 0.8 ml of phosphate-buffered saline 
(PBS) in tube 1 and 0.5 ml of PBS in tubes 2 and 3.
    (ii) Pipette 0.2 ml of the test serum into tube 1 and discard the 
pipette.
    (iii) With a pipette, mix the serum and PBS in tube 1 and withdraw 
0.5 ml and add to tube 2.
    (iv) Repeat the process in step (iii), mixing the contents of tube 2 
and transferring 0.5 ml to tube 3.
    (v) Conduct the test, as described for the serum plate test in 
paragraph (a), on the undiluted sample and on samples in tubes 1, 2, and 
3 after proper mixing of each dilution.
    (vi) To assist in the evaluation of the test, conduct concurrent SPD 
tests using both positive 1:80 and positive 1:160 HI sera for the 
mycoplasma being tested. The antigen should be pretested for reactivity 
with standard serum at the 1:5 and 1:10 dilution.
    (vii) Interpretation of the SPD test results should be based on the 
criteria in Sec.  147.6.
    (c) Tube agglutination test. (1) The mycoplasma tube agglutination 
test is conducted by mixing 0.08 ml of test serum with 1.0 ml of diluted 
(1:20) antigen in a tube and allowing the mixture to react for 18-24 
hours at 37[deg] C. The diluent will be the standard phosphate-buffered 
saline with phenol. This solution is made up as follows:

[[Page 827]]



------------------------------------------------------------------------
                                                                 Grams
------------------------------------------------------------------------
Sodium hydroxide (C.P.)......................................       0.15
Sodium chloride (C.P.).......................................       8.5
Potassium dihydrogen phosphate (KH2 PO4) (C.P.)..............       0.68
Phenol (Crystal) (C.P.)......................................       2.5
  Distilled water to make 1,000 ml
------------------------------------------------------------------------


The pH of the buffered phenolized saline will be 7.1-7.2 if all reagents 
are accurately measured. The stock tube antigen is diluted 1:20 with 
buffered phenolized saline. The procedures for the tube test are as 
follows:
    (i) Rack 12x75 mm clean tubes and identify the tubes according to 
the sample to be tested.
    (ii) Add 0.08 ml of the individual test serum to each tube. This 
will create approximately a 1:12.5 screening dilution of test serum when 
1.0 ml of diluted antigen is added. The use of a pipetting device will 
insure proper mixing of serum and antigen.
    (iii) To interpret positive reactions to the 1:12.5 dilution, two 
additional dilutions may be made by adding 0.04 ml of serum for 1:25 
dilution and 0.02 ml of serum for 1:50 dilution, with the addition of 
1.0 ml of diluted antigen as indicated in paragraph (c)(1)(ii) of this 
section.
    (iv) Shake racks and incubate test systems for 18-24 hours at 
37[deg] C.
    (2) Tests are read against a dark background under indirect 
fluorescent light. Regarded as a positive reaction is a clearing of the 
supernatant fluid, with visible sediment in the bottom of the tube. 
Incomplete reactions are suspect. Positive and negative control serums 
should be incorporated into each day's run of tests. Reactions at 1:25 
or greater are considered positive. They should be confirmed by the HI 
test. Incubation for periods greater than 24 hours may be helpful in 
evaluating suspicious reactions and need for possible retesting or other 
diagnostic tests.
    (d) Hemagglutination Inhibition (HI) test. The mycoplasma HI test is 
conducted by the constant-antigen, decreasing-serum method. This method 
requires using a 4-hemagglutination (HA) unit of diluted antigen. 
Differences in the number of HA units used will change the titers of 
positive sera markedly. Standard HA antigens for Mycoplasma 
gallisepticum, M. synoviae, and M. meleagridis are available from NVSL. 
The antigen has been titrated and diluted to approximately 1:640. The HA 
titration of each sample should be checked as described in paragraph 
(d)(2) on initial use or after long storage. To maintain HA activity, 
the undiluted HA antigen should be stored at -60[deg] to -70[deg] C. The 
test procedures are illustrated in Tables 2 and 3 of this paragraph.
    (1) Preparation of materials.
    (i) Prepare phosphate-buffered saline (PBS) as follows:

------------------------------------------------------------------------
                                                                 Grams
------------------------------------------------------------------------
Sodium hydroxide (C.P.)......................................       0.15
Sodium chloride (C.P.).......................................       8.5
Potassium dihydrogen phosphate (KH2 PO4) (C.P.)..............       0.68
  Distilled water to make 1,000 ml
------------------------------------------------------------------------


The pH of the PBS will be 7.1-7.2 if all reagents are accurately 
measured.
    (ii) Collect the turkey or chicken red blood cells (RBC's) in 
Alsever's solution which has been prepared as follows:

------------------------------------------------------------------------
                                                                  Grams
------------------------------------------------------------------------
Sodium citrate................................................       8.0
Sodium chloride...............................................       4.2
Dextrose......................................................      20.5
Distilled water to make 1,000 ml..............................
------------------------------------------------------------------------


The sodium citrate and sodium chloride are dissolved in 800 ml distilled 
water and sterilized at 15 lbs. pressure for 15 minutes. Dissolve the 
dextrose in 200 ml distilled water, sterilize by Seitz or other type of 
filtration and then add aseptically to the sterile sodium citrate and 
sodium chloride solution.
    (iii) From a turkey(s) or chicken(s) known to be free of the 
mycoplasma being tested, withdraw sufficient blood with a syringe 
containing Alsever's solution to give a ratio of 1 part blood to 5 parts 
Alsever's solution (e.g., 8 ml blood in 40 ml of Alsever's solution). 
Centrifuge the blood suspension at 1,000 rpm for 10 minutes and remove 
the Alsever's solution or supernatant with a pipette.
    (iv) Wash the RBC's two times in 10 or more parts of Alsever's 
solution, centrifuging after each washing. Centrifugation is at 1,000 
rpm for 10 minutes. The supernatant fluid is removed and the RBC deposit 
resuspended to give a 25 percent suspension of packed

[[Page 828]]

RBC's in Alsever's solution. (In testing either chicken or turkey sera, 
the homologous RBC system must be used; i.e., use chicken cells when 
testing chicken serum and turkey cells when testing turkey serum.) If 
this suspension is kept refrigerated, it should keep for 7 or 8 days 
after the blood has been collected.
    (v) For the test, 1 ml of the 25 percent RBC's is added to 99 ml of 
buffered saline to make a 0.25 percent RBC suspension.
    (2) Hemagglutination (HA) antigen titration. The HA stock antigen is 
stored at -70 [deg] C in PBS buffer containing 25 percent glycerin (vol/
vol) in a concentrated suspension (i.e., 320-640 HA units/ml) in 
screwtype vials. Under such conditions, potency will be retained for 
years. There will be a rapid loss of titer if improperly stored. The 
titer of HA antigen is determined as illustrated in Table 1 and 
described in paragraphs (d)(2)(i) through (x) of this section.
[GRAPHIC] [TIFF OMITTED] TC10SE91.012

    (i) Rack a series of 11 chemically clean 12x75 mm test tubes. Label 
the tubes 1-11 left to right.
    (ii) Put 0.8 ml of PBS in tube 1 and 0.5 ml of PBS in each of tubes 
2-11.
    (iii) Add 0.2 ml of antigen to tube 1. This will make a 1:5 dilution 
of antigen. Discard pipette.
    (iv) Mix contents of tube 1 thoroughly with a clean pipette, and 
transfer 0.5 ml to tube 2. This will make a 1:10 dilution of antigen in 
tube 2. Discard pipette.
    (v) Continue making serial twofold dilutions of antigen, changing 
pipettes after each transfer, through tube 10. This will result in a 
series of twofold dilutions ranging from 1:5 to 1:2560. Discard 0.5 ml 
of antigen dilution from tube 10.
    (vi) Add 0.5 ,ml of 0.25 percent RBC's to tubes 1-11. Tube 11 will 
serve as PBS/RBC control.
    (vii) Shake the rack and incubate at room temperature until the 
cells in the PBS/RBC control tube have settled into a compact button at 
the bottom of the tube.
    (viii) If turkey sera is also to be tested for HI titer, repeat 
steps outlined in paragraphs (d)(2)(i) through (vii) of this section, 
using 0.25 percent turkey RBC's.

[[Page 829]]

    (ix) The end point of the titration is the highest dilution of 
antigen that produces complete agglutination of the RBC's, as evidenced 
by the formation of a thin sheet of cells covering the concave bottom of 
the tube. For example, if complete agglutination is produced through 
tube 8 (a dilution of 1:640 of antigen), the antigen would be said to 
titer 640, the reciprocal of the dilution.
    (x) Specificity of HA antigen should be determined by conducting HI 
tests with specific chicken sera of variable HI titers. Specific turkey 
sera of varying HI titers should be used if turkey sera is also to be 
tested.
[GRAPHIC] [TIFF OMITTED] TC10SE91.013


[[Page 830]]


    (3) Reagents for mycoplasma HI test. (i) Eight-unit antigen 
(Dilution factor for stock antigen is established by dividing titer by 
8; i.e., 640 antigen is diluted 1:80 in PBS to make 8-unit antigen.)
    (ii) Four-unit antigen (made by diluting surplus 8-unit antigen 1:2 
with PBS).
    (iii) PBS at pH 7.0.
    (iv) Unknown test serums.
    (v) Positive control serum of known titer (should be from the same 
species as the unknown).
    (vi) Negative control serum (should be from the same species as the 
unknown).
    (vii) Solution of 0.25 percent washed RBC's.
    (4) Test outline.
    (i) Rack 10 chemically clean 12x75 mm tubes for each serum, 
including controls, to be tested. Identify each row of tubes, and label 
tubes in each row 1-10, left to right. In row 1, add tube 11 for a PBS/
RBC control.
    (ii) Put 0.8 ml of PBS in tube 1 of each test row; put 0.5 ml of 8-
unit antigen in tube 2 of each test row; put 0.5 ml of 4-unit antigen in 
each of tubes 3-10 in each test row; and put 0.5 ml of PBS in tube 11.
    (iii) Add 0.2 ml of test serum to tube 1. This tube will be the 
serum control in the test system.
    (iv) Mix and make 0.5 ml transfers from tube 1 through tube 10. This 
will result in serial twofold dilutions of serum starting with 1:5 and 
ending with 1:2560. Discard 0.5 ml from tube 10.
    (v) Rack five tubes in which to set up an antigen control.
    (vi) In tube 1, put 1.0 ml of 4-unit antigen; put 0.5 ml of PBS in 
tubes 2-5.
    (vii) Make 0.5 ml serial transfers from tube 1 through tube 5, 
changing pipettes after each transfer. Discard 0.5 ml from tube 5. This 
will result in a series of tubes respectively containing 4, 2, 1, \1/2\, 
and \1/4\ units of antigen.
    (viii) After 20-30 minutes at room temperature to permit antibody-
antigen reaction, add 0.5 ml of 0.25 percent washed RBC's to each tube. 
Shake racks and incubate as for HA titration.
    (ix) In this test system, positive serum should inhibit the HA 
activity of the antigen, while negative serum should have no effect. 
Inhibition will be evidenced by the formation of a free-flowing bottom 
of cells in the botton of the tube. The titer of the serum can be 
calculated as the reciprocal of the highest dilution of serum that 
produces complete HI. Controls should read as follows:
    (A) Serum control (tube 1). Cells should settle out.
    (B) PBS/RBC control (tube 11). Cells should settle out.
    (C) Antigen control. HA in tubes 1-3. Cells should settle out in 
tubes 4-5.
    (D) Positive and negative serum control. Positive control should 
inhibit to its known titer; negative control should have no inhibitory 
effect.
    (x) With this test system and 4 units of antigen, HI titers of 80 or 
above are considered positive and titers of 40 are strongly suspicious. 
However, titers of 10 or 20 are usually negative. Sample test results 
are illustrated in Table 4 in this paragraph.

                                                           Table 4--Sample Results of HI Tests
                                                                [Tube and Serum Dilution]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    1         2         3         4         5         6          7          8           9          10
                                                --------------------------------------------------------------------------------------------------------
                                                   1:5      1:10      1:20      1:40      1:80      1:160      1:320      1:640      1:1280      1:2560
--------------------------------------------------------------------------------------------------------------------------------------------------------
Serum A (HI neg.)..............................       -         +         +         +         +          +          +          +           +          +
Serum B (HI 1:40)..............................       -         -         -         -         +          +          +          +           +          +
Serum C (HI 1:160).............................       -         -         -         -         -          -          +          +           +          +
Serum D (HI 1:20)..............................       -         -         -         +         +          +          +          +           +          +
--------------------------------------------------------------------------------------------------------------------------------------------------------
+, HA.
-, no HA or HI.

    (xi) If serological results from agglutination tests complemented by 
the HI test are inconclusive, cultural examination, bio-assay, or 
retesting of samples after an interval of at least 21 days may be 
indicated.

[[Page 831]]

    (e) Procedure for mycolplasma hemagglutination inhibition tests 
using microtiter technique--(1) Procedure No. 1. The microtiter 
mycoplasma HI test was developed from the tube HI test described in 
Sec.  147.7(d). Refer to these procedures for preparation of materials 
not listed below.
    (i) Materials needed. (A) Microtiter equipment (minimal); i.e., 
microplates, microdiluters, micropipettes, go-no-go diluter delivery 
tester, (0.05 ml).
    (B) Phosphate-buffered saline (PBS).
    (C) Reagents from NVSL; i.e., HA antigen and negative and positive 
titered sera for the mycoplasma to be tested.
    (D) Homologous red blood cells (RBC's) suspension 0.5 percent (2 ml 
of 25 percent RBC's to 98 ml of PBS) obtained from birds free of the 
mycoplasma to be tested. (See paragraphs (d)(1)(ii) through (v) of this 
section for preparation of RBC's.)
    (ii) Microtiter hemagglutination (HA) antigen titration. (A) Mark 
off two rows of 10 wells each for antigen titer (HA is done in 
duplicate).
    (B) Mark last well in each row for cell controls.
    (C) Prepare in small test tube (12x75 mm) a starting dilution of 
antigen by combining 0.1 ml antigen with 0.9 ml PBS. This is a 1:10 
dilution.
    (D) Add 0.05 ml PBS to all wells, including cell controls.
    (E) Add 0.05 ml antigen (1:10 dilution) with diluters to the first 
well in both rows, mix thoroughly, transfer diluter to second well of 
each row and mix, continuing through the 10th well of each row. With 
mixture in diluter from last well, check diluter on go-no-go card, then 
place diluter in distilled water. If diluter checks out, antigen 
dilution will be 1:20, 1:40, 1:80, 1:160, 1:320, 1:640, 1:1280, 1:2560, 
1:5120.
    (F) Add 0.05 ml of 0.5 percent RBC suspension to all wells using a 
0.05 dropper.
    (G) Seal plate (if plate is to be held over 2 hours); shake and 
allow to stand at room temperature until cells in cell control gather in 
compact button. The titer is the highest dilution in which agglutination 
is complete. The dilution contains 1 HA unit in 0.05 ml.
    (H) Prepare a dilution of antigen which contains 8 HA units in 0.05 
ml. Example: if the antigen titer is 1:640, then that dilution contains 
1 HA unit per 0.05 ml. Then 640/8=80, or a dilution of 1:80 containing 8 
HA units. Or 640/4=160, a dilution of 1:160 containing 4 HA units per 
0.05 ml.
    (iii) Microtiter HI test. (A) Prepare two dilutions of antigen, one 
containing 8 HA units per 0.05 ml and one containing 4 HA units per 0.05 
ml. The 4-unit antigen can be prepared from the 8-unit antigen by mixing 
with equal parts of PBS.
    (B) Mark off one row of 8 wells for each test.
    (C) Prepare a 1:5 dilution of each sera to be tested in a small test 
tube (12x75 mm): 0.1 ml serum plus 0.4 ml PBS or 0.05 ml serum plus 0.20 
ml PBS.
    (D) Add 0.05 ml PBS with the 0.05 ml dropper to the first well in 
each row.
    (E) Add 0.05 ml of 8-unit antigen to well 2 in each row.
    (F) Add 0.05 ml of 4-unit antigen to well 3 through 8 for each row.
    (G) For each serum to be tested, load 0.05 ml diluter with 1:5 
dilution as prepared in paragraph (iii) above and place in first well of 
row.
    (H) Mix well and transfer loaded diluter to well 2. Continue serial 
twofold dilutions through well number 8.
    (I) Well 1 (serum dilution of 1:10) is serum control. Well 2=1:20 
dilution; well 3=1:40 dilution; well 4=1:80 dilution; well 5=1:160 
dilution; well 6=1:320 dilution; well 7=1:640 dilution; and well 
8=1:1280 dilution.
    (J) Antigen control. (1) Mark off 6 wells for antigen controls.
    (2) Add 0.05 ml PBS to wells 2, 3, 4, 5, and 6.
    (3) Add 0.05 ml 8-unit antigen to wells 1 and 2.
    (4) With empty diluter, mix contents of well 2. Continue serial 
twofold dilutions through well 6.
    (5) Well 1 contains 8 units; well 2 contains 4 units; well 3 
contains 2 units; well 4 contains 1 unit; well 5 contains \1/2\ unit; 
and well 6 contains \1/4\ unit.
    (6) Mark off two wells for cell controls and add 0.05 ml PBS to 
each.
    (7) After 20-30 minutes at average room temperature (20[deg]-
23[deg]C) to permit antibody-antigen reaction, add 0.05 ml of a 0.5 
percent suspension of RBC's to all wells.

[[Page 832]]

    (8) Seal all wells (if wells are to be held over 2 hours). Shake the 
plate thoroughly.
    (9) Incubate at room temperature for 30-45 minutes.
    (K) Interpretation: The HI titer is the highest serum dilution 
exhibiting complete inhibition of hemagglutination as indicated by 
flowing of cells when the plate is tilted. Serum having a titer of 1:80 
or greater is considered positive. A titer of 1:40 or 1:20 is 
suspicious.
    (2) Procedure No. 2. Purpose: To test for antibodies to avian 
mycoplasma by hemagglutination inhibition (HI). The test uses the 
constant antigen, titered-sera method for measuring antibodies to M. 
gallisepticum, M. synoviae, or M. meleagridis.
    (i) Materials needed. (A) M. gallisepticum, M. synoviae, and/or M. 
meleagridis HI antigens.
    (B) Positive and negative control sera.
    (C) Phosphate buffered saline (PBS).
    (D) Microtiter plates, 96-well, U-bottom.
    (E) 12-channel pipettor (Titerek).
    (F) 50 [mu]L pipettor (Pipetman P200).
    (G) Pipette tips.
    (H) 0.5 percent homologous red blood cells (RBC's) in PBS (use RBC's 
from the same species being tested).
    (I) Plate-sealing tape.
    (J) Mirrored plate reader.
    (ii) Microtiter hemagglutination antigen (HA) titration. (A) Perform 
standard hemagglutination test (HA) on mycoplasma antigen to determine 
titer of antigen.
    (1) Dispense 50 [mu]L of PBS into each well of 3 rows of a 96-well 
microtiter plate.
    (2) Dispense 50 [mu]L of stock antigen into the wells of 2 rows.
    (3) Perform serial two-fold dilutions (50 [mu]L) using a 12-channel 
pipettor. The dilution series will be from 1:2 to 1:4096.
    (4) Add 50 [mu]L of 0.5 percent homologous RBC's to each well of all 
3 rows. The row with no antigen serves as an RBC control.
    (B) Incubate at room temperature (approximately 30 minutes) until 
the control RBC's give tight buttons. The HA titer is read as the last 
well to give a complete lawn (hemagglutination).
    (C) Dilute stock antigen to 4 HA units for the HI test. The dilution 
required to give 4 HA units is calculated by dividing the stock antigen 
HA titer by 8. (Example: 1:320 HA units / 8 = 40, dilute stock antigen 
1:40.)
    (iii) Hemagglutination inhibition assay. (A) Label one column (A to 
H) of a 96-well, U-bottom microtiter plate for each sample, each 
positive and negative control sera, antigen backtitration, and RBC 
control.
    (B) Add 40 [mu]L of PBS to the top row of wells (row A) of the 
plate.
    (C) Add 25 [mu]L of PBS to all remaining wells of the plate.
    (D) Add 10 [mu]L of each test sera to well A of each column (making 
a 1:5 sera dilution).
    (E) Serially dilute 25 [mu]L from well A through H using a 12-
channel pipettor. Discard the final 25 [mu]L. Row A = 1:5...row H = 
1:640.
    (F) With an Oxford doser, add 25 [mu]L of 4 HA unit antigen to wells 
B through H. Well A serves as sera control.
    (G) Prepare an antigen backtitration by adding 25 [mu]L of PBS to 
each well of one column. Add 25 [mu]L of diluted antigen to well A and 
serially dilute 25 [mu]L from wells A to D. This prepares 1:2, 1:4, 1:8, 
and 1:16 dilutions. (It is recommended that the antigen control 
backtitration be performed before the diluted antigen is used in the 
assay. Dilution problems could be detected and corrected before the 
inappropriately diluted antigen is used in the assay.)
    (H) Leave a column of wells blank for an RBC control.
    (I) Agitate gently and incubate for 30 minutes at room temperature.
    (J) Add 50 [mu]L of 0.5 percent RBC's to all wells. Note: Do not 
agitate after RBC's have been added (agitation may result in false 
positive reactions by causing the RBC's to fall, resulting in ``false'' 
buttons).
    (K) Cover the plate with sealing tape. Incubate at room temperature 
for 30 minutes or until control RBC's give a tight button.
    (L) Read the reaction on a mirrored plate reader.
    (iv) Results. (A) The titer is reported as the reciprocal of the 
last dilution to give a tight button of RBC's. The final dilution scheme 
includes the antigen in the dilution calculation and is as follows: 
B=1:20, C=1:40, D=1:80, E=1:160, F=1:320, G=1:640, H=1:1,280.

[[Page 833]]

    (B) For the assay to be valid:
    (1) The positive control sera must give a result within one dilution 
of the previously determined titer.
    (2) The negative control sera must be negative.
    (3) The backtitration of the antigen must be 1:4 or 1:8.
    (4) The RBC control must give tight, non-hemolyzed buttons.
    (5) Sera controls (well A of each test sera) must not have non-
specific agglutination or hemolysis. If negative, report as ``negative 
with non-specific agglutination or non-specific hemolysis'' or ``unable 
to evaluate due to non-specific agglutination or hemolysis'' or treat 
the serum to remove the non-specific agglutination and repeat the test. 
(See paragraph (e)(2)(v) of this section.)
    (v) Treatment to remove non-specific agglutination. (A) Purpose. 
Treatment of serum to remove non-specific agglutination that is 
interfering with HI assays.
    (B) Specimen. Serum.
    (C) Materials. Homologous RBC's (chicken or turkey), 50 percent 
solution PBS, centrifuge, incubator, 4C (refrigerator).
    (D) Procedure. (1) Prepare a 1:5 dilution of test serum by adding 50 
[mu]L of serum to 200 [mu]L of PBS.
    (2) Prepare a 50 percent solution of RBC's by adding equal volumes 
of packed RBC's to PBS. Mix well.
    (3) Add 25 [mu]L of 50 percent RBC solution to the serum dilutions.
    (4) Vortex gently to mix.
    (5) Incubate at 4 [deg]C for 1 hour.
    (6) Centrifuge to pellet the RBC's.
    (7) Use the supernatant to perform the HI assay. Modify the dilution 
scheme in the assay to consider the initial 1:5 dilution prepared in the 
treatment. For the 1:5 dilution scheme, do not add PBS to row A. Add 50 
[mu]L of the 1:5 treated supernatant to row A. Serially dilute 25 [mu]L 
from rows A through H. This prepares a serum dilution of 1:10 through 
1:640 in rows B through H.

[49 FR 19803, May 10, 1984, as amended at 57 FR 57342, Dec. 4, 1992; 59 
FR 12799, Mar. 18, 1994; 63 FR 3, Jan. 2, 1998; 67 FR 8469, Feb. 25, 
2002]



Sec.  147.8  Procedures for preparing egg yolk samples for diagnostic 
tests.

    The following testing provisions may be used for retaining the 
classification U.S. M. Gallisepticum Clean under Sec.  
145.23(c)(1)(ii)(C) and Sec.  145.33(c)(1)(ii)(C), and for retaining the 
classification U.S. M. Synoviae Clean under Sec.  145.23(e)(1)(ii)(b) 
and Sec.  145.33(e)(1)(ii)(b) of this chapter.
    (a) Under the supervision of an Authorized Agent or State Inspector, 
the eggs which are used in egg yolk testing must be selected from the 
premises where the breeding flock is located, must include a 
representative sample of 30 eggs collected from a single day's 
production from the flock, must be identified as to flock of origin and 
pen, and must be delivered to an authorized laboratory for preparation 
for diagnostic testing.
    (b) The authorized laboratory must identify each egg as to the 
breeding flock and pen from which it originated, and maintain this 
identity through each of the following:
    (1) Crack the egg on the round end with a blunt instrument.
    (2) Place the contents of the egg in an open dish (or a receptacle 
to expose the yolk) and prick the yolk with a needle.
    (3) Using a 1 ml syringe without a needle, aspirate 0.5 ml of egg 
yolk from the opening in the yolk.
    (4) Dispense the yolk material in a tube. Aspirate and dispense 0.5 
ml of PBS (phosphate-buffered saline) into the same tube, and place in a 
rack.
    (5) After all the eggs are sampled, place the rack of tubes on a 
vortex shaker for 30 seconds.
    (6) Centrifuge the samples at 2500 RPM (1000xg) for 30 minutes.
    (7) Test the resultant supernatant for M. gallisepticum and M. 
synoviae by using test procedures specified for detecting IgG antibodies 
set forth for testing serum in Sec.  147.7 (for these tests the 
resultant supernatant would be substituted for serum); except that a 
single 1:20 dilution hemagglutination inhibition (HI) test may be used 
as a screening test in accordance with the procedures set forth in Sec.  
147.7.

    Note: For evaluating the test results of any egg yolk test, it 
should be remembered

[[Page 834]]

that a 1:2 dilution of the yolk in saline was made of the original 
specimen.

[50 FR 19900, May 13, 1985; 63 FR 3, Jan. 2, 1998]



Sec.  147.9  Standard test procedures for avian influenza.

    (a) The agar gel immunodiffusion (AGID) test should be considered 
the basic screening test for antibodies to Type A influenza viruses. The 
AGID test is used to detect circulating antibodies to Type A influenza 
group-specific antigens, namely the ribonucleoprotein (RNP) and matrix 
(M) proteins. Therefore, this test will detect antibodies to all 
influenza A viruses, regardless of subtype. The AGID test can also be 
used as a group-specific test to identify isolates as Type A influenza 
viruses. The method used is similar to that described by Beard. \6\ The 
basis for the AGID test is the concurrent migration of antigen and 
antibodies toward each other through an agar gel matrix. When the 
antigen and specific antibodies come in contact, they combine to form a 
precipitate that is trapped in the gel matrix and produces a visible 
line. The precipitin line forms where the concentration of antigen and 
antibodies is optimum. Differences in the relative concentration of the 
antigen or antibodies will shift the location of the line towards the 
well with the lowest concentration or result in the absence of a 
precipitin line. Electrolyte concentration, pH, temperature, and other 
variables also affect precipitate formation.
---------------------------------------------------------------------------

    \6\ Beard, C.W. Demonstration of type-specific influenza antibody in 
mammalian and avian sera by immunodiffusion. Bull. Wld. Hlth. Org. 
42:779-785. 1970.
---------------------------------------------------------------------------

    (1) Materials needed.
    (i) Refrigerator (4 [deg]C).
    (ii) Freezer (-20 [deg]C).
    (iii) Incubator or airtight container for room temperature 
(approximately 25 [deg]C) incubations.
    (iv) Autoclave.
    (v) Hot plate/stirrer and magnetic stir bar (optional).
    (vi) Vacuum pump.
    (vii) Microscope illuminator or other appropriate light source for 
viewing results.
    (viii) Immunodiffusion template cutter, seven-well pattern (a center 
well surrounded by six evenly spaced wells). Wells are 5.3 mm in 
diameter and 2.4 mm apart.
    (ix) Top loading balance (capable of measuring 0.1 gm differences).
    (x) Pipetting device capable of delivering 50[mu]l portions.
    (xi) Common laboratory supplies and glassware--Erlenmeyer flasks, 
graduated cylinders, pipettes, 100 x 15 mm or 60 x 15 mm petri dishes, 
flexible vacuum tubing, side-arm flask (500 mL or larger), and a 12- or 
14-gauge blunt-ended cannula.
    (2) Reagents needed.
    (i) Phosphate buffered saline (PBS), 0.01M, pH 7.2 (NVSL media 
30054 or equivalent).
    (ii) Agarose (Type II Medium grade, Sigma Chemical Co. Cat. 
A-6877 or equivalent).
    (iii) Avian influenza AGID antigen and positive control antiserum 
approved by the Department and the Official State Agency.
    (iv) Strong positive, weak positive, and negative control antisera 
approved by the Department and the Official State Agency (negative 
control antisera optional).
    (3) Preparing the avian influenza AGID agar. (i) Weigh 9 gm of 
agarose and 80 gm of NaCl and add to 1 liter of PBS (0.01 M, pH 7.2) in 
a 2 liter Erlenmeyer flask.
    (ii) To mix the agar, either:
    (A) Autoclave the mixture for 10 minutes and mix the contents by 
swirling after removing from the autoclave to ensure a homogeneous 
mixture of ingredients; or
    (B) Dissolve the mixture by bringing to a boil on a hot plate using 
a magnetic stir bar to mix the contents in the flask while heating. 
After boiling, allow the agar to cool at room temperature (approximately 
25 [deg]C) for 10 to 15 minutes before dispensing into petri plates.
    (iii) Agar can be dispensed into small quantities (daily working 
volumes) and stored in airtight containers at 4 [deg]C for several 
weeks, and melted and dispensed into plates as needed.

    Note: Do not use agar if microbial contamination or precipitate is 
observed.

    (4) Performing the AGID--(i) Detection of serum antibodies. (A) 
Dispense 15 to 17 mL of melted agar into a 100 x 15 mm

[[Page 835]]

petri plate or 5 to 6 mL agar into a 60 x 15 mm petri plate using a 25 
mL pipette. The agar thickness should be approximately 2.8 mm.
    (B) Allow plates to cool in a relatively dust-free environment with 
the lids off to permit the escape of water vapor. The lids should be 
left off for at least 15 minutes, but not longer than 30 minutes, as 
electrolyte concentration of the agar may change due to evaporation and 
adversely affect formation of precipitin lines.

    Note: Plates should be used within 24 hours after they are poured.

    (C) Record the sample identification, reagent lot numbers, test 
date, and identification of personnel performing and reading the test.
    (D) Using the template, cut the agar after it has hardened. Up to 
seven template patterns can be cut in a 100x15 mm plate and two patterns 
can be cut in a 60x15 mm plate.
    (E) Remove the agar plugs by aspiration with a 12- to 14-gauge 
cannula connected to a side arm flask with a piece of silicone or rubber 
tubing that is connected to a vacuum pump with tubing. Adjust the vacuum 
so that the agar surrounding the wells is not disturbed when removing 
the plugs.
    (F) To prepare the wells, either:
    (1) Place 50 [mu]l of avian influenza AGID antigen in the center 
well using a micropipette with an attached pipette tip. Place 50 [mu]l 
AI AGID positive control antiserum in each of two opposite wells, and 
add 50 [mu]l per well of test sera in the four remaining wells. This 
arrangement provides a positive control line on one side of the test 
serum, thus providing for the development of lines of identity (see 
figure 1); or
    (2) Place 50 [mu]l AI AGID positive control antiserum in each of 
three alternate peripheral wells, and add 50 [mu]l per well of test sera 
in the three remaining wells. This arrangement provides a positive 
control line on each side of the test serum, thus providing for the 
development of lines of identity on both sides of each test serum (see 
figure 2).

    Note: A pattern can be included with positive, weak positive, and 
negative reference serum in the test sera wells to aid in the 
interpretation of results (see figure 3).

    (G) Cover each plate after filling all wells and allow the plates to 
incubate for 24 hours at room temperature (approximately 25 [deg]C) in a 
closed chamber to prevent evaporation. Humidity should be provided by 
placing a damp paper towel in the incubation chamber. Note: Temperature 
changes during migration may lead to artifacts.
    (ii) Interpretation of test results. (A) Remove the lid and examine 
reactions from above by placing the plate(s) over a black background, 
and illuminate the plate with a light source directed at an angle from 
below. A microscope illuminator works well and allows for varying 
intensities of light and positions.
    (B) The type of reaction will vary with the concentration of 
antibody in the sample being tested. The positive control serum line is 
the basis for reading the test. If the line is not distinct, the test is 
not valid and must be repeated. The following types of reactions are 
observed (see figure 3):
    (1) Negative reaction. The control lines continue into the test 
sample well without bending or with a slight bend away from the antigen 
well and toward the positive control serum well.
    (2) Positive reaction. The control lines join with, and form a 
continuous line (line of identity) with, the line between the test serum 
and antigen. The location of the line will depend on the concentration 
of antibodies in the test serum. Weakly positive samples may not produce 
a complete line between the antigen and test serum but may only cause 
the tip or end of the control line to bend inward toward the test well.
    (3) Non-specific lines. These lines occasionally are observed 
between the antigen and test serum well. The control lines will pass 
through the non-specific line and continue on into the test serum well. 
The non-specific line does not form a continuous line with positive 
control lines.

[[Page 836]]

[GRAPHIC] [TIFF OMITTED] TR17FE00.009


[[Page 837]]


[GRAPHIC] [TIFF OMITTED] TR17FE00.010

    (b) The enzyme-linked immunosorbent assay (ELISA) may be used as a 
screening test for avian influenza. Use only federally licensed ELISA 
kits and follow the manufacturer's instructions. All ELISA-positive 
serum samples must be confirmed with the AGID test conducted in 
accordance with paragraph (a) of this section.

[65 FR 8019, Feb. 17, 2000]



             Subpart B_Bacteriological Examination Procedure



Sec.  147.10  Laboratory procedure recommended for the bacteriological 

examination of egg-type breeding flocks with salmonella enteritidis 
positive environments.

    Birds selected for bacteriological examination from egg-type 
breeding flocks positive for Salmonella enteritidis after environmental 
monitoring should be examined as described in Sec.  147.11(a) of this 
subpart, with the following exceptions and modifications allowed due to 
the high number of birds required for examination:
    (a) Except when visibly pathological tissues are present, direct 
culture, Sec.  147.11(a)(1) of this subpart, may be omitted; and
    (b) Enrichment culture of organ (non-intestinal) tissues using a 
non- selective broth, Sec.  147.11(a)(2) of this subpart, may be 
omitted.

[59 FR 12801, Mar. 18, 1994]



Sec.  147.11  Laboratory procedure recommended for the bacteriological 
examination of salmonella.

    (a) For egg- and meat-type chickens, waterfowl, exhibition poultry, 
and game birds. All reactors to the Pullorum-Typhoid tests, up to 25 
birds, and birds from Salmonella enteritidis (SE) positive environments 
should be cultured in accordance with both the direct (paragraph (a)(1)) 
and selective enrichment (paragraph (a)(2)) procedures described in this 
section. Careful aseptic technique should be used when collecting all 
tissue samples.

[[Page 838]]

    (1) Direct culture (refer to illustration 1). Grossly normal or 
diseased liver, heart, pericardial sac, spleen, lung, kidney, 
peritoneum, gallbladder, oviduct, misshapen ova or testes, inflamed or 
unabsorbed yolk sac, and other visibly pathological tissues where 
purulent, necrotic, or proliferative lesions are seen (including cysts, 
abscesses, hypopyon, and inflamed serosal surfaces) should be sampled 
for direct culture using either flamed wire loops or sterile swabs. 
Since some strains may not dependably survive and grow in certain 
selective media, inoculate non-selective plates (such as blood or 
nutrient agar) and selective plates (such as MacConkey [MAC] and 
brilliant green novobiocin [BGN] for pullorum-typhoid and MAC, BGN, and 
xylose-lysine-tergitol 4 [XLT 4] for SE). After inoculating the plates, 
pool the swabs from the various organs into a tube of non-selective 
broth (such as nutrient or brain-heart infusion). Refer to illustration 
1 for recommended bacteriological recovery and identification 
procedures.\7\ Proceed immediately with collection of organs and tissues 
for selective enrichment culture.
---------------------------------------------------------------------------

    \7\ Biochemical identification charts may be obtained from ``A 
Laboratory Manual for the Isolation and Identification of Avian 
Pathogens,'' chapter 2, Salmonellosis. Fourth edition, 1998, American 
Association of Avian Pathologists, Inc., Kennett Square, PA 19348.
---------------------------------------------------------------------------

    (2) Selective enrichment culture (refer to illustration 1). Collect 
and culture organ samples separately from intestinal samples, with 
intestinal tissues collected last to prevent cross-contamination. 
Samples from the following organs or sites should be collected for 
culture in selective enrichment broth:
    (i) Heart (apex, pericardial sac, and contents if present);
    (ii) Liver (portions exhibiting lesions or, in grossly normal 
organs, the drained gallbladder and adjacent liver tissues);
    (iii) Ovary-Testes (entire inactive ovary or testes, but if ovary is 
active, include any atypical ova);
    (iv) Oviduct (if active, include any debris and dehydrated ova);
    (v) Kidneys and spleen; and
    (vi) Other visibly pathological sites where purulent, necrotic, or 
proliferative lesions are seen.
    (3) From each bird, aseptically collect 10 to 15 grams of each organ 
or site listed in paragraph (a)(2) of this section. Mince, grind, or 
blend and place in a sterile plastic bag. All the organs or sites listed 
in paragraph (a)(2) of this section from the same bird may be pooled 
into one bag. Do not pool samples from more than one bird. Add 
sufficient tetrathionate enrichment broth to give a 1:10 (sample to 
enrichment) ratio. Follow the procedure outlined in illustration 1 for 
the isolation and identification of Salmonella.
    (4) From each bird, aseptically collect 10 to 15 grams of each of 
the following parts of the digestive tract: Crop wall, duodenum, jejunum 
(including remnant of yolk sac), both ceca, cecal tonsils, and rectum-
cloaca. Mince, grind, or blend tissues and pool them into a sterile 
plastic bag. Do not pool tissues from different birds into the same 
sample. Add sufficient tetrathionate enrichment broth to give a 1:10 
(sample to enrichment) ratio. Follow the procedure outlined in 
illustration 1 for the isolation and identification of Salmonella.
    (5) After selective enrichment, inoculate selective plates (such as 
MAC and BGN for pullorum-typhoid and MAC, BGN, and XLT 4) for SE. 
Inoculate three to five Salmonella-suspect colonies from plates into 
triple sugar iron (TSI) and lysine iron agar (LIA) slants. Screen 
colonies by serological (i.e., serogroup) and biochemical procedures 
(e.g., the Analytical Profile Index for Enterobacteriaceae [API]) as 
shown in illustration 1. As a supplement to screening three to five 
Salmonella-suspect colonies on TSI and LIA slants, a group D colony lift 
assay may be utilized to signal the presence of hard-to-detect group D 
Salmonella colonies on agar plates.
    (6) If the initial selective enrichment is negative for Salmonella, 
a delayed secondary enrichment (DSE) procedure is used. Leave the 
tetrathionate-enriched sample at room temperature for 5 to 7 days. 
Transfer 1 mL of the culture into 10 mL of fresh tetrathionate 
enrichment broth, incubate at 37 C for 20 to 24 hours, and plate as 
before.

[[Page 839]]

    (7) Serogroup all isolates identified as salmonellae and serotype 
all serogroup D1 isolates. Phage-type all SE isolates.
[GRAPHIC] [TIFF OMITTED] TR25FE02.000

    (b) For turkeys--(1) Bacteriological examination of Salmonella 
reactors and necropsy specimens. Grossly normal or diseased liver, 
heart, pericardial sac, spleen, lung, kidney, pancreas, peritoneum, 
drained gallbladder, oviduct,

[[Page 840]]

misshapen ova, testes, inflamed or unabsorbed yolk sac, and other 
visibly pathological tissues where purulent, necrotic, or proliferative 
lesions are seen (including cysts, abscesses, hypopyon, and inflamed 
serosal surfaces), should be directly cultured by means of a flamed wire 
loop or with sterile swabs.\8\ Careful aseptic technique must be 
utilized throughout the process of collecting tissues. Selective media 
should not be relied upon to deal with contaminants, since some strains 
may not dependably survive and grow in certain selective media. 
Inoculate veal infusion (VI) and brilliant green (BG) agar plates. 
Incubate the plates for 24 and 48 hours at 37[deg]C. The digestive 
system should always be cultured separately (see paragraph (b)(7) of 
this section) after other anatomical organs and systems have been 
collected and cultured.
---------------------------------------------------------------------------

    \8\ Culture media preparation and biochemical identification charts 
can be obtained from Culture Methods for the Detection of Animal 
Salmonellosis and Arizonosis, Committee on Salmonellosis and Arizonosis, 
AAVLD, 1976 Iowa State University Press, Ames, IA 50010.
---------------------------------------------------------------------------

    (2) Bacteriologic examination of environmental and other 
contaminated specimens. (i) Culture a representative sample of the 
specimen in tetrathionate Hajna (TTH) selective broth (TT Mueller-
Kauffmann or selenite-cystine is also acceptable) as a temperature of 
41-42 [deg]C for 24 hours. Note: Do not use selenite-cystine if double 
strength skim milk is used as a preservative for the sample.
    (ii) Inoculate an agar late of brilliant green novobiocin (BGN) and 
an agar plate of xylose-lysine-tergitol 4 (XLT4), incubate at 37 [deg]C 
for 24 hours, and retain culture tubes at room temperature for 5-7 days 
for possible reculturing of the negative tubes using 0.25 ml in TTH.
    (iii) Inoculate Salmonella suspect colonies to slants of triple 
sugar-iron (TSI) and lysine-iron (LI) agar and incubate at 37 [deg]C for 
24 hours. Five colony picks per plate should be taken unless 50 percent 
or more of the plates have Salmonella- like colonies. In that case, the 
number of picks may be reduced to three per plate. A group D colony lift 
assay may be utilized to signal the presence of the hard-to-detect group 
D salmonella colonies on agar culture plates.
    (iv) Conduct serologic screening of cultures revealing typical 
reactions of Salmonella on TSI and LI agar slants using somatic O-group 
antisera agglutination or transfer for further identification to 
appropriate biochemical tests such as: Dextrose, lactose, sucrose, 
mannitol, maltose, dulcitol, malonate, gelatin, urea broth, citrate, 
lysine decarboxylase, ornithine decarboxylase, methyl red and Voges-
Proskauer, KCN, salicin broths, indole, and hydrogen sulfide. Motility 
or non-motility is demonstrated by inoculating a suitable semisolid 
medium. The Analytical Profile Index API 20E) \9\ for Enterobacteriacea 
(APE) system may also be used for further identification if desired.
---------------------------------------------------------------------------

    \9\ We use trade names solely for the purpose of providing specific 
information. Mention of a trade name does not constitute a guarantee or 
warranty of the product by the U.S. Department of Agriculture or an 
endorsement over other products not mentioned.
---------------------------------------------------------------------------

    (v) Serotype all Salmonella group D cultures.
    (3) The following organs should be aseptically collected for 
culture:
    (i) Heart (apex, pericardial sac, and contents if present.);
    (ii) Liver (portions exhibiting lesions or, in grossly normal 
organs, the drained gallbladder and adjacent liver tissues.);
    (iii) Ovary-Testes (entire inactive ovary or testes, but if ovary is 
active, use own judgment and include any atypical ova.);
    (iv) Oviduct (if active, include any debris and dehydrated ova.);
    (v) Pancreas and kidneys; and
    (vi) Spleen.
    (4) Aseptically collect 10-15 g or whatever lesser amount is 
available of each organ or site listed in paragraph (b)(3) of this 
section from each reactor, and grind or blend them completely in 10 
times their volume of VI broth. Organs may be processed individually or 
in combinations where appropriate. Suspensions should be transferred in 
10-ml aliquots to 100-ml of both VI and tetrathionate brilliant green 
(TBG) broth and incubated at 37 [deg]C for 24 hours. Plate the VI broth 
on VI and BG

[[Page 841]]

agar and plate the TBG broth on BG agar and incubate at 37 [deg]C. 
Examine these plates after 24 and 48 hours of incubation. The contents 
of the gallbladder can be cultured separately by inoculating 10-ml of VI 
and TBG broth with cotton swabs and incubating at 37 [deg]C for 24 
hours. Plate on BG agar and incubate at 37 [deg]C. Examine these plates 
after 24 and 48 hours of incubation. If contamination with pseudomonas 
or proteus is a problem, make platings on BG sulfapyridine (BGS) agar.
    (5) Where field samples are directly inoculated into enrichment 
broths and a delay of several days occurs before they reach a 
laboratory, or if recovery of low numbers or organisms is expected from 
a primary culture, a secondary enrichment culture should be prepared. 
Subculture a week-old primary culture by transferring 1-ml of inoculum 
into a fresh tube 10-ml of enrichment broth. This secondary enrichment 
should be incubated at 37 [deg]C for 24 hours before plating. (See 
paragraph (b)(1) of this section.) TBG broth is recommended for this 
procedure.
    (6) Make a composite sample of the following parts of grossly normal 
or diseased tissues from the digestive tract: Crop wall, duodenum, 
jejunum (including remnant of yolk-sac attachment), both ceca, cecal 
tonsils, and rectum-cloaca. Aseptically collect 10-15 g of each organ or 
tissue, or whatever lesser amount is available, and grind or blend them 
completely in 10 times their volume of TBG broth. Transfer 10-ml of a 
composite sample of a suspension from the digestive tract into 100-ml of 
TBG broth, and incubate flasks at 42 [deg]C for 24 hours. Cultures may 
be incubated at 37 [deg]C if 42 [deg]C incubators are not available. The 
higher incubation temperatures for TBG broth reduce populations of 
competitive contaminants common in gut tissue. Plate on BG agar and 
incubate at 37 [deg]C. Examine the plates after 24 and 48 hours of 
incubation. If contamination with pseudomonas or proteus is a problem 
make platings on BGS agar.
    (7) If preferred, individual cotton swab samples may also be taken 
from the upper, middle, and lower intestinal tract (including both ceca 
and the rectum-cloaca). Deposit swabs in 10-ml of TBG broth and incubate 
and plate as described in paragraph (b)(6) of this section.
    (8) Transfer suspect colonies to triple-sugar-iron (TSI) agar and 
lysine-iron (LI) agar and incubate at 37 [deg]C for 24 hours.
    (9) Cultures revealing typical reactions of salmonellae on TSI and 
LI agar slants should be transferred to any of the following appropriate 
biochemical tests for final identification: Dextrose, lactose, sucrose, 
mannitol maltose, dulcitol, malonate, gelatin, urea broth, citrate, 
lysine decarboxylase, ornithine decarboxylase, methyl red and Voges-
Proskauer, KCN, salicin broths, indole, and hydrogen sulfide. Motility 
or non-motility is demonstrated by inoculating a suitable semisolid 
medium.\10\ The Analytical Profile Index for Enterobacteriaceae (API) 
system may be utilized for identification if feasible. For arizonae 
identification, make readings daily up to 10 days. An O-nitrophenyl-
beta-D-galactopyranside (ONPG) disc may be used to identify slow lactose 
fermenters.\11\
---------------------------------------------------------------------------

    \10\ Formulation for the semisolid motility medium can be obtained 
from: Isolation and Identification of Avian Pathogens, American 
Association of Avian Pathologists, University of Pennsylvania, New 
Bolton Center, Kennett Square, Pennsylvania 19348--1692, 1980.
    \11\ ONPG discs are available from: Baltimore Biological 
Laboratories, Cockeysville, MD 21030.
---------------------------------------------------------------------------

    (10) All salmonella cultures should be serologically typed.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23121, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 47 FR 21994, May 20, 1982; 50 FR 19900, May 13, 1985; 57 
FR 57342, Dec. 4, 1992; 59 FR 12801, Mar. 18, 1994; 61 FR 11521, Mar. 
21, 1996; 63 FR 3, Jan. 2, 1998; 65 FR 8019, 8023, Feb. 17, 2000; 67 FR 
8469, Feb. 25, 2002]



Sec.  147.12  Procedures for collection, isolation, and identification 

of Salmonella from environmental samples, cloacal swabs, chick box papers, 
and meconium samples.

    Information concerning the pen arrangement and number of birds per 
pen should be obtained from the owner so that the required number of 
samples

[[Page 842]]

per pen and per flock can be determined. A means of identifying each 
sample by pen of origin should be provided. The vehicle transporting the 
personnel taking the samples should be left as far as practical from the 
poultry pens. Sanitary precautions, including personal cleanliness, 
should be observed during the sampling procedure. The hands should be 
carefully washed with a sanitizing soap prior to the sampling. Outer 
clothing, including gloves, should be changed between visits to 
different premises so that clean clothing is worn upon entering each 
premises.
    The used and clean apparel should be kept separate. Boots or 
footwear should be cleaned and disinfected between visits to different 
premises. Disposable caps should be provided and discarded after use on 
each premises. After collection, the samples should be protected from 
drying, light, and excessive temperatures and delivered to the 
laboratory within one day. If delivery is delayed, samples should be 
refrigerated.
    (a) For egg- and meat-type chickens, waterfowl, exhibition poultry, 
and game birds. All samples and swabs described in this paragraph should 
be cultured in accordance with illustration 2 of Sec.  147.11, including 
delayed secondary enrichment. All salmonellae recovered shall be 
serogrouped or serotyped.
    (1) Environmental samples. Fecal material, litter, dust, or floor 
litter surface or nest box drag swab samples to be submitted for 
bacteriological examination shall be collected in accordance with the 
procedures described in paragraphs (a)(1), (a)(2), or (a)(3) of this 
section:
    (i) Procedure for sampling in broth. Authorized laboratories will 
provide capped tubes 1 to 2 cm in diameter and 15 to 20 cm in length 
that are two-thirds full of a recently made, refrigerated, sterile 
enrichment broth for each sample. Sufficient tubes shall be taken to the 
premises to provide at least one tube per pen or one tube per 500 birds, 
whichever is greater. At least one sterile, cotton-tipped applicator 
will be needed for each tube. The dry applicator is first placed in or 
drawn through fresh manure (under roost, near water troughs, fecal 
droppings, or diarrhetic droppings). After each streaking, place the 
cotton-tipped applicator in the tube of broth and swirl the applicator 
to remove the collected material. Withdraw the applicator from the tube 
and use it to take additional specimens by streaking on or through areas 
where defecation, trampling of feces, or settling of dust is common; 
e.g., on or near waterers, feeders, nests, or rafters, etc. When the 
volume of material collected equals approximately 10 percent of the 
volume of the broth (usually 10-12 streakings), place the applicator in 
the tube and break the stick in half, leaving the lower or cotton-tipped 
half in the broth and retaining the upper half for future disposal. 
Replace the cap on the inoculated tube and continue the sampling 
procedure in other areas of the pen.
    (ii) Procedure for sampling in dry containers. Place a sample of 
fecal material, litter, or dust in a sterile, sealable container. The 
sample shall consist of several specimens of material taken from a 
representative location in the pen or house. Collect at least 10 g 
(approximately a heaping tablespoonful) of material for each sample. 
Collect the specimens in each sample with a sterile tongue depressor or 
similar uncontaminated instrument. The samples shall vary in type and 
consistency. Half of the samples shall be comprised of material 
representing defecated matter from a large portion of the flock; i.e., 
trampled, caked material near waterers and feeders. The minimum number 
of samples to be taken shall be determined by the following: Five 
samples from pens or houses of up to 500 birds; Ten samples from pens or 
houses of 500 to 2,500 birds; Fifteen samples from pens or houses with 
more than 2,500 birds. The samples may be pooled to not fewer than five 
samples at the laboratory as long as the volume of material collected 
equals approximately 10 percent of the volume of the broth.
    (2) Cloacal swabs. Cloacal swabs for bacteriological examination 
shall be taken from each bird in the flock or from a minimum of 500 
birds in accordance with the procedure described in paragraph (a)(2)(i) 
of this section.
    (i) Procedure for taking cloacal swabs. The authorized laboratory 
will provide

[[Page 843]]

sterile capped tubes or other suitable containers and cotton-tipped 
applicators for use in taking the cloacal swabs. Insert the cotton-
tipped applicator into the cloaca and rectum in such a manner as to 
ensure the collection of fecal material. Place the swab and adhering 
fecal material in the tube and break the stick in half, keeping the 
upper half of the stick for future disposal. The cloacal swabs may be 
combined in the sterile tubes in multiples of five or in combinations 
specified by the authorized laboratory.
    (ii) [Reserved]
    (3) Drag-swabs. Utilization of drag swabs (DS) involves the exposure 
of gauze pads (or commercially available sponges designed for this 
purpose), a key component of a DS sampler, to the surface of random, 
flock-representative floor litter and nest box areas. The sampler pads 
shall be sterile and slightly moist to promote adherence of particulate 
material, and impregnated with double-strength skim milk \12\ to protect 
salmonella viability during sample collection, batching, storage, and 
shipment. Floor litter surface DS sample results tend to reflect the 
salmonella carrier/shedder status of a flock. Nonetheless, other 
environmental samples as described in paragraphs (a)(1)(i), (a)(1)(ii), 
or (a)(3)(iv) of this section shall also be periodically collected.
---------------------------------------------------------------------------

    \12\ Obtain procedure for preparing double strength skim milk from 
USDA-APHIS ``Recommended Sample Collection Methods for Environmental 
Samples,'' available from the National Poultry Improvement Plan, 
Veterinary Services, APHIS, USDA, 1498 Klondike Road, Suite 200, 
Conyers, GA 30094.
---------------------------------------------------------------------------

    (i) Drag-swab sampler assembly. Drag-swab (DS) samplers may be 
assembled using two 3- by 3-inch sterile gauze pads; size 20 wrapping 
twine; and paper clips, staples, or similar fasteners. Fold each gauze 
pad in half and attach one pad to a 2-foot-long (60 cm) piece of twine 
and the other to a 1-foot-long (30 cm) piece of twine. To attach a pad 
to the twine with a paper clip, bend the end wires of the paper clip 
slightly and push them through the fabric of the folded pad, thus 
securing the clips to the folded pads; then securely tie the twine to 
the free rounded end of the paper clip. To attach a pad to the twine 
with a staple, staple the twine to the pad near the center of the fold, 
applying the staple at a right angle to the twine and parallel to the 
fold. (A pre-tied knot in the free end of the twine will prevent the 
twine from slipping under the staple during use.) Once the pads and the 
twine have been attached, securely connect the free ends of both lengths 
of twine to a small loop tied at the end of a 5-foot-long piece of 
twine. The resulting assembly resembles the letter Y, with a long 
vertical stem and two diagonal branches of different lengths with a 
gauze pad securely attached to the end of each branch. Wrap the twine 
around each two-pad DS sampler to produce a small bundle. Autoclave the 
assembled DS sampler bundle and transfer it with sterile forceps or 
other aseptic method to a resealable sterile bag. Aseptically add 15 mL 
of double-strength skim milk to the bag and massage the milk into the 
gauze pads. Seal the bags and store at -20 [deg]C.
    (ii) Procedures and applications for DS samplers. DS samplers shall 
be completely thawed prior to use. Complete pad/twine/fastener 
assemblies shall be used to sample floor litter surfaces; nest box 
surfaces may be sampled using 3- by 3-inch sterile gauze pads 
impregnated with double-strength skim milk in the manner described in 
paragraph (a)(3)(i) of this section. In either instance, the Plan 
participant collecting the samples shall wear a fresh pair of disposable 
sterile gloves for each flock or house sampled. Each sampler bag shall 
be marked with the type of sample (floor litter or nest box surface) and 
the identity of the house or flock from which the sample was taken.
    (iii) Floor litter sampling technique. For flocks with fewer than 
500 breeders, at least one DS set (two DS pads) shall be dragged across 
the floor litter surface for a minimum of 15 minutes. For flocks with 
500 or more breeders, a minimum of two DS sets (four DS pads) shall be 
dragged across the floor litter surface for a minimum of 15 minutes per 
DS set. Upon completion of dragging, lower each DS pad by its attached 
twine into a separate, resealable sterile bag. Alternatively, each DS 
set of two pads may be lowered by its attached twine into the storage/
transport bag

[[Page 844]]

from which the DS set was originally taken. Remove the twine from the 
pad or DS set by grasping the pad or DS set through the sides of the bag 
with one hand while pulling on the twine with the other hand until the 
connection is broken. Seal the bags and promptly refrigerate them to 
between 2 and 4 [deg]C. Do not freeze. Discard the twine in an 
appropriate disposal bag.
    (iv) Nest box or egg belt sampling technique. Collect nest box or 
egg belt samples by using two 3-by-3 inch sterile gauze pads 
premoistened with double-strength skim milk and wiping the pads over 
assorted locations in about 10 percent of the total nesting area or the 
egg belt. Upon completion, place each pad in a separate, resealable 
sterile bag. Seal the bags and promptly refrigerate them to between 2 
and 4 [deg]C. Do not freeze.
    (v) Culturing of litter surface and nest box samples. When 
refrigerated to between 2 and 4 [deg]C, pads impregnated with double-
strength skim milk may be stored or batched for 5 to 7 days prior to 
culturing. Pads shipped singly or paired in a single bag shall not be 
pooled for culturing but shall be separately inoculated into 60 mL of 
selective enrichment broth.
    (4) Chick box papers. Samples from chick box papers may be 
bacteriologically examined for the presence of Salmonella. The Plan 
participant may collect the samples in accordance with paragraph 
(a)(4)(i) of this section or submit chick box papers directly to a 
laboratory in accordance with paragraph (a)(4)(ii) of this section. It 
is important that the paper be removed from the chick box before the box 
is placed in the brooding house.
    (i) Instructions for collecting samples from chick box papers:
    (A) Collect 1 chick box paper for each 10 boxes of chicks placed in 
a house and lay the papers on a clean surface.
    (B) Clean your hands and put on latex gloves. Do not apply 
disinfectant to the gloves. Change gloves after collecting samples from 
10 chick box papers or any time a glove is torn.
    (C) Saturate a sterile 3-by-3 inch gauze pad with double-strength 
skim milk (see footnote 12 to this section) and rub the pad across the 
surface of five chick box papers. Rub the pad over at least 75 percent 
of each paper and use sufficient pressure to rub any dry meconium off 
the paper. Pouring a small amount of double-strength skim milk (1 to 2 
tablespoons) on each paper will make it easier to collect samples.
    (D) After collecting samples from 10 chick box papers, place the two 
gauze pads used to collect the samples (i.e., one pad per 5 chick box 
papers) into an 18 oz. Whirl-Pak bag and add 1 to 2 tablespoons of 
double-strength skim milk.
    (E) Promptly refrigerate the Whirl-Pak bags containing the samples 
and transport them, on ice or otherwise refrigerated, to a laboratory 
within 48 hours of collection. The samples may be frozen for longer 
storage if the Plan participant is unable to transport them to a 
laboratory within 48 hours.
    (ii) The Plan participant may send chick box papers directly to a 
laboratory, where samples may be collected as described in paragraph 
(a)(4)(i) of this section. To send chick box papers directly to a 
laboratory:
    (A) Collect 1 chick box paper for each 10 boxes of chicks placed in 
a house and place the chick papers immediately into large plastic bags 
and seal the bags.
    (B) Place the plastic bags containing the chick box papers in a 
clean box and transport them within 48 hours to a laboratory. The 
plastic bags do not require refrigeration.
    (iii) The laboratory must follow the procedure set forth in 
paragraph (a)(5) of this section for testing chick meconium for 
Salmonella.
    (5) Chick meconium testing procedure for Salmonella.
    (i) Record the date, source, and flock destination on the ``Meconium 
Worksheet.''
    (ii) Shake each plastic bag of meconium until a uniform consistency 
is achieved.
    (iii) Transfer a 25 gm sample of meconium to a sterile container. 
Add 225 mL of a preenrichment broth to each sample (this is a 1:10 
dilution), mix gently, and incubate at 37 [deg]C for 18-24 hours.
    (iv) Enrich the sample with selective enrichment broth for 24 hours 
at 42 [deg]C.
    (v) Streak the enriched sample onto brilliant green novobiocin (BGN) 
agar

[[Page 845]]

and xylose-lysine-tergitol 4 (XLT4) agar.
    (vi) Incubate both plates at 37 [deg]C for 24 hours and process 
suspect Salmonella colonies according to paragraph (b) of this section.
    (b) Isolation and identification of Salmonella. Either of the two 
enrichment procedures or the rapid detection method in this paragraph 
may be used.
    (1) Tetrathionate enrichment with delayed secondary enrichment 
(DSE):
    (i) Add tetrathionate enrichment broth to the sample to give a 1:10 
(sample to enrichment) ratio. Incubate the sample at 37 or 41.5 [deg]C 
for 20 to 24 hours as shown in illustration 2.
    (ii) After selective enrichment, inoculate selective plates (such as 
BGN and XLT4). Incubate the plates at 37 [deg]C for 20 to 24 hours. 
Inoculate three to five Salmonella-suspect colonies from the plates into 
triple sugar iron (TSI) and lysine iron agar (LIA) slants. Incubate the 
slants at 37 [deg]C for 20 to 24 hours. Screen colonies by serological 
(i.e., serogroup) and biochemical (e.g., API) procedures as shown in 
illustration 2. As a supplement to screening three to five Salmonella-
suspect colonies on TSI and LIA slants, a group D colony lift assay may 
be utilized to signal the presence of hard-to-detect group D Salmonella 
colonies on agar plates.
    (iii) If the initial selective enrichment is negative for 
Salmonella, use a DSE procedure. Leave the original tetrathionate-
enriched sample at room temperature for 5 to 7 days. Transfer 1 mL of 
the culture into 10 mL of fresh tetrathionate enrichment broth, incubate 
at 37 [deg]C for 20 to 24 hours, and plate as in paragraph (b)(1)(ii) of 
this section.
    (iv) Serogroup all isolates identified as Salmonella and serotype 
all serogroup D isolates. Phage-type all Salmonella enteritidis 
isolates.
    (2) Pre-enrichment followed by selective enrichment. (See 
illustration 2.)

[[Page 846]]

[GRAPHIC] [TIFF OMITTED] TR25FE02.001

    (3) Approved rapid detection method. After selective enrichment, a 
rapid ruthenium-labeled Salmonella sandwich immunoassay may be used to 
determine the presence of Salmonella. Positive samples from the 
immunoassay are then inoculated to selective plates (such as BGN and 
XLT4). Incubate the

[[Page 847]]

plates at 37 [deg]C for 20 to 24 hours. Inoculate three to five 
Salmonella-suspect colonies from the plates into triple sugar iron (TSI) 
and lysine iron agar (LIA) slants. Incubate the slants at 37 [deg]C for 
20 to 24 hours. Screen colonies by serological (i.e., serogroup) and 
biochemical (e.g., API) procedures as shown in illustration 2. As a 
supplement to screening three to five Salmonella-suspect colonies on TSI 
and LIA slants, a group D colony lift assay may be utilized to signal 
the presence of hard-to-detect group D Salmonella colonies on agar 
plates.
    (c) For turkeys--(1) Environmental samples. Fecal material, litter, 
or dust to be submitted for bacteriological examination should be 
collected in accordance with the procedures described in paragraphs 
(c)(1)(i) or (c)(1)(ii) of this section:
    (i) Procedure for sampling in broth. Authorized laboratories will 
provide capped tubes 1-2 cm in diameter and 15-20 cm in length which are 
two-thirds full of a recently made, refrigerated, sterile enrichment 
broth (Selenite Brilliant Green Sulfapyridine or Tetrathionate Brilliant 
Green) for each sample. Sufficient tubes should be taken to the premises 
to provide at least one tube per pen or one tube per 500 birds, 
whichever is greater. At least one sterile, cotton-tipped applicator 
will be needed for each tube. The dry applicator is first placed or 
drawn through fresh manure (under roost, near water troughs, cecal 
droppings, or diarrhetic droppings). After this and each subsequent 
streaking, the cotton-tipped applicator is placed in the tube of broth 
and swirled to remove the collected material. The applicator is then 
withdrawn and is used for taking additional specimens by streaking on or 
through areas where defecation, trampling of feces, or settling of dust 
are common; i.e., on or near waterers, feeders, nests, or rafters, etc. 
When the volume of material collected equals approximately 10 percent of 
the volume of the broth (usually 10-12 streakings), the applicator is 
placed in the tube and the stick is broken in half. The lower or cotton-
tipped half is left in the broth, and the upper half is retained for 
future disposal. The cap is then replaced on the inoculated tube, and 
the sampling procedure is continued in other areas of the pen.
    (ii) Procedure for sampling in dry containers. A sample of fecal 
material, litter, or dust is placed in a sterile, sealable container. 
The sample shall consist of several specimens of material taken from a 
representative location in the pen or house. At least 10 g 
(approximately a heaping tablespoonful) of material shall be collected 
for each sample. The specimens in each sample shall be collected with a 
sterile tongue depressor or similar uncontaminated instrument. The 
samples should vary in type and consistency. Half of the samples should 
be comprised of material representing defecated matter from a large 
portion of the flock; i.e., trampled, caked material near waterers and 
feeders. The minimum number of samples to be taken shall be determined 
by the following:

Five samples from pens or houses of up to 500 birds;
Ten samples from pens or houses of 500 to 2,500 birds;
Fifteen samples from pens or houses with more than 2,500 birds.

    The composite samples above may be pooled to not less than five 
samples at the laboratory as long as the volume of material collected 
equals approximately 10 percent of the volume of the broth.
    (2) Cloacal swabs. Cloacal swabs for bacteriological examination are 
taken from each bird in the flock or from a minimum of 500 birds in 
accordance with the procedure described in paragraph (c)(2)(i) of this 
section.
    (i) Procedure for taking cloacal swabs. The authorized laboratory 
will provide sterile capped tubes or other suitable containers and 
cotton-tipped applicators for use in taking the cloacal swabs. The 
cotton-tipped applicator is inserted into the cloaca and rectum in such 
a manner as to insure the collection of fecal material. The swab and 
adhering fecal material is then placed in the tube and the stick is 
broken in half, with the upper half retained for future disposal. The 
cloacal swabs may be combined in the sterile tubes in multiples of five 
or in combinations specified by the authorized laboratory.
    (ii) [Reserved]

[[Page 848]]

    (3) Drag-swabs. Drag-swabs for bacteriological examination should 
involve the exposure of at least six unpooled pads per house to promote 
representative sampling and some element of quantification.
    (i) Drag-swab assembly. Assemble drag-swab sampling sets from 
folded-once 3-by-3-inch sterile gauze pads secured with paper clips. 
Bend end wires of each paper clip slightly to catch into the swab 
fabric, thus securing the clips to the folded pads. Use two pads, 
assembled as described to make each drag-swab sampling set. Securely 
connect one pad through the free rounded end of the paper clip to a 2-ft 
(0.6 m) length of size 20 fibrous wrapping twine. Similarly connect the 
other pad to a 1-ft (0.3 m) length of twine. Then securely connect the 
free ends of both lengths of twine to a small loop tied at the end of a 
similar 5-ft length of twine. The resulting assembly resembles the 
letter Y with a 5-ft long vertical stem and two diagonal branches (one 1 
ft long and the other 2 ft long), with a folded swab securely attached 
at the end of each branch. After assembly, place each two-pad drag-swab 
sampling set into a sterile bag.
    (ii) Procedure for taking drag-swab--(A) Floor litter: The Plan 
participants should collect two samples as follows: Drag four 3-by-3-
inch sterile gauze pads premoistened with double strength skim milk \13\ 
over the floor litter surface for 15 min minimally. Place the gauze pads 
used to collect the samples in 18-oz whirl-pack bags, two pads per bag 
with each bag containing 5 ml of double strength skim milk. This will 
maintain the moistness of the sample during transport. Mark the bags 
with the type of sample and the house identification.
---------------------------------------------------------------------------

    \13\ Obtain procedure for preparing double strength skim milk from 
USDA-APHIS ``Recommended Sample Collection Methods for Environmental 
Samples'' available from the National Poultry Improvement Plan, 
Veterinary Services, APHIS, USDA, 1498 Klondike Road, Suite 200, 
Conyers, GA 30094.
---------------------------------------------------------------------------

    (B) Nest-boxes. The Plan participant should collect one nest-box 
sample by using two 3-by-3-inch sterile gauze pads premoistened with 
double strength skim milk. Wipe the two gauze pads used to collect the 
sample over assorted locations of about 10 percent of the total nesting 
area. Place the gauze pads used to collect the sample in an 18-oz whirl-
pack bag containing 5 ml of double strength skim milk. Mark the bag with 
the type of sample and the house identification.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[38 FR 13709, May 24, 1973. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 57 FR 57342, Dec. 4, 1992; 59 FR 12805, Mar. 18, 1994; 59 
FR 67617, Dec. 30, 1994; 61 FR 11524, Mar. 21, 1996; 62 FR 44070, Aug. 
19, 1997; 63 FR 3, Jan. 2, 1998; 65 FR 8019, Feb. 17, 2000; 67 FR 8471, 
Feb. 25, 2002; 68 FR 64512, Nov. 14, 2003]



Sec.  147.13  Procedure for bacteriological culturing of eggshells for 
colon bacilli organisms.

    Proper precautions to avoid environmental contamination of the 
samples during the collection and laboratory process, and proper 
handling of the samples following collection are essential. Each State 
Inspector involved in eggshell culture activities must receive 
instruction in the necessary sanitation procedures, sampling procedures, 
and sample handling by the authorized laboratory involved. The Official 
State Agency will maintain a record showing that the required 
instruction was given to each State Inspector.
    (a) Sample selection. Forty (40) eggs in the top flats of each of 
three randomly selected cases of sanitized eggs from each flock will be 
utilized for each sampling.
    (b) Swab procedure. A 2.5 centimeter diameter circular area of the 
large end of each of the eggs will be rubbed with a sterile swab 
previously moistened with sterile lactose broth, or other suitable 
liquid media provided by the authorized laboratory. One swab will be 
used for five eggs, and four swabs will be pooled to each sterile, 
capped tube provided by the authorized laboratory.
    (1) From the tube containing four swabs and lactose broth or other 
suitable media, 1 ml. will be transferred to 10 ml. lactose in a 
fermentation tube.
    (2) Incubate at 37 [deg]C for 48 hours. The presence of acid, and 
gas in the amount of 10 percent or more after 24 and 48

[[Page 849]]

hours of incubation, provides a presumptive conclusion of the presence 
of colon bacilli organisms.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[41 FR 14256, Apr. 2, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 59 FR 12805, Mar. 18, 1994]



Sec.  147.14  Procedures to determine status and effectiveness of 
sanitation monitored program.

    The following monitoring procedures \14\ may be applied at the 
discretion of the Official State Agency:
---------------------------------------------------------------------------

    \14\ Laboratory procedures for monitoring operations proposed here 
are described in the following two publications: Isolation and 
Identification of Avian Pathogens, American Association of Avian 
Pathologists, University of Pennsylvania, New Bolton Center, Kennett 
Square, Pennsylvania 19348--1692, 1980, and Culture Methods for the 
Detection of Animal Salmonellosis and Arizonosis, Iowa State University 
Press, Ames, Iowa 50010, 1976.
---------------------------------------------------------------------------

    (a) Monitor effectiveness of sanitation program.
    (1) Culture the surface of cased eggs periodically for fecal 
contaminating organisms as described in Sec.  147.13.
    (2) Culture a sample of dead-in-shell eggs periodically from each 
breeding flock for coliforms. Such eggs should also be cultured for the 
dependable recovery of salmonellae. Culturing for the dependable 
recovery of salmonellae should include the use of:
    (i) Preenrichment broths supplemented with 35 mg ferrous sulfate per 
1,000 ml preenrichment to block iron-binding, Salmonella-inhibiting 
effects of egg conalbumin; and
    (ii) Tetrathionate selective enrichment broths, competitor-
controlling plating media (XLT4, BGN, etc.), delayed secondary 
enrichment procedures, and colony lift assays detailed in paragraph 
(a)(5) and illustration 2 of Sec.  147.11.

[41 FR 48726, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 57 FR 57343, Dec. 4, 1992; 59 FR 12805, Mar. 18, 1994; 59 
FR 59640, Nov. 18, 1994; 61 FR 11524, 11525, Mar. 21, 1996; 65 FR 8019, 
Feb. 17, 2000]



Sec.  147.15  Laboratory procedure recommended for the bacteriological 
examination of mycoplasma reactors.\15\
---------------------------------------------------------------------------

    \15\ Yoder, H. W., Jr., ``Mycoplasmosis.'' In: Isolation and 
Identification of Avian Pathogens. (Stephen B. Hitchner, Chairman, 
Charles H. Domermuth, H. Graham Purchase, James E. Williams.) 1980, pp. 
40-42, Creative Printing Company, Inc., Endwell, NY 13760.
---------------------------------------------------------------------------

    (a) Turbinates, trachea, air sacs, sinuses, nasal passages, 
respiratory exudates, synovial fluid, eggs (including yolk, yolk sacs, 
membranes and allantoic fluid), should be directly sampled with sterile 
swabs. Aseptic techniques are very important as some organisms may not 
be suppressed by the antimicrobial agents used in this procedure. Tissue 
suspensions from large volumes are sometimes desirable from the sites 
listed above and occasionally from the oviduct and cloaca. Tissues 
should be ground or blended completely in 10 times their volume of 
Mycoplasma Broth Medium (MBM). (See paragraph (f) of this section.) 
Specimens submitted to referral laboratories in order of preference for 
recovery of the mycoplasma organisms are: (1) live birds, (2) 
refrigerated fresh tissues, (3) tissue specimens packed with dry ice.
    (b) Inoculate 5-10 ml of MBM with a swab, wire loop or 0.1 ml of the 
tissue suspension. When evidence of growth is observed (lowered pH or 
turbidity of broth) transfer each broth culture as needed to maintain 
the original isolates. Incubate tubes at 37 [deg]C for at least 21 days 
before discarding as negative. When growth is first observed or if no 
growth occurs by the 4th or 5th day of incubation, inoculate broth 
culture onto a plate of Mycoplasma Agar Medium (MAM). (See paragraph (g) 
of this section.) Several cultures may be inoculated on one plate by 
using a wire loop or a cotton swab. Incubate plates 3-5 days at 37 
[deg]C in a high humidity chamber. If preferred, 5 percent CO\2\ may be 
added or a candle jar may be used. Tiny circular and translucent 
colonies with elevated centers are very suggestive of mycoplasma. 
Indirect lighting and a low power or dissecting

[[Page 850]]

microscope are recommended for observation of the colonies as they are 
rarely more than 0.2-0.3 mm in diameter.
    (c) Isolates must be serotyped.
    (1) Isolates may be shipped in MBM with ice packs if shipment will 
be in transit less than 2-3 days. Longer shipments require freezing of 
the MBM with dry ice, or shipping MAM slants at room temperature. 
Isolates must have indications of growth before shipment is made.
    (2) Isolates may be stored in MBM at -20 [deg]C for 2-3 weeks, or 
they may be stored at -68 [deg]C for several years.
    (d) Alternate method of culture: An overlay enrichment culture for 
fastidious and sensitive mycoplasma, especially for M. meleagridis 
should be included.
    (1) Pour 2-3 ml of MAM into a test tube and tilt the tube until a 
slant (approximately 45[deg]) is obtained. Other containers are 
acceptable.
    (2) Overlay the slant with sufficient MBM, so that the media 
(including inoculum) covers the agar slope.
    (3) Inoculate the culture as indicated in paragraph (b) of this 
section.
    (4) Incubate and examine the overlay as indicated in paragraph (b) 
of this section.
    (e) Preparation of media components:\16\
---------------------------------------------------------------------------

    \16\ Trade names are used in these procedures solely for the purpose 
of providing specific information. Mention of a trade name does not 
constitute a guarantee or warranty of the product by the U.S. Department 
of Agriculture or an endorsement over other products not mentioned.
---------------------------------------------------------------------------

    (1) Deionized distilled water suitable for cell culture fluids 
should be used.
    (2) All glassware should be carefully washed with a nonresidue 
detergent such as Alcojet and rinsed three times in tap water and twice 
in deionized distilled water.\17\
---------------------------------------------------------------------------

    \17\ Alcojet is available from: Alconox, Inc., New York, NY 10003.
---------------------------------------------------------------------------

    (3) Thallium acetate in a 10 percent solution is added to an 
approximate final concentration of 1:4000; however, highly contaminated 
specimens may require a final concentration of 1:2000.\18\ Thallium 
acetate is added to deionized distilled water first, except as noted in 
paragraph (e)(4) of this section, to prevent the precipitation of 
proteins.
---------------------------------------------------------------------------

    \18\ Thallium acetate may be obtained from Fischer Scientific 
Company.
---------------------------------------------------------------------------

    (4) Mycoplasma Broth Base, dextrose, phenol red, and cysteine 
hydrochloride are added to deionized distilled water first if autoclave 
sterilization is used.\19\ Thallium acetate and then the remaining 
components are added aseptically after cooling the autoclaved media to 
45 [deg]C or less.
---------------------------------------------------------------------------

    \19\ Mycoplasma Broth Base may be obtained from: (a) Product 
M 33600, Gibco Diagnostics, 2801 Industrial Drive, Madison, WI 
53711. (b) Product 3900-3212, Scott Laboratories, Inc., 8 
Westchester Plaza, Elmsford, NY 10523.
---------------------------------------------------------------------------

    (5) Use sterile deionized distilled water to reconstitute 
penicillin.
    (6) Sterile serum should be inactivated by heating at 56 [deg]C for 
30 minutes. Swine serum may be used for M. gallisepticum, M. synoviae, 
M. gallinarum, and M. meleagridis isolation; however, horse serum is 
usually recommended for M. meleagridis isolation.
    (7) Phenol red should be prepared as a 1 percent solution.
    (8) NAD (beta nicotinamide adenine dinucleotide or coenzyme I) 
should be prepared as a 1 percent solution.\20\
---------------------------------------------------------------------------

    \20\ NAD Grade III may be obtained from: Sigma Chemical Company, 
P.O. Box 14508, St. Louis, MO 63178.
---------------------------------------------------------------------------

    (9) Cysteine hydrochloride, prepared as a 1 percent solution, is 
used to reduce the NAD for M. synoviae growth.
    (10) A purified agar product such as Nobel (Special agar) is used in 
the MAM.\21\
---------------------------------------------------------------------------

    \21\ Noble Agar may be obtained from: Difco Laboratories, Box 1058-
A, Detroit, MI 48201.
---------------------------------------------------------------------------

    (11) Adjust the pH with NaOH.
    (12) Sterilization may be accomplished by two methods:
    (i) Filtration sterilization through a 0.20 micron filter is the 
recommended method. Aseptic techniques must be utilized.
    (ii) Autoclave sterilization at 120 [deg]C, 15 pounds pressure (103 
kPa), for 15 minutes may be used, if preferred, when following the 
procedure described in paragraph (e)(4) of this section.
    (13) Phenol red, dextrose, and NAD may be omitted when culturing for 
M. meleagridis and M. gallinarum.
    (14) When culturing for M. meleagridis from contaminated samples 
include 100 units/ml of Polymyxin B in MBM.

[[Page 851]]

    (f) Mycoplasma Broth Medium (Frey) is prepared as follows: To 850-
880 ml of deionized distilled water;
    Add:
Thallium acetate (ml)--2.5 (1:4000)
Potentially contaminated samples (ml)--5.0 (1:2000)
Mycoplasma Broth Base (g)--22.5
Aqueous penicillin (units)--500,000
Sterile serum (ml)--120 to 150.0
Phenol red plus (ml)--2.5
NAD (ml)--12.5
Cysteine hydrochloride (ml)--12.5
Dextrose (g)--1.0-1.5
Adjust pH to 7.8
Filter sterilize

    (1) Broth may be stored at 4 [deg]C for at least 2 weeks or at -40 
[deg]C for longer periods.
    (g) Mycoplasma Agar Medium (Frey) is prepared as follows: To 850-880 
ml of deionized distilled water;
    Add:
Mycoplasma Broth Base (g)--22.5
Adjust pH to 7.8
Purified agar (g)--12.0
Autoclave and cool in 45 [deg]C water bath
Thallium acetate (ml)--2.0; (1:4000)
Sterile serum at 45 [deg]C (ml)--150.0
Aqueous penicillin (units)--400,000
NAD (ml)--12.5
Cysteine hydrochloride (ml)--12.5

    (1) Rotate flask gently and pour about 15 ml of media into each 
petri dish.
    (2) Stack petri dishes only 2-3 high in a 37 [deg]C incubator up to 
2 hours to remove excess moisture.
    (3) Wrap inverted plates in sealed bundles and store at 4 [deg]C for 
not more than 15 days.
    (h) New component or media batches should be monitored to compensate 
for changes in formulation due to alterations of purity, concentration, 
preparation, etc. A known series of titrations from a single culture 
should be made on both new and old media. The media should be compared 
on the basis of growth, colony size, and numbers of colonies which 
develop.\22\
---------------------------------------------------------------------------

    \22\ ``Laboratory Procedures and Medium For The Isolation Of 
Mycoplasma From Clinical Materials.'' Laboratory Diagnosis of Mycoplasma 
in Food Animals, Proceedings of Nineteenth Annual Meeting, The American 
Association of Veterinary Laboratory Diagnosticians, 1976, pp. 106-115, 
AAVLD, 6101 Mineral Point Road, Madison, WI 53705.

[47 FR 21995, May 20, 1982, as amended at 57 FR 57343, Dec. 4, 1992; 59 
FR 12805, Mar. 18, 1994; 61 FR 11524, Mar. 21, 1996; 65 FR 8019, Feb. 
17, 2000]



Sec.  147.16  Procedure for the evaluation of mycoplasma reactors by in 
vivo bio-assay (enrichment).

    This procedure has been shown to be sensitive enough to detect less 
than 100 mycoplasma organisms under proper conditions.\23\ Proper 
conditions are defined in this section.
---------------------------------------------------------------------------

    \23\ Research results are described in the following two 
publications: (a) Bigland, C. H. and A. J. DaMassa, ``A Bio-Assay for 
Mycoplasma Gallisepticum.'' In: United States Livestock Sanitary 
Association Proceedings, 67th, 1963, pp. 541-549. (b) McMartin, D. A., 
``Mycoplasma Gallisepticum in the Respiratory Tract of the Fowl.'' In: 
The Veterinary Record, September 23, 1967, pp. 317-320.
---------------------------------------------------------------------------

    (a) Obtain chickens or turkeys (test birds) which are at least 3 
weeks of age and are free of M. gallisepticum, M. synoviae, and M. 
meleagridis and transport them in a manner to prevent their being 
contaminated by any infectious avian disease.
    (1) Maintain test birds in an area that has been effectively cleaned 
and disinfected.
    (2) The area should be isolated from other birds or animals.
    (3) Personnel caring for the test birds should take the necessary 
precautions (see Sec.  147.26(b)) to prevent the mechanical transfer of 
infectious avian diseases from other sources.
    (b) Test birds to be used for inoculation with contaminated tissues 
should be serologically negative by the serum plate agglutination test.
    (1) Inoculated test birds should be isolated from non-inoculated 
control birds for the length of any experiment.
    (c) Aseptically obtain tracheal, turbinate, and sinus mucosa, lung 
and sinus exudates, cervical, thoracic, and abdominal airsac tissues 
(including lesions), and portions of oviduct and synovial fluid from at 
least four suspect, donor birds. In a sterile device, blend the tissues 
completely in four times their volume of Mycoplasma Broth Medium (Frey), 
(see Sec.  147.15(f)). Suspensions may be made from tissue pools. 
Inoculate test birds within 30 minutes for preparation of suspensions.

[[Page 852]]

    (1) Inoculate at least four test birds for each suspension pool via 
the abdominal air sac and infraorbital sinus, with up to \1/2\ ml of 
inoculum per site.
    (2) Test birds should be bled every 7 days for 35 days to identify 
sero-converters.
    (3) At 35 days, test birds should be sacrificed and bacteriologic 
isolation and identification of mycoplasma attempted (see Sec.  147.15). 
Note especially the sites of inoculation for typical gross or 
microscopic mycoplasma lesions.
    (d) Donor birds are considered infected when:
    (1) Test birds have serum plate antibodies for the mycoplasma for 
which the donor birds were tested, regardless of HI test results, and 
control birds stay serologically negative; or
    (2) Mycoplasma organisms are isolated from the test birds and 
serotyped positive for the mycoplasma for which the donor birds were 
tested, and control birds stay serologically and culturally negative.
    (e) Laboratory findings may be verified by direct cultures of 
material from sick birds or by inoculating seronegative birds from the 
suspect flock and comparing serological findings with those from the 
test birds.

[47 FR 21996, May 20, 1982, as amended at 57 FR 57343, Dec. 4, 1992; 59 
FR 12805, Mar. 18, 1994; 61 FR 11524, Mar. 21, 1996; 65 FR 8019, Feb. 
17, 2000]



Sec.  147.17  Laboratory procedure recommended for the bacteriological 
examination of cull chicks for salmonella.

    The laboratory procedure described in this section is recommended 
for the bacteriological examination of cull chicks from egg-type and 
meat-type chicken flocks and waterfowl, exhibition poultry, and game 
bird flocks for salmonella.
    (a) From 25 randomly selected 1- to 5-day-old chicks that have not 
been placed in a brooding house, prepare 5 organ pools, 5 yolk pools, 
and 5 intestinal tissue pools as follows:
    (1) Organ pool: From each of five chicks, composite and mince 1- to 
2-gram samples of heart, lung, liver, and spleen tissues and the 
proximal wall of the bursa of Fabricius.
    (2) Yolk pool: From each of five chicks, composite and mince 1- to 
2-gram samples of the unabsorbed yolk sac or, if the yolk sac is 
essentially absent, the entire yolk stalk remnant.
    (3) Intestinal pool: From each of five chicks, composite and mince 
approximately 0.5 cm\2\ sections of the crop wall and 5-mm-long sections 
of the duodenum, cecum, and ileocecal junction.
    (b) Transfer each pool to tetrathionate selective enrichment broth 
(Hajna or Mueller-Kauffmann) at a ratio of 1 part tissue pool to 10 
parts broth.
    (c) Repeat the steps in paragraphs (a) and (b) of this section for 
each five-chick group until all 25 chicks have been examined, producing 
a total of 15 pools (5 organ, 5 yolk, and 5 intestinal).
    (d) Culture the 15 tetrathionate pools as outlined for selective 
enrichment in illustration 2 of Sec.  147.11. Incubate the organ and 
yolk pools for 24 hours at 37 [deg]C and the intestinal pools at 41.5 
[deg]C. Plate as described in illustration 2 of Sec.  147.11 and examine 
after both 24 and 48 hours of incubation. Confirm suspect colonies as 
described. Further culture all salmonella-negative tetrathionate broths 
by delayed secondary enrichment procedures described for environmental, 
organ, and intestinal samples in illustration 2 of Sec.  147.11. A 
colony lift assay may also be utilized as a supplement to TSI and LI 
agar picks of suspect colonies.

[61 FR 11525, Mar. 21, 1996]



                     Subpart C_Sanitation Procedures



Sec.  147.21  Flock sanitation.

    To aid in the maintenance of healthy flocks, the following 
procedures should be practiced:
    (a) Baby poultry should be started in a clean brooder house and 
maintained in constant isolation from older birds and other animals. 
Personnel that are in contact with older birds and other animals should 
take precautions, including disinfection of footwear and change of outer 
clothing, to prevent the introduction of infection through droppings 
that may adhere to the shoes, clothing, or hands. (See Sec.  147.24(a).)
    (b) Range used for growing young stock should not have been used for

[[Page 853]]

poultry the preceding year. Where broods of different ages must be kept 
on the same farm, there should be complete depopulation of brooder 
houses and other premises following infection of such premises by any 
contagious disease.
    (c) Poultry houses should be screened and proofed against free-
flying birds. An active rodent eradication campaign is an essential part 
of the general sanitation program. The area adjacent to the poultry 
house should be kept free from accumulated manure, rubbish, and 
unnecessary equipment. Dogs, cats, sheep, cattle, horses, and swine 
should never have access to poultry operations. Visitors should not be 
admitted to poultry areas, and authorized personnel should take the 
necessary precautions to prevent the introduction of disease.
    (d) Poultry houses and equipment should be thoroughly cleaned and 
disinfected prior to use for a new lot of birds. (See Sec.  147.24(a).) 
Feed and water containers should be situated where they cannot be 
contaminated by droppings and should be frequently cleaned and 
disinfected. Dropping boards or pits should be constructed so birds do 
not have access to the droppings.
    (e) Replacement breeders shall be housed at the proper density 
consistent with the type of building and locality and which will allow 
the litter to be maintained in a dry condition. Frequent stirring of the 
litter may be necessary to reduce excess moisture and prevent surface 
accumulation of droppings. Slat or wire floors should be constructed so 
as to permit free passage of droppings and to prevent the birds from 
coming in contact with the droppings. Nesting areas should be kept clean 
and, where appropriate, filled with clean nesting material.
    (f) When an outbreak of disease occurs in a flock, dead or sick 
birds should be taken, by private carrier, to a diagnostic laboratory 
for complete examination. All Salmonella cultures isolated should be 
typed serologically, and complete records maintained by the laboratory 
as to types recovered from each flock within an area. Records on 
isolations and serological types should be made available to Official 
State Agencies or other animal disease control regulatory agencies in 
the respective States for followup of foci of infection. Such 
information is necessary for the development of an effective Salmonella 
control program.
    (g) Introduction of started or mature birds should be avoided to 
reduce the possible hazard of introducing infectious diseases. If birds 
are to be introduced, the health status of both the flock and introduced 
birds should be evaluated.
    (h) In rearing broiler or replacement stock, a sound and adequate 
immunization program should be adopted. Since different geographic areas 
may require certain specific recommendations, the program recommended by 
the State experiment station or other State agencies should be followed.
    (i) Feed, pelleted by heat process, should be fed to all age groups. 
Proper feed pelleting procedures can destroy many disease producing 
organisms contaminating feedstuffs.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23121, Dec. 3, 1971, as amended at 41 FR 14257, Apr. 2, 1976; 41 
FR 48726, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and 
amended at 50 FR 19900, May 13, 1985; 59 FR 12805, Mar. 18, 1994]



Sec.  147.22  Hatching egg sanitation.

    Hatching eggs should be collected from the nests at frequent 
intervals and, to aid in the prevention of contamination with disease-
causing organisms, the following practices should be observed:
    (a) Cleaned and disinfected containers, such as egg flats, should be 
used in collecting the nest eggs for hatching. Egg handlers should 
thoroughly wash their hands with soap and water prior to and after egg 
collection. Clean outer garments should be worn.
    (b) Dirty eggs should not be used for hatching purposes and should 
be collected in a separate container from the nest eggs. Slightly soiled 
nest eggs may be gently dry cleaned by hand.
    (c) Hatching eggs should be stored in a designated egg room under 
conditions that will minimize egg sweating. The egg room walls, ceiling, 
floor, door, heater, and humidifier should be cleaned and disinfected 
after every egg

[[Page 854]]

pickup. Cleaning and disinfection procedures should be as outlined in 
Sec.  147.24.
    (d) The egg processing area should be cleaned and disinfected daily.
    (e) Effective rodent and insect control programs should be 
implemented.
    (f) The egg processing building or area should be designed, located, 
and constructed of such materials as to assure that proper egg 
sanitation procedures can be carried out, and that the building itself 
can be easily, effectively, and routinely sanitized.
    (g) All vehicles used for transporting eggs or chicks/poults should 
be cleaned and disinfected after use. Cleaning and disinfection 
procedures should be as outlined in Sec.  147.24.

[67 FR 8474, Feb. 25, 2002]



Sec.  147.23  Hatchery sanitation.

    An effective program for the prevention and control of Salmonella 
and other infections should include the following measures:
    (a) An effective hatchery sanitation program should be designed and 
implemented.
    (b) The hatchery building should be arranged so that separate rooms 
are provided for each of the four operations: Egg receiving, incubation 
and hatching, chick/poult processing, and egg tray and hatching basket 
washing. Traffic and airflow patterns in the hatchery should be from 
clean areas to dirty areas (i.e., from egg room to chick/poult 
processing rooms) and should avoid tracking from dirty areas back into 
clean areas.
    (c) The hatchery rooms, and tables, racks, and other equipment in 
them should be thoroughly cleaned and disinfected frequently. All 
hatchery wastes and offal should be burned or otherwise properly 
disposed of, and the containers used to remove such materials should be 
cleaned and sanitized after each use.
    (d) The hatching compartments of incubators, including the hatching 
trays, should be thoroughly cleaned and disinfected after each hatch.
    (e) Only clean eggs should be used for hatching purposes.
    (f) Only new or cleaned and disinfected egg cases should be used for 
transportation of hatching eggs. Soiled egg case fillers should be 
destroyed.
    (g) Day-old chicks, poults, or other newly hatched poultry should be 
distributed in clean, new boxes and new chick papers. All crates and 
vehicles used for transporting birds should be cleaned and disinfected 
after each use.

[67 FR 8474, Feb. 25, 2002]



Sec.  147.24  Cleaning and disinfecting.

    The following procedures are recommended:
    (a) In the poultry houses:
    (1) Remove all live ``escaped'' and dead birds from the building. 
Blow dust from equipment and other exposed surfaces. Empty the residual 
feed from the feed system and feed pans and remove it from the building. 
Disassemble feeding equipment and dump and scrape as needed to remove 
any and all feed cake and residue. Clean up spilled feed around the tank 
and clean out the tank. Rinse down and wash out the inside of the feed 
tank to decontaminate the surfaces and allow to dry.
    (2) Remove all litter and droppings to an isolated area where there 
is no opportunity for dissemination of any infectious disease organisms 
that may be present. Housing where poultry infected with a mycoplasmal 
disease were kept should remain closed for 7 days before removal of the 
litter.
    (3) Wash down the entire inside surfaces of the building and all the 
installed equipment such as curtains, ventilation ducts and openings, 
fans, fan housings and shutters, feeding equipment, watering equipment, 
etc. Use high pressure and high volume water spray (for example 200 
pounds per square inch and 10 gallons per minute or more) to soak into 
and remove the dirt to decontaminate the building. Scrub the walls, 
floors, and equipment with a hot soapy water solution. Rinse to remove 
soap.
    (4) Spray with a disinfectant which is registered by the 
Environmental Protection Agency as germicidal, fungicidal, 
pseudomonocidal, and tuberculocidal, in accordance with the 
specifications for use, as shown on the label of such disinfectant.
    (b) In the hatchers and hatchery rooms:

[[Page 855]]

    (1) Use cleaning agents and sanitizers that are registered by the 
U.S. Environmental Protection Agency as germicidal, fungicidal, 
pseudomonocidal, and tuberculocidal. Use manufacturer's recommended 
dilution. Remove loose organic debris by sweeping, scraping, vacuuming, 
brushing, or scrubbing, or by hosing surface with high pressure water 
(for example 200 pounds per square inch and 10 gallons per minute or 
more). Remove trays and all controls and fans for separate cleaning. Use 
hot water (minimum water temperature of 140 [deg]F) for cleaning 
hatching trays and chick separator equipment. Thoroughly wet the 
ceiling, walls, and floors with a stream of water, then scrub with a 
hard bristle brush. Use a cleaner/sanitizer that can penetrate protein 
and fatty deposits. Allow the chemical to cling to treated surfaces at 
least 10 minutes before rinsing off. Manually scrub any remaining 
deposits of organic material until they are removed. Rinse until there 
is no longer any deposit on the walls, particularly near the fan 
opening, and apply disinfectant. Use a clean and sanitized squeegee to 
remove excess water, working down from ceilings to walls to floors and 
being careful not to recontaminate cleaned areas.
    (2) Replace the cleaned fans and controls. Replace the trays, 
preferably still wet from cleaning, and bring the incubator to normal 
operating temperature.
    (3) The hatcher should be fumigated (see Sec.  147.25) or otherwise 
disinfected prior to the transfer of the eggs.
    (4) If the same machine is used for incubating and hatching, the 
entire machine should be cleaned after each hatch. A vacuum cleaner 
should be used to remove dust and down from the egg trays; then the 
entire machine should be vacuumed, mopped, and fumigated (see Sec.  
147.25) or otherwise sanitized.
    (c) The egg and chick/poult delivery truck drivers and helpers 
should use the following good biosecurity practices while picking up 
eggs or delivering chicks/poults:
    (1) Spray truck tires thoroughly with disinfectant before leaving 
the main road and entering the farm driveway.
    (2) Put on sturdy, disposable plastic boots or clean rubber boots 
before getting out of the truck cab. Put on a clean smock or coveralls 
and a hairnet before entering the poultry house.
    (3) After loading eggs or unloading chicks/poults, remove the dirty 
smock/coveralls and place into plastic garbage bag before loading in the 
truck. Be sure to keep clean coveralls separate from dirty ones.
    (4) Reenter the cab of the truck and remove boots before placing 
feet onto floorboards. Remove hairnet and leave with disposable boots on 
farm.
    (5) Sanitize hands using appropriate hand sanitizer.
    (6) Return to the hatchery or go to the next farm and repeat the 
process.

[36 FR 23121, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 49 FR 19806, May 10, 1984; 57 FR 57343, Dec. 4, 1992; 63 
FR 3, Jan. 2, 1998; 67 FR 8474, Feb. 25, 2002]



Sec.  147.25  Fumigation.

    Fumigation may be used for sanitizing eggs and hatchery equipment or 
rooms as a part of a sanitation program. APHIS disclaims any liability 
in the use of formaldehyde for failure on the part of the user to adhere 
to the Occupational Safety and Health Administration (OSHA) standards 
for formaldehyde fumigation, published in the Dec. 4, 1987, Federal 
Register (52 FR 46168, Docket Nos. H-225, 225A, and 225B).

[36 FR 23121, Dec. 3, 1971, as amended at 41 FR 14257, Apr. 2, 1976. 
Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19807, 
May 10, 1984; 54 FR 23958, June 5, 1989; 57 FR 57343, Dec. 4, 1992; 67 
FR 8475, Feb. 25, 2002]



Sec.  147.26  Procedures for establishing isolation and maintaining 

sanitation and good management practices for the control of Salmonella 
and Mycoplasma infections.

    (a) The following procedures are required for participation under 
the U.S. Sanitation Monitored, U.S. M. Gallisepticum Clean, U.S. M. 
Synoviae Clean, U.S. S. Enteritidis Monitored, and U.S. S. Enteritidis 
Clean classifications:
    (1) Allow no visitors except under controlled conditions to minimize 
the

[[Page 856]]

introduction of Salmonella and Mycoplasma. Such conditions must be 
approved by the Official State Agency and the Service;
    (2) Maintain breeder flocks on farms free from market birds and 
other domesticated fowl. Follow proper isolation procedures as approved 
by the Official State Agency;
    (3) Dispose of all dead birds by locally approved methods.
    (b) Recommended procedures:
    (1) Avoid the introduction of Salmonella, Mycoplasma gallisepticum, 
or Mycoplasma synoviae infected poultry;
    (2) Prevent indirect transmission from outside sources through 
contaminated equipment, footwear, clothing, vehicles, or other 
mechanical means;
    (3) Provide adequate isolation of breeder flocks to avoid airborne 
transmission from infected flocks;
    (4) Minimize contact of breeder flocks with free-flying birds;
    (5) Establish a rodent control program to keep the rodent population 
and other pests under control;
    (6) Tailor vaccination programs to needs of farm and area;
    (7) Clean and disinfect equipment after each use;
    (8) Provide clean footwear and provide an adequate security program;
    (9) Clean and disinfect houses before introducing a new flock;
    (10) Use clean, dry litter free of mold;
    (11) Keep accurate records of death losses;
    (12) Seek services of veterinary diagnostician if unaccountable 
mortality or signs of disease occur;
    (13) Adopt and maintain a clean-egg program.
    (14) Use only crates and vehicles that have been cleaned and 
disinfected in accordance with the provisions of Sec.  147.24(a) to haul 
live poultry to and from the premises.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[36 FR 23121, Dec. 3, 1971, as amended at 40 FR 1504, Jan. 8, 1975; 41 
FR 48727, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979; 47 
FR 746, Jan. 7, 1982; 47 FR 21996, May 20, 1982; 48 FR 57473, Dec. 30, 
1983; 61 FR 11525, Mar. 21, 1996; 67 FR 8475, Feb. 25, 2002]



Sec.  147.27  Procedures recommended to prevent the spread of disease 
by artificial insemination of turkeys.

    (a) The vehicle transporting the insemination crew should be left as 
far as practical from the turkey pens.
    (b) The personnel of the insemination crew should observe personal 
cleanliness, including the following sanitary procedures:
    (1) Outer clothing should be changed between visits to different 
premises so that clean clothing is worn upon entering each premises. The 
used apparel should be kept separate until laundered. This also applies 
to gloves worn while handling turkeys;
    (2) Boots or footwear should be cleaned and disinfected between 
visits to different premises;
    (3) Disposable caps should be provided and discarded after use on 
each premises.
    (c) The use of individual straw or similar technique is highly 
recommended. Insemination equipment which is to be reused should be 
cleaned and disinfected before reusing. Equipment used for the 
convenience of the workers should not be moved from premises to 
premises.
    (d) No obviously diseased flock should be inseminated. If evidence 
of active disease is noted after insemination is begun, operations 
should be stopped and the hatchery notified.
    (e) Care should be taken during the collection of semen to prevent 
fecal contamination. If fecal material is present, it should be removed 
before the semen is collected. Likewise, care should be taken not to 
introduce fecal material into the oviduct of the hen.

Subpart D [Reserved]



   Subpart E_Procedure for Changing National Poultry Improvement Plan



Sec.  147.41  Definitions.

    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.

[[Page 857]]

    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.
    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.

[36 FR 23121, Dec. 3, 1971, as amended at 38 FR 3038, Feb. 1, 1973. 
Redesignated at 44 FR 61586, Oct. 26, 1979; 59 FR 12805, Mar. 18, 1994]



Sec.  147.42  General.

    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.



Sec.  147.43  General Conference Committee.

    (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. 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 Federal Register announcement; and special 
inquiries for nominations from universities or colleges with minority/
disability enrollments and faculty members in poultry science or 
veterinary science.
    (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

[[Page 858]]

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) Recommended whether new proposals (i.e., proposals that have not 
been submitted as provided in Sec.  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 a forum 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.

[36 FR 23121, Dec. 3, 1971, as amended at 40 FR 1505, Jan. 8, 1975. 
Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 45 FR 10316, 
Feb. 15, 1980; 47 FR 21996, May 20, 1982; 50 FR 19900, May 13, 1985; 59 
FR 12805, Mar. 18, 1994; 61 FR 11525, Mar. 21, 1996; 65 FR 8023, Feb. 
17, 2000; 67 FR 8475, Feb. 25, 2002]



Sec.  147.44  Submitting, compiling, and distributing proposed changes.

    (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 Sec.  147.43(d)(2), 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

[[Page 859]]

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.

[36 FR 23121, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 49 FR 19807, May 10, 1984]



Sec.  147.45  Official delegates.

    Each cooperating State shall be entitled to one official delegate 
for each of the programs prescribed in subparts B, C, D, E, and F of 
part 145 of this chapter 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. Each official delegate 
shall endeavor to obtain, prior to the Conference, the recommendations 
of industry members of his State with respect to each proposed change.

[41 FR 48727, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 45 FR 10317, Feb. 15, 1980; 65 FR 8023, Feb. 17, 2000]



Sec.  147.46  Committee consideration of proposed changes.

    (a) The following five committees shall be established to give 
preliminary consideration to the proposed changes falling in their 
respective fields:
    (1) Egg-type chickens.
    (2) Meat-type chickens.
    (3) Turkeys.
    (4) Waterfowl, exhibition poultry, and game birds.
    (5) Ostriches, emus, rheas, and cassowaries.
    (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.
    (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.

[36 FR 23121, Dec. 3, 1971, as amended at 41 FR 48727, Nov. 5, 1976. 
Redesignated at 44 FR 61586, Oct. 26, 1979; 65 FR 8023, Feb. 17, 2000]



Sec.  147.47  Conference consideration of proposed changes.

    (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

[[Page 860]]

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 Sec.  
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 Sec.  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.

[36 FR 23121, Dec. 3, 1971, as amended at 41 FR 48727, Nov. 5, 1976. 
Redesignated at 44 FR 61586, Oct. 26, 1979]



Sec.  147.48  Approval of conference recommendations by the Department.

    Proposals adopted by the official delegates will be recommended to 
the Department for incorporation into the provisions of the NPIP. 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.

[[Page 861]]



                       SUBCHAPTER H_ANIMAL BREEDS





PART 151_RECOGNITION OF BREEDS AND BOOKS OF RECORD OF PUREBRED ANIMALS--Table of Contents



                               Definitions

Sec.
151.1 Definitions.

                    Certification of Purebred Animals

151.2 Issuance of a certificate of pure breeding.
151.3 Application for certificate of pure breeding.
151.4 Pedigree certificate.
151.5 Alteration of pedigree certificate.
151.6 Statement of owner, agent, or importer as to identity of animals.
151.7 Examination of animal.
151.8 Eligibility of an animal for certification.

                Recognition of Breeds and Books of Record

151.9 Recognized breeds and books of record.
151.10 Recognition of additional breeds and books of record.
151.11 Form of books of record.

    Authority: 19 U.S.C. 1202; 7 CFR 2.22, 2.80, and 371.4.

                               Definitions



Sec.  151.1  Definitions.

    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.
    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.
    (a) 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).
    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 Sec.  92.102 for birds, 
Sec.  92.203 for poultry, Sec.  92.303 for horses, Sec.  92.403 for 
ruminants, or Sec.  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

[[Page 862]]

the flock has been in existence at least ten years.

[23 FR 10103, Dec. 23, 1958, as amended at 24 FR 2643, Apr. 7, 1959; 26 
FR 6072, July 7, 1961; 36 FR 23356, Dec. 9, 1971; 54 FR 34969, 34970, 
Aug. 23, 1989; 55 FR 31562, Aug. 2, 1990]

                    Certification of Purebred Animals



Sec.  151.2  Issuance of a certificate of pure breeding.

    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.

[26 FR 6072, July 7, 1961, as amended at 54 FR 34969, Aug. 23, 1989]



Sec.  151.3  Application for certificate of pure breeding.

    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 Sec.  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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0011)

[26 FR 6072, July 7, 1961, as amended at 36 FR 23356, Dec. 9, 1971; 48 
FR 57473, Dec. 30, 1983; 55 FR 31562, Aug. 2, 1990]



Sec.  151.4  Pedigree certificate.

    A pedigree certificate for an animal of a breed listed in Sec.  
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 Sec.  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.

[26 FR 6072, July 7, 1961]



Sec.  151.5  Alteration of pedigree certificate.

    No pedigree certificate which in the opinion of the Administrator 
has been substantially altered will be accepted.

[23 FR 10104, Dec. 23, 1958, as amended at 54 FR 34969, Aug. 23, 1989]



Sec.  151.6  Statement of owner, agent, or importer as to identity of animals.

    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 Sec.  151.4. This form shall be 
presented to the inspector before the animal and pedigree certificate 
are examined as provided in Sec.  151.7.

[36 FR 23357, Dec. 9, 1971]



Sec.  151.7  Examination of animal.

    (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 Sec.  
92.600 of this chapter, and cats

[[Page 863]]

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 Sec.  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 Sec.  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.

[26 FR 6072, July 7, 1961, as amended at 54 FR 34970, Aug. 23, 1989; 55 
FR 31562, Aug. 2, 1990]



Sec.  151.8  Eligibility of an animal for certification.

    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 Sec.  151.9 and must not have been registered 
on inspection without regard to purity of breeding.

[23 FR 10104, Dec. 23, 1958]

                Recognition of Breeds and Books of Record



Sec.  151.9  Recognized breeds and books of record.

    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.

[[Page 864]]



                                 Cattle
------------------------------------------------------------------------
 Code     Name of breed    Book of record         By whom published
------------------------------------------------------------------------
  1101  Aberdeen-Angus..  Aberdeen-Angus    Aberdeen-Angus Cattle
                           Herd Book.        Society, Hugh R. Neilson,
                                             secretary, Pedigree House,
                                             17 Bon-Accord Sq.,
                                             Aberdeen, Scotland.
  1112  ......do........  New Zealand       New Zealand Aberdeen-Angus
                           Aberdeen-Angus    Cattle Breeders'
                           Herd Book.        Association, Post Office
                                             Box 83, Hastings, New
                                             Zealand.
   116  Aberdeen-Angus..  Irish Angus Herd  Irish Angus Cattle Society
                           Book.             Ltd., John L. Murphy,
                                             Secretary, Agriculture
                                             House, Kildare Street,
                                             Dublin 2, Ireland.
  1102  Africander......  Africander        The Africander Cattle
                           Cattle Herd       Breeders' Society, under
                           Book.             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  Royal Alderney Agricultural
                           Bailiwick of      Society (The Alderney
                           Guernsey          Branch of the Royal
                           (Alderney         Guernsey A. and H.
                           Branch).          Society), P.D. Sumner,
                                             secretary, The Bungalow,
                                             Butes, Alderney, Channel
                                             Isles.
  1202  Ayrshire........  Ayrshire Herd     Ayrshire Cattle Herd Book
                           Book.             Society of Great Britain
                                             and Ireland, John Graham,
                                             secretary, 1 Racecourse
                                             Rd., Ayr, Scotland.
  1301  Devon...........  Davy's Devon      Devon Cattle Breeders'
                           Herd Book.        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   Belted Galloway Cattle
                           Herd Book.        Society, J. Campbel Laing,
                                             secretary, Galloway Estate
                                             Office, Newton Stewart,
                                             Wigtownshire, Scotland.
  1104  Galloway........  Galloway Herd     Galloway Cattle Society of
                           Book.             Great Britain and Ireland,
                                             Donald M. McQueen,
                                             secretary, Roughhills,
                                             Dalbeattie, Scotland.
  1113  Gelbvieh........  Herd Book of the  American Gelbvieh
                           Gelbvieh.         Association, 10900 Dover
                                             Street, Westminster, CO
                                             80021.
  1203  Guernsey........  English Guernsey  English Guernsey Cattle
                           Herd Book.        Society, J. W. Barker,
                                             secretary, Mappin House,
                                             Winsley St., Oxford St.,
                                             London, W. 1, England.
  1204  ......do........  Herd Book of the  Royal Guernsey Agricultural
                           Baliwick of       and Horticultural Society,
                           Guernsey          H. C. Le Page, secretary,
                           (Guernsey         States Arcade Balcony, St.
                           Branch).          Peter Port, Guernsey,
                                             Channel Isles.
  1105  Hereford........  Herd Book of      Hereford Herd Book Society,
                           Hereford Cattle.  R.J. Bentley, secretary, 3
                                             Offa St., Hereford,
                                             England.
  1106  Highland........  Highland Herd     Highland Cattle Society of
                           Book.             Scotland, Donald G. Noble,
                                             secretary, 17 York Pl.,
                                             Perth, Scotland.
  1205  Holstein-         Friesch Rundvee-  Vereeniging: ``Het Friesch
         Friesian.         Stamboek.         Rundvee-Stamboek,'' Dr. J.
                                             M. Dijkstra, secretary,
                                             Zuiderplein 2-6,
                                             Leeuwarden, The
                                             Netherlands.
  1206  ......do........  Nederlandsch      Vereeniging: ``Het
                           Rundvee-          Nederlandsche Rundvee-
                           Stamboek.         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  Jersey Cattle Society of the
                           of United         United Kingdom, Edward
                           Kingdom.          Ashby, secretary, 19
                                             Bloomsbury Sq., London, W.
                                             C. 1, England.
  1303  Kerry...........  British Kerry     British Kerry Cattle
                           Cattle Herd       Society, R. O. Hubl,
                           Book.             secretary, The Milestone,
                                             Stanmore Hill, Stanmore,
                                             Middlesex, England.
  1304  ......do........  Kerry Cattle      Royal Dublin Society, Horace
                           Herd Book.        H. Poole, registrar, Ball's
                                             Bridge, Dublin, Ireland.
  1305  Lincoln Red.....  Lincoln Red Herd  Lincoln Red Cattle Society,
                           Book.             W. Dunnaway secretary,
                                             Agriculture House, Park
                                             St., Lincoln, England.
  1209  Red Danish......  Stambog over      De Samvirkende Danske
                           Koer af Rod       Landboforeninger, A. Wulff
                           Dansk Malkerace.  Pedersen, secretary,
                          Stambog over       Vindegade 72, Odense,
                           Tyre af Rod       Denmark.
                           Dansk Malkerace.
                          Register-Stambog
                           over Kvaeg af
                           Rod Dansk
                           Malkerace.
  1306  Red Poll........  Red Poll Herd     Red Poll Cattle Society of
                           Book.             Great Britain and Ireland,
                                             Inc., A. C. Burton,
                                             secretary, 32 Princes St.,
                                             Ipswich, Suffolk, England.
  1307  Shorthorn.......  Coates's Herd     Shorthorn Society of Great
                           Book.             Britain and Ireland, Arthur
                                             Greenhalgh, secretary,
                                             Victoria House, Southampton
                                             Row, London, W.C. 1,
                                             England.

[[Page 865]]

 
  1107  South Devon.....  Herd Book of      South Devon Herd Book
                           South Devon       Society, W. G. Turpitt,
                           Cattle.           secretary, 16 Sherborne
                                             Rd., Newton Abbot, Devon,
                                             England.
  1115  Simmental.......  Irish Simmental   Irish Simmental Cattle
                           Cattle Society.   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       Welsh Black Cattle Society,
                           Cattle Herd       G. Williams Edwards,
                           Book.             secretary, 13 Bangor St.,
                                             Caernarvon, No. Wales.
------------------------------------------------------------------------


                                 Horses
------------------------------------------------------------------------
 Code     Name of breed    Book of record         By whom published
------------------------------------------------------------------------
  2201  Arabian.........  Arab Horse Stud   The Arab Horse Society, Col.
                           Book.             R. C. de V. Askin,
                                             secretary, Beechmead,
                                             Rowledge, Farnham, Surrey,
                                             England.
  2202  ......do........  Polska Ksiega     Towarzystwo Hodowli Konia
                           Stadna Koni,      Arabskiego, Maria
                           Arabskich         Brykczynska, secretary,
                           Czystej Krwi.     Krako 1w, Sarego 2, Poland.
  2203  ......do........  General Stud      Weatherby & Sons, 15
                           Book.             Cavendish Sq., London, W.
                                             1, England.
  2204  ......do........  Registro-         Jefatura de Cria Caballar y
                           Matricula de      Remonta, Don Manuel Diaz
                           Caballos de       Calderon, Secretario Stud-
                           Pura Sangre.      book, Ministerio del
                                             Ejercito, Madrid, Spain.
  2205  ......do........  Stud Book         Ministerio de Hacienda de la
                           Argentino.        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         Commission du Studbook
                           Francais          Francais de Pur Sang, M.
                           Registre des      Maze-Sencier, Inspecteur
                           Chevaux de Pur    General, Chef, Service des
                           Sang.             Haras, Ministere de
                                             l'Agriculture, 78 rue de
                                             Varenne (7), Paris, France.
  2207  ......do........  Stud Book de      Instituto Nacional de
                           Venezuela.        Hipodromos, Jorge Coll
                                             Nunez, Jefe, Hipodromo ``La
                                             Rinconada,'' Caracas,
                                             Venezuela.
  2208  ......do........  The Arabian Stud  The Arabian Horse Club
                           Book.             Registry of America, Inc.,
                           (Recognition of   Henry B. Babson, secretary,
                           this book will    120 So. La Salle St.,
                           be restricted     Chicago 3, Ill.
                           to Arabian
                           horses which
                           originate for
                           importation in
                           Saudi Arabia,
                           or trace to
                           pure Arabian
                           stock of that
                           country.).
  2304  Arabian.........  Russian Arabian   Ministry of Agriculture
                           Stud Book of      USSR, All-Union Research
                           Moscow, Union     Institute of Horsebreeding.
                           of Soviet
                           Socialist
                           Republics.
  2101  Belgian.........  Stud-Book des     Societe 1 Royale ``Le Cheval
                           Chevaux de        de Trait Belge,'' Edgard
                           Trait Belges.     Bedoret, Secretaire
                                             general, 45a rue de
                                             l'Ecuyer, Brussels,
                                             Belgium.
  2209  Cleveland Bay...  Cleveland Bay     Cleveland Bay Horse Society,
                           Stud Book.        Oswald Welford, secretary,
                                             The Angelus, Roxby,
                                             Staithes, Saltburn,
                                             Yorkshire, England.
  2102  Clydesdale......  Clydesdale Stud-  Clydesdale Horse Society of
                           Book.             Great Britain & Ireland,
                                             Robert Jarvis, secretary,
                                             19 Hillington Gardens,
                                             Glasgow, S.W. 2, Scotland.
  2210  Criolla.........  ``Registre        Sociedad Rural Argentina, E.
                           Definitivo        F. Garay, Gerente Tecnico,
                           Seccion'' de      Florida 460, Buenos Aires,
                           Registro          Argentina.
                           Genealogico
                           para la Raza
                           Criolla.
  2301  Fjordhest         Stambok over      Statens Stambokkontor, Arne
         (formerly known   Fjordhest.        Hogstad, Statens
         as Westland).                       Stambokforer,
                                             Munkedamsveien 35 VI, Oslo,
                                             Norway.
  2211  Hackney.........  Hackney Stud      Hackney Horse Society, R. A.
                           Book.             Brown, secretary, 16
                                             Bedford Sq., London, W.C.
                                             1, England.
  2212  Holstein........  Holsteinisches    Verband der Zuchter des
                           Gestutbuch.       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           British Percheron Horse
                           Percheron Stud    Society, A. E. Vyse,
                           Book.             secretary, Owen Webb House,
                                             Gresham Rd., Cambridge,
                                             England.
  2104  ......do........  Stud-Book         Societe 1 Hippique
                           Percheron de      Percheronne de France, E.
                           France.           Lemarie, secretaire
                                             general, 7 rue Villette-
                                             Gate 1. Nogent-le-Rotrou (E-
                                             &-L), France.
  2302  Shetland Pony...  Shetland Pony     Shetland Pony Stud-Book
                           Stud-Book.        Society, Thomas H. F.
                                             Myles, secretary, 61 George
                                             St., Perth, Scotland.

[[Page 866]]

 
  2105  Shire...........  Shire Horse Stud  Shire Horse Society, A. G.
                           Book.             Holland, secretary, 17
                                             Devonshire St., London, W.
                                             1, England.
  2106  Suffolk.........  Suffolk Stud-     Suffolk Horse Society,
                           Book.             Raymond Keer, secretary, 6
                                             Church St., Woodbridge,
                                             Suffolk, England.
  2213  Thoroughbred....  Australian Stud   Australian Jockey Club and
                           Book.             Victoria Racing Club, W. J.
                                             McFadden, Keeper of the
                                             Stud Book, 6 Bligh St.,
                                             Sydney, N.S.W., Australia.
  2214  ......do........  General Stud      Weatherby & Sons, 15
                           Book.             Cavendish Sq., London, W.
                                             1, England.
  2215  ......do........  Jamaica Stud-     The Jockey Club of Jamaica,
                           Book.             Miss L. Pike, secretary, 10
                                             Duke St., Kingston,
                                             Jamaica, B.W.I.
  2216  ......do........  Stud Book de      Club Hipico de Santiago,
                           Chile.            Alejandro Obolensky Dadian,
                                             Jefe de Stud-Book, Casilla
                                             3674, Santiago, Chile.
  2217  ......do........  Stud Book de      Instituto Nacional de
                           Venezuela.        Hipodromos, Jorge Coll
                                             Nunez, Jefe, Hipodromo ``La
                                             Rinconada,'' Caracas,
                                             Venezuela.
  2218  ......do........  New Zealand Stud  New Zealand Racing
                           Book.             Conference, A. M. McBeath,
                                             secretary, P.O. Box 1430,
                                             Wellington, C. 1, New
                                             Zealand.
  2219  ......do........  Registro-         Jefatura de Cria Caballar y
                           Matricula de      Remonta, Don Manuel Diaz
                           Caballos de       Calderon, Secretario Stud-
                           Pura Sangre.      book, Ministerio del
                                             Ejercito, Madrid, Spain.
  2220  Thoroughbred....  Stud Book         Commission du Studbook
                           Francais          Francais de Pur Sang, M.
                           Registre des      Maze-Sencier, Inspecteur
                           Chevaux de Pur    General, Chef, Service des
                           Sang.             Haras, Ministere de
                                             l'Agriculture, 78 rue de
                                             Varenne (7), Paris, France.
  2221  ......do........  Libro             Jockey Club Italiano, Gen.
                           Genealogico dei   Federico Garofoli,
                           Cavalli di Puro   segretario, Corso Vittorio
                           Sangue.           Emanuele 87, Rome, Italy.
  2222  ......do........  Registre des      Jockey-Club de Belgique, Lt.
                           Chevaux de Pur    Col. Baron Jacques van
                           Sang.             Zuylen van Nyevelt,
                                             Secretaire general, 1 rue
                                             Guimard, Brussels 4,
                                             Belgium.
  2223  ......do........  Stud Book         Jockey Club Brasileiro,
                           Brasileiro.       Ricardo Xavier da Silveira,
                                             Diretor do Stud Book, Av.,
                                             Rio Branco 197, Rio de
                                             Janeiro, Brazil.
  2224  ......do........  Stud Book         Jockey Club del Pera,
                           Peruano.          Alberto Alvarez Calderon,
                                             Gerente, Union 1066, Lima,
                                             Peru.
  2225  ......do........  Stud Book         Ministerio de Hacienda de la
                           Argentino.        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     The Jockey Club, Mrs. L.
                           Book.             Brennan, Registrar, 300
                           (Recognition of   Park Ave., New York 22,
                           this book will    N.Y.
                           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.).
  2233  ......do........  Allgemeines       Direktorium fur
                           deutsches         Vollblutzucht und Rennen, 6
                           Gestubuch fur     Cologne Weidenpesch,
                           Vollblut.         Rennbahnstrasse 100,
                                             Postfach 180, Republic of
                                             Germany.
  2234  ......do........  Stud Book         Jefe del Stud Book Uruguayo,
                           Uruguayo.         Jose C. Frigerio, Head,
                                             Uruguayan Jockey Club,
                                             Montevideo, Uruguay.
  2235  ......do........  The General Stud  The Jockey Club of South
                           Book of South     Africa, Box 3409,
                           Africa.           Johannesburg, Union of
                                             South Africa.

[[Page 867]]

 
  2113  Trakehner.......  Trakehner Stud    American Trakehner
                           Book.             Association, 2305 November
                                             Lane, Reston, VA 22091.
  2303  Welsh Pony and    Welsh Stud Book.  Welsh Pony & Cob Society, J.
         Cob.                                A. George, secretary,
                                             Offices of the Royal Welsh
                                             Agricultural Society,
                                             Queen's Rd., Aberystwyth,
                                             Cardiganlshire, Wales.
  2240  Wielkopolskich..  Ksiega Stadna     Warm Blood & Full Blood
                           Koni              Breeders of the Great
                           Wielkopolskich.   Polish Horses, Pulewski 14,
                                             02-152 Warsaw, Poland.
------------------------------------------------------------------------


                                  Asses
------------------------------------------------------------------------
 Code     Name of breed    Book of record         By whom published
------------------------------------------------------------------------
  3001  Poitou..........  Jack and Jennet   Societe Centrale
                           Section of Stud-  d'Agriculture des Deux-
                           Book ou Livre     Sevres R. Martinet,
                           Genealogique      Secretaire, Cite
                           des Animaux       Administrative, rue
                           Mulassiers due    Duguesclin, Niort (Deux-
                           Poitou.           Sevres), France.
------------------------------------------------------------------------


                                  Sheep
------------------------------------------------------------------------
 Code     Name of breed    Book of record         By whom published
------------------------------------------------------------------------
  4101  Border Leicester  Border Leicester  Society of Border Leicester
                           Flock Book.       Sheep Breeders, Robert
                                             Jarvis, secretary, Room
                                             273, 93 Hope St., Glasgow,
                                             C. 2, Scotland.
  4102  Cheviot.........  Cheviot Sheep     Cheviot Sheep Society, Guy
                           Flock Book.       H. Armstrong, secretary,
                                             Commercial Bank Bldgs.,
                                             Hawick, Scotland.
  4103  Corriedale......  Flock Book for    The Australian Corriedale
                           Corriedale        Association, H.T.C.
                           Sheep in          Woodfull, secretary, Royal
                           Australia.        Showgrounds, Epsom Road,
                                             Ascot Vale, W. 2, Victoria,
                                             Australia.
  4104  Corriedale......  Corriedale Flock  The Corriedale Sheep
                           Book (New         Society, Inc., C. H.
                           Zealand).         Lawrence, secretary, 154
                                             Hereford St., Christchurch,
                                             New Zealand.
  4201  Dorset Horn.....  Dorset Horn       Dorset Horn Sheep Breeders'
                           Flock Book.       Association, E. F. B.
                                             Lucas, secretary, Bank
                                             Chambers, Dorchester,
                                             Dorset, England.
  4202  Hampshire Down..  Hampshire Down    Hampshire Down Sheep
                           Flock Book.       Breeders' Association, Miss
                                             Doris M. Stanbury,
                                             secretary, 38 Endless St.,
                                             Salisbury, Wilts., England.
  4105  Kent or Romney    Kent or Romney    Kent or Romney Marsh Sheep-
         Marsh.            Marsh Flock       Breeders' Association, G.
                           Book.             W. Tuffrey, secretary,
                                             Station Rd., Ashford, Kent,
                                             England.
  4203  Kerry Hill......  Kerry Hill Flock  Kerry Hill (Wales) Flock
                           Book.             Society, Ralph P. Evans,
                                             secretary, c/o The
                                             Radnorshire Co., Ltd.,
                                             Knighton, Radnorshire,
                                             Wales.
  4106  Leicester.......  Leicester Flock   Leicester Sheep Breeders'
                           Book.             Association, P. S.
                                             Atkinson, secretary, The
                                             Exchange, Exchange St.,
                                             Driffield, E. Yorks.,
                                             England.
  4107  Lincoln.........  Flock Book of     Lincoln Longwool Sheep
                           Lincoln           Breeders' Association,
                           Longwool Sheep.   Brian Shelley, secretary,
                                             Westminster Bank Chambers,
                                             8 Guildhall St., Lincoln,
                                             England.
  4204  Oxford Down.....  Flock Book of     Oxford Down Sheep Breeders'
                           Oxford Down       Association, Mrs. L. I.
                           Sheep.            Deacon, secretary,
                                             Thornyfields, Billing Rd.,
                                             Brafield-on-the-Green,
                                             Northampton, England.
  4108  Romney Marsh....  New Zealand       New Zealand Romney Marsh
                           Romney Marsh      Sheep Breeders'
                           Flock Book.       Association, Inc., R. J. J.
                                             Campbell, secretary, 117
                                             Kimbolton Rd., Feilding,
                                             New Zealand.
  4205  Ryeland.........  Ryeland Flock     Ryeland Flock Book Society,
                           Book.             Ltd., P. J. Hoskins,
                                             secretary, 20 King St.,
                                             Hereford, England.
  4206  Shropshire......  Shropshire Flock  Shropshire Sheep Breeders'
                           Book.             Association and Flock Book
                                             Society, Ivor Guy Mansell,
                                             secretary, College Hill,
                                             Shrewsbury, Shropshire,
                                             England.
  4207  Southdown.......  Southdown Flock   Southdown Sheep Society,
                           Book.             Inc., R. G. Noakes,
                                             secretary, Westways,
                                             Barming Woods, Maidstone,
                                             Kent, England.
  4218  ......do........  Southdown Sheep   The Southdown Sheep Society
                           Society of New    of New Zealand (Inc.), S.
                           Zealand (Inc.).   I. McKenzie, secretary,
                                             A.M.P., Chambers, 14
                                             Broadway, Palmerston North,
                                             New Zealand.
  4208  Suffolk.........  Suffolk Flock     Suffolk Sheep Society, Harry
                           Book.             A. Byford, secretary, 30
                                             Museum St., Ipswich,
                                             Suffolk, England.
  4109  Wensleydale.....  Wensleydale       The Wensleydale Longwool
                           Longwool Sheep    Sheep Breeders'
                           Flock Book.       Association, W. Dickinson,
                                             secretary, ``Cartmel,''
                                             Church Walk, Ulverston,
                                             Lancashire, England.

[[Page 868]]

 
  4001  Various           Flock Book for    Australian Society of
         recognized        British Breeds    Breeders of British Sheep,
         breeds.           of Sheep in       H.T.C. Woodfull, secretary,
                           Australia.        Royal Show Grounds, Epsom
                                             Rd., Ascot Vale, W. 2,
                                             Victoria, Australia.
  4002  ......do........  New Zealand       New Zealand Sheep Breeders'
                           Flock Book.       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        British Goat      British Goat Society, Miss
         Toggenburg.       Society Herd      M.F. Rigg, secretary, Diss,
                           Book (Saanen      Norfolk, England.
                           and Toggenburg
                           Sections).
------------------------------------------------------------------------


                                  Swine
------------------------------------------------------------------------
 Code     Name of breed    Book of record         By whom published
------------------------------------------------------------------------
  6001  Irish Large       Herd Book of      Royal Dublin Society, Horace
         White.            Irish Large       H. Poole, registrar, Ball's
                           White Pigs.       Bridge, Dublin, Ireland.
         Berkshire......
         Gloucestershire
         Old.
         Spots..........
         Large Black....
  6002   Large White....   Herd Book of     National Pig Breeders'
        Middle White....   the National      Association, E.G. Wake,
                           Pig Breeders'     secretary, 69 Clarendon
                           Association.      Rd., Watford, Herts,
                                             England
         Tamworth.......
         British
         Saddleback.
------------------------------------------------------------------------


                                  Dogs
------------------------------------------------------------------------
 Code     Name of breed    Book of record         By whom published
------------------------------------------------------------------------
  7306  Australian        The Working       The Working Kelpie Council,
         Kelpie.           Kelpie Council    P.O. Box E31 St. James,
                           National Stud     Sidney 2000, Australia.
                           Book.
  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   Masters of Foxhounds
                           Stud Book.        Association, Lt. Col. J. E.
                                             S. Chamberlayne, Hon.
                                             secretary, 51 Victoria St.,
                                             London, S. W. 1, England.
  7203  ......do........  Welsh Hound Stud  Welsh Hound Association,
                           Book.             Islwyn E. E. Davies, Hon.
                                             secretary, Berthddu,
                                             Llandinam, Montgomeryshire,
                                             East Wales.
  7302  German Shepherd.  Zuchtbuch fur     Verein fur deutsche
                           deutsche          Schaferhunde (SV), Hann
                           Schaferhunde      Kremhelmer,
                           (SZ).             Hauptgeschaftsfuhrer, Beim
                                             Schnarrbrunnen 4, Augsburg
                                             5, Germany.
  7303  Great Dane......  Zuchtbuch fur     Deutscher Doggen-Club,
                           Deutsche Doggen.  Richard Staadt, Prasident,
                                             Ellerstrasse 25, Solingen-
                                             Ohligs, Germany.
  7204  Greyhound.......  Australian        The Australian and New
                           Greyhound Stud    Zealand Greyhound
                           Book.             Association, Robert John
                                             Maidment, secretary, 349
                                             Collins St., Melbourne, C.
                                             1, Australia.
  7205  ......do........  Greyhound Stud    National Coursing Club,
                           Book.             Sydney H. Dalton,
                                             secretary, College Hill
                                             Chambers, London, E.C. 4.
                                             England.
  7206  ......do........  Irish Greyhound   Irish Coursing Club, Miss K.
                           Stud Book.        Butler, secretary, Davis
                                             Rd., Clonmel, Co.
                                             Tipperary, Ireland.
  7207  Harrier and       Harrier and       Association of Masters of
         Beagle.           Beagle Stud       Harriers and Beagles, J. J.
                           Book.             Kirkpatrick, Hon.
                                             secretary, East Wing,
                                             Kirtlington Park, Oxford,
                                             England.
  7304  Rottweiler......  Zucht- und        Allgemeiner Deutscher
                           Korbuch.          Rottweiler-Klub, Mrs.
                                             Josephine Rieble,
                                             Sekretarin, Vorsteigstrasse
                                             5, Stuttgart-West, Germany.
  7305  St. Bernard.....  Bernhardiner-     St. Bernhardsklub e. V.,
                           Zuchtbuch.        Franz Hrachowina,
                                             Zuchtbuchfuhrer,
                                             Bergmannstrasse 35, Munchen
                                             12, Germany.

[[Page 869]]

 
  7001  Various           Irish Kennel      Irish Kennel Club, Miss Maud
         recognized        Club Stud Book.   C. Fox, secretary, 23 Eden
         breeds.                             Quay, Dublin, C. 8,
                                             Ireland.
  7002  ......do........  Kennel Club Stud  English Kennel Club, E.
                           Book.             Holland Buckley, secretary,
                                             1-4 Clarges St.,
                                             Piccadilly, London, W. 1,
                                             England.
  7003  ......do........  Livre des         Societe 1 Centrale Canine
                           Origines          pour l'Amelioration des
                           Francais.         Races de Chiens en France,
                                             Col. Raoul Nicole,
                                             Directeur Administrateur, 3
                                             Rue de Choiseul, Paris 2,
                                             France.
  7004  ......do........  Livre des         Societe 1 Royale Saint-
                           Origines de la    Hubert, R. Willocq,
                           Societe 1         Secretaire 1, 391 Chaussee
                           Royale Saint-     Saint-Pierre, Brussels 4,
                           Hubert.           Belgium.
  7005  ......do........  Norsk             Norsk Kennel Klub, Olaf A.
                           Kennelklubs       Roig, secretary, Bjorn
                           Stambok.          Farmannsgate 16, Oslo,
                                             Norway.
  7006  ......do........  Zuchtbuch des     Klub fur Terrier e.V.,
                           Klub fur          Wilhelm Vahle, Sekretar,
                           Terrier e. V.     Schone Aussicht 9,
                                             Kelsterbach b. Frankfurt/
                                             Main, Germany.
  7007  ......do........  Schweizerisches   Schweizerische Kynologischen
                           Hunde-Stammbuch.  Gesellschaft, Carl Wittwer,
                                             secretary, Seestrasse 64,
                                             Kilchberg/Zurich,
                                             Switzerland.
  7008  ......do........  Svenska           Svenska Kennelklubben, Ivan
                           Kennelklubbens    Swedrup, secretary,
                           Register.         Linnegatan 25, Stockholm O
                                             4, Sweden.
------------------------------------------------------------------------


                                  Cats
------------------------------------------------------------------------
 Code     Name of breed    Book of record         By whom published
------------------------------------------------------------------------
  8001  Long-haired and   The Governing     The Governing Council of the
         short-haired.     Council of the    Cat Fancy, W.A. Hazeldine,
                           Cat Fancy Stud    secretary, 1 Roundwood Way,
                           Book.             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
------------------------------------------------------------------------
                                 Cattle
------------------------------------------------------------------------
 
 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.
------
                                 Horses
------------------------------------------------------------------------
 
 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.
------
                                  Sheep
------------------------------------------------------------------------
 
 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.
------
                                  Goats
------------------------------------------------------------------------
 
       Alpine.
       Angora.
5002   Nubian.
       Saanen.
       Toggenburg.
------

[[Page 870]]

 
                                  Swine
------------------------------------------------------------------------
 
       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 Stand 
ardbred 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.

(Sec. 101, 76 Stat. 72, Item 100.01, Title I, Tariff Act of 1930, as 
amended; 19 U.S.C. 1202, Item 100.01; 7 CFR 2.17, 2.51, and 371.2(d))

[23 FR 10104, Dec. 23, 1958]

    Editorial Note: For Federal Register citations affecting Sec.  
151.9, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  151.10  Recognition of additional breeds and books of record.

    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

[[Page 871]]

affecting the registration of animals in said book.

[24 FR 2644, Apr. 7, 1959, as amended at 54 FR 34970, Aug. 23, 1989]



Sec.  151.11  Form of books of record.

    (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.

[24 FR 2644, Apr. 7, 1959, as amended at 54 FR 34969, Aug. 23, 1989]

[[Page 872]]



       SUBCHAPTER I_VOLUNTARY INSPECTION AND CERTIFICATION SERVICE





PART 156_VOLUNTARY INSPECTION AND CERTIFICATION SERVICE--Table of Contents




Sec.
156.1 Meaning of words.
156.2 Definitions.
156.3 Kind of service; records.
156.4 Application for service.
156.5 Availability of service.
156.6 Certificates.
156.7 Fees and charges, including user fees under 9 CFR part 130.
156.8 Refusal of service; denial or withdrawal of service.

    Authority: 7 U.S.C. 1622 and 1624; 21 U.S.C. 136a; 7 CFR 2.22, 2.80, 
and 371.4.

    Source: 23 FR 10111, Dec. 23, 1958, unless otherwise noted.



Sec.  156.1  Meaning of words.

    Words used in this part in the singular form shall import the 
plural, and vice versa, as the case may demand.



Sec.  156.2  Definitions.

    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.
    Cooperative agreement. An agreement, between the Department and some 
other Federal or State agency, board of trade, chamber of commerce, or 
other agency, association, organization, person, or corporation as 
provided for in section 205 of the Agricultural Marketing Act of 1946 (7 
U.S.C. 1624), to conduct cooperatively 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 under a cooperative agreement 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.

[23 FR 10111, Dec. 23, 1958, as amended at 57 FR 30899, July 13, 1992; 
62 FR 19040, Apr. 18, 1997]



Sec.  156.3  Kind of service; records.

    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

[[Page 873]]

other information, as are needed to justify the issuance of the 
certificates required.

[23 FR 10111, Dec. 23, 1958, as amended at 62 FR 19040, Apr. 18, 1997]



Sec.  156.4  Application for service.

    Any person who is eligible under a cooperative agreement 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.

(Approved by the Office of Management and Budget under control number 
0579-0008)

[23 FR 10111, Dec. 23, 1958, as amended at 48 FR 57473, Dec. 30, 1983; 
57 FR 30899, July 13, 1992]



Sec.  156.5  Availability of service.

    Subject to Sec.  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; service is to be furnished under a cooperative agreement; 
and the requirements of Sec.  156.7 are met.

[23 FR 10111, Dec. 23, 1958, as amended at 57 FR 30899, July 13, 1992; 
62 FR 19040, Apr. 18, 1997]



Sec.  156.6  Certificates.

    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 Sec.  156.7. Copies of the certificates may be furnished 
without charge to other properly interested Federal agencies or under 
compulsory process.

[23 FR 10111, Dec. 23, 1958, as amended at 57 FR 30899, July 13, 1992; 
62 FR 19040, Apr. 18, 1997]



Sec.  156.7  Fees and charges, including user fees under 9 CFR part 130.

    Fees and charges, and user fees under 9 CFR part 130, for service 
(including travel and other expenses incurred in connection with the 
furnishing of service) under this part shall be paid by the applicant in 
accordance with the terms of the cooperative agreement under which 
service is furnished and in accordance with this section which shall be 
deemed to be incorporated in such agreement. If required by the 
Administrator, the fees and charges, and user fees under 9 CFR part 130, 
shall be paid in advance. Since the fees and charges, and user fees 
under 9 CFR part 130, are for the purpose of reimbursing the Department 
for all costs incurred in connection with the furnishing of service 
under this part, the appropriate fees and charges, and user fees under 9 
CFR part 130, to cover any such costs shall be paid even though service 
is withheld pursuant to Sec.  156.8.

[23 FR 10111, Dec. 23, 1958, as amended at 58 FR 67656, Dec. 22, 1993]



Sec.  156.8  Refusal of service; denial or withdrawal of service.

    (a) Service under this part will be refused if the conditions stated 
in Sec. Sec.  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

[[Page 874]]

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.

[23 FR 10111, Dec. 23, 1958, as amended at 57 FR 30899, July 13, 1992; 
62 FR 19040, Apr. 18, 1997]

[[Page 875]]



SUBCHAPTER J_ACCREDITATION OF VETERINARIANS AND SUSPENSION OR REVOCATION 
                          OF SUCH ACCREDITATION





PART 160_DEFINITION OF TERMS--Table of Contents




    Authority: 7 U.S.C. 8301-8317; 15 U.S.C. 1828; 7 CFR 2.22, 2.80, and 
371.4.



Sec.  160.1  Definitions.

    For the purposes of this subchapter the following words, phrases, 
names and terms shall be construed, respectively, to mean:
    Accredited veterinarian.\1\ 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, and D of 
this chapter.
---------------------------------------------------------------------------

    \1\ The provisions of subchapters B, C, and D of this chapter 
authorize Federal and State veterinarians and accredited veterinarians 
to perform specified functions. Full-time Federal (including military) 
and State employed veterinarians are authorized to perform such 
functions, pursuant to delegation of authority by the Administrator or 
cooperative agreements without specific accreditation under the 
provisions of this subchapter.
---------------------------------------------------------------------------

    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.
    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.
    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, form, record, report, tag, band, or other 
identification. Means any certificate, form, record, report, tag, band, 
or other identification, prescribed by statute or by regulations issued 
by the Administrator, for use by an accredited veterinarian performing 
official functions under this subchapter.
    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.

[[Page 876]]

    Veterinarian-in-Charge. The veterinary official of APHIS who is 
assigned by the Administrator to supervise and perform the official work 
of APHIS in a State or group of States.

[57 FR 54912, Nov. 23, 1992, as amended at 59 FR 40797, Aug. 10, 1994; 
60 FR 39842, Aug. 4, 1995; 62 FR 25445, May 9, 1997]



PART 161_REQUIREMENTS AND STANDARDS FOR ACCREDITED VETERINARIANS AND 
SUSPENSION OR REVOCATION OF SUCH ACCREDITATION--Table of Contents




Sec.
161.1 Statement of purpose; performance of accredited duties in 
          different States.
161.2 Requirements and application procedures for accreditation.
161.3 Standards for accredited veterinarian duties.
161.4 Suspension or revocation of veterinary accreditation; criminal and 
          civil penalties.

    Authority: 7 U.S.C. 8301-8317; 15 U.S.C. 1828; 7 CFR 2.22, 2.80, and 
371.4.

    Source: 57 FR 54912, Nov. 23, 1992, unless otherwise noted.



Sec.  161.1  Statement of purpose; performance of accredited duties in 
different 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) If an accredited veterinarian wishes to perform accredited 
duties in a State other than the State for which the veterinarian has 
completed an orientation in accordance with Sec.  161.2(a)(4), the 
accredited veterinarian shall so inform the Veterinarian-in-Charge of 
the new State. The Veterinarian-in-Charge of the new State may require 
the accredited veterinarian to complete, prior to performing any 
accredited duties in the new State, an orientation in animal health 
procedures and issues relevant to the new State. The Veterinarian-in-
Charge 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 problems in the new State, to prepare an 
accredited veterinarian from another State to perform accredited duties 
in the new State. The Veterinarian-in-Charge shall also give the State 
Animal Health Official of the new 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.
    (c) An accredited veterinarian may not perform accredited duties in 
a State in which the accredited veterinarian is not licensed or legally 
able to practice veterinary medicine.



Sec.  161.2  Requirements and application procedures for accreditation.

    (a) Initial accreditation. A veterinarian may apply for 
accreditation by completing an application for accreditation on Form 1-
36A, ``Application for Veterinary Accreditation,'' including 
certification that the applicant is able to perform the tasks listed in 
paragraph (d) of this section, and submitting it to the Veterinarian-in-
Charge in the State where he or she wishes to perform accredited duties.
    (1) Completed Forms 1-36A received by a Veterinarian-in-Charge 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, 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, the Veterinarian-in-Charge 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.
    (2) The Administrator is hereby authorized to accredit a 
veterinarian when he or she determines that:

[[Page 877]]

    (i) 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;
    (ii) The veterinarian is licensed or legally able to practice 
veterinary medicine in the State in which the veterinarian wishes to 
perform accredited duties. APHIS will confirm licensing status of the 
applicant by contacting the State board of veterinary medical examiners 
or any similar State organization that maintains records of 
veterinarians licensed in a State; and,
    (iii) The veterinarian has completed an orientation program approved 
by the Veterinarian-in-Charge for the State in which the veterinarian 
wishes to practice, 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 Veterinarian-in-Charge 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 
orientation program shall include the following topics:
    (A) Federal animal health laws, regulations, and rules;
    (B) Interstate movement requirements for animals;
    (C) Import and export requirements for animals;
    (D) USDA animal disease eradication and control programs;
    (E) Laboratory support in confirming disease diagnoses;
    (F) Ethical/Professional responsibilities of an accredited 
veterinarian; and,
    (G) Animal health procedures, issues, and information resources 
relevant to the State in which the veterinarian wishes to perform 
accredited duties.
    (b) Reaccreditation. A veterinarian whose accreditation has been 
revoked may apply for reaccreditation when the revocation has been in 
effect for not less than two years by completing an application for 
reaccreditation on Form 1-36A, ``Application for Veterinary 
Accreditation'', and submitting it to the Veterinarian-in-Charge of the 
State or area where he or she wishes to perform accredited work.
    (1) Completed Forms 1-36A received by a Veterinarian-in-Charge 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, 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, the Veterinarian-in-Charge 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) The Administrator is hereby authorized to reaccredit a 
veterinarian when he or she determines that:
    (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 Veterinarian-in-Charge for the State in which 
the veterinarian wishes to practice, 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 
Veterinarian-in-Charge 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

[[Page 878]]

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) Criminal conviction records adversely reflecting on the honesty 
or integrity of the applicant with regard to the performance or 
nonperformance of veterinary medical duties;
    (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 integrity of the applicant; and
    (D) Any other evidence reflecting on the professional integrity and 
reputation of the applicant.
    (c) 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 (b)(2)(ii) of this section before accreditation will be 
reinstated.
    (d) Tasks which applicants for accredited status must be able to 
perform. Applicants for accredited status must be able to:
    (1) Perform physical examinations of individual animals, and 
visually inspect herds or flocks, to determine whether the animals are 
free from any clinical signs suggestive of communicable disease;
    (2) Recognize the common breeds of livestock so as to be able to 
record breed information on official documents;
    (3) Recognize brucellosis tattoos and calfhood vaccination tags, and 
determine the state of origin of eartags, to properly identify animals 
in interstate commerce;
    (4) Estimate the age of livestock using a dental formula;
    (5) Apply an eartag, tattoo, backtag, and legband;
    (6) Certify the disease status of a poultry flock with regard to 
disease caused by Salmonella enteritidis, chlamydiosis and exotic 
Newcastle disease, by evaluating records of the flock's participation in 
and testing by Federal and State poultry health programs;
    (7) Properly complete certificates for domestic and international 
movement of animals;
    (8) Apply and remove official seals;
    (9) Perform a necropsy on livestock;
    (10) Recognize clinical signs and lesions of exotic animal diseases;
    (11) Plan a disease control strategy for a livestock unit;
    (12) Vaccinate for brucellosis and fill out the vaccination 
certificate;
    (13) Draw and ship blood for testing;
    (14) Perform a caudal fold test for tuberculosis;
    (15) Develop appropriate cleaning and disinfection plans to control 
communicable livestock disease spread; and
    (16) Explain basic principles for control of diseases for which 
APHIS or APHIS-State cooperative programs exist, such as brucellosis, 
pseudorabies, and tuberculosis.

(Approved by the Office of Management and Budget under control number 
0579-0032)

[57 FR 54912, Nov. 23, 1992, as amended at 61 FR 56891, Nov. 5, 1996]



Sec.  161.3  Standards for accredited veterinarian duties.

    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 Veterinarian-in-Charge and in accordance with 
any regulations and instructions issued to the accredited veterinarian 
by the Veterinarian-in-Charge, 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

[[Page 879]]

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 
Sec.  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 Veterinarian-in-Charge.
    (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 
Veterinarian-in-Charge.
    (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 Veterinarian-in-Charge or by a State Animal

[[Page 880]]

Health Official through the Veterinarian-in-Charge.
    (f) An accredited veterinarian shall immediately report to the 
Veterinarian-in-Charge 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 Sec.  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 Veterinarian-in-Charge, or by a State official through 
the Veterinarian-in-Charge, 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 
Veterinarian-in-Charge 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 Veterinarian-in-Charge 
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 Veterinarian-in-Charge.

[57 FR 54912, Nov. 23, 1992; 58 FR 8820, Feb. 17, 1993; 60 FR 39842, 
Aug. 4, 1995; 60 FR 55443, Nov. 1, 1995; 62 FR 25445, May 9, 1997; 67 FR 
11561, Mar. 15, 2002]



Sec.  161.4  Suspension or revocation of veterinary accreditation; 
criminal and civil penalties.

    (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 Sec.  
161.3 of this part, or, in lieu thereof, to issue a written notice of 
warning to the accredited veterinarian when the Administrator determines 
a notice of warning will be adequate to attain compliance with the 
Standards.
    (b) Accreditation shall be automatically terminated when an 
accredited veterinarian is not licensed or legally able to practice 
veterinary medicine in at least one State.
    (c) 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.
    (d) 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

[[Page 881]]

of, suspension or revocation of accredited veterinarian status in 
accordance with this section.

[57 FR 54912, Nov. 23, 1992, as amended at 68 FR 6346, Feb. 7, 2003]



PART 162_RULES OF PRACTICE GOVERNING REVOCATION OR SUSPENSION OF 
VETERINARIANS' ACCREDITATION--Table of Contents




                            Subpart A_General

Sec.
162.1 Scope and applicability of rules of practice.

                Subpart B_Supplemental Rules of Practice

162.10 Summary suspension of accreditation of veterinarians.
162.11 Notification.
162.12 Informal conference.
162.13 Formal complaint.

    Authority: 7 U.S.C. 8301-8317; 15 U.S.C. 1828; 7 CFR 2.22, 2.80, and 
371.4.

    Source: 57 FR 54915, Nov. 23, 1992, unless otherwise noted.



                            Subpart A_General



Sec.  162.1  Scope and applicability of rules of practice.

    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.



                Subpart B_Supplemental Rules of Practice



Sec.  162.10  Summary suspension of accreditation of veterinarians.

    In any situation where the Administrator has reason to believe that 
any veterinarian accredited under the provisions of 9 CFR parts 160 and 
161 of this subchapter has not complied with the ``Standards for 
Accredited Veterinarian Duties'' set forth in Sec.  161.3 of this 
subchapter, and deems such action necessary in order to prevent the 
introduction into the United States or the spread from one State to 
another of a contagious, infectious, or communicable disease of animals, 
or to insure that animals intended or offered for export to foreign 
countries are free from disease, the Administrator may suspend the 
accreditation of such veterinarian pending final determination in the 
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 pursuant to Sec.  1.147(b) 
of the Uniform Rules of Practice (7 CFR 1.147(b)) as promptly as 
circumstances permit. Such suspension shall have no relevance with 
respect to the final determination in the proceeding.



Sec.  162.11  Notification.

    The Veterinarian-in-Charge 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 Sec.  161.3 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 Veterinarian-in-Charge has arranged 
to hold an informal conference to discuss the matter.



Sec.  162.12  Informal conference.

    (a) The Veterinarian-in-Charge, 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 Veterinarian-in-Charge determines that an 
informal conference is inappropriate. An informal conference is 
inappropriate only if the Veterinarian-in-Charge 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 Sec.  161.3 of this 
subchapter are pending against the

[[Page 882]]

accredited veterinarian. An informal conference shall include the 
Veterinarian-in-Charge or his or her representative, the accredited 
veterinarian, and any other persons the Veterinarian-in-Charge 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) Prior to, during, or at the conclusion of the informal 
conference, the Veterinarian-in-Charge 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.
    (c) 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 
Veterinarian-in-Charge may issue such a consent order without further 
procedure.
    (d) 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 Veterinarian-in-Charge 
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 
Veterinarian-in-Charge 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.

[57 FR 54915, Nov. 23, 1992; 57 FR 60086, Dec. 18, 1992]



Sec.  162.13  Formal complaint.

    If a consent order has not been issued, or if, after an informal 
conference, the Veterinarian-in-Charge 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 Sec.  
1.135 of the Uniform Rules of Practice (7 CFR 1.135).

[[Page 883]]



                     SUBCHAPTER K_PUBLIC INFORMATION





PART 165_AVAILABILITY OF INFORMATION--Table of Contents






Sec.  165.1  Availability of information.

    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.

(5 U.S.C. 552, 559)

[32 FR 10915, July 26, 1967, as amended at 36 FR 24928, Dec. 24, 1971]

[[Page 884]]



                  SUBCHAPTER L_SWINE HEALTH PROTECTION





PART 166_SWINE HEALTH PROTECTION--Table of Contents




                           General Provisions

Sec.
166.1 Definitions in alphabetical order.
166.2 General restrictions.
166.3 Separation of swine from the garbage handling and treatment areas.
166.4 Storage of garbage.
166.5 Licensed garbage-treatment facility standards.
166.6 Swine feeding area standards.
166.7 Cooking standards.
166.8 Vehicles used to transport garbage.
166.9 Recordkeeping.
166.10 Licensing.
166.11 Suspension and revocation of licenses.
166.12 Cancellation of licenses.
166.13 Licensee responsibilities.
166.14 Cleaning and disinfecting.
166.15 State status.

    Authority: 7 U.S.C. 3801-3813; 7 CFR 2.22, 2.8, and 371.4

    Source: 47 FR 49945, Nov. 3, 1982, unless otherwise noted.

                           General Provisions



Sec.  166.1  Definitions in alphabetical order.

    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.

[[Page 885]]

    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 [deg]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 [deg]F. or 100 [deg]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.

[47 FR 49945, Nov. 3, 1982, as amended at 48 FR 22290, May 18, 1983; 52 
FR 4890, Feb. 18, 1987; 56 FR 26899, June 12, 1991; 66 FR 21064, Apr. 
27, 2001]



Sec.  166.2  General restrictions.

    (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: 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.

[47 FR 49945, Nov. 3, 1982, as amended at 49 FR 14497, Apr. 12, 1984; 52 
FR 4890, Feb. 18, 1987; 66 FR 21064, Apr. 27, 2001]



Sec.  166.3  Separation of swine from the garbage handling and treatment 
areas.

    (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.



Sec.  166.4  Storage of garbage.

    (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 Sec.  166.14 of

[[Page 886]]

this part; or (3) containers in which the garbage was treated.

[47 FR 49945, Nov. 3, 1982, as amended at 52 FR 4890, Feb. 18, 1987]



Sec.  166.5  Licensed garbage-treatment facility standards.

    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 Sec.  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.

[47 FR 49945, Nov. 3, 1982, as amended at 52 FR 4890, Feb. 18, 1987]



Sec.  166.6  Swine feeding area standards.

    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 Sec.  166.14(b) 
of this part.

[47 FR 49945, Nov. 3, 1982, as amended at 52 FR 4890, Feb. 18, 1987]



Sec.  166.7  Cooking standards.

    (a) Garbage shall be heated throughout at boiling (212 [deg]F. or 
100 [deg]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.



Sec.  166.8  Vehicles used to transport garbage.

    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 Sec.  166.14(c) of this part.

[47 FR 49945, Nov. 3, 1982, as amended at 52 FR 4890, Feb. 18, 1987]



Sec.  166.9  Recordkeeping.

    (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.

(Approved by the Office of Management and Budget under control number 
0579-0066)

[47 FR 49945, Nov. 3, 1982, as amended at 48 FR 57474, Dec. 30, 1983; 52 
FR 4890, Feb. 18, 1987]



Sec.  166.10  Licensing.

    (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

[[Page 887]]

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 Sec.  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.

(Approved by the Office of Management and Budget under control number 
0579-0065)

[47 FR 49945, Nov. 3, 1982, as amended at 48 FR 57474, Dec. 30, 1983; 49 
FR 14497, Apr. 12, 1984; 52 FR 4890, Feb. 18, 1987; 56 FR 26899, June 
12, 1991; 66 FR 21064, Apr. 27, 2001]



Sec.  166.11  Suspension and revocation of licenses.

    (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

[[Page 888]]

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 Sec.  166.10 of this part.

[47 FR 49945, Nov. 3, 1982, as amended at 52 FR 4890, Feb. 18, 1987; 56 
FR 26899, June 12, 1991]



Sec.  166.12  Cancellation of licenses.

    (a) The Area Veterinarian in Charge or, in States listed in Sec.  
166.15(d) of this part, the State animal health official shall cancel 
the license of a licensee when the Area Veterinarian in Charge or, in 
States listed in Sec.  166.15(d) of this part, 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, \1\ or, in States listed in Sec.  166.15(d) 
of this part, to the State animal health official. The Area Veterinarian 
in Charge or, in States listed in Sec.  166.15(d) of this part, the 
State animal health official shall cancel such license and shall notify 
the licensee of the cancellation in writing.
---------------------------------------------------------------------------

    \1\ The name and address of the Area Veterinarian in Charge may be 
obtained from the Veterinary Services, Operational Support, 4700 River 
Road, Unit 33, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (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 
Sec.  166.10 of this part.

[52 FR 4891, Feb. 18, 1987, as amended at 56 FR 26899, June 12, 1991; 59 
FR 67618, Dec. 30, 1994]



Sec.  166.13  Licensee responsibilities.

    (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

[[Page 889]]

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.

(Approved by the Office of Management and Budget under control number 
0579-0065)

[47 FR 49945, Nov. 3, 1982, as amended at 48 FR 57474, Dec. 30, 1983; 52 
FR 4890, Feb. 18, 1987. Redesignated at 52 FR 4891, Feb. 18, 1987]



Sec.  166.14  Cleaning and disinfecting.

    (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 Sec. Sec.  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.

[47 FR 49945, Nov. 3, 1982. Redesignated and amended at 52 FR 4891, Feb. 
18, 1987; 56 FR 26899, June 12, 1991; 68 FR 6346, Feb. 7, 2003]



Sec.  166.15  State status.

    (a) The following States prohibit the feeding of garbage to swine: 
Alabama, Delaware, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, 
Louisiana, Mississippi, Nebraska, New York, North

[[Page 890]]

Dakota, Oregon, South Carolina, South Dakota, Tennessee, Virginia, and 
Wisconsin.
    (b) The following States and Puerto Rico permit the feeding of 
treated garbage to swine: Alaska, Arizona, Arkansas, California, 
Colorado, Connecticut, Florida, Hawaii, Kentucky, Maine, Maryland, 
Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New 
Hampshire, New Jersey, New Mexico, North Carolina, Ohio, Oklahoma, 
Pennsylvania, Puerto Rico, Rhode Island, Texas, Utah, Vermont, 
Washington, West Virginia, and Wyoming.
    (c) The following States have primary enforcement responsibility 
under the Act: Alabama, Arizona, California, Colorado, Florida, Georgia, 
Hawaii, Idaho, Illinois, Indiana, Iowa, Michigan, Minnesota, 
Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, 
North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, 
Tennessee, Utah, Virginia, West Virginia, and Wisconsin.
    (d) The following States issue licenses under cooperative agreements 
with the Animal and Plant Health Inspection Service, but do not have 
primary enforcement responsibility under the Act: Kentucky, Maryland, 
Puerto Rico, Texas, and Washington.
    (e) The public may contact the Area Veterinarian in Charge, Animal 
and Plant Health Inspection Service, United States Department of 
Agiculture or State animal health official, or the Animal and Plant 
Health Inspection Service, Veterinary Services, Swine Health, 4700 River 
Road, Unit 37, Riverdale, Maryland 20737-1231, concerning the feeding of 
garbage to swine.

[47 FR 49945, Nov. 3, 1982, as amended at 51 FR 2348, Jan. 16, 1986; 51 
FR 15757, Apr. 28, 1986. Redesignated and amended at 52 FR 4891, Feb. 
18, 1987. 52 FR 13231, Apr. 22, 1987; 52 FR 34208, Sept. 10, 1987; 52 FR 
37283, Oct. 6, 1987; 55 FR 30688, July 27, 1990; 56 FR 7555, Feb. 25, 
1991; 56 FR 26899, June 12, 1991; 56 FR 37827, Aug. 9, 1991; 59 FR 
67618, Dec. 30, 1994; 68 FR 7415, Feb. 14, 2003]



PART 167_RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE SWINE HEALTH 
PROTECTION ACT--Table of Contents




                            Subpart A_General

Sec.
167.1 Scope and applicability of rules of practice.

                Subpart B_Supplemental Rules of Practice

167.10 Stipulations.

    Authority: 7 U.S.C. 3804, 3805, and 3811; 7 CFR 2.22, 2.80, and 
371.4.

    Source: 48 FR 30095, June 30, 1983, unless otherwise noted.



                            Subpart A_General



Sec.  167.1  Scope and applicability of rules of practice.

    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.



                Subpart B_Supplemental Rules of Practice



Sec.  167.10  Stipulations.

    (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

[[Page 891]]

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.

                        PARTS 168	199 [RESERVED]

[[Page 893]]



                              FINDING AIDS




  --------------------------------------------------------------------

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume of the Code of Federal Regulations 
which is published separately and revised annually.

  Material Approved for Incorporation by Reference
  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 895]]

            Material Approved for Incorporation by Reference

                     (Revised as of January 1, 2004)

  The Director of the Federal Register has approved under 5 U.S.C. 
552(a) and 1 CFR Part 51 the incorporation by reference of the following 
publications. This list contains only those incorporations by reference 
effective as of the revision date of this volume. Incorporations by 
reference found within a regulation are effective upon the effective 
date of that regulation. For more information on incorporation by 
reference, see the preliminary pages of this volume.


9 CFR (PARTS 1-199)

ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE
                                                                   9 CFR


Agriculture Department

  Veterinary Services, Animal and Plant Health 
  Inspection Service, USDA, 4700 River Road, 
  Riverdale, MD 20737-1231
Uniform Methods and Rules-Bovine Tuberculosis           77.1; 77.4; 77.5
  Eradication (March 13, 1985 Edition).
Uniform Methods and Rules-Bovine Tuberculosis           77.1; 77.4; 77.5
  Eradication (February 3, 1989 Edition).
Uniform Methods and Rules-Bovine Tuberculosis         77.1; 77.3, 77.4; 
  Eradication (January 22, 1999 Edition).                           77.5


AgriTech Systems, Inc.

  100 Fore Street, Portland, ME 04101
CITER Brucella Abortus Antibody Test               78.1(a)(9)
  Kit instructions, licensed and approved by USDA, 
  December 31, 1987.


State of Texas

  Texas Animal Health Commission (TAHC0), 2105 
  Kramer Lane, Austin, TX 78758
Texas Administrative Code, (Title 4 [Agriculture],                  72.5
  Part 2 [Texas Animal Health Commission], Chapter 
  41 [Fever Ticks]) Rule 41.2: ``Quarantine Line 
  Defining and Establishing Tick Eradication 
  Areas,'' effective April 8, 2001.


World Health Organization

  49 Sheridan Ave., Albany, NY 12210
Laboratory Techniques in Rabies, Chapter 37, 4th                 113.209
  Edition (1996).
Laboratory Techniques in Rabies, Third Ed. (1973)                113.129
  Edited by Martin M.Kaplan and Hilary Kaprowski.

[[Page 897]]



                    Table of CFR Titles and Chapters




                     (Revised as of January 1, 2004)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
        IV  Miscellaneous Agencies (Parts 400--500)

                          Title 2 [Reserved]

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  General Accounting Office (Parts 1--99)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Part 2100)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
        XV  Office of Administration, Executive Office of the 
                President (Parts 2500--2599)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Part 3201)
     XXIII  Department of Energy (Part 3301)
      XXIV  Federal Energy Regulatory Commission (Part 3401)
       XXV  Department of the Interior (Part 3501)
      XXVI  Department of Defense (Part 3601)

[[Page 898]]

    XXVIII  Department of Justice (Part 3801)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  Overseas Private Investment Corporation (Part 4301)
      XXXV  Office of Personnel Management (Part 4501)
        XL  Interstate Commerce Commission (Part 5001)
       XLI  Commodity Futures Trading Commission (Part 5101)
      XLII  Department of Labor (Part 5201)
     XLIII  National Science Foundation (Part 5301)
       XLV  Department of Health and Human Services (Part 5501)
      XLVI  Postal Rate Commission (Part 5601)
     XLVII  Federal Trade Commission (Part 5701)
    XLVIII  Nuclear Regulatory Commission (Part 5801)
         L  Department of Transportation (Part 6001)
       LII  Export-Import Bank of the United States (Part 6201)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Part 6401)
        LV  National Endowment for the Arts (Part 6501)
       LVI  National Endowment for the Humanities (Part 6601)
      LVII  General Services Administration (Part 6701)
     LVIII  Board of Governors of the Federal Reserve System (Part 
                6801)
       LIX  National Aeronautics and Space Administration (Part 
                6901)
        LX  United States Postal Service (Part 7001)
       LXI  National Labor Relations Board (Part 7101)
      LXII  Equal Employment Opportunity Commission (Part 7201)
     LXIII  Inter-American Foundation (Part 7301)
       LXV  Department of Housing and Urban Development (Part 
                7501)
      LXVI  National Archives and Records Administration (Part 
                7601)
     LXVII  Institute of Museum and Library Services (Part 7701)
      LXIX  Tennessee Valley Authority (Part 7901)
      LXXI  Consumer Product Safety Commission (Part 8101)
    LXXIII  Department of Agriculture (Part 8301)
     LXXIV  Federal Mine Safety and Health Review Commission (Part 
                8401)
     LXXVI  Federal Retirement Thrift Investment Board (Part 8601)
    LXXVII  Office of Management and Budget (Part 8701)

                      Title 6--Homeland Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 0--99)

[[Page 899]]

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Grain Inspection, Packers and Stockyards 
                Administration (Federal Grain Inspection Service), 
                Department of Agriculture (Parts 800--899)
        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  Rural Telephone Bank, Department of Agriculture (Parts 
                1600--1699)
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  Local Television Loan Guarantee Board (Parts 2200--
                2299)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy, Department of Agriculture (Parts 
                2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)

[[Page 900]]

      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  Cooperative State Research, Education, and Extension 
                Service, Department of Agriculture (Parts 3400--
                3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Immigration and 
                Naturalization) (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Grain Inspection, Packers and Stockyards 
                Administration (Packers and Stockyards Programs), 
                Department of Agriculture (Parts 200--299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Part 1800)

[[Page 901]]

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  Office of Thrift Supervision, Department of the 
                Treasury (Parts 500--599)
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  Federal Housing Finance Board (Parts 900--999)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board, Department of 
                Commerce (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board, 
                Department of Commerce (Parts 500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--499)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

[[Page 902]]

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)
      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  Technology Administration, Department of Commerce 
                (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399)

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)

[[Page 903]]

      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  Bureau of Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Bureau of Immigration and Customs Enforcement, 
                Department of Homeland Security (Parts 400--599)

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Employment Standards Administration, Department of 
                Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training, Department of Labor 
                (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  Broadcasting Board of Governors (Parts 500--599)
       VII  Overseas Private Investment Corporation (Parts 700--
                799)
        IX  Foreign Service Grievance Board Regulations (Parts 
                900--999)

[[Page 904]]

         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)
        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)

[[Page 905]]

      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--799)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900)
        VI  Office of the Assistant Secretary-Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Part 1200)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--899)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--699)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)

[[Page 906]]

       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)
        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Minerals Management Service, Department of the 
                Interior (Parts 200--299)
       III  Board of Surface Mining and Reclamation Appeals, 
                Department of the Interior (Parts 300--399)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)

[[Page 907]]

       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance
         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of International Investment, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Defense Logistics Agency (Parts 1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army (Parts 
                200--399)

[[Page 908]]

        IV  Saint Lawrence Seaway Development Corporation, 
                Department of Transportation (Parts 400--499)

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Vocational and Adult Education, Department 
                of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599)
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
        XI  National Institute for Literacy (Parts 1100--1199)
            Subtitle C--Regulations Relating to Education
       XII  National Council on Disability (Parts 1200--1299)

                        Title 35--Panama Canal

         I  Panama Canal Regulations (Parts 1--299)

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Part 1501)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

[[Page 909]]

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  Copyright Office, Library of Congress (Parts 200--299)
        IV  Assistant Secretary for Technology Policy, Department 
                of Commerce (Parts 400--499)
         V  Under Secretary for Technology, Department of Commerce 
                (Parts 500--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--99)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Rate Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)

          Title 41--Public Contracts and Property Management

            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
       105  General Services Administration (Parts 105-1--105-999)
       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)

[[Page 910]]

       128  Department of Justice (Parts 128-1--128-99)
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System
       201  Federal Information Resources Management Regulation 
                (Parts 201-1--201-99) [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-70)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--499)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1999)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 200--499)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10010)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare

[[Page 911]]

        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Office of Human Development Services, Department of 
                Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission on Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Part 2301)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)

[[Page 912]]

       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Department of Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  United States Agency for International Development 
                (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)
        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management, Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        35  Panama Canal Commission (Parts 3500--3599)
        44  Federal Emergency Management Agency (Parts 4400--4499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399)

[[Page 913]]

        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  General Services Administration Board of Contract 
                Appeals (Parts 6100--6199)
        63  Department of Transportation Board of Contract Appeals 
                (Parts 6300--6399)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Research and Special Programs Administration, 
                Department of Transportation (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board, Department of 
                Transportation (Parts 1000--1399)
        XI  Bureau of Transportation Statistics, Department of 
                Transportation (Parts 1400--1499)
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1599)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)
        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)

[[Page 914]]

         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

                      CFR Index and Finding Aids

            Subject/Agency Index
            List of Agency Prepared Indexes
            Parallel Tables of Statutory Authorities and Rules
            List of CFR Titles, Chapters, Subchapters, and Parts
            Alphabetical List of Agencies Appearing in the CFR

[[Page 915]]





           Alphabetical List of Agencies Appearing in the CFR




                     (Revised as of January 1, 2004)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Committee of the Federal Register  1, I
Advanced Research Projects Agency                 32, I
Advisory Council on Historic Preservation         36, VIII
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development, United      22, II
     States
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture Department                            5, LXXIII
  Agricultural Marketing Service                  7, I, IX, X, XI
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Cooperative State Research, Education, and      7, XXXIV
       Extension Service
  Economic Research Service                       7, XXXVII
  Energy, Office of                               7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Grain Inspection, Packers and Stockyards        7, VIII; 9, II
       Administration
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Telephone Bank                            7, XVI
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force Department                              32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX

[[Page 916]]

Architectural and Transportation Barriers         36, XI
     Compliance Board
Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI
Army Department                                   32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Benefits Review Board                             20, VII
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase From People Who Are
Broadcasting Board of Governors                   22, V
  Federal Acquisition Regulation                  48, 19
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X
Civil Rights, Commission on                       45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce Department                               44, IV
  Census Bureau                                   15, I
  Economic Affairs, Under Secretary               37, V
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Fishery Conservation and Management             50, VI
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II
  National Marine Fisheries Service               50, II, IV, VI
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Telecommunications and Information     15, XXIII; 47, III
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Productivity, Technology and Innovation,        37, IV
       Assistant Secretary for
  Secretary of Commerce, Office of                15, Subtitle A
  Technology, Under Secretary for                 37, V
  Technology Administration                       15, XI
  Technology Policy, Assistant Secretary for      37, IV
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Product Safety Commission                5, LXXI; 16, II
Cooperative State Research, Education, and        7, XXXIV
     Extension Service
Copyright Office                                  37, II
Corporation for National and Community Service    45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Court Services and Offender Supervision Agency    28, VIII
     for the District of Columbia
Customs and Border Protection Bureau              19, I
Defense Contract Audit Agency                     32, I
Defense Department                                5, XXVI; 32, Subtitle A; 
                                                  40, VII

[[Page 917]]

  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III, 
                                                  48, 51
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 2
  National Imagery and Mapping Agency             32, I
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
District of Columbia, Court Services and          28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Under Secretary                 37, V
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
  Vocational and Adult Education, Office of       34, IV
Educational Research and Improvement, Office of   34, VII
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             5, XXIII; 10, II, III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   5, LIV; 40, I, IV, VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Administration, Office of                       5, XV
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                5, III, LXXVII; 14, VI; 
                                                  48, 99
  National Drug Control Policy, Office of         21, III
  National Security Council                       32, XXI; 47, 2
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II

[[Page 918]]

  Trade Representative, Office of the United      15, XX
       States
Export-Import Bank of the United States           5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       11, I
Federal Emergency Management Agency               44, I
  Federal Acquisition Regulation                  48, 44
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Board                     12, IX
Federal Labor Relations Authority, and General    5, XIV; 22, XIV
     Counsel of the Federal Labor Relations 
     Authority
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Fine Arts, Commission on                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Fishery Conservation and Management               50, VI
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Accounting Office                         4, I
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5

[[Page 919]]

  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          5, XLV; 45, Subtitle A
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Human Development Services, Office of           45, XIII
  Indian Health Service                           25, V; 42, I
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  6, I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection Bureau            19, I
  Federal Emergency Management Agency             44, I
  Immigration and Customs Enforcement Bureau      19, IV
  Immigration and Naturalization                  8, I
  Transportation Security Administration          49, XII
Housing and Urban Development, Department of      5, LXV; 24, Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Human Development Services, Office of             45, XIII
Immigration and Customs Enforcement Bureau        19, IV
Immigration and Naturalization                    8, I
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V; 42, I
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General

[[Page 920]]

  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior Department
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  Minerals Management Service                     30, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Reclamation, Bureau of                          43, I
  Secretary of the Interior, Office of            43, Subtitle A
  Surface Mining and Reclamation Appeals, Board   30, III
       of
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Fishing and Related Activities      50, III
International Investment, Office of               31, VIII
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice Department                                5, XXVIII; 28, I, XI; 40, 
                                                  IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Offices of Independent Counsel                  28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor Department                                  5, XLII
  Benefits Review Board                           20, VII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Employment Standards Administration             20, VI
  Federal Acquisition Regulation                  48, 29
  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A

[[Page 921]]

  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Library of Congress                               36, VII
  Copyright Office                                37, II
Local Television Loan Guarantee Board             7, XX
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II
Micronesian Status Negotiations, Office for       32, XXVII
Mine Safety and Health Administration             30, I
Minerals Management Service                       30, II
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
National Aeronautics and Space Administration     5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   45, XII, XXV
National Archives and Records Administration      5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Bureau of Standards                      15, II
National Capital Planning Commission              1, IV
National Commission for Employment Policy         1, IV
National Commission on Libraries and Information  45, XVII
     Science
National Council on Disability                    34, XII
National Counterintelligence Center               32, XVIII
National Credit Union Administration              12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           21, III
National Foundation on the Arts and the           45, XI
     Humanities
National Highway Traffic Safety Administration    23, II, III; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute for Literacy                   34, XI
National Institute of Standards and Technology    15, II
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV, VI
National Mediation Board                          29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI
National Security Council and Office of Science   47, II
     and Technology Policy
National Telecommunications and Information       15, XXIII; 47, III
     Administration
National Transportation Safety Board              49, VIII
National Weather Service                          15, IX
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy Department                                   32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
   Commission
[[Page 922]]

Nuclear Regulatory Commission                     5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Offices of Independent Counsel                    28, VI
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Overseas Private Investment Corporation           5, XXXIII; 22, VII
Panama Canal Commission                           48, 35
Panama Canal Regulations                          35, I
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, XXXV; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
Postal Rate Commission                            5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Procurement and Property Management, Office of    7, XXXII
Productivity, Technology and Innovation,          37, IV
     Assistant Secretary
Public Contracts, Department of Labor             41, 50
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Regional Action Planning Commissions              13, V
Relocation Allowances                             41, 302
Research and Special Programs Administration      49, I
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Telephone Bank                              7, XVI
Rural Utilities Service                           7, XVII, XVIII, XLII
Saint Lawrence Seaway Development Corporation     33, IV
Science and Technology Policy, Office of          32, XXIV
Science and Technology Policy, Office of, and     47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                17, II
Selective Service System                          32, XVI
Small Business Administration                     13, I
Smithsonian Institution                           36, V
Social Security Administration                    20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State Department                                  22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining and Reclamation Appeals, Board of  30, III
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Technology Administration                         15, XI
Technology Policy, Assistant Secretary for        37, IV

[[Page 923]]

Technology, Under Secretary for                   37, V
Tennessee Valley Authority                        5, LXIX; 18, XIII
Thrift Supervision Office, Department of the      12, V
     Treasury
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     5, L
  Commercial Space Transportation                 14, III
  Contract Appeals, Board of                      48, 63
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 49, V
  Research and Special Programs Administration    49, I
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Surface Transportation Board                    49, X
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury Department                               5, XXI; 12, XV; 17, IV; 
                                                  31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection Bureau            19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Law Enforcement Training Center         31, VII
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  International Investment, Office of             31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
  Thrift Supervision, Office of                   12, V
Truman, Harry S. Scholarship Foundation           45, XVIII
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs Department                       38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Vocational and Adult Education, Office of         34, IV
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I
World Agricultural Outlook Board                  7, XXXVIII

[[Page 925]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations which were 
made by documents published in the Federal Register since January 1, 
2001, are enumerated in the following list. Entries indicate the nature 
of the changes effected. Page numbers refer to Federal Register pages. 
The user should consult the entries for chapters and parts as well as 
sections for revisions.
For the period before January 1, 2001, see the ``List of CFR Sections 
Affected, 1949-1963, 1964-1972, 1973-1985, and 1986-2000'' published in 
11 separate volumes.

                                  2001

9 CFR
                                                                   66 FR
                                                                    Page
Chapter I
1 Authority citation revised.......................................21061
2 Authority citation revised..................................239, 21061
2.129 (c) revised; (d) added.........................................239
    Regulation at 66 FR 239 eff. date delayed.......................8743
3.101 Revised........................................................251
    Regulation at 66 FR 251 eff. date delayed.......................8744
3.104 (a) revised....................................................252
    Regulation at 66 FR 252 eff. date delayed.......................8744
3.105 Revised........................................................252
    Regulation at 66 FR 252 eff. date delayed.......................8744
3.107 Revised........................................................253
    Regulation at 66 FR 253 eff. date delayed.......................8744
3.108 Revised........................................................253
    Regulation at 66 FR 253 eff. date delayed.......................8744
3.109 Revised........................................................253
    Regulation at 66 FR 253 eff. date delayed.......................8744
3.110 Revised........................................................253
    Regulation at 66 FR 253 eff. date delayed.......................8744
3.112 Revised........................................................254
    Regulation at 66 FR 254 eff. date delayed.......................8744
3.113 Revised........................................................255
    Regulation at 66 FR 255 eff. date delayed.......................8744
3.114 Revised........................................................255
    Regulation at 66 FR 255 eff. date delayed.......................8744
3.115 Revised........................................................256
    Regulation at 66 FR 256 eff. date delayed.......................8744
3.116 Revised........................................................256
    Regulation at 66 FR 256 eff. date delayed.......................8744
3.117 Revised........................................................256
    Regulation at 66 FR 256 eff. date delayed.......................8744
3.118 Revised........................................................257
    Regulation at 66 FR 257 eff. date delayed.......................8744
11 Authority citation revised......................................21061
49 Authority citation revised......................................21061
50 Authority citation revised......................................21061
50.3 Authority citation removed....................................21061
50.16 (a)(4) revised...............................................21061
51 Authority citation revised......................................21061
51.1 Amended; authority citation removed...........................21061
52 Authority citation revised......................................21061
53 Authority citation revised......................................21061
54 Authority citation revised......................................21061
    Revised........................................................43982
    Technical correction...........................................46066
    Eff. date corrected............................................46686
54.1 Amended.......................................................21061
70 Authority citation revised......................................21061
    Authority citation revised; eff. 2-5-02.......................636615
70.1 Amended; eff. 2-5-02..........................................63615
71 Authority citation revised......................................21061
71.1 Amended; eff. 1-22-02.........................................65602
71.19 (a)(1) introductory text amended; (h) and (i) added; eff. 1-
        22-02......................................................65603

[[Page 926]]

72 Authority citation revised......................................21061
72.6 Revised.......................................................21061
72.13 (a) Footnote 4 revised.......................................21062
73 Authority citation revised......................................21062
73.2 Authority citation removed....................................21062
73.3 Authority citation removed....................................21062
73.5 Authority citation removed....................................21062
73.6 Authority citation removed....................................21062
73.12 Authority citation removed...................................21062
74 Authority citation revised...............................21062, 37128
74.1 Revised.......................................................37128
75 Authority citation revised......................................21062
75.4 Amended.......................................................21062
77.7 Regulation at 65 FR 70286 confirmed...........................49271
77.9 Regulation at 65 FR 70286 confirmed...........................49271
78.41 Regulation at 65 FR 75582 confirmed..........................19847
    (a) and (b) amended; interim............................20900, 32894
    Regulation at 66 FR 20900 confirmed............................45749
    Regulation at 66 FR 32894 confirmed............................63910
79 Authority citation revised......................................21062
    Revised........................................................43990
    Technical correction....................................46066, 46686
79.2 (a)(2) introductory text Footnote 1 amended...................21062
79.3 (b) Footnote 2 amended........................................21062
80 Authority citation revised......................................21062
82 Authority citation revised......................................21062
82.30 Amended......................................................21062
82.32 Footnote 2 amended...........................................21062
82.33 (a)(2) Footnote 4 amended....................................21062
82.37 Footnote 7 amended...........................................21062
85 Authority citation revised......................................21063
85.1 Amended.......................................................21063
85.7 (b)(3)(i), (ii) and (c)(1) amended; eff. 1-22-02..............65604
85.8 (a)(3) amended; (a)(4) added; eff. 1-22-02....................65604
88 Added; eff. 2-5-02..............................................63615
89 Authority citation revised......................................21063
91 Authority citation revised......................................21063
92 Authority citation revised......................................21063
93.301 Regulation at 65 FR 78899 eff. date delayed..................8887
    Regulation at 65 FR 78899 eff. 2-16-01.........................11101
    (h)(6) and (7) amended.........................................55071
93.308 (a)(3) revised..............................................56034
93.400 Amended.....................................................20189
93.406 (a) and (c) revised.........................................20190
93.427 (c)(1) removed; (c)(2) through (5) redesignated as (c)(1) 
        through (4); new (c)(2) and (3) revised....................20190
94 Technical correction............................................18357
    Authority citation revised.....................................21063
94.1 (a)(2) amended; interim...................9643, 14826, 29689, 36697
    (a)(1) amended; interim........................................29899
    (a)(2) amended.................................................55876
    Regulation at 66 FR 29899 confirmed............................63911
94.4 (a) introductory text and (b) introductory text amended; 
        interim....................................................29899
    Regulation at 66 FR 29899 confirmed............................63911
94.5 (e)(2) revised................................................21063
94.11 (a) amended; interim.....................9643, 14826, 29689, 36697
    (a) amended....................................................55876
94.18 (a)(1) and (2) amended; interim................22426, 54643, 62914
    (a)(2) amended; interim........................................29900
    (b) amended; interim...........................................42600
    (a)(1) amended; interim........................................52484
    Regulation at 66 FR 29900 confirmed............................63910
    Regulation at 66 FR 22426 confirmed............................63912
94.21 Removed; interim.............................................29899
    Regulation at 66 FR 29899 confirmed............................63911
95 Authority citation revised......................................21063
95.1 Amended; interim..............................................42600
95.4 Revised; interim..............................................42600
95.29 Added; interim...............................................42601
96 Authority citation revised......................................21063
97 Authority citation revised......................................21063
98 Authority citation revised......................................21063
99 Authority citation revised......................................21063
101 Authority citation revised.....................................21063
102 Authority citation revised.....................................21063
103 Authority citation revised.....................................21063
103.2 Authority citation removed...................................21063
104 Authority citation revised.....................................21063
105 Authority citation revised.....................................21063
106 Authority citation revised.....................................21063
107 Authority citation revised.....................................21064

[[Page 927]]

108 Authority citation revised.....................................21064
109 Authority citation revised.....................................21064
112 Authority citation revised.....................................21064
113 Authority citation revised.....................................21064
114 Authority citation revised.....................................21064
115 Authority citation revised.....................................21064
116 Authority citation revised.....................................21064
116.1 Authority citation removed...................................21064
116.2 Authority citation removed...................................21064
116.3 Authority citation removed...................................21064
116.4 Authority citation removed...................................21064
116.6 Authority citation removed...................................21064
117 Authority citation revised.....................................21064
118 Authority citation revised.....................................21064
122 Authority citation revised.....................................21064
123 Authority citation revised.....................................21064
124 Authority citation revised.....................................21064
130.4 Added........................................................39631
130.8 (a) table amended............................................39632
145 Authority citation revised.....................................21064
147 Authority citation revised.....................................21064
151 Authority citation revised.....................................21064
156 Authority citation revised.....................................21064
160 Authority citation revised.....................................21064
161 Authority citation revised.....................................21064
162 Authority citation revised.....................................21064
166 Authority citation revised.....................................21064
166.1 Authority citation removed...................................21064
166.2 Authority citation removed...................................21064
166.10 Authority citation removed..................................21064
167 Authority citation revised.....................................21064

                                  2002

9 CFR
                                                                   67 FR
                                                                    Page
Chapter I
50 Authority citation revised......................................48750
50.1 Amended; interim........................................7590, 48750
50.2-50.14 (Subpart A) Heading added...............................48751
50.2 Revised; interim........................................7591, 48751
50.3 Revised; interim...............................................7591
50.4 Heading revised; (a) amended; (d) added; interim...............7591
50.6 Revised; interim...............................................7591
50.7 (a) and (b) amended; interim...................................7591
50.8 Amended; interim...............................................7591
50.9 Revised; interim...............................................7591
50.10 Amended; interim..............................................7592
50.11 Amended; interim..............................................7592
50.12 Amended; interim..............................................7592
50.13 Amended; interim..............................................7592
50.14 Revised; interim..............................................7592
50.15 Removed; interim..............................................7592
50.16 Removed; interim..............................................7592
50.17--50.22 (Subpart B) Added (OMB numbers); interim..............48751
53 Authority citation revised......................................67095
53.1 Amended; interim..............................................17610
53.2 (a) and (b) amended; interim..................................17610
    (b) amended; interim...........................................67095
53.4 (a) revised; interim..........................................17610
    (a) revised; (b) redesignated as (c); new (b) added; interim 
                                                                   67095
53.7 Amended; interim..............................................67095
53.8 Revised (OMB number); interim.................................67095
53.10 (e) added; interim...........................................17611
53.11 Added; interim...............................................67095
55 Added; interim...................................................5931
72.5 Amended; interim..............................................18467
    Regulation at 67 FR 18467 confirmed............................60855
77 Comment period extended.........................................50791
    Delay of compliance date.......................................79836
77.2 Amended........................................................7592
77.7 (b) revised; interim..........................................38844
77.9 (a) and (b) revised; interim..................................38844
78 Authority citation revised......................................70310
78.14 (a)(1) revised...............................................70310
82 Authority citation revised......................................70675
82.3 (c) revised; interim..........................................70675
91 Authority citation revised......................................11560
91.3 (a) revised; (c) amended......................................11560
93 Regulation at 67 FR 6369 eff. date confirmed....................20624
    Regulation at 67 FR 68021 eff. date confirmed..................78332
    Authority citation revised; eff. 1-7-03........................68022
    Authority citation revised.....................................72830
93.101 (c)(2)(i) amended...........................................52394
93.102 (d) amended..................................................6370
93.107 (b)(2) amended; eff. 1-7-03.................................68022
93.203 (d) amended..................................................6370
    (b) amended; eff. 1-7-03.......................................68022
93.301 (j)(7) revised (OMB number).................................11565
93.303 (b)(1) amended; eff. 1-7-03.................................68022

[[Page 928]]

93.304 (a)(3)(iv) and (vi) revised; (a)(3)(vii) added; interim.....72830
93.403 (b) amended; eff. 1-7-03....................................68022
93.405 OMB number..................................................11565
93.503 (b) amended; eff. 1-7-03....................................68022
93.505 OMB number..................................................11565
93.600 OMB number..................................................11565
93.703 (a)(2) amended; eff. 1-7-03.................................68022
94 Authority citation revised......................................47244
    Regulation at 67 FR 47244 confirmed............................66533
94.0 Amended; interim..............................................31937
94.1 (a)(2) amended..............................651, 1074, 37664, 77152
    (b)(2) amended; (c) redesignated as (d); new (c) added; 
interim (OMB number)...............................................31938
    (a)(2) and (3) amended.........................................44526
94.6 (a)(2) amended; interim.......................................59137
94.8
94.11 (a) amended.........................651, 1074, 37664, 44526, 77152
94.18 (a)(1) and (2) amended; interim..........4878, 12832, 12834, 44018
    Regulation at 66 FR 52484 confirmed.............................8182
    Regulation at 66 FR 54643 confirmed.............................9188
    Regulation at 66 FR 62914 confirmed............................15335
    Regulation at 67 FR 4878 confirmed.............................34591
    Regulation at 67 FR 12832 confirmed............................45896
    Regulation at 67 FR 12834 confirmed............................45897
    (a)(1) amended; interim........................................47244
    Regulation at 67 FR 44018 confirmed............................62171
    Regulation at 67 FR 47244 confirmed............................66533
97 Authority citation revised......................................48523
97.1 (a) introductory text and (3) revised; (b) amended............48523
97.2 Table amended.................................................11566
98 Authority citation revised; eff. 1-07-03........................68022
    Regulation at 67 FR 68021 eff. date confirmed..................78332
98.33 (b) amended; eff. 1-07-03....................................68022
113.3 (b)(8) revised...............................................15713
113.113 (a)(2) introductory text and (c)(1)(iv) revised............15714
121 Added (OMB numbers); interim...................................52388
    Revised; interim; eff. 2-11-03.................................76931
121.1 Amended; interim.............................................60520
130 Authority citation revised.....................................48524
130.7 (a) table revised............................................48524
130.20 (b)(1) amended..............................................48524
130.50 (b)(3)(i) table revised.....................................48524
145.1 Amended.......................................................8468
145.2 (e) added.....................................................8468
145.6 (a) revised; (b), (c) and (d) amended.........................8468
145.10 (a) and (l) removed; (m) amended.............................8468
145.13 Introductory text amended....................................8468
145.14 Introductory text and (a)(1) Footnote 1 amended..............8468
145.23 (d) introductory text, (1)(iv) and (vi) revised; (d)(1)(i) 
        amended.....................................................8469
145.24 (a)(2) amended...............................................8469
145.33 (c)(2), (h)(1)(i) and (vi) revised; (h) introductory text, 
        (1)(iv) and (3) amended.....................................8469
145.34 (a)(2) and (b)(2) amended....................................8469
145.44 (a)(2), (b)(2) and (c)(2) amended............................8469
145.53 (a) removed..................................................8469
145.54 (a)(2) amended...............................................8469
147.5 (c), (d) introductory text and (2) amended....................8469
147.7 (e)(2)(ii)(B) amended.........................................8469
147.11 (a) revised..................................................8469
147.12 Heading revised; (c) removed; (b) redesignated as (c); 
        (a)(4), (5) and new (b) added; (a) introductory text, 
        (1)(i), (3), (ii), (iv), (c)(1) introductory text and (2) 
        introductory text amended...................................8471
147.18 Removed......................................................8474
147.22 Revised......................................................8474
147.23 Revised......................................................8474
147.24 (a) introductory text, (b) introductory text and (3) 
        amended; (a)(1), (3) and (b)(1) revised; (c) redesignated 
        as (b)(4); new (c) added....................................8474
147.25 Amended......................................................8475
147.26 (a) revised; (b)(5) amended; (b)(10) removed; (b)(11) 
        through (15) redesignated as (b)(10) through (14)...........8475
147.43 (b) revised..................................................8475
161.3 (b) amended..................................................11561

[[Page 929]]

                                  2003

9 CFR
                                                                   68 FR
                                                                    Page
Chapter I
1 Policy statement.................................................58575
1.1 Amended........................................................12285
2 Policy statement.................................................58575
3 Policy statement.................................................58575
4 Authority citation revised........................................6342
11 Authority citation revised.......................................6342
12 Authority citation added.........................................6342
12.1 Authority citation removed.....................................6342
12.10 Authority citation removed....................................6342
49 Authority citation revised.......................................6342
49.1 Amended........................................................6342
50 Authority citation revised.......................................6342
50.17 (b)(1) and (d) revised.......................................10361
51 Authority citation revised.......................................6342
51.1 Amended........................................................6342
52 Authority citation revised.......................................6342
52.1 Amended........................................................6342
53 Authority citation revised.......................................6342
53.3 (d) amended....................................................6343
53.4 (a) and (b) revised...........................................42569
53.7 Revised.......................................................42569
53.8 (b) and (c) revised...........................................42570
53.11 Introductory text and (b) revised............................42570
54 Authority citation revised.......................................6343
70 Authority citation revised.......................................6343
70.1 Amended........................................................6343
71 Authority citation revised.......................................6343
71.1 Amended.......................................................62226
71.3 (b) amended...................................................16938
    (a) amended; (c)(4) removed; (c)(5) redesignated as new (c)(4)
                                                                   36899
    (c)(3) amended.................................................62226
71.18 (a)(5) amended...............................................62226
71.20 (a) amended..................................................62226
72 Authority citation revised.......................................6343
73 Authority citation revised.......................................6343
73.1b Amended.......................................................6343
74 Authority citation revised.......................................6343
75 Authority citation revised.......................................6343
77 Authority citation revised.......................................6343
    Compliance notification........................................47201
77.7 (a) amended; interim...................................20336, 43621
    Regulation at 68 FR 43621 confirmed............................65831
    Regulation at 68 FR 20336 confirmed............................65833
77.9 (a) amended; interim...................................20336, 43621
    Regulation at 68 FR 43621 confirmed............................65831
    Regulation at 68 FR 20336 confirmed............................65833
77.10 OMB number; interim...................................20336, 43621
    Regulation at 68 FR 43621 confirmed............................65831
    Regulation at 68 FR 20336 confirmed............................65833
78 Authority citation revised.......................................6343
79 Authority citation revised.......................................6343
79.2 (f)(3) amended.................................................6343
80 Authority citation revised.......................................6343
82 Authority citation revised.......................................1517
    Heading revised................................................36900
82.3 (c) revised; interim....................................1517, 54800
    (c) amended; interim...3376, 7413, 18532, 26987, 26989, 34781, 45744
82.16 Added; interim................................................1517
82.30--82.38 (Subpart C) Removed...................................36900
85 Authority citation revised.......................................6343
89 Authority citation revised.......................................6343
91 Authority citation revised.......................................6343
91.14 (a)(14) through (18) redesignated as (a)(15) through (19); 
        new (a)(14) added..........................................26991
    Regulation at 68 FR 26991 withdrawn............................37730
92 Authority citation revised.......................................6343
92.1 Amended.......................................................16938
92.2 (a)(1) redesignated as (a); (g) added; OMB number.............50054
92.3 Added.........................................................16938
93 Authority citation revised.......................................6343
93.101 (d)(1)(ii) amended...........................................6343
93.106 (a), (b)(4) and (c)(5)(iii) amended..........................6343
93.201 (b)(1)(ii) amended...........................................6344
93.202 (a) amended..................................................6344
93.207 Amended......................................................6344
93.301 (b)(1)(ii) amended...........................................6344
    (h)(6) and (7) amended; interim.................................7414
93.302 (a) amended..................................................6344
93.306 (a) designation removed; amended.............................6344
93.400 Amended.....................................................35533
93.401 (a), (b) introductory text and (1)(ii) amended...............6344
    (a) revised; interim...........................................31940
93.402 (a) amended..................................................6344
93.404 (a)(2) revised...............................................6344
    (a)(1) amended (OMB number)....................................35533
93.405 (d) amended..................................................6344
93.406 (a)(2)(i) and (iii) revised;(c) amended.....................35533
93.408 Amended......................................................6344
93.419 (b) amended..................................................6344

[[Page 930]]

93.423 (d) amended..................................................6344
93.424 (a)(1) and (2) amended;(a)(3) removed.......................35534
93.426 (a) amended..................................................6344
93.428 (c) amended..................................................6344
93.501 (a), (b) introductory text and (1)(ii) amended...............6344
93.502 (a) amended..................................................6344
93.504 (a)(2) revised...............................................6344
93.505 (c) amended..................................................6344
    (a) amended....................................................16938
93.507 (a) designation removed; amended.............................6344
93.517 (a) amended.................................................16938
93.520 Undesignated center heading amended..........................6344
94 Authority citation revised.......................................6345
    Heading revised................................................16938
94.0 Regulation at 67 FR 31937 confirmed............................5805
    Amended........................................................36900
94.1 Regulation at 67 FR 31938 confirmed............................5805
    (a) introductory text amended...................................6345
    (b)(2) and (d) introductory text revised; (b)(4) added.........31948
94.1a (a) introductory text amended.................................6345
94.4 (b)(2) amended.................................................6345
    (b)(5) revised; (b)(6), (7) and (8) redesignated as (b)(7), 
(8) and (9); new (b)(6) added; new (b)(8) revised..................15936
94.5 (e)(2) amended.................................................6345
94.6 (b) removed; (c), (d) and (e) redesignated as new (b), (c) 
        and (d); new (b)(2), (6), (c)(1)(ix)(C)(1) Footnote 7, 
        (2), (x), (2), (3) and (4) amended; heading, new (c) 
        heading, introductory text and Footnote 6 revised..........36900
94.7 Revised........................................................6345
94.9 Heading and (a) revised; (b) introductory text, (1)(iii)(C) 
        and (c) amended............................................16938
    (a) amended.............................................47841, 59531
94.10 Heading and (a) revised......................................16939
    (a) amended.............................................47841, 59531
94.12 (a) revised..................................................16939
    (c) added; OMB number..........................................53876
94.13 Introductory text revised....................................16939
94.15 (b)(4) and (c)(4) amended.....................................6345
94.17 Heading, (b) and (c) amended.................................16939
94.18 (a)(1) amended; interim......................................31940
94.20 (c) and (e) introductory text amended........................16939
94.21 Added........................................................31949
94.23 Added (OMB Number)...........................................16939
94.24 Added........................................................47841
95 Authority citation revised.......................................6345
96 Authority citation revised.......................................6345
97 Authority citation revised.......................................6345
97.1 (a) introductory text table and (3) table revised.............51882
98 Authority citation revised.......................................6345
98.15 (a)(1)(ii), (2)(ii), (5)(ii)(B), (7)(i)(B) and (8)(i)(B) 
        amended....................................................16940
98.32 (a) amended...................................................6345
98.34 (c)(7)(ii), (iii) concluding text and (D) amended............16940
98.38 Added (OMB Number)...........................................16940
99 Authority citation revised.......................................6345
99.1 Amended........................................................6345
113.29 Revised.....................................................57608
113.64 (e)(3) added................................................57608
113.100 (f) revised................................................35283
113.200 (f) revised................................................35283
113.300 (e) revised................................................57608
121.0 Revised; interim.............................................62220
122 Authority citation revised......................................6345
123 Authority citation revised......................................6346
124.2 Amended.......................................................6346
130 Authority citation revised......................................6346
130.1 Amended......................................................64507
130.2 (a) table and (b) table revised..............................51883
    Heading revised; (d) added.....................................62227
130.3 (a)(1) table revised.........................................51883
130.4 Table revised................................................51883
130.6 (a) table revised............................................51884
130.7 (a) table revised............................................51884
130.8 (a) table revised............................................51884
130.10 (a) table and (b) table revised.............................51885
130.11 (a) table revised....................................51885, 64507
130.14 (b) table amended...........................................16940
130.18 (b) table amended...........................................16940
130.20 (a) table and (b)(1) table revised..........................51886
130.30 (a) table and (b) table revised.............................51886
130.50 (b)(3)(i) table revised.....................................51887
130.51 (d) amended..................................................6346
145 Authority citation revised......................................6346
145.10 (r) amended; (t) added......................................64509
145.14 (a)(9) removed; (a)(6), (7) and (8) redesignated as (a)(7), 
        (8) and (9); new (a)(7) amended; new (a)(6) added..........64510

[[Page 931]]

145.22 (a) and (b) removed; (c), (d) and (e) redesignated as (a), 
        (b) and (c)................................................64510
145.32 (a) removed; (b), (c) and (d) redesignated as (a), (b) and 
        (c)........................................................64510
145.33 (c)(4), (e)(4), (h)(1)(ii)(A), (B), (i)(1)(iii), (j)(1) and 
        (k)(1) revised; (h)(6) added...............................64510
145.42 (b) removed; (c) and (d) redesignated as (b) and (c)........64511
145.43 (f)(3) revised; (g) added...................................64511
145.53 (e) added...................................................64512
147 Authority citation revised......................................6346
147.12 (b) introductory text amended; (b)(3) added.................64512
160 Authority citation revised......................................6346
161 Authority citation revised......................................6346
161.4 (d) amended...................................................6346
162 Authority citation revised......................................6346
166 Authority citation revised......................................6346
166.14 (a)(3) amended...............................................6346
166.15 (a), (b), and (c) amended....................................7415


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