[Title 9 CFR ]
[Code of Federal Regulations (annual edition) - January 1, 2021 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

                                      Title 9

                           Animals and Animal Products
                             ________________________

                                  Parts 1 to 199

                         Revised as of January 1, 2021

          Containing a codification of documents of general 
          applicability and future effect

          As of January 1, 2021
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

[[Page ii]]

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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:
      Table of CFR Titles and Chapters........................    1039
      Alphabetical List of Agencies Appearing in the CFR......    1059
      List of CFR Sections Affected...........................    1069

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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, 2021), 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.

PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
the revision date stated on the cover of each volume are not carried. 
Code users may find the text of provisions in effect on any given date 
in the past by using the appropriate List of CFR Sections Affected 
(LSA). For the convenience of the reader, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume. For changes to 
the Code prior to the LSA listings at the end of the volume, consult 
previous annual editions of the LSA. For changes to the Code prior to 
2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not dropped in error.

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.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed 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, 8601 Adelphi Road, College Park, MD 20740-6001, 
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 Authorities 
and Rules. A list of CFR titles, chapters, subchapters, 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.

[[Page vii]]

    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.

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, 8601 Adelphi Road, College Park, MD 
20740-6001 or e-mail [email protected].

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ELECTRONIC SERVICES

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Register, Public Laws, Public Papers of the Presidents of the United 
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law numbers, Federal Register finding aids, and related information. 
Connect to NARA's website at www.archives.gov/federal-register.
    The e-CFR is a regularly updated, unofficial editorial compilation 
of CFR material and Federal Register amendments, produced by the Office 
of the Federal Register and the Government Publishing Office. It is 
available at www.ecfr.gov.

    Oliver A. Potts,
    Director,
    Office of the Federal Register
    January 1, 2021







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                               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--Agricultural Marketing Service (Fair Trade 
Practices Program), 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, 2021.

    For this volume, Gabrielle E. Burns was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of John 
Hyrum Martinez, assisted by Stephen J. Frattini.

[[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

[[Page 3]]



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




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

                      SUBCHAPTER A--ANIMAL WELFARE
Part                                                                Page
1               Definition of terms.........................           7
2               Regulations.................................          12
3               Standards...................................          47
4               Rules of practice governing proceedings 
                    under the Animal Welfare Act............         128
11              Horse protection regulations................         129
12              Rules of practice governing proceedings 
                    under the Horse Protection Act..........         146
   SUBCHAPTER B--COOPERATIVE CONTROL AND ERADICATION OF LIVESTOCK OR 
                            POULTRY DISEASES
49              Rules of practice governing proceedings 
                    under certain acts......................         148
50              Animals destroyed because of tuberculosis...         148
51              Animals destroyed because of brucellosis....         158
52              Swine destroyed because of pseudorabies.....         171
53              Foot-and-mouth disease, pleuropneumonia, and 
                    certain other communicable diseases of 
                    livestock or poultry....................         175
54              Control of scrapie..........................         181
55              Control of chronic wasting disease..........         197
56              Control of H5/H7 low pathogenic avian 
                    influenza...............................         209
 SUBCHAPTER C--INTERSTATE TRANSPORTATION OF ANIMALS (INCLUDING POULTRY) 
                           AND ANIMAL PRODUCTS
70              Rules of practice governing proceedings 
                    under certain acts......................         218
71              General provisions..........................         218
72              Bovine babesiosis...........................         239
73              Scabies in cattle...........................         245

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74              Prohibition of interstate movement of land 
                    tortoises...............................         251
75              Communicable diseases in horses, asses, 
                    ponies, mules, and zebras...............         251
76              [Reserved]

77              Tuberculosis................................         253
78              Brucellosis.................................         284
79              Scrapie in sheep and goats..................         323
80              Johne's disease in domestic animals.........         348
81              Chronic wasting disease in deer, elk, and 
                    moose...................................         350
82              Newcastle Disease and chlamydiosis..........         353
85              Pseudorabies................................         369
86              Animal disease traceability.................         381
88              Commercial transportation of equines for 
                    slaughter...............................         390
89              Statement of policy under the Twenty-Eight 
                    Hour Law................................         393
SUBCHAPTER D--EXPORTATION AND IMPORTATION OF ANIMALS (INCLUDING POULTRY) 
                           AND ANIMAL PRODUCTS
91              Exportation of live animals, hatching eggs 
                    or other embryonated eggs, animal semen, 
                    animal embryos, and gametes from the 
                    United States...........................         395
92              Importation of animals and animal products: 
                    Procedures for requesting recognition of 
                    regions and compartments................         406
93              Importation of certain animals, birds, fish, 
                    and poultry, and certain animal, bird, 
                    and poultry products; requirements for 
                    means of conveyance and shipping 
                    containers..............................         414
94              Foot-and-mouth disease, Newcastle disease, 
                    highly pathogenic avian influenza, 
                    African swine fever, classical swine 
                    fever, swine vesicular disease, and 
                    bovine spongiform encephalopathy: 
                    Prohibited and restricted importations..         558
95              Sanitary control of animal byproducts 
                    (except casings), and hay and straw, 
                    offered for entry into the United States         613
96              Restriction of importations of foreign 
                    animal casings offered for entry into 
                    the United States.......................         635
97              Overtime services relating to imports and 
                    exports.................................         642
98              Importation of certain animal embryos and 
                    animal semen............................         649

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99              Rules of practice governing proceedings 
                    under certain acts......................         672
SUBCHAPTER E--VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS 
                               AND VECTORS
101             Definitions.................................         673
102             Licenses for biological products............         679
103             Experimental production, distribution, and 
                    evaluation of biological products prior 
                    to licensing............................         682
104             Permits for biological products.............         684
105             Suspension, revocation, or termination of 
                    biological licenses or permits..........         687
106             Exemption for biological products used in 
                    department programs or under department 
                    control or supervision..................         688
107             Exemptions from preparation pursuant to an 
                    unsuspended and unrevoked license.......         689
108             Facility requirements for licensed 
                    establishments..........................         690
109             Sterilization and pasteurization at licensed 
                    establishments..........................         693
112             Packaging and labeling......................         694
113             Standard requirements.......................         704
114             Production requirements for biological 
                    products................................         824
115             Inspections.................................         835
116             Records and reports.........................         835
117             Animals at licensed establishments..........         838
118             Detention; seizure and condemnation.........         840
121             Possession, use, and transfer of select 
                    agents and toxins.......................         841
122             Organisms and vectors.......................         863
123             Rules of practice governing proceedings 
                    under the Virus-Serum-Toxin Act.........         864
124             Patent term restoration.....................         864
                         SUBCHAPTER F--USER FEES
130             User fees...................................         870
                   SUBCHAPTER G--LIVESTOCK IMPROVEMENT
145             National Poultry Improvement Plan for 
                    Breeding Poultry........................         893
146             National Poultry Improvement Plan for 
                    Commercial Poultry......................         964
147             Auxiliary provisions on National Poultry 
                    Improvement Plan........................         977

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149             Voluntary Trichinae Certification Program...         986
                       SUBCHAPTER H--ANIMAL BREEDS
151             Recognition of breeds and books of record of 
                    purebred animals........................        1002
      SUBCHAPTER I--VOLUNTARY INSPECTION AND CERTIFICATION SERVICE
156             Voluntary inspection and certification 
                    service.................................        1013
     SUBCHAPTER J--ACCREDITATION OF VETERINARIANS AND SUSPENSION OR 
                    REVOCATION OF SUCH ACCREDITATION
160             Definition of terms.........................        1016
161             Requirements and standards for accredited 
                    veterinarians and suspension or 
                    revocation of such accreditation........        1017
162             Rules of practice governing revocation or 
                    suspension of veterinarians' 
                    accreditation...........................        1025
                    SUBCHAPTER K--PUBLIC INFORMATION
165             Availability of information.................        1028
                  SUBCHAPTER L--SWINE HEALTH PROTECTION
166             Swine health protection.....................        1029
167             Rules of practice governing proceedings 
                    under the Swine Health Protection Act...        1035
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.
    Act means the Act of August 24, 1966 (Pub. L. 89-544), (commonly 
known as the Laboratory Animal Welfare Act), as amended by the Act of 
December 24, 1970 (Pub. L. 91-579), (the Animal Welfare Act of 1970), 
the Act of April 22, 1976 (Pub. L. 94-279), (the Animal Welfare Act of 
1976), and the Act of December 23, 1985 (Pub. L. 99-198), (the Food 
Security Act of 1985), and as it may be subsequently amended.
    Activity means, for purposes of part 2, subpart C of this 
subchapter, those elements of research, testing, or teaching procedures 
that involve the care and use of animals.
    Administrative unit means the organizational or management unit at 
the departmental level of a research facility.
    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Ambient temperature means the air temperature surrounding the 
animal.
    Animal means any live or dead dog, cat, nonhuman primate, guinea 
pig, hamster, rabbit, or any other warmblooded animal, which is being 
used, or is intended for use for research, teaching, testing, 
experimentation, or exhibition purposes, or as a pet. This term excludes 
birds, rats of the genus Rattus, and mice of the genus Mus, bred for use 
in research; horses not used for research purposes; and other farm 
animals, such as, but not limited to, livestock or poultry used or 
intended for use as food or fiber, or livestock or poultry used or 
intended for use for improving animal nutrition, breeding, management, 
or production efficiency, or for improving the quality of food or fiber. 
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 members of the public and that 
directly abuts the interactive area.
    Business hours means a reasonable number of hours between 7 a.m. and 
7 p.m. each week of the year, during which inspections by APHIS may be 
made.
    Business year means the 12-month period during which business is 
conducted, and may be either on a calendar or fiscal-year basis.
    Carrier means the operator of any airline, railroad, motor carrier, 
shipping line, or other enterprise which is engaged in the business of 
transporting any animals for hire.

[[Page 8]]

    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 use as a pet; or any dog at the 
wholesale level for hunting, security, or breeding purposes. This term 
does not include: A retail pet store, as defined in this section; and 
any retail outlet where dogs are sold for hunting, breeding, or security 
purposes.
    Department means the U.S. Department of Agriculture.
    Deputy Administrator means the Deputy Administrator for Animal Care 
(AC) or any other official of AC to whom authority has been delegated to 
act in his stead.
    Dog means any live or dead dog (Canis familiaris) or any dog-hybrid 
cross.
    Dwarf hamster means any species of hamster such as the Chinese and 
Armenian species whose adult body size is substantially less than that 
attained by the Syrian or Golden species of hamsters.
    Endangered species means those species defined in the Endangered 
Species Act (16 U.S.C. 1531 et seq.) and as it may be subsequently 
amended.
    Euthanasia means the humane destruction of an animal accomplished by 
a method that produces rapid unconsciousness and subsequent death 
without evidence of pain or distress, or a method that utilizes 
anesthesia produced by an agent that causes painless loss of 
consciousness and subsequent death
    Exhibitor means any person (public or private) exhibiting any 
animals, which were purchased in commerce or the intended distribution 
of which affects

[[Page 9]]

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, an owner of a common, domesticated 
household pet who derives less than a substantial portion of income from 
a nonprimary source (as determined by the Secretary) for exhibiting an 
animal that exclusively resides at the residence of the pet owner, 
organizations sponsoring and all persons participating in State and 
country fairs, livestock shows, rodeos, field trials, coursing events, 
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 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

[[Page 10]]

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.
    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,

[[Page 11]]

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 a place of business or residence at which the 
seller, buyer, and the animal available for sale are physically present 
so that every buyer may personally observe the animal prior to 
purchasing and/or taking custody of that animal after purchase, and 
where only the following animals are sold or offered for sale, at 
retail, for use as pets: Dogs, cats, rabbits, guinea pigs, hamsters, 
gerbils, rats, mice, gophers, chinchillas, domesticated ferrets, 
domesticated farm-type animals, birds, and coldblooded species. Such 
definition excludes--
    (1) Establishments or persons who deal in dogs used for hunting, 
security, or breeding purposes;
    (2) Establishments or persons exhibiting, selling, or offering to 
exhibit or sell any wild or exotic or other nonpet species of 
warmblooded animals (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;

[[Page 12]]

    (4) Any establishment wholesaling any animals (except birds, rats, 
and mice); and
    (5) Any establishment exhibiting pet animals in a room that is 
separate from or adjacent to the retail pet store, or in an outside 
area, or anywhere off the retail pet store premises.
    Sanctuary area means that area in a primary enclosure for a swim-
with-the-dolphin program that is off-limits to the public and that 
directly abuts the buffer area.
    Sanitize means to make physically clean and to remove and destroy, 
to the maximum degree that is practical, agents injurious to health.
    Secretary means the Secretary of Agriculture of the United States or 
his representative who shall be an employee of the Department.
    Sheltered housing facility means a housing facility which provides 
the animals with shelter; protection from the elements; and protection 
from temperature extremes at all times. A sheltered housing facility may 
consist of runs or pens totally enclosed in a barn or building, or of 
connecting inside/outside runs or pens with the inside pens in a totally 
enclosed building.
    Standards means the requirements with respect to the humane housing, 
exhibition, handling, care, treatment, temperature, and transportation 
of animals by dealers, exhibitors research facilities, carriers, 
intermediate handlers, and operators of auction sales as set forth in 
part 3 of this subchapter.
    State means a State of the United States, the District of Columbia, 
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, 
or any other territory or possession of the United States.
    Study area means any building room, area, enclosure, or other 
containment outside of a core facility or centrally designated or 
managed area in which animals are housed for more than 12 hours.
    Swim-with-the-dolphin (SWTD) program means any human-cetacean 
interactive program in which a member of the public enters the primary 
enclosure in which an SWTD designated cetacean is housed to interact 
with the animal. This interaction includes, but such inclusions are not 
limited to, wading, swimming, snorkeling, or scuba diving in the 
enclosure. This interaction excludes, but such exclusions are not 
limited to, feeding and petting pools, and the participation of any 
member(s) of the public audience as a minor segment of an educational 
presentation or performance of a show.
    Transporting device means an interim vehicle or device, other than 
man, used to transport an animal between the primary conveyance and the 
terminal facility or in and around the terminal facility of a carrier or 
intermediate handler.
    Transporting vehicle means any truck, car, trailer, airplane, ship, 
or railroad car used for transporting animals.
    Weaned means that 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; 69 FR 31514, June 4, 2004; 69 FR 42099, July 14, 
2004; 78 FR 57249, Sept. 18, 2013; 83 FR 25554, June 4, 2018; 85 FR 
28795, May 13, 2020]

    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.

[[Page 13]]

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.
2.6-2.8 [Reserved]
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 license application.
2.12 Termination of a license.
2.13 Appeal of inspection report.

                         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; submission of 
          itineraries.
2.127 Publication of lists 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 dogs, cats, and other animals; dealers.
2.133 Certification for random source dogs and cats.
2.134 Contingency planning.

                   Subpart J_Importation of Live Dogs

2.150 Import permit.
2.151 Certifications.
2.152 Notification of arrival.
2.153 Dogs refused entry.

    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) No person shall operate as a dealer, exhibitor, or operator 
of an auction sale, without a valid license, except persons who are 
exempt from the licensing requirements under paragraph (a)(3) of this 
section. A person must be 18 years of age or older to obtain a license. 
A person seeking a license shall apply on a form which will be furnished 
by the Deputy Administrator. The applicant shall provide the information 
requested on the application form, including, but not limited to:
    (i) The name of the person applying for the license;
    (ii) A valid mailing address through which the applicant can be 
reached at all times;

[[Page 14]]

    (iii) Valid addresses for all locations, facilities, premises, or 
sites where animals, animal facilities, equipment, and records are held, 
kept, or maintained;
    (iv) The anticipated maximum number of animals on hand at any one 
time during the period of licensure;
    (v) The anticipated type of animals described in paragraph 
(b)(2)(ii) of this section to be owned, held, maintained, sold, or 
exhibited, including those animals leased, during the period of 
licensure;
    (vi) If the person is seeking a license as an exhibitor, whether the 
person intends to exhibit any animal at any location other than the 
person's location(s) listed pursuant to paragraph (a)(1)(iii) of this 
section; and
    (vii) Disclosure of any plea of nolo contendere (no contest) or 
finding of violation of Federal, State, or local laws or regulations 
pertaining to animal cruelty or the transportation, ownership, neglect, 
or welfare of animals.
    (2) The completed application form, along with a $120 license fee, 
shall be submitted to the appropriate Animal Care office.
    (3) The following persons are exempt from the licensing requirements 
under section 2 or section 3 of the Act:
    (i) Retail pet stores as defined in part 1 of this subchapter;
    (ii) Any person who sells or negotiates the sale or purchase of any 
animal except wild or exotic animals, dogs, or cats, and who derives no 
more than $500 gross income from the sale of such animals during any 
calendar year and is not otherwise required to obtain a license;
    (iii) Any person who maintains a total of four or fewer breeding 
female pet animals as defined in part 1 of this subchapter, small exotic 
or wild mammals (such as hedgehogs, degus, spiny mice, prairie dogs, 
flying squirrels, jerboas, domesticated ferrets, chinchillas, and 
gerbils), and/or domesticated farm-type animals (such as cows, goats, 
pigs, sheep, llamas, and alpacas) and sells only the offspring of these 
animals, which were born and raised on his or her premises, for pets or 
exhibition, and is not otherwise required to obtain a license. This 
exemption does not extend to any person residing in a household that 
collectively maintains a total of more than four of these breeding 
female animals, regardless of ownership, or to any person maintaining 
such breeding female animals on premises on which more than four of 
these breeding female animals are maintained, or to any person acting in 
concert with others where they collectively maintain a total of more 
than four of these breeding female animals, regardless of ownership;
    (iv) Any person who sells fewer than 25 dogs and/or cats per year, 
which were born and raised on his or her premises, for research, 
teaching, or testing purposes or to any research facility and is not 
otherwise required to obtain a license. This exemption does not extend 
to any person residing in a household that collectively sells 25 or more 
dogs and/or cats, regardless of ownership, nor to any person acting in 
concert with others where they collectively sell 25 or more dogs and/or 
cats, regardless of ownership. The sale of any dog or cat not born and 
raised on the premises for research purposes requires a license;
    (v) Any person who arranges for transportation or transports animals 
solely for the purpose of breeding, exhibiting in purebred shows, 
boarding (not in association with commercial transportation), grooming, 
or medical treatment, and is not otherwise required to obtain a license;
    (vi) Any person who buys, sells, transports, or negotiates the sale, 
purchase, or transportation of any animals used only for the purposes of 
food or fiber (including fur);
    (vii) Any person who maintains a total of eight or fewer pet animals 
as defined in part 1 of this subchapter, small exotic or wild mammals 
(such as hedgehogs, degus, spiny mice, prairie dogs, flying squirrels, 
jerboas, domesticated ferrets, chinchillas, and gerbils), and/or 
domesticated farm-type animals (such as cows, goats, pigs, sheep, 
llamas, and alpacas) for exhibition, and is not otherwise required to 
obtain a license. This exemption does not extend to any person acting in 
concert with others where they collectively maintain a total of more 
than eight of these animals for exhibition,

[[Page 15]]

regardless of possession and/or ownership;
    (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)(1) No person shall have more than one license. Licenses are 
issued to specific persons, and are issued for specific activities, 
types and numbers of animals, and approved sites. A new license must be 
obtained upon change of ownership, location, activities, or animals. A 
licensee shall notify Animal Care no fewer than 90 days and obtain a new 
license before any change in the name, address, substantial control or 
ownership of his business or operation, locations, activities, and 
number or type of animals described in paragraph (b)(2) of this section. 
Any person who is subject to the regulations in this subchapter and who 
intends to exhibit any animal at any location other than the person's 
approved site must provide that information on their application form in 
accordance with paragraph (a) of this section and submit written 
itineraries in accordance with Sec.2.126.
    (2) Licenses authorize a specific number and specific type(s) of 
animals, as follows:
    (i) Licenses authorize increments of 50 animals on hand at any 
single point in time during the period of licensure. A licensee must 
obtain a new license before any change resulting in more than the 
authorized number of animals on hand at any single point in time during 
the period of licensure.
    (ii) Licenses authorize the use of animals subject to subparts A 
through F in part 3 of this subchapter, except that, for animals subject 
to subparts D and F, licenses must specifically authorize the use of 
each of the following groups of animals: Group 5 (baboons and 
nonbrachiating species larger than 33 pounds) and Group 6 (great apes 
over 55 pounds and brachiating species) nonhuman primates; exotic and 
wild felids (including but not limited to lions, tigers, leopards, 
cheetahs, jaguars, cougars, lynx, servals, bobcats, and caracals, and 
any hybrid cross thereof); hyenas and/or exotic and wild canids 
(including but not limited to wolves, coyotes, foxes, and jackals); 
bears; and mega-herbivores (including but not limited to elephants, 
rhinoceroses, hippopotamuses, and giraffes). A licensee must obtain a 
new license before using any animal beyond those types or numbers of 
animals authorized under the existing license.
    (c) A license will be issued to any applicant, except as provided in 
Sec. Sec.2.9 through 2.11, when:
    (1) The applicant has met the requirements of this section and 
Sec. Sec.2.2 and 2.3; and
    (2) The applicant has paid a $120 license fee to the appropriate 
Animal Care office. The applicant may pay the fee by certified check, 
cashier's check, personal check, money order, or credit card. An 
applicant whose check is returned by a bank will be charged a fee of $20 
for each returned check. If an applicant's check is returned, subsequent 
fees must be paid by certified check, cashier's check, money order, or 
credit card.
    (d) The failure of any person to comply with any provision of the 
Act, or any of the provisions of the regulations or standards in this 
subchapter, shall constitute grounds for denial of a license or for its 
suspension or revocation by the Secretary, as provided in the Act.

(Approved by the Office of Management and Budget under control numbers 
0579-0036 and 0579-0470)

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998; 
69 FR 42099, July 14, 2004; 78 FR 57249, Sept. 18, 2013; 83 FR 25555, 
June 4, 2018; 85 FR 28795, May 13, 2020]



Sec.2.2  Acknowledgement of regulations and standards.

    Animal Care will supply a copy of the Act and the regulations and 
standards in this subchapter to an applicant upon request. Signing the 
application form is an acknowledgement that the applicant has reviewed 
the Act and the regulations and standards and agrees to comply with 
them.

(Approved by the Office of Management and Budget under control numbers 
0579-0036 and 0579-0470)

[85 FR 28796, May 13, 2020]

[[Page 16]]



Sec.2.3  Demonstration of compliance with standards and regulations.

    (a) Each applicant for a license must demonstrate that his or her 
location(s) and any animals, facilities, vehicles, equipment, or other 
locations used or intended for use in the business comply with the Act 
and the regulations and standards set forth in parts 2 and 3 of this 
subchapter. Each applicant must make his or her animals, locations, 
facilities, vehicles, equipment, and records available for inspection 
during business hours and at other times mutually agreeable to the 
applicant and APHIS, to ascertain the applicant's compliance with the 
Act and the regulations and standards.
    (b) Each applicant for a license must be inspected by APHIS and 
demonstrate compliance with the Act and the regulations and standards, 
as required in paragraph (a) of this section, before APHIS will issue a 
license. If the first inspection reveals that the applicant's animals, 
premises, facilities, vehicles, equipment, locations, or records do not 
meet the applicable requirements of this subchapter, APHIS will advise 
the applicant of existing deficiencies and the corrective measures that 
must be completed to come into compliance with the regulations and 
standards. An applicant who fails the first inspection may request up to 
two more inspections by APHIS to demonstrate his or her compliance with 
the Act and the regulations and standards. The applicant must request 
the second inspection, and if applicable, the third inspection, within 
60 days following the first inspection.
    (c) Any applicant who fails the third and final prelicense 
inspection may appeal all or part of the inspection findings to the 
Deputy Administrator. To appeal, the applicant must send a written 
statement contesting the inspection finding(s) and include any 
documentation or other information in support of the appeal. To receive 
consideration, the appeal must be received by the Deputy Administrator 
within 7 days of the date the applicant received the third prelicense 
inspection report. Within 7 days of receiving a timely appeal, the 
Deputy Administrator will issue a written response to notify the 
applicant whether APHIS will issue a license or deny the application.
    (d) If an applicant fails inspection or fails to request 
reinspections within the 60-day period, or fails to submit a timely 
appeal of the third prelicense inspection report as described in 
paragraph (c) of this section, the applicant cannot reapply for a 
license for a period of 6 months from the date of the failed third 
inspection or the expiration of the time to request a third inspection. 
No license will be issued until the applicant pays the license fee and 
demonstrates upon inspection that the animals, premises, facilities, 
vehicles, equipment, locations, and records are in compliance with all 
applicable requirements in the Act and the regulations and standards in 
this subchapter.

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

[85 FR 28796, May 13, 2020]



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 
for 3 years unless:
    (1) The license has been revoked or suspended pursuant to section 19 
of the Act or terminated pursuant to Sec.2.12.
    (2) The license is voluntarily terminated upon request of the 
licensee, in writing, to the Deputy Administrator.
    (3) The license has expired, except that:
    (i) The Deputy Administrator may issue a temporary license, which 
automatically expires after 120 days, to an applicant whose immediately 
preceding 3-year license has expired, if:
    (A) The applicant submits the appropriate application form before 
the expiration date of a preceding license; and
    (B) The applicant had no noncompliances with the Act and the 
regulations and standards in parts 2 and 3 of this subchapter documented 
in any inspection report during the preceding period of licensure.

[[Page 17]]

    (ii) For expedited hearings occurring under Sec.2.11(b)(2), a 
license will remain valid and effective until the administrative law 
judge issues his or her initial decision. Should the administrative law 
judge's initial decision affirm the denial of the license application, 
the applicant's license shall terminate immediately.
    (4) There will not be a refund of the license fee if a license is 
denied, or terminated, suspended, or revoked prior to its expiration 
date.
    (b) Any person who seeks the reinstatement of a license that has 
expired or been terminated must follow the procedure applicable to new 
applicants for a license set forth in Sec.2.1.
    (c) A license which is invalid under this part shall be surrendered 
to the Deputy Administrator. If the license cannot be found, the 
licensee shall provide a written statement so stating to the Deputy 
Administrator.

[85 FR 28796, May 13, 2020]



Sec. Sec.2.6-2.8  [Reserved]



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 activity upon which the order of 
suspension or revocation was based will not be licensed, or registered 
as a carrier, intermediate handler, dealer, exhibitor, or research 
facility, within the period during which the order of suspension or 
revocation is in effect.

[85 FR 28796, May 13, 2020]



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

    (a) Any person whose license or registration has been suspended for 
any reason shall not be licensed, or registered, in his or her own name 
or in any other manner, within the period during which the order of 
suspension is in effect. No partnership, firm, corporation, or other 
legal entity in which any such person has a substantial interest, 
financial or otherwise, will be licensed or registered during that 
period. Any person whose license has been suspended for any reason may 
apply to the Deputy Administrator, in writing, for reinstatement of his 
or her license or registration.
    (b) Any person whose license has been revoked shall not be licensed 
or registered, in his or her own name or in any other manner, and no 
partnership, firm, corporation, or other legal entity in which any such 
person has a substantial interest, financial or otherwise, will be 
licensed or registered.
    (c) Any person whose license has been suspended or revoked shall not 
buy, sell, transport, exhibit, or deliver for transportation, any animal 
during the period of suspension or revocation, under any circumstances, 
whether on his or her behalf or on the behalf of another licensee or 
registrant.

[85 FR 28796, May 13, 2020]



Sec.2.11  Denial of 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 through 
2.4 and has not paid the fees indicated in Sec.2.1;
    (2) Is not in compliance with the Act or any of the regulations or 
standards in this subchapter;
    (3) Has had a license revoked or whose license is suspended, as set 
forth in Sec.2.1(d);
    (4) Was an officer, agent, or employee of a licensee whose license 
has been suspended or revoked and who was responsible for or 
participated in the activity upon which the order of suspension or 
revocation was based, as set forth in Sec.2.9;
    (5) Has pled nolo contendere (no contest) or has been found to have 
violated any Federal, State, or local laws or regulations pertaining to 
animal cruelty within 3 years of application, or after 3 years if the 
Administrator determines that the circumstances render the applicant 
unfit to be licensed;
    (6) Is or would be operating in violation or circumvention of any 
Federal, State, or local laws; or
    (7) Has made any false or fraudulent statements or provided any 
false or fraudulent records to the Department or other government 
agencies, or has pled nolo contendere (no contest) or has

[[Page 18]]

been found to have violated any Federal, State, or local laws or 
regulations pertaining to the transportation, ownership, neglect, or 
welfare of animals, or is otherwise unfit to be licensed and the 
Administrator determines that the issuance of a license would be 
contrary to the purposes of the Act.
    (b)(1) An applicant whose initial license application has been 
denied may request a hearing in accordance with the applicable rules of 
practice in 7 CFR part 1 for the purpose of showing why the application 
for license should not be denied. The denial of an initial license 
application shall remain in effect until the final decision has been 
rendered. Should the license denial be upheld, the applicant may again 
apply for a license 1 year from the date of the final order denying the 
application, unless the order provides otherwise.
    (2) An applicant who submitted a timely appeal of a third prelicense 
inspection as described in Sec.2.3(c), and whose appeal results in the 
denial of the license application, may request an expedited hearing if 
the applicant held a valid license when he or she submitted the license 
application that has been denied and the Deputy Administrator received 
such license application no fewer than 90 days prior to the expiration 
of the valid license. If the applicant meets the criteria in this 
paragraph (b)(2), and notwithstanding the timeframes of the proceedings 
set forth in the applicable rules of practice (7 CFR 1.130 through 
1.151):
    (i) The applicant must submit the request for an expedited hearing 
within 30 days of receiving notice from the Deputy Administrator that 
the license application has been denied;
    (ii) The administrative law judge shall set the expedited hearing so 
that it occurs within 30 days of receiving a timely request for 
expedited hearing as described in paragraph (b)(2)(i) of this section; 
and
    (iii) The administrative law judge must issue an initial decision no 
later than 30 days after the expedited hearing.
    (iv) The applicant's license will remain valid until the 
administrative law judge issues his or her initial decision. Should the 
administrative law judge's initial decision affirm the denial of the 
license application, the applicant's license shall terminate 
immediately.
    (c) No partnership, firm, corporation, or other legal entity in 
which a person whose license application has been denied has a 
substantial interest, financial or otherwise, will be licensed within 1 
year of the license denial.
    (d) No license will be issued under circumstances that the 
Administrator determines would circumvent any order, stipulation, or 
settlement agreement suspending, revoking, terminating, or denying a 
license or disqualifying a person from engaging in activities under the 
Act.

[85 FR 28797, May 13, 2020]



Sec.2.12  Termination of a license.

    A license may be terminated at any time for any reason that a 
license application may be denied pursuant to Sec.2.11 after a hearing 
in accordance with the applicable rules of practice in 7 CFR part 1.

[85 FR 28797, May 13, 2020]



Sec.2.13  Appeal of inspection report.

    Except as otherwise provided in Sec.2.3(c), any licensee or 
registrant may appeal all or part of the inspection findings in an 
inspection report to the Deputy Administrator. To appeal, the licensee 
or registrant must send a written statement contesting the inspection 
finding(s) and include any documentation or other information in support 
of the appeal. To receive consideration, the appeal must be received by 
the Deputy Administrator within 21 days of the date the licensee or 
registrant received the inspection report that is the subject of the 
appeal.

[85 FR 28797, May 13, 2020]



                         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 Deputy

[[Page 19]]

Administrator. The registration form shall be filed with the Deputy 
Administrator for the State in which the registrant has his or her 
principal place of business, and shall be updated every 3 years by the 
completion and filing of a new registration form which will be provided 
by the Deputy Administrator.
    (b) A subsidiary of a business corporation, rather than the parent 
corporation, will be registered as an exhibitor unless the subsidiary is 
under such direct control of the parent corporation that the Secretary 
determines that it is necessary that the parent corporation be 
registered to effectuate the purposes of the Act.
    (c) No registrant or person required to be registered shall 
interfere with, threaten, abuse (including verbally abuse), or harass 
any APHIS official who is in the course of carrying out his or her 
duties.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998; 
69 FR 42101, July 14, 2004; 85 FR 28797, May 13, 2020]



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 Deputy Administrator.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998; 
85 FR 28797, May 13, 2020]



Sec.2.27  Notification of change of operation.

    (a) A registrant shall notify the Deputy Administrator by certified 
mail of any change in the name, address, or ownership, or other change 
in operations affecting its status as an exhibitor, carrier, or 
intermediate handler, within 10 days after making such change.
    (b)(1) A registrant which has not used, handled, or transported 
animals for a period of at least 2 years may be placed in an inactive 
status by making a written request to the Deputy Administrator a 
registrant shall notify the Deputy Administrator in writing at least 10 
days before using, handling, or transporting animals again after being 
in an inactive status.
    (2) A registrant which goes out of business or which ceases to 
function as a carrier, intermediate handler, or exhibitor, or which 
changes its method of operation so that it no longer uses, handles, or 
transports animals, and which does not plan to use, handle, or transport 
animals again at any time in the future, may have its registration 
canceled by making a written request to the Deputy Administrator. The 
former registrant is responsible for reregistering and demonstrating its 
compliance with the Act and regulations should it start using, handling, 
or transporting animals at any time after its registration is canceled.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998; 
85 FR 28797, May 13, 2020]



                      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 Deputy Administrator. The registration form shall 
be filed with the Deputy Administrator 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 Deputy Administrator. Except as 
provided in paragraph (a)(2) of this section, where a school or 
department of a university or college uses or intends to use live 
animals for research, tests, experiments, or teaching, the university or 
college rather than the school or department will be considered the 
research facility and will be required to register with the Secretary. 
An official who has the legal authority to bind the parent organization 
shall sign the registration form.
    (2) In any situation in which a school or department of a university 
or college demonstrates to the Secretary that it is a separate legal 
entity and its operations and administration are

[[Page 20]]

independent of those of the university or college, the school or 
department will be registered rather than the university or college.
    (3) A subsidiary of a business corporation, rather than the parent 
corporation, will be registered as a research facility unless the 
subsidiary is under such direct control of the parent corporation that 
the Secretary determines that it is necessary that the parent 
corporation be registered to effectuate the purposes of the Act.
    (b) Acknowledgment of regulations and standards. APHIS will supply a 
copy of the regulations and standards in this subchapter with each 
registration form. The research facility shall acknowledge receipt of 
and shall agree to comply with the regulations and standards by signing 
a form provided for this purpose by APHIS, and by filing it with the 
Deputy Administrator.
    (c) Notification of change of operation. (1) A research facility 
shall notify the Deputy Administrator by certified mail of any change in 
the name, address, or ownership, or other change in operations affecting 
its status as 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 Deputy Administrator. A 
research facility shall file an annual report of its status (active or 
inactive). A research facility shall notify the Deputy Administrator 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 Deputy Administrator. 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.
    (d) No research facility shall interfere with, threaten, abuse 
(including verbally abuse), or harass any APHIS official who is in the 
course of carrying out his or her duties.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998; 
69 FR 42101, July 14, 2004; 85 FR 28797, May 13, 2020]



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.
    (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:

[[Page 21]]

    (1) Review, at least once every six months, the research facility's 
program for humane care and use of animals, using title 9, chapter I, 
subchapter A--Animal Welfare, as a basis for evaluation;
    (2) Inspect, at least once every six months, all of the research 
facility's animal facilities, including animal study areas, using title 
9, chapter I, subchapter A-Animal Welfare, as a basis for evaluation; 
Provided, however, That animal areas containing free-living wild animals 
in their natural habitat need not be included in such inspection;
    (3) Prepare reports of its evaluations conducted as required by 
paragraphs (c)(1) and (2) of this section, and submit the reports to the 
Institutional Official of the research facility; Provided, however, That 
the IACUC may determine the best means of conducting evaluations of the 
research facility's programs and facilities; and Provided, further, That 
no Committee member wishing to participate in any evaluation conducted 
under this subpart may be excluded. The IACUC may use subcommittees 
composed of at least two Committee members and may invite ad hoc 
consultants to assist in conducting the evaluations, however, the IACUC 
remains responsible for the evaluations and reports as required by the 
Act and regulations. The reports shall be reviewed and signed by a 
majority of the IACUC members and must include any minority views. The 
reports shall be updated at least once every six months upon completion 
of the required semiannual evaluations and shall be maintained by the 
research facility and made available to APHIS and to officials of 
funding Federal agencies for inspection and copying upon request. The 
reports must contain a description of the nature and extent of the 
research facility's adherence to this subchapter, must identify 
specifically any departures from the provisions of title 9, chapter I, 
subchapter A--Animal Welfare, and must state the reasons for each 
departure. The reports must distinguish significant deficiencies from 
minor deficiencies. A significant deficiency is one which, with 
reference to Subchapter A, and, in the judgment of the IACUC and the 
Institutional Official, is or may be a threat to the health or safety of 
the animals. If program or facility deficiencies are noted, the reports 
must contain a reasonable and specific plan and schedule with dates for 
correcting each deficiency. Any failure to adhere to the plan and 
schedule that results in a significant deficiency remaining uncorrected 
shall be reported in writing within 15 business days by the IACUC, 
through the Institutional Official, to APHIS and any Federal agency 
funding that activity;
    (4) Review, and, if warranted, investigate concerns involving the 
care and use of animals at the research facility resulting from public 
complaints received and from reports of noncompliance received from 
laboratory or research facility personnel or employees;
    (5) Make recommendations to the Institutional Official regarding any 
aspect of the research facility's animal program, facilities, or 
personnel training;
    (6) Review and approve, require modifications in (to secure 
approval), or withhold approval of those components of proposed 
activities related to the care and use of animals, as specified in 
paragraph (d) of this section;
    (7) Review and approve, require modifications in (to secure 
approval), or withhold approval of proposed significant changes 
regarding the care and use of animals in ongoing activities; and
    (8) Be authorized to suspend an activity involving animals in 
accordance with the specifications set forth in paragraph (d)(6) of this 
section.
    (d) IACUC review of activities involving animals. (1) In order to 
approve proposed activities or proposed significant changes in ongoing 
activities, the IACUC shall conduct a review of those components of the 
activities related to the care and use of animals and determine that the 
proposed activities are in accordance with this subchapter unless 
acceptable justification for a departure is presented in writing; 
Provided, however, That field studies as defined in part 1 of this 
subchapter are exempt from this requirement. Further, the IACUC shall 
determine that the proposed activities or significant changes in ongoing 
activities meet the following requirements:

[[Page 22]]

    (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;
    (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

[[Page 23]]

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:
    (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, Aug. 31, 1989, as amended at 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

[[Page 24]]

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 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

[[Page 25]]

    (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 (or photographic identification card for nondrivers issued by a 
State) and State of the person, if he or she is not licensed or 
registered under the Act;
    (4) The date of acquisition of each dog or cat;
    (5) The official USDA tag number or tattoo assigned to each dog or 
cat under 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;
    (8) If dogs or cats are acquired from any person not licensed or 
registered under the Act and not a pound or shelter, the research 
facility must obtain a certification that the animals were born and 
raised on the person's premises and that the person has sold fewer than 
25 dogs and/or cats that year.
    (c) In addition to the information required to be kept and 
maintained by every research facility concerning each live dog or cat 
under paragraph (a) of this section, every research facility 
transporting, selling, or otherwise disposing of any live dog or cat to 
another person, shall make and maintain records or forms which fully and 
correctly disclose the following information:
    (1) The name and address of the person to whom a live dog or cat is 
transported, sold, or otherwise disposed of;
    (2) The date of transportation, sale, euthanasia, or other 
disposition of the animal; and
    (3) The method of transportation, including the name of the initial 
carrier or intermediate handler, or if a privately owned vehicle is used 
to transport the dog or cat, the name of the owner of the privately 
owned vehicle.
    (d)(1) The USDA Interstate and International Certificate of Health 
Examination for Small Animals (APHIS Form 7001) and Record of Aquisition 
and Dogs and Cats on Hand (APHIS Form 7005) are forms which may be used 
by research facilities to keep and maintain the information required by 
paragraph (b) of this section.
    (2) The USDA Interstate and International Certificate of Health 
Examination for Small Animals (APHIS Form 7001) and Record of 
Disposition of Dogs and Cats (APHIS Form 7006) are forms which may be 
used by research facilities to keep and maintain the information 
required by paragraph (c) of this section.

[[Page 26]]

    (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.

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

[54 FR 36147, Aug. 31, 1989, as amended at 58 FR 39129, July 22, 1993; 
60 FR 13895, Mar. 15, 1995; 69 FR 42101, July 14, 2004; 85 FR 28797, May 
13, 2020]



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 Deputy Administrator 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 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

[[Page 27]]

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; 
85 FR 28797, May 13, 2020]



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 lists of research facilities subject to the 
provisions of this part. APHIS will publish on its website lists of 
research facilities registered in accordance with the provisions of this 
subpart. The lists may also be obtained upon request from the Deputy 
Administrator.
    (d) Inspection for missing animals. Each research facility shall 
allow, upon request and during business hours, police or officers of 
other law enforcement agencies with general law enforcement authority 
(not those agencies whose duties are limited to enforcement of local 
animal regulations) to enter its place of business to inspect animals 
and records for the purpose of seeking animals that are missing, under 
the following conditions:
    (1) The police or other law officer shall furnish to the research 
facility a written description of the missing animal and the name and 
address of its owner before making a search;
    (2) The police or other law officer shall abide by all security 
measures required by the research facility to prevent the spread of 
disease, including the use of sterile clothing, footwear,

[[Page 28]]

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.
    (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

[[Page 29]]

    (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 Deputy 
Administrator. 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 certification. 
Requests should be addressed to the Animal and Plant Health Inspection 
Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 
20737-1234.
    (3) The U.S. Interstate and International Certificate of Health 
Examination for Small Animals (APHIS Form 7001) may be used for health 
certification by a licensed veterinarian as required by this section.
    (i) Holding of animals. If any research facility obtains prior 
approval of the Deputy Administrator, it may arrange to have another 
person hold animals: Provided, That:
    (1) The other person agrees, in writing, to comply with the 
regulations in this part and the standards in part 3 of this subchapter, 
and to allow inspection of the premises by an APHIS official during 
business hours;

[[Page 30]]

    (2) The animals remain under the total control and responsibility of 
the research facility; and
    (3) The Institutional Official agrees, in writing, that the other 
person or premises is a recognized animal site under its research 
facility registration. APHIS Form 7009 shall be used for approval.
    (4) The other person or premises must either be directly included in 
the research facility's contingency plan required under paragraph (l) of 
this section or must develop its own contingency plan in accordance with 
paragraph (l) of this section.
    (j) Holding period. Research facilities that obtain dogs and cats 
from sources other than dealers, exhibitors, and exempt persons shall 
hold the animals for 5 full days, not including the day of acquisition, 
after acquiring the animal, excluding time in transit, before they may 
be used by the facility. Research facilities shall comply with the 
identification of animals requirements set forth in 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 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.
    (l) Contingency planning. (1) Research facilities must develop, 
document, and follow an appropriate plan to provide for the humane 
handling, treatment, transportation, housing, and care of their animals 
in the event of an emergency or disaster (one which could reasonably be 
anticipated and expected to be detrimental to the good health and well-
being of the animals in their possession). Such contingency plans must:
    (i) Identify situations the facility might experience that would 
trigger the need for the measures identified in a contingency plan to be 
put into action including, but not limited to, emergencies such as 
electrical outages, faulty HVAC systems, fires, and animal escapes, as 
well as natural disasters the facility is most likely to experience.
    (ii) Outline specific tasks required to be carried out in response 
to the identified emergencies or disasters including, but not limited 
to, detailed animal evacuation instructions or shelter-in-place 
instructions and provisions for providing backup sources of food and 
water as well as sanitation, ventilation, bedding, veterinary care, 
etc.;
    (iii) Identify a chain of command and who (by name or by position 
title) will be responsible for fulfilling these tasks; and
    (iv) Address how response and recovery will be handled in terms of 
materials, resources, and training needed.
    (2) For current registrants, the contingency plan must be in place 
by July 29, 2013. For research facilities registered after this date, 
the contingency plan must be in place prior to conducting regulated 
activities. The plan must be reviewed by the research facility on at 
least an annual basis to ensure that it adequately addresses the 
criteria listed in paragraph (l)(1) of this section. Each registrant 
must maintain documentation of their annual reviews, including 
documenting any amendments or changes made to their plan since the 
previous year's review, such as changes made as a result of recently 
predicted, but historically unforeseen, circumstances (e.g., weather 
extremes). Contingency plans, as well as all annual review documentation 
and training records, must be made available to APHIS and any funding 
Federal agency representatives upon request. Facilities maintaining or 
otherwise handling marine mammals in captivity must also comply with the 
requirements of Sec.3.101(b) of this subchapter.
    (3) The facility must provide and document participation in and 
successful

[[Page 31]]

completion of training for its personnel regarding their roles and 
responsibilities as outlined in the plan. For current registrants, 
training of facility personnel must be completed by September 27, 2013; 
for research facilities registered after July 29, 2013, training of 
facility personnel must be completed within 60 days of the facility 
putting its contingency plan in place. Employees hired 30 days or more 
before the contingency plan is put in place must also be trained by that 
date. For employees hired less than 30 days before that date or after 
that date, training must be conducted within 30 days of their start 
date. Any changes to the plan as a result of the annual review must be 
communicated to employees through training which must be conducted 
within 30 days of making the changes.

[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; 69 FR 42101, July 14, 2004; 77 FR 76823, Dec. 31, 2012; 
85 FR 28797, May 13, 2020]

    Effective Date Note: At 78 FR 46255, July 31, 2013, in Sec.2.38, 
paragraph (l) was stayed indefinitely, effective July 31, 2013.



      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 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

[[Page 32]]

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 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

[[Page 33]]

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 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 Deputy 
Administrator. 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; 
85 FR 28798, May 13, 2020]



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

[[Page 34]]

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 (or photographic identification card for nondrivers issued by a 
State) and State of the person, if he or she is not licensed or 
registered under the Act;
    (iv) The name and address of the person to whom a dog or cat was 
sold or given and that person's license or registration number if he or 
she is licensed or registered under the Act;
    (v) The date a dog or cat was acquired or disposed of, including by 
euthanasia;
    (vi) The official USDA tag number or tattoo assigned to a dog or cat 
under 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) and Record of Disposition of 
Dogs and Cats (APHIS Form 7006) to make, keep, and maintain the 
information required by paragraph (a)(1) of this section: Provided, that 
if a dealer or exhibitor who uses a computerized recordkeeping system 
believes that APHIS Form 7005 and APHIS Form 7006 are unsuitable for him 
or her to make, keep, and maintain the information required by paragraph 
(a)(1) of this section, the dealer or exhibitor may request a variance 
from the requirement to use APHIS Form 7005 and APHIS Form 7006.

[[Page 35]]

    (i) The request for a variance must consist of a written statement 
describing why APHIS Form 7005 and APHIS Form 7006 are unsuitable for 
the dealer or exhibitor to make, keep, and maintain the information 
required by paragraph (a)(1) of this section, and a description of the 
computerized recordkeeping system the person would use in lieu of APHIS 
Form 7005 and APHIS Form 7006 to make, keep, and maintain the 
information required by paragraph (a)(1) of this section. APHIS will 
advise the person as to the disposition of his or her request for a 
variance from the requirement to use APHIS Form 7005 and APHIS Form 
7006.
    (ii) A dealer or exhibitor whose request for a variance has been 
denied may request a hearing in accordance with the applicable rules of 
practice for the purpose of showing why the request for a variance 
should not be denied. The denial of the variance shall remain in effect 
until the final legal decision has been rendered.
    (3) The USDA Interstate and International Certificate of Health 
Examination for Small Animals (APHIS Form 7001) may be used by dealers 
and exhibitors to make, keep, and maintain the information required by 
Sec.2.78.
    (4) One copy of the record containing the information required by 
paragraph (a)(1) of this section shall accompany each shipment of any 
dog or cat purchased or otherwise acquired by a dealer or exhibitor. One 
copy of the record containing the information required by paragraph 
(a)(1) of this section shall accompany each shipment of any dog or cat 
sold or otherwise disposed of by a dealer or exhibitor: Provided, 
however, that, except as provided in 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;
    (iii) The vehicle license number and State, and the driver's license 
number (or photographic identification card for nondrivers issued by a 
State) and State of the person, if he or she is not licensed or 
registered under the Act;
    (iv) The name and address of the person to whom an animal was sold 
or given;
    (v) The date of purchase, acquisition, sale, or disposal of the 
animal(s);
    (vi) The species of the animal(s); and
    (vii) The number of animals in the shipment.
    (2) Record of Animals on Hand (other than dogs and cats) (APHIS Form 
7019) and Record of Acquisition, Disposition, or Transport of Animals 
(other than dogs and cats) (APHIS Form 7020) are forms which may be used 
by dealers and exhibitors to keep and maintain the information required 
by paragraph (b)(1) of this section concerning animals other than dogs 
and cats except as provided in Sec.2.78.
    (3) One copy of the record containing the information required by 
paragraph (b)(1) of this section shall accompany each shipment of any 
animal(s) other than a dog or cat purchased or otherwise acquired by a 
dealer or exhibitor. One copy of the record containing the information 
required by paragraph (b)(1) of this section shall accompany each 
shipment of any animal other than a dog or cat sold or otherwise 
disposed of by a dealer or exhibitor; Provided, however, That 
information which indicates the source and date of acquisition of any 
animal other than a dog or cat need not appear on the copy of the record 
accompanying the shipment. The dealer or exhibitor shall retain one

[[Page 36]]

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; 69 FR 42102, 
July 14, 2004; 85 FR 28798, May 13, 2020]



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 (or photographic identification card for nondrivers issued by a 
State) and State of the person, if he or she is not licensed or 
registered under the Act;
    (5) The date of the consignment;
    (6) The official USDA tag number or tattoo assigned to the animal 
under 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.

[54 FR 36147, Aug. 31, 1989, as amended at 69 FR 42102, July 14, 2004]



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 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.2.78, tendered with each live dog, cat, or nonhuman primate.

[54 FR 36147, Aug. 31, 1989, as amended at 85 FR 28798, May 13, 2020]



Sec.2.78  Health certification and identification.

    (a) No dealer, exhibitor, operator of an auction sale, broker, or 
department,

[[Page 37]]

agency, or instrumentality of the United States or of any State or local 
government shall deliver to any intermediate handler or carrier for 
transportation, in commerce, or shall transport in commerce any dog, 
cat, or nonhuman primate unless the dog, cat, or nonhuman primate is 
accompanied by a health certificate executed and issued by a licensed 
veterinarian. The health certificate shall state that:
    (1) The licensed veterinarian inspected the dog, cat, or nonhuman 
primate on a specified date which shall not be more than 10 days prior 
to the delivery of the dog, cat, or nonhuman primate for transportation; 
and
    (2) when so inspected, the dog, cat, or nonhuman primate appeared to 
the licensed veterinarian to be free of any infectious disease or 
physical abnormality which would endanger the animal(s) or other animals 
or endanger public health.
    (b) The Secretary may provide exceptions to the health certification 
requirement on an individual basis for animals shipped to a research 
facility for purposes of research, testing, or experimentation when the 
research facility requires animals not eligible for certification. 
Requests should be addressed to the Animal and Plant Health Inspection 
Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 
20737-1234.
    (c) No intermediate handler or carrier to whom any live dog, cat, or 
nonhuman primate is delivered for transportation by any dealer, research 
facility, exhibitor, broker, operator of an auction sale, or department, 
agency, or instrumentality of the United States or any State or local 
government shall receive a live dog, cat, or nonhuman primate for 
transportation, in commerce, unless and until it is accompanied by a 
health certificate issued by a licensed veterinarian in accordance with 
paragraph (a) of this section, or an exemption issued by the Secretary 
in accordance with paragraph (b) of this section.
    (d) The U.S. Interstate and International Certificate of Health 
Examination for Small Animals (APHIS Form 7001) may be used for health 
certification by a licensed veterinarian as required by this section.

[54 FR 36147, Aug. 31, 1989, as amended at 59 FR 67612, Dec. 30, 1994; 
60 FR 13896, Mar. 15, 1995; 63 FR 62927, Nov. 10, 1998; 69 FR 42102, 
July 14, 2004]



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, 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

[[Page 38]]

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.



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;

[[Page 39]]

    (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 
Deputy Administrator, 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 
shall be used for approval.
    (4) The other person or premises must either be directly included in 
the dealer's or exhibitor's contingency plan required under Sec.2.134 
or must develop its own contingency plan in accordance with Sec.2.134.
    (b) If any intermediate handler obtains prior approval of the Deputy 
Administrator, it may arrange to have another person hold animals: 
Provided, That:
    (1) The other person agrees in writing to comply with the 
regulations in part 2 and the standards in part 3 of this subchapter and 
to allow inspection of the premises by an APHIS official during business 
hours; and
    (2) The animals remain under the total control and responsibility of 
the research facility or intermediate handler.
    (3) The other person or premises must either be directly included in 
the intermediate handler's contingency plan required under Sec.2.134 
or must develop its own contingency plan in accordance with Sec.2.134.

[54 FR 36147, Aug. 31, 1989, as amended at 60 FR 13896, Mar. 15, 1995; 
63 FR 62927, Nov. 10, 1998; 69 FR 42102, July 14, 2004; 77 FR 76823, 
Dec. 31, 2012; 85 FR 28798, May 13, 2020]



                         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 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; submission 
of itineraries.

    (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

[[Page 40]]

enforce the provisions of the Act, the regulations and the standards in 
this subchapter; and
    (5) To document, by the taking of photographs and other means, 
conditions and areas of noncompliance.
    (b) The use of a room, table, or other facilities necessary for the 
proper examination of the records and inspection of the property or 
animals must be extended to APHIS officials by the dealer, exhibitor, 
intermediate handler or carrier, and a responsible adult shall be made 
available to accompany APHIS officials during the inspection process.
    (c) Any person who is subject to the Animal Welfare regulations and 
who intends to exhibit any animal at any location other than the 
person's approved site (including, but not limited to, circuses, 
traveling educational exhibits, animal acts, and petting zoos), except 
for travel that does not extend overnight, shall submit a written 
itinerary to the Deputy Administrator. The itinerary shall be received 
by the Deputy Administrator no fewer than 2 days in advance of any 
travel and shall contain complete and accurate information concerning 
the whereabouts of any animal intended for exhibition at any location 
other than the person's approved site. If the exhibitor accepts an 
engagement for which travel will begin with less than 48 hours' notice, 
the exhibitor shall immediately contact the Deputy Administrator in 
writing with the required information. APHIS expects such situations to 
occur infrequently, and exhibitors who repeatedly provide less than 48 
hours' notice will, after notice by APHIS, be subject to increased 
scrutiny under the Act.
    (1) The itinerary shall include the following:
    (i) The name of the person who intends to exhibit the animal and 
transport the animal for exhibition purposes, including any business 
name and current Act license or registration number and, in the event 
that any animal is leased, borrowed, loaned, or under some similar 
arrangement, the name of the person who owns such animal;
    (ii) The name, identification number or identifying characteristics, 
species (common or scientific name), sex and age of each animal; and
    (iii) The names, dates, and locations (with addresses) where the 
animals will travel, be housed, and be exhibited, including all 
anticipated dates and locations (with addresses) for any stops and 
layovers that allow or require removal of the animals from the transport 
enclosures. Unanticipated delays of such length shall be reported to the 
Deputy Administrator the next APHIS business day. APHIS Regional offices 
are available each weekday, except on Federal holidays, from 8 a.m. to 5 
p.m.
    (2) The itinerary shall be revised as necessary, and the Deputy 
Administrator shall be notified of any changes. If initial notification 
of a change due to an emergency is made by a means other than email or 
facsimile, it shall be followed by written documentation at the earliest 
possible time. For changes that occur after normal APHIS business hours, 
the change shall be conveyed to the Deputy Administrator no later than 
the following APHIS business day. APHIS Regional offices are available 
each weekday, except on Federal holidays, from 8 a.m. to 5 p.m.

(Approved by the Office of Management and Budget under control number 
0579-0361)

[54 FR 36147, Aug. 31, 1989, as amended at 69 FR 42102, July 14, 2004; 
77 FR 76814, Dec. 31, 2012; 85 FR 28798, May 13, 2020]



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

    APHIS will publish on its website lists of persons licensed or 
registered in accordance with the provisions of this part. The lists may 
also be obtained upon request from the Deputy Administrator.

[85 FR 28798, May 13, 2020]



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

[[Page 41]]

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.
    (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) All licensees who maintain wild or exotic animals must 
demonstrate adequate experience and knowledge of the species they 
maintain.
    (b)(1) Handling of all animals shall be done as expeditiously and 
carefully as possible in a manner that does not cause trauma, 
overheating, excessive cooling, behavioral stress, physical harm, or 
unnecessary discomfort.
    (2)(i) Physical abuse shall not be used to train, work, or otherwise 
handle animals.
    (ii) Deprivation of food or water shall not be used to train, work, 
or otherwise handle animals; Provided, however, That the short-term 
withholding of food or water from animals by exhibitors is allowed by 
these regulations as long as each of the animals affected receives its 
full dietary and nutrition requirements each day.
    (c)(1) During public exhibition, any animal must be handled so there 
is minimal risk of harm to the animal

[[Page 42]]

and to the public, with sufficient distance and/or barriers between the 
animal and the general viewing public so as to assure the safety of 
animals and the public.
    (2) Performing animals shall be allowed a rest period between 
performances at least equal to the time for one performance.
    (3) Young or immature animals shall not be exposed to rough or 
excessive public handling or exhibited for periods of time which would 
be detrimental to their health or well-being.
    (4) Drugs, such as tranquilizers, shall not be used to facilitate, 
allow, or provide for public handling of the animals.
    (d)(1) Animals shall be exhibited only for periods of time and under 
conditions consistent with their good health and well-being.
    (2) A responsible, knowledgeable, and readily identifiable employee 
or attendant must be present at all times during periods of public 
contact.
    (3) During public exhibition, dangerous animals such as lions, 
tigers, wolves, bears, or elephants must be under the direct control and 
supervision of a knowledgeable and experienced animal handler.
    (4) If public feeding of animals is allowed, the food must be 
provided by the animal facility and shall be appropriate to the type of 
animal and its nutritional needs and diet.
    (e) When climatic conditions present a threat to an animal's health 
or well-being, appropriate measures must be taken to alleviate the 
impact of those conditions. An animal may never be subjected to any 
combination of temperature, humidity, and time that is detrimental to 
the animal's health or well-being, taking into consideration such 
factors as the animal's age, species, breed, overall health status, and 
acclimation.

[54 FR 36147, Aug. 31, 1989, as amended at 63 FR 10498, Mar. 4, 1998; 69 
FR 42102, July 14, 2004]



Sec.2.132  Procurement of dogs, cats, and other animals; 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 which it is located as an animal pound or shelter, such as a 
humane shelter or contract pound.
    (b) No person shall obtain live dogs, cats, or other animals by use 
of false pretenses, misrepresentation, or deception.
    (c) Any dealer, exhibitor, research facility, carrier, or 
intermediate handler who also operates a private or contract animal 
pound or shelter shall comply with the following:
    (1) The animal pound or shelter shall be located on premises that 
are physically separated from the licensed or registered facility. The 
animal housing facility of the pound or shelter shall not be adjacent to 
the licensed or registered facility.
    (2) Accurate and complete records shall be separately maintained by 
the licensee or registrant and by the pound or shelter. The records 
shall be in accordance with 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 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.
    (d) No dealer or exhibitor shall knowingly obtain any dog, cat, or 
other animal from any person who is required to be licensed but who does 
not hold a current, valid, and unsuspended license. No dealer or 
exhibitor shall

[[Page 43]]

knowingly obtain any dog or cat from any person who is not licensed, 
other than a pound or shelter, without obtaining a certification that 
the animals were born and raised on that person's premises and, if the 
animals are for research purposes, that the person has sold fewer than 
25 dogs and/or cats that year, or, if the animals are for use as pets, 
that the person does not maintain more than four breeding female dogs 
and/or cats.

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

[54 FR 36147, Aug. 31, 1989, as amended at 69 FR 42102, July 14, 2004; 
80 FR 3463, Jan. 23, 2015; 85 FR 28798, May 13, 2020]



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, 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

[[Page 44]]

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]



Sec.2.134  Contingency planning.

    (a) Dealers, exhibitors, intermediate handlers, and carriers must 
develop, document, and follow an appropriate plan to provide for the 
humane handling, treatment, transportation, housing, and care of their 
animals in the event of an emergency or disaster (one which could 
reasonably be anticipated and expected to be detrimental to the good 
health and well-being of the animals in their possession). Such 
contingency plans must:
    (1) Identify situations the licensee or registrant might experience 
that would trigger the need for the measures identified in a contingency 
plan to be put into action including, but not limited to, emergencies 
such as electrical outages, faulty HVAC systems, fires, mechanical 
breakdowns, and animal escapes, as well as natural disasters most likely 
to be experienced;
    (2) Outline specific tasks required to be carried out in response to 
the identified emergencies or disasters including, but not limited to, 
detailed animal evacuation instructions or shelter-in-place instructions 
and provisions for providing backup sources of food and water as well as 
sanitation, ventilation, bedding, veterinary care, etc.;
    (3) Identify a chain of command and who (by name or by position 
title) will be responsible for fulfilling these tasks; and
    (4) Address how response and recovery will be handled in terms of 
materials, resources, and training needed.
    (b) For current licensees and registrants, the contingency plan must 
be in place by July 29, 2013. For new dealers, exhibitors, intermediate 
handlers, and carriers licensed or registered after this date, the 
contingency plan must be in place prior to conducting regulated 
activities. The plan must be reviewed by the dealer, exhibitor, 
intermediate handler, or carrier on at least an annual basis to ensure 
that it adequately addresses the criteria listed in paragraph (a) of 
this section. Each licensee and registrant must maintain documentation 
of their annual reviews, including documenting any amendments or changes 
made to their plan since the previous year's review, such as changes 
made as a result of recently predicted, but historically unforeseen, 
circumstances (e.g., weather extremes). Contingency plans, as well as 
all annual review documentation and training records, must be made 
available to APHIS upon request. Traveling entities must carry a copy of 
their contingency plan with them at all times and make it available for 
APHIS inspection while in travel status. Dealers, exhibitors, 
intermediate handlers, and carriers maintaining or otherwise handling 
marine mammals in captivity must also comply with the requirements of 
Sec.3.101(b) of this subchapter.
    (c) Dealers, exhibitors, intermediate handlers, and carriers must 
provide and document participation in and successful completion of 
training for personnel regarding their roles and responsibilities as 
outlined in the plan. For current licensees and registrants, training of 
dealer, exhibitor, intermediate handler, and carrier personnel must be 
completed by September 27, 2013. For new dealers, exhibitors, 
intermediate handlers, or carriers licensed

[[Page 45]]

or registered after July 29, 2013, training of personnel must be 
completed within 60 days of the dealer, exhibitor, intermediate handler, 
or carrier putting their contingency plan in place. Employees hired 30 
days or more before their contingency plan is put in place must also be 
trained by that date. For employees hired less than 30 days before that 
date or after that date, training must be conducted within 30 days of 
their start date. Any changes to the plan as a result of the annual 
review must be communicated to employees through training which must be 
conducted within 30 days of making the changes.

[77 FR 76823, Dec. 31, 2012]

    Effective Date Note: At 78 FR 46255, July 31, 2013, Sec.2.134 was 
stayed indefinitely, effective July 31, 2013.



                   Subpart J_Importation of Live Dogs

    Source: 79 FR 48659, Aug. 18, 2014, unless otherwise noted.



Sec.2.150  Import permit.

    (a) No person shall import a live dog from any part of the world 
into the States for purposes of resale unless the dog is accompanied by 
an import permit issued by APHIS and is imported into the States within 
30 days after the proposed date of arrival stated in the import permit.
    (b) An application for an import permit must be submitted to the 
Animal and Plant Health Inspection Service, Animal Care, 4700 River Road 
Unit 84, Riverdale, MD 20737-1234 or though Animal Care's Web site 
(http://www.aphis.usda.gov/animal_welfare/). Application forms for 
import permits may be obtained from Animal Care at the address listed 
above.
    (c) The completed application must include the following 
information:
    (1) The name and address of the person intending to export the 
dog(s) to the States;
    (2) The name and address of the person intending to import the 
dog(s) into the States;
    (3) The number of dogs to be imported and the breed, sex, age, 
color, markings, and other identifying information of each dog;
    (4) The purpose of the importation;
    (5) The port of embarkation and the mode of transportation;
    (6) The port of entry in the United States;
    (7) The proposed date of arrival in the States; and
    (8) The name and address of the person to whom the dog(s) will be 
delivered in the States and, if the dog(s) is or are imported for resale 
for research purposes, the USDA registration number of the research 
facility where the dog will be used for research, tests, or experiments.
    (d) After receipt and review of the application by APHIS, an import 
permit indicating the applicable conditions for importation under this 
subpart may be issued for the importation of the dog(s) described in the 
application if such dog(s) appears to be eligible to be imported. Even 
though an import permit has been issued for the importation of a dog, 
the dog may only be imported if all applicable requirements of this 
subpart and any other applicable regulations of this subchapter and any 
other statute or regulation of any State or of the United States are 
met.

(Approved by the Office of Management and Budget under control number 
0579-0379)

[79 FR 48659, Aug. 18, 2014, as amended at 85 FR 28798, May 13, 2020]



Sec.2.151  Certifications.

    (a) Required certificates. Except as provided in paragraph (b) of 
this section, no person shall import a live dog from any part of the 
world into the States for purposes of resale unless the following 
conditions are met:
    (1) Health certificate. Each dog is accompanied by an original 
health certificate issued in English by a licensed veterinarian with a 
valid license to practice veterinary medicine in the country of export 
that:
    (i) Specifies the name and address of the person intending to import 
the dog into the States;
    (ii) Identifies the dog on the basis of breed, sex, age, color, 
markings, and other identifying information;
    (iii) States that the dog is at least 6 months of age;

[[Page 46]]

    (iv) States that the dog was vaccinated, not more than 12 months 
before the date of arrival at the U.S. port, for distemper, hepatitis, 
leptospirosis, parvovirus, and parainfluenza virus (DHLPP) at a 
frequency that provides continuous protection of the dog from those 
diseases and is in accordance with currently accepted practices as cited 
in veterinary medicine reference guides;
    (v) States that the dog is in good health (i.e., free of any 
infectious disease or physical abnormality which would endanger the dog 
or other animals or endanger public health, including, but not limited 
to, parasitic infection, emaciation, lesions of the skin, nervous system 
disturbances, jaundice, or diarrhea); and
    (vi) Bears the signature and the license number of the veterinarian 
issuing the certificate.
    (2) Rabies vaccination certificate. Each dog is accompanied by a 
valid rabies vaccination certificate \6\ that was issued in English by a 
licensed veterinarian with a valid license to practice veterinary 
medicine in the country of export for the dog not less than 3 months of 
age at the time of vaccination that:
---------------------------------------------------------------------------

    \6\ Alternatively, this requirement can be met by providing an exact 
copy of the rabies vaccination certificate if so required under the 
Public Health Service regulations in 42 CFR 71.51.
---------------------------------------------------------------------------

    (i) Specifies the name and address of the person intending to import 
the dog into the States;
    (ii) Identifies the dog on the basis of breed, sex, age, color, 
markings, and other identifying information;
    (iii) Specifies a date of rabies vaccination at least 30 days before 
the date of arrival of the dog at a U.S. port;
    (iv) Specifies a date of expiration of the vaccination which is 
after the date of arrival of the dog at a U.S. port. If no date of 
expiration is specified, then the date of vaccination shall be no more 
than 12 months before the date of arrival at a U.S. port; and
    (v) Bears the signature and the license number of the veterinarian 
issuing the certificate.
    (b) Exceptions--(1) Research. The provisions of paragraphs 
(a)(1)(iii), (a)(1)(iv), (a)(1)(v), and/or (a)(2) of this section do not 
apply to any person who imports a live dog from any part of the world 
into the States for resale for use in research, tests, or experiments at 
a research facility, provided that: Such person submits satisfactory 
evidence to Animal Care at the time of his or her application for an 
import permit that the specific provision(s) would interfere with the 
dog's use in such research, tests, or experiments in accordance with a 
research proposal and the proposal has been approved by the research 
facility IACUC.
    (2) Veterinary care. The provisions of paragraphs (a)(1)(iii) 
through (a)(1)(v) and (a)(2) of this section do not apply to any person 
who imports a live dog from any part of the world into the States for 
veterinary treatment by a licensed veterinarian and subsequent resale, 
provided that:
    (i) The original health certificate required in paragraph (a)(1) of 
this section states that the dog is in need of veterinary treatment that 
cannot be obtained in the country of export and states the name and 
address of the licensed veterinarian in the United States who intends to 
provide the dog such veterinary treatment; and
    (ii) The person who imports the dog completes a veterinary treatment 
agreement with Animal Care at the time of application for an import 
permit and confines the animal until the conditions specified in the 
agreement are met. Such conditions may include determinations by the 
licensed veterinarian in the United States that the dog is in good 
health, has been adequately vaccinated against DHLPP and rabies, and is 
at least 6 months of age. The person importing the dog shall bear the 
expense of veterinary treatment and confinement.
    (3) Dogs imported into Hawaii from the British Isles, Australia, 
Guam, or New Zealand. The provisions of paragraph (a)(1)(iii) of this 
section do not apply to any person who lawfully imports a live dog into 
the State of Hawaii from the British Isles, Australia, Guam, or New 
Zealand in compliance with the applicable regulations of the State of 
Hawaii, provided that the dog is not transported out of the State of 
Hawaii

[[Page 47]]

for purposes of resale at less than 6 months of age.

(Approved by the Office of Management and Budget under control number 
0579-0379)

[79 FR 48659, Aug. 18, 2014, as amended at 85 FR 28798, May 13, 2020]



Sec.2.152  Notification of arrival.

    Upon the arrival of a dog at the port of first arrival in the 
States, the person intending to import the dog, or his or her agent, 
must present the import permit and any applicable certifications and 
veterinary treatment agreement required by this subpart to the collector 
of customs for use at that port.

[79 FR 48659, Aug. 18, 2014, as amended at 85 FR 28798, May 13, 2020]



Sec.2.153  Dogs refused entry.

    Any dog refused entry into the States for noncompliance with the 
requirements of this subpart or the Act may be removed from the States 
or may be seized and the person intending to import the dog shall 
provide for the care (including appropriate veterinary care), 
forfeiture, and adoption of the dog, at his or her expense.

[79 FR 48659, Aug. 18, 2014, as amended at 85 FR 28798, May 13, 2020]



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 Veterinary care for dogs.
3.14 Consignments to carriers and intermediate handlers.
3.15 Primary enclosures used to transport live dogs and cats.
3.16 Primary conveyances (motor vehicle, rail, air, and marine).
3.17 Food and water requirements.
3.18 Care in transit.
3.19 Terminal facilities.
3.20 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.

                  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.

[[Page 48]]

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.
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.

[[Page 49]]

                   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 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

[[Page 50]]

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.
    (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

[[Page 51]]

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, 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;

[[Page 52]]

    (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 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

[[Page 53]]

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) 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) Each primary enclosure housing cats must be at least 24 in. high 
(60.96 cm);
    (ii) Cats up to and including 8.8 lbs (4 kg) must be provided with 
at least 3.0 ft \2\ (0.28 m \2\);
    (iii) Cats over 8.8 lbs (4 kg) must be provided with at least 4.0 ft 
\2\ (0.37 m \2\);
    (iv) Each queen with nursing kittens must be provided with an 
additional amount of floor space, based on her breed and behavioral 
characteristics, and in accordance with generally accepted husbandry 
practices. If the additional amount of floor space for each nursing 
kitten is equivalent to less than 5 percent of the minimum requirement 
for the queen, such housing must be approved by the attending 
veterinarian in the case of a research facility, and, in the case of 
dealers and exhibitors, such housing must be approved by the 
Administrator; and
    (v) The minimum floor space required by this section is exclusive of 
any food or water pans. The litter pan may be considered part of the 
floor space if properly cleaned and sanitized.
    (2) Compatibility. All cats housed in the same primary enclosure 
must be compatible, as determined by observation. Not more than 12 adult 
nonconditioned cats may be housed in the same primary enclosure. Queens 
in heat may not be housed in the same primary enclosure with sexually 
mature males, except for breeding. Except when maintained in breeding 
colonies, queens with litters may not be housed in the same primary 
enclosure with other adult cats, and kittens under 4 months of age may 
not be housed in the same primary enclosure with adult cats, other than 
the dam or foster dam. Cats

[[Page 54]]

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.3.15 other than 
the marking requirements in Sec.3.15(a)(6). When the show or act is 
not traveling, the cats must be placed in primary enclosures that meet 
the minimum requirements of this section.
    (c) Additional requirements for dogs--(1) Space. (i) Each dog housed 
in a primary enclosure (including weaned puppies) must be provided a 
minimum amount of floor space, calculated as follows: Find the 
mathematical square of the sum of the length of the dog in inches 
(measured from the tip of its nose to the base of its tail) plus 6 
inches; then divide the product by 144. The calculation is: (length of 
dog in inches + 6) 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.
    (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.3.15 other than 
the marking requirements in Sec.3.15(a)(6). When the show or act is 
not traveling, the dogs must be placed in primary enclosures that meet 
the minimum requirements of this section.
    (4) Prohibited means of primary enclosure. Permanent tethering of 
dogs is prohibited for use as primary enclosure. Temporary tethering of 
dogs is prohibited for use as primary enclosure unless approval is 
obtained from APHIS.
    (d) Innovative primary enclosures not precisely meeting the floor 
area and height requirements provided in paragraphs (b)(1) and (c)(1) of 
this section, but that provide the dogs or cats with a sufficient volume 
of space and the opportunity to express species-typical behavior, may be 
used at research

[[Page 55]]

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; 83 FR 25555, June 4, 
2018; 85 FR 28798, May 13, 2020]

                  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 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:

[[Page 56]]

    (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 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.

    (a) Potable water must be continuously available to the dogs, unless 
restricted by the attending veterinarian or except as provided in Sec.
3.17(a).
    (b) If potable water is not continuously available to the cats, it 
must be offered to the cats as often as necessary to ensure their health 
and well-being, but not less than twice daily for at least 1 hour each 
time, unless restricted by the attending veterinarian.
    (c) Water receptacles must be kept clean and sanitized in accordance 
with Sec.3.11(b) and before being used to water a different dog or cat 
or a different social grouping of dogs or cats.

[85 FR 28798, May 13, 2020]



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,

[[Page 57]]

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 
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  Veterinary care for dogs.

    (a) Each dealer, exhibitor, and research facility must follow an 
appropriate program of veterinary care for dogs that is developed, 
documented in writing, and signed by the attending veterinarian. 
Dealers, exhibitors, and

[[Page 58]]

research facilities must keep and maintain the written program and make 
it available for APHIS inspection. The written program of veterinary 
care must address the requirements for adequate veterinary care for 
every dealer and exhibitor in Sec.2.40 of this subchapter and every 
research facility in Sec.2.33 of this subchapter, and must also 
include:
    (1) Regularly scheduled visits, not less than once every 12 months, 
by the attending veterinarian to all premises where animals are kept, to 
assess and ensure the adequacy of veterinary care and other aspects of 
animal care and use;
    (2) A complete physical examination from head to tail of each dog by 
the attending veterinarian not less than once every 12 months;
    (3) Vaccinations for contagious and/or deadly diseases of dogs 
(including rabies, parvovirus and distemper) and sampling and treatment 
of parasites and other pests (including fleas, worms, coccidia, giardia, 
and heartworm) in accordance with a schedule approved by the attending 
veterinarian, unless otherwise required by a research protocol approved 
by the Committee at research facilities; and
    (4) Preventative care and treatment to ensure healthy and unmatted 
hair coats, properly trimmed nails, and clean and healthy eyes, ears, 
skin, and teeth, unless otherwise required by a research protocol 
approved by the Committee at research facilities.
    (b) Dealers, exhibitors, and research facilities must keep copies of 
medical records for dogs and make the records available for APHIS 
inspection. These records must include:
    (1) The identity of the animal, including identifying marks, 
tattoos, or tags on the animal and the animal's breed, sex, and age; 
Provided, however, that routine husbandry, such as vaccinations, 
preventive medical procedures, or treatments, performed on all animals 
in a group (or herd), may be kept on a single record;
    (2) If a problem is identified (such as a disease, injury, or 
illness), the date and a description of the problem, examination 
findings, test results, plan for treatment and care, and treatment 
procedures performed, when appropriate;
    (3) The names of all vaccines and treatments administered and the 
dates of administration; and
    (4) The dates and findings/results of all screening, routine, or 
other required or recommended test or examination.
    (c) Medical records for dogs shall be kept for the following 
periods:
    (1) The medical records for dogs shall be kept and maintained by the 
research facility for the duration of the research activity and for an 
additional 3 years after the dog is euthanized or disposed of, and for 
any period in excess of 3 years as necessary to comply with any 
applicable Federal, State, or local law.
    (2) The medical records for dogs shall be kept and maintained by the 
dealer or exhibitor for at least 1 year after the dog is euthanized or 
disposed of and for any period in excess of 1 year as necessary to 
comply with any applicable Federal, State, or local law.
    (3) Whenever the Administrator notifies a research facility, dealer, 
or exhibitor in writing that specified records shall be retained pending 
completion of an investigation or proceeding under the Act, the research 
facility, dealer, or exhibitor shall hold those records until their 
disposition is authorized by the Administrator.

(Approved by the Office of Management and Budget under control number 
0579-0470)

[85 FR 28798, May 13, 2020]



Sec.3.14  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

[[Page 59]]

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.3.17. The certification must include the following information for 
each dog and cat:
    (1) The consignor's name and address;
    (2) The tag number or tattoo assigned to each dog or cat under 
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.3.15. A carrier or 
intermediate handler must not accept a dog or cat for transport if the 
primary enclosure is obviously defective or damaged and cannot 
reasonably be expected to safely and comfortably contain the dog or cat 
without causing suffering or injury.
    (e) Carriers and intermediate handlers must not accept a dog or cat 
for transport in commerce unless their animal holding area meets the 
minimum temperature requirements provided in Sec. Sec.3.19 and 3.20, 
or unless the consignor provides them with a certificate signed by a 
veterinarian and dated no more than 10 days before delivery of the 
animal to the carrier or intermediate handler for transport in commerce, 
certifying that the animal is acclimated to temperatures lower than 
those required in Sec. Sec.3.19 and 3.20. Even if the carrier or 
intermediate handler receives this certification, the temperatures the 
dog or cat is exposed to while in a terminal facility must not be lower 
than 45 [deg]F (2.2 [deg]C) for more than 4 consecutive hours when dogs 
or cats are present, as set forth in Sec.3.19, nor lower than 45 
[deg]F (2.2 [deg]C) for more than 45 minutes, as set forth in Sec.
3.20, when moving dogs or cats to or from terminal facilities or primary 
conveyances. A copy of the certification must accompany the dog or cat 
to its destination and must include the following information:
    (1) The consignor's name and address;
    (2) The tag number or tattoo assigned to each dog or cat under 
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

[[Page 60]]

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)

[56 FR 6486, Feb. 15, 1991. Redesignated and amended at 85 FR 28798, 
28799, May 13, 2020]



Sec.3.15  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, 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.

[[Page 61]]

    (c) Ventilation. (1) Unless the primary enclosure is permanently 
affixed to the conveyance, there must be:
    (i) Ventilation openings located on two opposing walls of the 
primary enclosure and the openings must be at least 16 percent of the 
surface area of each such wall, and the total combined surface area of 
the ventilation openings must be at least 14 percent of the total 
combined surface area of all the walls of the primary enclosure; or
    (ii) Ventilation openings on three walls of the primary enclosure, 
and the openings on each of the two opposing walls must be at least 8 
percent of the total surface area of the two walls, and the ventilation 
openings on the third wall of the primary enclosure must be at least 50 
percent of the total surface area of that wall, and the total combined 
surface area of the ventilation openings must be at least 14 percent of 
the total combined surface area of all the walls of the primary 
enclosure; or
    (iii) Ventilation openings located on all four walls of the primary 
enclosure and the ventilation openings on each of the four walls must be 
at least 8 percent of the total surface area of each such wall, and the 
total combined surface area of the openings must be at least 14 percent 
of total combined surface area of all the walls of the primary 
enclosure; and
    (iv) At least one-third of the ventilation area must be located on 
the upper half of the primary enclosure.
    (2) Unless the primary enclosure is permanently affixed to the 
conveyance, projecting rims or similar devices must be located on the 
exterior of each enclosure wall having a ventilation opening, in order 
to prevent obstruction of the openings. The projecting rims or similar 
devices must be large enough to provide a minimum air circulation space 
of 0.75 in. (1.9 cm) between the primary enclosure and anything the 
enclosure is placed against.
    (3) If a primary enclosure is permanently affixed to the primary 
conveyance so that there is only a front ventilation opening for the 
enclosure, the primary enclosure must be affixed to the primary 
conveyance in such a way that the front ventilation opening cannot be 
blocked, and the front ventilation opening must open directly to an 
unobstructed aisle or passageway inside the conveyance. The ventilation 
opening must be at least 90 percent of the total area of the front wall 
of the enclosure, and must be covered with bars, wire mesh, or smooth 
expanded metal having air spaces.
    (d) Compatibility. (1) Live dogs or cats transported in the same 
primary enclosure must be of the same species and be maintained in 
compatible groups, except that dogs and cats that are private pets, are 
of comparable size, and are compatible, may be transported in the same 
primary enclosure.
    (2) Puppies or kittens 4 months of age or less may not be 
transported in the same primary enclosure with adult dogs or cats other 
than their dams.
    (3) Dogs or cats that are overly aggressive or exhibit a vicious 
disposition must be transported individually in a primary enclosure.
    (4) Any female dog or cat in heat (estrus) may not be transported in 
the same primary enclosure with any male dog or cat.
    (e) Space and placement. (1) Primary enclosures used to transport 
live dogs and cats must be large enough to ensure that each animal 
contained in the primary enclosure has enough space to turn about 
normally while standing, to stand and sit erect, and to lie in a natural 
position.
    (2) Primary enclosures used to transport dogs and cats must be 
positioned in the primary conveyance so as to provide protection from 
the elements.
    (f) Transportation by air. (1) No more than one live dog or cat, 6 
months of age or older, may be transported in the same primary enclosure 
when shipped via air carrier.
    (2) No more than one live puppy, 8 weeks to 6 months of age, and 
weighing over 20 lbs (9 kg), may be transported in a primary enclosure 
when shipped via air carrier.
    (3) No more than two live puppies or kittens, 8 weeks to 6 months of 
age, that are of comparable size, and weighing 20 lbs (9 kg) or less 
each, may be transported in the same primary enclosure when shipped via 
air carrier.
    (4) Weaned live puppies or kittens less than 8 weeks of age and of 
comparable size, or puppies or kittens that are less than 8 weeks of age 
that are

[[Page 62]]

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.3.14(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. 
Redesignated and amended at 85 FR 28798, 28799, May 13, 2020]



Sec.3.16  Primary conveyances (motor vehicle, rail, air, and marine).

    (a) The animal cargo space of primary conveyances used to transport 
dogs and cats must be designed, constructed, and maintained in a manner 
that at all times protects the health and well-being of the animals 
transported in them, ensures their safety and comfort, and prevents the 
entry of engine exhaust from the primary conveyance during 
transportation.
    (b) The animal cargo space must have a supply of air that is 
sufficient for the normal breathing of all the animals being transported 
in it.
    (c) Each primary enclosure containing dogs or cats must be 
positioned in the animal cargo space in a manner that provides 
protection from the elements and that allows each dog or cat enough air 
for normal breathing.
    (d) During air transportation, dogs and cats must be held in cargo 
areas that are heated or cooled as necessary to maintain an ambient 
temperature and humidity that ensures the health and well-being of the 
dogs or cats. The cargo areas must be pressurized when the primary 
conveyance used for air transportation is not on the ground, unless 
flying under 8,000 ft. Dogs and cats must have adequate air for 
breathing at all times when being transported.
    (e) During surface transportation, auxiliary ventilation, such as 
fans, blowers or air conditioning, must be used in any animal cargo 
space containing live dogs or cats when the ambient temperature within 
the animal cargo space reaches 85 [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

[[Page 63]]

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. Redesignated at 85 FR 28798, May 13, 2020]



Sec.3.17  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.
3.14(c). Each dog and cat must be offered food and potable water within 
4 hours before being transported in commerce. Consignors who are subject 
to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must certify 
that each dog and cat was offered food and potable water within the 4 
hours preceding delivery of the dog or cat to a carrier or intermediate 
handler for transportation in commerce, and must certify the date and 
time the food and potable water was offered, in accordance with Sec.
3.14(c).
    (b) Any dealer, research facility, including a Federal research 
facility, or exhibitor offering any dog or cat to a carrier or 
intermediate handler for transportation in commerce must securely attach 
to the outside of the primary enclosure used for transporting the dog or 
cat, written instructions for the in-transit food and water requirements 
for a 24-hour period for the dogs and cats contained in the enclosure. 
The instructions must be attached in a manner that makes them easily 
noticed and read.
    (c) Food and water receptacles must be securely attached inside the 
primary enclosure and placed so that the receptacles can be filled from 
outside the enclosure without opening the door. Food and water 
containers must be designed, constructed, and installed so that a dog or 
cat cannot leave the primary enclosure through the food or water 
opening.

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

[56 FR 6486, Feb. 15, 1991. Redesignated and amended at 85 FR 28798, 
28799, May 13, 2020]



Sec.3.18  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.3.16(e), and that all 
applicable standards of this subpart are being complied with. The 
regulated person must ensure that the operator or person accompanying 
the operator determines whether any of the dogs or cats are in obvious 
physical distress and obtains any veterinary care needed for the dogs or 
cats at the closest available veterinary facility.
    (b) Air transportation. During air transportation of dogs or cats, 
it is the responsibility of the carrier to observe the dogs or cats as 
frequently as circumstances allow, but not less than once every 4 hours 
if the animal cargo area is accessible during flight. If the animal 
cargo area is not accessible during flight, the carrier must observe the 
dogs or cats whenever they are loaded and unloaded and whenever the 
animal cargo space is otherwise accessible to make sure they have 
sufficient air for normal breathing, that the animal cargo area meets 
the heating and cooling requirements of Sec.3.16(d), and that all 
other applicable standards of this subpart are being complied with. The 
carrier must determine whether any of the dogs or cats are in obvious 
physical distress, and arrange for any needed veterinary care as soon as 
possible.
    (c) If a dog or cat is obviously ill, injured, or in physical 
distress, it must not be transported in commerce, except

[[Page 64]]

to receive veterinary care for the condition.
    (d) Removal during transportation in commerce prohibited. Except 
during the cleaning of primary enclosures, as required in Sec.3.15(b), 
during transportation in commerce a dog or cat must not be removed from 
its primary enclosure, unless it is placed in another primary enclosure 
or facility that meets the requirements of Sec.3.6 or Sec.3.15.
    (e) The transportation regulations contained in this subpart must be 
complied with until a consignee takes physical delivery of the dog or 
cat if the animal is consigned for transportation, or until the animal 
is returned to the consignor.

[56 FR 6486, Feb. 15, 1991. Redesignated and amended at 85 FR 28798, 
28799, May 13, 2020]



Sec.3.19  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 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.3.14(f).

[56 FR 6486, Feb. 15, 1991, as amended at 63 FR 10499, Mar. 4, 1998. 
Redesignated and amended at 85 FR 28798, 28799, May 13, 2020]



Sec.3.20  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

[[Page 65]]

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.3.19(d). The preceding 
requirements are in addition to, not in place of, all other requirements 
pertaining to climatic conditions in parts 2 and 3 of this chapter.
    (2) Shelter from rain and snow. Sufficient protection must be 
provided to allow the dogs and cats to remain dry during rain, snow, and 
other precipitation.
    (3) Shelter from cold temperatures. Transporting devices on which 
live dogs or cats are placed to move them must be covered to protect the 
animals when the outdoor temperature falls below 50 [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.3.14(e). The temperature must be measured in the 
manner provided in Sec.3.19(d). The preceding requirements are in 
addition to, not in place of, all other requirements pertaining to 
climatic conditions in parts 2 and 3 of this chapter.
    (b) Any person handling a primary enclosure containing a dog or cat 
must use care and must avoid causing physical harm or distress to the 
dog or cat.
    (1) A primary enclosure containing a live dog or cat must not be 
placed on unattended conveyor belts, or on elevated conveyor belts, such 
as baggage claim conveyor belts and inclined conveyor ramps that lead to 
baggage claim areas, at any time; except that a primary enclosure may be 
placed on inclined conveyor ramps used to load and unload aircraft if an 
attendant is present at each end of the conveyor belt.
    (2) A primary enclosure containing a dog or cat must not be tossed, 
dropped, or needlessly tilted, and must not be stacked in a manner that 
may reasonably be expected to result in its falling. It must be handled 
and positioned in the manner that written instructions and arrows on the 
outside of the primary enclosure indicate.
    (c) This section applies to movement of a dog or cat from primary 
conveyance to primary conveyance, within a primary conveyance or 
terminal facility, and to or from a terminal facility or a primary 
conveyance.

(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. 
Redesignated and amended at 85 FR 28798, 28799, May 13, 2020]



 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]

[[Page 66]]



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.
    (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.

[[Page 67]]

    (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:

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

[[Page 68]]

    (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.
    (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

[[Page 69]]

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 government for shipment, in commerce, more than 4 hours prior 
to the scheduled departure of the primary conveyance on which it is to 
be transported: Provided, however, That the carrier or intermediate 
handler and any dealer, research facility, exhibitor, operator of an 
auction sale, or other person, or any department, agency, or 
instrumentality of the United States or any State or local government 
may mutually agree to extend the time of acceptance to not more than 6 
hours if specific prior scheduling of the animal shipment to destination 
has been made.
    (b) Any carrier or intermediate handler shall only accept for 
transportation or transport, in commerce any live guinea pig or hamster 
in a primary enclosure which conforms to the requirements set forth in 
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 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

[[Page 70]]

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 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

[[Page 71]]

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 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.

[[Page 72]]

    (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 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

[[Page 73]]

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 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.

[[Page 74]]

    (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 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.

[[Page 75]]



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:

----------------------------------------------------------------------------------------------------------------
                                       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]

[[Page 76]]

                  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 
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,

[[Page 77]]

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 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

[[Page 78]]

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 minimum air circulation space 1.9 centimeters 
(.75 inch) between the primary enclosure and any adjacent cargo or 
conveyance wall; and
    (6) Except as provided in paragraph (h) of this section, adequate 
handholds or other devices for lifting shall be provided on the exterior 
of the primary enclosure to enable the primary enclosure to be lifted 
without tilting and to ensure that the person handling the primary 
enclosure will not be in contact with the rabbit.
    (b) Live rabbits transported in the same primary enclosure shall be 
maintained in compatible groups and shall not be transported in the same 
primary enclosure with other species of animals.
    (c) Primary enclosures used to transport live rabbits shall be large 
enough to ensure that each rabbit contained therein has sufficient space 
to turn about freely and to make normal postural adjustments.
    (d) Not more than 15 live rabbits shall be transported in the same 
primary enclosure.
    (e) Primary enclosures used to transport live rabbits as provided in 
this section shall have solid bottoms to prevent leakage in shipment and 
shall be cleaned and sanitized in a manner prescribed in 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 words ``Live Animal'' in letters not less 
than 2.5 centimeters (1 inch) in height, and with arrows or

[[Page 79]]

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; 85 FR 28799, May 13, 2020]



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 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 the responsibility of 
the driver

[[Page 80]]

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 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.

[[Page 81]]

    (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 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

[[Page 82]]

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 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

[[Page 83]]

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 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

[[Page 84]]

(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 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

[[Page 85]]

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 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)

[56 FR 6495, Feb. 15, 1991, as amended at 85 FR 28799, May 13, 2020]



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

[[Page 86]]

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 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) 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

[[Page 87]]

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) 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)
4..............................  22.0-33.0.........  (10-15)..........        6.0     (0.56)     32      (81.28)
5..............................  33.0-55.0.........  (15-25)..........        8.0     (0.74)     36      (91.44)
6..............................  over 55.0.........  (over 25)........       25.1     (2.33)     84     (213.36)
----------------------------------------------------------------------------------------------------------------

    (2) Dealers. exhibitors, and research facilities, including Federal 
research facilities, must provide great apes weighing over 110 lbs. (50 
kg) an additional volume of space in excess of that required for Group 6 
animals as set forth in paragraph (b)(1) of this section, to allow for 
normal postural adjustments.
    (3) In the case of research facilities, any exemption from these 
standards must be required by a research proposal or in the judgment of 
the attending veterinarian and must be approved by the Committee. In the 
case of dealers and exhibitors, any exemption from these standards must 
be required in the judgment of the attending veterinarian and approved 
by the Administrator.
    (4) When more than one nonhuman primate is housed in a primary 
enclosure, the minimum space requirement for the enclosure is the sum of 
the minimum floor area space required for each individual nonhuman 
primate in the table in paragraph (b)(1) of this section, and the 
minimum height requirement for the largest nonhuman primate housed in 
the enclosure. Provided however, that mothers with infants less than 6 
months of age may be maintained together in primary enclosures that meet 
the floor area space and height requirements of the mother.
    (c) Innovative primary enclosures not precisely meeting the floor 
area and height requirements provided in paragraph (b) of this section, 
but that do provide nonhuman primates with a sufficient volume of space 
and the opportunity to express species-typical behavior, may be used at 
research facilities when approved by the Committee, and

[[Page 88]]

by dealers and exhibitors when approved by the Administrator.

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

[56 FR 6495, Feb. 15, 1991, as amended at 83 FR 25555, June 4, 2018]



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 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

[[Page 89]]

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)

                  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

[[Page 90]]

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 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

[[Page 91]]

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 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

[[Page 92]]

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 
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;

[[Page 93]]

    (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 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

[[Page 94]]

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.
    (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.

[[Page 95]]

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 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.

[[Page 96]]

    (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 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

[[Page 97]]

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 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,

[[Page 98]]

    (4) The time period requested for a variance,
    (5) The specific reasons why a variance is requested, and
    (6) The estimated cost of coming into compliance, if construction is 
involved.
    (c) After receipt of an application for a variance, the Deputy 
Administrator may require the submission in writing of a report by two 
experts recommended by the American Association of Zoological Parks and 
Aquariums and approved by the Deputy Administrator concerning potential 
adverse impacts on the animals involved or on other matters relating to 
the effects of the requested variance on the health and well-being of 
such marine mammals. Such a report will be required only in those cases 
when the Deputy Administrator determines that such expertise is 
necessary to determine whether the granting of a variance would cause a 
situation detrimental to the health and well-being of the marine mammals 
involved. The cost of such report is to be paid by the applicant.
    (d) Variances granted for facilities because of ill or infirm marine 
mammals that cannot be moved without placing their well-being in 
jeopardy, or for facilities within 0.3048 meters (1 foot) of compliance 
with any space requirement may be granted for up to the life of the 
marine mammals involved. Otherwise, variances shall be granted for a 
period not exceeding July 30, 1986, Provided, however, That under 
circumstances deemed justified by the Deputy Administrator, a maximum 
extension of 1 year may be granted to attain full compliance. A written 
request for the extension must be received by the Deputy Administrator 
by May 30, 1986. Consideration for extension by the Deputy Administrator 
will be limited to unforeseen or unusual situations such as when 
necessary public funds cannot be allocated in an appropriate time frame 
for a facility to attain full compliance by July 30, 1986.
    (e) The Deputy Administrator shall deny any application for a 
variance if he determines that it is not justified under the 
circumstances or that allowing it will be detrimental to the health and 
well-being of the marine mammals involved.
    (f) Any facility housing marine mammals that does not meet all of 
the space requirements as of July 30, 1984, must meet all of the 
requirements by September 28, 1984, or may operate without meeting such 
requirements until action is taken on an application for a variance if 
the application is submitted to the Deputy Administrator on or before 
September 28, 1984.
    (g) A research facility may be granted a variance from specified 
requirements of this subpart when such variance is necessary for 
research purposes and is fully explained in the experimental design. Any 
time limitation stated in this section shall not be applicable in such 
case.

[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.

[[Page 99]]

    (4) Facilities that utilize natural water areas, such as tidal 
basins, bays, or estuaries (subject to natural tidewater action), for 
housing marine mammals are exempt from the drainage requirements of 
paragraph (c)(1) of this section.
    (b) Water and power supply. Reliable and adequate sources of water 
and electric power must be provided by the facility housing marine 
mammals. Written contingency plans must be submitted to and approved by 
the Deputy Administrator regarding emergency sources of water and 
electric power in the event of failure of the primary sources, when such 
failure could reasonably be expected to be detrimental to the good 
health and well-being of the marine mammals housed in the facility. 
Contingency plans must include, but not be limited to, specific animal 
evacuation plans in the event of a disaster and should describe back-up 
systems and/or arrangements for relocating marine mammals requiring 
artificially cooled or heated water. If the emergency contingency plan 
includes release of marine mammals, the plan must include provision for 
recall training and retrieval of such animals. Facilities handling 
marine mammals must also comply with the requirements of Sec.2.134 of 
this subchapter.
    (c) Drainage. (1) Adequate drainage must be provided for all primary 
enclosure pools and must be located so that all of the water contained 
in such pools may be effectively eliminated when necessary for cleaning 
the pool or for other purposes. Drainage effluent from primary enclosure 
pools must be disposed of in a manner that complies with all applicable 
Federal, State, and local pollution control laws.
    (2) Drainage must be provided for primary enclosures and areas 
immediately surrounding pools. All drain covers and strainers must be 
securely fastened in order to minimize the potential risk of animal 
entrapment. Drains must be located so as to rapidly eliminate excess 
water (except in pools). Drainage effluent must be disposed of in a 
manner that complies with all applicable Federal, State, and local 
pollution control laws.
    (d) Storage. Supplies of food must be stored in facilities that 
adequately protect such supplies from deterioration, spoilage (harmful 
microbial growth), and vermin or other contamination. Refrigerators and 
freezers (or chilled and/or iced coolers for under 12 hours) must be 
used for perishable food. No substances that are known to be or may be 
toxic or harmful to marine mammals may be stored or maintained in the 
marine mammal food storage or preparation areas, except that cleaning 
agents may be kept in secured cabinets designed and located to prevent 
food contamination. Food, supplements, and medications may not be used 
beyond commonly accepted shelf life or date listed on the label.
    (e) Waste disposal. Provision must be made for the removal and 
disposal of animal and food wastes, dead animals, trash, and debris. 
Disposal facilities must be provided and operated in a manner that will 
minimize odors and the risk of vermin infestation and disease hazards. 
All waste disposal procedures must comply with all applicable Federal, 
State, and local laws pertaining to pollution control, protection of the 
environment, and public health.
    (f) Employee washroom facilities. Washroom facilities containing 
basins, sinks, and, as appropriate, showers, must be provided and 
conveniently located to maintain cleanliness among employees, 
attendants, and volunteers. These facilities must be cleaned and 
sanitized daily.
    (g) Enclosure or pool environmental enhancements. Any nonfood 
objects provided for the entertainment or stimulation of marine mammals 
must be of sufficient size and strength to not be ingestible, readily 
breakable, or likely to cause injury to marine mammals, and be able to 
be cleaned, sanitized, and/or replaced effectively.

[66 FR 251, Jan. 3, 2001, as amended at 77 FR 76824, Dec. 31, 2012]



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

[[Page 100]]

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 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

[[Page 101]]

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 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.

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

[[Page 102]]

    (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
       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.


[[Page 103]]


    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
    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

[[Page 104]]

 
    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 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

[[Page 105]]

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

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/9 x 0.8361.

    (c) Sirenians. Primary enclosures housing sirenians shall contain a 
pool of water and may consist entirely of a pool of water.
    (1) The required MHD of a primary enclosure pool for sirenians shall 
be

[[Page 106]]

two times the average adult length of the longest species of sirenian to 
be housed therein. Calculations shall be based on the average adult 
length of such sirenians as measured in a horizontal line from the tip 
of the muzzle to the notch in the tail fluke of dugongs and from the tip 
of the muzzle to the most distal point in the rounded tail of the 
manatee.
    (2) The minimum depth requirements for primary enclosure pools for 
all sirenians shall be one-half the average adult length of the longest 
species to be housed therein, or 1.52 meters (5.0 feet), whichever is 
greater. Those parts of the primary enclosure pool which do not meet the 
minimum depth requirements cannot be included when calculating space 
requirements for sirenians.
    (3) A pool which satisfies the required MHD and depth shall be 
adequate for one or two sirenians. Volume and surface area requirements 
for additional animals shall be calculated using the same formula as for 
Group I cetaceans, except that the figure for depth requirement for 
sirenians shall be one-half the average adult length or 1.52 meters (5.0 
feet), whichever is greater.
    (d) Pinnipeds. (1) Primary enclosures housing pinnipeds shall 
contain a pool of water and a dry resting or social activity area that 
must be close enough to the surface of the water to allow easy access 
for entering or leaving the pool. For the purposes of this subpart, 
pinnipeds have been divided into Group I pinnipeds and Group II 
pinnipeds as shown in Table III in this section. In certain instances 
some Group I pinnipeds shall be considered as Group II pinnipeds. (See 
Table III).
    (2) The minimum size of the dry resting or social activity area of 
the primary enclosure for pinnipeds (exclusive of the pool of water) 
shall be based on the average adult length of each pinniped contained 
therein, as measured in a horizontal or extended position in a straight 
line from the tip of its nose to the tip of its tail. The minimum size 
of the dry resting or social activity area shall be computed using the 
following methods:
    (i) Group I pinnipeds. Square the average adult length of each 
pinniped to be contained in the primary enclosure. Add the figures 
obtained for each of the pinnipeds in the primary enclosure to determine 
the dry resting or social activity area required for such pinnipeds. If 
only a single Group I pinniped is maintained in the primary enclosure, 
the minimum dry resting or social activity area shall be twice the 
square of the average adult length of that single Group I pinniped. 
Examples:

(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 = 2 x (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\ x 1.5 = social and DRA required
2nd pinniped (avg. adult length) \2\ x 1.4 = social and DRA required
3rd pinniped (avg. adult length) \1\ x 1.3 = social and DRA required
4th pinniped (avg. adult length) \2\ x 1.2 = social and DRA required
5th pinniped (avg. adult length) \2\ x 1.1 = social and DRA required
Each pinniped over 5 (avg. adult length) \2\ = social and DRA required
------------------------------------------------------------------------
Total minimum social activity and dry resting area required for all
 pinnipeds housed in a primary enclosure.
 

If all the pinnipeds in the primary enclosure are of the same species, 
the same descending order of calculation shall apply. Example: Hooded 
seal--average adult length of male =

[[Page 107]]

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\ x 1.5] + [(8.5) \2\ x 1.4] + [(6.6) \2\ x 1.3] + [(6.6) \2\ x 
1.2].

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.
    (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-

[[Page 108]]

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]

                  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

[[Page 109]]

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 maintain water 
quality standards. Facilities using natural seawater shall be exempt 
from pH and chemical testing unless chemicals are added to maintain 
water quality. However, they are required to test for coliforms. Records 
must be kept documenting the time when all such samples were taken and 
the results of the sampling. Records of all such test results shall be 
maintained by management for a 1-year period and must be made available 
for inspection purposes on request.
    (c) Salinity. Primary enclosure pools of water shall be salinized 
for marine cetaceans as well as for those other marine mammals which 
require salinized water for their good health and well-being. The 
salinity of the water in such pools shall be maintained within a range 
of 15-36 parts per thousand.
    (d) Filtration and water flow. Water quality must be maintained by 
filtration, chemical treatment, or other means so as to comply with the 
water quality standards specified in this section.



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

[[Page 110]]

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 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 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

[[Page 111]]

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. 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

[[Page 112]]

and must be presented to APHIS inspectors when requested.

[66 FR 253, Jan. 3, 2001, as amended at 85 FR 28799, May 13, 2020]



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
    
    (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

[[Page 113]]

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.
    (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;

[[Page 114]]

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;
    (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

[[Page 115]]

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 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.

    Editorial Note: At 85 FR 28799, May 13, 2020, Sec.3.111 was 
amended; however, the amendment could not be incorporated because the 
section was suspended at 64 FR 15920, 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

[[Page 116]]

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.
    (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:

[[Page 117]]

    (a) Primary enclosures that are used to transport marine mammals 
other than cetaceans and sirenians must:
    (1) Be constructed from materials of sufficient structural strength 
to contain the marine mammals;
    (2) Be constructed from material that is durable, nontoxic, and 
cannot be chewed and/or swallowed;
    (3) Be able to withstand the normal rigors of transportation;
    (4) Have interiors that are free from any protrusions or hazardous 
openings that could be injurious to the marine mammals contained within;
    (5) Be constructed so that no parts of the contained marine mammals 
are exposed to the outside of the enclosures in any way that may cause 
injury to the animals or to persons who are nearby or who handle the 
enclosures;
    (6) Have openings that provide access into the enclosures and are 
secured with locking devices of a type that cannot be accidentally 
opened;
    (7) Have such openings located in a manner that makes them easily 
accessible at all times for emergency removal and potential treatment of 
any live marine mammal contained within;
    (8) Have air inlets at heights that will provide cross ventilation 
at all levels (particularly when the marine mammals are in a prone 
position), are located on all four sides of the enclosures, and cover 
not less than 20 percent of the total surface area of each side of the 
enclosures;
    (9) Have projecting rims or other devices placed on any ends and 
sides of the enclosures that have ventilation openings so that there is 
a minimum air circulation space of 7.6 centimeters (3.0 inches) between 
the enclosures and any adjacent cargo or conveyance wall;
    (10) Be constructed so as to provide sufficient air circulation 
space to maintain the temperature limits set forth in this subpart; and
    (11) Be equipped with adequate handholds or other devices on the 
exterior of the enclosures to enable them to be lifted without 
unnecessary tilting and to ensure that the persons handling the 
enclosures will not come in contact with any marine mammal contained 
inside.
    (b) Straps, slings, harnesses, or other devices used for body 
support or restraint, when transporting marine mammals such as cetaceans 
and sirenians must:
    (1) Be designed so as not to prevent access to the marine mammals by 
attendants for the purpose of administering in-transit care;
    (2) Be equipped with special padding to prevent trauma or injury at 
critical weight pressure points on the body of the marine mammals; and
    (3) Be capable of keeping the animals from thrashing about and 
causing injury to themselves or their attendants, and yet be adequately 
designed so as not to cause injury to the animals.
    (c) Primary enclosures used to transport marine mammals must be 
large enough to assure that:
    (1) In the case of pinnipeds, polar bears, and sea otters, each 
animal has sufficient space to turn about freely in a stance whereby all 
four feet or flippers are on the floor and the animal can sit in an 
upright position and lie in a natural position;
    (2) In the case of cetaceans and sirenians, each animal has 
sufficient space for support of its body in slings, harnesses, or other 
supporting devices, if used (as prescribed in paragraph (b) of this 
section), without causing injury to such cetaceans or sirenians due to 
contact with the primary transport enclosure: Provided, however, That 
animals may be restricted in their movements according to professionally 
accepted standards when such freedom of movement would constitute a 
danger to the animals, their handlers, or other persons.
    (d) Marine mammals transported in the same primary enclosure must be 
of the same species and maintained in compatible groups. Marine mammals 
that have not reached puberty may not be transported in the same primary 
enclosure with adult marine mammals other than their dams. Socially 
dependent animals (e.g., sibling, dam, and other members of a family 
group) must be allowed visual and olfactory contact whenever reasonable. 
Female marine mammals may not be transported in the same primary 
enclosure with any mature male marine mammals.
    (e) Primary enclosures used to transport marine mammals as provided 
in this section must have solid bottoms to

[[Page 118]]

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 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

[[Page 119]]

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 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

[[Page 120]]

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]



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.

[[Page 121]]

                   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 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

[[Page 122]]

to pollution control or the protection of the environment.
    (d) Perimeter fence. On or after May 17, 2000, all outdoor housing 
facilities (i.e., facilities not entirely indoors) must be enclosed by a 
perimeter fence that is of sufficient height to keep animals and 
unauthorized persons out. Fences less than 8 feet high for potentially 
dangerous animals, such as, but not limited to, large felines (e.g., 
lions, tigers, leopards, cougars, etc.), bears, wolves, rhinoceros, and 
elephants, or less than 6 feet high for other animals must be approved 
in writing by the Administrator. The fence must be constructed so that 
it protects the animals in the facility by restricting animals and 
unauthorized persons from going through it or under it and having 
contact with the animals in the facility, and so that it can function as 
a secondary containment system for the animals in the facility. It must 
be of sufficient distance from the outside of the primary enclosure to 
prevent physical contact between animals inside the enclosure and 
animals or persons outside the perimeter fence. Such fences less than 3 
feet in distance from the primary enclosure must be approved in writing 
by the Administrator. A perimeter fence is not required:
    (1) Where the outside walls of the primary enclosure are made of 
sturdy, durable material, which may include certain types of concrete, 
wood, plastic, metal, or glass, and are high enough and constructed in a 
manner that restricts entry by animals and unauthorized persons and the 
Administrator gives written approval; or
    (2) Where the outdoor housing facility is protected by an effective 
natural barrier that restricts the animals to the facility and restricts 
entry by animals and unauthorized persons and the Administrator gives 
written approval; or
    (3) Where appropriate alternative security measures are employed and 
the Administrator gives written approval; or
    (4) For traveling facilities where appropriate alternative security 
measures are employed; or
    (5) Where the outdoor housing facility houses only domesticated 
farm-type animals, such as, but not limited to, cows, sheep, goats, 
pigs, horses (for regulated purposes), or donkeys, and the facility has 
in place effective and customary containment and security measures.

[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; 83 
FR 25555, June 4, 2018]



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.

[[Page 123]]



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, 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

[[Page 124]]

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 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

[[Page 125]]

on the upper one-half of the primary enclosure; (5) except as provided 
in paragraph (g) of this section, projecting rims or other devices shall 
be on the exterior of the outside walls with any ventilation openings to 
prevent obstruction of the ventilation openings and to provide a minimum 
air circulation space of 1.9 centimeters (.75 inch) between the primary 
enclosure and any adjacent cargo or conveyance wall; and (6) except as 
provided in paragraph (g) of this section, adequate handholds or other 
devices for lifting shall be provided on the exterior of the primary 
enclosure to enable the primary enclosure to be lifted without tilting 
and to ensure that the person handling the primary enclosure will not be 
in contact with the animal.
    (b) Live animals transported in the same primary enclosure shall be 
of the same species and maintained in compatible groups. Live animals 
that have not reached puberty shall not be transported in the same 
primary enclosure with adult animals other than their dams. Socially 
dependent animals (e.g., sibling, dam, and other members of a family 
group) must be allowed visual and olfactory contact. Any female animal 
in season (estrus) shall not be transported in the same primary 
enclosure with any male animal.
    (c) Primary enclosures used to transport live animals shall be large 
enough to ensure that each animal contained therein has sufficient space 
to turn about freely and to make normal postural adjustments: Provided, 
however, That certain species may be restricted in their movements 
according to professionally acceptable standards when such freedom of 
movement would constitute a danger to the animals, their handlers, or 
other persons.
    (d) Primary enclosures used to transport live animals as provided in 
this section shall have solid bottoms to prevent leakage in shipment and 
still be cleaned and sanitized in a manner prescribed in 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

[[Page 126]]

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, 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

[[Page 127]]

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 
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

[[Page 128]]

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, 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.

[[Page 129]]



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 management.
11.21 Inspection procedures for designated qualified persons (DQPs).
11.22 Records required and disposition thereof.
11.23 Inspection of records.
11.24 Reporting by management.
11.25 Minimum penalties to be assessed and enforced by HIOs that license 
          DQPs.
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 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

[[Page 130]]

or presented for sale or auction, or any person who allows any horse in 
his custody or under his direction, control, or supervision to be 
entered or presented for sale or auction in any horse sale or horse 
auction; or (4) any person who sells or auctions any horse, any person 
who allows his horse to be sold or auctioned, or any person who directs 
or allows any horse in his custody or under his direction, control, or 
supervision to be sold or auctioned.
    Horse means any member of the species Equus caballus.
    Horse exhibition means a public display of any horses, singly or in 
groups, but not in competition, except events where speed is the prime 
factor, rodeo events, parades, or trail rides.
    Horse industry organization or association means an organized group 
of people, having a formal structure, who are engaged in the promotion 
of horses through the showing, exhibiting, sale, auction, registry, or 
any activity which contributes to the advancement of the horse.
    Horse sale or horse auction means any event, public or private, at 
which horses are sold or auctioned, regardless of whether or not said 
horses are exhibited prior to or during the sale or auction.
    Horse show means a public display of any horses, in competition, 
except events where speed is the prime factor, rodeo events, parades, or 
trail rides.
    Inspection means the examination of any horse and any records 
pertaining to any horse by use of whatever means are deemed appropriate 
and necessary for the purpose of determining compliance with the Act and 
regulations. Such inspection may include, but is not limited to, visual 
examination of a horse and records, actual physical examination of a 
horse including touching, rubbing, palpating and observation of vital 
signs, and the use of any diagnostic device or instrument, and may 
require the removal of any shoe, pad, action device, or any other 
equipment, substance or paraphernalia from the horse when deemed 
necessary by the person conducting such inspection.
    Lubricant means mineral oil, glycerine or petrolatum, or mixtures 
exclusively thereof, that is applied to the limbs of a horse solely for 
protective and lubricating purposes while the horse is being shown or 
exhibited at a horse show, horse exhibition, horse sale or horse 
auction.
    Management means any person or persons who organize, exercise 
control over, or administer or are responsible for organizing, 
directing, or administering any horse show, horse exhibition, horse sale 
or horse auction and specifically includes, but is not limited to, the 
sponsoring organization and show manager.
    Person means any individual, corporation, company, association, 
firm, partnership, society, organization, joint stock company, or other 
legal entity.
    Regional Director means the APHIS veterinarian who is assigned by 
the Administrator to supervise and perform official duties of APHIS 
under the Act in a specified State or States. \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

[[Page 131]]

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.
    (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.

[[Page 132]]

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.
    (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,

[[Page 133]]

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:
    (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

[[Page 134]]

horse sale or auction until such inspection has been completed and the 
horse has been released by an APHIS representative.
    (c) For the purpose of examination, testing, or taking of evidence, 
APHIS representatives may detain for a period not to exceed 24 hours any 
horse, at any horse show, horse exhibition, or horse sale or auction, 
which is sore or which an APHIS veterinarian has probable cause to 
believe is sore. Such detained horse may be marked for identification 
and any such identifying markings shall not be removed by any person 
other than an APHIS representative.
    (d) Detained horses shall be kept under the supervision of an APHIS 
representative or secured under an official USDA seal or seals in a 
horse stall, horse trailer, or other facility to which access shall be 
limited. It shall be the policy of APHIS to have at least one 
representative present in the immediate detention area when a horse is 
being held in detention. The official USDA seal or seals may not be 
broken or removed by any person other than an APHIS representative, 
unless:
    (1) The life or well-being of the detained horse is immediately 
endangered by fire, flood, windstorm, or other dire circumstances that 
are beyond human control.
    (2) The detained horse is in need of such immediate veterinary 
attention that its life may be in peril before an APHIS representative 
can be located.
    (3) The horse has been detained for a maximum 24-hour detention 
period, and an APHIS representative is not available to release the 
horse.
    (e) The owner, exhibitor, trainer, or other person having custody of 
or responsibility for any horse detained by APHIS for further 
examination, testing, or the taking of evidence shall be allowed to 
feed, water, and provide other normal custodial and maintenance care, 
such as walking, grooming, etc., for such detained horse: Provided, 
That:
    (1) Such feeding, watering, and other normal custodial and 
maintenance care of the detained horse is rendered under the direct 
supervision of an APHIS representative.
    (2) Any non-emergency veterinary care of the detained horse 
requiring the use, application, or injection of any drugs or other 
medication for therapeutic or other purposes is rendered by a Doctor of 
Veterinary Medicine in the presence of an APHIS representative and, the 
identity and dosage of the drug or other medication used, applied, or 
injected and its purpose is furnished in writing to the APHIS 
representative prior to such use, application, or injection by the 
Doctor of Veterinary Medicine attending the horse. The use, application, 
or injection of such drug or other medication must be approved by the 
APHIS Show Veterinarian or his appointed representative.
    (f) It shall be the policy of APHIS to inform the owner, trainer, 
exhibitor, or other person having immediate custody of or responsibility 
for any horse allegedly found to be in violation of the Act or the 
regulations of such alleged violation or violations before the horse is 
released by an APHIS representative.
    (g) The owner, trainer, exhibitor, or other person having immediate 
custody of or responsibility for any horse or horses that an APHIS 
representative determines shall be detained for examination, testing, or 
taking of evidence pursuant to paragraph (e) of this section shall be 
informed after such determination is made and shall allow said horse to 
be immediately put under the supervisory custody of APHIS or secured 
under official USDA seal as provided in paragraph (d) of this section 
until the completion of such examination, testing, or gathering of 
evidence, or until the 24-hour detention period expires.
    (h) The owner, trainer, exhibitor, or other person having custody of 
or responsibility for any horse allegedly found to be in violation of 
the Act or regulations, and who has been notified of such alleged 
violation by an APHIS representative as stated in paragraph (f) of this 
section, may request reexamination and testing of said horse within a 
24-hour period: Provided, That:
    (1) Such request is made to the APHIS Show Veterinarian immediately 
after the horse has been examined by APHIS representatives and before 
such horse has been removed from the APHIS inspection facilities; and

[[Page 135]]

    (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 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,

[[Page 136]]

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:
    (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

[[Page 137]]

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 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

[[Page 138]]

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 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.

[[Page 139]]

    (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 records required in paragraph 
(d)(1) of this section and other available sources, to the Department on 
a monthly basis:
    (i) The identity of all horse shows, horse exhibitions, horse sales, 
or horse auctions that have retained the services of DQP's licensed by 
said organization or association during the month covered by the report. 
Information concerning the identity of such horse shows, horse 
exhibitions, horse sales, or horse auctions shall include:
    (A) The name and location of the show, exhibition, sale, or auction.
    (B) The name and address of the manager.
    (C) The date or dates of the show, exhibition, sale, or auction.
    (ii) The identity of all horses at each horse show, horse 
exhibition, horse sale, or horse auction that the licensed DQP 
recommended be disqualified or excused for any reason. The information 
concerning the identity of such horses shall include:
    (A) The registered name of each horse.
    (B) The name and address of the owner, trainer, exhibitor, or other 
person having custody of or responsibility for the care of each such 
horse disqualified or excused.
    (4) Each horse industry organization or association having a 
Department certified DQP program shall provide, by certified mail if 
personal service is not possible, to the trainer and owner of each horse 
allegedly found in violation of the Act or its regulations or otherwise 
disqualified or excused for any reason, the following information;
    (i) The name and date of the show, exhibition, sale, or auction.
    (ii) The name of the horse and the reason why said horse was 
excused, disqualified, or alleged to be in violation of the Act or its 
regulations.
    (5) Each horse industry organization or association having a 
Department certified DQP program shall provide each of its licensed 
DQP's with a current list of all persons that have been disqualified by 
order of the Secretary from showing or exhibiting any horse, or judging 
or managing any horse show, horse exhibition, horse sale, or horse 
auction. The Department will make such list available, on a current 
basis, to organizations and associations maintaining a certified DQP 
program.
    (6) Each horse industry organization or association having a 
Department certified DQP program shall develop and provide a continuing 
education program for licensed DQP's which provides not less than 4 
hours of instruction per year to each licensed DQP.
    (7) Each horse industry organization or association having a 
Department certified DQP program shall promulgate standards of conduct 
for its DQP's, and shall provide administrative procedures within the 
organization or association for initiating, maintaining, and enforcing 
such standards. The procedures shall include the causes for and methods 
to be utilized for canceling the license of any DQP who fails to 
properly and adequately carry out his duties. Minimum standards of 
conduct for DQP's shall include the following;
    (i) A DQP shall not exhibit any horse at any horse show or horse 
exhibition, or sell, auction, or pruchase any horse sold at a horse sale 
or horse auction at which he or she has been appointed to inspect 
horses;

[[Page 140]]

    (ii) A DQP shall not inspect horses at any horse show, horse 
exhibition, horse sale or horse auction in which a horse or horses owned 
by a member of the DQP's immediate family or the DQP's employer are 
competing or are being offered for sale;
    (iii) A DQP shall follow the uniform inspection procedures of his 
certified organization or association when inspecting horses; and
    (iv) The DQP shall immediately inform management of each case 
regarding any horse which, in his opinion, is in violation of the Act or 
regulations.
    (e) Prohibition of appointment of certain persons to perform duties 
under the Act. The management of any horse show, horse exhibition, horse 
sale, or horse auction shall not appoint any person to detect and 
diagnose horses which are sore or to otherwise inspect horses for the 
purpose of enforcing the Act, if that person:
    (1) Does not hold a valid, current DQP license issued by a horse 
industry organization or association having a DQP program certified by 
the Department.
    (2) Has had his DQP license canceled by the licensing organization 
or association.
    (3) Is disqualified by the Secretary from performing diagnosis, 
detection, and inspection under the Act, after notice and opportunity 
for a hearing, \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.
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    \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 part, may have such 
certification of its DQP program revoked, unless, upon written 
notification from the Department of

[[Page 141]]

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 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; 77 FR 
33618, June 7, 2012]



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

[[Page 142]]

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.
    \6\ See footnote 6 to Sec.11.7.
---------------------------------------------------------------------------

    (2) The DQP shall physically inspect: (i) All Tennessee Walking 
Horses and racking horses entered for sale or auction, (ii) all 
Tennessee Walking Horses and racking horses entered in any animated gait 
class (whether under saddle, horse to cart, or otherwise), (iii) all 
Tennessee Walking Horses and racking horses entered for exhibition 
before they are admitted to be shown, exhibited, sold, or auctioned, and 
(iv) all Tennessee Walking Horses and racking horses tyed first in their 
class or event at any horse show, horse exhibition, horse sale, or horse 
auction. Such inspection shall be for the purpose of determining whether 
any such horses are in violation of the Act or regulations. Such 
physical examination shall be conducted in accordance with the 
inspection procedures provided for in 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 exhibition involving said horse has begun or before said 
horse is offered for sale or auction.
    (c) The management of any horse show, exhibition, sale, or auction 
that designates and appoints a DQP to inspect horses shall appoint and 
designate at least two DQP's when more than 150 horses are entered.

(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
(DQPs).

    (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,

[[Page 143]]

pads, and other equipment shall be observed and/or examined to assure 
that they are in compliance with the regulations. All such equipment on 
horses examined postshow, and on horses examined preshow that are not 
clearly in compliance, shall be weighed and/or measured.
    (4) The DQP shall instruct the custodian of the horse to control it 
by holding the reins approximately 18 inches from the bit shank. The DQP 
shall not be required to examine a horse if it is presented in a manner 
that might cause the horse not to react to a DQP's examination, or if 
whips, cigarette smoke, or other actions or paraphernalia are used to 
distract a horse during examination. All such incidents shall be 
reported to the show management and the DQP licensing organization.
    (b) The DQP shall inspect horses no more than three classes ahead of 
the time the inspected horses are to be shown, except that, in shows 
with fewer than 150 horses, the DQP shall inspect horses no more than 2 
classes ahead of the time the inspected horses are to be shown. 
Inspected horses shall be held in a designated area that is under 
observation by the DQP or APHIS representative. Horses shall not be 
permitted to leave the designated area before showing. Only the horse, 
the rider, the groom, the trainer, the DQP(s) and APHIS representatives 
shall be allowed in the designated area.
    (c) The DQP may carry out additional inspection procedures as he 
deems necessary to determine whether the horse is sore.
    (d) The HIO that licensed the DQP shall assess and enforce penalties 
for violations in accordance with Sec.11.25 and shall report all 
violations in accordance with Sec.11.20(b)(3).

[55 FR 41993, Oct. 17, 1990, as amended at 56 FR 13750, Apr. 4, 1991; 57 
FR 62175, Dec. 30, 1992; 77 FR 33618, June 7, 2012; 78 FR 27001, May 9, 
2013]



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 records required in this 
section.
    (c) The management of any horse show, horse exhibition, or horse 
sale or auction containing Tennessee Walking

[[Page 144]]

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 pertaining to any horse, 
either required in any part of the regulations, or otherwise maintained, 
during ordinary business hours or such other times as may be mutually 
agreed upon. A room, table, or other facilities necessary for proper 
examination of such records shall be made available to the APHIS 
representative.
    (b) Horse industry organizations or associations who train, 
maintain, and license DQP's under a certified DQP program shall permit 
any APHIS representative, upon request, to examine and copy any and all 
records relating to the DQP program which are required by any part of 
the regulations. Such requests shall be made during ordinary business 
hours or such other times as mutually agreed upon. A room, table or 
other facilities necessary for proper examination shall be made 
available upon the request of the APHIS representative.

[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.11.25  Minimum penalties to be assessed and enforced by HIOs 
that license DQPs.

    (a) Rulebook. Each HIO that licenses DQPs in accordance with Sec.
11.7 must include in its rulebook, and enforce, penalties for the 
violations listed in this section that equal or exceed the penalties 
listed in paragraph (c) of this section and must also enforce the 
requirement in paragraph (d) of this section.
    (b) Suspensions. (1) For the violations listed in paragraph (c) of 
this section that require a suspension, any individuals who are 
responsible for showing the horse, exhibiting the horse, entering or 
allowing the entry of the horse in a show or exhibition, selling the 
horse, auctioning the horse, or offering the horse for sale or auction 
must be

[[Page 145]]

suspended. This may include, but may not be limited to, the manager, 
trainer, rider, custodian, or seller, as applicable. In addition, if the 
owner allowed any activity listed in this paragraph, the owner must be 
suspended as well.
    (2) Any person who is responsible for the shipping, moving, 
delivering, or receiving of any horse that is found to be bilaterally 
sore or unilaterally sore as defined in paragraph (c) of this section, 
in violation of the scar rule in Sec.11.3, or in violation of the 
prohibition against the use of foreign substances in Sec.11.2(c), with 
reason to believe that such horse was to be shown, exhibited, entered 
for the purpose of being shown or exhibited, sold, auctioned, or offered 
for sale in any horse show, horse exhibition, or horse sale or auction, 
must be suspended; Provided, that this requirement does not apply if the 
horse was transported by a common or contract carrier or an employee 
thereof in the usual course of the carrier's business or the employee's 
employment, unless the carrier or employee had reason to believe that 
the horse was sore.
    (3) A person who is suspended must not be permitted to show or 
exhibit any horse or judge or manage any horse show, horse exhibition, 
or horse sale or auction for the duration of the suspension.
    (4) Any person with multiple suspensions must serve them 
consecutively, not concurrently.
    (c) Minimum penalties--(1) Bilateral sore. A horse is found to be 
sore in both its forelimbs or hindlimbs. The horse must be dismissed 
from the remainder of the horse show, exhibition, sale, or auction. 
First offense: Suspension for 1 year. Second offense: Suspension for 2 
years. Third offense and any subsequent offenses: Suspension for 4 
years.
    (2) Unilateral sore. A horse is found to be sore in one of its 
forelimbs or hindlimbs. The horse must be dismissed from the remainder 
of the horse show, exhibition, sale, or auction. First offense: 
Suspension for 60 days. Second offense: Suspension for 120 days. Third 
offense and any subsequent offenses: Suspension for 1 year.
    (3) Scar rule violation. A horse is found to be in violation of the 
scar rule in Sec.11.3. The horse must be dismissed from the remainder 
of the horse show, exhibition, sale, or auction. First offense: 
Suspension for 2 weeks (14 days). Second offense: Suspension for 60 
days. Third offense and any subsequent offenses: Suspension for 1 year.
    (4) Foreign substance violations. Violations of the prohibition 
against the use of foreign substances in Sec.11.2(c).
    (i) Before or during the show, exhibition, sale, or auction. The 
horse must be dismissed from the remainder of the horse show, 
exhibition, sale, or auction.
    (ii) After the show, exhibition, sale, or auction. Suspension for 2 
weeks (14 days). The horse must be dismissed from the remainder of the 
horse show, exhibition, sale, or auction.
    (5) Equipment violation. Violations of the equipment-related 
prohibitions in Sec.11.2(b)(1) through (b)(10) and (b)(12) through 
(b)(17).
    (i) Before or during the show, exhibition, sale, or auction. The 
horse must be dismissed from the remainder of the horse show, 
exhibition, sale, or auction.
    (ii) After the show, exhibition, sale, or auction. Suspension for 2 
weeks (14 days). The horse must be dismissed from the remainder of the 
horse show, exhibition, sale, or auction.
    (6) Shoeing violation. Violation of the shoeing-related prohibitions 
in Sec.11.2(b)(18) and (b)(19). The horse must be dismissed from the 
remainder of the horse show, exhibition, sale, or auction.
    (7) Heel-toe ratio. Violation of the heel-toe ratio requirement in 
Sec.11.2(b)(11). The horse must be dismissed from the remainder of the 
horse show, exhibition, sale, or auction.
    (8) Suspension violation. A violation of any suspension penalty 
previously issued. Suspension for an additional 6 months (180 days) for 
each occurrence.
    (d) Unruly or fractious horse. A horse that cannot be inspected in 
accordance with Sec.11.21. The horse must be dismissed from the 
individual class for which it was to be inspected.
    (e) Appeals. The HIO must provide a process in its rulebook for 
alleged violators to appeal penalties. The process must be approved by 
the Department. For all appeals, the appeal must be granted and the case 
heard and decided by the HIO or the violator must begin

[[Page 146]]

serving the penalty within 60 days of the date of the violation. The HIO 
must submit to the Department all decisions on penalty appeals within 30 
days of the completion of the appeal. When a penalty is overturned on 
appeal, the HIO must also submit evidence composing the record of the 
HIO's decision on the appeal.
    (f) Departmental prosecution. The Department retains the authority 
to initiate enforcement proceedings with respect to any violation of the 
Act, including violations for which penalties are assessed in accordance 
with this section, and to impose the penalties authorized by the Act if 
the Department determines that such actions are necessary to fulfill the 
purpose of the Act and this part. In addition, the Department reserves 
the right to inform the Attorney General of any violation of the Act or 
of this part, including violations for which penalties are assessed in 
accordance with this section.

[77 FR 33618, June 7, 2012, as amended at 79 FR 3071, Jan. 17, 2014]



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 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.

[[Page 147]]

                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 148]]



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 149]]

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 150]]

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 151]]

    (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 152]]

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 153]]



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 154]]

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 155]]

    (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 156]]

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 157]]

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 158]]

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

    \1 2\ [Reserved]
    \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.

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



Sec.50.21  Schedule of payments.

    (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



            Subpart A_Indemnity for Cattle, Bison, and Swine

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.

            Subpart B_Indemnity for Sheep, Goats, and Horses

51.20 Definitions.
51.21 Cooperation with States.
51.22 Payment to owners for goats, sheep, and horses destroyed.
51.23 Eligibility for indemnity.
51.24 Maximum per-head indemnity amounts.
51.25 Proof of destruction.
51.26 Record of tests.
51.27 Identification of goats, sheep, and horses to be destroyed.
51.28 Moving goats, sheep, and horses to be destroyed.
51.29 Destruction of animals; time limit.
51.30 Claims for indemnity.
51.31 Disinfecting premises, conveyances, and materials.
51.32 Claims not allowed.
51.33 Multiple indemnity payments.

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



            Subpart A_Indemnity for Cattle, Bison, and Swine



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

[[Page 159]]

part 161 of this title to perform functions specified in parts 1, 2, 3, 
and 11 of subchapter A, and subchapters B, C, and D of this chapter, and 
to perform functions required by cooperative state-federal disease 
control and eradication programs.
    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Animal and Plant Health Inspection Service. The Animal and Plant 
Health Inspection Service of the United States Department of Agriculture 
(APHIS or Service).
    Animals. Cattle, bison, and breeding swine.
    APHIS representative. An individual employed by APHIS who is 
authorized to perform the function involved.
    Appraisal. An estimate of the fair market value of an animal to be 
destroyed because of brucellosis. The estimate shall be based upon the 
meat, dairy, or breeding value of the animal.
    Brucellosis exposed animal. Except for a brucellosis reactor animal, 
any animal that: (1) Is part of or has been in contact with a herd known 
to be affected; or (2) has been in contact with a brucellosis reactor 
animal for a period of 24 hours or longer; or (3) has been in contact 
with a brucellosis reactor animal which has aborted, calved or farrowed 
within the past 30 days, or has a vaginal or uterine discharge.
    Brucellosis reactor animal. Any animal classified as a brucellosis 
reactor as provided in the definition of official test in 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

[[Page 160]]

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 
subpart issued by an APHIS representative, state representative, or 
accredited veterinarian listing the disease status and identification of 
the animal, where consigned, cleaning and disinfecting requirements, and 
proof of slaughter certification.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, or joint stock company, or other legal entity.
    Recognized slaughtering establishment. Any slaughtering 
establishment operating under the Federal Meat Inspection Act (21 U.S.C. 
601 et seq.)or a State meat inspection act. \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 purebreeding of animal species for a 
specific breed whose characteristics are set forth in Constitutions, By-
Laws, and other rules of the association. The records maintained by such 
an association shall include an Official Herd Book or other 
recordkeeping format and Certificates of Registration or Recordation 
which identify an animal as a registered animal of that registered breed 
association. Known registered breed associations are: American Angus 
Association, American Beefalo Association, Inc., The American Black 
Maine-Anjou Association, American Blonde d'Aquitaine Association, 
American Brahman Breeders Association, American Brahmental Association, 
American Breed Association, Inc., American Chianina Association, 
American Dexter Cattle Association, American Galloway Breeders 
Association, American Gelbvieh Association, American Guernsey Cattle 
Club, American Hereford Association, American International Charolais 
Association, American (International Marchigiana Society, American 
Jersey Cattle Club, American Maine-Anjou Association, American Milking 
Shorthorn Society, American Murray Grey Association, American Normande 
Association, American Pinzgauer Association, American Polled Hereford 
Association, American Red Brangus Association, American Red Poll 
Association, American Salers Association, American Scotch Highland 
Breeders Association, American Shorthorn Association, American Simmental 
Association, Inc., American Tarentaise Association, Ankina Breeders, 
Inc., Ayrshire Breeders Association, Barzona Breed Association of 
America, Beefmaster Breeders Universal, Belted Galloway Society, 
Brahmanstein Breeders Association, Brown Swiss Beef International, Inc., 
Brown Swiss Cattle Breeders Association of U.S.A., Char-Swiss Breeders 
Association, Devon Cattle Association, Inc., Dutch Belted Cattle 
Association of America, Inc., Foundation Beefmaster Association, 
Galloway Cattle Society of America, Inc., Galloway Performance 
International, Holstein-Friesian Association of America, International 
Braford Association, International Brangus Breeders Association, Inc., 
International Maine-Anjou Association, Marky Cattle Association, Mid 
America RX \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.

[[Page 161]]

    Registered cattle. Cattle for which individual records of ancestry 
are recorded and maintained by a breed association whose purpose is the 
improvement of the bovine species, and for which individual registration 
certificates are issued and recorded by such breed association.
    Registered swine. Any breeding swine for which a certificate of pure 
breeding has been issued by a purebred swine association.
    Sexually intact exposed female calf. A female bovine less than 6 
months of age that is nursed by a brucellosis reactor at the time such 
reactor is condemned, and that has not been altered to make it incapable 
of reproduction.
    Specifically approved stockyard. Premises approved by the 
Administrator, in accordance with 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 at www.govinfo.gov.



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

[[Page 162]]

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
    (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

[[Page 163]]

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 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]

    Editorial Note: For Federal Register citations affecting Sec.51.3, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfo.gov.



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

[[Page 164]]

seal numbers must be recorded on the accompanying permit.
    (4) Reactor and exposed cattle and bison in herds scheduled for herd 
depopulation may be moved interstate without eartagging or branding if 
they are identified by USDA approved backtags and either accompanied 
directly to slaughter by an APHIS or State representative or moved 
directly to slaughter in vehicles closed with official seals. Such 
official seals must be applied and removed by an APHIS representative, 
State representative, accredited veterinarian, or an individual 
authorized for this purpose by an APHIS representative.
    (c) Swine shall be individually identified by tagging with a metal 
tag bearing a serial number and inscription ``U.S. Reactor'' or a 
similar State reactor tag or other identification approved by the 
Administrator, upon request in specific cases, attached to the left ear 
of each animal.

(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

[[Page 165]]

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 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

[[Page 166]]

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 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]



            Subpart B_Indemnity for Sheep, Goats, and Horses

    Source: 69 FR 41912, July 13, 2004, unless otherwise noted.



Sec.51.20  Definitions.

    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

[[Page 167]]

functions required by cooperative State-Federal disease control and 
eradication programs.
    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Affected herd/flock. Any herd or flock in which any cattle, bison, 
breeding swine, sheep, or goat has been classified as a brucellosis 
reactor and which has not been released from quarantine.
    Animal. Sheep, goats, and horses.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    APHIS representative. An individual employed by APHIS who is 
authorized to perform the function involved.
    Appraisal. An estimate of the fair market value of an animal to be 
destroyed because of brucellosis.
    Brucellosis exposed. Except for brucellosis reactors, animals that 
are part of a herd known to be affected, or are in a quarantined feedlot 
or a quarantined pasture, or are brucellosis suspects, or that have been 
in contact with a brucellosis reactor for a period of 24 hours or more, 
or for a period of less than 24 hours if the brucellosis reactor has 
aborted, calved, or farrowed within the past 30 days or has a vaginal or 
uterine discharge.
    Brucellosis reactor animal. (1) Any sheep or goat that has been 
determined by a designated brucellosis epidemiologist \1\ to be affected 
with brucellosis, based on test results, herd/flock history, and/or 
culture results. Any test used for cattle and bison under the APHIS 
official brucellosis eradication program (see part 78 of this chapter) 
may be used, but test results must be interpreted by a designated 
brucellosis epidemiologist.
---------------------------------------------------------------------------

    \1\ Requirements for designated brucellosis epidemiologists are 
contained in Veterinary Services Memorandum No. 551.10. A copy of this 
memorandum may be obtained from an APHIS representative, the State 
animal health official, or a State representative.
---------------------------------------------------------------------------

    (2) Any horse that has been determined by a designated brucellosis 
epidemiologist to be affected with brucellosis, based on epidemiological 
information or culture results, or positive results for brucellosis in 
accordance with one of the following tests:

------------------------------------------------------------------------
                   Test                           Positive results
------------------------------------------------------------------------
Standard plate test (SPT).................  If antibody titer positive
                                             at 1:100 dilution or
                                             higher.
Standard tube test (STT)..................  If antibody titer positive
                                             at 1:100 dilution or
                                             higher.
Rivanol test..............................  If antibody titer positive
                                             at 1:50 dilution or higher.
Particle concentration fluorescence         If reading is 0.3 or lower.
 immunoassay (PCFIA).
Complement fixation test (CF).............  If reading is 2 + :20
                                             dilution.
------------------------------------------------------------------------

    (3) Any cattle, bison, or swine classified as a brucellosis reactor 
as provided in the definition of official test in Sec.78.1 of this 
chapter.
    Condemn. The determination made by an APHIS representative, State 
representative, or accredited veterinarian that animals for which 
indemnity is sought under this subpart will be destroyed.
    Designated brucellosis epidemiologist. An epidemiologist selected by 
the State animal health official and the Veterinarian in Charge to 
perform the functions required. The regional epidemiologist and the 
APHIS brucellosis staff must concur in the selection and appointment of 
the designated epidemiologist.
    Destroyed. Condemned under State authority and slaughtered or 
otherwise dies.
    Flock. Any group of sheep maintained on common ground for any 
purpose, or two or more groups of sheep under common ownership or 
supervision, geographically separated but which have an interchange or 
movement of animals without regard to health status.
    Herd. Any group of goats, or mixed sheep and goats, maintained on 
common ground for any purpose, or two or more groups of goats, or two or 
more groups of mixed sheep and goats, under common ownership or 
supervision, geographically separated but which have an interchange or 
movement of animals without regard to health status.
    Herd/flock depopulation. Removal by slaughter or other means of 
destruction of all sheep or goats in a flock or herd, or from a specific 
premises or under common ownership prior to restocking such premises 
with new animals.

[[Page 168]]

    Mortgage. Any mortgage, lien, or interest that is recorded under 
State law or identified in the indemnity claim form filed in accordance 
with this subpart, and held by any person other than the one claiming 
indemnity.
    Official seal. A serially numbered metal strip consisting of a self-
locking device on one end and a slot on the other end, which forms a 
loop when the ends are engaged and which cannot be reused if opened, and 
is applied by a representative of the Veterinarian in Charge or the 
State animal health official.
    Owner. Any person who has legal or rightful title to sheep, goats, 
and horses, whether or not the animals are subject to a mortgage.
    Permit. An official document for movement of animals under this 
subpart issued by an APHIS representative, State representative, or 
accredited veterinarian listing the disease status and identification of 
the animal, where consigned, cleaning and disinfecting requirements, and 
proof of slaughter certification.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, or joint stock company, or other legal entity.
    Registered sheep and goats. Sheep and goats for which individual 
records of ancestry are recorded and maintained by a breed association 
whose purpose is the improvement of the species, and for which 
individual registration certificates are issued and recorded by such 
breed association.
    State. Any State, the District of Columbia, Puerto Rico, the Virgin 
Islands of the United States, Guam, the Northern Mariana Islands, or any 
other territory or possession of the United States.
    State representative. An individual employed in animal health 
activities by a State or a political subdivision thereof, and who is 
authorized by such State or political subdivision to perform the 
function involved under a cooperative agreement with the United States 
Department of Agriculture.
    Veterinarian in Charge. The APHIS veterinary official who is 
assigned by the Administrator to supervise and perform the official 
animal health work of APHIS in the State or area concerned, or any 
person authorized to act for the Veterinarian in Charge.



Sec.51.21  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.



Sec.51.22  Payment to owners for goats, sheep, and horses destroyed.

    (a) The Administrator may authorize the payment of Federal indemnity 
by the U.S. Department of Agriculture to any owner whose goats, sheep, 
or horses are destroyed after having been approved for destruction by 
APHIS. \1\ Goats or sheep must be destroyed as part of a whole herd/
flock depopulation to be eligible for Federal indemnity.
---------------------------------------------------------------------------

    \1\ The Administrator will authorize payment of Federal indemnity by 
the U.S. Department of Agriculture as provided in Sec.51.24: (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.
---------------------------------------------------------------------------

    (b) The amount of Federal indemnity will be determined in accordance 
with the regulations in this part that were in effect on the date 
infected animals were found, or the date that the whole-herd/flock 
depopulation or destruction of individual animals was approved.
    (c) Prior to payment of indemnity, proof of destruction must be 
furnished to the Veterinarian in Charge.



Sec.51.23  Eligibility for indemnity.

    Owners of animals destroyed because of brucellosis are eligible to 
receive Federal indemnity for their animals if the animals are:
    (a) Sheep and goats in an affected herd or flock;
    (b) Sheep and goats that were obtained from a herd or flock that was 
subsequently found to be an affected herd or flock. Epidemiological 
information such as test results, herd/flock history, and related 
evidence will be used to establish a probable date when the herd or 
flock was first affected with

[[Page 169]]

brucellosis. Animals removed from the herd or flock after that date will 
be considered exposed to the disease and eligible for indemnity; those 
removed before that date will not;
    (c) Individual horses that have been found to be brucellosis reactor 
animals.



Sec.51.24  Maximum per-head indemnity amounts.

    Owners of the types of animals listed in Sec.51.22 of this subpart 
are eligible to receive Federal indemnity for their animals. All animals 
must be individually appraised to determine their fair market value. The 
indemnity amount will be the appraised value minus the salvage value of 
the animal, up to a maximum of $20,000 per animal in the case of horses. 
An independent appraiser selected by the Administrator will conduct 
appraisals. APHIS will pay the cost of appraisals.



Sec.51.25  Proof of destruction.

    The Veterinarian in Charge will accept any of the following 
documents as proof of destruction:
    (a) A postmortem report;
    (b) A meat inspection certification of slaughter;
    (c) A written statement by a State representative, APHIS 
representative, or accredited veterinarian attesting to the destruction 
of the animals;
    (d) A written, sworn statement by the owner or caretaker of the 
animal attesting to the destruction of the animals;
    (e) A permit (VS Form 1-27) consigning the animal from a farm or 
livestock market directly to a slaughter establishment; or
    (f) In unique situations where none of the documents listed above 
are available, other similarly reliable forms of proof of destruction.

(Approved by the Office of Management and Budget under control number 
0579-0185)



Sec.51.26  Record of tests.

    An APHIS representative, State representative, or accredited 
veterinarian will compile, on an APHIS-approved form, a complete test 
record for each animal. The claimant must provide any information 
necessary to complete the form. The test record must include the type of 
test and the test results for each animal. It must also include the 
individual identification of each tested animal. Any unique, 
individually numbered identification is acceptable. The animal's owner 
and the appropriate State veterinarian's office will each receive a copy 
of the test record.

(Approved by the Office of Management and Budget under control number 
0579-0185)



Sec.51.27  Identification of goats, sheep, and horses to be destroyed.

    The claimant must ensure that any goats, sheep, and horses for which 
indemnity is claimed are marked with unique, individually numbered 
identification showing they are to be destroyed. This must be done 
within 15 days after the animals are condemned. The Veterinarian in 
Charge may extend the time limit to 30 days when the Veterinarian in 
Charge receives a request for extension prior to the expiration date of 
the original 15-day period, and when the Veterinarian in Charge 
determines that the extension will not adversely affect the brucellosis 
eradication program. However, the Administrator may extend the time 
limit beyond 30 days when unusual or unforeseen circumstances occur that 
prevent or hinder the identification of the animal within 30 days, such 
as, but not limited to, floods, storms, or other Acts of God, which are 
beyond the control of the owner, or when identification is delayed due 
to requirements of another Federal agency.

(Approved by the Office of Management and Budget under control number 
0579-0185)



Sec.51.28  Moving goats, sheep, and horses to be destroyed.

    Goats, sheep, and horses to be destroyed because of brucellosis must 
be accompanied by a permit and either:
    (a) Accompanied directly to slaughter by an APHIS or State 
representative; or
    (b) Moved in vehicles closed with official seals applied and removed 
by an APHIS representative, State representative, accredited 
veterinarian, or an individual authorized for this purpose by an APHIS 
representative. The official

[[Page 170]]

seal numbers must be recorded on the accompanying permit.

(Approved by the Office of Management and Budget under control number 
0579-0185)



Sec.51.29  Destruction of animals; time limit.

    (a) The claimant must ensure that goats, sheep, and horses infected 
with or exposed to B. abortus are either:
    (1) Sold under permit to a recognized slaughtering establishment;
    (2) Moved to an approved stockyard for sale to a recognized 
slaughtering establishment; or
    (3) Destroyed and buried, incinerated, or rendered in accordance 
with applicable State law.
    (b) The claimant must ensure that goats and sheep destroyed because 
of B. melitensis are destroyed and buried, incinerated, or rendered in 
accordance with applicable State law.
    (c) Indemnity will be paid under this part only if the animals are 
destroyed within 15 days after the date they are marked with 
identification showing they are to be destroyed. However, the 
Veterinarian in Charge may extend the time limit to 30 days if:
    (1) The animals' owner asks the Veterinarian in Charge for an 
extension before the initial 15-day period expires, or the animals were 
sold for slaughter before the original 15-day period expires; and
    (2) The Veterinarian in Charge determines that extending the time 
limit will not adversely affect the Brucellosis Eradication Program.
    (d) The Administrator may extend the time limit beyond 30 days when 
unusual and unforeseen circumstances occur that prevent or hinder the 
destruction of the animals within 30 days, such as, but not limited to, 
floods, storms, or other Acts of God, which are beyond the control of 
the owner, or when destruction is delayed due to requirements of another 
Federal agency.

(Approved by the Office of Management and Budget under control number 
0579-0185)



Sec.51.30  Claims for indemnity.

    (a) Claims for indemnity for goats, sheep, and horses destroyed 
because of brucellosis must be made using an indemnity claim form 
furnished by APHIS. On the form, the owner of the animals must certify 
whether the animals are subject to a mortgage. If the owner states there 
is a mortgage, the claim form must be signed by the owner and by each 
mortgage holder, consenting to the payment of any indemnity allowed to 
the owner. Payment will be made only if the claimant has submitted a 
complete indemnity claim form to the Veterinarian in Charge and the 
claim has been approved by the Veterinarian in Charge or by an APHIS 
representative designated by him or her. The Veterinarian in Charge or 
an APHIS representative designated by the Veterinarian in Charge will 
record on the APHIS indemnity claim form the amount of Federal and State 
indemnity payments that appear to be due to the owner of the animals. 
The owner of the animals will receive a copy of the completed APHIS 
indemnity claim form. The owner is responsible for paying all fees for 
holding the animals on the farm pending disposal and for all trucking 
fees.
    (b) Claims for indemnity for registered sheep and registered goats 
must be accompanied by the animal's registration papers, issued in the 
name of the owner. If the registration papers are unavailable or if the 
animal is less than 1 year old and not registered at the time the claim 
for indemnity is submitted, the Veterinarian in Charge may grant a 60-
day extension or the Administrator may grant an extension longer than 60 
days for the presentation of registration papers. Any animal that is not 
registered but is eligible for registration at the time the claim is 
submitted will be considered unregistered unless the animal has been in 
the flock for less than 12 months.

(Approved by the Office of Management and Budget under control number 
0579-0185)



Sec.51.31  Disinfecting premises, conveyances, and materials.

    All premises, including all structures, holding facilities, 
conveyances, and materials contaminated because they have been used by 
animals destroyed because of brucellosis, must be properly cleaned and 
disinfected in accordance with recommendations of the

[[Page 171]]

APHIS or State representative. Cleaning and disinfecting must be 
completed within 15 days from the date the animals were removed from the 
premises, except that the Veterinarian in Charge may extend the time 
limit for disinfection to 30 days when he or she receives a request 
prior the expiration date of the original 15 days, and when the 
Veterinarian in Charge determines that an extension will not adversely 
affect the Brucellosis Eradication Program. The Administrator may extend 
the time limit beyond 30 days when unusual and unforeseen circumstances 
occur that prevent or hinder disinfection of the premises, conveyances, 
and materials within 30 days, such as, but not limited to floods, 
storms, or other Acts of God, which are beyond the control of the owner. 
A premises may be exempted from such cleaning and disinfecting 
requirements if the APHIS or State representative recommends it in 
writing and the Veterinarian in Charge approves.

(Approved by the Office of Management and Budget under control number 
0579-0185)



Sec.51.32  Claims not allowed.

    Claims for indemnity for goats, sheep, and horses destroyed because 
of brucellosis will not be allowed if any of the following circumstances 
exist:
    (a) The claimant has failed to comply with any of the requirements 
of this part;
    (b) The claim is based on a brucellosis test, and the person who 
administered the test was not properly trained, authorized, or certified 
at the time of the test;
    (c) Testing of goats, sheep, and horses in the herd or flock for 
brucellosis was not done under APHIS or State supervision, or by an 
accredited veterinarian;
    (d) There is substantial evidence that the claim is an unlawful or 
improper attempt to obtain indemnity; or
    (e) If, at the time of test or condemnation, the animals belonged to 
or were upon the premises of any person to whom they had been sold for 
slaughter, shipped for slaughter, or delivered for slaughter.



Sec.51.33  Multiple indemnity payments.

    APHIS has indemnity programs for several other livestock diseases. 
However, if a claim is paid for indemnity for animals destroyed because 
of brucellosis, no other claims for indemnity will be paid for the same 
animals.



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 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

[[Page 172]]

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 
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

[[Page 173]]

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 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]

[[Page 174]]



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 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

[[Page 175]]

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, 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, eggs, or materials.
53.4 Destruction of animals or eggs.
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, eggs, or materials.
53.10 Claims not allowed.
53.11 Highly 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, contagious pleuropneumonia, 
Newcastle disease, highly pathogenic avian influenza, infectious salmon 
anemia, spring viremia of carp, or any other communicable disease of 
livestock or poultry that in the opinion of the Secretary constitutes an 
emergency and threatens the livestock or poultry of the United States.
    Highly pathogenic avian influenza. (1) Any influenza virus that 
kills at least 75 percent of eight 4- to 6-week-old susceptible chickens 
within 10 days following intravenous inoculation with 0.2 ml of a 1:10 
dilution of a bacteria-free, infectious allantoic fluid;
    (2) Any H5 or H7 virus that does not meet the criteria in paragraph 
(1) of this definition, but has an amino acid sequence at the 
hemagglutinin cleavage site that is compatible with highly pathogenic 
avian influenza viruses; or
    (3) Any influenza virus that is not an H5 or H7 subtype and that 
kills one to five chickens and grows in cell culture in the absence of 
trypsin.
    Inspector in charge. An APHIS employee who is designated by the 
Administrator to take charge of work in connection with the control and 
eradication of disease.
    ISA Program veterinarian. The APHIS veterinarian assigned to manage 
the infectious salmon anemia program for APHIS in the State of Maine and 
who reports to the Area Veterinarian in Charge.
    Materials. Parts of barns or other structures, straw, hay, and other 
feed for animals, farm products or equipment, clothing, and articles 
stored in or adjacent to barns or other structures.
    Mortgage. Any mortgage, lien, or other security or beneficial 
interest held by any person other than the one claiming indemnity.

[[Page 176]]

    Newcastle disease. Newcastle disease is an acute, rapidly spreading, 
and usually fatal viral infection of poultry caused by an avian 
paramyxovirus serotype 1 that meets one of the following criteria for 
virulence: The virus has an intracerebral pathogenicity index (ICPI) in 
day-old chicks (Gallus gallus) of 0.7 or greater; or multiple basic 
amino acids have been demonstrated in the virus (either directly or by 
deduction) at the C-terminus of the F2 protein and phenylalanine at 
residue 117, which is the N-terminus of the F1 protein. The term 
``multiple basic amino acids'' refers to at least three arginine or 
lysine residues between residues 113 and 116. In this definition, amino 
acid residues are numbered from the N-terminus of the amino acid 
sequence deduced from the nucleotide sequence of the F0 gene; 113-116 
corresponds to residues -4 to -1 from the cleavage site. Failure to 
demonstrate the characteristic pattern of amino acid residues as 
described above may require characterization of the isolated virus by an 
ICPI test. A failure to detect a cleavage site that is consistent with 
virulent strains does not confirm the absence of a virulent virus.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, joint stock company, or other legal entity.
    Pet bird. Any bird that is kept for personal pleasure and is not for 
sale.
    Poultry. Chickens, ducks, geese, swans, turkeys, pigeons, doves, 
pheasants, grouse, partridges, quail, guinea fowl, and pea fowl.
    Poultry biosecurity plan. A document utilized by an owner and/or 
contractor describing the management practices and principles that are 
used to prevent the introduction and spread of infectious diseases of 
poultry at a specific facility.
    Secretary. The Secretary of Agriculture of the United States, or any 
officer or employee of the Department to whom authority has been or may 
be delegated to act in the Secretary's stead.
    State. Each of the States of the United States, the District of 
Columbia, Puerto Rico, the Northern Mariana Islands, Guam, the Virgin 
Islands of the United States, or any other territory or possession of 
the United States.

[61 FR 56882, Nov. 5, 1996, as amended at 67 FR 17610, Apr. 11, 2002; 69 
FR 27827, May 17, 2004; 74 FR 18287, Apr. 22, 2009; 78 FR 19082, Mar. 
29, 2013; 83 FR 15492, Apr. 11, 2018; 83 FR 40438, Aug. 15, 2018]



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 to pay 50 
percent (and in the case of Newcastle disease or highly pathogenic avian 
influenza, up to 100 percent, and in the case of infectious salmon 
anemia, up to 60 percent) of the expenses of purchase, destruction and 
disposition of animals, eggs, and materials required to be destroyed 
because of being contaminated by or exposed to such disease: Provided, 
however, that if the animals or eggs were exposed to such disease prior 
to or during interstate movement and the owners or parties contracting 
with the owners to raise or care for the animals or eggs are not 
eligible to receive indemnity from any State, the Department may pay up 
to 100 percent of the purchase, destruction, and disposition of animals, 
eggs, and materials required to be destroyed; Provided further, that the 
cooperative program for the purchase, destruction, and disposition of 
birds shall be limited to birds which are identified in documentation 
pursuant to Agreements between the Department and the particular State 
involved relating to cooperative animal (including poultry) disease 
prevention, control, and eradication, as constituting a threat to the 
poultry industry of the United States;

[[Page 177]]

And provided further, that the Secretary may authorize other 
arrangements for the payment of such expenses upon finding that an 
extraordinary emergency exists.

[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; 78 FR 19082, Mar. 29, 2013; 81 FR 
6750, Feb. 9, 2016]



Sec.53.3  Appraisal of animals, eggs, or materials.

    (a) Animals or eggs affected by or exposed to disease, and materials 
required to be destroyed because of being contaminated by or exposed to 
disease shall be appraised by an APHIS employee and a representative of 
the State jointly, or, if the State authorities approve, by an APHIS 
employee alone.
    (b) The appraisal of animals shall be based on the fair market value 
and shall be determined by the meat, egg production, dairy or breeding 
value of such animals. Animals may be appraised in groups providing they 
are the same species and type and providing that where appraisal is by 
the head each animal in the group is the same value per head or where 
appraisal is by the pound each animal in the group is the same value per 
pound.
    (c) Appraisals of animals shall be reported on forms furnished by 
APHIS. Reports of appraisals shall show the number of animals of each 
species and the value per head or the weight and value by pound.
    (d) Appraisals of materials shall be reported on forms furnished by 
APHIS. Reports of appraisals of materials shall, when practicable, show 
the number, size or quantity, unit price, and total value of each kind 
of material appraised.
    (e) Indemnity for eggs required to be destroyed due to an outbreak 
of highly pathogenic avian influenza will be based on the fair market 
value of the eggs, as determined by an appraisal. Appraisals of eggs 
shall be reported on forms furnished by APHIS. The amount of indemnity 
paid, together with the amount for net salvage the owner or contractor 
received, if any, shall not exceed the appraised fair market value of 
the eggs.

[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; 81 FR 6750, Feb. 9, 2016]



Sec.53.4  Destruction of animals or eggs.

    (a) Except as provided in paragraph (b) of this section, animals 
infected with or exposed to disease shall be killed promptly after 
appraisal and disposed of by burial or burning, unless otherwise 
specifically provided by the Administrator, at his or her discretion. In 
the case of animals depopulated due to spring viremia of carp or 
infectious salmon anemia, salvageable fish may be sold for rendering, 
processing, or any other purpose approved by the Administrator. The 
proceeds gained from the sale of the fish will be subtracted from any 
payment from APHIS for which the producer or owner is eligible under 
Sec.53.2(b) or Sec.53.11.
    (b) Eggs infected with, exposed to, or contaminated by highly 
pathogenic avian influenza shall be disposed of pursuant to the 
regulations in this part under the supervision of an APHIS employee who 
shall prepare and transmit to the Administrator a report identifying all 
eggs disposed thereof.
    (c) The killing of animals and the burial, burning, or other 
disposal of carcasses of animals pursuant to the regulations in this 
part shall be supervised by an APHIS employee who shall prepare and 
transmit to the Administrator a report identifying the animals and 
showing the disposition thereof.

[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; 69 FR 27827, May 17, 
2004; 71 FR 56323, Sept. 26, 2006; 81 FR 6750, Feb. 9, 2016]



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.

[[Page 178]]

    (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 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) Claims for the following must be presented to APHIS, through the 
inspector in charge, on a form approved by the Administrator:
    (1) Compensation for the value of animals;
    (2) The cost of burial, burning, or other disposition of animals;
    (3) The value of material destroyed; and
    (4) The expenses of destruction.
    (b) [Reserved]

(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; 71 
FR 56323, Sept. 26, 2006]



Sec.53.9  Mortgage against animals, eggs, or materials.

    When animals, eggs, or materials have been destroyed pursuant to the 
requirements contained in this part, any claim for indemnity shall be 
presented on forms furnished by APHIS on which the owner of the animals, 
eggs, or materials shall certify that the animals, eggs, or materials 
covered thereby, are, or are not, subject to any mortgage as defined in 
this part. If the owner states there is a mortgage, forms furnished by 
APHIS shall be signed by the owner and by each person holding a mortgage 
on the animals, eggs, or materials, consenting to the payment of any 
indemnity allowed to the person specified thereon.

[28 FR 5935, June 13, 1963, as amended at 56 FR 51974, Oct. 17, 1991; 81 
FR 6750, Feb. 9, 2016]



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, eggs, or materials unless they shall have been 
appraised as prescribed in this part and the owners thereof shall have 
executed a written agreement to the appraisals.
    (d) The Department will not allow claims arising out of the 
destruction of animals, eggs, or materials which have been moved or 
handled by the owner thereof or its officer, employee, or agent, acting 
within the scope of his or its office, employment or agency, in

[[Page 179]]

violation of a law or regulation administered by the Secretary for the 
prevention of the introduction into or the dissemination within the 
United States of any communicable disease of livestock or poultry for 
which the animal or material was destroyed, or in violation of a law or 
regulation for the enforcement of which the Secretary enters or has 
entered into a cooperative agreement for the control and eradication of 
such disease.
    (e) The Department will not allow claims arising out of the 
destruction of fish due to infectious salmon anemia (ISA) unless the 
claimants have agreed in writing to participate fully in the cooperative 
ISA control program administered by APHIS and the State of Maine. 
Participants in the ISA control program must:
    (1) Establish and maintain a veterinary client-patient relationship 
with an APHIS accredited veterinarian and inform the ISA Program 
Veterinarian in writing of the name of their accredited veterinarian at 
the time the participant enrolls in the ISA program and within 15 days 
of any change in accredited veterinarians.
    (2) Cooperate with and assist in periodic on-site disease 
surveillance, testing, and reporting activities for ISA, which will be 
conducted by their APHIS accredited veterinarian or a State or Federal 
official as directed by the ISA Program Veterinarian.
    (3) Develop and implement biosecurity protocols for use at all 
participant-leased finfish sites and participant-operated vessels 
engaged in aquaculture operations throughout Maine. A copy of these 
protocols shall be submitted to the ISA Program Veterinarian at the time 
the participant enrolls in the ISA program and within 15 days of any 
change in the protocols.
    (4) Develop, with the involvement of the participant's accredited 
veterinarian and the fish site health manager, a site-specific ISA 
action plan for the control and management of ISA. A copy of the action 
plan shall be submitted to APHIS for review at the time the participant 
enrolls in the ISA program and within 15 days of any change in the 
action plan.
    (5) Participate in the State of Maine's integrated pest management 
(IPM) program for the control of sea lice on salmonids. A copy of the 
management plan developed by the participant for the State IPM program 
shall be submitted to APHIS for review at the time the participant 
enrolls in the ISA program and within 15 days of any change in the 
management plan.
    (6) Submit to the ISA Program Veterinarian at the time the 
participant enrolls in the ISA program a complete and current fish 
inventory information for each participant-leased finfish site with site 
and cage identifiers. Fish inventory information must include the 
numbers, age, date of saltwater transfer, vaccination status, and 
previous therapeutant history for all fish in each participant-leased 
finfish site.
    (7) Maintain, and make available to the ISA Program Veterinarian 
upon request, mortality data for each participant-leased finfish site 
and pen in production.
    (8) Cooperate with and assist APHIS in the completion of biosecurity 
audits at all participant-leased finfish sites and participant-operated 
vessels involved in salmonid aquaculture.
    (f) The Department will not allow claims arising out of the 
destruction of fish due to spring viremia of carp (SVC) unless the 
claimants have done the following:
    (1) Depopulated all SVC-infected and SVC-exposed fish on their 
property under the supervision of USDA or State officials;
    (2) Thoroughly cleaned and disinfected all affected sites and all 
affected equipment under the supervision of USDA or State officials;
    (3) If an affected site is to be restocked after cleaning and 
disinfection, the claimant must have done the following:
    (i) Restocked with fish certified free of SVC by an APHIS-approved 
laboratory or in accordance with the diagnostic procedures described in 
the Office of International des Epizooties Manual of Diagnostic Tests 
For Aquatic Animals;
    (ii) Demonstrated that their water sources are from first-use spring 
water, spring water without fish, well water, ozone or ultraviolet 
treated surface water, or bore-hole water and are free

[[Page 180]]

of wild carp and any other SVC-susceptible species; and
    (iii) Prevented the migration of wild carp and any other wild SVC-
susceptible species into their farming establishment.

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

    (g)(1) Except as provided in paragraph (g)(2) of this section, the 
Department will not allow claims arising out of the destruction of 
animals or eggs destroyed due to an outbreak of highly pathogenic avian 
influenza unless the owner of the animals or eggs and, if applicable, 
any party that enters into a contract with the owner to grow or care for 
the poultry or eggs, had in place, at the time of detection of highly 
pathogenic avian influenza, and was following a poultry biosecurity plan 
that meets the requirements of Sec.53.11(e).
    (2) Owners and contractors are exempted from the requirements of 
paragraph (g)(1) of this section if the facilities where the animals or 
eggs are raised or cared for falls under one of the following 
categories:
    (i) Premises meeting the criteria of the National Poultry 
Improvement Plan regulations in Sec. Sec.146.22(b) or 146.52(c) of 
this chapter;
    (ii) Premises on which fewer than 100,000 broilers are raised 
annually; and
    (iii) Premises on which fewer than 30,000 meat turkeys are raised 
annually.

(Approved by the Office of Management and Budget under control number 
0579-0440)

[28 FR 5935, June 13, 1963, as amended at 45 FR 86411, Dec. 31, 1980; 56 
FR 51974; 67 FR 17611, Apr. 11, 2002; 69 FR 27827, May 17, 2004; 81 FR 
6750, Feb. 9, 2016; 83 FR 40438, Aug. 15, 2018]



Sec.53.11  Highly pathogenic avian influenza; conditions for payment.

    (a) When poultry or eggs have been destroyed pursuant to this part, 
the Administrator may pay claims to any party with whom the owner of the 
poultry or eggs has entered into a contract for the growing or care of 
the poultry or eggs. The indemnity the Administrator may pay to such a 
party or parties shall be determined as by the following method:
    (1) Divide the value in dollars of the contract the owner entered 
into with the contractor by the duration in days of the contract as it 
was signed prior to the highly pathogenic avian influenza outbreak;
    (2) Multiply this figure by the time in days between the date the 
contractor began to provide services relating to the destroyed poultry 
or eggs under the contract and the date the poultry or eggs were 
destroyed due to highly pathogenic avian influenza.
    (b) If a contractor receiving indemnity under this section has 
received any payment under his or her contract from the owner of the 
poultry or eggs at the time the poultry or eggs are destroyed, the 
amount of indemnity for which the contractor is eligible will be reduced 
by the amount of the payment the contractor has already received.
    (c) If indemnity is paid to a contractor under this section, the 
owner of the poultry or eggs will be eligible to receive the difference 
between the indemnity paid to the contractors and the total amount of 
indemnity that may be paid for the poultry or eggs.
    (d) In the event that determination of indemnity due a contractor 
using the method described in paragraph (a) of this section is 
determined to be impractical or inappropriate, APHIS may use any other 
method that the Administrator deems appropriate to make that 
determination.
    (e)(1) The owner and, if applicable, the contractor, unless exempted 
under Sec.53.10(g)(2), must have a poultry biosecurity plan that is 
approved by the Administrator. Approved biosecurity principles are 
listed in the NPIP Program Standards, as defined in Sec.147.51 of this 
chapter. Alternative biosecurity principles may also be approved by the 
Administrator in accordance with Sec.147.53(d)(2) of this chapter.
    (2)(i) The biosecurity plan shall be audited at least once every 2 
years or a sufficient number of times during that period to satisfy the 
owner and/or contractor's Official State Agency that the plan is in 
compliance with the biosecurity principles contained in the NPIP Program 
Standards. The audit will include, but may not be limited to, a review 
of the biosecurity plan, as

[[Page 181]]

well as documentation that it is being implemented.
    (ii) To be recognized as being in compliance with the biosecurity 
principles and eligible for indemnity, owners and contractors who fail 
the initial audit conducted by the NPIP Official State Agency must have 
a check audit performed by a team appointed by National NPIP Office and 
must demonstrate that they have implemented applicable biosecurity 
measures. The team will consist of an APHIS poultry subject matter 
expert, the Official State Agency, and a licensed, accredited, industry 
poultry veterinarian.
    (f) Proposed updates to the NPIP Program Standards will be announced 
to the public through a Federal Register notice, as described in Sec.
147.53(e) of this chapter.

(Approved by the Office of Management and Budget under control number 
0579-0440)

[81 FR 6750, Feb. 9, 2016, as amended at 83 FR 40438, Aug. 15, 2018]



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 flocks under investigation and flocks subject to 
          flock plans and post-exposure management and monitoring plans.
54.9 Waiver of requirements for scrapie control pilot projects.
54.10 Program approval of tests for scrapie.
54.11 Approval of laboratories to run official scrapie tests and 
          official genotype tests.

           Subpart B_Scrapie Free 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.
    Area veterinarian in charge. The veterinary official of APHIS who is 
assigned by the Administrator to supervise and perform the official 
animal health work of APHIS in the State concerned.
    Breed association and registries. Organizations that maintain the 
permanent records of ancestry or pedigrees of animals (including the 
animal's sire and dam), individual identification of animals, and 
ownership of animals.
    Classification or reclassification investigation. An epidemiological 
investigation conducted or directed by a DSE for the purpose of 
designating or redesignating the status (e.g., scrapie-positive, 
exposed, high-risk, suspect, infected, noncompliant, source, etc.) of a 
flock or animal. In conducting such an investigation, the DSE will 
evaluate the available records for flocks and individual animals and 
conduct or direct any testing needed to assess the status of a flock or 
animal. The status of an animal or flock will be determined based on the 
applicable definitions in this section and, when needed to make

[[Page 182]]

a designation under Sec.79.4 of this chapter, official genotype test 
results, exposure risk, scrapie type involved, results of official 
scrapie testing on live or dead animals, or any combination of these.
    Commingle, commingled, commingling. Animals grouped together and 
having physical contact with each other, including contact through a 
fence, but not limited contacts. Commingling also includes sharing the 
same section in a transportation unit where there is physical contact.
    Designated scrapie epidemiologist DSE. An epidemiologist who has 
demonstrated the knowledge and ability to perform the functions required 
and who has been selected by the State animal health official and the 
area veterinarian in charge. The regional epidemiologist and the APHIS 
National Scrapie Program Coordinator must concur in the selection and 
appointment of the designated scrapie epidemiologist. The designated 
scrapie epidemiologist must satisfactorily complete training designated 
by APHIS.
    Destroyed. Euthanized and the carcass disposed of by means 
authorized by the Administrator that will prevent its use as feed or 
food.
    Electronic implant. Any radio frequency identification implant 
device approved for use in the scrapie program by the Administrator. The 
Administrator will approve an electronic implant after determining that 
it is tamper resistant, not harmful to the animal, and readable by 
equipment available to APHIS and State representatives.
    Exposed animal. Any animal or embryo that:
    (1) Has been in a flock with a scrapie-positive female animal;
    (2) Has been in an enclosure with a scrapie-positive female animal 
at any location;
    (3) Resides in a noncompliant flock; or
    (4) Has resided on the premises of a flock before or while it was 
designated by a DSE an infected or source flock and before a flock plan 
was completed. An animal shall not be designated an exposed animal if it 
only resided on the premises before the date that infection was most 
likely introduced to the premises as determined by a Federal or State 
representative. If the probable date of infection cannot be determined 
based on the epidemiologic investigation, a date 2 years before the 
birth of the oldest scrapie-positive animal born in that flock will be 
used. If the actual birth date is unknown, the date of birth will be 
estimated based on examination of the teeth and any available records. 
If an age estimate cannot be made, the animal will be assumed to have 
been 48 months of age on the date samples were collected for scrapie 
diagnosis. Exposed animals will be further designated as genetically 
resistant exposed sheep, genetically less susceptible exposed sheep, 
genetically susceptible exposed animals, or low-risk exposed animals. An 
animal will no longer be an exposed animal if it is redesignated in 
accordance with Sec.79.4 of this chapter.
    Exposed flock. (1) Any flock that was designated by a DSE as an 
infected or source flock that has completed a flock plan, and that 
retained a female genetically susceptible exposed animal;
    (2) Any flock under investigation that retains a female genetically 
susceptible exposed animal or a suspect animal, or whose owner declines 
to complete genotyping and live-animal and/or post-mortem scrapie 
testing required by the APHIS or State representative investigating the 
flock; or
    (3) Any noncompliant flock or any flock for which a PEMMP is 
required that is not in compliance with the conditions of the PEMMP.
    Flock. All animals that are maintained on a single premises and all 
animals under common ownership or supervision on two or more premises 
with animal interchange between the premises. Changes in ownership of 
part or all of a flock do not change the identity of the flock or the 
regulatory requirements applicable to the flock. Animals maintained 
temporarily on a premises for activities such as shows and sales or 
while in marketing channels are not a flock. More than one flock may be 
maintained on a single premises if:
    (1) The flocks are enrolled as separate flocks in the SFCP; or

[[Page 183]]

    (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 Free Flock Certification Program standards and the Scrapie 
Eradication Uniform Methods and Rules.
    Flock of origin. The flock in which an animal most recently resided 
in which it either was born, gave birth, or was used for breeding 
purposes. The determination of an animal's flock of origin may be based 
either on the physical presence of the animal in the flock, the presence 
of official identification on the animal traceable to the flock, the 
presence of other identification on the animal that is listed on the 
bill of sale, or other evidence, such as registry records.
    Flock plan. A written flock management agreement signed by the owner 
of a flock, the accredited veterinarian, if one is employed by the 
owner, and a State or APHIS representative in which each participant 
agrees to undertake actions specified in the flock plan to control the 
spread of scrapie from, and eradicate scrapie in, an infected flock or 
source flock or to reduce the risk of the occurrence of scrapie in a 
flock that contains a high-risk or an exposed animal. As part of a flock 
plan, the flock owner must provide the facilities and personnel needed 
to carry out the requirements of the flock plan. The flock plan must 
include the requirements in Sec.54.8(a) through (j).
    Flock sire. A sexually intact male animal that has produced 
offspring in the preceding 12 months or that was used for breeding 
during the current breeding cycle.
    Flock under investigation. Any flock in which an APHIS or State 
representative has determined that a scrapie-suspect animal, high-risk 
animal, or scrapie-positive animal resides or may have resided.
    Genetically less susceptible exposed sheep. Any sheep or sheep 
embryo that is:
    (1) An exposed sheep or sheep embryo of genotype AA QR, unless the 
Administrator determines that it is epidemiologically linked to a 
scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR 
sheep are not less susceptible; or
    (2) An exposed sheep or sheep embryo of genotype AV QR, unless the 
Administrator determines that it is epidemiologically linked to a 
scrapie-positive RR or QR sheep, to a flock that the Administrator has 
determined may be affected by valine-associated scrapie (based on an 
evaluation of the genotypes of the scrapie-positive animals linked to 
the flock), or to another scrapie type to which AV QR sheep are not less 
susceptible; or
    (3) An exposed sheep or sheep embryo of a genotype that has been 
exposed to a scrapie type to which the Administrator has determined that 
genotype is less susceptible. In this definition R refers to codon 171 
and A refers to codon 136, and Q represents any genotype other than R at 
codon 171 and V represents any genotype other than A at codon 136.
    Genetically resistant exposed sheep. Any exposed sheep or sheep 
embryo of genotype RR at codon 171 unless the Administrator determines 
that it is epidemiologically linked to a scrapie-positive RR sheep or to 
a scrapie type to which RR sheep are not resistant.
    Genetically resistant sheep. Any sheep or sheep embryo of genotype 
RR at codon 171 unless the Administrator determines that it is 
epidemiologically linked to a scrapie-positive RR sheep or to a scrapie 
type that affects RR at codon 171 sheep.
    Genetically susceptible animal. Any goat or goat embryo, sheep or 
sheep

[[Page 184]]

embryo of a genotype other than RR or QR, where Q represents any 
genotype other than R at codon 171 or sheep or sheep embryo of 
undetermined genotype.
    Genetically susceptible exposed animal. Excluding low-risk exposed 
animals, any exposed animal or embryo that is also:
    (1) A genetically susceptible animal; or
    (2) A sheep or sheep embryo of genotype AV QR that the Administrator 
determines is epidemiologically linked to a scrapie-positive RR or QR 
sheep, to a flock that the Administrator has determined may be affected 
by valine-associated scrapie (based on an evaluation of the genotypes of 
the scrapie-positive animals linked to the flock), or to a scrapie type 
to which AV QR sheep are susceptible; or
    (3) A sheep or sheep embryo of genotype AA QR that the Administrator 
determines is epidemiologically linked to a scrapie-positive RR or AA QR 
sheep or to a scrapie type to which AA QR sheep are susceptible; or
    (4) A sheep or sheep embryo of genotype RR that the Administrator 
determines is epidemiologically linked to a scrapie-positive RR sheep or 
to a scrapie type to which RR sheep are susceptible.
    (5) Note: In this definition R refers to codon 171 and A refers to 
codon 136, and Q represents any genotype other than R at codon 171 and V 
represents any genotype other than A at codon 136.
    High-risk animal. The female offspring or embryo of a scrapie-
positive female animal, or any suspect animal, or a female genetically 
susceptible exposed animal, or any exposed animal that the Administrator 
determines to be a potential risk. The Administrator may base the 
determination that an exposed animal poses a potential risk on the 
scrapie type, the epidemiology of the flock or flocks with which it is 
epidemiologically linked, including genetics of the positive sheep, the 
prevalence of scrapie in the flock, any history of recurrent infection, 
and other flock or animal characteristics. An animal will no longer be a 
high-risk animal if it is redesignated in accordance with Sec.79.4 of 
this chapter.
    Infected flock. The flock of origin of a female animal that a State 
or APHIS representative has determined to be a scrapie-positive animal; 
or any flock in which a State or APHIS representative has determined 
that a scrapie-positive female animal has resided unless an 
epidemiologic investigation conducted by a State or APHIS representative 
shows that the animal did not lamb or abort in the flock. A flock will 
no longer be considered an infected flock after it has completed the 
requirements of a flock plan.
    Interstate certificate of veterinary inspection (ICVI). An official 
document issued by a Federal, State, Tribal, or accredited veterinarian 
certifying the inspection of animals in preparation for interstate 
movement or other uses as described in this part and in accordance with 
Sec.79.5 of this chapter.
    Limited contacts. Incidental contacts between animals from different 
flocks off the flock's premises such as at fairs, shows, exhibitions and 
sales; between ewes being inseminated, flushed, or implanted; or between 
rams at ram test or collection stations. Embryo transfer and artificial 
insemination equipment and surgical tools must be sterilized between 
animals for these contacts to be considered limited contacts. Limited 
contacts do not include any contact, incidental or otherwise, with 
animals in the same flock or with a female animal during or up to 30 
days after she lambed, kidded or aborted or when there is any visible 
vaginal discharge. Limited contacts do not include any activity where 
uninhibited contact occurs, such as sharing an enclosure, sharing a 
section of a transport vehicle, or residing in other flocks for breeding 
or other purposes. Examples of limited contacts may be found in the 
Scrapie Free Flock Certification Program standards.
    Live-animal screening test. Any test for the diagnosis of scrapie in 
a live animal that is approved by the Administrator as usually reliable 
but not definitive for diagnosing scrapie, and that is conducted in a 
laboratory approved by the Administrator. \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.

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

[[Page 185]]

    Low-risk exposed animal. Any exposed animal to which the 
Administrator has determined one or more of the following applies:
    (1) The positive animal that was the source of exposure was not born 
in the flock and did not lamb in the flock or in an enclosure where the 
exposed animal resided;
    (2) The Administrator and State representative concur that the 
animal is unlikely to be infected due to factors such as, but not 
limited to, where the animal resided or the time period the animal 
resided in the flock;
    (3) The exposed animal is male and was not born in an infected or 
source flock;
    (4) The exposed animal is a castrated male;
    (5) The exposed animal is an embryo of a genetically resistant 
exposed sheep or a genetically less susceptible exposed sheep unless 
placed in a recipient that was a genetically susceptible exposed animal; 
or
    (6) The animal was exposed to a scrapie type and/or is of a genotype 
that the Administrator has determined poses low risk of scrapie 
transmission.
    Mortgage. Any mortgage, lien, or other security or interest held by 
any person other than the one claiming indemnity.
    National Scrapie Database. A database designated by the 
Administrator in which APHIS and State animal health agencies 
cooperatively enter data concerning scrapie outbreaks, flocks and 
premises affected by scrapie, individual animal identification and 
premises identification data, and other data to support the Scrapie 
Eradication Program and the Scrapie Free Flock Certification Program.
    National Veterinary Services Laboratories (NVSL). The National 
Veterinary Services Laboratories, APHIS, U.S. Department of Agriculture, 
or an NVSL cooperating or contract laboratory.
    Noncompliant flock. (1) Any source, infected, or exposed flock or 
flock under investigation whose owner declines to enter into a flock 
plan or post-exposure management and monitoring plan agreement within 30 
days of being so designated, or whose owner is not in compliance with 
either agreement;
    (2) Any exposed flock or flock under investigation whose owner fails 
to make animals available for testing within 60 days of notification, or 
as mutually agreed, or whose owner fails to submit required postmortem 
samples;
    (3) Any flock whose owner has misrepresented, or who employs a 
person who has misrepresented, the scrapie status of an animal or any 
other information on a certificate, permit, owner/hauler statement, or 
other official document within the last 5 years; or
    (4) Any flock whose owner or manager has moved, or who employs a 
person who has moved, an animal in violation of this chapter within the 
last 5 years.
    Official genotype test. A test to determine the genotype of a live 
or dead animal conducted at either the National Veterinary Services 
Laboratories or at an approved laboratory. The test subject must be an 
animal that is officially identified and the test accurately recorded on 
an official form supplied or approved by APHIS, with the samples 
collected and shipped to the laboratory using a shipping method 
specified by the laboratory by:
    (1) An accredited veterinarian;
    (2) A State or APHIS representative; or
    (3) The animal's owner or owner's agent, using a tamper-resistant 
sampling kit approved by APHIS for this purpose.

[[Page 186]]

    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.
    Program approved test. A test for the diagnosis of scrapie approved 
by the Administrator for use in the scrapie eradication or certification 
program in accordance with Sec.54.10.
    Restricted animal sale or restricted livestock facility. A sale 
where any animals in slaughter channels are maintained separate from 
other animals not in slaughter channels unless they are from the same 
flock of origin and are sold in lots that consist entirely of animals 
sold for slaughter only, or a livestock facility at which all animals 
are in slaughter channels, and where the sale or facility manager 
maintains a copy of, or maintains a record of, the information from the 
owner/hauler statement for all animals entering and leaving the sale or 
facility. A restricted animal sale may be held at a livestock facility 
that is not restricted.
    Scrapie control pilot project. A pilot project authorized by the 
Administrator in writing, designed to test or improve program procedures 
or to facilitate research, in order to control and eradicate scrapie. In 
addition to APHIS, participants may include State animal health 
agencies, flock owners, and other parties as necessary.
    Scrapie Eradication Program. The cooperative State-Federal program 
administered by APHIS and Consistent States to control and eradicate 
scrapie.
    Scrapie Eradication Uniform Methods and Rules (UM&R). Cooperative 
procedures and standards adopted by APHIS and Consistent States for 
controlling and eradicating scrapie. The UM&R will be reviewed at least 
annually by representatives of the livestock industry and appropriate 
State and Federal agencies and the public and will be revised, and 
published as needed by APHIS.
    Scrapie Free Flock Certification Program (SFCP). The cooperative 
Federal-State-industry voluntary program for the control of scrapie 
conducted in accordance with this subpart.
    Scrapie Free Flock Certification Program standards. Cooperative 
procedures and standards adopted by APHIS and State scrapie 
certification boards for reducing the incidence and controlling the 
spread of scrapie through flock certification. \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/animal-health/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 ELISA, and/or 
western blotting on CNS and/or peripheral tissue samples from a live or 
a dead animal for which a given method has been approved by the 
Administrator for use on that tissue;

[[Page 187]]

    (3) Bioassay;
    (4) Scrapie associated fibrils (SAF) detected by electron 
microscopy; or
    (5) Any other method or combination of methods approved by the 
Administrator in accordance with 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.
---------------------------------------------------------------------------

    Slaughter channels. Animals in slaughter channels include any animal 
that is sold, transferred, or moved either directly to or through a 
restricted animal sale or restricted livestock facility to an official 
slaughter establishment that is under Food Safety and Inspection Service 
(FSIS) jurisdiction per the Federal Meat Inspection Act (FMIA) or under 
State inspection that FSIS has recognized as at least equal to Federal 
inspection or to a custom exempt slaughter establishment as defined by 
FSIS (9 CFR 303.1) for immediate slaughter or to an individual for 
immediate slaughter for personal use or to a terminal feedlot.
    Source flock. A flock in which a State or APHIS representative has 
determined that at least one animal was born that was diagnosed as a 
scrapie-positive animal at an age of 72 months or less. The 
determination that an animal was born in a flock will be based on such 
information as the presence of official identification on the animal 
traceable to the flock, the presence of other identification on the 
animal that is listed on the bill of sale, or other evidence, such as 
registry records, to show that a scrapie-positive animal was born in the 
flock, combined with the absence of records indicating that the animal 
was purchased from outside and added to the flock. If DNA from the 
animal was previously collected by an accredited veterinarian and stored 
at an approved genotyping laboratory, or if DNA collection and storage 
are required for breed registration and the breed registration has 
appropriate safeguards in place to ensure the integrity of the banking 
process, the owner may request verification of the animal's identity 
based on DNA comparison if adequate records and identification have been 
maintained by the owner and the repository to show that the archived DNA 
is that of the animal that has been traced to the flock. The owner will 
be responsible for all costs for the DNA comparison. A flock will no 
longer be a source flock after it has completed the requirements of a 
flock plan.
    State. Each of the 50 States, the District of Columbia, the Northern 
Mariana Islands, Puerto Rico, and all territories or possessions of the 
United States.
    State representative. An individual employed in animal health 
activities by a State or a political subdivision of a State and who is 
authorized by the State or political subdivision to perform the function 
involved.
    Suspect animal. An animal will be designated a suspect animal in 
accordance with Sec.79.4 of this chapter if it is:
    (1) A mature sheep or goat as evidenced by eruption of the first 
incisor that has been condemned by FSIS or a State inspection authority 
for central nervous system (CNS) signs, or that exhibits any of the 
following clinical signs of scrapie and has been determined to be 
suspicious for scrapie by an accredited veterinarian or a State or USDA 
representative, based on one or more of the following signs and the 
severity of the signs: Weakness of any kind including, but not limited 
to, stumbling, falling down, or having difficulty rising, not including 
those with visible traumatic injuries and no other

[[Page 188]]

signs of scrapie; behavioral abnormalities; significant weight loss 
despite retention of appetite or in an animal with adequate dentition; 
increased sensitivity to noise and sudden movement; tremors; star 
gazing; head pressing; bilateral gait abnormalities such as but not 
limited to incoordination, ataxia, high stepping gait of forelimbs, 
bunny-hop movement of rear legs, or swaying of back end, but not 
including abnormalities involving only one leg or one front and one back 
leg; repeated intense rubbing with bare areas or damaged wool in similar 
locations on both sides of the animal's body or, if on the head, both 
sides of the poll; abraded, rough, thickened, or hyperpigmented areas of 
skin in areas of wool/hair loss in similar locations on both sides of 
the animal's body or, if on the head, both sides of the poll; or other 
signs of CNS disease. An animal will no longer be a suspect animal if it 
is redesignated in accordance with Sec.79.4 of this chapter.
    (2) A sheep or goat that has tested positive for scrapie or for the 
proteinase resistant protein associated with scrapie on a live-animal 
screening test or any other test, unless the animal is designated a 
scrapie-positive animal.
    (3) A sheep or goat that has tested inconclusive or suggestive on an 
official test for scrapie.
    Tamper-resistant sampling kit. A device or method for collecting DNA 
samples from sheep or goats that is approved by the Administrator and 
that identifies both the sample and the animal at the time the sample is 
collected. These devices or methods must ensure that the sample, its 
corresponding label, and the official ID device or method applied to the 
animal meets the requirements of Sec.79.2(k) of this chapter and that 
the sample is from the same animal to which the official ID device or 
method was applied. The kit must include an APHIS-approved official form 
or another form, device, or method acceptable to APHIS for transmitting 
the information required to APHIS and the approved laboratory.
    Terminal feedlot. (1) A dry lot approved by a State or APHIS 
representative or an accredited veterinarian who is authorized by the 
Administrator to perform this function where animals in the terminal 
feedlot are separated from all other animals by at least 30 feet at all 
times or are separated by a solid wall through, over, or under which 
fluids cannot pass and contact cannot occur and must be cleaned of all 
organic material prior to being used to contain sheep or goats that are 
not in slaughter channels, where only castrated males are maintained 
with female animals and from which animals are moved only to another 
terminal feedlot or directly to slaughter; or
    (2) A dry lot approved by a State or APHIS representative or an 
accredited veterinarian who is authorized by the Administrator to 
perform this function where only animals that either are not pregnant 
based on the animal being male, an owner certification that any female 
animals have not been exposed to a male in the preceding 6 months, an 
ICVI issued by an accredited veterinarian stating the animals are not 
pregnant, or the animals are under 6 months of age at time of receipt, 
where only castrated males are maintained with female animals, and all 
animals in the terminal feedlot are separated from all other animals 
such that physical contact cannot occur including through a fence and 
from which animals are moved only to another terminal feedlot or 
directly to slaughter; or
    (3) A pasture when approved by and maintained under the supervision 
of the State and in which only nonpregnant animals are permitted based 
on the animal being male, an owner certification that any female animals 
have not been exposed to a male in the preceding 6 months, or an ICVI 
issued by an accredited veterinarian stating the animals are not 
pregnant, or the animals are under 6 months of age at time of receipt, 
where only castrated males are maintained with female animals, where 
there is no direct fence-to-fence contact with another flock, and from 
which animals are moved only to another terminal feedlot or directly to 
slaughter.
    (4) Records of all animals entering and leaving a terminal feedlot 
must be maintained for 5 years after the animal leaves the feedlot and 
must meet the requirements of Sec.79.2 of this chapter,

[[Page 189]]

including either a copy of the required owner/hauler statements for 
animals entering and leaving the facility or the information required to 
be on the statements. Records must be made available for inspection and 
copying by an APHIS or State representative upon request.
    Unofficial test. Any test for the diagnosis of scrapie or for the 
detection of the proteinase resistant protein associated with scrapie in 
a live or dead animal that either has not been approved by the 
Administrator or that was not conducted at an approved laboratory or at 
the National Veterinary Services Laboratories.

[66 FR 43982, Aug. 21, 2001, as amended at 84 FR 11179, Mar. 25, 2019]



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 
Free Flock Certification Program within that State. These agreements 
will describe the respective roles of APHIS and State personnel in 
implementing the Scrapie Eradication Program and the Scrapie Free Flock 
Certification Program. Each agreement may specify the financial, 
material, and personnel resources to be committed to these programs and 
other scrapie control measures by APHIS and the State; assign specific 
activities related to the control of scrapie within a State to APHIS or 
State personnel; establish schedules for APHIS representatives or State 
representatives to visit flocks; establish procedures for maintaining 
and sharing program records specified in this part, and specify other 
responsibilities of State representatives and APHIS representatives in 
support of the Scrapie Eradication Program and the Scrapie Free Flock 
Certification Program.

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

[66 FR 43982, Aug. 21, 2001, as amended at 84 FR 11182, Mar. 25, 2019]



                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 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) Indemnity will be paid to an owner only for animals actually in 
a flock at the time indemnity is first offered in writing, and for 
offspring born to animals in that flock within 60 days after the time 
indemnity is first offered in writing. Animals removed from the flock as 
part of an investigation or a post-exposure management and monitoring 
plan (PEMMP) will be paid indemnity based on the calculated prices at 
the time an APHIS representative designates, in writing, the animals for 
removal. If an owner declines to remove an animal within 60 days of when 
indemnity is first offered the owner will receive the lower value of 
when indemnity was first offered in writing or when the animal was 
actually removed. APHIS may withdraw an indemnity offer if an owner does 
not make animals available for inventory, gestational assessment, and 
testing within 30 days, does not remove an animal within 60 days of the 
written indemnity offer or by the date specified in a flock plan or 
PEMMP, or fails to provide APHIS animal registration certificates, sale 
and movement records, or other records requested in accordance with 
Sec.54.5. No indemnity will be paid for any animal, or the progeny of 
any animal, that has been moved or handled by the owner in violation of

[[Page 190]]

the requirements of the Animal Health Protection Act or the regulations 
promulgated thereunder. No indemnity will be paid for an animal added to 
the premises while a flock is under investigation or while it is an 
infected or source flock other than natural additions. No indemnity will 
be paid for natural additions born more than 60 days after the owner is 
notified they are eligible for indemnity unless the Administrator makes 
a determination that the dam could not be removed within the allowed 
time as a result of conditions outside the control of the owner. No 
indemnity will be paid unless the owner has signed and is in compliance 
with the requirements of a flock plan or post-exposure management and 
monitoring plan (PEMMP) as described in Sec.54.8 unless the 
requirement for a flock plan or PEMMP has been waived by the 
Administrator. No indemnity will be paid until the premises, including 
all structures, holding facilities, conveyances, and materials 
contaminated because of occupation or use by the depopulated animals, 
have been properly cleaned and disinfected in accordance with Sec.
54.7(e), unless premises or portions of premises have been exempted from 
the cleaning and disinfecting requirements per Sec.54.8(j)(1); Except 
that, partial indemnity may be paid when the Administrator determines 
that weather or other factors outside the control of the owner make 
immediate disinfection impractical. No indemnity will be paid to an 
owner for any animals if the owner established or increased his flock 
for the purpose of collecting or increasing indemnity.

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

[66 FR 43982, Aug. 21, 2001, as amended at 84 FR 11182, Mar. 25, 2019]



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); 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.

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

[66 FR 43982, Aug. 21, 2001, as amended at 84 FR 11182, Mar. 25, 2019]



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;

[[Page 191]]

    (b) If the owner maintains any flock after the payment of indemnity 
or acquires a new flock that is housed on the same premises within 5 
years after the last high-risk or scrapie-positive animal is removed, 
the owner will maintain the flock in accordance with a post-exposure 
management and monitoring plan for 5 years;
    (c) If the animal for which indemnity is paid is subject to any 
mortgage, the owner consents to the payment of the indemnity, up to the 
value of the mortgage, to the person(s) holding the mortgage;
    (d) That the animal may be removed to a U.S. Department of 
Agriculture facility or a quarantined research facility, or euthanized 
and necropsied and tissues removed for diagnostic or other purposes.

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

[66 FR 43982, Aug. 21, 2001, as amended at 84 FR 11183, Mar. 25, 2019]



Sec.54.6  Amount of indemnity payments.

    (a) Indemnity. Indemnity paid for sheep and goats in accordance with 
Sec.54.3 will be the fair market value of the animals. APHIS' 
determination of fair market value will be based on available price 
report data that most accurately reflect the type of animal being 
indemnified and the time at which the animal was indemnified. Premiums 
will be paid for certain types of sheep and goats, including, but not 
limited to: Registered animals, flock sires, pregnant animals and early-
maturing ewes; Except that, no premium will be added for animals of any 
age that were in slaughter channels when indemnity was offered. To 
calculate indemnity, APHIS will use price information provided by the 
Agricultural Marketing Service (AMS) or other available price 
information and any other data necessary to establish the value of 
different types of sheep and goats. A detailed description of the 
methods APHIS uses to calculate indemnity for sheep and goats is 
available at http://www.aphis.usda.gov/animal-health/scrapie.
    (b) Age and number of animals. If records and identification are 
inadequate to determine the actual age of animals, an APHIS or State 
representative will count all sexually intact animals that are 
apparently under 1 year of age, and those that are apparently at least 1 
and under 2 years of age, based on examination of their teeth, and the 
indemnity for these animals will be calculated. The total number of 
these animals will be subtracted from the total number of sexually 
intact animals in the group to be indemnified, and indemnity for the 
remainder will be calculated based on the assumption that the remainder 
of the flock is 80 percent aged 2 to 6 years and 20 percent aged 6 to 8 
years.
    (c) Animal weights. If the owner disagrees with the average weight 
estimate, he may have the animals weighed at a public scale at his own 
expense, provided that the animals may not come in contact with other 
sheep or goats during movement to the public scales, and will be paid 
based on the actual weight multiplied by the price per pound for the 
class of animal as calculated in paragraph (a) of this section.

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

[84 FR 11183, Mar. 25, 2019]



Sec.54.7  Procedures for destruction of animals.

    (a) Animals for which indemnification is sought must be destroyed on 
the premises where they are held, pastured, or penned at the time 
indemnity is approved or moved to an approved research facility, unless 
the APHIS representative involved approves in advance of destruction 
moving the animals to another location for destruction.
    (b) The carcasses of animals destroyed in accordance with this 
section are authorized by the Administrator to be buried, incinerated, 
or disposed of by other methods in accordance with local, State, and 
Federal laws. The carcasses of scrapie-positive and suspect animals may 
not be processed for human or animal food.
    (c) The destruction of animals and disposition of their carcasses in 
accordance with this part must be monitored by an APHIS representative 
who will prepare and transmit to the Administrator a report identifying 
the animals and showing their disposition.

[[Page 192]]

    (d) APHIS may pay the reasonable costs of disposal for animals that 
are indemnified. To obtain reimbursement for disposal costs, animal 
owners must obtain written approval of the disposal costs from APHIS, 
prior to disposal. For reimbursement to be made, the owner of the 
animals must present the Veterinary Services, Field Operations, Area 
Veterinarian in Charge (AVIC) responsible for the State involved with a 
copy of either a receipt for expenses paid or a bill for services 
rendered. Any bill for services rendered by the owner must not be 
greater than the normal fee for similar services provided by a 
commercial hauler or disposal facility.
    (e) Cleaning and disinfection of premises and equipment. When 
required, cleaning and disinfection shall be conducted under the 
supervision of a State or APHIS representative as follows. Additional 
guidance on acceptable means of cleaning and disinfection is also 
available in the Scrapie Program Standards Volume 1: National Scrapie 
Eradication Program and Scrapie Program Standards Volume 2: Scrapie Free 
Flock Certification Program (SFCP):
    (1) Drylot areas. When required, remove the manure and top 1-2 
inches of soil to reduce contamination. Bury, till under, or compost the 
removed material in areas not accessed by domestic or wild ruminants.
    (2) Cement, wood, metal and other non-earth surfaces, tools, 
equipment, instruments, feed, hay, bedding, and other materials. Organic 
and/or inorganic materials may be disposed of by incineration or burial. 
Inorganic material and wood structures may be cleaned and disinfected. 
To disinfect, remove all organic material and incinerate, bury, till 
under, or compost the removed organic material in areas not accessed by 
domestic or wild ruminants until it can be incinerated, buried, or 
tilled under. Clean and wash all surfaces, tools, equipment, and 
instruments using hot water and detergent. Allow all surfaces, tools, 
equipment, and instruments to dry completely before disinfecting and 
sanitizing using one of the following methods:
    (i) Autoclave instruments, small tools, and other items at 136 
[deg]C for 1 hour;
    (ii) 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.
    (iii) Use a product registered by the U.S. Environmental Protection 
Agency (EPA) specifically for reduction of prion infectivity at these 
sites in accordance with the label.
    (iv) Use a product in accordance with an emergency exemption issued 
by the EPA for reduction of prion infectivity at these sites.

(Approved by the Office of Management and Budget under control number 
0579-0469)

[66 FR 43982, Aug. 21, 2001, as amended at 84 FR 11183, Mar. 25, 2019]



Sec.54.8  Requirements for flocks under investigation and flocks 
subject to flock plans and post-exposure management and monitoring
plans.

    (a) For animals in a flock under investigation, flock plan, or post-
exposure management and monitoring plan (PEMMP), the official 
identification must provide a unique identification number that is 
applied by the owner of the flock or his or her agent and must be linked 
to that flock in the National Scrapie Database. APHIS may specify the 
type of official identification that may be used in order to maximize 
retention of the means of identification, identify restricted or test 
positive animals or to facilitate the testing or inventory of the 
animals. The owner of the flock or his or her agent must officially 
identify and maintain the identity of:
    (1) All animals in the flock while it is subject to a flock plan or 
PEMMP;
    (2) Any high-risk or genetically susceptible exposed animals in the 
flock and any other restricted animals;
    (3) Any animals designated for testing by an APHIS representative or 
State representative until testing is completed, results reported, and 
animals classified; and
    (4) All sexually intact animals, all exposed animals, and animals 18

[[Page 193]]

months of age and older (as evidenced by the eruption of the second 
incisor) prior to a change in ownership and before they are moved off 
the premises of the flock.
    (b) For flocks under a flock plan or PEMMP, the flock owner must 
maintain the following records for 5 years or until the flock plan and/
or PEMMP is completed, whichever is longer.
    (1) For acquired animals, the date of acquisition, name and address 
of the person from whom the animal was acquired, any identifying marks, 
or identification devices present on the animal including but not 
limited to the animal's individual official identification number(s) 
from its electronic implant, flank tattoo, ear tattoo, tamper-resistant 
eartag, or, in the case of goats, tail fold tattoo, and any secondary 
form of identification the owner of the flock may choose to maintain and 
the records required by Sec.79.2 of this chapter.
    (2) For animals leaving the premises of the flock, the disposition 
of the animal, including, any identifying marks or identification 
devices present on the animal, including but not limited to the animal's 
individual official identification number from its electronic implant, 
flank tattoo, ear tattoo, tamper-resistant eartag, or, in the case of 
goats, a tail fold tattoo, and any secondary form of identification the 
owner of the flock may choose to maintain, the date and cause of death, 
if known, or date of removal from the flock and name and address of the 
person to whom the animal was transferred and the records required by 
Sec.79.2 of this chapter.
    (c) Upon request by a State or APHIS representative or as required 
in a PEMMP, the owner of the flock or his or her agent must have an 
accredited veterinarian collect tissues from animals for scrapie 
diagnostic purposes and submit them to a laboratory designated by a 
State or APHIS representative or collect and submit samples by another 
method acceptable to APHIS.
    (d) Upon request by a State or APHIS representative, the owner of 
the flock or his or her agent must make animals in the flock available 
for inspection and or testing and the records required to be kept as a 
part of these plans available for inspection and copying.
    (e) The owner of the flock or his or her agent must meet 
requirements found necessary by a DSE to monitor for scrapie and to 
prevent the recurrence of scrapie in the flock and to prevent the spread 
of scrapie from the flock. These other requirements may include, but are 
not limited to: Utilization of a live-animal screening test; reporting 
animals found dead and collecting and submitting test samples from them; 
restrictions on the animals that may be moved from the flock; use of 
genetically resistant rams; segregated lambing; cleaning and 
disinfection of lambing facilities; and/or education of the owner of the 
flock and personnel working with the flock in techniques to recognize 
clinical signs of scrapie and to control the spread of scrapie.
    (f) The owner of the flock or his or her agent must immediately 
report the following animals to a State representative, APHIS 
representative, or an accredited veterinarian; ensure that samples are 
properly collected for testing if the animal dies; allow the animals to 
be tested, and not remove them from a flock without written permission 
of a State or APHIS representative:
    (1) Any sheep or goat exhibiting weight loss despite retention of 
appetite; behavioral abnormalities; pruritus (itching); wool pulling; 
wool loss; biting at legs or side; lip smacking; motor abnormalities 
such as incoordination, high stepping gait of forelimbs, bunny hop 
movement of rear legs, or swaying of back end; increased sensitivity to 
noise and sudden movement; tremor; star gazing; head pressing; 
recumbency; rubbing, or other signs of neurological disease or chronic 
wasting illness; and
    (2) Any sheep or goat in the flock that has tested positive for 
scrapie or for the proteinase resistant protein associated with scrapie 
on a live-animal screening test or any other test.
    (g) An epidemiologic investigation must be conducted to identify 
high-risk and exposed animals that currently reside in the flock or that 
previously resided in the flock, and all

[[Page 194]]

high-risk animals, scrapie-positive animals, and suspect animals must be 
removed from the flock except as provided in paragraph (h) of this 
section. The animals must be removed either by movement to an approved 
research facility or by euthanasia and disposal of the carcasses by 
burial, incineration, or other methods approved by the Administrator and 
in accordance with local, State, and Federal laws, or upon request in 
individual cases by another means determined by the Administrator to be 
sufficient to prevent the spread of scrapie.
    (h) The Administrator may allow high-risk animals that are not 
suspect animals to be retained under restriction if they are not 
genetically susceptible animals or if they have tested ``PrPsc not 
detected'' on a live animal scrapie test approved for this purpose by 
the Administrator and are maintained in a manner that the Administrator 
determines minimizes the risk of scrapie transmission, e.g., bred only 
to genetically resistant sheep, segregated for lambing, and cleaning and 
disinfection of the lambing area. Such animals may be retained only if 
the exempted animal's official identification and the requirements for 
minimizing the risk of scrapie transmission are documented in the PEMMP 
and the owner is in compliance with the PEMMP. All such animals must be 
tested for scrapie when they are euthanized or die or if they are later 
determined to be suspect animals.
    (i) The owner of the flock, or his or her agent, must request breed 
associations and registries, livestock facilities, and packers to 
disclose records to APHIS representatives or State representatives, to 
be used to identify source flocks and trace exposed animals, including 
high-risk animals.
    (j) The flock plan will include a description of the types of 
animals that must be removed from a flock, the timeframes in which they 
must be removed and any other actions that must be accomplished in order 
for the flock plan to be completed. Flock plans shall require an owner 
to agree to:
    (1) Clean and disinfect the premises in accordance with Sec.
54.7(e). Premises or portions of premises may be exempted from the 
cleaning and disinfecting requirements if a designated scrapie 
epidemiologist determines, based on an epidemiologic investigation, that 
cleaning and disinfection of such buildings, holding facilities, 
conveyances, or other materials on the premises will not significantly 
reduce the risk of the spread of scrapie, either because effective 
disinfection is not possible or because the normal operations on the 
premises prevent transmission of scrapie. No confined area where a 
scrapie-positive animal was born, lambed or aborted may be exempted;
    (2) Agree to conduct a post-exposure management and monitoring plan 
(PEMMP); and
    (3) Comply with any other conditions in the flock plan;
    (k) A PEMMP will be required for exposed flocks and may be required 
for flocks under investigation that were not source or infected flocks. 
A PEMMP may also be required for flocks that formerly were exposed 
flocks or flocks under investigation as a condition for being 
redesignated. A designated scrapie epidemiologist shall determine when 
to require a PEMMP and the monitoring requirements for these flocks 
based on the findings of the classification or reclassification 
investigation.
    (l) Provided that, the Administrator may waive the requirement for a 
flock plan or PEMMP or waive any of the requirements in a flock plan or 
PEMMP after determining that the flock poses a low risk of scrapie 
transmission.

(Approved by the Office of Management and Budget under control numbers 
0579-0101 and 0579-0469)

[84 FR 11183, Mar. 25, 2019]



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

[[Page 195]]

    (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  Program approval of tests for scrapie.

    (a) The Administrator may approve new tests or test methods for the 
diagnosis of scrapie conducted on live or dead animals for use in the 
Scrapie Eradication Program and/or the Scrapie Free Flock Certification 
Program. The Administrator will base the approval or disapproval of a 
test on the evaluation by APHIS and, when appropriate, outside 
scientists, of:
    (1) A standardized test protocol that must include a description of 
the test, a description of the reagents, materials, and equipment used 
for the test, the test methodology, and any control or quality assurance 
procedures;
    (2) Data to support repeatability, that is, the ability to reproduce 
the same result repeatedly on a given sample;
    (3) Data to support reproducibility, that is, data to show that 
similar results can be produced when the test is run at other 
laboratories;
    (4) Data to support the diagnostic and in the case of assays the 
analytical sensitivity and specificity of the test; and
    (5) Any other data or information requested by the Administrator to 
determine the suitability of the test for program use. This may include 
but is not limited to past performance, cost of test materials and 
equipment, ease of test performance, generation of waste, and potential 
use of existing equipment.
    (b) To be approved for program use, a scrapie test must be able to 
be readily and successfully performed at the National Veterinary 
Services Laboratories.
    (c) The test must have a reliable, timely, and cost effective method 
of proficiency testing.
    (d) The Administrator may decline to evaluate any test kit for 
program approval that has not been licensed for the intended use and may 
decline to evaluate any test or test method for program use unless the 
requester can demonstrate that the new method offers a significant 
advantage over currently approved methods.
    (e) A test or combination of tests may be approved for the 
identification of suspect animals, or scrapie-positive animals, or for 
other purposes such as flock certification. For a test to be approved 
for the identification of scrapie-positive animals, the test must 
demonstrate a diagnostic specificity comparable to that of current 
program-approved tests, and the sensitivity of the test will also be 
considered in determining the approved uses of the test within the 
program. For a test to be approved for the removal of high-risk, 
exposed, or suspect animal designations the test must have a diagnostic 
sensitivity at least comparable to that of current program-approved 
tests used for this purpose. Since the purpose of a screening test is 
usually to identify a subset of animals for further testing, for a test 
to be approved as a screening test for the identification of suspect 
animals, the test must be usually reliable but need not be definitive 
for diagnosing scrapie.
    (f) Specific guidelines for use of program-approved tests within the 
Scrapie Eradication Program or Scrapie Free Flock Certification Program 
will be made available on the scrapie website at http://
www.aphis.usda.gov/animal-health/scrapie. Guidelines will be based on 
the characteristics of the test, including specificity, sensitivity, and 
predictive value in defined groups of animals.
    (g) If an owner elects to have an unofficial test conducted on an 
animal for scrapie, or for the proteinase resistant protein associated 
with scrapie, and that animal tests positive to such a test, the animal 
will be designated a suspect animal, unless the test is conducted as 
part of a research protocol and the protocol includes appropriate 
measures to prevent the spread of scrapie.
    (h) The Administrator may withdraw or suspend approval of any test 
or test method if the test or method does not perform at an acceptable 
level following approval or if a more effective

[[Page 196]]

test or test method is subsequently approved. The Administrator shall 
give written notice of the suspension or proposed withdrawal to the 
director of the laboratories using the test or method or in the case of 
test kits to the manufacturer and shall give the director or 
manufacturer an opportunity to respond. Such action shall become 
effective upon oral or written notification, whichever is earlier, to 
the laboratory or manufacturer. If there are conflicts as to any 
material fact concerning the reason for withdrawal, a hearing may be 
requested in accordance with the procedure in Sec.79.4(c)(3) of this 
chapter. The action under appeal shall continue in effect pending the 
final determination of the Administrator, unless otherwise ordered by 
the Administrator. The Administrator's final determination constitutes 
final agency action.

(Approved by the Office of Management and Budget under control number 
0579-0469)

[84 FR 11185, Mar. 25, 2019]



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 and conduct the testing 
who are qualified to conduct the test based on education, training, and 
experience and who have been trained by the National Veterinary Services 
Laboratories (NVSL) or who have completed equivalent training approved 
by NVSL;
    (2) Has adequate facilities and equipment to conduct the test;
    (3) Follows standard test protocols that are approved or provided by 
NVSL;
    (4) Meets check test proficiency requirements and consistently 
produces accurate test results as determined by NVSL review;
    (5) Meets recordkeeping requirements;
    (6) Will retain records, slides, blocks, and other specimens from 
all cases for at least 1 year and from positive cases and DNA from all 
genotype tests for at least 5 years and will forward copies of records 
and any of these materials to NVSL within 5 business days of request; 
Except that, NVSL may authorize a shorter retention time in a standard 
operating procedure or contract;
    (7) Will allow APHIS to inspect the laboratory without notice during 
normal business hours. An inspection may include, but is not limited to, 
review and copying of records, examination of slides, review of quality 
control procedures, observation of sample handling/tracking procedures, 
observation of the test being conducted, and interviewing of personnel;
    (8) Will report all test results to State and Federal animal health 
officials and record them in the National Scrapie Database within 
timeframes and in the manner and format specified by the Administrator; 
and
    (9) Complies with any other written guidance provided to the 
laboratory by the Administrator.
    (b) A laboratory may request approval to conduct one or more types 
of program-approved scrapie test or genotype test on one or more types 
of tissue. To be approved, a laboratory must meet the requirements in 
paragraph (a) of this section for each type of test and for each type of 
tissue for which they request approval.
    (c) The Administrator may suspend or withdraw approval of any 
laboratory for failure to meet any of the conditions required by 
paragraph (a) of this section. The Administrator shall give written 
notice of the suspension or the proposed withdrawal to the director of 
the laboratory and shall give the director an opportunity to respond. 
Such action shall become effective upon oral or written notification, 
whichever is earlier, to the laboratory or manufacturer. If there are 
conflicts as to any material fact concerning the reason for withdrawal, 
a hearing may be requested in accordance with the procedure in Sec.
79.4(c)(3) of this chapter. The action under appeal shall continue in 
effect pending the final determination of the Administrator, unless 
otherwise ordered by the Administrator. The Administrator's final 
determination constitutes final agency action.
    (d) The Administrator may require approved laboratories to reimburse

[[Page 197]]

APHIS for part or all of the costs associated with the approval and 
monitoring of the laboratory.

(Approved by the Office of Management and Budget under control numbers 
0579-0101 and 0579-0469)

[84 FR 11185, Mar. 25, 2019]



           Subpart B_Scrapie Free 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 
Free Flock Certification Program by sending a written request to a State 
scrapie certification board or to the Veterinary Services, Field 
Operations, AVIC responsible for the State involved. A notice containing 
a current list of flocks participating in the Scrapie Free Flock 
Certification Program, and the certification status of each flock, may 
be obtained from the APHIS website at http://www.aphis.usda.gov/animal-
health/scrapie. A list of noncompliant flocks and a list of flocks that 
sold exposed animals that could not be traced may also be obtained from 
this site, and these lists may be obtained by writing to the National 
Scrapie Program Coordinator, Strategy and Policy, VS, APHIS, 4700 River 
Road Unit 43, Riverdale, MD 20737-1235.

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

[84 FR 11185, Mar. 25, 2019]



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_Chronic Wasting Disease Herd Certification Program

55.21 Administration.
55.22 Participation and enrollment.
55.23 Responsibilities of States and enrolled herd owners.
55.24 Herd status.
55.25 Animal identification.

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

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

[[Page 198]]



Sec.55.1  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, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Animal. Any farmed or captive deer, elk, or moose.
    Animal identification. A device or means of animal identification 
approved for use under this part by APHIS. Examples of animal 
identification devices that APHIS has approved are listed in Sec.
55.25.
    Animal identification number (AIN). A numbering system for the 
official identification of individual animals in the United States. The 
AIN contains 15 digits, with the first 3 being the country code (840 for 
the United States), the alpha characters USA, or the numeric code 
assigned to the manufacturer of the identification device by the 
International Committee on Animal Recording.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    APHIS employee. Any individual employed by the Animal and Plant 
Health Inspection Service who is authorized by the Administrator to do 
any work or perform any duty in connection with the control and 
eradication of disease.
    Approved State CWD Herd Certification Program. A program operated by 
a State government for certification of cervid herds with respect to CWD 
that the Administrator has determined to meet the requirements of Sec.
55.23(a).
    Cervid. All members of the family Cervidae and hybrids, including 
deer, elk, moose, caribou, reindeer, and related species. For the 
purposes of this part, the term ``cervid'' refers specifically to 
cervids susceptible to CWD. These are animals in the genera Odocoileus, 
Cervus, and Alces and their hybrids, i.e., deer, elk, and moose.
    Commingled, commingling. Animals are commingled if they have direct 
contact with each other, have less than 10 feet of physical separation, 
or share equipment, pasture, or water sources/watershed. Animals are 
considered to have commingled if they have had such contact with a 
positive animal or contaminated premises within the last 5 years.
    CWD-exposed animal. An animal that is part of a CWD-positive herd, 
or that has been exposed to a CWD-positive animal or contaminated 
premises within the previous 5 years.
    CWD-exposed herd. A herd in which a CWD-positive animal has resided 
within 5 years prior to that animal's diagnosis as CWD-positive, as 
determined by an APHIS employee or State representative.
    CWD Herd Certification Program. The Chronic Wasting Disease Herd 
Certification Program established by this part. This program includes 
both herds that are directly enrolled in the CWD Herd Certification 
Program and herds that are included based on their participation in 
Approved State CWD Herd Certification Programs.
    CWD-positive animal. An animal that has had a diagnosis of CWD 
established through official confirmatory testing conducted by the 
National Veterinary Services Laboratories.
    CWD positive herd. A herd in which a CWD positive animal resided at 
the time it was diagnosed and which has not been released from 
quarantine.
    CWD-source herd. A herd that is identified through testing, 
tracebacks, and/or epidemiological evaluations to be the source of CWD-
positive animals identified in other herds.
    CWD-suspect animal. An animal for which an APHIS employee or State 
representative has determined that unofficial CWD test results, 
laboratory evidence or clinical signs suggest a diagnosis of CWD, but 
for which official laboratory results have been inconclusive or not yet 
conducted.
    CWD-suspect herd. A herd for which unofficial CWD test results, 
laboratory evidence, or clinical signs suggest a diagnosis of CWD, as 
determined by an APHIS employee or State representative, but for which 
official laboratory results have been inconclusive or not yet conducted.
    Deer, elk, and moose. All animals in the genera Odocoileus, Cervus, 
and Alces and their hybrids.

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    Department. The United States Department of Agriculture.
    Farmed or captive. Privately or publicly maintained or held for 
economic or other purposes within a perimeter fence or confined area, or 
captured from a free-ranging population for interstate movement and 
release.
    Herd. One or more animals that are:
    (1) Under common ownership or supervision and are grouped on one or 
more parts of any single premises (lot, farm, or ranch) or
    (2) All animals under common ownership or supervision on two or more 
premises which are geographically separated but on which animals have 
been interchanged or had direct or indirect contact with one another.
    Herd plan. A written herd and/or premises management agreement 
developed by APHIS in collaboration with the herd owner, State 
representatives, and other affected parties. The herd plan will not be 
valid until it has been reviewed and signed by the Administrator, the 
State representative, and the herd owner. A herd plan sets out the steps 
to be taken to control the spread of CWD from a CWD-positive herd, to 
control the risk of CWD in a CWD-exposed or CWD-suspect herd, or to 
prevent introduction of CWD into that herd or any other herd. A herd 
plan will require specified means of identification for each animal in 
the herd; regular examination of animals in the herd by a veterinarian 
for clinical signs of disease; reporting to a State or APHIS 
representative of any clinical signs of a central nervous system disease 
or chronic wasting condition in the herd; maintaining records of the 
acquisition and disposition of all animals entering or leaving the herd, 
including the date of acquisition or removal, name and address of the 
person from whom the animal was acquired or to whom it was disposed; and 
the cause of death, if the animal died while in the herd. A herd plan 
may also contain additional requirements to prevent or control the 
possible spread of CWD, depending on the particular circumstances of the 
herd and its premises, including but not limited to depopulation of the 
herd, specifying the time for which a premises must not contain cervids 
after CWD-positive, -exposed, or -suspect animals are removed from the 
premises; fencing requirements; selective culling of animals; 
restrictions on sharing and movement of possibly contaminated livestock 
equipment; premises cleaning and disinfection requirements; or other 
requirements. A herd plan may be reviewed and changes to it suggested at 
any time by any party signatory to it, in response to changes in the 
situation of the herd or premises or improvements in understanding of 
the nature of CWD epidemiology or techniques to prevent its spread. The 
revised herd plan will become effective after it is reviewed by the 
Administrator and signed by the Administrator, the State representative, 
and the herd owner.
    Herd status. The status of a herd assigned under the CWD Herd 
Certification Program in accordance with Sec.55.24, indicating a 
herd's relative risk for CWD. Herd status is based on the number of 
years of monitoring without evidence of the disease and any specific 
determinations that the herd has contained or has been exposed to a CWD-
positive, -exposed or -suspect animal.
    Materials. Parts of barns or other structures, straw, hay, and other 
feed for animals, farm products or equipment, clothing, and any other 
articles on the premises that have been in contact with captive cervids.
    Mortgage. Any mortgage, lien, or other security or beneficial 
interest held by any person other than the one claiming indemnity.
    National Uniform Eartagging System. A numbering system for the 
official identification of individual animals in the United States 
providing a nationally unique identification number for each animal. The 
National Uniform Eartagging System employs an eight- or nine-character 
alphanumeric format, consisting of a two-number State or territory code, 
followed by two or three letters and four additional numbers. Official 
APHIS disease control programs may specify which format to employ.
    Official animal identification. A device or means of animal 
identification approved for use under this part by APHIS to uniquely 
identify individual animals. Examples of approved official animal 
identification devices are listed

[[Page 200]]

in Sec.55.25. The official animal identification must include a 
nationally unique animal identification number that adheres to one of 
the following numbering systems:
    (1) National Uniform Eartagging System. The CWD program allows the 
use of either the eight-character or nine-character format for cervids.
    (2) Animal identification number (AIN).
    (3) Premises-based number system. The premises-based number system 
combines an official premises identification number (PIN), as defined in 
this section, with a producer's livestock production numbering system to 
provide a unique identification number. The PIN and the production 
number must both appear on the official tag.
    (4) Any other numbering system approved by the Administrator for the 
identification of animals in commerce.
    Official appraiser (APHIS official appraiser, State official 
appraiser). A person authorized by APHIS (an APHIS official appraiser) 
or a State (a State official appraiser) to appraise animals for the 
purposes of this part. An official appraiser may be an APHIS employee, a 
State employee, or a professional livestock appraiser working under 
contract to APHIS or a State.
    Official CWD test. Any test for the diagnosis of CWD approved by the 
Administrator and conducted in a laboratory approved by the 
Administrator in accordance with Sec.55.8 of this part.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, joint stock company, or other legal entity.
    Premises identification number (PIN). A nationally unique number 
assigned by a State, Tribal, and/or Federal animal health authority to a 
premises that is, in the judgment of the State, Tribal, and/or Federal 
animal health authority, a geographically distinct location from other 
premises. The premises identification number is associated with an 
address, geospatial coordinates, and/or location descriptors which 
provide a verifiably unique location. The premises identification number 
may be used in conjunction with a producer's own livestock production 
numbering system to provide a unique identification number for an 
animal. It may also be used as a component of a group/lot identification 
number. The premises identification number may consist of:
    (1) The State's two-letter postal abbreviation followed by the 
premises' assigned number; or
    (2) A seven-character alphanumeric code, with the right-most 
character being a check digit. The check digit number is based upon the 
ISO 7064 Mod 36/37 check digit algorithm.
    Secretary. The Secretary of Agriculture of the United States, or any 
officer or employee of the Department delegated to act in the 
Secretary's stead.
    State. Each of the States of the United States, the District of 
Columbia, Puerto Rico, the Northern Mariana Islands, Guam, the Virgin 
Islands of the United States, or any other territory or possession of 
the United States.
    State representative. A person regularly employed in the animal 
health work of a State and who is authorized by that State to perform 
the function involved.
    Trace back herd. A herd in which a CWD-positive animal formerly 
resided.
    Trace forward herd. A herd that has received exposed animals from a 
CWD-positive herd within 5 years prior to the diagnosis of CWD in the 
positive herd or from the identified date of entry of CWD into the 
positive herd.
    Veterinarian in charge. The veterinary official of Veterinary 
Services, APHIS, who is assigned by the Administrator to supervise and 
perform official animal health work for APHIS in the State concerned.

[67 FR 5931, Feb. 8, 2002, as amended at 71 FR 41701, July 21, 2006; 77 
FR 35565, June 13, 2012; 79 FR 23891, Apr. 29, 2014]



        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

[[Page 201]]

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 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

[[Page 202]]

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 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.

[[Page 203]]

    (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.
---------------------------------------------------------------------------

    (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_Chronic Wasting Disease Herd Certification Program

    Source: 77 FR 35566, June 13, 2012, unless otherwise noted.



Sec.55.21  Administration.

    The CWD Herd Certification Program is a cooperative effort between 
APHIS, State animal health and wildlife agencies, and deer, elk, and 
moose owners. APHIS coordinates with these State agencies to encourage 
deer, elk, and moose owners to certify their herds as low risk for CWD 
by being in continuous compliance with the CWD Herd Certification 
Program standards.



Sec.55.22  Participation and enrollment.

    (a) Participation by States. Any State that operates a State program 
to certify the CWD status of deer, elk, or moose may request the 
Administrator to designate the State program as an Approved State CWD 
Herd Certification Program. The Administrator will approve or disapprove 
a State program in accordance with Sec.55.23(a). In States with an 
Approved State CWD Herd Certification Program, program activities will 
be conducted in accordance with the guidelines of that program as long 
as the State program meets the minimum requirements of this part. A list 
of Approved State

[[Page 204]]

CWD Herd Certification Programs may be obtained by writing to the 
National Center for Animal Health Program, VS, APHIS, 4700 River Road 
Unit 43, Riverdale, MD 20737-1235.
    (b) Participation by owners. Any owner of a farmed or captive deer, 
elk, or moose herd may apply to enroll in an Approved State CWD Herd 
Certification Program by sending a written request to the appropriate 
State agency. Subject to the availability of appropriated funds for a 
Federal CWD Herd Certification Program, the owner may apply to the APHIS 
veterinarian in charge if no Approved State CWD Herd Certification 
Program exists in the herd's State. APHIS or the State will determine 
the herd's eligibility, and if needed will require the owner to submit 
more details about the herd animals and operations. An application for 
participation may be denied if APHIS or the State determines that the 
applicant has previously violated State or Federal laws or regulations 
for livestock, and that the nature of the violation indicates that the 
applicant may not faithfully comply with the requirements of the CWD 
Herd Certification Program. If the enrolling herd is a CWD-positive herd 
or CWD-exposed herd, immediately after enrollment it must begin 
complying with a herd plan developed in accordance with Sec.55.24. 
After determining that the herd is eligible to participate in accordance 
with this paragraph, APHIS or the appropriate State agency will send the 
herd owner a notice of enrollment that includes the herd's enrollment 
date. Inquiries regarding which herds are participating in the CWD Herd 
Certification Program and their certification should be directed to the 
State representative of the relevant State.
    (1) Enrollment date. With the exceptions listed in this paragraph, 
the enrollment date for any herd that joins the CWD Herd Certification 
Program after August 13, 2012 will be the date the herd is approved for 
participation.
    (i) For herds already participating in State CWD programs, the 
enrollment date will be the first day that the herd participated in a 
State program that APHIS subsequently determines qualifies as an 
Approved State CWD Herd Certification Program in accordance with Sec.
55.23(a) of this part.
    (ii) For herds that enroll directly in the Federal CWD Herd 
Certification Program, which is allowed only when there is no Approved 
State CWD Herd Certification Program in their State and which is subject 
to the availability of appropriated funds, the enrollment date will be 
the earlier of:
    (A) The date APHIS approves enrollment; or
    (B) If APHIS determines that the herd owner has maintained the herd 
in a manner that substantially meets the conditions specified in Sec.
55.23(b) for herd owners, the first day that the herd participated in 
such a program. However, in such cases the enrollment date may not be 
set at a date more than 3 years prior to the date that APHIS approved 
enrollment of the herd.
    (iii) For new herds that were formed from and contain only animals 
from herds enrolled in the CWD Herd Certification Program, the 
enrollment date will be the latest enrollment date for any source herd 
for the animals.
    (2) [Reserved]

(Approved by the Office of Management and Budget under control number 
0579-0237)



Sec.55.23  Responsibilities of States and enrolled herd owners.

    (a) Approval of State programs and responsibilities of States. In 
reviewing a State program's eligibility to be designated an Approved 
State CWD Herd Certification Program, the Administrator will evaluate a 
written statement from the State that describes the State's CWD control 
and deer, elk, and moose herd certification activities and that cites 
relevant State statutes, regulations, and directives pertaining to 
animal health activities and reports and publications of the State. In 
determining whether the State program qualifies, the Administrator will 
determine whether the State:
    (1) Has the authority, based on State law or regulation, to restrict 
the intrastate movement of all CWD-positive, CWD-suspect, and CWD-
exposed animals.
    (2) Has the authority, based on State law or regulation, to require 
the prompt reporting of any animal suspected of having CWD and test 
results

[[Page 205]]

for any animals tested for CWD to State or Federal animal health 
authorities.
    (3) Has, in cooperation with APHIS personnel, drafted and signed a 
memorandum of understanding with APHIS that delineates the respective 
roles of the State and APHIS in CWD Herd Certification Program 
implementation.
    (4) Has placed all known CWD-positive, CWD-exposed, and CWD-suspect 
animals and herds under movement restrictions, with movement of animals 
from them only for destruction or under permit.
    (5) Has effectively implemented policies to:
    (i) Promptly investigate all animals reported as CWD-suspect 
animals;
    (ii) Designate herds as CWD-positive, CWD-exposed, or CWD-suspect 
and promptly restrict movement of animals from the herd after an APHIS 
employee or State representative determines that the herd contains or 
has contained a CWD-positive animal;
    (iii) Remove herd movement restrictions only after completion of a 
herd plan agreed upon by the State representative, APHIS, and the owner;
    (iv) Conduct an epidemiologic investigation of CWD-positive, CWD-
exposed, and CWD-suspect herds that includes the designation of suspect 
and exposed animals and that identifies animals to be traced;
    (v) Conduct tracebacks of CWD-positive animals and traceouts of CWD-
exposed animals and report any out-of-State traces to the appropriate 
State promptly after receipt of notification of a CWD-positive animal; 
and
    (vi) Conduct tracebacks based on slaughter or other sampling 
promptly after receipt of notification of a CWD-positive animal at 
slaughter.
    (6) Effectively monitors and enforces State quarantines and State 
reporting laws and regulations for CWD.
    (7) Has designated at least one State animal health official, or has 
worked with APHIS to designate an APHIS official, to coordinate CWD Herd 
Certification Program activities in the State.
    (8) Has programs to educate those engaged in the interstate movement 
of deer, elk, and moose regarding the identification and recordkeeping 
requirements of this part.
    (9) Requires, based on State law or regulation, and effectively 
enforces identification of all animals in herds participating in the CWD 
Herd Certification Program;
    (10) Maintains in the CWD National Database administered by APHIS, 
or in a State database approved by the Administrator as compatible with 
the CWD National Database, the State's:
    (i) Premises information and assigned premises numbers;
    (ii) Individual animal information on all deer, elk, and moose in 
herds participating in the CWD Herd Certification Program in the State;
    (iii) Individual animal information on all out-of-State deer, elk, 
and moose to be traced; and
    (iv) Accurate herd status data.
    (11) Requires that tissues from all CWD-exposed or CWD-suspect 
animals that die or are depopulated or otherwise killed be submitted to 
a laboratory authorized by the Administrator to conduct official CWD 
tests and requires appropriate disposal of the carcasses of CWD-
positive, CWD-exposed, and CWD-suspect animals.
    (b) Responsibilities of enrolled herd owners. Herd owners who enroll 
in the CWD Herd Certification Program agree to maintain their herds in 
accordance with the following conditions:
    (1) Each animal in the herd must be identified using means of animal 
identification specified in Sec.55.25. All animals in an enrolled herd 
must be identified before reaching 12 months of age. In addition, all 
animals of any age in an enrolled herd must be identified before being 
moved from the herd premises. In addition, all animals in an enrolled 
herd must be identified before the inventory required under paragraph 
(b)(4) of this section, and animals found to be in violation of this 
requirement during the inventory must be identified during or after the 
inventory on a schedule specified by the APHIS employee or State 
representative conducting the inventory;
    (2) The herd premises must have perimeter fencing adequate to 
prevent ingress or egress of cervids. This fencing must also comply with 
any applicable State regulations;
    (3) The owner must immediately report to an APHIS employee or State

[[Page 206]]

representative all animals that escape or disappear, and all deaths 
(including animals killed on premises maintained for hunting and animals 
sent to slaughter) of deer, elk, and moose in the herd aged 12 months or 
older; Except that, APHIS employees or State representatives may approve 
reporting schedules other than immediate notification when herd 
conditions warrant it in the opinion of both APHIS and the State. The 
report must include the identification numbers of the animals involved 
and the estimated time and date of the death, escape, or disappearance. 
For animals that die (including animals killed on premises maintained 
for hunting and animals sent to slaughter), the owner must inform an 
APHIS or State representative and must make the carcasses of the animals 
available for tissue sampling and testing in accordance with 
instructions from the APHIS or State representative. In cases where 
animals escape or disappear and thus are not available for tissue 
sampling and testing, or when the owner provides samples that are of 
such poor quality that they cannot be tested for CWD, an APHIS 
representative will investigate whether the unavailability of animals or 
usable samples for testing constitutes a failure to comply with program 
requirements and will affect the herd's status in the CWD Herd 
Certification Program;
    (4) The owner must maintain herd records that include a complete 
inventory of animals that states the species, age, and sex of each 
animal, the date of acquisition and source of each animal that was not 
born into the herd, the date of disposal and destination of any animal 
removed from the herd, and all individual identification numbers (from 
tags, tattoos, electronic implants, etc.) associated with each animal. 
Upon request by an APHIS employee or State representative, the owner 
must allow either of these officials or a designated accredited 
veterinarian access to the premises and herd to conduct an inventory. 
The owner will be responsible for assembling, handling, and restraining 
the animals and for all costs incurred to present the animals for 
inspection. The APHIS employee or State representative may order either 
an inventory that consists of review of herd records with visual 
examination of an enclosed group of animals, or a complete physical herd 
inventory with verification to reconcile all animals and identifications 
with the records maintained by the owner. In the latter case, the owner 
must present the entire herd for inspection under conditions where the 
APHIS employee, State representative, or accredited veterinarian can 
safely read all identification on the animals. During inventories, the 
owner must cooperate with the inspector to resolve any discrepancies to 
the satisfaction of the person performing the inventory. Inventory of a 
herd will be conducted no more frequently than once per year, unless an 
APHIS employee, State representative, or accredited veterinarian 
determines that more frequent inventories are needed based on 
indications that the herd may not be in compliance with CWD Herd 
Certification Program requirements. A complete physical herd inventory 
must be performed on a herd in accordance with this paragraph at the 
time a herd is enrolled in the CWD Herd Certification Program; Except 
that, APHIS may accept a complete physical herd inventory performed by 
an APHIS employee, State representative, or accredited veterinarian not 
more than 1 year before the herd's date of enrollment in the CWD Herd 
Certification Program as fulfilling the requirement for an initial 
inventory. In addition, a complete physical herd inventory must be 
performed for all herds enrolled in the CWD Herd Certification Program 
no more than 3 years after the last complete physical herd inventory for 
the herd;
    (5) If an owner wishes to maintain separate herds, he or she must 
maintain separate herd inventories, records, working facilities, water 
sources, equipment, and land use. There must be a buffer zone of at 
least 30 feet between the perimeter fencing around separate herds, and 
no commingling of animals may occur. Movement of animals between herds 
must be recorded as if they were separately owned herds;
    (6) New animals may be introduced into the herd only from other 
herds enrolled in the CWD Herd Certification Program. If animals are 
received from

[[Page 207]]

an enrolled herd with a lower program status, the receiving herd will 
revert to that lower program status. If animals are obtained from a herd 
not participating in the program, then the receiving herd will be 
required to start over in the program.

(Approved by the Office of Management and Budget under control number 
0579-0237)



Sec.55.24  Herd status.

    (a) Initial and subsequent status. When a herd is first enrolled in 
the CWD Herd Certification Program, it will be placed in First Year 
status; except that, if the herd is composed solely of animals obtained 
from herds already enrolled in the Program, the newly enrolled herd will 
have the same status as the lowest status of any herd that provided 
animals for the new herd. If the herd continues to meet the requirements 
of the CWD Herd Certification Program, each year, on the anniversary of 
the enrollment date the herd status will be upgraded by 1 year; i.e., 
Second Year status, Third Year status, Fourth Year status, and Fifth 
Year status. One year from the date a herd is placed in Fifth Year 
status, the herd status will be changed to Certified, and the herd will 
remain in Certified status as long as it is enrolled in the program, 
provided its status is not lost or suspended in accordance with this 
section.
    (b) Loss or suspension of herd status. (1) If a herd is designated a 
CWD-positive herd or a CWD-exposed herd, it will immediately lose its 
program status and may only reenroll after entering into a herd plan.
    (2) If a herd is designated a CWD-suspect herd, a trace back herd, 
or a trace forward herd, it will immediately be placed in Suspended 
status pending an epidemiologic investigation by APHIS or a State animal 
health agency. If the epidemiologic investigation determines that the 
herd was not commingled with a CWD-positive animal, the herd will be 
reinstated to its former program status, and the time spent in Suspended 
status will count toward its promotion to the next herd status level.
    (i) If the epidemiologic investigation determines that the herd was 
commingled with a CWD-positive animal, the herd will lose its program 
status and will be designated a CWD-exposed herd.
    (ii) If the epidemiological investigation is unable to make a 
determination regarding the exposure of the herd, because the necessary 
animal or animals are no longer available for testing (i.e., a trace 
animal from a known positive herd died and was not tested) or for other 
reasons, the herd status will continue as Suspended unless and until a 
herd plan is developed for the herd. If a herd plan is developed and 
implemented, the herd will be reinstated to its former program status, 
and the time spent in Suspended status will count toward its promotion 
to the next herd status level; Except that, if the epidemiological 
investigation finds that the owner of the herd has not fully complied 
with program requirements for animal identification, animal testing, and 
recordkeeping, the herd will be reinstated into the CWD Herd 
Certification Program at the First Year status level, with a new 
enrollment date set at the date the herd entered into Suspended status. 
Any herd reinstated after being placed in Suspended status must then 
comply with the requirements of the herd plan as well as the 
requirements of the CWD Herd Certification Program. The herd plan will 
require testing of all animals that die in the herd for any reason, 
regardless of the age of the animal, may require movement restrictions 
for animals in the herd based on epidemiologic evidence regarding the 
risk posed by the animals in question, and may include other 
requirements found necessary to control the risk of spreading CWD.
    (3) If an APHIS or State representative determines that animals from 
a herd enrolled in the program have commingled with animals from a herd 
with a lower program status, the herd with the higher program status 
will be reduced to the status of the herd with which its animals 
commingled.
    (c) Cancellation of enrollment by Administrator. The Administrator 
may cancel the enrollment of an enrolled herd by giving written notice 
to the herd owner. In the event of such cancellation, any herd enrolled 
in the CWD Herd Certification Program by that herd owner may not reach 
Certified

[[Page 208]]

status until 5 years after the herd owner's new application for 
enrollment is approved by APHIS, regardless of the status of the animals 
of which the herd is composed. The Administrator may cancel enrollment 
after determining that the herd owner failed to comply with any 
requirements of this subpart. Before enrollment is canceled, an APHIS 
representative will inform the herd owner of the reasons for the 
proposed cancellation.
    (1) Herd owners may appeal designation of an animal as CWD-positive, 
cancellation of enrollment of a herd, or loss or suspension of herd 
status by writing to the Administrator within 10 days after being 
informed of the reasons for the action. The appeal must include all of 
the facts and reasons upon which the herd owner relies to show that the 
reasons for the action are incorrect or do not support the action. 
Specifically, to appeal designation of an animal as CWD-positive, the 
owner may present as evidence the results of a DNA test requested and 
paid for by the owner to determine whether previous official CWD test 
results were correctly associated with an animal that belonged to the 
owner. If the owner intends to present such test results as evidence, he 
or she shall request the tests and state this in the written notice sent 
to the Administrator. In such cases the Administrator may postpone a 
decision on the appeal for a reasonable period pending receipt of such 
test results. To this end, laboratories approved under Sec.55.8 are 
authorized to conduct DNA tests to compare tissue samples tested for CWD 
to samples from tissues that were collected at the same time from the 
same animal and are attached to an official identification device. Such 
DNA tests are available only if the animal owner arranged to submit 
animal tissue attached to an official identification device along with 
the other tissues that were collected for the official CWD test. The 
Administrator will grant or deny the appeal in writing as promptly as 
circumstances permit, stating the reason for his or her decision. If the 
Administrator grants an appeal of the status of a CWD-positive animal, 
the animal shall be redesignated as CWD-suspect pending further 
investigation to establish the final status of the animal and its herd. 
If there is a conflict as to any material fact, a hearing will be held 
to resolve the conflict. Rules of practice concerning the hearing will 
be adopted by the Administrator.
    (2) [Reserved]
    (d) Herd status of animals added to herds. A herd may add animals 
from herds with the same or a higher herd status in the CWD Herd 
Certification Program with no negative impact on the certification 
status of the receiving herd. \5\ If animals are acquired from a herd 
with a lower herd status, the receiving herd reverts to the program 
status of the sending herd. If a herd participating in the CWD Herd 
Certification Program acquires animals from a nonparticipating herd, the 
receiving herd reverts to First Year status with a new enrollment date 
of the date of acquisition of the animal.
---------------------------------------------------------------------------

    \5\ Note that in addition to this requirement, Sec.81.3 of this 
chapter restricts the interstate movement of farmed and captive deer, 
elk, and moose based on their status in the CWD Herd Certification 
Program.

(Approved by the Office of Management and Budget under control number 
0579-0237)



Sec.55.25  Animal identification.

    Each animal required to be identified by this subpart must have at 
least two forms of animal identification attached to the animal. One of 
the animal identifications must be official animal identification as 
defined in this part, with a nationally unique animal identification 
number that is linked to that animal in the CWD National Database or in 
an approved State database. The second animal identification must be 
unique for the individual animal within the herd and also must be linked 
to that animal and herd in the CWD National Database or in an approved 
State database. The means of animal identification must be approved for 
this use by APHIS, and must be an electronic implant, flank tattoo, ear 
tattoo, tamper-resistant ear tag, or other device approved by APHIS.

(Approved by the Office of Management and Budget under control number 
0579-0237)

[[Page 209]]



PART 56_CONTROL OF H5/H7 LOW PATHOGENIC AVIAN INFLUENZA--
Table of Contents



Sec.
56.1 Definitions.
56.2 Cooperation with States.
56.3 Payment of indemnity and/or compensation.
56.4 Determination of indemnity and/or compensation amounts.
56.5 Destruction and disposal of poultry and cleaning and disinfection 
          (virus elimination) of premises, conveyances, and materials.
56.6 Presentation of claims for indemnity and/or compensation.
56.7 Mortgage against poultry or eggs.
56.8 Conditions for payment.
56.9 Claims not allowed.
56.10 Initial State response and containment plan.

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

    Source: 71 FR 56323, Sept. 26, 2006, unless otherwise noted.



Sec.56.1  Definitions.

    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any other employee of the Animal and Plant Health Inspection 
Service delegated to act in the Administrator's stead.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the U.S. Department of Agriculture.
    Breeding flock. A flock that is composed of stock that has been 
developed for commercial egg or meat production and is maintained for 
the principal purpose of producing progeny for the ultimate production 
of eggs or meat for human consumption.
    Classification. A designation earned by participation in a Plan 
program.
    Cleaning. The removal of gross contamination, organic material, and 
debris from the premises or respective structures, via mechanical means 
like sweeping (dry cleaning) and/or the use of water and soap or 
detergent (wet cleaning), in order to minimize organic material to 
prepare for effective disinfection.
    Commercial flock or slaughter plant. A commercial poultry flock or 
slaughter plant that is required because of its size to participate in 
the special provisions in part 146 of this chapter in order to 
participate in the Plan.
    Compensation. In the case of H5/H7 LPAI detection, compensation 
specifically refers to reimbursement for the activities associated with 
the depopulation of infected or exposed poultry, including the disposal 
of contaminated carcasses and materials and the cleaning and 
disinfection of premises, conveyances, and materials that came into 
contact with infected or exposed poultry. In the case of contaminated 
materials, if the cost of cleaning and disinfection would exceed the 
value of the materials, or cleaning and disinfection would be 
impracticable for any reason, APHIS' Veterinary Services will base 
compensation on the fair market value (depreciated value) of those 
materials. Compensation does not include payment for depopulated birds 
or eggs destroyed (see definition of Indemnity in this section).
    Cooperating State Agency. Any State authority recognized by the 
Department to cooperate in the administration of the provisions of this 
part 56. This may include the State animal health authority or the 
Official State Agency.
    Department. The U.S. Department of Agriculture.
    Disinfection. Methods used on surfaces to destroy or eliminate H5/H7 
LPAI virus through physical (e.g., heat) or chemical (e.g., 
disinfectant) means. A combination of methods may be required.
    Domesticated. Propagated and maintained under the control of a 
person.
    Flock plan. A written flock management agreement developed by APHIS 
and the Official State Agency with input from the flock owner and other 
affected parties. A flock plan sets out the steps to be taken to 
eradicate H5/H7 LPAI from a positive flock, or to prevent introduction 
of H5/H7 LPAI into another flock. A flock plan shall include, but is not 
necessarily limited to, poultry and poultry product movement and 
geographically appropriate infected and control/monitoring zones. 
Control measures in the flock plan should include detailed plans for 
safe handling of conveyances, containers, and other associated materials 
that could serve as fomites; disposal of

[[Page 210]]

flocks; cleaning and disinfection; downtime; and repopulation.
    H5/H7 low pathogenic avian influenza (LPAI). An infection of poultry 
caused by an influenza A virus of H5 or H7 subtype that has an 
intravenous pathogenicity index in 6-week-old chickens less than or 
equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-
old chickens infected intravenously, or an infection with influenza A 
viruses of H5 or H7 subtype with a cleavage site that is not consistent 
with a previously identified highly pathogenic avian influenza virus.
    H5/H7 LPAI virus actively infected (infectious). (1) Poultry will be 
considered to be actively infected with H5/H7 LPAI for the purposes of 
this part if:
    (i) H5/H7 LPAI virus has been isolated and identified as such from 
poultry; or
    (ii) Viral antigen or viral RNA specific to the H5 or H7 subtype of 
AI virus has been detected in poultry.
    (2) The official determination that H5/H7 LPAI virus has been 
isolated and identified, or viral antigen or viral RNA specific to the 
H5 or H7 subtype of AI virus has been detected, may only be made by the 
National Veterinary Services Laboratories.
    H5/H7 LPAI virus exposed (non-infectious). (1) Poultry will be 
considered to be exposed (non-infectious) to H5/H7 LPAI for the purposes 
of this part if:
    (i) Antibodies to the H5 or H7 subtype of the AI virus that are not 
a consequence of vaccination have been detected in poultry; and
    (ii) Samples collected from the flock using real-time reverse 
transcription polymerase chain reaction (RT-PCR) or virus isolation are 
determined to be not infectious for H5/H7 LPAI.
    (2) The official determination that H5/H7 LPAI virus exposure has 
occurred is by the identification of antibodies to the H5 or H7 subtype 
of AI virus detected and may only be made by the National Veterinary 
Services Laboratories.
    Indemnity. Payments representing the fair market value of destroyed 
birds and eggs. Indemnity does not include reimbursements for 
depopulation, disposal, destroyed materials, or cleaning and 
disinfection (virus elimination) activities; these activities are 
covered under compensation (see definition of Compensation in this 
section).
    Mortgage. Any mortgage, lien, or other security or beneficial 
interest held by any person other than the one claiming indemnity for 
the destruction of poultry or eggs due to H5/H7 LPAI.
    Official appraiser (APHIS official appraiser, State official 
appraiser). A person authorized by APHIS to appraise poultry for the 
purposes of this part. A State official appraiser is selected by a State 
and authorized by APHIS.
    Official State Agency. The State authority recognized by the 
Department to cooperate in the administration of the Plan.
    Plan. The provisions of the National Poultry Improvement Plan 
contained in parts 145, 146, and 147 of this chapter.
    Poultry. Domesticated fowl, including chickens, turkeys, ostriches, 
emus, rheas, cassowaries, waterfowl, and game birds, except doves and 
pigeons, which are bred for the primary purpose of producing eggs or 
meat.
    Secretary. The Secretary of the United States Department of 
Agriculture, or any officer or employee of the Department delegated to 
act in the Secretary's stead.
    State. Any of the States, the District of Columbia, the Commonwealth 
of Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, 
the Virgin Islands of the United States, or any territory or possession 
of the United States.
    Table-egg layer. A domesticated chicken grown for the primary 
purpose of producing eggs for human consumption.
    United States. All of the States.
    Virus elimination (VE). Cleaning and disinfection measures conducted 
to destroy or eliminate all AI virus on an affected premises.

[71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10656, Mar. 9, 2010; 
76 FR 15792, Mar. 22, 2011; 79 FR 38753, July 9, 2014; 81 FR 53249, Aug. 
12, 2016; 85 FR 62562, Oct. 5, 2020]



Sec.56.2  Cooperation with States.

    (a) The Administrator has been delegated the authority to cooperate 
with Cooperating State Agencies in the

[[Page 211]]

eradication of H5/H7 LPAI. This cooperation may include, but is not 
necessarily limited to, the following activities:
    (1) Payment to Cooperating State Agencies for surveillance and 
monitoring associated with poultry that have been infected with or 
exposed to H5/H7 LPAI;
    (2) Transfer of vaccine for H5/H7 LPAI to Cooperating State Agencies 
if provided for in the initial State response and containment plan 
approved by APHIS under Sec.56.10; and
    (3) Payment for vaccine administration by Cooperating State 
Agencies, if provided for in the initial State response and containment 
plan approved by APHIS under Sec.56.10.
    (b)(1) Any payment made to a State or an Official State Agency for 
the activities listed in paragraphs (a)(1) and (a)(3) of this section 
must be made through a cooperative agreement between the Cooperating 
State Agency and APHIS. The payment for which the Cooperating State 
Agency is eligible will be determined in the cooperative agreement.
    (i) For any Cooperating State Agency that participates in the 
National Poultry Improvement Plan diagnostic surveillance program for 
H5/H7 LPAI, as described in Sec.146.14 of this chapter, and has an 
initial State response and containment plan for H5/H7 LPAI that is 
approved by APHIS, as described in Sec.56.10 of this part, the 
cooperative agreement will provide that the Cooperating State Agency is 
eligible for payment of 100 percent of the costs of surveillance and 
monitoring and 100 percent of the costs of vaccine administration, as 
determined in the cooperative agreement.
    (ii) For any Cooperating State Agency that does not meet the 
criteria in paragraph (b)(1)(i) of this section, the cooperative 
agreement will provide that the Cooperating State Agency is eligible for 
payment of 25 percent of the costs of surveillance and monitoring and 25 
percent of the costs of vaccine administration, as determined in the 
cooperative agreement.
    (2) Transfer of vaccine under paragraph (a)(2) of this section must 
be accomplished through a cooperative agreement between the Cooperating 
State Agency and APHIS.
    (c) Cooperating State Agencies will be responsible for making the 
determination to request Federal assistance under this part in the event 
of an outbreak of H5/H7 LPAI.

[71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10656, Mar. 9, 2010]



Sec.56.3  Payment of indemnity and/or compensation.

    (a) Activities eligible for indemnity and/or compensation. The 
Administrator may pay indemnity and/or compensation for the activities 
listed in this paragraph (a), as provided in paragraph (b) of this 
section:
    (1) Destruction and disposal of poultry that were infected with or 
exposed to H5/H7 LPAI;
    (2) Destruction of any eggs destroyed during testing of poultry for 
H5/H7 LPAI during an outbreak of H5/H7 LPAI; and
    (3) Cleaning and disinfection of premises, conveyances, and 
materials that came into contact with poultry that were infected with or 
exposed to H5/H7 LPAI; or, in the case of materials, if the cost of 
cleaning and disinfection would exceed the value of the materials or 
cleaning and disinfection would be impracticable for any reason, the 
destruction and disposal of the materials.
    (b) Percentage of costs eligible for indemnity and/or compensation. 
Except for poultry that are described by the categories in this 
paragraph (b), the Administrator is authorized to pay 100 percent of the 
costs and/or compensation, as determined in accordance with Sec.56.4, 
of the activities described in paragraphs (a)(1) through (3) of this 
section, regardless of whether the infected or exposed poultry 
participate in the Plan. For infected or exposed poultry that are 
described by the categories in this paragraph (b), the Administrator is 
authorized to pay 25 percent of the costs of the activities described in 
paragraphs (a)(1) through (3) of this section:
    (1)(i) The poultry are from a breeding flock, commercial flock, or 
slaughter plant that participates in any Plan program in part 145 or 146 
of this chapter but that does not participate in the

[[Page 212]]

U.S. Avian Influenza Clean, U.S. H5/H7 Avian Influenza Clean, or U.S. 
H5/H7 Avian Influenza Monitored program of the Plan available to the 
flock in part 145 or 146 of this chapter; and
    (ii) The poultry are from:
    (A) A commercial table-egg laying premises with at least 75,000 
birds; or
    (B) A meat-type chicken slaughter plant that slaughters at least 
200,000 meat-type chickens in an operating week; or
    (C) A meat-type turkey slaughter plant that slaughters at least 2 
million meat-type turkeys in a 12-month period; or
    (D) A commercial waterfowl and commercial upland game bird slaughter 
plant that slaughters at least 50,000 birds annually; or
    (E) A raised-for-release upland game bird premises, raised-for-
release waterfowl premises, and commercial upland game bird or 
commercial waterfowl producing eggs for human consumption premises that 
raise at least 25,000 birds annually; or
    (F) A breeder flock premises with at least 5,000 birds.
    (2) The poultry are located in a State that does not participate in 
the diagnostic surveillance program for H5/H7 LPAI, as described in 
Sec.146.14 of this chapter, or that does not have an initial State 
response and containment plan for H5/H7 LPAI that is approved by APHIS 
under Sec.56.10, unless such poultry participate in the Plan with 
another State that does participate in the diagnostic surveillance 
program for H5/H7 LPAI, as described in Sec.146.14 of this chapter, 
and has an initial State response and containment plan for H5/H7 LPAI 
that is approved by APHIS under Sec.56.10.
    (c) Other sources of payment. If the recipient of indemnity and/or 
compensation for any of the activities listed in paragraphs (a)(1) 
through (3) of this section also receives payment for any of those 
activities from a State or from other sources, the indemnity and/or 
compensation provided under this part may be reduced by the total amount 
of payment received from the State or other sources to the extent that 
total payments do not exceed 100 percent of total reimbursable indemnity 
and/or compensation amounts.

[71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10657, Mar. 9, 2010; 
76 FR 15792, Mar. 22, 2011; 76 FR 65935, Oct. 25, 2011; 85 FR 62562, 
Oct. 5, 2020]



Sec.56.4  Determination of indemnity and/or compensation amounts.

    (a) Destruction and disposal of poultry. (1) Indemnity for the 
destruction of poultry and/or eggs infected with or exposed to H5/H7 
LPAI will be based on the fair market value of the poultry and/or eggs, 
as determined by an appraisal. Poultry infected with or exposed to H5/H7 
LPAI that are removed by APHIS or a Cooperating State Agency from a 
flock will be appraised by an APHIS official appraiser and a State 
official appraiser jointly, or, if APHIS and State authorities agree, by 
either an APHIS official appraiser or a State official appraiser alone. 
For laying hens, the appraised value should include the hen's projected 
future egg production. Appraisals of poultry must be reported on forms 
furnished by APHIS and signed by the appraisers and must be signed by 
the owners of the poultry to indicate agreement with the appraisal 
amount. Appraisals of poultry must be signed by the owners of the 
poultry prior to the destruction of the poultry, unless the owners, 
APHIS, and the Cooperating State Agency agree that the poultry may be 
destroyed immediately. Reports of appraisals must show the number of 
birds and the value per head.
    (2) Compensation for disposal of poultry and/or eggs infected with 
or exposed to H5/H7 LPAI will be based on receipts or other 
documentation maintained by the claimant verifying expenditures for 
disposal activities authorized by this part. Any disposal of poultry 
infected with or exposed to H5/H7 LPAI for which compensation is 
requested must be performed under a compliance agreement between the 
claimant and APHIS. APHIS will review claims for compensation for 
disposal to ensure that all expenditures relate directly to activities 
described in Sec.56.5 and in the initial State response and 
containment plan described in Sec.56.10. If disposal is performed by 
the Cooperating State Agency, APHIS

[[Page 213]]

will compensate the Cooperating State Agency for disposal under a 
cooperative agreement.
    (3) The destruction and disposal of the poultry and/or eggs must be 
conducted in accordance with the initial State response and containment 
plan for H5/H7 LPAI, as described in Sec.56.10.
    (b) Cleaning and disinfection (virus elimination). (1) Compensation 
for cleaning and disinfection (virus elimination) of premises, 
conveyances, and materials that came into contact with poultry that are 
infected with or exposed to H5/H7 LPAI will be determined using the 
current APHIS flat-rate virus elimination (VE) calculator in effect at 
the time of the infection, except in instances when the claimant and 
APHIS jointly agree the VE calculator is not applicable to the premises 
type.
    (2) For premises types for which a flat-rate VE calculator is not 
applicable, reimbursement will be based on receipts or other 
documentation maintained by the claimant verifying expenditures for 
cleaning and disinfection (virus elimination) activities authorized by 
this part. Any cleaning and disinfection (virus elimination) of 
premises, conveyances, and materials for which compensation is requested 
must be performed under a compliance agreement between the claimant, the 
Cooperating State Agency, and APHIS. APHIS will review claims for 
compensation for cleaning and disinfection (virus elimination) to ensure 
that all expenditures relate directly to activities described in Sec.
56.5 and in the initial State response and containment plan described in 
Sec.56.10.
    (i) In the case of materials, if the cost of cleaning and 
disinfection (virus elimination) would exceed the value of the materials 
or cleaning and disinfection (virus elimination) would be impracticable 
for any reason, compensation for the destruction of the materials will 
be based on the fair market value (depreciated value) of those 
materials, as determined by an appraisal. Materials will be appraised by 
an APHIS official appraiser. Compensation for disposal of the materials 
will be based on receipts or other documentation maintained by the 
claimant verifying expenditures for disposal activities authorized by 
this part. Appraisals of materials must be reported on forms furnished 
by APHIS and must be signed by the appraisers and by the owners of the 
materials to indicate agreement with the appraisal amount. Appraisals of 
materials must be signed and received by APHIS prior to the disassembly 
or destruction of the materials, unless the owners, APHIS, and the 
Cooperating State Agency agree in writing that the materials may be 
disassembled and/or destroyed immediately. Any disposal of materials for 
which compensation is requested must be performed under a compliance 
agreement between the claimant, the Cooperating State Agency, and APHIS. 
APHIS will review claims for compensation for disposal to ensure that 
all expenditures relate directly to activities described in Sec.56.5 
and in the initial State response and containment plan described in 
Sec.56.10.
    (ii) [Reserved]
    (c) Requirements for compliance agreements. The compliance agreement 
is a comprehensive document that describes the depopulation, disposal, 
and cleaning and disinfection plans for poultry that were infected with 
or exposed to H5/H7 LPAI, or a premises that contained such poultry. The 
compliance agreement must set out cost estimates that include labor, 
materials, supplies, equipment, personal protective equipment, and any 
additional information deemed necessary by APHIS. A compliance agreement 
is comparable to a statement of work and must indicate what tasks will 
be completed, who will be responsible for each task, and how much the 
work is expected to cost. A compliance agreement may also be referred to 
as a detailed financial plan. Once work associated with the compliance 
agreement is completed, receipts and documentation detailing the 
activities specified in the agreement should be forwarded to APHIS for 
review, approval, and final payment. This documentation should be 
submitted to APHIS no later than 30 days after the quarantine release of 
the affected or exposed premises.


(Approved by the Office of Management and Budget under control numbers 
0579-0007 and 0579-0474)

[85 FR 62563, Oct. 5, 2020]

[[Page 214]]



Sec.56.5  Destruction and disposal of poultry and cleaning and disinfection (virus elimination) of premises, conveyances, and materials.

    (a) Destruction of poultry. Poultry that are infected with or 
exposed to H5/H7 LPAI may be required to be destroyed at the discretion 
of the Cooperating State Agency and APHIS and in accordance with the 
initial State response and containment plan described in Sec.56.10. 
The Cooperating State Agency and APHIS will select a method to use for 
the destruction of such poultry based on the following factors:
    (1) The species, size, and number of the poultry to be destroyed;
    (2) The environment in which the poultry are maintained;
    (3) The risk to human health or safety of the method used;
    (4) Whether the method requires specialized equipment or training;
    (5) The risk that the method poses of spreading the H5/H7 LPAI 
virus;
    (6) Any hazard the method could pose to the environment;
    (7) The degree of bird control and restraint required to administer 
the destruction method;
    (8) The speed with which destruction must be conducted; and
    (9) Consistency of the method with humane euthanasia guidelines.
    (b) Disposal of poultry. Carcasses of poultry that have died from 
H5/H7 LPAI infection or poultry that have been humanely slaughtered to 
fulfill depopulation requirements must be disposed of promptly and 
efficiently in accordance with the initial State response and 
containment plan described in Sec.56.10 to prevent the spread of H5/H7 
LPAI infection. Disposal methods will be selected by the Cooperating 
State Agency and APHIS and may include one or more of the following: 
Burial, incineration, composting, or rendering. Regardless of the method 
used, strict biosecurity procedures must be implemented and enforced for 
all personnel and vehicular movement into and out of the area in 
accordance with the initial State response and containment plan to 
prevent dissemination of the H5/H7 LPAI virus.
    (c) Controlled marketing. (1) At the discretion of the Cooperating 
State Agency and APHIS, poultry that has been infected with or exposed 
to H5/H7 LPAI may be allowed to move for controlled marketing and 
maintain their current National Poultry Improvement Plan (NPIP) 
certifications in accordance with the initial State response and 
containment plan described in Sec.56.10 and in accordance with the 
following requirements:
    (i) Poultry infected with or exposed to H5/H7 LPAI must not be 
transported to a market for controlled marketing until approved by the 
Cooperating State Agency in accordance with the initial State response 
and containment plan described in Sec.56.10.
    (ii) Within 7 days prior to slaughter, each flock to be moved for 
controlled marketing must be tested for H5/H7 LPAI using a test approved 
by the Cooperating State Agency and found to be free of the virus.
    (iii) Routes to slaughter must avoid other commercial poultry 
operations whenever possible. All load-out equipment, trailers, and 
trucks used on premises that have housed poultry that were infected with 
or exposed to H5/H7 LPAI must be cleaned and disinfected and not enter 
other poultry premises or facilities for 48 hours after removing such 
poultry from their premises.
    (iv) Flocks moved for controlled marketing must be the last poultry 
marketed during the week they are marketed.
    (2) Poultry moved for controlled marketing will not be eligible for 
indemnity under Sec.56.3. However, any costs related to cleaning and 
disinfection (virus elimination) of premises, conveyances, and materials 
that came into contact with poultry that are moved for controlled 
marketing will be eligible for compensation under Sec.56.3.
    (d) Cleaning and disinfection (virus elimination) of premises, 
conveyances, and materials. Premises, conveyances, and materials that 
came into contact with poultry infected with or exposed to H5/H7 LPAI 
must be cleaned and disinfected; Provided, that materials for which the 
cost of cleaning and disinfection would exceed the value of the 
materials or for which cleaning and disinfection would be impracticable 
for any reason may be destroyed and disposed. Cleaning and disinfection 
must be performed in accordance with the

[[Page 215]]

initial State response and containment plan described in Sec.56.10, 
which must be approved by APHIS. Cleaning and disinfection must also be 
performed in accordance with any applicable State and local 
environmental regulations.

[71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10657, Mar. 9, 2010; 
79 FR 38753, July 9, 2014; 85 FR 62563, Oct. 5, 2020]



Sec.56.6  Presentation of claims for indemnity and/or compensation.

    Claims for the following must be documented on a form furnished by 
APHIS and presented to an APHIS employee or the State representative 
authorized to accept the claims:
    (a) Indemnity for the value of poultry to be destroyed due to 
infection with or exposure to H5/H7 LPAI;
    (b) Indemnity for the value of eggs to be destroyed due to infection 
or exposure to H5/H7 LPAI; and
    (c) Compensation for the cost of cleaning and disinfection (virus 
elimination) of premises, conveyances, and materials that came into 
contact with poultry infected with or exposed to H5/H7 LPAI, or, in the 
case of materials, if the cost of cleaning and disinfection (virus 
elimination) would exceed the value of the materials or cleaning and 
disinfection (virus elimination) would be impracticable for any reason, 
the cost of destruction and disposal for the materials.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10657, Mar. 9, 2010; 
85 FR 62564, Oct. 5, 2020]



Sec.56.7  Mortgage against poultry or eggs.

    When poultry or eggs have been destroyed under this part, any claim 
for indemnity must be presented on forms furnished by APHIS. The owner 
of the poultry or eggs must certify on the forms that the poultry or 
eggs covered are, or are not, subject to any mortgage as defined in this 
part. If the owner states there is a mortgage, the owner and each person 
holding a mortgage on the poultry or eggs must sign the APHIS-furnished 
form, consenting to the payment of indemnity to the person specified on 
the form.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10657, Mar. 9, 2010]



Sec.56.8  Conditions for payment.

    (a) When poultry or eggs have been destroyed pursuant to this part, 
the Administrator shall pay claims to any party with which the owner of 
the poultry or eggs has entered into a contract for the growing or care 
of the poultry or eggs. The indemnity the Administrator shall pay to 
such a party or parties shall be determined as follows:
    (1) Divide the value of the contract the owner of the poultry or 
eggs entered into with another party for the growing and care of the 
poultry or eggs in dollars by the duration of the contract as it was 
signed prior to the H5/H7 LPAI outbreak in days;
    (2) Multiply this figure by the time in days between the date the 
other party began to provide services relating to the destroyed poultry 
or eggs under the contract and the date the poultry or eggs were 
destroyed due to H5/H7 LPAI.
    (b)(1) If indemnity for the destroyed poultry or eggs is being 
provided for 100 percent of eligible costs under Sec.56.3(b), the 
Administrator may pay contractors eligible for indemnity under this 
section 100 percent of the amount determined in paragraph (a) of this 
section.
    (2) If indemnity for the destroyed poultry or eggs is being provided 
for 25 percent of eligible costs under Sec.56.3(b), the Administrator 
may pay contractors eligible for indemnity under this section 25 percent 
of the amount determined in paragraph (a) of this section.
    (c) If a contractor receiving indemnity under this section has 
received any payment under his or her contract from the owner of the 
poultry or eggs at the time the poultry or eggs are destroyed, the 
amount of indemnity for which the contract grower is eligible will be 
reduced by the amount of the payment the contract grower has already 
received.
    (d) If indemnity is paid to a contractor under this section, the 
owner of the poultry or eggs will be eligible to

[[Page 216]]

receive the difference between the indemnity paid to the growers and the 
total amount of indemnity that may be paid for the poultry or eggs.
    (e) In the event that determination of indemnity to a party with 
which the owner of destroyed poultry or eggs has entered into a contract 
for the growing or care of the poultry or eggs using the method 
described in paragraph (a) of this section is determined to be 
impractical or inappropriate, APHIS may use any other method that the 
Administrator deems appropriate to make that determination.

[71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10657, Mar. 9, 2010; 
85 FR 62564, Oct. 5, 2020]



Sec.56.9  Claims not allowed.

    (a) The Department will not allow claims arising out of the 
destruction of poultry unless the poultry have been appraised as 
prescribed in this part and the owners have signed the appraisal form 
indicating agreement with the appraisal amount as required by Sec.
56.4(a).
    (b) The Department will not allow claims arising out of the 
destruction of poultry unless the owners have signed a written agreement 
with APHIS in which they agree that if they maintain poultry in the 
future on the premises used for poultry for which indemnity and/or 
compensation is paid, they will maintain the poultry in accordance with 
a plan set forth by the Cooperating State Agency and will not introduce 
poultry onto the premises until after the date specified by the 
Cooperating State Agency. Persons who do not maintain their poultry and 
premises in accordance with this written agreement will not be eligible 
to receive indemnity and/or compensation under this part.
    (c) The Department will not allow claims arising out of the 
destruction of poultry unless the poultry have been moved or handled by 
the owner in accordance with an agreement for the control and 
eradication of H5/H7 LPAI and in accordance with part 56, for any 
progeny of any poultry unless the poultry have been moved or handled by 
the owner in accordance with an agreement for the control and 
eradication of H5/H7 LPAI and in accordance with part 56, or for any 
poultry that become or have become infected with or exposed to H5/H7 
LPAI because of actions not in accordance with an agreement for the 
control and eradication of H5/H7 LPAI or a violation of this part.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10657, Mar. 9, 2010; 
85 FR 62564, Oct. 5, 2020]



Sec.56.10  Initial State response and containment plan.

    (a) In order for poultry owners within a State to be eligible for 
indemnity and/or compensation for 100 percent of eligible costs under 
Sec.56.3(b), the State in which the poultry participate in the Plan 
must have in place an initial State response and containment plan that 
has been approved by APHIS. The initial State response and containment 
plan must be developed by the Official State Agency. In States where the 
Official State Agency is different than the Cooperating State Agency, 
the Cooperating State Agency must also participate in the development of 
the plan. The plan must be administered by the Cooperating State Agency 
of the relevant State. This plan must include:
    (1) Provisions for a standing emergency disease management 
committee, regular meetings, and exercises, including coordination with 
any tribal governments that may be affected;
    (2) A minimum biosecurity plan followed by all poultry producers;
    (3) Provisions for adequate diagnostic resources;
    (4) Detailed, specific procedures for initial handling and 
investigation of suspected cases of H5/H7 LPAI;
    (5) Detailed, specific procedures for reporting test results to 
APHIS. These procedures must be developed after appropriate consultation 
with poultry producers in the State and must provide for the reporting 
only of confirmed cases of H5/H7 LPAI in accordance with Sec.146.13 of 
this chapter;
    (6) Detailed, strict quarantine measures for presumptive and 
confirmed index cases;
    (7) Provisions for developing flock plans for infected and exposed 
flocks;
    (8) Detailed plans for disposal of infected flocks, including 
preexisting agreements with regulatory agencies

[[Page 217]]

and detailed plans for carcass disposal, disposal sites, and resources 
for conducting disposal, and detailed plans for disposal of materials 
that come into contact with poultry infected with or exposed to H5/H7 
LPAI;
    (9) Detailed plans for cleaning and disinfection of premises, 
repopulation, and monitoring after repopulation;
    (10) Provisions for appropriate control/monitoring zones, contact 
surveys, and movement restrictions;
    (11) Provisions for monitoring activities in control zones;
    (12) If vaccination is considered as an option, a written plan for 
use in place with proper controls and provisions for APHIS approval of 
any use of vaccine;
    (13) Plans for H5/H7 LPAI-negative flocks that provide for 
quarantine, testing, and controlled marketing; and
    (14) Public awareness and education programs regarding avian 
influenza.
    (b) If a State is designated a U.S. Avian Influenza Monitored State, 
Layers under Sec.146.24(a) of this chapter or a U.S. Avian Influenza 
Monitored State, Turkeys under Sec.146.44(a) of this chapter, it will 
lose that status during any outbreak of H5/H7 LPAI and for 90 days after 
the destruction and disposal of all infected or exposed birds and 
cleaning and disinfection of all affected premises are completed.

(Approved by the Office of Management and Budget under control number 
0579-0474)

[71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10658, Mar. 9, 2010; 
85 FR 62564, Oct. 5, 2020]

[[Page 218]]



 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 219]]

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 [Reserved]
71.19 Identification of swine in interstate commerce.
71.20 Approval of livestock facilities.
71.21 Tissue and blood testing at slaughter.
71.22 Approval of laboratories to conduct official testing.

    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).
    Animal identification number (AIN). A numbering system for the 
official identification of individual animals in the United States that 
provides a nationally unique identification number for each animal. The 
AIN consists of 15 digits, with the first 3 being the country code (840 
for the United States or a unique country code for any U.S. territory 
that has such a code and elects to use it in place of the 840 code). The 
alpha characters USA or the numeric code assigned to the manufacturer of 
the identification device by the International Committee on Animal 
Recording may be used as an alternative to the 840 or other prefix 
representing a U.S territory; however, only the AIN beginning with the 
840 or other prefix representing a U.S. territory will be recognized as 
official for use on AIN tags applied to animals on or after March 11, 
2015. The AIN beginning with the 840 prefix may not be applied to 
animals known to have been born outside the United States.
    APHIS representative. An individual employed by APHIS who is 
authorized to perform the function involved.
    Approved laboratory. A laboratory approved by the Administrator to 
conduct official testing in accordance with the regulations in Sec.
71.22.
    Approved livestock facility. A stockyard, livestock market, buying 
station, concentration point, or any other premises under State or 
Federal veterinary supervision where livestock are assembled and that 
has been approved under 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.
    Breeding sheep and goats. Any sexually intact sheep or goat that is 
not moving either directly to slaughter or through one or more 
restricted sales and/or terminal feedlots and then directly to 
slaughter.
    Breeder swine. Sexually intact swine over 6 months of age.
    Commingling. The mixing or assembling of swine from one premises 
with swine from any other premises, including, but not limited to, 
loading swine from more than one premises on the same truck, trailer, 
vessel, or railroad car, unless swine from different premises are kept 
separate on the means of conveyance by dividers.
    Consistent States. Those States listed as consistent States in Sec.
79.1 of this subchapter because they meet certain standards, as provided 
in Sec.79.6 of this subchapter, for conducting an active

[[Page 220]]

State scrapie program involving the identification of scrapie in sheep 
and goats for the purpose of controlling the spread of scrapie.
    Department. The United States Department of Agriculture.
    Feeder swine. Swine under 6 months of age that are not slaughter 
swine.
    Flock-based number system. The flock-based number system combines a 
flock identification number (FIN) with a producer's unique livestock 
production numbering system to provide a nationally unique 
identification number for an animal.
    Flock identification number (FIN). A nationally unique number 
assigned by a State, Tribal, or Federal animal health authority to a 
group of animals that are managed as a unit on one or more premises and 
are under the same ownership.
    Food Safety and Inspection Service (FSIS). The Food Safety and 
Inspection Service, United States Department of Agriculture.
    Free area. The States, Territories, or the District of Columbia or 
portions thereof not quarantined by the Secretary of Agriculture for the 
specific contagious, infectious, or communicable animal disease 
mentioned in each part.
    Group/lot identification number (GIN). The identification number 
used to uniquely identify a ``unit of animals'' of the same species that 
is managed together as one group throughout the preharvest production 
chain. When a GIN is used, it is recorded on documents accompanying the 
animals moving interstate; it is not necessary to have the GIN attached 
to each animal.
    Horses. Horses, asses, mules, ponies, and zebras.
    Inconsistent States. Those States not included in the list of 
consistent States appearing in Sec.79.1 of this subchapter.
    Interstate. From one State into or through any other State.
    Interstate commerce. Trade, traffic, transportation, or other 
commerce between a place in a State and any place outside of that State, 
or between points within a State but through any place outside of that 
State.
    Interstate swine movement report. A paper or electronic document 
signed by a producer moving swine giving notice that a group of animals 
is being moved across State lines in a swine production system. This 
document must contain the name of the swine production system; the name, 
location, and premises identification number of the premises from which 
the swine are to be moved; the name, location, and premises 
identification number of the premises to which the swine are to be 
moved; the date of movement; and the number, age, and type of swine to 
be moved. This document must also contain a description of any 
individual or group identification associated with the swine, the name 
of the swine production system accredited veterinarian(s), the health 
status of the herd from which the swine are to be moved, including any 
disease of regulatory concern to APHIS or to the States involved, and an 
accurate statement that swine on the premises from which the swine are 
to be moved have been inspected by the swine production system 
accredited veterinarian(s) within 30 days prior to the interstate 
movement and consistent with the dates specified by the premises' swine 
production health plan and found free from signs of communicable 
disease.
    Livestock. All farm-raised animals.
    Livestock market. A stockyard, buying station, concentration point, 
or any other premises where livestock are assembled for sale or sale 
purposes.
    Move. To carry, enter, import, mail, ship, or transport; to aid, 
abet, cause, or induce carrying, entering, importing, mailing, shipping, 
or transporting; to offer to carry, enter, import, mail, ship, or 
transport; to receive in order to carry, enter, import, mail, ship, or 
transport; or to allow any of these activities.
    National Animal Health Laboratory Network (NAHLN). The NAHLN is a 
nationally coordinated network and partnership of primarily Federal, 
State, and university-associated animal health laboratories that provide 
animal health diagnostic testing, methods research and development, and 
expertise for education and extension to detect biological threats to 
the nation's animal agriculture, thus protecting animal health, public 
health, and the nation's food supply.

[[Page 221]]

    National Uniform Eartagging System (NUES). A numbering system for 
the official identification of individual animals in the United States 
that provides a nationally unique identification number for each animal.
    Official Brand Inspection Agency. The duly constituted body elected, 
appointed, or delegated or granted authority by a State or governmental 
subdivision thereof, to administer laws, regulations, ordinances or 
rules pertaining to the brand identification of livestock.
    Official brand inspection certificate. A certificate issued by an 
official brand inspection agency in any State in which such certificates 
are required for movement of livestock.
    Official eartag. An identification tag approved by APHIS that bears 
an official identification number for individual animals. Beginning 
March 11, 2014, all official eartags manufactured must bear an official 
eartag shield. Beginning March 11, 2015, all official eartags applied to 
animals must bear an official eartag shield. The design, size, shape, 
color, and other characteristics of the official eartag will depend on 
the needs of the users, subject to the approval of the Administrator. 
The official eartag must be tamper-resistant and have a high retention 
rate in the animal.
    Official eartag shield. The shield-shaped graphic of the U.S. Route 
Shield with ``U.S.'' or the State postal abbreviation or Tribal alpha 
code imprinted within the shield.
    Official identification device or method. A means approved by the 
Administrator of applying an official identification number to an animal 
of a specific species or associating an official identification number 
with an animal or group of animals of a specific species.
    Official identification number. A nationally unique number that is 
permanently associated with an animal or group of animals and that 
adheres to one of the following systems:
    (1) National Uniform Eartagging System (NUES).
    (2) Animal identification number (AIN).
    (3) Location-based number system.
    (4) Flock-based number system.
    (5) Any other numbering system approved by the Administrator for the 
official identification of animals.
    Official swine tattoo. A tattoo, conforming to the six-character 
alpha-numeric National Tattoo System, that provides a unique 
identification for each herd or lot of swine.
    Official testing. Testing to determine the disease status of animals 
for use in State-Federal programs. Tests are approved by the 
Administrator and conducted by qualified analysts in an approved 
laboratory.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, or joint stock company, or other legal entity.
    Premises. A location where livestock or poultry are housed or kept.
    Premises identification number (PIN). A nationally unique number 
assigned by a State, Tribal, and/or Federal animal health authority to a 
premises that is, in the judgment of the State, Tribal, and/or Federal 
animal health authority a geographically distinct location from other 
premises. The PIN may be used in conjunction with a producer's own 
unique livestock production numbering system to provide a nationally 
unique and herd-unique identification number for an animal. It may be 
used as a component of a group/lot identification number (GIN).
    Purebred registry association. A swine breed association formed and 
perpetuated for the maintenance of records of purebreeding of swine 
species for a specific breed whose characteristics are set forth in 
constitutions, by-laws, and other rules of the association.
    Quarantined area. The States, Territories, or the District of 
Columbia or portions thereof quarantined by the Secretary of Agriculture 
for the specific contagious, infectious, or communicable animal disease 
mentioned in each part.
    Slaughter swine. Swine being sold or moved for slaughter purposes 
only.
    State. Any of the 50 States, the Commonwealth of Puerto Rico, the 
Commonwealth of the Northern Mariana Islands, the District of Columbia, 
and any territories and possessions of the United States.
    State animal health official. The State official responsible for 
livestock and

[[Page 222]]

poultry disease control and eradication programs.
    State representative. An individual employed in animal health work 
by a State or a political subdivision thereof and authorized by such 
State or political subdivision to perform the function involved.
    Swine production health plan. A written agreement developed for a 
swine production system designed to maintain the health of the swine and 
detect signs of communicable disease.
    The plan must identify all premises that are part of the swine 
production system and that receive or send swine in interstate commerce 
and must provide for health monitoring of all swine within the system. 
Such health monitoring must include inspections by the swine production 
system accredited veterinarian(s). Inspections of all identified 
premises that contain swine that are or will be in the process of moving 
interstate within the swine production system and of all swine on those 
premises must be conducted by the accredited veterinarian(s) at 
intervals of no greater than 30 days. Inspections of all identified 
receiving premises that contain only swine that have completed their 
interstate movement within a single swine production system and of all 
swine on those premises must be conducted in accordance with State 
regulations. The plan must also describe the recordkeeping system of the 
swine production system. The plan will not be valid unless it is signed 
by an official of each swine production system identified in the plan, 
the swine production system accredited veterinarian(s), an APHIS 
representative, and the State animal health official from each State in 
which the swine production system has premises. In the plan, the swine 
production system must acknowledge that it has been informed of and has 
notified the managers of all its premises listed in the plan that any 
failure of the participants in the swine production system to abide by 
the provisions of the plan and the applicable provisions of this part 
and part 85 of this chapter constitutes a basis for the cancellation of 
the swine production health plan, as well as other administrative or 
criminal sanctions, as appropriate.
    Swine production system. A swine production enterprise that consists 
of multiple sites of production; i.e., sow herds, nursery herds, and 
growing or finishing herds, but not including slaughter plants or 
livestock markets, that are connected by ownership or contractual 
relationships, between which swine move while remaining under the 
control of a single owner or a group of contractually connected owners.
    Swine production system accredited veterinarian. An accredited 
veterinarian who is named in a swine production health plan for a 
premises within a swine production system and who performs inspection of 
such premises and animals and other duties related to the movement of 
swine in a swine production system.
    Tick infested. Infested with the ticks Boophilus annulatus 
(Margaropus annulatus), Boophilus microplus, or Rhipicephalus evertsi 
evertsi.
    United States. All of the States.
    United States Department of Agriculture (USDA) approved backtag. A 
backtag issued by APHIS that provides a temporary unique identification 
for each animal.

[28 FR 5937, June 13, 1963]

    Editorial Note: For Federal Register citations affecting Sec.71.1, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfo.gov.



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

[[Page 223]]

from the quarantined area or will indicate the regulations under which 
interstate movements may be made.

[34 FR 15641, Oct. 9, 1969]



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, African 
swine fever, classical swine fever, Teschen disease, contagious bovine 
pleuropneumonia, highly pathogenic avian influenza, dourine, contagious 
equine metritis, vesicular exanthema, screwworms and glanders, scabies 
in sheep or any other communicable foreign disease not known to exist in 
the United States, shall not be moved interstate.
    (c) Notwithstanding the provisions of paragraphs (a) and (b) of this 
section:
    (1) Domestic animals that have reacted to an official test for 
brucellosis, are not affected with any other disease referred to in this 
section, and are not tick infested may be moved interstate in accordance 
with part 78 of this chapter.
    (2) Domestic animals that are positive to an official Johne's 
disease test, are not affected with any other disease referred to in 
this section, and are not tick infested may be moved interstate in 
accordance with part 80 of this chapter.
    (3) Cattle which have reacted to the tuberculin test, which are not 
affected with any other disease referred to in this section and are not 
tick infested, may be moved interstate in accordance with the provisions 
of 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.
    (5) [Reserved]
    (6) Sheep or goats designated, with regard to scrapie, as exposed 
animals, high-risk animals, suspect animals, or scrapie-positive 
animals, as those terms are defined in part 79 of this subchapter, may 
be moved interstate only in accordance with part 79 of this subchapter.
    (d) Notwithstanding the provisions of paragraphs (a) and (b) of this 
section, livestock which is found to be diseased may be moved interstate 
in accordance with paragraphs (d)(1) through (6) of this section: 
Provided, That such livestock is not tick infested or affected with any 
disease referred to in this section other than the diseases named in 
this paragraph: And provided further, That such livestock is accompanied 
by a certificate, issued by an APHIS or State representative or 
accredited veterinarian stating the destination of the animals; the 
purpose for which they are to be moved; the number of animals covered by 
the certificate; the point from which the animals are moved interstate; 
and the name and address of the owner or shipper.
    (1) Livestock affected with one or more of the following diseases 
may be moved interstate for immediate slaughter to a slaughtering 
establishment where State or Federal meat inspection is maintained; 
Actinomycosis, actinobacillosis, anaplasmosis, atrophic rhinitis, 
contagious ecthyma, foot rot, infectious keratitis, ram epididymitis, 
ringworm, swine influenza, arthritis (simple lesions only), and shipping 
fever.
    (2) Cattle with slight unopened cases of actinomycosis or 
actinobacillosis (or both) may be moved interstate to a feed lot in the 
State of destination: Provided, That such cattle are not affected with 
any other disease named in this paragraph.
    (3) Sheep affected with or exposed to contagious ecthyma may be 
moved interstate to a feed lot located in a State the laws, rules, or 
regulations of which require that such sheep be segregated or 
quarantined under a permit from an official of such State: Provided,

[[Page 224]]

That such sheep are not affected with any other disease named in this 
paragraph.
    (4) Livestock affected with one or more of the following diseases 
may be moved interstate for any purpose to a State the laws, rules, or 
regulations of which require that such livestock be segregated or 
quarantined under a permit from the appropriate livestock sanitary 
official of such State: actinomycosis, actinobacillosis, contagious 
ecthyma, foot rot, and shipping fever: Provided, That such livestock is 
not affected with any other disease named in this paragraph.
    (5) Livestock affected with infectious keratitis or ringworm (or 
both) may be moved interstate for any purpose if treated under the 
supervision of an APHIS or State representative or an accredited 
veterinarian prior to movement: Provided, That such livestock is not 
affected with any other disease named in this paragraph. Livestock 
affected with infectious keratitis or ringworm (or both) and also with 
another disease named in this paragraph may be moved interstate only 
under the applicable provisions of paragraphs (d)(1) through (4) of this 
section after being so treated for infectious keratitis or ringworm (or 
both). Such livestock will be subject to further treatment at 
destination, if required.
    (6) Fish affected with spring viremia of carp may be moved 
interstate only if they are being moved directly to a facility to be 
processed into food for human consumption.
    (7) Other movements. The Administrator may provide for the movement, 
not otherwise provided for in this paragraph, of animals affected with 
the diseases named in paragraph (d)(1) of this section, under such 
conditions as he may prescribe to prevent the spread of disease. The 
Administrator will promptly notify the appropriate livestock sanitary 
officials of the States involved of any such action.
    (e) Notwithstanding the provisions of paragraphs (a) and (b) of this 
section, the Administrator in specific cases and under such conditions 
as he may prescribe to prevent the dissemination of disease may provide 
for the interstate movement of individual animals affected with 
contagious, infectious, or communicable disease to a designated 
diagnostic or research facility when accompanied by a permit from the 
appropriate livestock sanitary official in the State of destination: 
Provided, That animals so moved shall be maintained in quarantine at 
such designated facility until freed of disease as determined by tests 
recognized by the Department, until natural death, or until disposal by 
euthanasia.
    (f) Before offering cattle or other livestock or poultry for 
interstate transportation, transporting them interstate, or introducing 
them into any stockyards or upon routes of traffic for interstate 
transportation, all persons, companies, or corporations are required to 
exercise reasonable diligence to ascertain whether such animals or 
poultry are affected with any contagious, infectious, or communicable 
disease, or have been exposed to the contagion or infection of any such 
disease by contact with other animals or poultry so diseased or by 
location in pens, cars, or other vehicles, or upon premises that have 
contained animals or poultry so diseased.

[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 at www.govinfo.gov.



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

[[Page 225]]

71.12 by such person under the supervision of an APHIS or State 
representative or an accredited veterinarian before such premises are 
again used for livestock or poultry.
    (b) Yards, pens, chutes, alleys, and other facilities and premises 
which have contained interstate shipments of cattle, sheep, swine, 
poultry, or other animals affected with, or carrying the infection of, 
any contagious, infectious, or communicable disease of livestock or 
poultry other than slight unopened cases of actinomycosis or 
actinobacillosis (or both), bovine foot rot, atrophic rhinitis, ram 
epididymitis, ringworm, infectious keratitis, and arthritis (simple 
lesions only), shall be cleaned and disinfected under the supervision of 
an APHIS or State representative or an accredited veterinarian in 
accordance with 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, goats, swine, poultry, or other animals affected with, or 
carrying the infection of, any contagious, infectious, or communicable 
disease of livestock or poultry, other than slight unopened cases of 
actinomycosis or actinobacillosis (or both), atrophic rhinitis, bovine 
foot rot, brucellosis, ram epididymitis, ringworm, infectious keratitis, 
and arthritis (simple lesions only), shall be cleaned and disinfected 
under APHIS supervision in accordance with 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

[[Page 226]]

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; 74 FR 14709, Apr. 1, 2009]



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 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

[[Page 227]]

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]



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

[[Page 228]]

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 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]

[[Page 229]]



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]



Sec.71.18  [Reserved]



Sec.71.19  Identification of swine in interstate commerce.

    (a)(1) Except as provided in paragraphs (c) and (g) of this section, 
no swine may be sold, transported, received for transportation, or 
offered for sale or transportation, in interstate commerce, unless each 
swine is identified at whichever of the following comes first:
    (i) The point of first commingling of the swine in interstate 
commerce with swine from any other source;
    (ii) Upon unloading of the swine in interstate commerce at any 
livestock market;
    (iii) Upon transfer of ownership of the swine in interstate 
commerce; or
    (iv) Upon arrival of the swine in interstate commerce at their final 
destination.
    (2) The identification shall be by means of identification approved 
by the Administrator and listed in paragraph (b) of this section. All 
swine shall remain so identified while they are in interstate commerce.
    (3) Each person who buys or sells, for his or her own account or as 
the agent of the buyer or seller, transports, receives for 
transportation, offers for sale or transportation, or otherwise handles 
swine in interstate commerce, is responsible for the identification of 
the swine as provided by this section.
    (b) Means of swine identification approved by the Administrator are:
    (1) Official eartags, when used on any swine;
    (2) United States Department of Agriculture (USDA) approved backtag, 
when used on swine moving to slaughter;
    (3) Official swine tattoos, when used on swine moving to slaughter, 
when the use of the official swine tattoo has been requested by a user 
or the State animal health official, and the Administrator authorizes 
its use in writing based on a determination that the tattoo will be 
retained and visible on the carcass of the swine after slaughter, so as 
to provide identification of the swine;
    (4) Tattoos of at least 4-characters when used on swine moving to 
slaughter, except sows and boars as provided in 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;
    (7) For slaughter swine and feeder swine, an eartag or tattoo 
bearing the premises identification number assigned by the State animal 
health official to the premises on which the swine originated; and
    (8) Any other official identification device or method that is 
approved by the Administrator.
    (c) Swine that are kept as a group are not required to be 
individually identified when in interstate commerce if:
    (1) They were born on the same premises;
    (2) They were raised on the same premises where they were born;
    (3) They are moved in a group directly to a slaughtering 
establishment from the place where they were raised;
    (4) They are not mixed with swine from any other premises, between 
the time they are born and the time they arrive at the slaughtering 
establishment; and
    (5) They are slaughtered one after another, as a group, and not 
mixed with other swine at slaughter; or approved identification is 
applied to the swine after entry into the slaughtering establishment.
    (d) Serial numbers of United States Department of Agriculture (USDA) 
approved backtag and official swine tattoos will be assigned to each 
person

[[Page 230]]

who applies to the State animal health official or the area veterinarian 
in charge for the State in which that person maintains his/her or its 
place of business. Serial numbers of official eartags will be assigned 
to each accredited veterinarian or State or Federal representative who 
requests official eartags from the State animal health official or the 
area veterinarian in charge, whoever is responsible for issuing official 
eartags in that State. Persons assigned serial numbers of United States 
Department of Agriculture (USDA) approved backtag, official swine 
tattoos, and official eartags must:
    (1) Record the following information on a document:
    (i) All serial numbers applied to the swine;
    (ii) Any other serial numbers and approved identification appearing 
on the swine that are needed to identify the swine to its previous owner 
and location;
    (iii) The street address, including the city and state, or the 
township, county, and state, of the premises where the approved means of 
identification were applied; and
    (iv) The telephone number, if available, of the person who owns or 
possesses the swine.
    (2) Maintain these records at the person's place of business for 2 
years; and
    (3) Make these records available for inspection and copying during 
ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday) 
upon request by any authorized employee of the United States Department 
of Agriculture, upon that employee's request and presentation of his or 
her official credentials.
    (e)(1) Each person who buys or sells, for his or her own account or 
as the agent of the buyer or seller, transports, receives for 
transportation, offers for sale or transportation, or otherwise handles 
swine in interstate commerce, must keep records relating to the transfer 
of ownership, shipment, or handling of the swine, such as yarding 
receipts, sale tickets, invoices, and waybills upon which is recorded:
    (i) All serial numbers and other approved means of identification 
appearing on the swine that are necessary to identify it to the person 
from whom it was purchased or otherwise obtained; and
    (ii) The street address, including city and state, or the township, 
county, and state, and the telephone number, if available, of the person 
from whom the swine were purchased or otherwise obtained.
    (2) Each person required to keep records under this paragraph must 
maintain the records at his/her or its place of business for at least 2 
years after the person has sold or otherwise disposed of the swine to 
another person, and for such further period as the Administrator may 
require by written notice to the person, for purposes of any 
investigation or action involving the swine identified in the records. 
The person shall make the records available for inspection and copying 
during ordinary business hours (8 a.m. to 5:30 p.m., Monday through 
Friday) by any authorized employee of the United States Department of 
Agriculture, upon that employee's request and presentation of his or her 
official credentials.
    (f) No person may remove or tamper with any approved means of 
identification required to be on swine pursuant to this section while it 
is in interstate commerce, except at the time of slaughter as provided 
in 9 CFR 309.16(e).
    (g) Swine moving interstate within a swine production system. Swine 
moving within a swine production system to other than slaughter or a 
livestock market are not required to be individually identified when 
moved in interstate commerce under the following conditions:
    (1) The swine may be moved interstate only to another premises 
identified in a valid swine production health plan for that swine 
production system.
    (2) The swine production system must operate under a valid swine 
production health plan, in which both the sending and receiving States 
have agreed to allow the movement.
    (3) The swine must have been found free from signs of any 
communicable

[[Page 231]]

disease during the most recent inspection of the premises by the swine 
production system accredited veterinarian(s) within 30 days prior to 
movement.
    (4) Prior to the movement of any swine, the producer(s) moving swine 
must deliver the required interstate swine movement report to the 
following individuals identified in the swine production health plan:
    (i) The swine production system accredited veterinarian for the 
premises from which the swine are to be moved, and
    (ii) The State animal health officials for the sending and receiving 
States, and any other State employees designated by the State animal 
health officials.
    (5) The receiving premises must not commingle swine received from 
different premises in a manner that prevents identification of the 
premises that sent the swine or groups of swine. This may be achieved by 
use of permanent premises or individual identification marks on animals, 
by keeping groups of animals received from one premises physically 
separate from animals received from other premises, or by any other 
effective means.
    (6) Each premises must maintain, for 3 years after their date of 
creation, records that will allow an APHIS representative or State 
animal health official to trace any animal on the premises back to its 
previous premises, and must maintain copies of each swine production 
health plan signed by the producer, all interstate swine movement 
reports issued by the producer, and all reports the swine production 
system accredited veterinarian(s) issue documenting the health status of 
the swine on the premises.
    (7) Each premises must allow APHIS representatives and State animal 
health officials access to the premises upon request to inspect animals 
and review records.
    (8) Once a month, each swine production system must send APHIS a 
written summary based on the interstate swine movement report data that 
shows how many animals were moved in the past month, the premises from 
which they were moved, and the premises to which they were moved.
    (h) Cancellation of and withdrawal from a swine production health 
plan. The following procedures apply to cancellation of, or withdrawal 
from, a swine production health plan:
    (1) A State animal health official may cancel his or her State's 
participation in a swine production health plan by giving written notice 
to all swine producers, APHIS representatives, accredited veterinarians, 
and other State animal health officials listed in the plan. Withdrawal 
shall be effective upon the date specified by the State animal health 
official in the notice, but for shipments in transit, withdrawal shall 
become effective 7 days after the date of such notice. Upon withdrawal 
of a State, the swine production health plan may continue to operate 
among the other States and parties signatory to the plan.
    (2) A swine production system may withdraw one or more of its 
premises from participation in the plan upon giving written notice to 
the Administrator, the accredited veterinarian(s), all swine producers 
listed in the plan, and State animal health officials listed in the 
plan. Withdrawal shall be effective upon the date specified by the swine 
production system in the written notice, but for shipments in transit, 
withdrawal shall become effective 7 days after the date of such notice.
    (3) The Administrator may cancel a swine production health plan by 
giving written notice to all swine producers, accredited veterinarians, 
and State animal health officials listed in the plan. The Administrator 
shall cancel a swine production health plan after determining that swine 
movements within the swine production system have occurred that were not 
in compliance with the swine production health plan or with other 
requirements of this chapter. Before a swine health production plan is 
canceled, an APHIS representative will inform a representative of the 
swine production system of the reasons for the proposed cancellation. 
The swine production system may appeal the proposed cancellation in 
writing to the Administrator within 10 days after being informed of the 
reasons for the proposed cancellation. The appeal must include all of 
the facts and

[[Page 232]]

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; 69 FR 
64649, Nov. 8, 2004; 74 FR 14709, Apr. 1, 2009; 78 FR 2064, Jan. 9, 
2013]



Sec.71.20  Approval of livestock facilities.

    (a) To qualify for approval by the Administrator as an approved 
livestock facility \1\ and to retain such designation, the individual 
legally responsible for the day-to-day operations of the livestock 
facility shall execute the following agreement:
---------------------------------------------------------------------------

    \1\ 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, 79, and 85.
    (4) An APHIS representative, State representative, or accredited 
veterinarian shall be immediately notified of the presence at the 
facility of any livestock that are known to be infected, exposed, high-
risk and scrapie-positive or suspect, or that show signs of possibly 
being infected, with any infectious, contagious, or communicable 
disease.
    (5) Any reactor, suspect, exposed, high-risk, or scrapie positive 
livestock shall be held in quarantined pens apart from all other 
livestock at the facility. This requirement shall not apply to scrapie-
exposed sheep that are not also designated high-risk animals or to sheep 
or goats designated under 9 CFR part 79 as scrapie-exposed or high-risk 
animals that either are not pregnant based on the animal being male, an 
owner certification that any female animals have not been exposed to a 
male in the preceding 6 months, or a certificate issued by an accredited 
veterinarian stating the animals are open; or that the animals are under 
12 months of age and are not visibly pregnant and are maintained in the 
same pen only with other animals that will be moved directly to 
slaughter or to a terminal feedlot in accordance with 9 CFR parts 71 and 
79.
    (6) No reactor, suspect, exposed, high-risk, or scrapie-positive 
livestock, nor any livestock that show signs of being infected with any 
infectious, contagious, or communicable disease, may be sold at or moved 
from the facility, except in accordance with 9 CFR parts 71, 75, 78, 79, 
and 85.

[[Page 233]]

                                 Records

    (7) Documents such as weight tickets, sales slips, and records of 
origin, identification, and destination that related to livestock that 
are in, or that have been in, the facility shall be maintained by the 
facility. For poultry and swine, such documents must be kept for at 
least 2 years, and for cattle and bison, sheep and goats, cervids, and 
equines, for at least 5 years. APHIS representatives and State 
representatives shall be permitted to review and copy those documents 
during normal business hours.

                             Identification

    (8) All livestock must be officially identified in accordance with 
the applicable regulations in 9 CFR parts 71, 75, 78, 79, 85, and 86 at 
the time of, or prior to, entry into the facility.

                        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 as well as 9 CFR 54.7(e)(2) if the disease of concern is scrapie 
and the quarantined animal gave birth or aborted at the facility, before 
being used to pen livestock that are not reactor, suspect, exposed, 
high-risk, or scrapie-positive animals.
    (12) Quarantined pens shall have adequate drainage, and the floors 
and those parts of the walls of the quarantined pens with which reactor, 
suspect, exposed, high-risk, or scrapie-positive livestock, their 
excrement, or discharges may have contact shall be constructed of 
materials that are substantially impervious to moisture and able to 
withstand continued cleaning and disinfection.
    (13) Electrical outlets shall be provided at the chute area for 
branding purposes.

          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.

[[Page 234]]

    (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]
--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.
    (17) Sheep and goats:

--This facility will handle breeding sheep or goats: [Initials of 
operator, date]
--This facility will handle slaughter sheep or goats: [Initials of 
operator, date]
--This facility will handle scrapie-exposed goats or high-risk sheep or 
goats: [Initials of operator, date]
--This facility will not handle goats known to be scrapie-exposed or 
sheep or goats known to be high-risk animals, nor permit such animals to 
enter the facility: [Initials of operator, date]

    (i) All sheep and goats must be received, handled, and released by 
the facility only in accordance with 9 CFR parts 71 and 79.
    (ii) All sheep and goats at the facility must be officially 
identified and relevant records related to those identified animals must 
be maintained by the facility operator, as required under 9 CFR part 79.
    (iii) The identity of sheep and goats from consistent States and 
inconsistent States must be maintained by the facility operator.
    (iv) Sexually intact animals that do not meet the requirements of 
part 79 to be sold as breeding animals must be maintained in separated 
enclosures at all times from animals that may be offered for sale as 
breeding animals unless all animals maintained in an enclosure arrived 
at the facility as part of the same consignment and are separated prior 
to sale.
    (v) Any sheep or goats that are designated, with regard to scrapie, 
as high-risk, suspect or scrapie-positive animals, and goats designated 
with regard to scrapie as exposed animals, excluding slaughter sheep or 
goats that are designated as exposed or high-risk animals and are not 
pregnant, must be held in quarantined pens while at the facility.

[[Page 235]]

                                Approvals

    (18) Request for approval:
    I hereby request approval for this facility to operate as an 
approved livestock facility for the classes of livestock indicated in 
paragraphs (14) through (17) of this agreement. I acknowledge that I 
have received a copy of 9 CFR parts 71, 75, 78, 79, and 85, and 
acknowledge that I have been informed and understand that failure to 
abide by the provisions of this agreement and the applicable provisions 
of 9 CFR parts 71, 75, 78, 79, and 85 constitutes a basis for the 
withdrawal of this approval. [Printed name and signature of operator, 
date of signature]
    (19) Pre-approval inspection of livestock facility conducted by 
[printed name and title of APHIS representative] on [date of 
inspection].
    (20) Recommend approval:
    [Printed name and signature of State animal health official, date of 
signature]
    [Printed name and signature of area veterinarian in charge, date of 
signature]
    (21) Approval granted:
    [Printed name and signature of the Administrator, Animal and Plant 
Health Inspection Service, date of signature]

    (b) Denial and withdrawal of approval. The Administrator may deny or 
withdraw the approval of a livestock facility to receive livestock moved 
interstate under this subchapter upon a determination that the livestock 
facility is not or has not been maintained and operated in accordance 
with the agreement set forth in paragraph (a) of this section.
    (1) In the case of a denial, the operator of the facility will be 
informed of the reasons for the denial and may appeal the decision in 
writing to the Administrator within 10 days after receiving notification 
of the denial. The appeal must include all of the facts and reasons upon 
which the person relies to show that the livestock facility was 
wrongfully denied approval to receive livestock moved interstate under 
this subchapter. The Administrator will grant or deny the appeal in 
writing as promptly as circumstances permit, stating the reason for his 
or her decision. If there is a conflict as to any material fact, a 
hearing will be held to resolve the conflict. Rules of practice 
concerning the hearing will be adopted by the Administrator.
    (2) In the case of withdrawal, before such action is taken, the 
operator of the facility will be informed of the reasons for the 
proposed withdrawal. The operator of the facility may appeal the 
proposed withdrawal in writing to the Administrator within 10 days after 
being informed of the reasons for the proposed withdrawal. The appeal 
must include all of the facts and reasons upon which the person relies 
to show that the reasons for the proposed withdrawal are incorrect or do 
not support the withdrawal of the approval of the livestock facility to 
receive livestock moved interstate under this subchapter. The 
Administrator will grant or deny the appeal in writing as promptly as 
circumstances permit, stating the reason for his or her decision. If 
there is a conflict as to any material fact, a hearing will be held to 
resolve the conflict. Rules of practice concerning the hearing will be 
adopted by the Administrator. However, withdrawal shall become effective 
pending final determination in the proceeding when the Administrator 
determines that such action is necessary to protect the public health, 
interest, or safety. Such withdrawal shall be effective upon oral or 
written notification, whichever is earlier, to the operator of the 
facility. In the event of oral notification, written confirmation shall 
be given as promptly as circumstances allow. This withdrawal shall 
continue in effect pending the completion of the proceeding, and any 
judicial review thereof, unless otherwise ordered by the Administrator.
    (3) Approval for a livestock facility to handle livestock under this 
subchapter will be automatically withdrawn by the Administrator when:
    (i) The operator of the facility notifies the Administrator, in 
writing, that the facility no longer handles livestock moved interstate 
under this subchapter; or
    (ii) The person who signed the agreement executed in accordance with 
paragraph (a) of this section is no longer responsible for the day-to-
day operations of the facility.

(Approved by the Office of Management and Budget under control numbers 
0579-0258 and 0579-0342)

[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; 74 FR 14709, Apr. 1, 
2009; 78 FR 26489, May 7, 2013; 85 FR 4194, Jan. 24, 2020]

[[Page 236]]



Sec.71.21  Tissue and blood testing at slaughter.

    (a) Any person moving livestock or poultry interstate for slaughter 
or rendering may only move the animals to a slaughtering establishment 
or a rendering establishment that has been listed by the Administrator 
\2\ for the purposes of this part. Livestock or poultry may not be 
removed from the premises of a slaughtering establishment or a rendering 
establishment listed by the Administrator except under a permit issued 
by APHIS, and in accordance with applicable FSIS regulations in this 
title. A slaughtering establishment or rendering establishment may 
receive livestock or poultry in interstate commerce only if the 
establishment has been listed by the Administrator. The Administrator 
may list a slaughtering establishment or a rendering establishment after 
determining that collecting samples for testing from the establishment 
is not currently necessary for the purposes of APHIS disease 
surveillance programs and the establishment has agreed to allow testing 
and to provide the access and facilities required by this section upon 
future APHIS notification that testing is required at the establishment. 
The Administrator will list a slaughtering or rendering establishment 
after determining that it meets the following facility and access 
requirements:
---------------------------------------------------------------------------

    \2\ A list of these slaughtering or rendering establishments may be 
obtained by writing to National Center for Animal Health Programs, VS, 
APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (1) The owner or operator of the establishment must agree, in 
writing, to meet the requirements for a listed facility under this 
section by signing a listing agreement.
    (2) The establishment provides space and equipment in accordance 
with paragraph (b) of this section \3\ within their facility for blood 
and tissue sample collection;
---------------------------------------------------------------------------

    \3\ FSIS also has equipment and space requirements for official 
establishments at Sec.307.2(c) of this title.
---------------------------------------------------------------------------

    (3) The establishment allows APHIS, FSIS, or APHIS contractors to 
take blood and tissue samples from all livestock or poultry at the 
facility without cost to the United States, and specifically allows 
these personnel access to the processing line to collect samples; and
    (4) The establishment allows APHIS, FSIS, or APHIS contractors to 
record the identification of individual animals and retain any external 
or internal identification devices.
    (5) The management of the slaughtering or rendering establishment 
agrees that weight tickets, sales slips, and records of origin, 
identification, and destination that relate to livestock that are in, or 
have been in, the establishment will be maintained by the establishment. 
For poultry and swine, such documents must be kept for at least 2 years, 
and for cattle and bison, sheep and goats, cervids, and equines, for at 
least 5 years. APHIS, APHIS contractors, and State animal health 
representatives will be permitted to review and copy or scan these 
documents during normal business hours.
    (b) The establishment must provide office and sample collection 
space, including necessary furnishings, light, heat, and janitor 
service, rent free, for the use by APHIS, FSIS, or APHIS contractors 
collecting samples for blood and tissue testing under this section. The 
Administrator will inform each establishment of the exact amount and 
type of space required, taking into account whether APHIS will be 
conducting complete tests at the facility, or only collecting samples 
and sending them elsewhere for testing. At the discretion of the 
Administrator, small plants need not furnish facilities as prescribed in 
this section if adequate facilities exist in a nearby convenient 
location. In granting or denying listing of an establishment, the 
Administrator will consider whether the space at the facility:
    (1) Is conveniently located, properly ventilated, and provided with 
lockers suitable for the protection and storage of supplies;
    (2) Has sufficient light to be adequate for proper conduct of sample 
collection and processing;
    (3) Includes racks, receptacles, or other suitable devices for 
retaining such parts as the head, glands, and viscera, and all parts and 
blood to be

[[Page 237]]

collected, until after the post-mortem examination is completed;
    (4) Includes tables, benches, and other equipment on which sample 
collection and processing are to be performed, of such design, material, 
and construction as to enable sample collection and processing in a 
safe, ready, efficient, and clean manner;
    (5) Has adequate arrangements, including liquid soap and cleansers, 
for cleansing and disinfecting hands, dissection tools, floors, and 
other articles and places that may be contaminated by diseased carcasses 
or otherwise; and
    (6) Has adequate facilities, including denaturing materials, for the 
proper disposal in accordance with this chapter of tissue, blood, and 
other waste generated during test sample collection.
    (c) The Administrator will give the operator of the establishment 
actual notice that APHIS, FSIS, or an APHIS contractor will be taking 
blood and/or tissue samples at the establishment. The Administrator may 
give the operator of the establishment notice in any form or by any 
means that the Administrator reasonably believes will reach the operator 
of the establishment prior to the start of sample collection.
    (1) The notice will include the anticipated date and time sample 
collection will begin. The notice will also include the anticipated 
ending date and time.
    (2) The Administrator will give the operator of the establishment as 
much advance notice as possible. However, the actual amount of notice 
will depend on the specific situation.
    (d) Denial and withdrawal of listing. The Administrator may deny or 
withdraw the listing of an establishment upon a determination that the 
establishment is not in compliance with the requirements of this 
section.
    (1) In the case of a denial, the operator of the establishment will 
be informed of the reasons for the denial and may appeal the decision in 
writing to the Administrator within 10 days after receiving notification 
of the denial. The appeal must include all of the facts and reasons upon 
which the person relies to show that the establishment was wrongfully 
denied listing. The Administrator will grant or deny the appeal in 
writing as promptly as circumstances permit, stating the reason for his 
or her decision. If there is a conflict as to any material fact, a 
hearing will be held to resolve the conflict. Rules of practice 
concerning the hearing will be adopted by the Administrator.
    (2) In the case of withdrawal, before such action is taken, the 
operator of the establishment will be informed of the reasons for the 
proposed withdrawal. The operator of the establishment may appeal the 
proposed withdrawal in writing to the Administrator within 10 days after 
being informed of the reasons for the proposed withdrawal. The appeal 
must include all of the facts and reasons upon which the person relies 
to show that the reasons for the proposed withdrawal are incorrect or do 
not support the withdrawal of the listing. The Administrator will grant 
or deny the appeal in writing as promptly as circumstances permit, 
stating the reason for his or her decision. If there is a conflict as to 
any material fact, a hearing will be held to resolve the conflict. Rules 
of practice concerning the hearing will be adopted by the Administrator. 
However, withdrawal shall become effective pending final determination 
in the proceeding when the Administrator determines that such action is 
necessary to protect the public health, interest, or safety. Such 
withdrawal shall be effective upon oral or written notification, 
whichever is earlier, to the operator of the establishment. In the event 
of oral notification, written confirmation shall be given as promptly as 
circumstances allow. This withdrawal shall continue in effect pending 
the completion of the proceeding, and any judicial review thereof, 
unless otherwise ordered by the Administrator.

(Approved by the Office of Management and Budget under control numbers 
0579-0212 and 0579-0342)

[69 FR 10150, Mar. 4, 2004, as amended at 78 FR 26489, May 7, 2013; 85 
FR 4194, Jan. 24, 2020]



Sec.71.22  Approval of laboratories to conduct official testing.

    (a) Approvals. State, university, and private laboratories must 
obtain APHIS approval to conduct official testing for those diseases 
covered by

[[Page 238]]

subchapters B, C, and D of this chapter. Laboratories seeking approval 
must meet the requirements of this section.
    (b) Facilities. Official testing must be performed in laboratory 
facilities with controlled conditions, instrumentation appropriate for 
the testing being conducted, and biosecurity measures commensurate with 
the disease of diagnostic concern; each of these facility requirements 
must be acceptable to APHIS. Approved laboratories must agree to 
periodic, unannounced inspection by APHIS personnel or other APHIS-
approved inspectors following an APHIS-approved checklist.
    (c) Quality system. Laboratories must operate under a quality system 
acceptable to APHIS. Components of such systems include acceptable 
documentation of procedures, recordkeeping, training, reporting, and 
corrective actions taken if standards and procedures are not reached or 
maintained. Adherence to certain nationally or internationally 
established quality systems recognized by APHIS may be used to meet all 
or part of this requirement.\4\ Quality system records are subject to 
review during facility inspections.
---------------------------------------------------------------------------

    \4\ A list of established quality systems recognized by APHIS is 
available on the internet at https://www.nahln.org.
---------------------------------------------------------------------------

    (d) Procedures. All official testing must be conducted using APHIS-
approved assay methods,\5\ which may include standard operating 
procedures recognized by the National Veterinary Services Laboratories 
(NVSL) or National Animal Health Laboratory Network, and/or diagnostic 
test kits licensed by the USDA.
---------------------------------------------------------------------------

    \5\ A list of approved assay methods is available on the APHIS 
Laboratory Portal website at https://www.nahln.org and at https://
www.aphis.usda.gov/aphis/ ourfocus/animalhealth/ animal-disease-
information.
---------------------------------------------------------------------------

    (e) Training. Official testing must be conducted only by those 
individuals who have completed APHIS-approved training and have passed 
proficiency tests administered by APHIS or its official designee. These 
tests will be administered annually or as necessary at an interval 
stipulated by APHIS. Supervisory oversight of official testing must be 
performed by qualified individuals, as determined by APHIS.
    (f) Reporting. Approved laboratories must report test results to 
APHIS and State animal health officials using an individualized (by 
disease) timeline established by APHIS at the time of laboratory 
approval.
    (g) Applications for approval. (1) Laboratories must use APHIS 
application forms, including an agreement to meet the obligations to 
APHIS listed in this section, and submit completed forms to the NVSL 
Director. The Director will make a preliminary determination of the 
application's acceptability, based on initial review of submitted 
materials and, when appropriate, a needs assessment for diagnostic 
capacity. These determinations are made on an annual basis, or as needed 
based on the number of applications received.
    (2) Applicants will be informed of the preliminary determination. If 
positive, applicants will then be able to request a facility inspection 
and personnel training, conducted in accordance with this section. If 
negative, APHIS will provide a rationale for the denial. Denied 
applicants may appeal any denials in accordance with the regulations in 
paragraph (j) of this section;
    (3) When all requirements in this section have been met, the NVSL 
Director will issue a final approval. Approvals are specific to those 
lab personnel working at the inspected, approved laboratory who have met 
the eligibility and proficiency requirements. Denied applicants may 
appeal any denials in accordance with the regulations in paragraph (j) 
of this section.
    (h) Maintenance of approved status. (1) Previously approved 
laboratories that wish to maintain their approved status must reapply 
for APHIS approval at least 1 month before their approval term expires, 
or at least every 2 years, whichever comes first. Laboratories wishing 
to maintain approved status must submit a renewal application form, as 
supplied by APHIS, to the NVSL Director.
    (2) Approved laboratories must have at least one individual with the 
required training and unexpired proficiency certification in their 
employ at all times.
    (3) Approved laboratories must perform the minimum number of tests 
to maintain proficiency, as stipulated by

[[Page 239]]

APHIS in the guidance documents developed for individual test types.
    (i) Probation, suspension, and rescission of laboratory approval. 
(1) Laboratories not conducting the minimum number of tests as required 
by paragraph (h)(3) of this section during a single reporting period 
will be assigned probationary status. A reporting period is less than or 
equal to the time for which the laboratory has been approved to conduct 
testing by APHIS. Laboratories on probation may continue to conduct 
official testing. If the minimum required number of tests are not 
performed during two consecutive reporting periods, the laboratory will 
not be eligible for renewal of APHIS approval. Exceptions to this 
requirement may be granted by the NVSL Director upon request.
    (2) Approval to conduct official testing will be suspended in the 
event that a laboratory experiences changes that may impact its ability 
to provide quality testing services. These changes include: No longer 
employing an individual approved to conduct official testing, a move to 
different facilities, or a natural disaster that impacts power or water 
systems. Laboratories with suspended status will not be approved to 
conduct official testing. Laboratories will be restored to approved 
status upon training and/or testing new personnel, successful inspection 
of new facilities, and/or correction of noncompliance issues. Reapproval 
will involve resubmitting those sections of the application materials 
required by the NVSL Director.
    (3) Approval may be rescinded at any time, at the discretion of the 
NVSL Director, if a laboratory fails to meet its obligations to APHIS, 
as listed in the agreement signed by the laboratory during the 
application process. The NVSL Director will issue a notice to the 
laboratory, providing the justification for the proposed removal. 
Laboratories will have 30 days to respond in writing to the concerns 
provided before the NVSL Director finalizes the removal decision.
    (j) Appeals. Appeal of any denial, probation, suspension, or 
rescission of laboratory approval must be made in writing to the APHIS 
Administrator or the Administrator's official designee within 30 days of 
the laboratory's receipt of the NVSL Director's decision. Responses to 
these appeals will be provided within 60 days of receipt by APHIS.

(Approved by the Office of Management and Budget under control number 
0579-0472)

[85 FR 4194, Jan. 24, 2020]



PART 72_BOVINE BABESIOSIS--Table of Contents



Sec.
72.1 Interstate movement of infested or exposed animals prohibited.
72.2 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.

[[Page 240]]

72.21 Animals infested with or exposed to ticks subject to same 
          restrictions as cattle.
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  Interstate movement of infested or exposed animals
prohibited.

    No animals infested with ticks [Boophilus annulatus or Rhipicephalus 
(Boophilus) annulatus, Margaropus annulatus, Boophilus microplus or 
Rhipicephalus (Boophilus) microplus, or Babesiasis (Babesiosis) species 
vectors of Margaropus, Rhipicephalus, Amblyomma, Demacentor, or Ixodes] 
or exposed to tick infestation may be moved interstate, except as 
provided in this part.

[78 FR 8960, Feb. 7, 2013]



Sec.72.2  Restrictions on movement of cattle.

    Notice is hereby given that the contagious, infectious, and 
communicable disease known as bovine piroplasmosis, bovine babesiosis, 
redwater, or splenetic, southern, cattle, Texas or tick fever exists in 
cattle in portions of the State of Texas and the Virgin Islands of the 
United States. Notice is also hereby given that ticks which are vectors 
of said disease exist in the Northern Mariana Islands, the Commonwealth 
of Puerto Rico, and the Island of Guam. Therefore, portions of the State 
of Texas, the Virgin Islands of the United States, the Northern Mariana 
Islands, the Commonwealth of Puerto Rico and the Island of Guam are 
hereby quarantined as provided in 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, as amended at 78 FR 8960, Feb. 7, 2013]



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 quarantined area described in 
the regulations of the Texas Animal Health Commission (TAHC) contained 
in Sec. Sec.41.14 through 41.22 of title 4, part II, of the Texas 
Administrative Code (4 TAC 41.14 through 41.22), effective June 23, 
2002, which is incorporated by reference. This incorporation by 
reference was approved by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of 4 TAC 41.14 
through 41.22 may be obtained from the TAHC at 2105 Kramer Lane, Austin, 
TX 78758, and from area offices of the TAHC, which are listed in local 
Texas telephone directories. The TAHC also maintains a copy of its 
regulations on its Internet homepage at http://www.tahc.state.tx.us/. 
Copies may be inspected at the Animal and Plant Health Inspection 
Service, Veterinary Services, suite 3B08, 4700 River Road, Riverdale, 
MD, or at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_ register/
code_of_federal _regulations/ibr_locations.html.

[69 FR 8329, Feb. 24, 2004, as amended at 69 FR 18803, Apr. 9, 2004]

[[Page 241]]



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 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.

[[Page 242]]



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.



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 U.S. 
Department of Agriculture in official dipping for interstate movement 
are:
    (1) Approved proprietary brands of coumaphos (Co-Ral [supreg]), 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\
    (2) [Reserved]
    (c) Approval of dips. Proprietary brands of dips are permitted to be 
used for purposes of this part only when approved by the Administrator, 
APHIS. Before a dip will be specifically approved as a permitted dip for 
the eradication of ticks, APHIS will require that the product be 
registered under the provisions of the Federal Insecticide, Fungicide 
and Rodenticide Act, as amended (7 U.S.C. 135 et seq.); that its 
efficacy and stability have been demonstrated; that trials have been 
conducted to determine that its concentration can be maintained and that 
under actual field conditions the dipping of cattle with a solution of 
definite strength will effectually eradicate ticks without injury to the 
animals dipped.
    (d) Tissue residues; restriction on slaughter. Tissue residues are 
created following use of certain dips. Animals treated with such dips 
should not be slaughtered for food purposes until the expiration of such 
period as may be required under the Federal Meat Inspection Act (21 
U.S.C. 601 et seq.). The length of this period shall be specified on 
each certificate issued by the inspector who supervises the dipping.

[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; 78 FR 8961, Feb. 7, 
2013]



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 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

[[Page 243]]

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]



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

[[Page 244]]

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]



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

[[Page 245]]

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 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

[[Page 246]]

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 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

[[Page 247]]

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 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]

[[Page 248]]



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]



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

[[Page 249]]

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 [supreg]), 25 
percent wettable powder or flowable form used at a concentration of 0.30 
percent.
    (4) Approved proprietary brands of organophosphorous insecticides 
(Prolate [supreg]) 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 baths approved by the APHIS. \1\ The dipping bath for toxaphene 
emulsions must be kept within a temperature range of 40-80 [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

[[Page 250]]

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\
---------------------------------------------------------------------------

    \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.''
---------------------------------------------------------------------------

    (a) Cattle affected with scabies or which just prior to movement 
were affected with or exposed to scabies may be moved interstate from a 
nonquarantined area after being treated with ivermectin under the 
supervision of an APHIS inspector or State inspector in accordance with 
the directions on the label of the drug if the following conditions are 
met:
    (1) Such cattle are kept physically separated for 14 days following 
treatment from all cattle not part of the group treated together with 
ivermectin (regardless of whether the cattle are moved interstate before 
the end of the 14-day period); and
    (2) If such cattle are moved interstate before the end of the 14th 
day following treatment, at the time of interstate movement they are 
accompanied by a certificate issued and signed by an APHIS inspector or 
State inspector identifying the group of cattle treated with ivermectin 
and stating the date on which the cattle were treated with ivermectin; 
and
    (3) If such cattle are moved interstate before the end of the 14th 
day following treatment, at the time of interstate movement the means of 
conveyance carrying them is placarded and the billing marked in 
accordance with 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

[[Page 251]]

    (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.

                    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.

    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.

    (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

[[Page 252]]

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

    Operator. The individual responsible for the day-to-day operations 
of the specifically approved stockyard.
    Permit. An official document (VS Form 1-27 or a State form which 
contains the same information, but not a ``permit for entry'') issued by 
an APHIS representative, State representative, or accredited 
veterinarian which lists the owner's name and address, points of origin 
and destination, number of animals covered, purpose of the movement, and 
one of the following: The individual animal registered breed association 
registration tattoo, individual animal registered breed association 
registration number, or similar individual identification, including 
name, age, sex, breed, color, and markings.
    Reactor. Any horse, ass, mule, pony or zebra which is subjected to 
an official test in accordance with the regulations in Sec.71.22 of 
this subchapter and found positive.
    State. Any State, the District of Columbia, Puerto Rico, the Virgin 
Islands of the United States, Guam, the Northern Mariana Islands, or any 
other territory or possession of the United States.
    State animal health official. The 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

[[Page 253]]

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.

(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; 85 FR 4195, Jan. 24, 2020]

                    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.

[[Page 254]]

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, edition) has been approved for incorporation by reference into the 
Code of Federal Regulations by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
    (a) The procedures specified in the Uniform Methods and Rules--
Bovine Tuberculosis Eradication (January 22, 1999, edition) must be 
followed for the interstate movement of certain animals regulated under 
this part.
    (b) Availability. Copies of the Uniform Methods and Rules--Bovine 
Tuberculosis Eradication:
    (1) Are available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_ register/code_of_federal _regulations/
ibr_locations.html;
    (2) Are available for inspection at the APHIS reading room, room 
1141, USDA South Building, 14th Street and Independence Avenue, SW., 
Washington, DC; or
    (3) May be obtained from the National Animal Health Programs, 
Veterinary Services, APHIS, 4700 River Road Unit 43, Riverdale, MD 
20737-1231.

[65 FR 63517, Oct. 23, 2000, as amended at 69 FR 18803, Apr. 9, 2004]



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.
    Affected herd. A herd of livestock in which there is strong and 
substantial evidence that Mycobacterium bovis exists. This evidence 
should include, but is not limited to, any of the following: 
Histopathology, polymerase chain reaction (PCR) assay, bacterial 
isolation or detection, testing data, or epidemiologic evidence such as 
contact with known sources of infection.
    Animal. All species of animals except man, birds, or reptiles.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Animal identification number (AIN). A numbering system for the 
official identification of individual animals in the United States that 
provides a nationally unique identification number for each animal. The 
AIN consists of 15 digits, with the first 3 being the country code (840 
for the United States or a unique country code for any U.S. territory 
that has such a code and elects to use it in place of the 840 code). The

[[Page 255]]

alpha characters USA or the numeric code assigned to the manufacturer of 
the identification device by the International Committee on Animal 
Recording may be used as an alternative to the 840 or other prefix 
representing a U.S territory; however, only the AIN beginning with the 
840 or other prefix representing a U.S. territory will be recognized as 
official for use on AIN tags applied to animals on or after March 11, 
2015. The AIN beginning with the 840 prefix may not be applied to 
animals known to have been born outside the United States.
    APHIS representative. An individual employed by APHIS who is 
authorized to perform the function involved.
    Area veterinarian in charge. The veterinary official of APHIS who is 
assigned by the Administrator to supervise and perform the official 
animal health work of APHIS in the State concerned.
    Cooperating State and Federal animal health officials. The State and 
Federal animal health officials responsible for overseeing and 
implementing the National Cooperative State/Federal Bovine Tuberculosis 
Eradication Program.
    Depopulate. To destroy all livestock in a herd by slaughter or by 
death otherwise.
    Directly. Moved in a means of conveyance, without stopping to unload 
while en route, except for stops of less than 24 hours to feed, water, 
or rest the animals being moved, and with no commingling of animals at 
such stops.
    Epidemiologic investigation. An investigation that is conducted by a 
State in conjunction with APHIS representatives, in which an official 
test for tuberculosis is conducted on all livestock in any tuberculosis-
affected herd in a State or zone, all livestock in any herd into which 
livestock from the affected herd have been moved, all potential 
tuberculosis source herds, and all livestock herds and animals that are 
likely to have been exposed to the affected herd.
    Herd. Except for livestock assembled at feedlots, any group of 
livestock maintained for at least 4 months on common ground for any 
purpose, or two or more groups of livestock under common ownership or 
supervision, geographically separated but that have an interchange or 
movement of livestock without regard to health status, as determined by 
the Administrator.
    Interstate. From one State into or through any other State.
    Interstate certificate of veterinary inspection (ICVI). An official 
document issued by a Federal, State, Tribal, or accredited veterinarian 
certifying the inspection of animals in preparation for interstate 
movement.
    (a) The ICVI must show the species of animals covered by the ICVI; 
the number of animals covered by the ICVI; the purpose for which the 
animals are to be moved; the address at which the animals were loaded 
for interstate movement; the address to which the animals are destined; 
and the names of the consignor and the consignee and their addresses if 
different from the address at which the animals were loaded or the 
address to which the animals are destined. Additionally, unless the 
species-specific requirements for ICVIs provide an exception, the ICVI 
must list the official identification number of each animal, except as 
provided in paragraph (b) of this definition, or group of animals moved 
that is required to be officially identified, or, if an alternative form 
of identification has been agreed upon by the sending and receiving 
States, the ICVI must include a record of that identification. If 
animals moving under a GIN also have individual official identification, 
only the GIN must be listed on the ICVI. An ICVI may not be issued for 
any animal that is not officially identified if official identification 
is required. If the animals are not required by the regulations to be 
officially identified, the ICVI must state the exemption that applies 
(e.g., the cattle and bison do not belong to one of the classes of 
cattle and bison to which the official identification requirements of 9 
CFR part 86 apply). If the animals are required to be officially 
identified but the identification number does not have to be recorded on 
the ICVI, the ICVI must state that all animals to be moved under the 
ICVI are officially identified.

[[Page 256]]

    (b) As an alternative to typing or writing individual animal 
identification on an ICVI, if agreed to by the receiving State or Tribe, 
another document may be used to provide this information, but only under 
the following conditions:
    (1) The document must be a State form or APHIS form that requires 
individual identification of animals or a printout of official 
identification numbers generated by computer or other means;
    (2) A legible copy of the document must be stapled to the original 
and each copy of the ICVI;
    (3) Each copy of the document must identify each animal to be moved 
with the ICVI, but any information pertaining to other animals, and any 
unused space on the document for recording animal identification, must 
be crossed out in ink; and
    (4) The following information must be written in ink in the 
identification column on the original and each copy of the ICVI and must 
be circled or boxed, also in ink, so that no additional information can 
be added:
    (i) The name of the document; and
    (ii) Either the unique serial number on the document or, if the 
document is not imprinted with a serial number, both the name of the 
person who prepared the document and the date the document was signed.
    Livestock. All farm-raised animals.
    Location-based numbering system. The location-based number system 
combines a State or Tribal issued location identification (LID) number 
or a premises identification number (PIN) with a producer's unique 
livestock production numbering system to provide a nationally unique and 
herd-unique identification number for an animal.
    Location identification (LID) number. A nationally unique number 
issued by a State, Tribal, and/or Federal animal health authority to a 
location as determined by the State or Tribe in which it is issued. The 
LID number may be used in conjunction with a producer's own unique 
livestock production numbering system to provide a nationally unique and 
herd-unique identification number for an animal. It may also be used as 
a component of a group/lot identification number (GIN).
    Move. To carry, enter, import, mail, ship, or transport; to aid, 
abet, cause, or induce carrying, entering, importing, mailing, shipping, 
or transporting; to offer to carry, enter, import, mail, ship, or 
transport; to receive in order to carry, enter, import, mail, ship, or 
transport; or to allow any of these activities.
    National Uniform Eartagging System (NUES). A numbering system for 
the official identification of individual animals in the United States 
that provides a nationally unique identification number for each animal.
    Official eartag. An identification tag approved by APHIS that bears 
an official identification number for individual animals. Beginning 
March 11, 2014, all official eartags manufactured must bear an official 
eartag shield. Beginning March 11, 2015, all official eartags applied to 
animals must bear an official eartag shield. The design, size, shape, 
color, and other characteristics of the official eartag will depend on 
the needs of the users, subject to the approval of the Administrator. 
The official eartag must be tamper-resistant and have a high retention 
rate in the animal.
    Official eartag shield. The shield-shaped graphic of the U.S. Route 
Shield with ``U.S.'' or the State postal abbreviation or Tribal alpha 
code imprinted within the shield.
    Official identification number. A nationally unique number that is 
permanently associated with an animal or group of animals and that 
adheres to one of the following systems:
    (1) National Uniform Eartagging System (NUES).
    (2) Animal identification number (AIN).
    (3) Flock-based number system.
    (4) Location-based number system.
    (5) Any other numbering system approved by the Administrator for the 
official identification of animals.
    Official seal. A seal issued by a State or APHIS representative, 
consisting of a serially numbered, metal or plastic strip, with a self-
locking device on one end and a slot on the other end, which forms a 
loop when the ends are engaged and that cannot be reused if opened, or a 
serially numbered, self-locking button that can be used for this 
purpose.

[[Page 257]]

    Officially identified. Identified by means of an official eartag or 
by means of an individual tattoo or hot brand that provides unique 
identification for each animal.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, joint stock company, or other legal entity.
    Premises identification number (PIN). A nationally unique number 
assigned by a State, Tribal, and/or Federal animal health authority to a 
premises that is, in the judgment of the State, Tribal, and/or Federal 
animal health authority a geographically distinct location from other 
premises. The PIN may be used in conjunction with a producer's own 
livestock production numbering system to provide a nationally unique and 
herd-unique identification number for an animal. It may be used as a 
component of a group/lot identification number (GIN).
    Recognized slaughtering establishment. Any slaughtering facility 
operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), 
the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or State 
meat or poultry inspection acts that is approved in accordance with 9 
CFR 71.21.
    State. Any State, the District of Columbia, Puerto Rico, or any 
territory of the United States.
    State animal health official. The State official responsible for 
livestock and poultry disease control and eradication programs.
    State representative. A veterinarian or other person employed in 
livestock sanitary work of a State or a political subdivision of a State 
and who is authorized by such State or political subdivision of a State 
to perform the function involved under a memorandum of understanding 
with APHIS.
    Transportation document. Any document accompanying the interstate 
movement of livestock, such as an owner's statement, manifest, switch 
order, or vehicle record, on which is stated the point from which the 
animals are moved interstate, the destination of the animals, the number 
of animals covered by the document, and the name and address of the 
owner or shipper.
    Tuberculosis. The contagious, infectious, and communicable disease 
caused by Mycobacterium bovis. (Also referred to as bovine 
tuberculosis.)
    United States. All of the States.
    United States Department of Agriculture (USDA) approved backtag. A 
backtag issued by APHIS that provides a temporary unique identification 
for each animal.
    Zone. A defined geographic land area identifiable by geological, 
political, manmade, or surveyed boundaries, with mechanisms of disease 
spread, epidemiological characteristics, and the ability to control the 
movement of animals across the boundaries of the zone taken into 
account.

[65 FR 63517, Oct. 23, 2000, as amended at 66 FR 7592, Feb. 20, 2002; 69 
FR 64649, Nov. 8, 2004; 70 FR 61026, Oct. 20, 2005; 72 FR 39305, July 
18, 2007; 73 FR 54062, Sept. 18, 2008; 78 FR 2064, Jan. 9, 2013; 79 FR 
43926, July 29, 2014]



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 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

[[Page 258]]

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 by the Administrator based on a risk assessment conducted by 
APHIS.
    Accredited herd. To establish or maintain accredited herd status, 
the herd owner must comply with all of the provisions of the ``Uniform 
Methods and Rules--Bovine Tuberculosis Eradication'' regarding 
accredited herds. All cattle and bison in a herd must be free from 
tuberculosis.
    Approved feedlot. A confined area approved jointly by the State 
animal health official and the Administrator for feeding cattle and 
bison for slaughter, with no provisions for pasturing or grazing.
    Cattle and bison not known to be affected. All cattle and bison 
except those originating from tuberculosis affected herds or from herds 
containing tuberculosis suspect cattle or bison.
    Department. The U.S. Department of Agriculture (USDA).
    Exposed cattle and bison. Cattle and bison, except reactor cattle 
and bison, that are part of an affected herd.
    Feedlot. A facility for congregating finished fed cattle prior to 
their being shipped to slaughter.

[[Page 259]]

    Finished fed cattle. Cattle fattened on a ration of feed 
concentrates to reach a slaughter condition equivalent to that which 
would be attained on full feed with a high concentrate grain ration for 
90 days.
    Modified accredited advanced State or zone. A State or zone that is 
or is part of a State that has the authority to enforce and complies 
with the provisions of the ``Uniform Methods and Rules--Bovine 
Tuberculosis Eradication'' and in which tuberculosis has been prevalent 
in less than 0.01 percent of the total number of herds of cattle and 
bison in the State or zone for each of the most recent 2 years. Except 
that: The Administrator, upon his or her review, may allow a State or 
zone with fewer than 30,000 herds to have up to 3 affected herds for 
each of the most recent 2 years, depending on the veterinary 
infrastructure, livestock demographics, and tuberculosis control and 
eradication measures in the State or zone.
    Modified accredited State or zone. A State or zone that is or is 
part of a State that has the authority to enforce and complies with the 
provisions of the ``Uniform Methods and Rules--Bovine Tuberculosis 
Eradication'' and in which tuberculosis has been prevalent in less than 
0.1 percent of the total number of herds of cattle and bison in the 
State or zone for the most recent year. Except that: The Administrator, 
upon his or her review, may allow a State or zone with fewer than 10,000 
herds to have up to 10 affected herds for the most recent year, 
depending on the veterinary infrastructure, livestock demographics, and 
tuberculosis control and eradication measures in the State or zone.
    Negative cattle and bison. Cattle and bison that are classified 
negative for tuberculosis in accordance with the ``Uniform Methods and 
Rules--Bovine Tuberculosis Eradication,'' based on the results of an 
official tuberculin test.
    Nonaccredited State or zone. A State or zone that is or is part of a 
State that does not meet the standards of the ``Uniform Methods and 
Rules--Bovine Tuberculosis Eradication'' or in which tuberculosis is 
prevalent in 0.5 percent or more of the total number of herds of cattle 
and bison in the State or zone.
    Official tuberculin test. Any test for tuberculosis conducted on 
cattle or bison in accordance with the ``Uniform Methods and Rules--
Bovine Tuberculosis Eradication.''
    Permit. An official document issued for movement of cattle or bison 
under this part by an APHIS representative, State representative, or an 
accredited veterinarian at the point of origin of a shipment of cattle 
or bison to be moved directly to slaughter, that shows the tuberculosis 
status of each animal (reactor, suspect, or exposed), the eartag number 
of each animal and the name of the owner of such animal, the 
establishment to which the animals are to be moved, the purpose for 
which the animals are to be moved, and that they are eligible for such 
movement under the applicable provisions of 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.''
    Recognized slaughtering establishment. Any slaughtering facility 
operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), 
the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or State 
meat or poultry inspection acts that is approved in accordance with 9 
CFR 71.21.
    Suspect cattle and bison. Cattle and bison that are classified as 
suspects for tuberculosis in accordance with the ``Uniform Methods and 
Rules--Bovine Tuberculosis Eradication.''

[[Page 260]]

    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.

[65 FR 63517, Oct. 23, 2000, as amended at 70 FR 61026, Oct. 20, 2005; 
78 FR 2065, Jan. 9, 2013]



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, California, Colorado, Connecticut, Delaware, Florida, 
Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, 
Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, 
Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New 
Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, 
Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, 
Tennessee, Texas, Utah, Vermont, Virginia, the Virgin Islands of the 
United States, Washington, West Virginia, Wisconsin, and Wyoming.
    (b) The following are accredited-free zones:
    (1) All of the State of Michigan except for the zone that comprises 
those counties in Michigan described in Sec.77.11(b)(1).
    (2) [Reserved]
    (c) If an affected herd is detected in a State or zone classified as 
accredited-free, and the herd is depopulated and an epidemiologic 
investigation is completed within 90 days of the detection of the 
affected herd with no evidence of the spread of tuberculosis, the State 
or zone may retain its accredited-free status. If two or more affected 
herds are detected in an accredited-free State or zone within a 48-month 
period, the State or zone will be removed from the list of accredited-
free States or zones and will be reclassified as modified accredited 
advanced.
    (d) If any livestock other than cattle or bison are included in a 
newly assembled herd on a premises where a tuberculous herd has been 
depopulated, the State or zone must apply the herd test requirements 
contained in the ``Uniform Methods and Rules--Bovine Tuberculosis 
Eradication'' (January 22, 1999, edition), which is incorporated by 
reference at 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 
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

[[Page 261]]

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]

    Editorial Note: For Federal Register citations affecting Sec.77.7, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfo.gov.



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 in accordance with 9 CFR part 86 without further 
restriction under this part.

[78 FR 2065, Jan. 9, 2013]



Sec.77.9  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 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 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

[[Page 262]]

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]

    Editorial Note: For Federal Register citations affecting Sec.77.9, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfo.gov.



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 in accordance with 9 CFR part 
86 and, if moved anywhere other than directly to slaughter at a 
recognized slaughtering establishment, under one of the following 
additional conditions:
    (a) The cattle or bison are sexually intact heifers moved to an 
approved feedlot, or are steers or spayed heifers, and are officially 
identified.
    (b) The cattle or bison are from an accredited herd, are officially 
identified, and are accompanied by an ICVI stating that the accredited 
herd completed the testing necessary for accredited status with negative 
results within 1 year prior to the date of movement.
    (c) The cattle or bison are sexually intact animals; are not from an 
accredited herd; are officially identified; and are accompanied by an 
ICVI stating that they were negative to an official tuberculin test 
conducted within 60 days prior to the date of movement.

(Approved by the Office of Management and Budget under control numbers 
0579-0146, 0579-0220, and 0579-0229)

[78 FR 2065, Jan. 9, 2013]



Sec.77.11  Modified accredited States or zones.

    (a) The following are modified accredited States: None.
    (b) The following are modified accredited zones:
    (1) A zone in Michigan that comprises Alcona, Alpena, Montmorency, 
and Oscoda Counties.
    (2) [Reserved]
    (c) If any livestock other than cattle or bison are included in a 
newly assembled herd on a premises where a tuberculous herd has been 
depopulated, the State or zone must apply the herd test requirements 
contained in the ``Uniform Methods and Rules--Bovine Tuberculosis 
Eradication'' (January 22, 1999, edition), which is incorporated by 
reference at 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 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.

[[Page 263]]

    (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, as amended at 
69 FR 20809, Apr. 19, 2004; 73 FR 19142, Apr. 9, 2008; 73 FR 60102, Oct. 
10, 2008; 74 FR 67053, Dec. 18, 2009; 75 FR 60588, Oct. 1, 2010; 76 FR 
56636, Sept. 14, 2011]



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 in accordance with 9 CFR part 
86 and, if moved anywhere other than directly to slaughter at a 
recognized slaughtering establishment, under one of the following 
additional conditions:
    (a) The cattle or bison are sexually intact heifers moved to an 
approved feedlot, or are steers or spayed heifers; are officially 
identified, and are accompanied by an ICVI stating that they were 
classified negative to an official tuberculin test conducted within 60 
days prior to the date of movement.
    (b) The cattle or bison are from an accredited herd, are officially 
identified, and are accompanied by an ICVI stating that the accredited 
herd completed the testing necessary for accredited status with negative 
results within 1 year prior to the date of movement.
    (c) The cattle or bison are sexually intact animals; are not from an 
accredited herd; are officially identified; and are accompanied by an 
ICVI stating that the herd from which they originated was negative to a 
whole herd test conducted within 1 year prior to the date of movement 
and that the individual animals to be moved were negative to an 
additional official tuberculin test conducted within 60 days prior to 
the date of movement, except that the additional test is not required if 
the animals are moved interstate within 60 days following the whole herd 
test.

(Approved by the Office of Management and Budget under control number 
0579-0146)

[78 FR 2066, Jan. 9, 2013]



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 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

[[Page 264]]

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 in accordance with 9 CFR part 
86 and, if moved anywhere other than directly to slaughter at a 
recognized slaughtering establishment, under one of the following 
additional conditions:
    (a) The cattle or bison are sexually intact heifers moved to an 
approved feedlot, or are steers or spayed heifers; are officially 
identified; and are accompanied by an ICVI stating that the herd from 
which they originated was negative to a whole herd test conducted within 
1 year prior to the date of movement and that the individual animals to 
be moved were negative to an additional official tuberculin test 
conducted within 60 days prior to the date of movement; Except that: The 
additional test is not required if the animals are moved interstate 
within 6 months following the whole herd test.
    (b) The cattle or bison are from an accredited herd; are officially 
identified; and are accompanied by an ICVI stating that the accredited 
herd completed the testing necessary for accredited status with negative 
results within 1 year prior to the date of movement and that the animals 
to be moved were negative to an official tuberculin test conducted 
within 60 days prior to the date of movement.
    (c) The cattle or bison are sexually intact animals; are not from an 
accredited herd; are officially identified; and are accompanied by an 
ICVI stating that the herd from which they originated was negative to a 
whole herd test conducted within 1 year prior to the date of movement 
and that the individual animals to be moved were negative to two 
additional official tuberculin tests conducted at least 60 days apart 
and no more than 6 months apart, with the second test conducted within 
60 days prior to the date of movement; Except that: The second 
additional test is not required if the animals are moved interstate 
within 60 days following the whole herd test.

(Approved by the Office of Management and Budget under control number 
0579-0146)

[78 FR 2066, Jan. 9, 2013]



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

[[Page 265]]

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 a recognized slaughtering establishment.

[65 FR 63517, Oct. 23, 2000, as amended at 78 FR 2066, Jan. 9, 2013]



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 a recognized slaughtering 
establishment and only in accordance with the following conditions:
    (1) Reactor cattle and bison must be individually identified by 
attaching to the left ear an approved metal eartag bearing a serial 
number and the inscription ``U.S. Reactor,'' or a similar State reactor 
tag, and must be:
    (i) Branded with the letter ``T,'' at least 5 by 5 centimeters (2 by 
2 inches) in size, high on the left hip near the tailhead; or
    (ii) Permanently identified with the letters ``TB'' tattooed legibly 
in the left ear and sprayed with yellow paint on the left ear and either 
accompanied directly to slaughter by an APHIS or State representative or 
moved directly to slaughter in vehicles closed with official seals. Such 
official seals must be applied and removed by an APHIS representative, 
State representative, accredited veterinarian, or an individual 
authorized for this purpose by an APHIS representative.
    (2) The reactor cattle or bison must be accompanied by a permit; and
    (3) The reactor cattle or bison may not be moved interstate in a 
means of conveyance containing any animals susceptible to tuberculosis 
unless all of the animals are being moved directly to slaughter; and
    (4) Any person who moves reactor cattle or bison interstate under 
this paragraph must plainly write or stamp upon the face of the VS Form 
1-27 the words ``Tuberculin Reactor'' and the following statement: 
``This conveyance must be cleaned and disinfected in accordance with 9 
CFR 77.17(a)(5).''; and
    (5) Each means of conveyance in which reactor cattle or bison have 
been transported interstate under this paragraph must be cleaned and 
disinfected by the carrier, in accordance with the provisions of 
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 slaughter to a recognized slaughtering 
establishment and only in accordance with the following conditions:
    (1) Exposed cattle and bison must be individually identified by 
attaching to either ear an approved metal eartag bearing a serial number 
and must be:
    (i) Branded with the letter ``S,'' at least 5 by 5 centimeters (2 by 
2 inches) in size, high on the left hip near the tailhead; or
    (ii) Accompanied directly to slaughter by an APHIS or State 
representative; or
    (iii) Moved directly to slaughter in vehicles closed with official 
seals. Such

[[Page 266]]

official seals must be applied and removed by an APHIS representative, 
State representative, accredited veterinarian, or an individual 
authorized for this purpose by an APHIS representative.
    (2) The exposed cattle and bison must be moved in accordance with 
paragraphs (a)(2), (a)(3), and (a)(5) of this section.
    (c) Suspect cattle and bison. Suspect cattle or bison from herds in 
which no reactor cattle or bison have been disclosed on an official 
tuberculin test, as well as negative cattle or bison from such herds, 
may be moved interstate only if they are moved directly to slaughter to 
a recognized slaughtering establishment in accordance with 9 CFR part 
86.

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

[65 FR 63517, Oct. 23, 2000, as amended at 78 FR 2066, Jan. 9, 2013]



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 two 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 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

[[Page 267]]

and wildlife are not at risk of being infected with tuberculosis, as 
determined by the Administrator based on a risk assessment conducted by 
APHIS.
    Captive cervid. All species of deer, elk, moose, and all other 
members of the family Cervidae raised or maintained in captivity for the 
production of meat and other agricultural products, for sport, or for 
exhibition, including time such animals are moved interstate; or any 
wild cervid that is moved interstate, during the period of time from 
capture until release into the wild. A captive cervid that escapes will 
continue to be considered a captive cervid as long as it bears an 
official eartag or other identification approved by the Administrator as 
unique and traceable with which to trace the animal back to its herd of 
origin.
    Comparative cervical tuberculin (CCT) test. The intradermal 
injection of biologically balanced USDA bovine PPD tuberculin and avian 
PPD tuberculin at separate sites in the mid-cervical area to determine 
the probable presence of bovine tuberculosis (M. bovis) by comparing the 
response of the two tuberculins at 72 hours (plus or minus 6 hours) 
following injection.
    Designated accredited veterinarian. An accredited veterinarian who 
is trained and approved by cooperating State and Federal animal health 
officials to conduct the single cervical tuberculin (SCT) test or draw 
blood for the DPP[supreg] test on captive cervids.
    Dual Path Platform (DPP[supreg]) test. A serological assay to 
determine the presence of antibodies to bovine tuberculosis (M. bovis) 
in elk, red deer, white-tailed deer, fallow deer, and reindeer, in which 
a blood sample taken from a captive cervid and a buffer solution are 
placed on a strip. The diluted sample then migrates to another strip, 
which contains an antibody-detecting reagent. This latter strip 
indicates if antibodies are present in the sample.
    Exposed captive cervid. Any captive cervid that has been exposed to 
tuberculosis by reason of associating with captive cervids, cattle, 
bison, or other livestock from which M. bovis has been isolated.
    Modified accredited State or zone. A State or zone that is or is 
part of a State that has the authority to enforce and complies with the 
provisions of the ``Uniform Methods and Rules--Bovine Tuberculosis 
Eradication'' and in which tuberculosis has been prevalent in less than 
0.1 percent of the total number of herds of captive cervids in the State 
or zone for the most recent year. Except that: The Administrator, upon 
his or her review, may allow a State or zone with fewer than 10,000 
herds to have up to 10 affected herds for the most recent year, 
depending on the veterinary infrastructure, livestock demographics, and 
tuberculosis control and eradication measures in the State or zone.
    Modified accredited advanced State or zone. A State or zone that is 
or is part of a State that has the authority to enforce and complies 
with the provisions of the ``Uniform Methods and Rules--Bovine 
Tuberculosis Eradication'' and in which tuberculosis has been prevalent 
in less than 0.01 percent of the total number of herds of captive 
cervids in the State or zone for the most recent 2 years. Except that: 
The Administrator, upon his or her review, may allow a State or zone 
with fewer than 30,000 herds to have up to 3 affected herds for each of 
the most recent 2 years, depending on the veterinary infrastructure, 
livestock demographics, and tuberculosis control and eradication 
measures in the State or zone.
    Monitored herd. A herd on which identification records are 
maintained on captive cervids inspected for tuberculosis at an approved 
slaughtering establishment or an approved diagnostic laboratory and on 
captive cervids tested for tuberculosis in accordance with interstate 
movement requirements, and which meets the standards set forth in Sec.
77.37.
    Negative. Showing no response to an official tuberculosis test or 
classified negative for tuberculosis by the testing veterinarian based 
upon history, supplemental tests, examination of the carcass, and 
histopathology and culture of selected tissues.
    No gross lesions (NGL). Having no visible lesions indicative of 
bovine tuberculosis detected upon necropsy or slaughter inspection.
    Nonaccredited State or zone. A State or zone that is or is part of a 
State or

[[Page 268]]

zone that does not meet the standards of the ``Uniform Methods and 
Rules--Bovine Tuberculosis Eradication'' or in which tuberculosis is 
prevalent in 0.5 percent or more of the total number of herds of captive 
cervids in the State or zone.
    Official tuberculosis test. Any of the following tests for bovine 
tuberculosis in captive cervids, applied and reported in accordance with 
this part:
    (1) The single cervical tuberculin (SCT) test.
    (2) The comparative cervical tuberculin test (CCT) test.
    (3) The Dual Path Platform (DPP[supreg]) 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 an official 
tuberculosis test and is classified a reactor by the testing 
veterinarian; or any suspect captive cervid that is classified a reactor 
upon slaughter inspection or necropsy after histopathology and/or 
culture of selected tissues by the USDA or State veterinarian performing 
or supervising the slaughter inspection or necropsy.
    Regular-kill slaughter animal. An animal that is slaughtered for 
food or any reason other than because of a disease regulated under 9 CFR 
chapter I (such as tuberculosis, brucellosis, or any other livestock 
disease for which movement of animals is restricted under 9 CFR chapter 
I).
    Single cervical tuberculin (SCT) test. The intradermal injection of 
0.1 mL (5,000 tuberculin units) of USDA PPD bovis tuberculin in the mid-
cervical area with a reading by visual observation and palpation at 72 
hours (plus or minus 6 hours) following injection.
    Suspect. Any captive cervid that is not negative to an official 
tuberculosis test and that is not classified as a reactor by the testing 
veterinarian.
    Tuberculin. A product that is approved by and produced under USDA 
license for injection into cervids and other animals for the purpose of 
detecting bovine tuberculosis.
    Tuberculous. Having lesions indicative of tuberculosis, infected 
with tuberculosis based on isolation of M. bovis, or being from a herd 
in which M. bovis has been isolated.
    USDA. The United States Department of Agriculture.
    Whole herd test. An official tuberculosis test of all captive 
cervids in a herd that are 12 months of age or older, and of all captive 
cervids in the herd that are less than 12 months of age and were not 
born into the herd, except those captive cervids that are less than 12 
months of age and were born in and originated from an accredited herd.
    Zero percent prevalence. No finding of tuberculosis in any herd of 
captive cervids in a State or zone.

[65 FR 63517, Oct. 23, 2000, as amended at 70 FR 61026, Oct. 20, 2005; 
71 FR 24805, Apr. 27, 2006; 78 FR 1721, Jan. 9, 2013; 79 FR 43926, July 
29, 2014]



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.



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,

[[Page 269]]

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 in accordance with 9 CFR part 86 and without further 
restriction under this part.

[78 FR 2066, Jan. 9, 2013]



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 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

[[Page 270]]

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 in accordance with 9 CFR part 
86 and, if moved anywhere other than directly to slaughter at a 
recognized slaughtering establishment, under one of the following 
additional conditions:
    (a) The captive cervids are from an accredited herd, qualified herd, 
or monitored herd; are officially identified; and are accompanied by an 
ICVI stating that the herd completed the requirements for accredited 
herd, qualified herd, or monitored herd status within 24 months prior to 
the date of movement.
    (b) The captive cervids are officially identified and are 
accompanied by an ICVI stating that they were negative to an official 
tuberculin test conducted within 90 days prior to the date of movement.

(Approved by the Office of Management and Budget under control number 
0579-0146)

[78 FR 2066, Jan. 9, 2013]



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, Connecticut, Delaware, Florida, 
Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, 
Louisiana, Maine, Maryland, Massachusetts,

[[Page 271]]

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 in accordance with 9 CFR part 86 and, if moved anywhere 
other than directly to slaughter at a recognized slaughtering 
establishment, under one of the following additional conditions:
    (a) The captive cervids are from an accredited herd, are officially 
identified, and are accompanied by an ICVI

[[Page 272]]

stating that the accredited herd completed the testing necessary for 
accredited status with negative results within 24 months prior to the 
date of movement.
    (b) The captive cervids are sexually intact animals; are not from an 
accredited herd; are officially identified; and are accompanied by an 
ICVI stating that the herd from which they originated was negative to a 
whole herd test conducted within 1 year prior to the date of movement 
and that the individual animals to be moved were negative to an 
additional official tuberculin test conducted within 90 days prior to 
the date of movement; Except that: The additional test is not required 
if the animals are moved interstate within 6 months following the whole 
herd test.

(Approved by the Office of Management and Budget under control number 
0579-0146)

[78 FR 2066, Jan. 9, 2013]



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

[[Page 273]]

an accreditation preparatory State or zone, and that are not known to be 
infected with or exposed to tuberculosis, may be moved interstate only 
in accordance with 9 CFR part 86 and, if moved anywhere other than 
directly to slaughter at a recognized slaughtering establishment, under 
one of the following additional conditions:
    (a) The captive cervids are from an accredited herd; are officially 
identified; and are accompanied by an ICVI stating that the accredited 
herd completed the testing necessary for accredited status with negative 
results within 24 months prior to the date of movement and that the 
individual animals to be moved were negative to an official tuberculin 
test conducted within 90 days prior to the date of movement.
    (b) The captive cervids are sexually intact animals; are not from an 
accredited herd; are officially identified; and are accompanied by an 
ICVI stating that the herd from which they originated was negative to a 
whole herd test conducted within 1 year prior to the date of movement 
and that the individual animals to be moved were negative to two 
additional official tuberculin tests conducted at least 90 days apart 
and no more than 6 months apart, with the second test conducted within 
90 days prior to the date of movement; Except that: The second 
additional test is not required if the animals are moved interstate 
within 6 months following the whole herd test.

(Approved by the Office of Management and Budget under control number 
0579-0146)

[78 FR 2067, Jan. 9, 2013]



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 a recognized slaughtering establishment.

[65 FR 63517, Oct. 23, 2000, as amended at 78 FR 2067, Jan. 9, 2013]



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 9 CFR part 86, no captive cervid may be moved interstate unless it 
has been tested using an official tuberculosis test, and it is moved in 
compliance with this part.
    (b) No captive cervid with a response to any official tuberculosis 
test is eligible for interstate movement unless the captive cervid 
subsequently tests negative to a supplemental official tuberculosis test 
or is moved interstate directly to slaughter or necropsy in accordance 
with 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 officially 
identified and accompanied by an ICVI issued within 30 days of the 
movement by a State or Federal animal health official or an accredited 
veterinarian.
    (d) Captive cervids in zoological parks that have been accredited by 
the American Zoo and Aquarium Association (AZA) are exempt from the 
regulations in this part when the captive cervids are moved directly 
interstate between AZA member facilities. Any captive cervids moved 
interstate that are not moved directly from an AZA

[[Page 274]]

member facility to another AZA member facility must be moved in 
accordance with the regulations in this subpart.

[65 FR 63517, Oct. 23, 2000, as amended at 78 FR 2067, Jan. 9, 2013]



Sec.77.33  Testing procedures for tuberculosis in captive cervids.

    (a) Approved testers. Except as explained in paragraphs (a)(1) or 
(a)(2) of this section, official tuberculosis tests may only be given by 
a veterinarian employed by the State in which the test is administered 
or by a veterinarian employed by USDA.
    (1) A designated accredited veterinarian may conduct the SCT test, 
except as provided in Sec.77.34(a)(1)(ii) and Sec.77.39(e) and (f).
    (2) A designated accredited veterinarian may draw blood for the 
DPP[supreg] test.
    (b) Approved diagnostic laboratories. (1) With one exception, 
histopathology and culture results for all tuberculosis diagnoses will 
be accepted only from the National Veterinary Services Laboratories 
(NVSL) in Ames, IA. The exception is that results will be accepted from 
a laboratory of the Food Safety and Inspection Service, USDA, for tissue 
examination of regular-kill slaughter animals in those cases where no 
submission is made to NVSL.
    (2) [Reserved]
    (c) Identification. Any captive cervid tested with an official 
tuberculosis test must bear official identification in the form of an 
official eartag, or another identification device or method approved by 
the Administrator as unique and traceable, at the time of the official 
tuberculosis test. Use of any identification device or method other than 
an official eartag must first be approved by the Administrator as unique 
and traceable. Written requests for approval must be sent to National 
Animal Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, 
MD 20737-1231.
    (d) Reporting of tests--(1) SCT and CCT tests. For the SCT and CCT 
tests, the testing veterinarian must submit a report to cooperating 
State and Federal animal health officials of the State in which the 
captive cervid is tested. The report must include the following 
information for all SCT and CCT tests administered: The number of the 
individual eartag or other identification approved by the Administrator; 
the age, sex, and breed of each captive cervid tested; a record of all 
responses; the size of each response for the CCT test; and the test 
interpretation.
    (2) DPP[supreg] test. The veterinarian who draws blood from the 
captive cervid must submit a form specified by APHIS for such requests 
to NVSL to perform the DPP[supreg] test on the blood sample. The form is 
available at the following Web site: http://www.aphis.usda.gov/wps/
portal /footer/resources/forms; click on the ``VS forms'' link on that 
Web page. The veterinarian must also fill out the relevant portions of a 
test record. This form may be obtained by contacting the local district 
VS office, information regarding which is available at: http://
www.aphis.usda.gov/ wps/portal/aphis/ourfocus/ 
animalhealth?1dmy&urile=wcm%3 apath%3a%2Faphis_content _library%2Fsa_ 
our_focus%2Fsa_ animal_health%2Fsa_ contact_us%2Fsa_ map%2Fct_state_ 
contacts_map. This record must be sent to the offices of the State and 
Federal animal health officials in the State.
    (e) Test interpretation. (1) Interpretation of an SCT test will be 
based upon the judgment of the testing veterinarian after observation 
and palpation of the injection site, in accordance with the 
classification requirements described in 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 DPP[supreg] test results will be in accordance 
with the classification requirements described in Sec.77.34.
    (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

[[Page 275]]

and any captive cervids other than natural additions (captive cervids 
born into the herd) under 1 year of age.

(Approved by the Office of Management and Budget under control number 
0579-0412)

[65 FR 63517, Oct. 23, 2000, as amended at 71 FR 24806, Apr. 27, 2006; 
78 FR 1722, Jan. 9, 2013; 79 FR 43926, July 29, 2014]



Sec.77.34  Official tuberculosis tests.

    (a) Primary tests--(1) Single cervical tuberculin (SCT) test. (i) 
The SCT test is a primary test that may be used in individual captive 
cervids and in herds of unknown tuberculous status. Each captive cervid 
that responds to the SCT test must be classified as a suspect until it 
is retested with the CCT test and is either found negative for 
tuberculosis or is classified as a reactor, unless, with exception of a 
designated accredited veterinarian, the testing veterinarian determines 
that the captive cervid should be classified as a reactor based on its 
response to the SCT test. A designated accredited veterinarian must 
classify a responding captive cervid as a suspect, unless APHIS 
determines, based on epidemiological evidence, that the captive cervid 
should be classified as a reactor. A captive cervid that responds to the 
SCT test must not be retested using the DPP[supreg] test.
    (ii) The SCT test is a primary test that may be used in affected 
herds and in herds that have received captive cervids from an affected 
herd. When used with affected herds or in herds that have received a 
captive cervid from an affected herd, the SCT test may only be 
administered by a veterinarian employed by the State in which the test 
is administered or employed by USDA. In affected herds or herds that 
have received captive cervids from an affected herd, each captive cervid 
that responds to the SCT test must be classified as a reactor, unless 
APHIS determines, based on epidemiological evidence, that the cervid 
should be classified as a suspect because of possible exposure to a 
tuberculous animal.
    (2) DPP[supreg] test. (i) The DPP[supreg] test is a primary test 
that may be used in individual captive elk, red deer, white-tailed deer, 
fallow deer, and reindeer, and in herds of these species that are of 
unknown tuberculous status. Except as specified in paragraph (a)(2)(ii) 
of this section, each captive cervid that has non-negative test results 
to this initial DPP[supreg] test will be classified as a suspect and 
retested with the DPP[supreg] test. A captive cervid that has non-
negative test results to the DPP[supreg] test must not be retested using 
the SCT or CCT test.
    (ii) The DPP[supreg] test is a primary test that may be used in 
affected herds of captive elk, red deer, white-tailed deer, fallow deer, 
and reindeer, and in herds of these species that have received captive 
cervids from an affected herd. In such herds, each captive cervid that 
has non-negative test results to the DPP[supreg] test will be classified 
as a reactor, unless APHIS determines that the captive cervid should be 
classified as a suspect because of possible exposure to a tuberculous 
animal.
    (b) Supplemental tests--(1) Comparative cervical tuberculin (CCT) 
test. (i) The CCT test is a supplemental test that may only be used in 
order to retest captive cervids that have been classified as suspects 
after being tested with the SCT test. The CCT test may be used in 
affected herds only after the herd has tested negative to at least two 
whole herd SCT tests and only with the prior written consent of APHIS. 
The CCT test may not be used as a primary test.
    (ii) A captive cervid tested with the CCT test must be classified as 
negative if it has a response to the bovine PPD tuberculin that is less 
than 1 mm.
    (iii) Unless the testing veterinarian determines that the captive 
cervid should be classified as a reactor because of possible exposure to 
a tuberculous animal, a captive cervid tested with the CCT test must be 
classified as a suspect if:
    (A) It has a response to the bovine PPD tuberculin that is greater 
than 2 mm and that is equal to the response to the avian PPD tuberculin; 
or
    (B) It has a response to the bovine PPD tuberculin that is equal to 
or greater than 1 mm and equal to or less than 2 mm and that is equal to 
or greater than the response to the avian PPD tuberculin.
    (iv) A captive cervid tested with the CCT test must be classified as 
a reactor if:

[[Page 276]]

    (A) It has a response to the bovine PPD tuberculin that is greater 
than 2 mm and that is at least 0.5 mm greater than the response to the 
avian PPD tuberculin; or
    (B) It has been classified as a suspect on two successive CCT tests.
    (C) Any exceptions to the reactor classification under the 
conditions in paragraph (b)(1)(iv) of this section must be justified by 
the testing veterinarian in writing and have the concurrence of APHIS.
    (2) DPP[supreg] test. The DPP[supreg] test may be used as a 
supplemental test in order to retest captive cervids that have been 
classified as suspects based on an initial DPP[supreg] test. In such 
instances, the supplemental DPP[supreg] test must evaluate a new serum 
sample drawn from the cervid no sooner than 30 days after the initial 
DPP[supreg] test. A captive cervid that has non-negative test results on 
two successive DPP[supreg] tests will be classified as a reactor, unless 
APHIS determines that another disease classification is warranted.

[78 FR 1722, Jan. 9, 2013, as amended at 79 FR 43926, July 29, 2014]



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 two 
consecutive official tuberculosis tests, conducted at 9-15 month 
intervals. However, captive cervids under 1 year of age that are not 
natural additions to the herd do not have to be tested if they were born 
in and originate from an accredited herd.
    (2) The owner of the herd must have a document issued by cooperating 
State or Federal animal health officials stating that the herd has met 
the requirements in paragraph (a)(1) of this section and is classified 
as an accredited herd.
    (b) Movement allowed. Except as provided in 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 officially identified and is accompanied by an 
ICVI, 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 
ICVI.
    (c) Herd additions allowed. No captive cervid may be added to an 
accredited herd except in accordance with paragraphs (c)(4) and (c)(5), 
and either paragraph (c)(1), (c)(2), or (c)(3) of this section, as 
follows:
    (1) The captive cervid to be added must be moved directly from an 
accredited herd;
    (2) The captive cervid to be added must be moved directly from a 
qualified or monitored herd and must have tested negative to an official 
tuberculosis test conducted within 90 days prior to movement to the 
premises of the accredited herd. Any captive cervid moved from a 
qualified or monitored herd must also be isolated from all members of 
the accredited herd until it tests negative to an official tuberculosis 
test conducted at least 90 days following the date of arrival at the 
premises of the accredited herd. If a group of captive cervids is being 
moved together, the entire group must be isolated from all other 
livestock during the testing period, but captive cervids in the group 
need not be isolated from each other during that period. Such herd 
additions will not receive status as members of the accredited herd for 
purposes of interstate movement until they have tested negative to an 
official tuberculosis test and have been released from isolation; or
    (3) If the captive cervid to be added is not being moved directly 
from a classified herd, the captive cervid must be isolated from all 
other members of the herd of origin and must test negative to two 
official tuberculosis tests. The isolation must begin at the time of the 
first official tuberculosis test. The tests must be conducted at least 
90 days apart, and the second test must be conducted within 90 days 
prior to movement to the premises of the accredited herd. The captive 
cervid must

[[Page 277]]

also be isolated from all members of the accredited herd until it tests 
negative to an official tuberculosis test conducted at least 90 days 
following the date of arrival at the premises of the accredited herd. If 
a group of captive cervids is being moved together, the entire group 
must be isolated from all other animals during the testing period, but 
captive cervids in the group need not be isolated from each other during 
that period. Such herd additions will not receive status as members of 
the accredited herd for purposes of interstate movement until they have 
tested negative to an official tuberculosis test and have been released 
from isolation.
    (4) A captive cervid to be added must not have been exposed during 
the 90 days prior to its movement to either:
    (i) A captive cervid from a herd with a lower classification status 
than its own; or
    (ii) Any tuberculous livestock.
    (d) Maintenance of accredited herd status. To maintain status as an 
accredited herd, the herd must test negative to an official tuberculosis 
test within 33-39 months from the anniversary date of the second 
consecutive test with no evidence of tuberculosis disclosed (that is, 
the test on which the herd was recognized as accredited or the 
accrediting test). Each time the herd is tested for reaccreditation, it 
must be tested 33-39 months from the anniversary date of the accrediting 
test, not from the last date of reaccreditation (for example, if a herd 
is accredited on January 1 of a given year, the anniversary date will be 
January 1 of every third year). Accredited herd status is valid for 36 
months (1,095 days) from the anniversary date of the accrediting test. 
If the herd is tested between 36 and 39 months after the anniversary 
date, its accredited herd status will be suspended for the interim 
between the anniversary date and the reaccreditation test. During the 
suspension period, the herd will be considered ``unclassified'' and 
captive cervids may be moved interstate from the herd only in accordance 
with the movement requirements for the State or zone in which the herd 
is located.

[65 FR 63517, Oct. 23, 2000, as amended at 71 FR 24806, Apr. 27, 2006; 
78 FR 2067, Jan. 9, 2013]



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 officially identified and is accompanied 
by an ICVI, 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 ICVI must also state 
that the captive cervid has tested negative to an official tuberculosis 
test conducted within 90 days prior to the date of movement. If a group 
of captive cervids from a qualified herd is being moved interstate 
together to the same destination, all captive cervids in the group may 
be moved under one ICVI.
    (3) Captive cervids under 1 year of age that are natural additions 
to the qualified herd or that were born in and

[[Page 278]]

originate from a classified herd may move without testing, provided that 
they are officially identified and that the ICVI accompanying them 
states that the captive cervids are natural additions to the qualified 
herd or were born in and originated from a classified herd and have not 
been exposed to captive cervids from an unclassified herd.
    (4) Captive cervids being moved interstate for the purpose of 
exhibition only may be moved without testing, provided they are returned 
to the premises of origin no more than 90 days after leaving the 
premises, have no contact with other livestock during movement and 
exhibition, are officially identified, and are accompanied by an ICVI 
that includes a statement that the captive cervid is from a qualified 
herd and will otherwise meet the requirements of this paragraph.
    (c) Herd additions allowed. No captive cervid may be added to a 
qualified herd except in accordance with paragraph (c)(4) and either 
paragraph (c)(1), (c)(2), or (c)(3) of this section, as follows:
    (1) The captive cervid to be added must be moved directly from an 
accredited herd;
    (2) The captive cervid to be added must be moved directly from a 
qualified or monitored herd and must have tested negative to an official 
tuberculosis test conducted within 90 days prior to movement to the 
premises of the accredited herd;
    (3) If the captive cervid to be added is not being moved directly 
from a classified herd, the captive cervid must be isolated from all 
other animals in its herd of origin and must test negative to two 
official tuberculosis tests prior to movement. The isolation must begin 
at the time of the first official tuberculosis test. The tests must be 
conducted at least 90 days apart, and the second test must be conducted 
within 90 days prior to movement to the premises of the qualified herd. 
The captive cervid must then be kept in isolation from all animals until 
it tests negative to an official tuberculosis test conducted at least 90 
days following the date of arrival at the premises of the qualified 
herd. If a group of captive cervids is being moved together, the entire 
group must be isolated from all other livestock during the testing 
period, but captive cervids in the group need not be isolated from each 
other during that period. Such herd additions will not receive status as 
members of the qualified herd for purposes of interstate movement until 
they have tested negative to an official tuberculosis test and been 
released from isolation.
    (4) A captive cervid to be added must not have been exposed during 
the 90 days prior to its movement to either:
    (i) A captive cervid from a herd with a lower classification status 
than its own; or
    (ii) Any tuberculous livestock.
    (d) Maintenance of qualified herd status. To maintain status as a 
qualified herd, the herd must test negative to an official tuberculosis 
test within 9-15 months from the anniversary date of the first test with 
no evidence of tuberculosis disclosed (this is the qualifying test). 
Each time the herd is retested for qualified status, it must be tested 
9-15 months from the anniversary date of the qualifying test, not from 
the last date of requalification (for example, if a herd is qualified on 
January 1 of a given year, the anniversary date will be January 1 of 
each consecutive year). Qualified herd status remains in effect for 12 
months (365 days) following the anniversary date of the qualifying test. 
Qualified herd status will be suspended between the anniversary date and 
the requalifying test, if the herd is not tested within 12 months. 
During the suspension period, the herd will be considered 
``unclassified'' and captive cervids may be moved interstate from the 
herd only in accordance with the movement requirements for the State or 
zone in which the herd is located.

[65 FR 63517, Oct. 23, 2000, as amended at 78 FR 2067, Jan. 9, 2013]



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

[[Page 279]]

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. \2\ 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.
---------------------------------------------------------------------------

    \2\ 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 officially identified and is accompanied 
by an ICVI, 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 ICVI must also state that the 
captive cervid has tested negative to an official tuberculosis test 
conducted within 90 days prior to the date of movement. If a group of 
captive cervids from a monitored herd is being moved interstate together 
to the same destination, all captive cervids in the group may be moved 
under one ICVI.
    (3) Captive cervids under 1 year of age that are natural additions 
to the monitored herd or that were born in and originate from a 
classified herd may move without testing, provided that they are 
officially identified and that the ICVI accompanying them states that 
the captive cervids are natural additions to the monitored herd or were 
born in and originated from a classified herd and have not been exposed 
to captive cervids from an unclassified herd.
    (c) Herd additions allowed. No captive cervid may be added to a 
monitored herd except in accordance with paragraph (c)(4) and either 
paragraph (c)(1), (c)(2), or (c)(3) of this section, as follows:
    (1) The captive cervid to be added must be moved directly from an 
accredited herd;
    (2) The captive cervid to be added must be moved directly from a 
qualified or monitored herd and must have tested negative to an official 
tuberculosis test conducted within 90 days prior to movement to the 
premises of the monitored herd; or
    (3) If the captive cervid to be added is not being moved directly 
from a classified herd, the captive cervid must be isolated from all 
other animals and must test negative to two official tuberculosis tests. 
The isolation must begin at the time of the first official tuberculosis 
test. The tests must be conducted at least 90 days apart, and the second 
test must be conducted within 90 days prior to movement to the premises 
of the monitored herd. The captive cervid must then be kept in isolation 
from all animals until it tests negative to an official tuberculosis 
test conducted at least 90 days following the date it arrives at the 
premises of the monitored herd. If a group of captive cervids is being 
moved together, the entire group must be isolated from all other animals 
during the testing period, but captive cervids in the group need not be 
isolated from each other during that period. Such herd additions will 
not receive status as members of the monitored herd for purposes of 
interstate movement until they have tested negative to an official 
tuberculosis test and been released from isolation.
    (4) A captive cervid to be added must not have been exposed during 
the 90 days prior to its movement to either:

[[Page 280]]

    (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.

[65 FR 63517, Oct. 23, 2000, as amended at 71 FR 24806, Apr. 27, 2006; 
78 FR 2067, Jan. 9, 2013]



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.



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 and found negative for 
tuberculosis. Retesting must be as follows:
    (A) The first CCT test must be administered within the first 10 days 
following the SCT test or, if not, must be administered at least 90 days 
after the SCT test. If the CCT test is administered within 10 days of 
the SCT test, the injection must be on the side of the neck opposite the 
injection for the SCT test.
    (B) [Reserved]
    (ii) A captive cervid classified as a suspect on the first CCT test 
must be quarantined until the following has occurred:
    (A) A suspect on the first CCT test is tested with a second CCT test 
at least 90 days after the first CCT test and is found negative for 
tuberculosis.
    (B) [Reserved]
    (iii) A captive cervid classified as a suspect on an initial 
DPP[supreg] test must be slaughtered or otherwise must be quarantined 
until it is retested using the DPP[supreg] test. A captive cervid that 
has negative test results to this second DPP[supreg] test may be 
released from quarantine. A captive cervid that has non-negative test 
results to this second DPP[supreg] test must be classified as a reactor 
and may only be moved in accordance with paragraph (b) of this section.
    (2) The remainder of the herd. Any herd containing a suspect to an 
official tuberculosis test must be quarantined until the suspect is 
retested by the CCT test, DPP[supreg] 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

[[Page 281]]

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.
    (iv) If no evidence of tuberculosis is found in any reactor upon 
slaughter inspection or necropsy, but it is not possible to conduct a 
whole herd test on the remainder of the herd, the herd will be 
evaluated, based on criteria such as the testing history of the herd and 
the State history of tuberculosis infection, by APHIS to determine 
whether the herd may be released from quarantine.
    (c) Herds found to have only lesions of tuberculosis. A herd in 
which captive cervids with lesions compatible with or suggestive of 
tuberculosis are found by histopathology without the isolation of M. 
bovis may be released from quarantine and return to the herd 
classification status in effect before the herd was quarantined, with 
the concurrence of APHIS, if the herd tests negative to tuberculosis on 
a whole herd test conducted 90 days following the removal of the 
lesioned captive cervid, provided the herd has not been exposed to M. 
bovis during the 90 days. To maintain its herd classification status, 
the herd must test negative to two annual whole herd tests beginning 10-
12 months after the herd is released from quarantine. If any captive 
cervids in the herd respond to one of the tests, the herd will be 
subject to the provisions of paragraph (a) or (b) of this section. If 
the herd is not given the two annual whole herd tests, it will become an 
unclassified herd.
    (d) Affected herds. A herd determined to be an affected herd must be 
quarantined until the herd has tested negative to three whole herd tests 
in succession, with the first test given 90 days or more after the last 
test yielding a reactor and the last two tests given at intervals of not 
less than 180 days. If the herd tests negative to the three whole herd 
tests, it will be released from quarantine, but will be considered an 
unclassified herd, and captive cervids may only be moved interstate from 
the herd in accordance with the movement requirements for the State or 
zone in which the herd is located. In addition, the herd must be given 
five consecutive annual whole herd tests after release from quarantine. 
(These five tests will count toward qualifying the herd for herd 
classification.) As an alternative to testing, the herd may be 
depopulated.

[[Page 282]]

    (e) Herds that have received captive cervids from an affected herd. 
If a herd has received captive cervids from an affected herd, the 
captive cervids from the affected herd of origin will be considered 
exposed to tuberculosis. The exposed captive cervids and the receiving 
herd must be quarantined. The exposed captive cervids must be 
slaughtered, necropsied, or tested with the SCT test by a veterinarian 
employed by the State in which the test is administered or employed by 
USDA, or tested with the DPP[supreg] test. Any exposed captive cervid 
that responds to the SCT test must be classified as a reactor and must 
be inspected at slaughter or necropsied. Any exposed captive cervid that 
has non-negative test results to the DPP[supreg] test must be classified 
as a reactor and must be inspected at slaughter or necropsied. Any 
exposed captive cervid that tests negative to the SCT or DPP[supreg] 
test will be considered as part of the affected herd of origin for 
purposes of testing, quarantine, and the five annual whole herd tests 
required for affected herds in paragraph (d) of this section.
    (1) If bovine tuberculosis is confirmed in any of the exposed 
captive cervids by bacterial isolation of M. bovis, the receiving herd 
will be classified as an affected herd and will be subject to the 
provisions for affected herds in paragraph (d) of this section.
    (2) If any of the exposed captive cervids are found to exhibit 
lesions compatible with or suggestive of tuberculosis, found by 
histopathology, without the isolation of M. bovis, the receiving herd 
will be subject to appropriate testing as determined by APHIS.
    (3) If all the exposed captive cervids test negative for 
tuberculosis, the receiving herd will be released from quarantine if it 
is given a whole herd test and is found negative for tuberculosis and 
will return to the herd classification in effect before the herd was 
quarantined. In addition, the receiving herd will must be retested with 
the SCT or DPP[supreg] test 1 year after release from quarantine in 
order for captive cervids from the herd to continue to be moved 
interstate. Supplemental diagnostic tests may be used if any captive 
cervids in the herd show a response to the SCT test or have non-negative 
test results to the DPP[supreg] test.
    (f) Source herds. A herd suspected of being the source of 
tuberculous captive cervids based on a slaughter traceback investigation 
must be quarantined upon notification (by the person conducting the 
investigation) to the USDA area veterinarian in charge for the State in 
which the herd resides, and a herd test must be scheduled. If the herd 
is suspected of being the source of slaughter captive cervids having 
lesions of tuberculosis, the herd test must be done by a veterinarian 
employed by the State in which the test is administered or employed by 
USDA.
    (1) If the herd is identified as the source of captive cervids 
having lesions of tuberculosis and M. bovis has been confirmed by 
bacterial isolation from the slaughter animal, all captive cervids in 
the herd that respond to the SCT must be classified as reactors. All 
captive cervids in the herd that respond to the DPP[supreg] test must be 
classified as reactors. If none respond to the SCT test or have non-
negative test results to the DPP[supreg] test, the herd may be released 
from quarantine and will return to the herd classification status in 
effect before the herd was quarantined, unless APHIS determines that 
additional testing is appropriate to ensure the herd's freedom from 
tuberculosis.
    (2) If the herd is identified as the source of captive cervids that 
exhibit lesions compatible with or suggestive of tuberculosis, found by 
histopathology, without the isolation of M. bovis, all captive cervids 
in the herd that respond to the SCT test or the DPP[supreg] 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

[[Page 283]]

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.

[65 FR 63517, Oct. 23, 2000, as amended at 71 FR 24806, Apr. 27, 2006; 
78 FR 1723, Jan. 9, 2013; 79 FR 43926, July 29, 2014]



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 a recognized 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 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:

[[Page 284]]

    (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.

[65 FR 63517, Oct. 23, 2000, as amended at 78 FR 2068, Jan. 9, 2013]



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.
78.14 Rodeo cattle.
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
Animal identification number
APHIS representative
Approved brucella vaccine
Approved individual herd plan
Approved intermediate handling facility

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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
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 in accordance with the provisions of part 161 of this 
title to perform functions specified in parts 1, 2, 3, and 11 of 
subchapter A, and subchapters B, C, and D of this chapter, and to 
perform functions required by cooperative State-Federal disease control 
and eradication programs.
    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Animals. Cattle, bison, and swine.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Animal identification number (AIN). A numbering system for the 
official identification of individual animals in the United States that 
provides a nationally unique identification number for each animal. The 
AIN consists of 15 digits, with the first 3 being the country code (840 
for the United States or a unique country code for any U.S. territory 
that has such a code and elects to use it in place of the 840 code). The 
alpha characters USA or the numeric code assigned to the manufacturer of 
the identification device by the International Committee on Animal 
Recording may be used as an alternative to the 840 or other prefix 
representing a U.S territory; however, only the AIN beginning with the 
840 or other prefix representing a U.S. territory will be recognized as 
official for use on AIN tags applied to animals on or after March 11, 
2015. The AIN beginning with the 840 prefix may not be applied to 
animals known to have been born outside the United States.
    APHIS representative. An individual employed by APHIS who is 
authorized to perform the function involved.

[[Page 286]]

    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 2 years; (e) State representatives and APHIS 
representatives shall be granted, at reasonable hours, access to all 
documents required to be maintained by the facility and authority to 
reproduce the documents; and (f) Each entrance and exit to the facility 
must prominently display a sign bearing the following words: ``All 
cattle and bison entering this facility must go directly to slaughter or 
a quarantined feedlot''. The Administrator may withdraw or deny approval 
of any intermediate handling facility in accordance with 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 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

[[Page 287]]

found positive or reclassified as a brucellosis reactor by a designated 
epidemiologist as provided for in the definition of official test.
    Brucellosis ring test. The brucellosis ring test is conducted on 
composite milk or cream samples from dairy herds and is interpreted as 
either negative or suspicious (positive). Herds which are negative to 
the brucellosis ring test and which are not quarantined as brucellosis 
affected are classified as brucellosis negative for public health 
ordinances and surveillance purposes. Herds classified as suspicious 
require a herd blood test to determine animal and herd status.
    Brucellosis suspect. An animal subjected to an official test 
resulting in a brucellosis suspect classification or reclassified as a 
brucellosis suspect by a designated epidemiologist as provided for in 
the definition of official test.
    Certified brucellosis-free herd. A herd of cattle or bison which has 
qualified for and whose owner has been issued a certified brucellosis-
free herd certificate signed by the appropriate State animal health 
official and the Veterinarian in Charge.
    (a) Certification. The following methods may be used to qualify a 
herd:
    (1) By conducting at least two consecutive negative herd blood tests 
not less than 10 months nor more than 14 months apart; or
    (2) As an alternative for dairy cattle, by conducting a minimum of 
four consecutive negative brucellosis ring tests, or other official 
brucellosis milk test approved by the Administrator, at not less than 
90-day intervals, followed by a negative herd blood test within 90 days 
after the last negative brucellosis ring test or other official 
brucellosis milk test approved by the Administrator.
    (b) Maintaining certification. Certified brucellosis-free herd 
status will remain in effect for 1 year beginning with the date of 
issuance of the certified brucellosis-free herd certificate. The 
following methods may be used to maintain herd certification:
    (1) A negative herd blood test must be conducted within 10 to 12 
months of the last certification date for continuous status. Lapsed 
certification may be reinstated if a herd blood test is conducted within 
14 months of the last certification date. A new recertification test 
date may be established if requested by the owner and if the herd is 
negative to a herd blood test on that date, provided that date is within 
1 year of the previous certification date.
    (2) As an alternative for dairy cattle, a minimum of four 
consecutive negative brucellosis ring tests, or other official 
brucellosis milk test approved by the Administrator, must be conducted 
at approximately 90-day intervals, with the fourth test conducted within 
60 days before the 1-year anniversary of the previous certification 
date.
    (3) The Administrator may allow another testing protocol to be used 
if the Administrator determines that such a protocol is adequate to 
determine there is no evidence of brucellosis in the herd.
    (c) Loss of certification. A herd which loses certified brucellosis-
free herd status because a brucellosis reactor is found in the herd may 
be recertified only by repeating the certification process, except that 
certified brucellosis-free herd status may be reinstated without 
repeating the certification process if epidemiological studies and 
bacteriological cultures conducted by an APHIS representative or State 
representative show that the herd was not affected with Brucella 
abortus.
    Class A State or area. A State or area which meets standards for 
classification as a Class A State or area and is certified as such on 
initial classification or on reclassification by the State animal health 
official, the Veterinarian in Charge, and the Administrator. Any 
reclassification will be made in accordance with 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

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collected from at least 95 percent of all cows and bulls 2 years of age 
or over at each recognized slaughtering establishment and subjected to 
an official test;
    (ii) Brucellosis reactors--(A) Tracebacks. At least 90 percent of 
all brucellosis reactors found in the course of MCI testing must be 
traced to the farm of origin.
    (B) Successfully closed cases. The State or area must successfully 
close at least 95 percent of the MCI reactor cases traced to the farm of 
origin during the 12-consecutive-month period immediately prior to the 
most recent anniversary of the date the State or area was classified 
Class A. To successfully close an MCI reactor case, State 
representatives or APHIS representatives must conduct an epidemiologic 
investigation at the farm of origin within 15 days after notification by 
the cooperative State-Federal laboratory that brucellosis reactors were 
found on the MCI test. Herd blood tests must be conducted or the herd 
must be confined to the premises under quarantine within 30 days after 
notification that brucellosis reactors were found on the MCI test, 
unless a designated epidemiologist determines that:
    (1) The brucellosis reactor is located in a herd in a different 
State than the State where the MCI blood sample was collected. In such 
cases a State representative or APHIS representative must give written 
notice of the MCI test results to the State animal health official in 
the State where the brucellosis reactor is located; or
    (2) Evidence indicates that the brucellosis reactor is from a herd 
that no longer presents a risk of spreading brucellosis, or is from a 
herd that is unlikely to be infected with brucellosis. Such evidence 
could include, but is not limited to, situations where:
    (i) The brucellosis reactor is traced back to a herd that has been 
sold for slaughter in entirety;
    (ii) The brucellosis reactor is traced back to a herd that is 
certified brucellosis free and is 100-percent vaccinated; or
    (iii) The brucellosis reactor showed a low titer in the MCI test and 
is traced back to a dairy herd that is 100 percent vaccinated and has 
tested negative to the most recent brucellosis ring test required by 
this section for herds producing milk for sale.
    (3) Epidemiologic surveillance--(i) Adjacent herds. All adjacent 
herds or other herds having contact with cattle or bison in a herd known 
to be affected shall have an approved individual herd plan in effect 
within 15 days of notification of brucellosis in the herd known to be 
affected;
    (ii) Epidemiologically traced herds. All herds from which cattle or 
bison are moved into a herd known to be affected and all herds which 
have received cattle or bison from a herd known to be affected shall 
have an approved individual herd plan in effect within 15 days of 
locating the source herd or recipient herd.
    (iii) Each State shall ensure that such approved individual herd 
plans are effectively complied with, as determined by the Administrator.
    (b) Herd infection rate--(1) Percentage of herds affected. States or 
areas must not exceed a cattle or bison herd infection rate, based on 
the number of herds found to have brucellosis reactors within the State 
or area during any 12 consecutive months due to field strain Brucella 
abortus, of 0.25 percent or 2.5 herds per 1,000, except in States with 
10,000 or fewer herds. A special review by the Administrator will be 
made to determine if such small herd population States would qualify for 
Class A status. Locations of herds, sources of brucellosis, and 
brucellosis control measures taken by the State will be considered.
    (2) Epidemiologic investigation. Within 15 days after notification 
by the cooperative State-Federal laboratory that brucellosis reactors 
have been found in any herd, State representatives or APHIS 
representatives shall investigate that herd to identify possible sources 
of brucellosis. All possible sources of brucellosis identified shall be 
contacted within an additional 15 days to determine appropriate action.
    (3) All herds known to be affected shall have approved individual 
herd plans in effect within 15 days after notification by a State 
representative or APHIS representative of a brucellosis reactor in the 
herd. Each State shall ensure that such approved individual herd plans 
are effectively complied

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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 cows and bulls 2 years of age or over at each 
recognized slaughtering establishment and subjected to an official test;
    (ii) Brucellosis reactors--(A) Tracebacks. At least 80 percent of 
all brucellosis reactors found in the course of MCI testing must be 
traced to the farm of origin.
    (B) Successfully closed cases. The State or area must successfully 
close at least 90 percent of the MCI reactor cases traced to the farm of 
origin during the 12-consecutive-month period immediately prior to the 
most recent anniversary of the date the State or area was classified 
Class B. To successfully close an MCI reactor case, State 
representatives or APHIS representatives must conduct an epidemiologic 
investigation at the farm of origin within 30 days after notification by 
the cooperative State-Federal laboratory that brucellosis reactors were 
found on the MCI test. Herd blood tests must be conducted or the herd 
must be confined to the premises under quarantine within 30 days after 
notification that brucellosis reactors were found on the MCI test, 
unless a designated epidemiologist determines that:
    (1) The brucellosis reactor is located in a herd in a different 
State than the State where the MCI blood sample was collected. In such 
cases a State representative or APHIS representative must give written 
notice of the MCI test results to the State animal health official in 
the State where the brucellosis reactor is located; or
    (2) Evidence indicates that the brucellosis reactor is from a herd 
that no longer presents a risk of spreading brucellosis, or is from a 
herd that is unlikely to be infected with brucellosis. Such evidence 
could include, but is not limited to, situations where:
    (i) The brucellosis reactor is traced back to a herd that has been 
sold for slaughter in entirety;
    (ii) The brucellosis reactor is traced back to a herd that is 
certified brucellosis free and is 100-percent vaccinated; or
    (iii) The brucellosis reactor showed a low titer in the MCI test and 
is traced back to a dairy herd that is 100 percent vaccinated and has 
tested negative to the most recent brucellosis ring test required by 
this section for herds producing milk for sale.
    (3) Epidemiologic surveillance--(i) Adjacent herds. All adjacent 
herds or other herds having contact with cattle or bison in a herd known 
to be affected shall have an approved individual herd plan in effect 
within 45 days of notification of brucellosis in the herd known to be 
affected;
    (ii) Epidemiologically traced herds. All herds from which cattle or 
bison are moved into a herd known to be affected and all herds which 
have received cattle or bison from a herd known to be affected shall 
have an approved individual herd plan in effect within 45 days of 
locating the source herd or recipient herd.
    (iii) Each State shall ensure that such approved individual herd 
plans are effectively complied with, as determined by the Administrator.
    (b) Herd infection rate--(1) Percentage of herds affected. States or 
areas must not exceed a cattle or bison herd infection rate, based on 
the number of herds found to have brucellosis reactors within the State 
or area during any 12 consecutive months due to field strain Brucella 
abortus, of 1.5 percent or 15 herds per 1,000, except in States with 
1,000 or fewer herds. A special review

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by the Administrator will be made to determine if such small herd 
population States would qualify for Class B status. Locations of herds, 
sources of brucellosis, and brucellosis control measures taken by the 
State will be considered.
    (2) Epidemiologic investigation. Within 45 days after notification 
by the cooperative State-Federal laboratory that brucellosis reactors 
have been found in any herd, State representatives or APHIS 
representatives shall investigate that herd to identify possible sources 
of brucellosis. All possible sources of brucellosis identified shall be 
contacted within an additional 30 days to determine appropriate action.
    (3) All herds known to be affected shall have approved individual 
herd plans in effect within 45 days after notification by a State 
representative or APHIS representative of a brucellosis reactor in the 
herd. Each State shall ensure that such approved individual herd plans 
are effectively complied with, as determined by the Administrator.
    Class C State or area. A State or area which meets standards for 
classification as a Class C State or area and is certified as such on 
initial classification or on reclassification by the State animal health 
official, the Veterinarian in Charge, and the Administrator. Any 
reclassification will be made in accordance with 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 or bison in a herd known 
to be affected shall have an approved individual herd

[[Page 291]]

plan in effect within 45 days of notification of brucellosis in the herd 
known to be affected;
    (ii) Epidemiologically traced herds. All herds from which cattle or 
bison are moved into a herd known to be affected and all herds which 
have received cattle or bison from a herd known to be affected shall 
have an approved individual herd plan in effect within 45 days of 
locating the source herd or recipient herd.
    (iii) Each State shall ensure that such approved individual herd 
plans are effectively complied with, as determined by the Administrator.
    (b) Herd infection rate--(1) Percentage of herds affected. States or 
areas exceed a cattle or bison herd infection rate, based on the number 
of herds found to have brucellosis reactors within the State or area 
during any 12 consecutive months due to field strain Brucella abortus, 
of 1.5 percent or 15 herds per 1,000, except in States with 1,000 or 
fewer herds. A special review by the Administrator will be made to 
determine if such small herd population States should be classified as a 
Class C State. Locations of herds, sources of brucellosis, and 
brucellosis control measures taken by the State will be considered.
    (2) Epidemiologic investigation. Within 45 days after notification 
by the cooperative State-Federal laboratory that brucellosis reactors 
have been found in any herd, State representatives or APHIS 
representatives shall investigate that herd to identify possible sources 
of brucellosis. All possible sources of brucellosis identified shall be 
contacted within an additional 30 days to determine appropriate action.
    (3) All herds known to be affected shall have approved individual 
herd plans in effect within 45 days after notification by a State 
representative or APHIS representative of a brucellosis reactor in the 
herd. Each State shall ensure that such approved individual herd plans 
are effectively complied with, as determined by the Administrator.
    (c) Compliance with minimum procedural standards. (1) A State must 
implement and maintain minimum procedural standards.
    (2) A State or area must make continued progress over a 2-year 
period in reducing the prevalence of brucellosis as determined by 
epidemiologic evaluation or it will be placed under Federal quarantine.
    Class Free State or area. A State or area which meets standards for 
classification as a Class Free State or area and is certified as such on 
initial classification or on reclassification by the State animal health 
official, the Veterinarian in Charge, and the Administrator. For initial 
classification or reclassification, all cattle herds in the State or 
area must have remained free of Brucella abortus for 12 consecutive 
months, based on surveillance and epidemiologic investigations as 
required for Class A States or areas, and the State or area must have a 
cattle herd infection rate, based on the number of herds found to have 
brucellosis reactors within the State or area during any 12 consecutive 
months due to Brucella abortus, of 0.0 percent or 0 herds per 1,000. The 
Administrator may reclassify a State or area to a lower status upon 
finding that continued detection of brucellosis presents a risk that the 
disease will spread. Any reclassification will be made in accordance 
with 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 
foci of brucellosis in any species of domestic livestock are left 
uncontrolled. The following are the standards to maintain Class Free 
status.
    (a) Surveillance--(1) Testing requirements--(i) States or areas that 
have been Class Free for 5 consecutive years or longer and that do not 
have B. abortus in wildlife. All recognized slaughtering establishments 
in the State or area, upon request by APHIS, must agree to participate 
in market cattle identification (MCI) testing as part of the national 
brucellosis surveillance plan.
    (ii) States or areas that have not been Class Free for 5 consecutive 
years or

[[Page 292]]

longer or that have B. abortus in wildlife. The State or area must carry 
out testing as provided in paragraphs (a)(1)(ii)(A) and (a)(1)(ii)(B) or 
(a)(1)(ii)(C) of this definition:
    (A) Brucellosis ring test. The State or area shall conduct as many 
brucellosis ring tests per year as are necessary to ensure that all 
herds producing milk for sale are tested at least twice per year at 
approximately 6-month intervals. Another official brucellosis milk test 
may be used as approved by the Administrator.
    (B) Market Cattle Identification (MCI) program. All recognized 
slaughtering establishments in the State or area must participate in the 
MCI program. Blood samples shall be collected from at least 95 percent 
of all cows and bulls 2 years of age or over at each recognized 
slaughtering establishment and subjected to an official test.
    (C) Alternative surveillance plan. As an alternative to the testing 
described in paragraphs (a)(1)(ii)(A) and (a)(1)(ii)(B) of this 
definition, the State or area may develop an alternative surveillance 
plan that would have to meet or exceed the level of disease detection 
provided by combined brucellosis ring testing and collection of blood 
samples from at least 95 percent of test eligible slaughter cattle 
slaughtered within the State. The alternative surveillance plan must be 
developed in conjunction with the State animal health official and the 
area veterinarian in charge.
    (2) Brucellosis reactors. All Class Free States or areas must comply 
with the following requirements upon detection of a brucellosis reactor:
    (i) Tracebacks. The State or area must trace at least 90 percent of 
all brucellosis reactors found in the course of MCI testing to the farm 
of origin.
    (ii) Successfully closed cases. The State or area must successfully 
close at least 95 percent of the MCI reactor cases traced to the farm of 
origin during the 12-consecutive-month period immediately prior to the 
most recent anniversary of the date the State or area was classified 
Class Free. To successfully close an MCI reactor case, State 
representatives or APHIS representatives must conduct an epidemiologic 
investigation at the farm of origin within 15 days after notification by 
the cooperative State-Federal laboratory that brucellosis reactors were 
found on the MCI test. Herd blood tests must be conducted or the herd 
must be confined to the premises under quarantine within 30 days after 
notification that brucellosis reactors were found on the MCI test, 
unless a designated epidemiologist determines that:
    (A) The brucellosis reactor is located in a herd in a different 
State than the State where the MCI blood sample was collected. In such 
cases a State representative or APHIS representative must give written 
notice of the MCI test results to the State animal health official in 
the State where the brucellosis reactor is located; or
    (B) Evidence indicates that the brucellosis reactor is from a herd 
that no longer presents a risk of spreading brucellosis, or is from a 
herd that is unlikely to be infected with brucellosis. Such evidence 
could include, but is not limited to, situations where:
    (1) The brucellosis reactor is traced back to a herd that has been 
sold for slaughter in entirety;
    (2) The brucellosis reactor is traced back to a herd that is 
certified brucellosis free and is 100-percent vaccinated; or
    (3) The brucellosis reactor showed a low titer in the MCI test and 
is traced back to a dairy herd that is 100 percent vaccinated and has 
tested negative to the most recent brucellosis ring test required by 
this section for herds producing milk for sale.
    (iii) Epidemiologic surveillance--(A) Adjacent herds. All adjacent 
herds or other herds having contact with cattle or bison in a herd known 
to be affected shall be placed under quarantine and have an approved 
individual herd plan in effect within 15 days after notification of 
brucellosis in the herd known to be affected;
    (B) Epidemiologically traced herds. All herds from which cattle or 
bison are moved into a herd known to be affected and all herds which 
have received cattle or bison from a herd known to be affected shall be 
placed under quarantine and have an approved individual herd plan in 
effect within 15 days of locating the source herd or recipient herd. 
Each State shall ensure that such

[[Page 293]]

approved individual herd plans are effectively complied with, as 
determined by the Administrator.
    (b) Herd infection rate--(1) Affected herds. Except as provided in 
paragraph (b)(4) of this definition, all cattle and bison herds in the 
State or area must remain free of Brucella abortus.
    (2) Epidemiologic investigation. Within 15 days after notification 
by the cooperative State-Federal laboratory that brucellosis reactors 
have been found in any herd, State representatives or APHIS 
representatives shall investigate that herd to identify possible sources 
of brucellosis. All possible sources of brucellosis identified shall be 
contacted within an additional 15 days to determine appropriate action.
    (3) Approved herd plans. All herds known to be affected shall have 
approved individual herd plans in effect within 15 days after 
notification by a State representative or APHIS representative of a 
brucellosis reactor in the herd. Each State shall ensure that such 
approved individual herd plans are effectively complied with, as 
determined by the Administrator.
    (4) Affected herd. If any herd in a Class Free State or area is 
found to be affected with brucellosis, the State or area may retain its 
Class Free status if it meets the conditions of this paragraph.
    (i) The affected herd. (A) The affected herd must be quarantined 
immediately, and, within 60 days, tested for brucellosis and 
depopulated; or
    (B) The affected herd must be quarantined immediately and tested for 
brucellosis as required by the Administrator until there is no evidence 
of brucellosis in the herd; and
    (ii) Other herds. An epidemiological investigation must be performed 
within 60 days of the detection of an infected animal in a herd. All 
herds on premises adjacent to the affected herd (adjacent herds), all 
herds from which animals may have been brought into the affected herd 
(source herds), and all herds that may have had contact with or accepted 
animals from the affected herd (contact herds) must be epidemiologically 
investigated, and each of those herds must be placed under an approved 
individual herd plan. If the investigating epidemiologist determines 
that a herd blood test for a particular adjacent herd, source herd, or 
contact herd is not warranted, the epidemiologist must include that 
determination, and the reasons supporting it, in the individual herd 
plan.
    (iii) APHIS review. After the close of the 60-day period following 
the date an animal in the herd is determined to be infected, APHIS will 
conduct a review to confirm that the requirements of paragraphs 
(b)(4)(i) and (b)(4)(ii) of this definition have been satisfied and that 
the State or area is in compliance with all other applicable provisions.
    (c) Brucellosis management plans. (1) Any State in which the 
Administrator has determined wildlife are infected with B. abortus must 
develop and implement a brucellosis management plan approved by the 
Administrator. The existence of B. abortus in wildlife will be 
determined by the Administrator, based on, but not limited to, 
histopathology, testing data, or epidemiology. The Administrator may 
also require a Class Free State or area to develop and implement a 
brucellosis management plan under any other circumstances if the 
Administrator determines it is necessary to prevent the spread of 
brucellosis. The State must sign a memorandum of understanding (MOU) 
with the Administrator that describes its brucellosis management plan. 
The MOU must be updated annually. The Administrator may reclassify to a 
lower status any State or area that has not implemented an approved 
brucellosis management plan within 6 months of being required to develop 
one.
    (2) The brucellosis management plan reflected in the MOU must:
    (i) Define and explain the basis for the geographic area in which a 
disease risk exists from B. abortus and to which the brucellosis 
management plan activities apply;
    (ii) Describe epidemiologic assessment and surveillance activities 
to identify occurrence of B. abortus in domestic livestock and wildlife 
and potential risks for spread of disease; and
    (iii) Describe mitigation activities to prevent the spread of B. 
abortus from domestic livestock and/or wildlife, as applicable, within 
or from the brucellosis management area.

[[Page 294]]

    Commuter herd. A herd of cattle or bison moved interstate during the 
course of normal livestock management operations and without change of 
ownership directly between two premises, as provided in a commuter herd 
agreement.
    Commuter herd agreement. A written agreement between the owner(s) of 
a herd of cattle or bison and the animal health officials for the States 
or Tribes of origin and destination specifying the conditions required 
for the interstate movement from one premises to another in the course 
of normal livestock management operations and specifying the time 
period, up to 1 year, that the agreement is effective. A commuter herd 
agreement may be renewed annually.
    Complete herd test (CHT). An official swine brucellosis test of all 
swine on a premises that are 6 months of age or older and maintained for 
breeding purposes.
    Confirmatory test. A follow-up test to verify any official test 
results. Confirmatory tests include the standard tube test, the Rivanol 
test, the complement fixation test (CF), the fluorescence polarization 
assay (FP assay), the particle concentration fluorescence immunoassay 
(PCFIA), the semen plasma test, and the standard plate test.
    Dairy cattle. All cattle, regardless of age or sex or current use, 
that are of a breed(s) used to produce milk or other dairy products for 
human consumption, including, but not limited to, Ayrshire, Brown Swiss, 
Holstein, Jersey, Guernsey, Milking Shorthorn, and Red and Whites.
    Designated epidemiologist. An epidemiologist selected by the State 
animal health official and the Veterinarian in Charge to perform the 
functions required. The regional epidemiologist and the APHIS 
brucellosis staff must concur in the selection and appointment of the 
designated epidemiologist.
    Directly. Moved in a means of conveyance, without stopping to unload 
while en route, except for stops of less than 24 hours to feed, water or 
rest the animals being moved, and with no commingling of animals at such 
stops.
    Epidemiologist. A veterinarian who has received a master's degree in 
epidemiology or completed a course of study in epidemiology sponsored by 
the Animal and Plant Health Inspection Service, United States Department 
of Agriculture.
    Epidemiology. A branch of medical science that deals with the 
incidence, distribution, and control of disease in the animal 
population.
    Farm of origin. (a) Premises where cattle or bison are born and 
remain prior to movement from the premises but which are not used to 
assemble cattle or bison from any other premises for 4 months before 
such movement; or
    (b) Premises where cattle or bison remain for not less than 4 months 
immediately before movement from the premises but which are not used to 
assemble cattle or bison from any other premises for 4 months before 
such movement.
    Feral swine. Free-roaming swine. Formerly free-roaming swine could 
qualify for reclassification as domestic swine upon testing negative to 
an official swine brucellosis test after a period of at least 60 days' 
confinement in isolation from other feral swine.
    Finished fed cattle. Cattle fattened on a ration of feed 
concentrates to reach a slaughter condition equivalent to that which 
would be attained on full feed with a high concentrate grain ration for 
90 days.
    Herd. (a) All animals under common ownership or supervision that are 
grouped on one or more parts of any single premises (lot, farm, or 
ranch); or
    (b) All animals under common ownership or supervision on two or more 
premises which are geographically separated but on which animals from 
the different premises have been interchanged or had contact with each 
other.
    (c) For the purposes of this part, the term herd does not include 
animals that are contained within a federally approved research 
facility.
    Herd blood test. A blood test for brucellosis conducted in a herd on 
all cattle and bison 18 months of age or older, except for steers and 
spayed heifers, and except when conducting herd blood tests as part of 
affected herd investigations or other epidemiological investigations or 
when the Administrator determines testing at a younger age is

[[Page 295]]

necessary to prevent the spread of brucellosis.
    Herd known to be affected. Any herd in which any animal has been 
classified as a brucellosis reactor and which has not been released from 
quarantine.
    Herd not known to be affected. Any herd in which no animal has been 
classified as a brucellosis reactor or any herd in which one or more 
animals have been classified as brucellosis reactors but which has been 
released from quarantine.
    Herd of origin of swine. Any herd in which swine are farrowed and 
remain until movement or any herd in which swine remain for 30 days 
immediately prior to movement.
    Interstate. From any State into or through any other State.
    Interstate certificate of veterinary inspection (ICVI). An official 
document issued by a Federal, State, Tribal, or accredited veterinarian 
certifying the inspection of animals in preparation for interstate 
movement.
    (1) The ICVI must show the species of animals covered by the ICVI; 
the number of animals covered by the ICVI; the purpose for which the 
animals are to be moved; the address at which the animals were loaded 
for interstate movement; the address to which the animals are destined; 
and the names of the consignor and the consignee and their addresses if 
different from the address at which the animals were loaded or the 
address to which the animals are destined. Additionally, unless the 
species-specific requirements for ICVIs provide an exception, the ICVI 
must list the official identification number of each animal, except as 
provided in paragraph (2) of this definition, or group of animals moved 
that is required to be officially identified, or, if an alternative form 
of identification has been agreed upon by the sending and receiving 
States, the ICVI must include a record of that identification. If 
animals moving under a GIN also have individual official identification, 
only the GIN must be listed on the ICVI. An ICVI may not be issued for 
any animal that is not officially identified if official identification 
is required. If the animals are not required by the regulations to be 
officially identified, the ICVI must state the exemption that applies 
(e.g., the cattle and bison do not belong to one of the classes of 
cattle and bison to which the official identification requirements of 9 
CFR part 86 apply). If the animals are required to be officially 
identified but the identification number does not have to be recorded on 
the ICVI, the ICVI must state that all animals to be moved under the 
ICVI are officially identified.
    (2) As an alternative to typing or writing individual animal 
identification on an ICVI, if agreed to by the receiving State or Tribe, 
another document may be used to provide this information, but only under 
the following conditions:
    (i) The document must be a State form or APHIS form that requires 
individual identification of animals or a printout of official 
identification numbers generated by computer or other means;
    (ii) A legible copy of the document must be stapled to the original 
and each copy of the ICVI;
    (iii) Each copy of the document must identify each animal to be 
moved with the ICVI, 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
    (iv) The following information must be written in ink in the 
identification column on the original and each copy of the ICVI and must 
be circled or boxed, also in ink, so that no additional information can 
be added:
    (A) The name of the document; and
    (B) Either the unique serial number on the document or, if the 
document is not imprinted with a serial number, both the name of the 
person who prepared the document and the date the document was signed.
    Location-based number system. The location-based number system 
combines a State or Tribal issued location identification (LID) number 
or a premises identification number (PIN) with a producer's unique 
livestock production numbering system to provide a nationally unique and 
herd-unique identification number for an animal.
    Location identification (LID) number. A nationally unique number 
issued by a State, Tribal, and/or Federal animal

[[Page 296]]

health authority to a location as determined by the State or Tribe in 
which it is issued. The LID number may be used in conjunction with a 
producer's own unique livestock production numbering system to provide a 
nationally unique and herd-unique identification number for an animal. 
It may also be used as a component of a group/lot identification number 
(GIN).
    Market cattle identification test cattle. Cows and bulls 18 months 
of age or over which have been moved to recognized slaughtering 
establishments, and test-eligible cattle which are subjected to an 
official test for the purposes of movement at farms, ranches, auction 
markets, stockyards, quarantined feedlots, or other assembly points. 
Such cattle must be identified with an official identification device as 
specified in Sec.86.4(a) of this chapter prior to or at the first 
market, stockyard, quarantined feedlot, or slaughtering establishment 
they reach.
    Market swine test (MST) reactor. Market swine test swine with a 
positive reaction to a swine brucellosis confirmatory test or other 
official test, if no confirmatory test is performed.
    Market swine test swine. Sows and boars which have been moved to 
slaughtering establishments and sows and boars which are subjected to an 
official test for the purposes of movement at farms, ranches, auction 
markets, stockyards, or other assembly points.
    Monitored-negative feral swine population. Feral swine indicating no 
evidence of infection (indicators would include positive blood tests or 
clinical signs, such as abortion) and originating from a specified, 
geographically isolated area (a forest area, hunting preserve, or swamp, 
for example) may be classified by the designated epidemiologist as a 
monitored-negative feral swine population.
    Moved. Shipped, transported, delivered, or received for movement, or 
otherwise aided, induced, or caused to be moved.
    Moved (movement) in interstate commerce. Moved from the point of 
origin of the interstate movement to the animals' final destination, 
such as a slaughtering establishment or a farm for breeding or raising, 
and including any temporary stops for any purpose along the way, such as 
at a stockyard or dealer premises for feed, water, rest, or sale.
    National Uniform Eartagging System (NUES). A numbering system for 
the official identification of individual animals in the United States 
that provides a nationally unique identification number for each animal.
    Official adult vaccinate. (a) Female cattle or female bison older 
than the specified ages defined for official calfhood vaccinate and 
vaccinated by an APHIS representative, State representative, or 
accredited veterinarian with a reduced dose approved brucella vaccine, 
diluted so as to contain at least 300 million and not more than 1 
billion live cells per 2 mL dose of Brucella abortus Strain 19 vaccine 
or at the dosage indicated on the label instructions for other approved 
brucella vaccines, as part of a whole herd vaccination plan authorized 
jointly by the State animal health official and the Veterinarian in 
Charge; and
    (b)(1) Permanently identified by a ``V'' hot brand high on the hip 
near the tailhead at least 5 by 5 centimeters (2 by 2 inches) in size, 
or by an official AV (adult vaccination) tattoo in the right ear 
preceded by the quarter of the year and followed by the last digit of 
the year; and
    (2) Identified with an official eartag or individual animal 
registered breed association registration brand or individual animal 
registered breed association tattoo.
    Official brand inspection certificate. A document issued by an 
official brand inspection agency in any State which requires such 
documents for movement of cattle or bison.
    Official brand recording agency. The duly constituted body 
authorized by a State or governmental subdivision thereof to administer 
laws, regulations, ordinances or rules pertaining to the brand 
identification of cattle or bison.
    Official calfhood vaccinate. (a) Female cattle or female bison 
vaccinated while from 4 through 12 months of age by an APHIS 
representative, State representative, or accredited veterinarian with a 
reduced dose approved brucella vaccine containing at least 2.7 billion 
and not

[[Page 297]]

more than 10 billion live cells per 2 mL dose of Brucella abortus Strain 
19 vaccine or at the dosage indicated on the label instructions for 
other approved brucella vaccines; and
    (b) Permanently identified by a tattoo and by an official 
vaccination eartag in the right ear. However, if already identified with 
an official eartag prior to vaccination, an additional tag is not 
required. The tattoo must include the U.S. Registered Shield and ``V,'' 
preceded by the quarter of the year and followed by the last digit of 
the year of vaccination. Individual animal registered breed association 
registration brands or individual animal registered breed association 
registration tattoos may be substituted for official eartags.
    Official eartag. An identification tag approved by APHIS that bears 
an official identification number for individual animals. Beginning 
March 11, 2014, all official eartags manufactured must bear an official 
eartag shield. Beginning March 11, 2015, all official eartags applied to 
animals must bear an official eartag shield. The design, size, shape, 
color, and other characteristics of the official eartag will depend on 
the needs of the users, subject to the approval of the Administrator. 
The official eartag must be tamper-resistant and have a high retention 
rate in the animal.
    Official eartag shield. The shield-shaped graphic of the U.S. Route 
Shield with ``U.S.'' or the State postal abbreviation or Tribal alpha 
code imprinted within the shield.
    Official identification number. A nationally unique number that is 
permanently associated with an animal or group of animals and that 
adheres to one of the following systems:
    (1) National Uniform Eartagging System.
    (2) Animal identification number (AIN).
    (3) Location-based number system.
    (4) Flock-based number system.
    (5) Any other numbering system approved by the Administrator for the 
official identification of animals.
    Officially identified. Identified by means of an official 
identification device or method approved by the Administrator.
    Official seal. A serially numbered, metal or plastic strip, 
consisting of a self-locking device on one end and a slot on the other 
end, which forms a loop when the ends are engaged and which cannot be 
reused if opened, or a serially numbered, self-locking button which can 
be used for this purpose.
    Official swine tattoo. A tattoo, conforming to the six-character 
alpha-numeric National Tattoo System, that provides a unique 
identification for each herd or lot of swine.
    Official test--(a) Classification of cattle and bison--(1) Standard 
card test. (i) A test to determine the brucellosis disease status of 
test-eligible cattle and bison when conducted according to instructions 
approved by APHIS and the State in which the test is to be conducted and 
when conducted under the following circumstances:
    (A) When conditions and time are such that no other test is 
available; or
    (B) When the owner or the owner's agent requests it because of time 
or situation constraints; or
    (C) In specifically approved stockyards when the State animal health 
official either:
    (1) Designates the standard card test as the official test for 
determining the brucellosis disease status of cattle and bison in all 
specifically approved stockyards in the State. In these States, no other 
official test except the Buffered Acidified Plate Antigen test shall be 
used in specifically approved stockyards; or
    (2) Designates the standard card test as the official test for 
determining the brucellosis disease status of non-vaccinated cattle or 
bison (the CITE [supreg] 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 [supreg] 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,

[[Page 298]]

and shall be classified as brucellosis reactors if any one of the 
supplemental tests conducted has a positive reaction; or
    (D) To test market cattle identification (MCI) program test samples. 
Cattle and bison which test positive to the BAPA test or RST under the 
MCI program must be retested using the standard card test or the 
standard plate or tube agglutination test.
    (ii) Results of the standard card test also may be used to 
supplement the results of other official tests conducted in the 
cooperative State-Federal laboratory to give the designated 
epidemiologist additional information when classifying cattle and bison.
    (iii) Standard card test results are interpreted as either negative 
or positive. A moderate to marked clumping agglutination reaction is a 
positive result. Test-eligible cattle and bison positive to the standard 
card test are classified as brucellosis reactors. Test-eligible cattle 
and bison negative to the standard card test are classified as 
brucellosis negative.
    (2) Standard tube test (STT) or standard plate test (SPT). A test to 
determine the brucellosis disease status of test-eligible cattle and 
bison when conducted according to instructions approved by APHIS and the 
State in which the test is to be conducted. Cattle and bison are 
classified according to the following agglutination reactions:

  SPT OR STT Classification--Official Vaccinates Vaccinated With a Brucella Abortus Strain 19 Approved Brucella
                                                     Vaccine
----------------------------------------------------------------------------------------------------------------
                             Titer                                               Classification
----------------------------------------------------------------------------------------------------------------
                 1:50                           1:100                    1:200
----------------------------------------------------------------------------------------------------------------
-....................................  -......................  -......................  Negative.
I....................................  -......................  -......................   Do.
 +...................................  -......................  -......................   Do.
 +...................................  I......................  -......................  Suspect.
 +...................................   +.....................  -......................   Do.
 +...................................   +.....................  I......................   Do.
 +...................................   +.....................   +.....................  Reactor.
----------------------------------------------------------------------------------------------------------------
- No agglutination.
I Incomplete agglutination.
 + Complete agglutination.


    Official Vaccinates Vaccinated With an Approved Brucella Vaccine Other Than a Brucella Abortus Strain 19
                                            Approved Brucella Vaccine
----------------------------------------------------------------------------------------------------------------
                                         Titer
----------------------------------------------------------------------------------------      Classification
                 1:50                           1:100                    1:200
----------------------------------------------------------------------------------------------------------------
-....................................  -......................  -......................  Negative.
I....................................  -......................  -......................  Suspect.
 +...................................  -......................  -......................   Do.
 +...................................  I......................  -......................   Do.
 +...................................   +.....................  -......................  Reactor.
 +...................................   +.....................  I......................   Do.
 +...................................   +.....................   +.....................   Do.
----------------------------------------------------------------------------------------------------------------
- No agglutination.
I Incomplete agglutination.
 + Complete agglutination.


                             All Cattle and Bison Which Are Not Official Vaccinates
----------------------------------------------------------------------------------------------------------------
                             Titer                                               Classification
----------------------------------------------------------------------------------------------------------------
                 1:50                           1:100                    1:200
----------------------------------------------------------------------------------------------------------------
-....................................  -......................  -......................  Negative.
I....................................  -......................  -......................  Suspect.
 +...................................  -......................  -......................   Do.
 +...................................  I......................  -......................   Do.
 +...................................   +.....................  -......................  Reactor.
 +...................................   +.....................  I......................   Do.
 +...................................   +.....................   +.....................   Do.
----------------------------------------------------------------------------------------------------------------
- No agglutination.
I Incomplete agglutination.
 + Complete agglutination.

    (3) Manual complement-fixation (CF) test. A test to determine the 
brucellosis disease status of test-eligible cattle and bison when 
conducted according to instructions approved by APHIS and the State in 
which the test is to be conducted. Cattle and bison are classified 
according to the following reactions:
    (i) Cattle and bison which are not official vaccinates:
    (A) Fifty percent fixation (2 plus) in a dilution of 1:20 or 
higher--brucellosis reactor;
    (B) Fifty percent fixation (2 plus) in a dilution of 1:10 but less 
than 50 percent fixation (2 plus) in a dilution of 1:20--brucellosis 
suspect;
    (C) Less than 50 percent fixation (2 plus) in a dilution of 1:10--
brucellosis negative;
    (ii) Official vaccinates vaccinated with a Brucella abortus Strain 
19 approved brucella vaccine:
    (A) Twenty-five percent fixation (1 plus) in a dilution of 1:40 or 
higher--brucellosis reactor;
    (B) Fifty percent fixation (2 plus) in a dilution of 1:10 but less 
than 25 percent

[[Page 299]]

fixation (1 plus) in a dilution of 1:40--brucellosis suspect;
    (C) Less than 50 percent fixation (2 plus) in a dilution of 1:10--
brucellosis negative.
    (iii) Official vaccinates vaccinated with an approved brucella 
vaccine other than a Brucella abortus Strain 19 approved brucella 
vaccine:
    (A) Fifty percent fixation (2 plus) in a dilution of 1:20 or 
higher--brucellosis reactor;
    (B) Fifty percent fixation (2 plus) in a dilution of 1:10 but less 
than 50 percent fixation (2 plus) in a dilution of 1:20--brucellosis 
suspect;
    (C) Less than 50 percent fixation (2 plus) in a dilution of 1:10--
brucellosis negative.
    (4) Technicon automated complement-fixation test. A test to 
determine the brucellosis disease status of test-eligible cattle and 
bison when conducted according to instructions approved by APHIS and the 
State in which the test is to be conducted. Cattle and bison are 
classified according to the following reactions:
    (i) Cattle and bison which are not official vaccinates:
    (A) Fixation in a dilution of 1:10 or higher--brucellosis reactor;
    (B) Fixation in a dilution of 1:5 but no fixation in a dilution of 
1:10--brucellosis suspect;
    (C) No fixation in a dilution of 1:5 or lower--brucellosis negative;
    (ii) Official vaccinates vaccinated with a Brucella abortus Strain 
19 approved brucella vaccine:
    (A) Fixation in a dilution of 1:20 or higher--brucellosis reactor;
    (B) Fixation in a dilution of 1:10 but no fixation in a dilution of 
1:20--brucellosis suspect;
    (C) Fixation in a dilution of 1:5 or less but no fixation in a 
dilution of 1:10--brucellosis negative.
    (iii) Official vaccinates vaccinated with an approved brucella 
vaccine other than a Brucella abortus Strain 19 approved brucella 
vaccine:
    (A) Fixation in a dilution of 1:10 or higher--brucellosis reactor;
    (B) Fixation in a dilution of 1:5 but no fixation in a dilution of 
1:10--brucellosis suspect;
    (C) No fixation in a dilution of 1:5 or lower--brucellosis negative.
    (5) Rivanol test. A test to determine the brucellosis disease status 
of test-eligible cattle and bison when conducted according to 
instructions approved by APHIS and the State in which the test is to be 
conducted. Cattle and bison are classified according to the following 
agglutination reactions:
    (i) Cattle and bison which are not official vaccinates:
    (A) Complete agglutination at a titer of 1:25 or higher--brucellosis 
reactor;
    (B) Less than complete agglutination at a titer of 1:25--brucellosis 
negative;
    (ii) Official adult vaccinates more than 5 months after vaccination 
with a Brucella abortus Strain 19 approved brucella vaccine and official 
calfhood vaccinates vaccinated with a Brucella abortus Strain 19 
approved brucella vaccine:
    (A) Incomplete agglutination at a titer of 1:100 or higher--
brucellosis reactor;
    (B) Complete agglutination at a titer of 1:25 or higher when the 
manual or technicon automated complement-fixation test is not 
conducted--brucellosis reactor;
    (C) Complete agglutination at a titer of 1:50 or less when the 
manual complement-fixation test or the technicon automated complement-
fixation test is conducted and results in a classification of 
brucellosis suspect or brucellosis negative--brucellosis suspect;
    (D) Less than complete agglutination at a titer of 1:25--brucellosis 
negative;
    (iii) Official adult vaccinates less than 5 months after vaccination 
with a Brucella abortus Strain 19 approved brucella vaccine: Less than 
complete agglutination at the 1:50 titer--brucellosis negative.
    (iv) Official vaccinates vaccinated with an approved brucella 
vaccine other than a Brucella abortus Strain 19 approved brucella 
vaccine:
    (A) Complete agglutination at a titer of 1:25 or higher--brucellosis 
reactor;
    (B) Less than complete agglutination at a titer of 1:25--brucellosis 
negative.
    (6) Semen plasma test. A test to determine the brucellosis disease 
status of bulls used for artificial insemination when conducted in 
conjunction with an official serological test and according to 
instructions approved by APHIS and the State in which the test is to be

[[Page 300]]

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 [supreg]) 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 [supreg] Brucella abortus Antibody Test Kit 
instructions, licensed by the United States Department of Agriculture 
and approved as of December 31, 1987, and incorporated by reference. 
This incorporation by reference was approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies may be obtained from AgriTech Systems, Inc., 100 Fore Street, 
Portland, ME 04101. Copies may be inspected at the Animal and Plant 
Health Inspection Service, Veterinary Services, Operational Support, 
4700 River Road Unit 33, Riverdale, Maryland 20737-1231, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_ register/code_of_ federal_regulations/ 
ibr_locations.html.
    (10) Particle concentration fluorescence immunoassay (PCFIA) test. 
An automated serologic test to determine the brucellosis disease status 
of test-eligible cattle and bison when conducted according to 
instructions approved by APHIS. Cattle and bison are classified 
according to the following ratio between the test sample and a known 
negative sample (S/N ratio):

------------------------------------------------------------------------
               S/N ratio                          Classification
------------------------------------------------------------------------
Greater than .60.......................  Negative.
Greater than .30 but less than or equal  Suspect.
 to .60.
.30 or less............................  Positive.
------------------------------------------------------------------------

    (11) D-Tec [supreg] 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

[[Page 301]]

positive to the RAP test shall be subjected to other official tests to 
determine their brucellosis disease classification.
    (13) Fluorescence polarization assay (FP assay). An automated 
serologic test to determine the brucellosis status of test-eligible 
cattle and bison when conducted according to instructions approved by 
APHIS. FP assays are interpreted as either positive, negative, or 
suspect. A 10-microliter sample is used. If a sample reads <10 
millipolarization units (mP) above the mean negative control, the sample 
is considered negative. If a sample reads 20 mP above the 
mean negative control, the sample is considered positive. Samples that 
read between 10 and 20 mP above the negative control mean should be 
retested using 20 microliters of sample. If the 20-microliter sample is 
20 mP above the mean negative control, the sample is 
considered positive. If the 20-microliter sample is still in the 10 to 
20 mP range above the mean negative control, the sample is considered 
suspect. If the 20-microliter sample is <10 mP above the mean negative 
control, the sample is considered negative. Cattle and bison negative to 
the FP assay are classified as brucellosis negative. Cattle and bison 
with positive FP assay results are classified as brucellosis reactors, 
while cattle and bison with suspect FP assay results are classified as 
brucellosis suspects.
    (14) The evaluation of test results for all cattle and bison shall 
be the responsibility of a designated epidemiologist in each State. The 
designated epidemiologist shall consider the animal and herd history and 
other epidemiologic factors when determining the brucellosis 
classification of cattle and bison. Deviations from the brucellosis 
classification criteria as provided in this definition of official test 
are acceptable when made by the designated epidemiologist.
    (i) The designated epidemiologist may consider the results of CITE 
[supreg] tests when evaluating the results of standard card tests of 
cattle and bison.
    (b) Classification of swine--(1) Standard card test. A test to 
determine the brucellosis disease status of swine. Standard card test 
results are interpreted as either negative or positive. A moderate to 
marked clumping agglutination reaction is a positive result. Swine 
negative to the standard card test are classified as brucellosis 
negative. Swine positive to the standard card test in a herd not known 
to be affected but negative to any other official test or 
bacteriological culture for brucella are classified as brucellosis 
suspects. Other swine positive to the standard card test are classified 
as brucellosis reactors.
    (2) Standard tube test. A test to determine the brucellosis disease 
status of swine.
    (i) If all of the following apply: (A) The swine are part of a herd 
not known to be affected; (B) No swine tested, individually or as part 
of a group, has a complete agglutination reaction at a dilution of 1:100 
or higher; and (C) the swine are tested as part of a herd blood test or 
are part of a validated brucellosis-free herd, then the swine are 
classified according to the following agglutination reactions:

----------------------------------------------------------------------------------------------------------------
                             Titer                                               Classification
----------------------------------------------------------------------------------------------------------------
                 1:25                            1:50                    1:100
----------------------------------------------------------------------------------------------------------------
I....................................  ]--....................  -......................  Negative.
 +...................................  -......................  -......................   Do.
 +...................................  I......................  -......................   Do.
 +...................................   +.....................  -......................   Do.
 +...................................   +.....................  I......................   Do.
----------------------------------------------------------------------------------------------------------------
- No agglutination.
I Incomplete agglutination.
 + Complete agglutination.

    (ii) If any of the following apply: (A) The swine are part of a herd 
known to be affected; (B) Any swine tested, individually or as part of a 
group, has a complete agglutination reaction at a dilution of 1:100 or 
higher or; (C) The swine are not part of a validated brucellosis-free 
herd and are not being tested as part of a herd blood test, then the 
swine are classified according to the following agglutination reactions:

----------------------------------------------------------------------------------------------------------------
                             Titer                                               Classification
----------------------------------------------------------------------------------------------------------------
                 1:25                            1:50                    1:100
----------------------------------------------------------------------------------------------------------------
I....................................  -......................  -......................  Negative.
 +...................................  -......................  -......................  Reactor.
 +...................................  I......................  -......................   Do.
 +...................................   +.....................  -......................   Do.
 +...................................   +.....................  I......................   Do.
 +...................................   +.....................   +.....................   Do.
----------------------------------------------------------------------------------------------------------------
- No agglutination.
I Incomplete agglutination.
 + Complete agglutination.


[[Page 302]]

    (3) Particle concentration fluoresence immunoassay (PCFIA). An 
automated serologic test to determine the brucellosis disease status of 
test-eligible swine when conducted according to instructions approved by 
the Animal and Plant Health Inspection Service. Swine are classified 
according to the following ratios between the test sample and a known 
negative sample (S/N ratio):

------------------------------------------------------------------------
                 S/N Ratio                         Classification
------------------------------------------------------------------------
0.71 or greater...........................  Negative.
0.51 to 0.70..............................  Suspect.
0.50 or less..............................  Reactor.
------------------------------------------------------------------------

    (4) Rapid Automated Presumptive (RAP) test. An automated serologic 
test to detect the presence of Brucella antibodies in test-eligible 
swine. RAP test results are interpreted as either positive or negative; 
the results are interpreted and reported by a scanning autoreader that 
measures agglutination based on alterations in light transmission 
through each test well. Swine negative to the RAP test are classified as 
brucellosis negative; swine positive to the RAP test shall be subjected 
to other official tests to determine their brucellosis disease 
classification.
    (5) Fluorescence polarization assay (FP assay). An automated 
serologic test to determine the brucellosis status of test-eligible 
swine when conducted according to instructions approved by APHIS. FP 
assays are interpreted as either positive, negative, or suspect. A 40-
microliter sample is used. If a sample reads <10 millipolarization units 
(mP) above the mean negative control, the sample is considered negative. 
If a sample reads 20 mP above the mean negative control, the 
sample is considered positive. Samples that read between 10 and 20 mP 
above the negative control mean must be retested using 40 microliters of 
sample. If the 40-microliter sample is 20 mP above the mean 
negative control, the sample is considered positive. If the 40-
microliter sample is still in the 10 to 20 mP range above the mean 
negative control, the sample is considered suspect. If the 40-microliter 
sample is <10 mP above the mean negative control, the sample is 
considered negative. Swine with negative FP assay results are classified 
as brucellosis negative. Swine with positive FP assay results are 
classified as brucellosis reactors, while swine with suspect FP assay 
results are classified as brucellosis suspects.
    (6) The evaluation of test results for all swine shall be the 
responsibility of a designated epidemiologist in each State. The 
designated epidemiologist shall consider the animal and herd history and 
other epidemiologic factors when determining the brucellosis 
classification of swine. Deviations from the brucellosis classification 
criteria as provided in this definition of official test are acceptable 
when made by the designated epidemiologist.
    Official vaccinate. An official calfhood vaccinate or an official 
adult vaccinate. The accredited veterinarian, State representative or 
APHIS representative who performs the vaccination must forward a 
completed official vaccination certificate for each animal vaccinated to 
the State animal health official of the State in which the animal was 
vaccinated.
    Official vaccination eartag. An APHIS approved identification eartag 
conforming to the alpha-numeric National Uniform Eartagging System which 
provides unique identification for each animal. The eartag shall have a 
``V'' followed by 2 letters and 4 numbers. States which require more 
official vaccination eartags than the number of combinations available 
in the ``V'' series of tags shall use a ``T'' or ``S'' followed by 2 
letters and 4 numbers. Duplicate reissue of official vaccination eartags 
shall not be made more often than once each 15 years.
    Originate. (a) Animals will have the status of the herd from which 
they are moved if:
    (1) They were born and maintained in the herd since birth; or
    (2) They have been in the herd for at least 120 days.
    (b) Animals will have the status of the State or area from which 
they are moved if:
    (1) They were born and maintained in the State or area since birth; 
or
    (2) They were previously moved from a State or area of equal or 
higher class to the State or area; or
    (3) They were previously moved from a State or area of lower class 
to the

[[Page 303]]

State or area where they are now located and have been in the new State 
or area for at least 120 days.
    (c) Cattle or bison penned in a specifically approved stockyard with 
cattle or bison from a lower class State or area, in violation of the 
requirements set forth in 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 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

[[Page 304]]

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 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

[[Page 305]]

and bison entering and leaving the quarantined pasture. All brucellosis 
exposed cattle and bison must vacate the premises on or before the 
expiration of approval, which may not last longer than 10 months.
    Recognized slaughtering establishment. Any slaughtering facility 
operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), 
the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or State 
meat or poultry inspection acts that is approved in accordance with 9 
CFR 71.21.
    Rodeo cattle. Cattle used at rodeos or competitive events.
    ``S'' branded. Branding with a hot iron the letter ``S'' high on the 
left hip near the tailhead and at least 5 by 5 centimeters (2 by 2 
inches) in size.
    ``S'' brand permit. A document prepared at the point of origin which 
lists the points of origin and destination, the number of animals 
covered, the purpose of movement, and one of the following: The official 
eartag number, individual animal registered breed association 
registration tattoo, individual animal registered breed association 
registration brand, individual animal registered breed association 
registration number, United States Department of Agriculture backtag 
(when applied serially, only the beginning and the ending numbers need 
be recorded), or similar individual identification. If the document is 
prepared at a quarantined feedlot, it shall be prepared by an accredited 
veterinarian, a State representative, or an individual designated for 
that purpose by the State animal health official. If the document is 
prepared at any other point of origin, it shall be prepared by an 
accredited veterinarian, State representative, or APHIS representative. 
(A new ``S'' brand permit is required for each change in destination. 
However, ``S'' brand permits accompanying cattle or bison to approved 
intermediate handling facilities may list either the approved 
intermediate handling facility, a quarantined feedlot, or a recognized 
slaughtering establishment as the point of destination. If the ``S'' 
brand permit lists a quarantined feedlot or a recognized slaughtering 
establishment as the point of destination, the ``S'' brand permit must 
list the approved intermediate handling facility as a temporary stopping 
point, and no additional ``S'' brand permit is required for the 
subsequent movement of the cattle or bison from the approved 
intermediate handling facility to the quarantined feedlot or to the 
recognized slaughtering establishment. Subsequent movements from the 
quarantined feedlot shall be subject to requirements set forth in the 
definition of ``quarantined feedlot'' in this section.)
    Sow. A female swine which is parturient or postparturient.
    Specifically approved stockyard. \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:

[[Page 306]]

    (a) Cattle and bison which are not official vaccinates and which 
have lost their first pair of temporary incisors (18 months of age or 
over), except steers and spayed heifers;
    (b) Official calfhood vaccinates 18 months of age or over which are 
parturient or postparturient;
    (c) Official calfhood vaccinates of beef breeds or bison with the 
first pair of permanent incisors fully erupted (2 years of age or over); 
and
    (d) Official calfhood vaccinates of dairy breeds with partial 
eruption of the first pair of permanent incisors (20 months of age or 
over).
    United States. All of the States.
    United States Department of Agriculture backtag. A backtag issued by 
APHIS that provides unique identification for each animal.
    Validated brucellosis-free herd. (a) A swine herd not known to be 
infected with swine brucellosis, located in a validated brucellosis-free 
State; or
    (b) A swine herd in a State that has not been validated as 
brucellosis-free, provided the herd meets the conditions for validation, 
as follows:
    (1) Validation. A swine herd may be validated as brucellosis-free if 
it has been found brucellosis negative after either a complete-herd test 
(CHT) or an incremental CHT. The incremental CHT may be conducted by 
testing all breeding swine 6 months of age or older with negative 
results within 365 days, either in four 25-percent increments, with 
those tests being conducted on the 90th, 180th, 270th, and 360th days of 
the testing cycle, or in 10-percent increments every 25-35 days until 
100 percent of those swine have been tested. In cases where 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

[[Page 307]]

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 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 at www.govinfo.gov.



Sec.78.2  Handling of certificates, permits, and ``S'' brand permits
for interstate movement of animals.

    (a) Any ICVI, other interstate movement document used in lieu of an 
ICVI, permit, or ``S'' brand permit required by this part for the 
interstate movement of animals shall be delivered to the person moving 
the animals by the shipper or shipper's agent at the time the animals 
are delivered for movement and shall accompany the animals to their 
destination and be delivered to the consignee or the person receiving 
the animals.
    (b) The APHIS representative, State representative, Tribal 
representative, or accredited veterinarian issuing an ICVI or other 
interstate movement document used in lieu of an ICVI or a permit, except 
for permits for entry and ``S'' brand permits, that is required for the 
interstate movement of animals under this part shall forward a copy of 
the ICVI, other interstate movement document used in lieu of an ICVI, or 
permit to the State animal health official of the State of origin within 
5 working days. The State animal health official of the State of origin 
shall forward a copy of the ICVI, other interstate movement document 
used in lieu of an ICVI, or permit to the State animal health official 
of the State of destination within 5 working days.

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

[78 FR 2069, Jan. 9, 2013]



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.

[[Page 308]]



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 and with 9 CFR part 86. Cattle moved interstate under permit in 
accordance with this subpart are not required to be accompanied by an 
interstate certificate of veterinary inspection or owner-shipper 
statement.

[78 FR 2069, Jan. 9, 2013]



Sec.78.6  Steers and spayed heifers.

    Steers and spayed heifers may be moved interstate in accordance with 
9 CFR part 86 and without further restriction under this subpart.

[78 FR 2069, Jan. 9, 2013]



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
    (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

[[Page 309]]

    (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
    (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,

[[Page 310]]

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:
    (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 under 
this subpart. Female cattle which are not test eligible and are from 
herds not known to be affected may be moved interstate only in 
accordance with 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

[[Page 311]]

slaughtering establishment if accompanied by a permit.
    (iii) Such cattle may be moved interstate from other than a farm of 
origin directly to an approved intermediate handling facility and then 
directly to a recognized slaughtering establishment if such cattle are 
accompanied by a permit.
    (2) Movement to quarantined feedlots. Such cattle may be moved 
interstate without restriction under this subpart directly to a 
quarantined feedlot, or directly to a specifically approved stockyard 
and then directly to a quarantined feedlot, or directly to a 
specifically approved stockyard and then directly to an approved 
intermediate handling facility and then directly to a quarantined 
feedlot, or directly to an approved intermediate handling facility and 
then directly to a quarantined feedlot.
    (3) Movement other than in accordance with paragraphs (a)(1) and (2) 
of this section. Such cattle may be moved interstate other than in 
accordance with paragraphs (a)(1) and (2) of this section only if:
    (i) Such cattle are moved interstate from a farm of origin directly 
to a specifically approved stockyard; or
    (ii) Such cattle are moved interstate as part of a commuter herd in 
accordance with a commuter herd agreement or other documents as agreed 
to by the shipping and receiving States or Tribes.
    (iii) Such cattle are moved interstate accompanied by an ICVI which 
states, in addition to the items specified in 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

[[Page 312]]

one farm or State or area apart from other animals.
    (3) Movement other than in accordance with paragraphs (b)(1) and (2) 
of this section. Such cattle may be moved interstate other than in 
accordance with paragraphs (b)(1) and (2) of this section only if:
    (i) Such cattle originate in a certified brucellosis-free herd and 
are accompanied interstate by an ICVI which states, in addition to the 
items specified in 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 an 
ICVI 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 as part of a commuter herd in accordance 
with a commuter herd agreement or other documents as agreed to by the 
shipping and receiving States or Tribes..
    (c) Class B States/areas. Test-eligible cattle which originate in 
Class B States or areas, are not brucellosis exposed, and are from a 
herd not known to be affected may be moved interstate from Class B 
States or areas only under the conditions specified below:
    (1) Movement to recognized slaughtering establishments. (i) Such 
cattle may be moved interstate from a farm of origin or a nonquarantined 
feedlot directly to a recognized slaughtering establishment without 
further restriction under this subpart.
    (ii) Such cattle may be moved interstate from a farm of origin 
directly to an approved intermediate handling facility without further 
restriction under this subpart.
    (iii) Such cattle may be moved interstate from a nonquarantined 
feedlot directly to an approved intermediate handling facility and then 
directly to a recognized slaughtering establishment if they are 
accompanied by a permit or ``S'' brand permit.
    (iv) Such cattle may be moved interstate from a farm of origin or a 
nonquarantined feedlot directly to a specifically approved stockyard and 
then to a recognized slaughtering establishment if:
    (A) They are negative to an official test conducted at the 
specifically approved stockyard and are accompanied to slaughter by an 
ICVI or ``S'' brand permit which states, in addition to the items 
specified in 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

[[Page 313]]

    (D) They are accompanied by an ``S'' brand permit and moved in 
vehicles closed with official seals applied and removed by an APHIS 
representative, State representative, accredited veterinarian, or an 
individual authorized for this purpose by an APHIS representative. The 
official seal numbers must be recorded on the accompanying ``S'' brand 
permit.
    (vi) Such cattle from other than a farm of origin or a 
nonquarantined feedlot may be moved interstate to a recognized 
slaughtering establishment only if:
    (A) They are negative to an official test within 30 days prior to 
such interstate movement and are accompanied by an ICVI or ``S'' brand 
permit which states, in addition to the items specified in 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 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 an ICVI

[[Page 314]]

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 an ICVI 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 interstate movement, have been issued a permit for entry, and 
are accompanied interstate by an ICVI which states, in addition to the 
items specified in 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 as part of a commuter herd in 
accordance with a commuter herd agreement or other documents as agreed 
to by the shipping and receiving States or Tribes, and
    (A) The cattle being moved originate from a herd in which:
    (1) All the cattle were negative to a herd blood test within 1 year 
prior to the interstate movement;
    (2) Any cattle added to the herd after such herd blood test were 
negative to an official test within 30 days prior to the date the cattle 
were added to the herd;
    (3) None of the cattle in the herd have come in contact with any 
other cattle; and
    (B) The cattle are accompanied interstate by a document which states 
the dates and results of the herd blood test and the name of the 
laboratory in which the official tests were conducted.
    (v) The State animal health officials of the State of origin and 
State of destination may waive the requirements of paragraph (c)(3)(iv) 
of this section in writing.
    (d) Class C States/areas. All female cattle and test-eligible male 
cattle which originate in Class C States or areas, are not brucellosis 
exposed, and are from a herd not known to be affected may be moved 
interstate from Class C States or areas only under the conditions 
specified below:
    (1) Movement to recognized slaughtering establishments. (i) Such 
cattle may be moved interstate from a farm of origin or a nonquarantined 
feedlot directly to a recognized slaughtering establishment without 
further restriction under this subpart.
    (ii) Such cattle may be moved interstate from a farm of origin 
directly to an approved intermediate handling facility without further 
restriction under this subpart.
    (iii) Such cattle may be moved interstate from a nonquarantined 
feedlot directly to an approved intermediate handling facility and then 
directly to a recognized slaughtering establishment if they are 
accompanied by a permit or ``S'' brand permit.
    (iv) Such cattle may be moved interstate from a farm of origin or a 
nonquarantined feedlot directly to a specifically approved stockyard and 
then to a recognized slaughtering establishment if:
    (A) They are negative to an official test conducted at the 
specifically approved stockyard and are accompanied by an ICVI or ``S'' 
brand permit which states, in addition to the items specified in 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

[[Page 315]]

    (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 an ICVI 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:

[[Page 316]]

    (A) A quarantined feedlot if such cattle are ``S'' branded upon 
arrival at the quarantined feedlot; or
    (B) A specifically approved stockyard and then directly to a 
quarantined feedlot, or directly to an approved intermediate handling 
facility and then directly to a quarantined feedlot, if the cattle are 
``S'' branded upon arrival at the specifically approved stockyard and 
are accompanied to the quarantined feedlot by an ``S'' brand permit; or
    (C) An approved intermediate handling facility and then directly to 
a quarantined feedlot, if the cattle are ``S'' branded upon arrival at 
the approved intermediate handling facility and are accompanied to the 
quarantined feedlot by an ``S'' brand permit; or
    (D) A quarantined feedlot, a specifically approved stockyard and 
then directly to a quarantined feedlot, or an approved intermediate 
handling facility and then directly to a quarantined feedlot if the 
cattle are accompanied by an ``S'' brand permit and moved in vehicles 
closed with official seals applied and removed by an APHIS 
representative, State representative, accredited veterinarian, or an 
individual authorized for this purpose by an APHIS representative. The 
official seal numbers must be recorded on the accompanying ``S'' brand 
permit.
    (ii) Such cattle from other than a farm of origin may be moved 
interstate to a quarantined feedlot if:
    (A) They are negative to an official test within 30 days prior to 
such movement and are accompanied by an ICVI which states, in addition 
to the items specified in 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 an ICVI which states, in addition to the items 
specified in Sec.78.1, 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; 78 FR 2069, Jan. 9, 
2013]



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

[[Page 317]]

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. 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, 9 CFR part 86, and this section.
    (a) Steers and spayed heifers. Steers and spayed heifers may be 
moved interstate without further restriction under this section.
    (b) Brucellosis reactor cattle. Brucellosis reactor cattle may be 
moved interstate in accordance with 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

[[Page 318]]

such interstate movement and are accompanied by an ICVI 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 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 
an ICVI 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 an ICVI 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; 78 FR 2070, Jan. 9, 2013]



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]

[[Page 319]]



Sec.78.14  Rodeo cattle.

    (a) Rodeo cattle that are test-eligible and that are from a herd not 
known to be affected may be moved interstate if:
    (1) They are classified as brucellosis negative based upon an 
official test conducted less than 365 days before the date of interstate 
movement: Provided, however, That: The official test is not required for 
rodeo cattle that are moved only between Class Free States;
    (2) The cattle are identified with an official eartag or any other 
official identification device or method approved by the Administrator 
in accordance with Sec.78.5;
    (3) There is no change of ownership since the date of the last 
official test;
    (4) An ICVI accompanies each interstate movement of the cattle; and
    (5) A permit for entry is issued for each interstate movement of the 
cattle.
    (b) Cattle that would qualify as rodeo cattle, but that are used for 
breeding purposes during the 365 days following the date of being 
tested, may be moved interstate only if they meet the requirements for 
cattle in this subpart and in 9 CFR part 86.

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

[78 FR 2070, Jan. 9, 2013]



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 and with 9 CFR part 86.

[51 FR 32580, Sept. 12, 1986, as amended at 78 FR 2070, Jan. 9, 2013]



Sec.78.21  Bison steers and spayed heifers.

    Bison steers and spayed heifers may be moved interstate without 
further restriction under this subpart.

[51 FR 32580, Sept. 12, 1986, as amended at 78 FR 2070, Jan. 9, 2013]



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

[[Page 320]]

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
    (ii) Directly to an approved intermediate handling facility and then 
directly to a recognized slaughtering establishment.
    (b) Movement to quarantined feedlots. Brucellosis exposed bison may 
be moved directly to a quarantined feedlot or, from a farm of origin, 
directly to a specifically approved stockyard approved to receive 
brucellosis exposed bison and then directly to a quarantined feedlot. 
Such bison shall be accompanied by a permit or ``S'' brand permit.
    (c) Movement other than in accordance with paragraphs (a) or (b) of 
this section. Brucellosis exposed bison which are from herds known to be 
affected, but which are not part of a herd being depopulated under part 
51 of this chapter, may move without further restriction under this 
subpart if the bison:
    (1) Are under 6 months of age and were weaned from brucellosis 
reactor or brucellosis exposed bison not less than 30 days immediately 
preceding interstate movement; or
    (2) Are under 6 months of age and nursing brucellosis exposed bison 
in a herd subjected to a herd blood test within 10 days prior to 
interstate movement; or
    (3) Are official vaccinates under 1 year of age from a herd 
following an approved individual herd plan.

(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; 
78 FR 2070, Jan. 9, 2013]



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 further restriction under this 
subpart.
    (b) Movement to quarantined feedlots. Bison from herds not known to 
be affected may be moved directly to a quarantined feedlot without 
further restriction under this subpart.
    (c) Movement from public zoo to public zoo. Bison from herds not 
known to be affected may be moved from a zoo owned by a governmental 
agency to another such zoo if handled in accordance with 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 an ICVI.
    (2) Such bison which are official vaccinates under 2 years of age 
and are not parturient or postparturient may be moved interstate when 
accompanied by an ICVI.
    (3) Such bison may be moved interstate if they are negative to an 
official test within 30 days prior to such movement and are accompanied 
by an ICVI which states, in addition to the items specified in Sec.
78.1, the dates and results of the official tests.
    (4) Such bison may be moved interstate if they originate in a 
certified

[[Page 321]]

brucellosis-free herd and are accompanied by an ICVI 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; 
78 FR 2070, Jan. 9, 2013]



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]



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

[[Page 322]]

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 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

[[Page 323]]

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 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, Missouri, Montana, 
Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North 
Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto 
Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, 
Utah, Vermont, Virgin Islands, Virginia, Washington, West Virginia, 
Wisconsin, and Wyoming.
    (b) Class A. None.
    (c) Class B. None.

[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 at www.govinfo.gov.



Sec.78.42  Quarantined areas.

    None.



Sec.78.43  Validated brucellosis-free States.

    Alabama, Alaska, Arizona, Arkansas, California, Colorado, 
Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, 
Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, 
Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, 
Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North 
Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto 
Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, 
Utah, Vermont, Virgin Islands, Virginia, Washington, West Virginia, 
Wisconsin, Wyoming.

[53 FR 4382, Feb. 16, 1988; 53 FR 21979, June 13, 1988]

    Editorial Note: For Federal Register citations affecting Sec.
78.43, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



PART 79_SCRAPIE IN SHEEP AND GOATS--Table of Contents



Sec.
79.1 Definitions.
79.2 Identification and records requirements for 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 Interstate Certificates of Veterinary Inspection 
          (ICVI).
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.

[[Page 324]]


    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.
    Animal identification number (AIN). This term has the meaning set 
forth in Sec.86.1 of this subchapter, except that only AIN devices 
approved and distributed in accordance with Sec.79.2(k) and methods 
approved for use in sheep and goats in accordance with Sec.79.2(a)(2) 
are included.
    APHIS representative. An individual employed by APHIS in animal 
health activities who is authorized by the Administrator to perform the 
function involved.
    Approved laboratory. A laboratory approved by the Administrator in 
accordance with 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 that maintain the 
permanent records of ancestry or pedigrees of animals (including the 
animal's sire and dam), individual identification of animals, and 
ownership of animals.
    Classification or reclassification investigation. An epidemiological 
investigation conducted or directed by a DSE for the purpose of 
designating or redesignating the status (e.g., exposed, high-risk, 
infected, source, suspect, etc.) of a flock or animal. In conducting 
such an investigation, the DSE will evaluate the available records for 
flocks and individual animals and conduct or direct any testing needed 
to assess the status of a flock or animal. The status of an animal or 
flock will be determined based on the applicable definitions in this 
section and, when needed to make a designation under Sec.79.4, 
official genotype test results, exposure risk, scrapie type involved, 
and/or results of official scrapie testing on live or dead animals.
    Commercial hair sheep. Any commercial sheep with hair rather than 
wool that is either a full-blooded hair sheep or that resulted from the 
cross of a hair sheep with a whitefaced wool sheep.
    Commercial sheep or goat. Any animal from a flock from which animals 
are moved only either directly to slaughter or through slaughter 
channels to slaughter or any animal that is raised only for meat or 
fiber production and that is not registered with a sheep or goat 
registry or used for exhibition.
    Commingle, commingled, commingling. Animals grouped together and 
having physical contact with each other, including contact through a 
fence, but not limited contacts. Commingling also includes sharing the 
same section in a transportation unit where there is physical contact.
    Consistent State. (1) A State that the Administrator has determined 
conducts an active State scrapie control program that meets the 
requirements of Sec.79.6 or effectively enforces a State designed plan 
that the Administrator determines is at least as effective in 
controlling scrapie as the requirements of Sec.79.6.
    (2) A list of Consistent States can be found on the internet at 
http://www.aphis.usda.gov/animal-health/scrapie.
    Designated scrapie epidemiologist. An epidemiologist who has 
demonstrated the knowledge and ability to perform the functions required 
and who has been selected by the State animal

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health official and the area veterinarian in charge. The regional 
epidemiologist and the APHIS National Scrapie Program Coordinator must 
concur in the selection and appointment of the designated scrapie 
epidemiologist. The designated scrapie epidemiologist must 
satisfactorily complete training designated by APHIS.
    Direct movement to slaughter. Transported to a facility for 
slaughter, without stops or unloading except for feeding and watering 
during which the animals are not commingled with any other animals.
    Electronic implant. Any radio frequency identification implant 
device approved for use in the scrapie program by the Administrator. The 
Administrator will approve an electronic implant after determining that 
it is tamper resistant, not harmful to the animal, and readable by 
equipment available to APHIS and State representatives.
    Exposed animal. Any animal or embryo that:
    (1) Has been in a flock with a scrapie-positive female animal;
    (2) Has been in an enclosure with a scrapie-positive female animal 
at any location;
    (3) Resides in a noncompliant flock; or
    (4) Has resided on the premises of a flock before or while it was 
designated an infected or source flock and before a flock plan was 
completed. An animal shall not be designated an exposed animal if it 
only resided on the premises before the date that infection was most 
likely introduced to the premises as determined by a Federal or State 
representative. If the probable date of infection cannot be determined 
based on the epidemiologic investigation, a date 2 years before the 
birth of the oldest scrapie-positive animal born in that flock will be 
used. If the actual birth date is unknown, the date of birth will be 
estimated based on examination of the teeth and any available records. 
If an age estimate cannot be made, the animal will be assumed to have 
been 48 months of age on the date samples were collected for scrapie 
diagnosis. Exposed animals will be further designated as genetically 
resistant exposed sheep, genetically less susceptible exposed sheep, 
genetically susceptible exposed animals, or low-risk exposed animals. An 
animal will no longer be an exposed animal if it is redesignated in 
accordance with Sec.79.4.
    Exposed flock. (1) Any flock that was designated an infected or 
source flock that has completed a flock plan and that retained a female 
genetically susceptible exposed animal;
    (2) Any flock under investigation that retains a female genetically 
susceptible exposed animal or a suspect animal, or whose owner declines 
to complete genotyping and live-animal and/or post-mortem scrapie 
testing required by the APHIS or State representative investigating the 
flock; or
    (3) Any noncompliant flock or any flock for which a PEMMP is 
required that is not in compliance with the conditions of the PEMMP. A 
flock will no longer be an exposed flock if it is redesignated in 
accordance with Sec.79.4.
    Flock. All animals that are maintained on a single premises and all 
animals under common ownership or supervision on two or more premises 
with animal interchange between the premises. Changes in ownership of 
part or all of a flock do not change the identity of the flock or the 
regulatory requirements applicable to the flock. Animals maintained 
temporarily on a premises for activities such as shows and sales or 
while in marketing channels are not a flock. More than one flock may be 
maintained on a single premises if:
    (1) The flocks are enrolled as separate flocks in the SFCP; or
    (2) A State or APHIS representative determines, based upon 
examination of flock records, that:
    (i) There is no interchange of animals between the flocks;
    (ii) The flocks never commingle and are kept at least 30 feet apart 
at all times or are separated by a solid wall through, over, or under 
which fluids cannot pass and through which contact cannot occur;
    (iii) The flocks have separate flock records and identification;
    (iv) The flocks have separate lambing facilities, including 
buildings and pastures, and a pasture or building used

[[Page 326]]

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 identification (ID) number. A nationally unique number 
assigned by a State, federally recognized Tribal or Federal animal 
health authority to a group of animals that are managed as a unit on one 
or more premises and are under the same ownership. The flock ID number 
must begin with the State postal abbreviation or APHIS-assigned Tribal 
code, must have no more than nine alphanumeric characters, and must not 
contain the characters ``I'', ``O'', or ``Q'' other than as part of the 
State postal abbreviation or another standardized format authorized by 
the administrator and recorded in the National Scrapie Database. APHIS 
may assign Tribal codes to any federally recognized Tribe that maintains 
sheep or goats on Tribal lands. The flock ID number must be recorded in 
and linked to one or more PINs or LIDs in the National Scrapie Database.
    Flock of origin. The flock in which an animal most recently resided 
in which it either was born, gave birth, or was used for breeding 
purposes. The determination of an animal's flock of origin may be based 
either on the physical presence of the animal in the flock, the presence 
of official identification on the animal traceable to the flock, the 
presence of other identification on the animal that is listed on the 
bill of sale, or other evidence, such as registry records.
    Flock plan. A written flock management agreement signed by the owner 
of a flock, the accredited veterinarian, if one is employed by the 
owner, and a State or APHIS representative in which each participant 
agrees to undertake actions specified in the flock plan to control the 
spread of scrapie from, and eradicate scrapie in, an infected flock or 
source flock or to reduce the risk of the occurrence of scrapie in a 
flock that contains a high-risk or an exposed animal. As part of a flock 
plan, the flock owner must provide the facilities and personnel needed 
to carry out the requirements of the flock plan. The flock plan must 
include the requirements in Sec.54.8(a) through (j) of this chapter.
    Flock under investigation. Any flock in which an APHIS or State 
representative has determined that a scrapie suspect animal, high-risk 
animal, or scrapie-positive animal resides or may have resided. A flock 
will no longer be a flock under investigation if it is redesignated in 
accordance with Sec.79.4.
    Genetically less susceptible exposed sheep. Any sheep or sheep 
embryo that is:
    (1) An exposed sheep or sheep embryo of genotype AA QR, unless the 
Administrator determines that it is epidemiologically linked to a 
scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR 
sheep are not less susceptible; or
    (2) An exposed sheep or sheep embryo of genotype AV QR, unless the 
Administrator determines that it is epidemiologically linked to a 
scrapie-positive RR or QR sheep, to a flock that the Administrator has 
determined may be affected by valine-associated scrapie (based on an 
evaluation of the genotypes of the scrapie-positive animals linked to 
the flock), or to another scrapie type to which the Administrator has 
determined AV QR sheep are not less susceptible; or
    (3) An exposed sheep or sheep embryo of a genotype that has been 
exposed to a scrapie type to which the Administrator has determined that 
genotype is less susceptible.
    (4) Note: In this definition R refers to codon 171 and A refers to 
codon 136, and Q represents any genotype other than R at codon 171 and V 
represents any genotype other than A at codon 136.
    Genetically resistant exposed sheep. Any exposed sheep or sheep 
embryo of genotype RR at codon 171 unless the Administrator determines 
that it is epidemiologically linked to a scrapie-positive RR sheep or to 
a scrapie type to which RR sheep are not resistant.
    Genetically resistant sheep. Any sheep or sheep embryo of genotype 
RR at codon 171 unless it is epidemiologically linked to a scrapie-
positive RR sheep

[[Page 327]]

or to a scrapie type that affects RR at codon 171 sheep.
    Genetically susceptible animal. Any goat or goat embryo, sheep or 
sheep embryo of a genotype other than RR or QR, where Q represents any 
genotype other than R at codon 171 or sheep or sheep embryo of 
undetermined genotype.
    Genetically susceptible exposed animal. Excluding low-risk exposed 
animals, any exposed animal or embryo that is also:
    (1) A genetically susceptible animal; or
    (2) A sheep or sheep embryo of genotype AV QR that the Administrator 
has determined is epidemiologically linked to a scrapie-positive RR or 
QR sheep, to a flock that the Administrator has determined may be 
affected by valine-associated scrapie (based on an evaluation of the 
genotypes of the scrapie-positive animals linked to the flock), or to a 
scrapie type to which AV QR sheep are susceptible; or
    (3) A sheep or sheep embryo of genotype AA QR that the Administrator 
has determined is epidemiologically linked to a scrapie-positive RR or 
AA QR sheep or to a scrapie type to which AA QR sheep are susceptible; 
or
    (4) A sheep or sheep embryo of genotype RR that the Administrator 
has determined is epidemiologically linked to a scrapie-positive RR 
sheep or to a scrapie type to which RR sheep are susceptible.
    (5) Note: In this definition, R refers to codon 171 and A refers to 
codon 136, and Q represents any genotype other than R at codon 171 and V 
represents any genotype other than A at codon 136.
    Group/lot identification number (GIN). The identification number 
used to uniquely identify a unit of animals that is managed together as 
one group. The format of the GIN may be either as defined in Sec.86.1 
of this chapter, or the flock identification number followed by a six-
digit representation of the date on which the group or lot of animals 
was assembled (MM/DD/YY). If more than one group is created on the same 
date a sequential number will be added to the end of the GIN. A group 
lot comprised of animals from a single flock of origin may be subdivided 
after leaving the premises on which the group lot was formed by adding 
an S followed by a sequential number to the end of the GIN to create a 
GIN for each sub group. If a flock identification number is used, the 
flock identification number, date, and sequential number(s) will be 
separated by hyphens.
    High-risk animal. The female offspring or embryo of a scrapie-
positive female animal, or any suspect animal, or a female genetically 
susceptible exposed animal, or any exposed animal that the Administrator 
determines to be a potential risk. The Administrator may base the 
determination that an exposed animal poses a potential risk on the 
scrapie type, the epidemiology of the flock or flocks with which it is 
epidemiologically linked, including genetics of the positive sheep, the 
prevalence of scrapie in the flock, any history of recurrent infection, 
and other animal or flock characteristics. An animal will no longer be a 
high-risk animal if it is redesignated in accordance with Sec.79.4.
    Inconsistent State. Any State other than a Consistent State.
    Infected flock. The flock of origin of a female animal that a State 
or APHIS representative has determined to be a scrapie-positive animal; 
or any flock in which a State or APHIS representative has determined 
that a scrapie-positive female animal has resided unless an 
epidemiologic investigation conducted by a State or APHIS representative 
shows that the animal did not lamb or abort in the flock. A flock will 
no longer be considered an infected flock after it has completed the 
requirements of a flock plan.
    Interstate certificate of veterinary inspection (ICVI). An official 
document issued by a Federal, State, Tribal, or accredited veterinarian 
certifying the inspection of animals in preparation for interstate 
movement or other uses as described in this part and in accordance with 
Sec.79.5.
    Interstate commerce. Trade, traffic, transportation, or other 
commerce between a place in a State and any place outside of that State, 
or between points within a State but through any place outside that 
State.
    Limited contacts. Incidental contacts between animals from different 
flocks off the flock's premises such as at fairs,

[[Page 328]]

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 flock. A flock composed of commercial 
whitefaced, whitefaced cross, or commercial hair sheep or commercial 
goats that were born in, and have resided throughout their lives in, 
flocks with no known risk factors for scrapie, including any exposure to 
female blackfaced sheep other than whiteface crosses born on the 
premises; that has never contained a scrapie-positive female, suspect 
female, or high-risk animal; and that has never been an infected, 
exposed, or source flock or a flock under investigation. The animals are 
identified with a legible permanent brand or ear notch pattern 
registered with an official brand registry or with an official flock 
identification eartag. The term ``brand'' includes official brand 
registry brands on eartags in those States whose brand law or regulation 
recognizes brands placed on eartags as official brands. Low-risk 
commercial flocks may exist only in a State where in the previous 10 
years no flock that had met the definition of a low-risk commercial 
flock prior to a classification investigation was designated a source or 
infected flock.
    Low-risk exposed animal. Any exposed animal to which the 
Administrator has determined one or more of the following applies:
    (1) The positive animal that was the source of exposure was not born 
in the flock and did not lamb in the flock or in an enclosure where the 
exposed animal resided;
    (2) The Administrator and State representative concur that the 
animal is unlikely to be infected due to factors such as, but not 
limited to, where the animal resided or the time period the animal 
resided in the flock;
    (3) The exposed animal is male and was not born in an infected or 
source flock;
    (4) The exposed animal is a castrated male;
    (5) The exposed animal is an embryo of a genetically resistant 
exposed sheep or a genetically less susceptible exposed sheep unless 
placed in a recipient that was a genetically susceptible exposed animal; 
or
    (6) The animal was exposed to a scrapie type and/or is of a genotype 
that the Administrator has determined poses low risk of transmission.
    National Scrapie Database. A database designated by the 
Administrator in which APHIS and State animal health

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agencies cooperatively enter data concerning scrapie outbreaks, flocks 
and premises affected by scrapie, individual animal identification and 
premises identification data, and other data to support the Scrapie 
Eradication Program and the Scrapie Flock Certification Program.
    National Uniform Eartagging System (NUES). This term has the meaning 
set forth in Sec.86.1 of this subchapter.
    Noncompliant flock. (1) Any source or infected flock whose owner 
declines to enter into a flock plan or post-exposure management and 
monitoring plan agreement within 30 days of being so designated, or 
whose owner is not in compliance with either agreement;
    (2) Any exposed flock whose owner fails to make animals available 
for testing within 60 days of notification, or as mutually agreed, or 
whose owner fails to submit required postmortem samples;
    (3) Any flock whose owner has misrepresented, or who employs a 
person who has misrepresented, the scrapie status of an animal or any 
other information on a certificate, permit, owner/hauler statement, or 
other official document within the last 5 years; or
    (4) Any flock whose owner or manager has moved, or who employs a 
person who has moved, an animal in violation of this chapter within the 
last 5 years.
    Official eartag. This term has the meaning set forth in Sec.86.1 
of this subchapter, except that only eartags approved and distributed in 
accordance with Sec.79.2(k) are included.
    Official genotype test. A test to determine the genotype of a live 
or dead animal conducted at either the National Veterinary Services 
Laboratories or at an approved laboratory. The test subject must be an 
animal that is officially identified and the test accurately recorded on 
an official form supplied or approved by APHIS, with the samples 
collected and shipped to the laboratory using a shipping method 
specified by the laboratory by:
    (1) An accredited veterinarian;
    (2) A State or APHIS representative; or
    (3) The animal's owner or owner's agent, using a tamper-resistant 
sampling kit approved by APHIS for this purpose.
    Official identification. Identification mark or device approved by 
APHIS for use in the Scrapie Eradication Program. Examples are listed in 
Sec.79.2(a)(2).
    Official identification device or method. This term has the meaning 
set forth in Sec.86.1 of this subchapter, except that only devices 
approved and distributed in accordance with Sec.79.2(k) and methods 
approved for use in sheep and goats in accordance with Sec.79.2(a)(2) 
are included.
    Official identification number. This term has the meaning set forth 
in Sec.86.1 of this subchapter.
    Officially identified. Identified by means of an official 
identification device or method approved by the Administrator for use in 
sheep and goats in accordance with this part.
    Official test. Any test for the diagnosis of scrapie in a live or 
dead animal that is approved by the Administrator for that use and 
conducted either at an approved laboratory or at the National Veterinary 
Services Laboratories.
    Owner. A person, partnership, company, corporation, or any other 
legal entity who has legal or rightful title to animals, whether or not 
they are subject to a mortgage.
    Owner/hauler statement. (1) A signed written statement by the owner 
or hauler that includes:
    (i) The name, address, and phone number of the owner and, if 
different, the hauler;
    (ii) The date the animals were moved;
    (iii) The flock identification number or PIN assigned to the flock 
or premises of the animals;
    (iv) If moving individually unidentified animals or other animals 
required to move with a group/lot identification number, the group/lot 
identification number and any information required to officially 
identify the animals;
    (v) The number of animals;
    (vi) The species, breed, and class of animals. If breed is unknown, 
for sheep the face color and for goats the type (milk, fiber, or meat) 
must be recorded instead; and

[[Page 330]]

    (vii) The name and address of point of origin, if different from the 
owner's address, and the destination name and address.
    (2) An existing document that includes the information required in 
paragraphs (1)(i) to (vii) of this definition and that is signed by the 
owner or the hauler may be used as an owner/hauler statement.
    Ownership brand. A unique permanent legible brand or earnotch 
pattern applied to an animal that indicates ownership by a particular 
person when the brand pattern is registered with a State's official 
brand recording agency.
    Permit. An official document issued in connection with the 
interstate movement of animals (VS Form 1-27 or a State form that 
contains the same information) that is issued by an APHIS 
representative, State representative, or an accredited veterinarian 
authorized to sign such permits. A new permit is required for each 
change in destination for an animal. A permit lists the owner's name and 
address; points of origin and destination; number of animals covered; 
purpose of the movement; whether the animals are from an exposed, 
noncompliant, infected, or source flock; whether the animal is a high-
risk, exposed, scrapie-positive, or scrapie suspect animal; 
transportation vehicle license number or other identification number; 
and seal number (if a seal is required). A permit also lists all 
official identification on the animals covered, including the official 
eartag number, individual animal registered breed association 
registration tattoo, individual animal registered breed association 
registration brand, United States Department of Agriculture backtag 
(when applied serially, only the beginning and the ending numbers need 
be recorded), individual animal registered breed association 
registration number, or any other form of official identification 
present on the animal.
    Person. An individual, partnership, company, corporation, or any 
other legal entity.
    Premises identification. An APHIS approved eartag, backtag, or 
legible tattoo bearing the premises identification number (PIN), as 
defined in this section, or a flock identification number, or a legible 
permanent brand or ear notch pattern registered with an official brand 
registry. Premises identification may be used when official individual 
animal identification is required, if the premises identification method 
either includes a unique animal number or is used in conjunction with 
the producer's livestock production numbering system to provide a unique 
identification number and where, if brands or ear notches are used, the 
animals are accompanied by an official brand inspection certificate. 
Clearly visible and/or legible paint brands may be used on animals 
moving directly to slaughter and on animals moving for grazing or other 
management purposes without change in ownership.
    Premises identification number (PIN). This term has the meaning set 
forth in Sec.86.1 of this subchapter. APHIS may also maintain 
historical and/or State premises numbers and link them to the premises 
identification number in records and databases. Such secondary or 
historical numbers are typically the State's two-letter postal 
abbreviation followed by a number assigned by the State.
    Restricted animal sale or restricted livestock facility. A sale 
where any animals in slaughter channels are maintained separate from 
other animals not in slaughter channels other than animals from the same 
flock of origin and are sold in lots that consist entirely of animals 
sold for slaughter only or a livestock facility at which all animals are 
in slaughter channels and where the sale or facility manager maintains a 
copy of, or maintains a record of, the information from, the owner/
hauler statement for all animals entering and leaving the sale or 
facility. A restricted animal sale may be held at a livestock facility 
that is not restricted.
    Scrapie Eradication Program. The cooperative State-Federal program 
administered by APHIS and Consistent States to control and eradicate 
scrapie.
    Scrapie Eradication Uniform Methods and Rules (UM&R). Cooperative 
procedures and standards adopted by APHIS and Consistent States for 
controlling and eradicating scrapie. The UM&R will be reviewed at least 
annually by

[[Page 331]]

representatives of the livestock industry, appropriate State and Federal 
agencies, and the public and will be drafted, revised, and published as 
needed by APHIS.
    Scrapie Free Flock Certification Program (SFCP). The cooperative 
Federal-State-industry voluntary program for the control of scrapie 
conducted in accordance with subpart B of part 54 of this chapter.
    Scrapie Free Flock Certification Program standards. Cooperative 
procedures and standards adopted by APHIS and State Scrapie 
Certification Boards for reducing the incidence and controlling the 
spread of scrapie through flock certification. \2\
---------------------------------------------------------------------------

    \2\ Individual copies of the SFCP standards may be obtained on the 
World Wide Web at URL http://www.aphis.usda.gov/animal-health/scrapie, 
or from the Animal and Plant Health Inspection Service, National Animal 
Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-
1235.
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    Scrapie-positive animal. An animal for which a diagnosis of scrapie 
has been made by the National Veterinary Services Laboratories or 
another laboratory authorized by the Administrator to conduct scrapie 
tests in accordance with this chapter, through:
    (1) Histopathological examination of central nervous system (CNS) 
tissues from the animal for characteristic microscopic lesions of 
scrapie;
    (2) The use of proteinase-resistant protein analysis methods 
including but not limited to immunohistochemistry, and/or ELISA, and/or 
western blotting on CNS and/or peripheral tissue samples from a live or 
a dead animal for which a given method has been approved by the 
Administrator for use on that tissue;
    (3) Bioassay;
    (4) Scrapie associated fibrils (SAF) detected by electron 
microscopy; or
    (5) Any other method or combination of methods approved by the 
Administrator in accordance with Sec.54.10 of this chapter. \3\
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    \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.
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    Slaughter channels. Animals in slaughter channels include any animal 
that is sold, transferred, or moved either directly to or through a 
restricted animal sale or restricted livestock facility to an official 
slaughter establishment that is under Food Safety and Inspection Service 
(FSIS) jurisdiction per the Federal Meat Inspection Act (FMIA) or under 
State inspection that FSIS has recognized as at least equal to Federal 
inspection or to a custom exempt slaughter establishment as defined by 
FSIS (9 CFR 303.1) for immediate slaughter or to an individual for 
immediate slaughter for personal use or to a terminal feedlot.
    Source flock. A flock in which a State or APHIS representative has 
determined that at least one animal was born that was diagnosed as a 
scrapie-positive animal at an age of 72 months or less. The 
determination that an animal was born in a flock will be based on such 
information as the presence of official identification on the animal 
traceable to the flock, the presence of other identification on the 
animal that is listed on the bill of sale, or other evidence, such as 
registry records, to show that a scrapie-positive animal was born in the 
flock, combined with the absence of records indicating that the animal 
was purchased from outside and added to the flock. If DNA from the 
animal was previously collected by an accredited veterinarian and stored 
at an approved genotyping laboratory, or if DNA collection and storage 
are required for breed registration and the

[[Page 332]]

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 if it is:
    (1) A mature sheep or goat as evidenced by eruption of the first 
incisor that has been condemned by FSIS or a State inspection authority 
for central nervous system (CNS) signs, or that exhibits any of the 
following clinical signs of scrapie and has been determined to be 
suspicious for scrapie by an accredited veterinarian or a State or USDA 
representative, based on one or more of the following signs and the 
severity of the signs: Weakness of any kind including, but not limited 
to, stumbling, falling down, or having difficulty rising, not including 
those with visible traumatic injuries and no other signs of scrapie; 
behavioral abnormalities; significant weight loss despite retention of 
appetite or in an animal with adequate dentition; increased sensitivity 
to noise and sudden movement; tremors; star gazing; head pressing; 
bilateral gait abnormalities such as but not limited to incoordination, 
ataxia, high stepping gait of forelimbs, bunny-hop movement of rear 
legs, or swaying of back end, but not including abnormalities involving 
only one leg or one front and one back leg; repeated intense rubbing 
with bare areas or damaged wool in similar locations on both sides of 
the animal's body or, if on the head, both sides of the poll; abraded, 
rough, thickened, or hyperpigmented areas of skin in areas of wool/hair 
loss in similar locations on both sides of the animal's body or, if on 
the head, both sides of the poll; or other signs of CNS disease. An 
animal will no longer be a suspect animal if it is redesignated in 
accordance with Sec.79.4.
    (2) A sheep or goat that has tested positive for scrapie or for the 
proteinase resistant protein associated with scrapie on a live-animal 
screening test or any other test, unless the animal is designated a 
scrapie-positive animal.
    (3) A sheep or goat that has tested inconclusive or suggestive on an 
official test for scrapie.
    Terminal feedlot. (1) A dry lot approved by a State or APHIS 
representative or an accredited veterinarian who is authorized by the 
Administrator to perform this function where animals in the terminal 
feedlot are separated from all other animals by at least 30 feet at all 
times or are separated by a solid wall through, over, or under which 
fluids cannot pass and contact cannot occur and must be cleaned of all 
organic material prior to being used to contain sheep or goats that are 
not in slaughter channels, where only castrated males are maintained 
with female animals and from which animals are moved only to another 
terminal feedlot or directly to slaughter; or
    (2) A dry lot approved by a State or APHIS representative or an 
accredited veterinarian authorized by the Administrator to perform this 
function where only animals that either are not pregnant based on the 
animal being male, an owner certification that any female animals have 
not been exposed to a male in the preceding 6 months, an ICVI issued by 
an accredited veterinarian stating the animals are not pregnant, or the 
animals are under 6 months of age at time of receipt, where only 
castrated males are maintained with female animals, and all animals in 
the terminal feedlot are separated from all other animals such that 
physical contact cannot occur including

[[Page 333]]

through a fence and from which animals are moved only to another 
terminal feedlot or directly to slaughter; or
    (3) A pasture when approved by and maintained under the supervision 
of the State and in which only nonpregnant animals are permitted based 
on the animal being male, an owner certification that any female animals 
have not been exposed to a male in the preceding 6 months, or an ICVI 
issued by an accredited veterinarian stating the animals are not 
pregnant, or the animals are under 6 months of age at time of receipt, 
where only castrated males are maintained with female animals, where 
there is no direct fence-to-fence contact with another flock, and from 
which animals are moved only to another terminal feedlot or directly to 
slaughter.
    (4) Records of all animals entering and leaving a terminal feedlot 
must be maintained for 5 years after the animal leaves the feedlot and 
must meet the requirements of Sec.79.2, including either a copy of the 
required owner/hauler statements for animals entering and leaving the 
facility or the information required to be on the statements. Records 
must be made available for inspection and copying by an APHIS or State 
representative upon request.
    Test eligible. An animal that meets a test protocol's age and post-
exposure elapsed time requirements for the test to be meaningfully 
applied.
    United States. All of the States.
    Unofficial test. Any test for the diagnosis of scrapie or for the 
detection of the proteinase resistant protein associated with scrapie in 
a live or dead animal that either has not been approved by the 
Administrator or that was not conducted at an approved laboratory or at 
the National Veterinary Services Laboratories.

[66 FR 43990, Aug. 21, 2001, as amended at 69 FR 64650, Nov. 8, 2004; 72 
FR 39306, July 18, 2007; 73 FR 54062, Sept. 18, 2008; 84 FR 11186, Mar. 
25, 2019]



Sec.79.2  Identification and records requirements for sheep and goats
in interstate commerce.

    (a) No sheep or goat that is required to be individually identified 
or group identified by Sec.79.3 may be sold, disposed of, acquired, 
exhibited, transported, received for transportation, offered for sale or 
transportation, loaded, unloaded, or otherwise handled in interstate 
commerce or commingled with such animals or be loaded or unloaded at a 
premises or animal concentration point (including premises that exhibit 
animals) where animals are received that have been in interstate 
commerce or from which animals are moved in interstate commerce unless 
each sheep or goat has been identified in accordance with this section.
    (1) The sheep or goat must be identified to its flock of origin and 
to its flock of birth \4\ by the owner of the animal or his or her 
agent, at whichever of the following points in interstate commerce comes 
first:
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    \4\ You need not identify an animal to its flock of birth or its 
flock of origin if this information is unknown because the animal 
changed ownership while it was exempted from flock of origin 
identification requirements in accordance with Sec.79.6(a)(12). Such 
animals may be moved interstate with individual animal identification 
that is only traceable to the State of origin and to the owner of the 
animals at the time they were so identified. To use this exemption the 
person applying the identification must have supporting documentation 
indicating that the animals were born and had resided throughout their 
life in the State.
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    (i) Prior to the point of first commingling of the sheep or goats 
with sheep or goats from any other flock of origin;
    (ii) Upon unloading of the sheep or goats at a livestock facility 
approved in accordance with Sec.71.20 of this subchapter and that has 
agreed to act as an agent for the owner to apply official identification 
and prior to commingling with animals from another flock of origin. Such 
facilities may identify animals after sale if the facility maintains 
unidentified animals from different flocks of origin or, when required, 
different flocks of birth in separate enclosures until officially 
identified. The animals must be accompanied by an owner/hauler statement 
that contains the information needed for the livestock facility to 
officially identify the animals to their flock of origin and, when 
required, their flock of birth;
    (iii) Upon transfer of ownership of the sheep or goats;

[[Page 334]]

    (iv) If the owner of the premises or the owner of the animal engages 
in the interstate commerce of animals, then prior to moving a sheep or 
goat from the premises on which it resides, unless the animals are 
moving to a livestock facility approved to handle the species and class 
of animal to be moved as described in Sec.71.20 of this subchapter 
that has agreed to act as an agent for the owner to apply official 
identification and in accordance with paragraph (a)(1)(ii) of this 
section or to a slaughter plant listed in accordance with Sec.71.21 of 
this subchapter as part of a group lot. Unless prohibited by State law 
or regulation, this does not preclude a person from moving animals as 
part of a group lot directly to another site in the same State to have 
official eartags that have been assigned to the animal's flock of origin 
in the National Scrapie Database applied to the animals;
    (v) In the case of animals that have only resided on premises and in 
flocks owned by persons that do not engage in interstate commerce, upon 
unloading a sheep or goat at a livestock facility or other premises 
where animals are received that have been in interstate commerce or from 
which animals are moved in interstate commerce and prior to commingling 
with animals from another flock of origin. Such animals must be 
accompanied by an owner/hauler statement that contains the information 
needed to officially identify the animals to their flock of origin and, 
when required, their flock of birth; or
    (vi) Before moving a sheep or goat across a State line, unless 
moving to an approved livestock facility that is approved to handle that 
species and class of animals as described in Sec.71.20 of this 
subchapter that has agreed to act as an agent for the owner to apply 
official identification, and prior to commingling with animals from 
another flock of origin. Such animals must be accompanied by an owner/
hauler statement that contains the information needed for the livestock 
facility to officially identify the animals to their flock of origin 
and, when required, their flock of birth.
    (2) The sheep or goats must be identified and remain identified 
using a device or method approved in accordance with paragraph (k) of 
this section. All animals required to be individually identified by 
Sec.79.3 shall be identified with official identification devices or 
methods. A list of approved identification devices and methods, 
including restrictions on their use, is available at http://
www.aphis.usda.gov/animal-health/scrapie. Written requests for approval 
of sheep or goat identification device types or methods not listed at 
http://www.aphis.usda.gov/animal-health/scrapie should be sent to the 
National Scrapie Program Coordinator, Strategy and Policy, VS, APHIS, 
4700 River Road Unit 43, Riverdale, MD 20737-1235. If the Administrator 
determines that an identification device or method will provide an 
effective means of tracing sheep and goats in interstate commerce, APHIS 
will provide public notice that the device type or method, along with 
any restrictions on its use, has been added to the list of approved 
devices and methods of official sheep and goat identification.
    (3) No person shall buy or sell, for his or her own account or as 
the agent of the buyer or seller, transport, receive for transportation, 
offer for sale or transportation, load, unload, or otherwise handle any 
animal that is in or has been in interstate commerce that has not been 
identified as required by this section including loading or unloading at 
a premises (including premises that exhibit animals) where animals are 
received that have been in interstate commerce or from which animals are 
moved in interstate commerce. No person shall commingle animals with any 
animal that is in or has been in interstate commerce that has not been 
identified as required by this section. If the person transporting 
animals is aware of any animal in the shipment that loses its 
identification to its flock of origin while in interstate commerce, the 
person transporting the animal is required to inform the receiving party 
of this fact, and it is the responsibility of the person who has control 
or possession of the animal upon unloading/delivery to identify the 
animal or have the animal identified prior to commingling it with any 
other animals. This shall be done by applying individual animal 
identification to the

[[Page 335]]

animal as required in paragraph (a)(2) of this section and recording the 
means of identification and the corresponding animal identification 
number on the waybill or other shipping document. If the flock of origin 
cannot be determined, all possible flocks of origin shall be listed on 
the record, or if this cannot be done, the animal must be identified 
with a slaughter only eartag and may only move in slaughter channels or, 
in the case of sheep, may be officially identified and moved for other 
purposes if the animal is inspected by an accredited veterinarian, found 
free of evidence of infectious or contagious disease and officially 
genotyped as AA QR or AA RR.
    (b) The State Animal Health Official or Veterinary Services, Field 
Operations, Area Veterinarian in Charge (AVIC) responsible for the State 
involved, whoever is responsible for issuing official identification 
devices or numbers in that State and for assigning flock identification 
numbers and premises identification numbers in that State in the 
National Scrapie Database, may issue sets of unique serial numbers or 
flock identification/production numbers for use on official individual 
identification devices (such as eartags or tattoos). Flock 
identification/production numbers may only be assigned to owners of 
breeding flocks.
    (1) Animals not in slaughter channels. Official identification 
numbers for use on animals not in slaughter channels may only be 
assigned either directly to the owner of a breeding flock for 
application to animals that originated in a breeding flock owned by them 
or, in the case of official serial numbers or serial number devices, to 
APHIS or State representatives or accredited veterinarians or other 
responsible individuals as described in paragraphs (b)(2) and (3) of 
this section APHIS or State representatives may apply official 
identification to animals or issue official identification to owners of 
breeding flocks for application to animals in those flocks. APHIS and 
State personnel who apply or issue official identification must provide 
to APHIS, in a manner acceptable to APHIS, assignment data associating 
the serial numbers applied to animals or issued to owners, to the flock 
of origin and, when required, the flock of birth. Accredited 
veterinarians who apply official serial numbers or devices when 
requested by APHIS a must provide to APHIS, in a manner acceptable to 
APHIS, assignment data associating the serial sequences applied to 
animals to the flock of origin and, when required, the flock of birth. 
One such method would be to enter the data into the National Scrapie 
Database. Such requests may be made directly to a person or persons or 
to accredited veterinarians as a group through amendment of the Scrapie 
Program Standards Volume 1: National Scrapie Eradication Program.
    (2) Assignment of serial numbers. The official responsible for 
issuing eartags in a State may also assign serial numbers of official 
eartags to other responsible persons, such as 4-H leaders, if the State 
Animal Health Official and Veterinary Services, Field Operations, AVIC 
responsible for the State involved agree that such assignments will 
improve scrapie control and eradication within the State. Such persons 
assigned serial numbers may either directly apply eartags to animals, or 
may reassign eartag numbers to producers. Such persons must maintain 
appropriate records in accordance with paragraph (g) of this section 
that permit traceback of animals to their flock of origin, or flock of 
birth when required, and must either reassign the tags in the National 
Scrapie Database or, if permitted by the Veterinary Services, Field 
Operations, AVIC responsible for the State involved, provide a written 
record of the reassignment to the Field Office or the State Office for 
entry into the National Scrapie Database.
    (3) Persons handling sheep and goats in commerce. Sets of unique 
individual identification serial numbers may be assigned to persons who 
handle sheep and goats, that did not originate in a breeding flock owned 
by them, if they apply to and are approved by the State Animal Health 
Official or the Veterinary Services, Field Operations, AVIC responsible 
for the State in which the person maintains his or her business 
location, whichever is responsible for issuing official identification 
devices

[[Page 336]]

or numbers in that State and for assigning flock identification numbers 
and premises identification numbers in that State in the National 
Scrapie Database. When requested by APHIS, persons who apply official 
identification to sheep or goats that did not originate in a breeding 
flock owned by them must provide, in a manner acceptable to APHIS, 
assignment data associating assigned serial sequences to the flock of 
origin and, when required, the flock of birth. One such method would be 
to enter the data into the National Scrapie Database. The request may be 
made directly to a person or persons or to a class of persons through 
amendment of the Scrapie Program Standards Volume 1: National Scrapie 
Eradication Program. The State Animal Health Official or the 
Administrator may limit the assignment of official identification 
devices or numbers to persons, or classes of persons, for use on animals 
that did not originate in a breeding flock owned by them to slaughter 
only devices or numbers.
    (4) Breed registries. Sets of unique individual identification 
numbers may also be assigned by the Administrator to breed registries 
that agree to reassign the sequences to the flock of origin and, and 
when required, the flock of birth and to provide associated registry 
identifiers such as registry tattoo numbers to APHIS in the National 
Scrapie Database.
    (5) Noncompliance. In addition to any applicable criminal or civil 
penalties any person who fails to comply with the requirements of this 
section or that makes false statements in order to acquire official 
identification numbers or devices shall not be assigned official 
identification numbers or official identification devices for a period 
of at least 1 year. If a person who is not in compliance with these 
requirements has already been assigned such numbers, the Administrator 
may withdraw the assignment by giving notice to such person. Such 
withdrawal or failure to assign official identification numbers may be 
appealed in accordance with Sec.79.4(c)(3). A person shall be subject 
to criminal and civil penalties if he or she continues to use assigned 
numbers that have been withdrawn from his or her use.
    (c) No person shall apply a premises or flock identification number 
or a brand or earnotch pattern to an animal that did not originate on 
the premises or flock to which the number was assigned by a State or 
APHIS representative or to which the brand or earnotch pattern has been 
assigned by an official brand registry. This includes individual 
identification such as USDA eartags that have been assigned to a 
premises or flock and registration tattoos that contain prefixes that 
have been assigned to a premises or flock for use as premises or flock 
identification. Unless the number sequence was issued specifically for 
use on animals born in a flock, this would not preclude the owner of a 
flock from using an official premises or flock identification number tag 
assigned to that flock on an animal owned by him or her that resides in 
that flock but that was born or previously resided on a different 
premises as long as the records required in paragraph (g) of this 
section are maintained.
    (d) No person shall sell or transfer an official identification 
device or number assigned to his or her premises or flock except when it 
is transferred with a sheep or goat to which it has been applied as 
official identification or as directed in writing by an APHIS or State 
representative.
    (e) No person shall use an official identification device or number 
provided for the identification of sheep and goats other than for the 
identification of a sheep or goat.
    (f) Persons who engage in the interstate commerce of animals 
including persons that handle or own animals that have been in 
interstate commerce or that purchase, acquire, sell, or dispose of sheep 
and/or goats from or to persons who engage in the interstate commerce of 
animals, whether or not the animals are required to be officially 
identified, must maintain business records (such as yarding receipts, 
sale tickets, invoices, and waybills) for 5 years. These persons must 
make the records available for inspection and copying by any authorized 
USDA or State representative upon that representative's request and 
presentation

[[Page 337]]

of his or her official credentials. The records must include the 
following information:
    (1) The number of animals purchased or sold (or transferred without 
sale);
    (2) The date of purchase, sale, or other transfer;
    (3) The name and address of the person from whom the animals were 
purchased or otherwise acquired or to whom they were sold or otherwise 
transferred;
    (4) The species, breed, and class of animal. If breed is unknown, 
for sheep the face color and for goats the type (milk, fiber, or meat) 
must be recorded instead;
    (5) A copy of the brand inspection certificate for animals 
officially identified with brands or ear notches;
    (6) A copy of any certificate or owner/hauler statement required for 
movement of the animals purchased, sold, or otherwise transferred; and
    (7) If the flock of origin or the receiving flock is under a flock 
plan or post-exposure management and monitoring plan, any additional 
records required by the plan.
    (g) Persons who apply official individual or group/lot 
identification to animals must maintain records for 5 years. These 
persons must make the records available for inspection and copying by 
any authorized USDA or State representative upon that representative's 
request and presentation of his or her official credentials. The records 
must include the following information:
    (1) The flock identification number of the flock of origin, the name 
and address of the person who currently owns the animals, and the name 
and address of the owner of the flock of origin if different;
    (2) The name and address of the owner of the flock of birth, if 
known, for animals in another flock and not already identified to flock 
of birth;
    (3) The date the animals were officially identified;
    (4) The number of sheep and the number of goats identified;
    (5) The breed and class of the animals. If breed is unknown, for 
sheep the face color and for goats the type (milk, fiber, or meat) must 
be recorded instead;
    (6) The official identification numbers applied to animals by 
species or the GIN applied in the case of a group lot;
    (7) Whether the animals were identified with ``Slaughter Only'' or 
``Meat'' identification devices; and
    (8) Any GIN with which the animal was previously identified.
    (h) Official identification devices are intended to provide 
permanent identification of livestock and to ensure the ability to find 
the source of animal disease outbreaks. Removal of these devices, 
including devices applied to imported animals in their countries of 
origin and recognized by the Administrator as official, is prohibited 
except at the time of slaughter, at any other location upon the death of 
the animal, or as otherwise approved by the State or Tribal animal 
health official or the Veterinary Services, Field Operations, AVIC 
responsible for the State involved when a device needs to be replaced.
    (1) All man-made identification devices affixed to sheep or goats 
moved interstate must be removed at slaughter and correlated with the 
carcasses through final inspection by means approved by the Food Safety 
and Inspection Service (FSIS). If diagnostic samples, including whole 
heads, are taken, the identification devices must be packaged with the 
samples and must be left attached to approximately 1 inch of tissue or 
to the whole head to allow for identity testing and be correlated with 
the carcasses through final inspection by means approved by FSIS. 
Devices collected at slaughter must be made available to APHIS and FSIS.
    (2) All official identification devices affixed to sheep or goat 
carcasses moved interstate for rendering must be removed at the 
rendering facility and made available to APHIS. If diagnostic samples, 
including whole heads, are taken, the identification devices must be 
packaged with the samples and must be left attached to approximately 1 
inch of tissue or to the whole head to allow for identity testing.
    (3) If a sheep or goat loses an official identification device 
except while in interstate commerce as described in paragraph (a)(3) of 
this section and needs a new one, the person applying

[[Page 338]]

the new official identification device must record the official 
identification number from the old device, if known, in addition to the 
information required to be recorded in accordance with paragraph (g) of 
this section.
    (i) Replacement of official identification devices for reasons other 
than loss include:
    (1) Circumstances under which a State or Tribal animal health 
official or the Veterinary Services, Field Operations, AVIC responsible 
for the State involved may authorize replacement of an official 
identification device include, but are not limited to:
    (i) Deterioration of the device such that loss of the device appears 
likely or the number can no longer be read;
    (ii) Infection at the site where the device is attached, 
necessitating application of a device at another location (e.g., a 
slightly different location of an eartag in the ear);
    (iii) Malfunction of the electronic component of a radio frequency 
identification (RFID) device; or
    (iv) Incompatibility or inoperability of the electronic component of 
an RFID device with the management system or unacceptable functionality 
of the management system due to use of an RFID device.
    (2) Any time an official identification device is replaced, as 
authorized by the State or Tribal animal health official or the 
Veterinary Services, Field Operations, AVIC responsible for the State 
involved, the person replacing the device must record the following 
information about the event and maintain the record for 5 years:
    (i) The date when the device was removed;
    (ii) The address of the location and the name, phone number and 
email address of the person responsible for the location where the 
device was removed;
    (iii) The official identification number (to the extent possible) on 
the device removed;
    (iv) The type of device removed (e.g., metal eartag, RFID eartag);
    (v) The reason for the removal of the device;
    (vi) The new official identification number on the replacement 
device; and
    (vii) The type of replacement device applied.
    (j) Beginning on April 24, 2019, no more than one official eartag 
may be applied to an animal; except that:
    (1) Another official eartag may be applied providing it bears the 
same official identification number as an existing one.
    (2) In specific cases when the need to maintain the identity of an 
animal is intensified (e.g., such as for export shipments, quarantined 
herds, field trials, experiments, or disease surveys), a State or Tribal 
animal health official or the Veterinary Services, Field Operations, 
AVIC responsible for the State involved may approve the application of a 
second official eartag. The person applying the second official eartag 
must record the following information about the event and maintain the 
record for 5 years: The date the second official eartag is added; the 
reason for the additional official eartag device; and the official 
identification numbers of both official eartags.
    (3) An eartag with an animal identification number (AIN) beginning 
with the 840 prefix (either radio frequency identification or visual-
only tag) may be applied to an animal that is already officially 
identified with another eartag. The person applying the AIN eartag must 
record the date the AIN tag is added and the official identification 
numbers of all official eartags on the animal and must maintain those 
records for 5 years.
    (4) An official eartag that utilizes a flock identification number 
may be applied to a sheep or goat that is already officially identified 
with an official eartag if the animal has resided in the flock to which 
the flock identification number is assigned.
    (k) Requirements for approval of official identification devices 
include:
    (1) The Administrator may approve companies to produce official 
identification devices for use on sheep or goats. Devices may be 
plastic, metal, or other suitable materials and must be an appropriate 
size for use in sheep and goats. Devices must be able to legibly 
accommodate the required alphanumeric sequences. Devices must resist 
removal and be difficult to place on another animal once removed unless 
the construction of the device makes such tampering evident, but need 
not be

[[Page 339]]

tamper-proof. Devices must be readily distinguishable as USDA official 
sheep and goat identification devices; must carry the alphanumeric 
sequences, symbols, or logos specified by APHIS; must be an allowed 
color for the intended use, and must have a means of discouraging 
counterfeiting, such as use of a unique copyrighted logo or trade mark. 
Devices for use only on animals in slaughter channels must be medium 
blue and marked with the words ``Meat'' or ``Slaughter Only''. Devices 
that use RFID must conform to ISO 11784 and ISO 11785 standards unless 
otherwise approved. The Administrator may specify the color, shape or 
size of a device for an intended use to make them readily identifiable.
    (2) Written requests for approval of official identification devices 
for sheep and goats should be sent to the National Scrapie Program 
Coordinator, Strategy and Policy, VS, APHIS, 4700 River Road Unit 43, 
Riverdale, MD 20737-1235. The request must include:
    (i) The materials used in the device and in the case of RFID the 
transponder type and data regarding the lifespan and read range.
    (ii) Any available data regarding the durability of the device, 
durability and legibility of the identification numbers, rate of adverse 
reactions such as ear infections, and retention rates of the devices in 
animals, preferably sheep and/or goats.
    (iii) A signed statement agreeing to:
    (A) Send official identification devices only to a State or APHIS 
representative, to the owner of a premises or to the contact person for 
a premises at the address listed in the National Scrapie Database, or as 
directed by APHIS;
    (B) When requested by APHIS, provide a report by State of all tags 
produced, including the tag sequences produced and the name and address 
of the person to whom the tags were shipped, and provide supplemental 
reports of this information when requested by APHIS;
    (C) Maintain the security and confidentiality of all tag recipient 
information acquired as a result of being an approved tag manufacturer 
and utilize the information only to provide official identification 
tags; and
    (D) Enter the sequences of tags shipped in the National Scrapie 
Database through an internet web page interface or other means specified 
by APHIS prior to shipping the identification device.
    (iv) Twenty-five sample devices. Additional tags must be submitted 
if requested by APHIS.
    (3) Approval will only be given for devices for which data have been 
provided supporting high legibility, readability (visual and RFID), and 
retention rates in sheep and goats that minimize injury throughout their 
lifespan, or for which there is a reasonable expectation of such 
performance. Approval to produce official identification devices will be 
valid for 1 year and must be renewed annually. The Administrator may 
grant provisional approval to produce devices for periods of less than 1 
year in cases where there is limited or incomplete data. The 
Administrator may decline to renew a company's approval or suspend or 
withdraw approval if the devices do not show adequate retention and 
durability or cause injury in field use or if any of the requirements of 
this section are not met by the tag company. Companies shall be given 60 
days' written notice of intent to withdraw approval. Any person who is 
approved to produce official identification tags in accordance with this 
section and who knowingly produces tags that are not in compliance with 
the requirements of this section, and any person who is not approved to 
produce such tags but does so, shall be subject to such civil penalties 
and such criminal liabilities as are provided by 18 U.S.C. 1001, 7 
U.S.C. 8313, or other applicable Federal statutes. Such action may be in 
addition to, or in lieu of, withdrawal of approval to produce tags.

(Approved by the Office of Management and Budget under control numbers 
0579-0101 and 0579-0469)

[84 FR 11189, Mar. 25, 2019; 84 FR 28202, June 18, 2019]



Sec.79.3  General restrictions.

    The following prohibitions and movement conditions apply to the 
movement of or commingling with sheep and goats in interstate commerce, 
and no sheep or goat may be sold, disposed of,

[[Page 340]]

acquired, exhibited, transported, received for transportation, offered 
for sale or transportation, loaded, unloaded, or otherwise handled in 
interstate commerce, or commingled with such animals, or be loaded or 
unloaded at a premises or animal concentration point (including premises 
that exhibit animals) where animals are received that have been in 
interstate commerce or from which animals are moved in interstate 
commerce except in compliance with this part.
    (a) No sexually intact animal of any age or castrated animal 18 
months of age and older (as evidenced by the eruption of the second 
incisor) may be moved or commingled with animals in interstate commerce 
unless it is individually identified to its flock of birth \5\ and is 
accompanied by an ICVI, except that an ICVI is not required unless the 
animal is moved across a State line, and except for the following, which 
may move with group lot identification and an owner/hauler statement:
---------------------------------------------------------------------------

    \5\ You need not identify an animal to its flock of birth or its 
flock of origin if this information is unknown because the animal 
changed ownership while it was exempted from flock of origin 
identification requirements in accordance with Sec.79.6(a)(10)(i). 
Such animals may be moved interstate with individual animal 
identification that is only traceable to the State of origin and to the 
owner of the animals at the time they were so identified. To use this 
exemption the person applying the identification must have supporting 
documentation indicating that the animals were born and had resided 
throughout their life in the State.
---------------------------------------------------------------------------

    (1) Animals in slaughter channels that are under 18 months of age 
(as evidenced by the eruption of the second incisor);
    (2) Animals in slaughter channels at 18 months and older (as 
evidenced by the eruption of the second incisor) if the animals were 
kept as a group on the same premises on which they were born and have 
not been maintained in the same enclosure with unidentified animals from 
another flock at any time, including throughout the feeding, marketing, 
and slaughter process;
    (3) An owner/hauler statement may be used instead of an ICVI for 
mixed source animals in slaughter channels 18 months of age and older 
(as evidenced by the eruption of the second incisor) that are identified 
with official individual identification or in the case of animals from 
flocks that are low-risk commercial flocks that are identified using 
identification methods or devices approved for this purpose;
    (4) Animals moving for grazing or other management purposes between 
two premises both owned or leased by the flock owner and recorded in the 
National Scrapie Database as additional flock premises and where 
commingling will not occur with unidentified animals that were born in 
another flock or any animal that is not part of the flock. A request to 
APHIS to enter additional flock premises in the National Scrapie 
Database is required before animals are first moved to the premises. 
Notification is not required for each subsequent movement of animals to 
that premises. Neither group lot ID nor an owner/hauler statement is 
required for movements of a flock or its members for flock management 
purposes within a contiguous premises spanning two or more States. This 
provision does not include the transiting or sale of animals through 
such a premises in circumvention of the other requirements of this part; 
and
    (5) Animals moving to a livestock facility approved in accordance 
with Sec.71.20 of this subchapter and that has agreed to act as an 
agent for the owner to apply official identification if the animals have 
been in the same flock in which they were born and have not been 
maintained in the same enclosure with unidentified animals born in 
another flock at any time. Such facilities may identify animals after 
sale if the facility maintains unidentified animals from different 
flocks of origin or when required birth in separate enclosures until 
officially identified.
    (b) No scrapie-positive or suspect animal may be moved other than by 
permit to an APHIS approved research or quarantine facility or for 
destruction under APHIS or State supervision. Such animals must be 
individually identified and listed on the permit.
    (c) No indemnified high-risk animal or indemnified sexually intact 
genetically susceptible exposed animal may be moved other than by permit 
to an

[[Page 341]]

APHIS approved research or quarantine facility or for destruction at 
another site. Such animals that are not indemnified and are not scrapie-
positive or suspect animals may be moved to slaughter under permit. 
Animals moved in accordance with this paragraph must be individually 
identified and listed on the permit.
    (d) No exposed animal may be moved unless it is officially 
individually identified.
    (e) No animal may be moved from an infected flock or source flock 
except as allowed by an approved flock plan.
    (f) No animal may be moved from an exposed flock, a flock under 
investigation or a flock subject to a PEMMP except as allowed in a PEMMP 
or where a PEMMP is not required, as allowed by written instructions 
from an APHIS or State representative.
    (g) Animals moved to slaughter:
    (1) Once an animal enters slaughter channels the animal may not be 
removed from slaughter channels. An animal is in slaughter channels if 
it was sold through a restricted animal sale, resided in a terminal 
feedlot, was sold with a bill of sale marked for slaughter only, was 
identified with an identification device or tattoo marked ``Slaughter 
Only'' or ``MEAT'' or was moved in a manner not permitted for other 
classes of animals. Animals in slaughter channels may move either 
directly to a slaughter establishment that is under Food Safety and 
Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection 
Act (FMIA) or under State inspection that FSIS has recognized as at 
least equal to Federal inspection or to a custom exempt slaughter 
establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter 
or to an individual for immediate slaughter for personal use or to a 
terminal feedlot, or may move indirectly to such a destination through a 
restricted animal sale or restricted livestock facility. Once an animal 
has entered slaughter channels it may only be officially identified with 
an official blue eartag marked with the words ``Meat'' or ``Slaughter 
Only'' or an ear tattoo reading ``Meat.'' Animals in slaughter channels 
must be accompanied by an owner/hauler statement. The statement must 
also include the name and address of the person or livestock facility 
from which and where they were acquired, if different from the owner; 
the slaughter establishment, restricted animal sale, restricted 
livestock facility or terminal feedlot to which they are being moved, 
and a statement that the animals are in slaughter channels. A copy of 
the owner/hauler statement must be provided to the slaughter 
establishment, restricted animal sale, restricted livestock facility or 
terminal feedlot to which the animals are moved. Any bill of sale 
regarding the animals must indicate that the animals were sold for 
slaughter only.
    (2) Animals that were in slaughter channels before arriving at a 
sale and animals that cannot meet the ID and ICVI requirements for 
unrestricted movement prior to leaving a sale may not be sold at an 
unrestricted sale. This does not preclude animals sold at an 
unrestricted sale from being moved in slaughter channels after sale if 
identified as required for animals in slaughter channels.
    (3) Animals in slaughter channels may not be held in the same 
enclosure with sexually intact animals from another flock of origin that 
are not in slaughter channels.
    (h) No animals designated for testing as part of a classification or 
reclassification investigation may be moved until testing is completed 
and results reported, except for movement by permit for testing, 
slaughter, research, or destruction. Such animals must be individually 
identified and listed on the permit.
    (i) The following animals, if not restricted as part of a flock plan 
or PEMMP, may be moved to any destination without further restriction 
after being officially identified and designated or redesignated by a 
DSE to be:
    (1) Genetically resistant exposed sheep;
    (2) Genetically less susceptible exposed sheep; or
    (3) Low-risk exposed animals.
    (j) Animals moved from Inconsistent States must meet the following 
requirements in addition to other requirements of this section.
    (1) Sheep and goats not in slaughter channels must be enrolled in 
the

[[Page 342]]

Scrapie Free Flock Certification Program or an equivalent APHIS 
recognized program or be sheep that are officially genotyped and 
determined to be AA QR or AA RR, be officially identified, and be 
accompanied by an ICVI that also states the individual animal 
identification numbers, the flock of origin, and the flock of birth, if 
different.
    (2) Animals in slaughter channels must be officially identified with 
an official blue eartag marked with the words ``Meat'' or ``Slaughter 
Only'' and may move only directly to slaughter or to a terminal feedlot. 
Animals 18 months of age and older (as evidenced by the eruption of the 
second incisor) in slaughter channels must also be accompanied by an 
ICVI that states the individual animal identification numbers, and the 
flock of birth (and the flock of origin, if different).
    (k) APHIS may enter into compliance agreements with persons such as 
dealers and owners of slaughter establishments and markets whereby 
animals may be received unidentified or without a required owner/hauler 
statement even if they cannot be identified to their flock of birth or 
origin because they were moved or commingled while unidentified, in 
violation of this part or a State requirement as provided by Sec.79.6. 
Provided that, the agreement requires the person signing the agreement 
to report the violation to the Veterinary Services, Field Operations, 
AVIC responsible for the State involved so that corrective action can be 
taken against the principal violator. In such cases the animal must be 
identified with a slaughter only tag, and is moved only in slaughter 
channels or, in the case of sheep, moved for other purposes if the 
animal is inspected by an accredited veterinarian, found free of 
evidence of infectious or contagious disease, and officially genotyped 
as AA QR or AA RR where Q and R refer to codon 171 and A refers to codon 
136. APHIS may also enter into compliance agreements with persons or in 
the case of approved livestock facilities may amend an approved 
livestock facility agreement to establish alternative methods to 
maintain the traceability of animals in slaughter channels to their 
flock of origin or waive the requirement for individual official 
identification of animals in slaughter channels if adequate surveillance 
has been conducted on the flock of origin or an alternative plan is in 
place to conduct surveillance on animals from the flock of origin when 
the Administrator and the State Animal Health Official agree that the 
application of an allowed official identification device or method is 
unsuitable for a specific circumstance. An example of a specific 
circumstance could be large unruly horned male goats moving through 
approved livestock facilities.

(Approved by the Office of Management and Budget under control numbers 
0579-0101 and 0579-0469)

[84 FR 11193, Mar. 25, 2019]



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. Based on a classification investigation as defined 
in Sec.79.1, including testing of animals, if needed, a designated 
scrapie epidemiologist will designate a flock to be an exposed flock, an 
infected flock, a source flock, a flock under investigation, and/or a 
non-compliant flock, or designate an animal to be a scrapie-positive 
animal, high-risk animal, exposed animal, genetically susceptible 
exposed animal, genetically resistant exposed sheep, genetically less 
susceptible exposed sheep, low-risk exposed animal, and/or a suspect 
animal after determining that the flock or animal meets the criteria of 
the relevant definition in Sec.79.1.
    (b) Redesignation. A reclassification investigation as defined in 
Sec.79.1 may be conducted to determine whether the current designated 
status of a flock or animal may be changed or removed. Reclassification 
investigations will be initiated and conducted, and redesignation 
decisions will be made, in accordance with procedures approved by the 
Administrator. These procedures are available at http://
www.aphis.usda.gov/animal-health/scrapie.
    (c) Testing and notification procedures. Any animal that may be a 
high-risk animal, any animal that may have been exposed to the lambing 
of a high-risk animal, any suspect animal, and

[[Page 343]]

any animal that was born in the flock after a high-risk animal may have 
lambed may be selected for testing by the DSE or an APHIS or State 
representative working under the direction of a DSE or the 
Administrator. Which animals are selected and the method of testing 
selected animals will be based on the risk associated with the flock and 
the type and number of animals available for test. When flock records 
are adequate to determine that all high-risk animals that lambed in the 
flock are available for testing, the testing may be limited to 
postmortem testing of all high-risk and suspect animals. Testing may 
also include an official genotype test, live-animal testing using a 
live-animal official test, the postmortem examination and testing of 
genetically susceptible animals in the flock that cannot be evaluated by 
a live animal test, postmortem examination of other animals, and 
postmortem examination and testing of animals found dead or cull animals 
at slaughter. Animals may not be tested for scrapie to establish the 
designation of the flock until they are test eligible. Animals are 
generally considered test eligible when the animals are over 14 months 
of age if born after the exposure or are 18 months post exposure. If 
testing these animals is necessary to establish the status of a flock 
they must be held for later testing unless sent directly to slaughter or 
a terminal feedlot.
    (1) Noncooperation. If an owner does not make his or her animals 
available for testing within 60 days of notification by an APHIS or 
State representative, within 60 days of becoming test eligible, or as 
mutually agreed in writing by the Administrator and the owner, or fails 
to submit required postmortem samples, the flock will be designated a 
source, infected, or exposed flock, whichever definition applies and a 
noncompliant flock.
    (2) Notice to owner. As soon as possible after making a designation 
or redesignation determination, a State or APHIS representative will 
attempt to notify the owner(s) of the flock(s) or animal(s) in writing 
of the designation.
    (3) Appeal. The owner of an animal may appeal the designation of an 
animal as a scrapie-positive animal, high-risk animal, exposed animal, 
genetically susceptible exposed animal, genetically resistant exposed 
sheep, genetically less susceptible exposed sheep, low-risk exposed 
animal, or a suspect animal. The owner of a flock may appeal the 
designation of the flock as an exposed flock, an infected flock, a 
source flock, a flock under investigation, or a non-compliant flock. The 
owner of a laboratory or test manufacturing facility may appeal the 
suspension or withdrawal of approval for a laboratory or a test. To do 
so, the owner must appeal by writing to the Administrator within 10 days 
after being informed of the reasons for the proposed action. The appeal 
must include all of the facts and reasons upon which the owner relies to 
show that the proposed action is incorrect or is not supported. The 
Administrator will grant or deny the appeal in writing as promptly as 
circumstances permit, stating the reason for his or her decision. If 
there is a conflict as to any material fact, a hearing will be held to 
resolve the conflict. Rules of practice concerning the hearing will be 
adopted by the Administrator. The action under appeal shall continue in 
effect pending the final determination of the Administrator, unless 
otherwise ordered by the Administrator. The final determination of the 
Administrator shall become effective upon oral or written notification, 
whichever is earlier, to the owner. In the event of oral notification, 
written confirmation shall be given as promptly as circumstances allow. 
The Administrator's final determination constitutes final agency action.

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

[84 FR 11195, Mar. 25, 2019]



Sec.79.5  Issuance of Interstate Certificates of Veterinary Inspection
(ICVI).

    (a) ICVIs are required as specified by Sec.79.3 for certain 
interstate movements of sheep or goats and may be used to meet the 
requirements for entry into terminal feedlots. An ICVI and all copies 
must be legible and must show the following information, except when 
Sec.79.3 states that the information is not

[[Page 344]]

required for the specific type of interstate movement:
    (1) The ICVI must show the species, breed or, if breed is unknown, 
the face color of sheep or the type of goats (milk, fiber, or meat), and 
class of animal, such as replacement ewe lambs, slaughter lambs or kids, 
cull ewes, club lambs, bred ewes, etc.; the number of animals covered by 
the ICVI; the purpose for which the animals are to be moved; the address 
at which the animals were loaded for interstate movement or for movement 
to a terminal feedlot when an ICVI is required; the address to which the 
animals are destined; and the names of the consignor and the consignee 
and their addresses if different from the address at which the animals 
were loaded or the address to which the animals are destined; and if 
different the current owner;
    (2) Each animal's official individual identification numbers: 
Provided, that, in the case of animals identified with official 
identifications devices or methods that include the flock identification 
number(s) assigned to the flock(s) of origin in the National Scrapie 
Database and an individual animal number unique within the flock, the 
flock identification number(s) may be recorded instead of the individual 
identification numbers, and for animals allowed by Sec.79.3 to move 
with group lot identification, the group lot number may be recorded 
instead of the individual identification numbers. An ICVI may not be 
issued for any animal that is not officially identified if official 
identification is required. If the animals are not required by the 
regulations to be officially identified, the ICVI must state the 
exemption that applies (e.g., sheep and goats moving for grazing without 
change of ownership). If the animals are required to be officially 
identified but the identification number is not required to be recorded 
on the ICVI, the ICVI must state that all animals to be moved under the 
ICVI are officially identified and state the exemption that applies 
(e.g. the ewes are identified with flock of origin tags so only the 
flock ID must be recorded on the ICVI); and
    (3) A statement by the issuing accredited, State, or Federal 
veterinarian to the effect that on the date of issuance the animals were 
free of evidence of infectious or contagious disease and insofar as can 
be determined exposure thereto. This statement may be made with respect 
to scrapie for animals exposed to scrapie that's movement is not 
restricted that have been designated genetically resistant or less 
susceptible sheep or low-risk exposed animals. Except as provided in 
paragraphs (b) and (c) of this section, all information required by this 
paragraph must be typed or legibly written on the ICVI. Note that in 
accordance with paragraphs (a), (b), and (e) of Sec.79.3, scrapie-
positive, suspect, and high-risk animals, some exposed animals, and some 
animals that originated in an infected or source flock require permits 
rather than ICVIs.
    (4) The ICVI must be signed by the issuing State, Federal, Tribal or 
accredited veterinarian and must be legible on all copies.
    (b) As an alternative to typing or writing individual animal 
identification on an ICVI, if agreed to by the receiving State or Tribe, 
another document may be used to provide this information, but only under 
the following conditions:
    (1) The document must be a State form or APHIS form that requires 
individual identification of animals or a printout of official 
identification numbers generated by computer or other means;
    (2) A legible copy of the document must be stapled to the original 
and each copy of the ICVI;
    (3) Each copy of the document must identify each animal to be moved 
with the ICVI, but any information pertaining to other animals, and any 
unused space on the document for recording animal identification, must 
be crossed out in ink; and
    (4) The following information must be written in ink in the 
identification column on the original and each copy of the ICVI and must 
be circled or boxed, also in ink, so that no additional information can 
be added:
    (i) The name of the document; and
    (ii) Either the unique serial number on the document or, if the 
document is not imprinted with a serial number,

[[Page 345]]

both the name of the person who prepared the document and the date the 
document was signed.
    (c) Ownership brands documents attached to ICVIs. As an alternative 
to typing or writing ownership brands on an ICVI, an official brand 
inspection certificate may be used to provide this information, but only 
under the following conditions:
    (1) A legible copy of the official brand inspection certificate must 
be stapled to the original and each copy of the ICVI;
    (2) Each copy of the official brand inspection certificate must show 
the ownership brand of each animal to be moved with the ICVI, but any 
other ownership brands, and any unused space for recording ownership 
brands, must be crossed out in ink; and
    (3) The following information must be typed or written in ink in the 
official identification column on the original and each copy of the ICVI 
and must be circled or boxed, also in ink, so that no additional 
information can be added:
    (i) The name of the attached document; and
    (ii) Either the serial number on the official brand inspection 
certificate or, if the official brand inspection certificate is not 
imprinted with a serial number, both the name of the person who prepared 
the official brand inspection certificate and the date it was signed.
    (d) If more than one page is used each page must be sequentially 
numbered with the page number and the total number of pages (for example 
1 of 2, 2 of 2).

(Approved by the Office of Management and Budget under control numbers 
0579-0101 and 0579-0469)

[84 FR 11195, Mar. 25, 2019]



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, including scrapie surveillance activities, and certifying 
that these activities meet the requirements of this section. In 
determining whether a State is a Consistent State, the Administrator 
will determine whether the State:
    (1) Has the authority, based on State law or regulation, to restrict 
the movement of all scrapie-infected and source flocks.
    (2) Has the authority, based on State law or regulation, to require 
the reporting of any animal suspected of having scrapie and test results 
for any animals tested for scrapie to State or Federal animal health 
authorities.
    (3) Has, in cooperation with APHIS personnel, drafted and signed a 
memorandum of understanding between APHIS and the State that delineates 
the respective roles of each in the National Scrapie Program 
implementation.
    (4) Has placed all known scrapie-infected and source flocks under 
movement restrictions, with movement of animals only to slaughter, to 
feedlots under permit and movement restrictions that ensure later 
movement to slaughter, for destruction, or for research. Scrapie-
positive and suspect animals may be moved only for transport to an 
approved research facility or for purposes of destruction.
    (5) Has effectively implemented policies to:
    (i) Investigate all animals reported as scrapie suspect animals 
within 7 days of notification;
    (ii) Designate a flock's status, within 15 days of notification that 
the flock contains a scrapie-positive animal, based on an investigation 
by State or Federal animal health authorities and in accordance with 
this part;
    (iii) Restrict the movement, in accordance with paragraph (a)(4) of 
this section, of newly designated scrapie-infected and source flocks 
within 7 days after they are designated in accordance with 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

[[Page 346]]

project, or as permitted by the conditions of such a flock plan, and 
after agreement by the owner to comply with a 5-year post-exposure 
management and monitoring plan;
    (v) Conduct an epidemiologic investigation of source and infected 
flocks that includes the designation of high-risk and exposed animals 
and that identifies animals to be traced;
    (vi) Conduct tracebacks of scrapie-positive animals and traceouts of 
high-risk and exposed animals and report any out-of-State traces to the 
appropriate State within 45 days of receipt of notification of a 
scrapie-positive animal; and
    (vii) Conduct tracebacks based on slaughter sampling within 15 days 
of receipt of notification of a scrapie-positive animal at slaughter.
    (6) Effectively monitors and enforces quarantines.
    (7) Effectively enforces State reporting laws and regulations for 
scrapie.
    (8) Has designated at least one APHIS or State animal health 
official to coordinate scrapie program activities in the State and to 
serve as the designated scrapie epidemiologist in the State.
    (9) Has educated those engaged in the interstate movement of sheep 
and goats regarding the identification and recordkeeping requirements of 
this part.
    (10) Has effectively implemented ongoing scrapie surveillance that 
meets the following criteria:
    (i) Collects and submits surveillance samples from targeted animals 
slaughtered in State-inspected establishments and from slaughter 
establishments within the State that are not covered under Sec.71.21 
of this subchapter, or allows and facilitates the collection of such 
samples by USDA personnel or contractors; and
    (ii) Transmits required submission and epidemiological information 
for all scrapie samples using the electronic submission system provided 
by APHIS for inclusion in the National Scrapie Database and for 
transmission of the submission information to an approved laboratory; 
and
    (iii) Achieves the annual State-level scrapie surveillance minimums 
for sheep and goats originating from the State as determined annually by 
the Administrator with input from the States and made available to the 
public at http://www.aphis.usda.gov/animal-health/scrapie at least 6 
months before the start of the collection period; or
    (iv) Conducts annual surveillance at a level that will detect 
scrapie if it is present at a prevalence of 0.1 percent in the 
population of targeted animals originating in the State, with a 95 
percent confidence.
    (11) If a State does not meet the requirements of paragraph (a)(10) 
of this section as of April 24, 2019, the State must provide APHIS with 
a plan and a timeline for complying with all the requirements of 
paragraph (a)(10) by April 24, 2020, and must meet the requirements of 
paragraph (a)(10) of this section by April 26, 2021.
    (12) Requires, based on State law or regulation, and effectively 
enforces official identification upon change of ownership of all animals 
of any age not in slaughter channels and any sheep over 18 months of age 
as evidenced by eruption of the second incisor such that the animal may 
be traced to its flock of birth; provided that:
    (i) A State may exempt commercial goats in intrastate commerce that 
have not been in contact with sheep from this identification requirement 
if there has been in that State no case of scrapie in a commercial goat 
in the past 10 years that originated in that State and cannot be 
attributed to exposure to infected sheep, and there are no exposed 
commercial goat herds in that State; and
    (ii) A State may exempt commercial whitefaced sheep or commercial 
hair sheep under 18 months of age in intrastate commerce from this 
identification requirement if there has been in that State no case of 
scrapie in the exempted class that originated from that State, and there 
are no exposed commercial whitefaced or hair sheep flocks in that State 
that have been exposed by a female animal.
    (iii) States that exempt these types of commercial animals must put 
in place the regulations necessary to require identification of these 
animals within 90 days of these conditions no longer existing.

[[Page 347]]

    (13) Maintains in the National Scrapie Database administered by 
APHIS, or in a State database approved by the Administrator as 
compatible with the National Scrapie Database, the State's:
    (i) Premises information and assigned premises numbers and 
individual identification number sequences assigned for use as premises 
identification;
    (ii) Individual animal information on all scrapie-positive, suspect, 
high-risk, and exposed animals in the State;
    (iii) Individual animal information on all out-of-State animals to 
be traced; and
    (iv) Accurate flock status data.
    (14) Requires official individual identification of any live 
scrapie-positive, suspect, or high-risk animal of any age and of any 
sexually intact exposed animal of more than 1 year of age or any 
sexually intact exposed animal of less than 1 year of age upon change of 
ownership (except for exposed animals moving in slaughter channels at 
less than 1 year of age), whether or not the animal resides in a source 
or infected flock.
    (15) Effectively enforces movement restrictions on all scrapie-
positive, suspect, and high-risk animals throughout their lives unless 
they are moved in accordance with Sec.79.3.
    (16) Requires that tissues from all scrapie-positive or suspect 
animals and female high-risk animals that have lambed (when they have 
died or have been destroyed) be submitted to a laboratory authorized by 
the Administrator to conduct scrapie tests and requires complete 
destruction of the carcasses of scrapie-positive and suspect animals.
    (17) Prohibits any animal from being removed from slaughter channels 
unless it is identified to the flock of birth, is not from an 
Inconsistent State, and is not scrapie-exposed or from an infected or 
source flock.
    (b) If the Administrator determines that statutory changes are 
needed to bring a State into full compliance, the Administrator may 
grant up to a 2-year extension from the date the State is notified of 
the deficiency to allow a State to acquire additional authorities before 
removing a State's Consistent Status. The decision to grant an extension 
will be based on the State's ability to prevent the movement of scrapie-
infected animals out of the State and on the progress being made in 
making the needed statutory changes.
    (c) When the Administrator determines that a State should be added 
to or removed from the list of Consistent States, APHIS will publish a 
notice in the Federal Register advising the public of the 
Administrator's determination, providing the reasons for that 
determination, and soliciting public comments. After considering any 
comments we receive, APHIS will publish a second notice either advising 
the public that the Administrator has decided to add or remove theState 
from the list of Consistent States or notifying the public that the 
Administrator has decided not to make any changes to the list of 
Consistent States, depending on the information presented in the 
comments.

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

[66 FR 43990, Aug. 21, 2001, as amended at 84 FR 11196, Mar. 25, 2019]



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 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]

[[Page 348]]



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.
    Animal identification number (AIN). A numbering system for the 
official identification of individual animals in the United States 
providing a nationally unique identification number for each animal. The 
AIN contains 15 digits, with the first 3 being the country code (840 for 
the United States), the alpha characters USA, or the numeric code 
assigned to the manufacturer of the identification device by the 
International Committee on Animal Recording. The AIN beginning with the 
840 prefix may be used only on animals born in the United States.
    APHIS. The Animal and Plant Health Inspection Service of the United 
States Department of Agriculture.
    APHIS representative. An individual employed by APHIS who is 
authorized to perform the function involved.
    Approved livestock facility. A stockyard, livestock market, buying 
station, concentration point, or any other premises that has been 
approved under 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 tag providing unique 
identification for individual animals. An official eartag which contains 
or displays an AIN with an 840 prefix must bear the U.S. shield. The 
design, size, shape, color, and other characteristics of the official 
eartag will depend on the needs of the users, subject to the approval of 
the Administrator. The official eartag must be tamper-resistant and have 
a high retention rate in the animal. Official eartags must adhere to one 
of the following numbering systems:
    (1) National Uniform Eartagging System.
    (2) Animal identification number (AIN).
    (3) Premises-based number system. The premises-based number system 
combines an official premises identification number (PIN), as defined in 
this section, with a producer's livestock production numbering system to 
provide a unique identification number. The PIN and the production 
number must both appear on the official tag.
    (4) Any other numbering system approved by the Administrator for the 
identification of animals in commerce.
    Official Johne's disease test. An organism detection test approved 
by the Administrator and conducted in a laboratory approved by the 
Administrator. \1\
---------------------------------------------------------------------------

    \1\ The list of approved laboratories is available on the internet 
at https://www.nahln.org or upon request from the Animal and Plant 
Health Inspection Service, Veterinary Services, National Veterinary 
Services Laboratories, P.O. Box 844, Ames, IA 50010-0844.
---------------------------------------------------------------------------

    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,

[[Page 349]]

and any additional information required by this part.
    Premises identification number (PIN). A nationally unique number 
assigned by a State, Tribal, and/or Federal animal health authority to a 
premises that is, in the judgment of the State, Tribal, and/or Federal 
animal health authority, a geographically distinct location from other 
premises. The premises identification number is associated with an 
address, geospatial coordinates, and/or other location descriptors which 
provide a verifiably unique location. The premises identification number 
may be used in conjunction with a producer's own livestock production 
numbering system to provide a unique identification number for an 
animal. The premises identification number may consist of:
    (1) The State's two-letter postal abbreviation followed by the 
premises' assigned number; or
    (2) A seven-character alphanumeric code, with the right-most 
character being a check digit. The check digit number is based upon the 
ISO 7064 Mod 36/37 check digit algorithm.
    Recognized slaughtering establishment. A slaughtering establishment 
\2\ operating under the Federal Meat Inspection Act (21 U.S.C. 601 et 
seq.) or a State inspected slaughtering establishment.
---------------------------------------------------------------------------

    \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.
    United States. All of the States.

[65 FR 18878, Apr. 10, 2000, as amended at 69 FR 64650, Nov. 8, 2004; 72 
FR 39306, July 18, 2007; 73 FR 54062, Sept. 18, 2008; 85 FR 4195, Jan. 
24, 2020]



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.

[[Page 350]]



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 81_CHRONIC WASTING DISEASE IN DEER, ELK, AND MOOSE--
Table of Contents



Sec.
81.1 Definitions.
81.2 Identification of deer, elk, and moose in interstate commerce.
81.3 General restrictions.
81.4 Issuance of certificates.
81.5 Movement of deer, elk, or moose through a State to another State.
81.6 Federal preemption of State and local laws and regulations with 
          respect to CWD.

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

    Source: 77 FR 35569, June 13, 2012, unless otherwise noted.



Sec.81.1  Definitions.

    These definitions are applicable to this part:
    Accredited veterinarian. A veterinarian approved by the 
Administrator in accordance with part 161 of this chapter to perform 
functions specified in subchapters B, C, and D of this chapter.
    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Animal. Any farmed or captive deer, elk, or moose.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Animal identification. A device or means of animal identification 
approved for use under this part by APHIS. Examples of animal 
identification devices that APHIS has approved are listed in Sec.55.25 
of this chapter.
    Animal identification number (AIN). A numbering system for the 
official identification of individual animals in the United States. The 
AIN contains 15 digits, with the first 3 being the country code (840 for 
the United States), the alpha characters USA, or the numeric code 
assigned to the manufacturer of the identification device by the 
International Committee on Animal Recording.
    APHIS employee. Any individual employed by the Animal and Plant 
Health Inspection Service who is authorized by the Administrator to do 
any work or perform any duty in connection with the control and 
eradication of disease.
    Cervid. All members of the family Cervidae and hybrids, including 
deer, elk, moose, caribou, reindeer, and related species. For the 
purposes of this part, the term ``cervid'' refers specifically to 
cervids susceptible to CWD. These are animals in the genera Odocoileus, 
Cervus, and Alces and their hybrids, i.e., deer, elk, and moose.
    Chronic wasting disease (CWD). A transmissible spongiform 
encephalopathy of cervids. Clinical signs in affected animals include, 
but are not limited to, loss of body condition, behavioral changes, 
excessive salivation, increased drinking and urination, depression, and 
eventual death.
    CWD Herd Certification Program. The Chronic Wasting Disease Herd 
Certification Program established in part 55 of this chapter.
    Deer, elk, and moose. All animals in the genera Odocoileus, Cervus, 
and Alces and their hybrids.
    Farmed or captive. Privately or publicly maintained or held for 
economic or other purposes within a perimeter fence or confined area, or 
captured from a wild population for interstate movement and release.
    National Uniform Eartagging System. A numbering system for the 
official identification of individual animals in the United States 
providing a nationally unique identification number for each animal. The 
National Uniform Eartagging System employs an eight-

[[Page 351]]

or nine-character alphanumeric format, consisting of a two-number State 
or territory code, followed by two or three letters and four additional 
numbers. Official APHIS disease control programs may specify which 
format to employ.
    Official animal identification. A device or means of animal 
identification approved for use under this part by APHIS to uniquely 
identify individual animals. Examples of approved official animal 
identification devices are listed in Sec.55.25 of this chapter. The 
official animal identification must include a nationally unique animal 
identification number that adheres to one of the following numbering 
systems:
    (1) National Uniform Eartagging System. The CWD program allows the 
use of either the eight-character or nine-character format for cervids.
    (2) Animal identification number (AIN).
    (3) Premises-based number system. The premises-based number system 
combines an official premises identification number (PIN), as defined in 
this section, with a producer's livestock production numbering system to 
provide a unique identification number. The PIN and the production 
number must both appear on the official tag.
    (4) Any other numbering system approved by the Administrator for the 
identification of animals in commerce.
    Premises identification number (PIN). A nationally unique number 
assigned by a State, Tribal, and/or Federal animal health authority to a 
premises that is, in the judgment of the State, Tribal, and/or Federal 
animal health authority, a geographically distinct location from other 
premises. The premises identification number is associated with an 
address, geospatial coordinates, and/or location descriptors which 
provide a verifiably unique location. The premises identification number 
may be used in conjunction with a producer's own livestock production 
numbering system to provide a unique identification number for an 
animal. It may also be used as a component of a group/lot identification 
number. The premises identification number may consist of:
    (1) The State's two-letter postal abbreviation followed by the 
premises' assigned number; or
    (2) A seven-character alphanumeric code, with the right-most 
character being a check digit. The check digit number is based upon the 
ISO 7064 Mod 36/37 check digit algorithm.
    Recognized slaughtering establishment. An establishment where 
slaughtering operations are regularly carried out under Federal or State 
inspection and which has been approved by the Animal and Plant Health 
Inspection Service to receive animals for slaughter.

[77 FR 35569, June 13, 2012, as amended at 79 FR 23891, Apr. 29, 2014]



Sec.81.2  Identification of deer, elk, and moose in interstate
commerce.

    Each animal required to be identified by this part must have at 
least two forms of animal identification attached to the animal. The 
means of animal identification must be approved for this use by APHIS, 
and must be an electronic implant, flank tattoo, ear tattoo, tamper-
resistant ear tag, or other device approved by APHIS. One of the animal 
identifications must be an official animal identification as defined in 
this part, with a nationally unique animal identification number that is 
linked to that animal in the CWD National Database or in an approved 
State database. The second animal identification must be unique for the 
individual animal within the herd and also must be linked to that animal 
and herd in the CWD National Database or in an approved State database.

(Approved by the Office of Management and Budget under control number 
0579-0237)



Sec.81.3  General restrictions.

    No farmed or captive deer, elk, or moose may be moved interstate 
unless it meets the requirements of this section.
    (a) Animals in the CWD Herd Certification Program. The captive deer, 
elk, or moose is:
    (1) Enrolled in the CWD Herd Certification Program and the herd has 
achieved Certified status in accordance with Sec.55.24 of this 
chapter; and
    (2) Is accompanied by a certificate issued in accordance with Sec.
81.4 that

[[Page 352]]

identifies its herd of origin and that states that the animal's herd has 
achieved Certified status and that the animal does not show clinical 
signs associated with CWD.
    (b) Animals captured for interstate movement and release. If the 
captive deer, elk, or moose was captured from a wild population for 
interstate movement and release, each animal must have two forms of 
animal identification, one of which is official animal identification, 
and the certificate issued in accordance with Sec.81.4 that 
accompanies the animal must state that the source population has been 
documented to be low risk for CWD, based on a CWD surveillance program 
in wild cervid populations that is approved by the State Government of 
the receiving State and by APHIS.
    (c) Animals moved to slaughter. The farmed or captive deer, elk, or 
moose must be moved directly to a recognized slaughtering establishment 
for slaughter, must have two forms of animal identification, one of 
which is official animal identification, and must be accompanied by a 
certificate issued in accordance with Sec.81.4.
    (d) Research animal movements and permits. A research animal permit 
is required for the interstate movement of cervids for research 
purposes. The permit will specify any special conditions of the movement 
determined by the Administrator to be necessary to prevent the 
dissemination of CWD. The Administrator may, at his or her discretion, 
issue the permit if he or she determines that the destination facility 
has adequate biosecurity and that the movement authorized will not 
result in the interstate dissemination of CWD.
    (1) To apply for a research animal permit, contact an APHIS employee 
or State representative and provide the following information:
    (i) The name and address of the person to whom the special permit is 
issued, the address at which the research cervids to be moved interstate 
are being held, and the name and address of the person receiving the 
cervids to be moved interstate;
    (ii) The number and type of cervids to be moved interstate;
    (iii) The reason for the interstate movement;
    (iv) Any safeguards in place to prevent transmission of CWD during 
movement or at the receiving location; and
    (v) The date on which movement will occur.
    (2) A copy of the research animal permit must accompany the cervids 
moved, and copies must be submitted so that a copy is received by the 
State animal health official and the veterinarian in charge for the 
State of destination at least 72 hours prior to the arrival of the 
cervids at the destination listed on the research animal permit.
    (e) Interstate movements approved by the Administrator. 
Notwithstanding any other provision of this part, interstate movement of 
farmed or captive deer, elk, and moose may be allowed on a case-by-case 
basis when the Administrator determines that adequate survey and 
mitigation procedures are in place to prevent dissemination of CWD and 
issues a permit for the movement.



Sec.81.4  Issuance of certificates.

    (a) Information required on certificates. A certificate must show 
any official animal identification numbers of each animal to be moved. A 
certificate must also show the number of animals covered by the 
certificate; the purpose for which the animals are to be moved; the 
points of origin and destination; the consignor; and the consignee. The 
certificate must include a statement by the issuing accredited 
veterinarian, State veterinarian, or Federal veterinarian that the 
animals were not exhibiting clinical signs associated with CWD at the 
time of examination. The certificate must also include a statement that 
the animals are from a herd that has achieved Certified status in the 
CWD Herd Certification Program, and must provide the herd's program 
status, with the following exceptions:
    (1) Certificates issued for animals captured from a wild population 
for interstate movement and release do not need to state that the 
animals are from a herd that has achieved Certified status in the CWD 
Herd Certification Program but must include the statement required in 
Sec.81.3(b); and

[[Page 353]]

    (2) Certificates issued for animals moved directly to slaughter do 
not need to state that the animals are from a herd that has achieved 
Certified status in the CWD Herd Certification Program and must state 
that an APHIS employee or State representative has been notified in 
advance of the date the animals are being moved to slaughter.
    (b) Animal identification documents attached to certificates. As an 
alternative to typing or writing individual animal identification on a 
certificate, another document may be used to provide this information, 
but only under the following conditions:
    (1) The document must be a State form or APHIS form that requires 
individual identification of animals;
    (2) A legible copy of the document must be stapled to the original 
and each copy of the certificate;
    (3) Each copy of the document must identify each animal to be moved 
with the certificate, but any information pertaining to other animals, 
and any unused space on the document for recording animal 
identification, must be crossed out in ink; and
    (4) The following information must be typed or written in ink in the 
identification column on the original and each copy of the certificate 
and must be circled or boxed, also in ink, so that no additional 
information can be added:
    (i) The name of the document; and
    (ii) Either the serial number on the document or, if the document is 
not imprinted with a serial number, both the name of the person who 
issued the document and the date the document was issued.

(Approved by the Office of Management and Budget under control number 
0579-0237)



Sec.81.5  Movement of deer, elk, or moose through a State to another
State.

    Farmed or captive deer, elk, or moose may be moved through a State 
or locality whose laws or regulations on the movement of those animals 
are more restrictive than this part to another State under the following 
conditions:
    (a) The farmed or captive deer, elk, or moose must be eligible to 
move interstate under Sec.81.3.
    (b) The farmed or captive deer, elk, or moose must meet the entry 
requirements of the destination State listed on the certificate or 
permit accompanying the animal.
    (c) Except in emergencies, the farmed or captive deer, elk, or moose 
must not be unloaded until their arrival at their destination.



Sec.81.6  Federal preemption of State and local laws and regulations
with respect to CWD.

    State and local laws and regulations on farmed or captive deer, elk, 
or moose with respect to CWD that are more restrictive than the 
regulations in this part are not preempted by this part, except as 
described in Sec.81.5.



PART 82_NEWCASTLE DISEASE AND CHLAMYDIOSIS--Table of Contents



                       Subpart A_Newcastle Disease

Sec.
82.1 Definitions.
82.2 Criteria for determining birds or poultry to be infected with, 
          exposed to, or free from Newcastle disease.
82.3 Quarantined areas.
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.

[[Page 354]]

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_Newcastle Disease

    Editorial Note: Nomenclature changes to subpart A of part 82 appear 
at 78 FR 19083, Mar. 29, 2013.



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.
    Commercial birds. Birds that are moved or kept for resale, breeding, 
public display, or any other purpose, except pet birds.
    Dressed carcasses. Carcasses of birds or poultry that have been 
eviscerated, with heads and feet removed, or parts or products of such 
carcasses.
    Exposed. At risk of developing Newcastle disease because of 
association with birds or poultry infected with Newcastle disease, 
excrement from birds or poultry infected with Newcastle disease, or 
other material touched by birds or poultry infected with Newcastle 
disease, or because there is reason to believe that association has 
occurred with Newcastle disease or vectors of Newcastle disease, as 
determined by either a Federal veterinarian or a State veterinarian.
    Federal representative. An individual employed and authorized by the 
Federal government to perform the tasks required by this subpart.
    Federal veterinarian. A veterinarian employed and authorized by the 
Federal government to perform the tasks required by this subpart.
    Hatching eggs. Eggs in which birds or poultry are allowed to 
develop.
    Infected. Affected by the virus or bacterium that causes the 
specified disease.
    Interstate. From one State into or through any other State.
    Known to be exposed. Determined by either a Federal veterinarian or 
a State veterinarian to be at risk of developing Newcastle disease 
because of association with birds or poultry infected with Newcastle 
disease, excrement from birds or poultry infected with Newcastle 
disease, or other material touched by birds or poultry infected with 
Newcastle disease, or because there is reason to believe that 
association has occurred with Newcastle disease or vectors of Newcastle 
disease, as determined by either a Federal veterinarian or a State 
veterinarian.
    Known to be infected. Determined by either a Federal veterinarian or 
a State veterinarian to be affected by the virus or bacterium that 
causes the specified disease.
    Litter. Material that is used to collect and absorb bodily wastes 
from birds or poultry.
    Moved. Shipped, transported or otherwise moved, or delivered or 
received for movement, by any person.
    Newcastle disease. Newcastle disease is an acute, rapidly spreading, 
and usually fatal viral infection of poultry caused by an avian 
paramyxovirus serotype 1 that meets one of the following criteria for 
virulence: The virus has an intracerebral pathogenicity index (ICPI) in 
day-old chicks (Gallus gallus) of 0.7 or greater; or multiple basic 
amino acids have been demonstrated in the virus (either directly or by 
deduction) at the C-terminus of the F2 protein and phenylalanine at 
residue 117, which is the N-terminus of the F1 protein. The term 
``multiple basic amino acids'' refers to at least three arginine or 
lysine residues between residues 113 and 116. In this definition, amino 
acid residues are numbered from the N-terminus of the amino acid 
sequence deduced from the nucleotide sequence of the F0 gene; 113-116 
corresponds to residues -4 to -1

[[Page 355]]

from the cleavage site. Failure to demonstrate the characteristic 
pattern of amino acid residues as described above may require 
characterization of the isolated virus by an ICPI test. A failure to 
detect a cleavage site that is consistent with virulent strains does not 
confirm the absence of a virulent virus.
    Official seal. A serially numbered metal or plastic strip, 
consisting of a self-locking device on one end and a slot on the other 
end, that forms a loop when the ends are engaged and that cannot be 
reused if opened, or a serially numbered, self-locking button that can 
be used for this purpose.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, joint stock company, or other legal entity.
    Pet birds. Birds, except ratites, that are kept for the personal 
pleasure of their individual owners and are not intended for resale.
    Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, 
partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys.
    Ratites. Cassowaries, emus, kiwis, ostriches, and rheas.
    Recognized slaughtering establishment. Any slaughtering facility 
operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), 
the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or State 
meat or poultry inspection acts.
    Render. Reduce, convert, or melt down by heating to a temperature of 
at least 230 [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.

[61 FR 56883, Nov. 5, 1996, as amended at 73 FR 30297, May 27, 2008; 74 
FR 18287, Apr. 22, 2009; 78 FR 19083, Mar. 29, 2013]



Sec.82.2  Criteria for determining birds or poultry to be infected 
with, exposed to, or free from Newcastle disease.

    (a) The determination that birds or poultry are infected with 
Newcastle disease 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 Newcastle disease); diagnostic tests; 
\2\ or epidemiological evidence (evaluation of clinical evidence and the 
degree of risk posed by the potential spread of Newcastle disease 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 Newcastle disease or with excrement from birds 
or poultry infected with Newcastle disease, or if the birds and poultry 
have shared feed or water with birds or poultry infected with Newcastle 
disease).
---------------------------------------------------------------------------

    \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 Newcastle disease 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 Newcastle 
disease must be made by either a Federal

[[Page 356]]

veterinarian or a State veterinarian. They will base that determination 
on an evaluation of all related circumstances, including: the proximity 
of the birds or poultry to birds or poultry infected with Newcastle 
disease, to excrement from birds or poultry infected with Newcastle 
disease, and to other material touched by birds or poultry infected with 
Newcastle disease; the number of birds or poultry infected with 
Newcastle disease to which the birds or poultry were exposed; the 
species involved; the virulence of the Newcastle disease to which the 
birds or poultry were exposed; and the length of time the birds or 
poultry were in contact with birds or poultry infected with Newcastle 
disease, and to material touched by birds or poultry infected with 
Newcastle disease. Birds or poultry determined to be exposed to 
Newcastle disease will continue to be treated as exposed unless they are 
subsequently determined to be infected with Newcastle disease or until 
either a Federal veterinarian or a State veterinarian finds them to be 
free of Newcastle disease based on one or more of the factors listed in 
---------------------------------------------------------------------------
paragraph (a) of this section.

(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 Newcastle disease 
are located will be designated as a quarantined area. A quarantined area 
is any geographical area, which may be a premises or all or part of a 
State, deemed by epidemiological evaluation to be sufficient to contain 
all birds or poultry known to be infected with or exposed to Newcastle 
disease. Less than an entire State will be designated as a quarantined 
area only if the State enforces restrictions on intrastate movements 
from the quarantined area that are at least as stringent as this 
subpart.
    (b) Any area designated as a quarantined area because of Newcastle 
disease will remain designated as a quarantined area until all of the 
requirements of Sec.82.14 have been met.
    (c) The following areas are quarantined because of Newcastle 
disease: There are no areas in the United States quarantined because of 
Newcastle disease.

[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 Newcastle disease, or are from a flock 
of birds or poultry infected with Newcastle disease;
    (2) Litter used by or manure generated by birds or poultry, or a 
flock of birds or poultry, infected with Newcastle disease, except as 
provided in Sec.82.7(b);
    (3) Any eggs from birds or poultry, or a flock of birds or poultry, 
infected with Newcastle disease;
    (4) Hatching eggs from flocks of birds or poultry exposed to 
Newcastle disease; and
    (5) Live birds or live poultry from flocks infected with or exposed 
to Newcastle disease.
    (b) Restrictions. The following articles may be moved interstate 
from a quarantined area only in accordance with this subpart:
    (1) Live birds or live poultry not known to be infected with or 
exposed to Newcastle disease;
    (2) Dressed carcasses of birds and poultry, and other dead birds and 
dead poultry, including any parts of the birds or poultry, that are not 
known to be infected with Newcastle disease;
    (3) Litter used by or manure generated by birds or poultry not known 
to be infected with Newcastle disease;
    (4) Eggs, other than hatching eggs, from birds or poultry from 
flocks not known to be infected with Newcastle disease;
    (5) Hatching eggs from birds or poultry not known to be infected 
with or exposed to Newcastle disease; and
    (6) Cages, coops, containers, troughs, vehicles, or other equipment 
used for birds, poultry, eggs, manure, or litter.

[[Page 357]]

    (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.

[61 FR 56883, Nov. 5, 1996, as amended at 73 FR 30297, May 27, 2008]



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 only if the birds are not known to be 
infected with or exposed to Newcastle disease and the following 
requirements are fulfilled:
    (1) Epidemiological and testing requirements. For all pet birds 
moved interstate, epidemiological evidence must indicate that the birds 
are not infected with any communicable disease.
    (i) Pet birds that have been under the control and ownership of the 
owner for at least 90 days. Pet birds that have been under the ownership 
and control of the individual to whom the permit is issued for the 90 
days before interstate movement, show no clinical signs of sickness 
(such as diarrhea, nasal discharge, ocular discharge, ruffled feathers, 
or lack of appetite) during the 90 days before interstate movement, and 
have been maintained apart from other birds and poultry in the 
quarantined area during the 90 days before interstate movement may be 
moved to a location outside the quarantined area for subsequent 
examination. The individual to whom the permit is issued must maintain 
ownership and control of the birds and maintain them apart from other 
birds and poultry from the time they arrive at the place to which the 
individual is taking them until a Federal representative or State 
representative \3\ examines the birds and determines that the birds show 
no clinical signs of Newcastle disease. The examination will not be less 
than 30 days after the interstate movement. The individual to whom the 
permit is issued must allow Federal representatives and State 
representatives to examine the birds at any time until they are declared 
free of Newcastle disease by either a Federal veterinarian or a State 
veterinarian.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (ii) All other pet birds. Pet birds that do not meet the criteria in 
paragraph (a)(2)(i) of this section may only be moved to a USDA-approved 
quarantine facility outside the quarantined area for a 30-day quarantine 
before being released. The individual to whom the permit is issued must 
maintain ownership and control of the birds and maintain them isolated 
from other birds or poultry until the time they arrive at the USDA-
approved quarantine facility. The pet bird owner is responsible for all 
costs associated for keeping his or her pet birds at the USDA-approved 
quarantine facility for the 30-day quarantine period.
    (2) Movement restrictions. All pet birds must be moved interstate 
from a quarantined area under the following conditions:
    (i) The birds are accompanied by a permit obtained in accordance 
with Sec.82.11.
    (ii) The birds are moved interstate by the individual to whom the 
permit is issued.
    (iii) The birds are caged while being moved interstate.
    (iv) Within 24 hours of a bird's dying or showing clinical signs of 
sickness (such as diarrhea, nasal discharge, ocular discharge, ruffled 
feathers, or lack of appetite), the individual to whom the permit is 
issued notifies the veterinarian in charge or the State animal health 
official \4\ in the State to which the birds are moved.
---------------------------------------------------------------------------

    \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 20737-1231, or by referring to the 
local telephone book.
---------------------------------------------------------------------------

    (v) The individual to whom the permit is issued submits copies of 
the permit so that a copy is received by the State animal health 
official and the veterinarian in charge for the State of

[[Page 358]]

destination within 72 hours of the arrival of the birds at the 
destination listed on the permit.
    (b) Other birds (including commercial birds) and poultry. Except as 
provided for pet birds in paragraph (a) of this section, a person may 
move live birds (including commercial birds) and live poultry that are 
not known to be infected with or exposed to Newcastle disease interstate 
from a quarantined area only if:
    (1) The birds and poultry are accompanied by a permit obtained in 
accordance with 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 or ratites, the poultry or ratites 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)

[61 FR 56883, Nov. 5, 1996, as amended at 73 FR 30297, May 27, 2008]



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 Newcastle disease 
may be moved interstate from a quarantined area only if:
    (1) The dead birds and dead poultry are accompanied by a permit 
obtained in accordance with 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 
Newcastle disease; and
    (7) Copies of the permit accompanying the dead birds and dead 
poultry interstate are submitted so that a copy is received by the State 
animal health official and the veterinarian in charge for the State of 
destination within 72 hours of the arrival of the dead birds and dead 
poultry at the destination listed on the permit required by paragraph 
(a)(1) of this section.
    (b) Dressed carcasses from birds and poultry that are not known to 
be infected with Newcastle disease may be moved interstate from a 
quarantined area only if:

[[Page 359]]

    (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 have been processed in one of the 
following ways:
    (i) They are packed in hermetically sealed containers and cooked by 
a commercial method after such packing to produce articles which are 
shelf-stable without refrigeration; or
    (ii) They have been thoroughly cooked and have a thoroughly cooked 
appearance throughout;
    (3) If the dressed carcasses are from poultry, the processing 
establishment that treats the dressed carcasses in accordance with 
paragraph (b)(2) of this section employs the following safeguards:
    (i) If receiving or handling any live poultry, there must be 
complete separation between the slaughter portion of the establishment 
and the portions of the establishment in which further processing takes 
place;
    (ii) If the plant processes dressed carcasses from both quarantined 
and nonquarantined areas, all areas, utensils, and equipment likely to 
contact the poultry carcasses to be processed, including skimming, 
deboning, cutting, and packing areas, are cleaned and disinfected in 
accordance with part 71 of this chapter between the processing of 
dressed poultry carcasses from the quarantined area and the processing 
of dressed poultry carcasses from nonquarantined areas;
    (iii) The dressed carcasses are stored in a manner that ensures that 
no cross-contamination with potentially infectious materials, such as 
raw or unprocessed products, occurs;
    (4) The dressed carcasses are accompanied by a permit obtained in 
accordance with Sec.82.11;
    (5) The dressed carcasses are moved in a means of conveyance either 
under official seal or accompanied by a Federal representative;
    (6) The dressed carcasses are not unloaded until their arrival at 
the destination listed on the permit required by paragraph (b)(4) of 
this section;
    (7) The dressed carcasses are moved, without stopping, to the 
destination listed on the permit required by paragraph (b)(4) of this 
section, except for normal traffic conditions, such as traffic lights 
and stop signs; and
    (8) Copies of the permit accompanying the dressed carcasses are 
submitted so that a copy is received by the State animal health official 
and the veterinarian in charge for the State of destination within 72 
hours of the arrival of the dressed carcasses at the destination listed 
on the permit required by paragraph (b)(4) of this section.

(Approved by the Office of Management and Budget under control number 
0579-0116)

[61 FR 56883, Nov. 5, 1996, as amended at 73 FR 30298, May 27, 2008]



Sec.82.7  Interstate movement of manure and litter from a quarantined
area.

    (a) Manure generated by and litter used by birds or poultry not 
known to be infected with Newcastle disease may be moved interstate from 
a quarantined area only if:
    (1) The manure and litter is accompanied by a permit obtained in 
accordance with Sec.82.11;
    (2) 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) or subjected to any other treatment approved by the 
Administrator as being adequate to prevent the dissemination of 
Newcastle disease, and then placed either in a previously unused 
container or in a container that has been cleaned and disinfected, since 
last being used, in accordance with part 71 of this chapter;
    (3) The declaration or affidavit required by 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
    (4) Copies of the permit accompanying the manure and litter 
interstate are submitted so that a copy is received by the State animal 
health official and the veterinarian in charge for the State of 
destination within 72 hours of the arrival of the manure and litter at 
the destination listed on the permit.
    (b) Compost derived from manure generated by and litter used by 
birds or

[[Page 360]]

poultry known to be infected with Newcastle disease may be moved 
interstate from a quarantined area only if:
    (1) The manure and litter is accompanied by a permit obtained in 
accordance with Sec.82.11;
    (2) All birds and poultry have been removed from the premises where 
the manure or litter is held;
    (3) After all birds are removed from the premises where the manure 
or litter is held, all manure and litter inside and outside the bird or 
poultry house remains undisturbed for at least 28 days before being 
moved from the infected premises for composting;
    (4) Composting is done at a site approved by the Administrator and 
under a protocol approved by the Administrator as being adequate to 
prevent the dissemination of Newcastle disease. All manure and litter 
from the infected premises must be moved to the composting site at the 
same time;
    (5) Following the composting process, the composted manure or litter 
remains undisturbed for an additional 15 days before movement;
    (6) After this 15-day period, all of the composted manure or litter 
from the infected site is removed at the same time;
    (7) The resulting compost must be transported either in a previously 
unused container or in a container that has been cleaned and 
disinfected, since last being used, in accordance with part 71 of this 
chapter;
    (8) The vehicle in which the resulting compost is to be transported 
has been cleaned and disinfected, since last being used, in accordance 
with part 71 of this chapter; and
    (9) Copies of the permit accompanying the compost derived from the 
manure and the litter are submitted so that a copy is received by the 
State animal health official and the veterinarian in charge for the 
State of destination within 72 hours of arrival of the compost at the 
destination listed on the permit.

[61 FR 56883, Nov. 5, 1996, as amended at 73 FR 30298, May 27, 2008]



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 Newcastle disease 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 9 
CFR part 590;
    (3) The establishment that processes the eggs, other than hatching 
eggs, for sale establishes procedures adequate to ensure that the eggs 
are free of Newcastle disease, including:
    (i) The establishment separates processing and layer facilities, the 
incoming and outgoing eggs at the establishment, and any flocks that may 
reside at the establishment;
    (ii) The establishment implements controls to ensure that trucks, 
shipping companies, or other visitors do not expose the processing plant 
to Newcastle disease;
    (iii) Equipment used in the establishment is cleaned and disinfected 
in accordance with part 71 of this chapter at intervals determined by 
the Administrator to ensure that the equipment cannot transmit Newcastle 
disease to the eggs, other than hatching eggs, being processed; and
    (iv) The eggs are packed either in previously unused flats or cases, 
or in used plastic flats that were cleaned or disinfected since last 
being used, in accordance with part 71 of this chapter;
    (4) The eggs are moved to a facility where they are examined to 
ensure they have been cleaned and sanitized in accordance with paragraph 
(a)(2) of this section; and
    (5) Copies of the permit accompanying the eggs interstate are 
submitted so that a copy is received by both the State animal health 
official and the veterinarian in charge for the State of destination 
within 72 hours of the arrival of the eggs at the facility.
    (b) Any flats or cases intended for reuse after being used to move 
eggs interstate to a facility under this section must be cleaned and 
disinfected in accordance with part 71 of this chapter

[[Page 361]]

before being moved to a premises where birds or poultry are kept.

[61 FR 56883, Nov. 5, 1996, as amended at 73 FR 30299, May 27, 2008]



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 Newcastle disease may be moved interstate from a quarantined 
area only if:
    (a) The hatching eggs are accompanied by a permit obtained in 
accordance with 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;
    (c) The hatching eggs have been kept in accordance with the 
sanitation practices specified in Sec. Sec.147.22 and 147.25 of the 
National Poultry Improvement Plan; and
    (d) The hatching eggs are held in the State of destination at a 
premises designated jointly by the veterinarian in charge and the State 
animal health official from the time of arrival until hatch and the 
birds and poultry hatched from the eggs are held at the designated 
premises for not less than 30 days following hatch. During this holding 
period, the eggs and any birds or poultry hatched from the eggs are 
subject to any inspections, disinfections, and tests as may be required 
by the Administrator to determine their freedom from Newcastle disease.

[61 FR 56883, Nov. 5, 1996, as amended at 73 FR 30299, May 27, 2008]



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, 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

[[Page 362]]

movement will not cause a risk of the spread of Newcastle disease.
    (e) Vehicles, cages, coops, containers, troughs, and other equipment 
that are moved interstate under this section must be accompanied by a 
permit obtained in accordance with 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 Newcastle disease. A special permit is required for 
the disposal of dead birds or dead poultry that are infected with 
Newcastle disease, or dead birds or dead poultry from flocks infected 
with Newcastle disease, or manure generated by or eggs from birds or 
poultry infected with Newcastle disease, in a manner other than is 
specifically prescribed in this subpart, and for cleaning and 
disinfection carried out in a manner other than is specifically 
prescribed in this subpart, under special conditions determined by the 
Administrator to be necessary to prevent the dissemination of Newcastle 
disease. To apply for a special permit, contact the veterinarian in 
charge \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 Newcastle disease.
---------------------------------------------------------------------------

    \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:

[[Page 363]]

    (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 Newcastle disease, or, in the case of a special permit, 
that the special permit is not required under this subpart, the 
Administrator may deny the request for a permit or special permit. If 
the request is denied, the Administrator will send the applicant a 
written notice explaining why the permit or special permit was denied.
    (b) Withdrawal. The Administrator may withdraw a permit or special 
permit, orally or in writing, if he or she determines the person to whom 
the permit or special permit has been issued is violating either this 
subpart or some condition specified in the permit or special permit. The 
Administrator may withdraw the permit or special permit without advance 
notice if he or she determines that the person to whom the permit or 
special permit has been issued is violating either this subpart or some 
condition specified in the permit or special permit in a way that 
threatens the public health, interest, or safety. The Administrator will 
send the person to whom the permit or special permit has been issued a 
written explanation of why the permit or special permit is to be or was 
withdrawn.
    (c) Appeals. Denial or withdrawal of a permit or special permit may 
be appealed to the Administrator within 10 days after receipt of the 
written notice of denial or withdrawal. The appeal must be in writing 
\10\ 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 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 Newcastle disease in the 
quarantined area have been found to be free of Newcastle disease;
    (b) All birds and poultry infected with Newcastle disease in the 
quarantined area have been euthanized;
    (c) All birds and poultry, including any parts of the birds and 
poultry, euthanized in accordance with paragraph (b) of this section, 
and all birds and poultry in the quarantined area,

[[Page 364]]

including any parts of the birds and poultry, that died from any cause 
other than slaughter, have been buried, reduced to ashes by 
incineration, rendered, or reduced to dust by composting:
    (1) If the birds and poultry are buried, all birds and poultry 
infected with Newcastle disease must be buried in the quarantined area. 
The birds and poultry must be buried in a location that meets all United 
States Environmental Protection Agency, State, and local requirements 
for landfills. They must be buried at least 6 feet deep and be covered 
at the time of burial with soil; and
    (2) If the birds and poultry are composted, all birds and poultry 
infected with Newcastle disease must be composted in the quarantined 
area. The birds and poultry must be composted according to the following 
instructions or according to another procedure approved by the 
Administrator as being adequate to prevent the dissemination of 
Newcastle disease:
    (i) Place a 1-foot layer of litter and manure in a free-standing 
composter bin, unless the compost pile will be covered in accordance 
with paragraph (c)(2)(ii) of this section. Add a 6-inch layer of straw, 
peanut hulls, or wood chips. Add a layer of dead birds or dead poultry, 
leaving 6 inches between the carcasses and the bin walls. Add water 
sparingly and cover with 6 inches of a dry mixture of litter and manure. 
Repeat the layering process two more times and cap with a double layer 
of dry manure cake. After the bin is capped off and covered, monitor the 
temperature in the compost pile daily, using a 36-inch probe-type 
thermometer. The temperature of the compost pile must reach at least 140 
[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 Newcastle disease in the quarantined area have been buried, reduced 
to ashes by incineration, or rendered. If the eggs are buried, the eggs 
must be buried in the quarantined area in a location that meets all 
United States Environmental Protection Agency requirements and all State 
and local requirements for landfills. The eggs must be buried at least 6 
feet deep and be covered at the time of burial with soil;
    (e) All manure generated by or litter used by birds or poultry 
infected with or exposed to Newcastle disease in the quarantined area 
has been reduced to ashes by incineration, or has been buried, 
composted, or spread on a field and turned under, as follows:
    (1) Burial. If the manure or litter is buried, the manure and litter 
must be buried at least 6 feet deep and covered at the time of burial 
with soil. The manure and litter must be buried in the quarantined area 
in a location that meets all United States Environmental Protection 
Agency and State and local requirements for landfills;
    (2) Composting. If the manure and litter is composted, the manure 
and litter must be composted in the quarantined area. The manure and 
litter must be composted according to the following method, or according 
to another procedure approved by the Administrator as being adequate to 
prevent the dissemination of Newcastle disease: Place the manure and 
litter in rows 3 to 5 feet

[[Page 365]]

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 Newcastle disease or their excrement or litter have had 
physical contact have been cleaned and disinfected in accordance with 
part 71 of this chapter. The vehicles have been inspected after 
cleaning, and before disinfection, by a Federal representative or State 
representative, and then have been disinfected in the presence of a 
Federal representative or State representative with a disinfectant 
listed in part 71 of this chapter;
    (g) All cages, coops, containers, troughs, and other equipment used 
for birds or poultry infected with or exposed to Newcastle disease, or 
their excrement or litter have been reduced to ashes by incineration, or 
have been cleaned and disinfected in accordance with part 71 of this 
chapter. The items must be inspected after cleaning, and before 
disinfection, by a Federal representative or State representative, and 
then must be disinfected in the presence of a Federal representative or 
State representative, with a disinfectant listed in part 71 of this 
chapter; and
    (h) The premises where birds or poultry infected with or exposed to 
Newcastle disease were located have been cleaned and disinfected in 
accordance with part 71 of this chapter. The premises have been 
inspected after cleaning, and before disinfection, by a Federal 
representative or State representative, and then have been disinfected 
in the presence of a Federal representative or State representative with 
a disinfectant listed in part 71 of this chapter.
    (i) After the other conditions of this section are fulfilled, an 
area will not be released from quarantine until followup surveillance 
over a period of time determined by the Administrator indicates 
Newcastle disease is not present in the quarantined area.

(Approved by the Office of Management and Budget under control number 
0579-0116)

[61 FR 56883, Nov. 5, 1996, as amended at 73 FR 30299, May 27, 2008]



Sec.82.15  Replacement birds and poultry.

    Birds and poultry that have been destroyed because of a quarantine 
for Newcastle disease may not be replaced by birds or poultry moved 
interstate into the quarantined area until the Administrator decides 
that Newcastle disease has been eradicated and that replacement birds or 
poultry will not become infected with Newcastle disease.



Sec.82.16  Extraordinary emergencies; applicability of regulations.

    When, in accordance with sec. 10407 of the Animal Health Protection 
Act (7

[[Page 366]]

U.S.C. 8306), the Secretary of Agriculture determines that an 
extraordinary emergency exists because of Newcastle disease, the 
regulations in this subpart regarding interstate movement shall be 
applicable to intrastate movement within any State or portion of a State 
subject to the Secretary's declaration of extraordinary emergency until 
such time as the Secretary terminates that declaration.

[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.



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

[[Page 367]]

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 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)

[[Page 368]]



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 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

[[Page 369]]

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

    Approved livestock market. A stockyard, livestock market, buying 
station, concentration point or any other premises under State or 
Federal veterinary supervision where swine are assembled for sale or 
sale purposes, and which has been approved by the Administrator under 
Sec.71.20 of this chapter. \2 3\
---------------------------------------------------------------------------

    \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.

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

[[Page 370]]

    Certificate. An official document issued by an Animal and Plant 
Health Inspection Service representative, State representative, or 
accredited veterinarian for and prior to the interstate movement of 
swine that are not known to be infected with or exposed to pseudorabies, 
and are not pseudorabies vaccinates, except for official gene-altered 
pseudorabies vaccinates vaccinated with a glycoprotein I (gpI) deleted 
gene-altered pseudorabies vaccine or from a qualified negative gene-
altered vaccinated herd. The document must state: (a) The number and 
description of the swine to be moved; (b) That the swine to be moved are 
not known to be infected with or exposed to pseudorabies; (c) The 
purpose for which the swine are to be moved; (d) The points of origin 
and destination; (e) The consignor and consignee; and (f) Any additional 
information required by this part.
    Common ground. The ground, areas, buildings or equipment communally 
shared by any specific group or groups of livestock.
    Contact. Direct access to other swine, their excrement, or 
discharges; or sharing a building with a common ventilation system with 
other swine, or being within ten feet of other swine if not sharing a 
building with a common ventilation system.
    Exposed livestock. Any livestock that has been in contact with an 
animal infected with pseudorabies, including all livestock in a known 
infected herd; except that livestock, other than swine, that have not 
been exposed to a clinical case of the disease for a period of 10 
consecutive days shall no longer be considered to be exposed livestock.
    Exposed swine. Any swine that has been in contact with an animal 
infected with pseudorabies, including all swine in a known infected 
herd.
    Farm of origin. A farm where the swine were born, or on which they 
have resided for at least 90 consecutive days immediately prior to the 
interstate shipment.
    Feedlot. A premises where swine are fed physically separated from 
swine kept for breeding or other purposes and from which such swine are 
moved directly to a recognized slaughtering establishment or directly 
through one or more slaughter markets and then directly to a recognized 
slaughtering establishment, quarantined herd, or quarantined feedlot.
    Herd. Any group of livestock maintained on common ground for any 
purpose, or two or more groups of livestock under common ownership or 
supervision, geographically separated, but which have an interchange or 
movement of animals without regard to whether the animals are infected 
with or exposed to pseudorabies.
    Infected livestock. Any livestock determined to be infected with 
pseudorabies by an official pseudorabies test, or diagnosed by an 
official pseudorabies epidemiologist as having pseudorabies.
    Interstate. From any State into or through any other State.
    Isolation. Separation of swine by a physical barrier in such a 
manner that other swine do not have access to the isolated swine's body, 
excrement, or discharges; not allowing the isolated swine to share a 
building with a common ventilation system with other swine; and not 
allowing the isolated swine to be within ten feet of other swine if not 
sharing a building with a common ventilation system.
    Known infected herd. Any herd in which any livestock has been 
determined to be infected with pseudorabies by an official pseudorabies 
test, an approved differential pseudorabies test, or diagnosed by an 
official pseudorabies epidemiologist as having pseudorabies.
    (a) A herd of livestock, other than swine, shall no longer be 
classified as a known infected herd after 10 days since the last 
clinical case of pseudorabies in the herd.
    (b) A herd of swine which has been released from pseudorabies 
quarantine in

[[Page 371]]

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\
---------------------------------------------------------------------------

    \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 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

[[Page 372]]

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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

    \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.
---------------------------------------------------------------------------

    Owner-shipper statement. A statement signed by the owner or shipper 
of swine which states: (a) The number of swine to be moved; (b) the 
points of origin and destination; (c) the consignor and consignee; and 
(d) any additional information required by this part.
    Permit. An official document issued for and prior to the interstate 
movement of pseudorabies infected, exposed or vaccinated swine under 
this part by an Animal and Plant Health Inspection Service 
representative, State representative, or an accredited veterinarian 
which states: (a) The number of swine to be moved; (b) the purpose for 
which the swine are to be moved; (c) the points of origin and 
destination; (d) the consignor and the consignee; and (e) any additional 
information required by this part.
    Pseudorabies. The contagious, infectious, and communicable disease 
of livestock and other animals also known as Aujeszky's disease, mad 
itch, or infectious bulbar paralysis.
    Pseudorabies controlled vaccinated herd. (a) Pseudorabies controlled 
vaccinated herd status is attained by subjecting all swine over 6 months 
of age to an official pseudorabies serologic

[[Page 373]]

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 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

[[Page 374]]

pseudorabies test conducted within 30 days of the first test shows them 
to be negative. If the results of the second test are negative, no 
additional testing is required before the herd may be vaccinated in 
accordance with paragraph (a)(3). If the results of the second test are 
positive, all swine that tested positive must be removed from the herd. 
Not less than 30 days after any positive swine are removed from the 
herd, all remaining swine in the herd, except suckling swine, must be 
tested with an official pseudorabies serologic test and found negative. 
Not less than 30 days after this negative test, the herd must be tested 
again in accordance with paragraph (a)(1).
    (3) Not more than 30 days after test results show the herd to be 
negative for pseudorabies in accordance with paragraph (a)(1), all swine 
in the herd over 6 months of age must be vaccinated with an official 
gene-altered pseudorabies vaccine. Only one official gene-altered 
pseudorabies vaccine may be used in the herd.
    (b) Any herd designated as a qualified pseudorabies negative herd 
may achieve new status as a qualified negative gene-altered vaccinated 
herd if all swine in the herd over 6 months of age are vaccinated with 
an official gene-altered pseudorabies vaccine. Only one official gene-
altered pseudorabies vaccine may be used in the herd.
    (c) Any herd in which no swine are known to be infected with or 
exposed to pseudorabies, and in which the only swine vaccinated for 
pseudorabies are official gene-altered pseudorabies vaccinates, may 
achieve status as a qualified negative gene-altered vaccinated herd 
under the following conditions:
    (1) Only one official gene-altered pseudorabies vaccine may be used 
in the herd.
    (2) All swine in the herd over 6 months of age must be tested with 
an approved differential pseudorabies test. For a minimum of 60 days 
before the test, the herd must not have been a known infected herd. 
During the 90 days before the test, at least 90 percent of the swine in 
the herd either must have been on the premises and a part of the herd or 
must have entered the herd directly from a qualified pseudorabies 
negative herd or a qualified negative gene-altered vaccinated herd. If 
any of the tested swine are found positive on this test, the 
requirements in paragraph (c)(3) must be met.
    (3) All swine positive on an approved differential pseudorabies test 
must be removed from the herd, or must be isolated until another 
approved differential pseudorabies test conducted within 30 days of the 
first test shows them to be negative. If the results of the second test 
are negative, no additional testing is required before the herd may be 
vaccinated in accordance with paragraph (c)(4). If the results of the 
second test are positive, all swine that tested positive must be removed 
from the herd. No less than 30 days after any negative swine are removed 
from the herd, all remaining swine in the herd, except suckling swine, 
must be tested with an approved differential pseudorabies test and found 
negative. No less than 30 days after this negative test, the herd must 
be tested again in accordance with paragraph (c)(2).
    (4) No more than 30 days after test results show the herd to be 
negative for pseudorabies in accordance with paragraph (c)(2), all swine 
in the herd over 6 months of age that are not already official gene-
altered pseudorabies vaccinates must be vaccinated with an official 
gene-altered pseudorabies vaccine. Only one official gene-altered 
pseudorabies vaccine may be used in the herd.
    (d) Qualified negative gene-altered vaccinated herd status is 
maintained under the following conditions:
    (1) All swine over 6 months of age in the herd must be official 
gene-altered pseudorabies vaccinates, and only one official gene-altered 
pseudorabies vaccine may be used in the herd.
    (2) All swine over 6 months of age in the herd must be tested at 
least once a year with an approved differential pseudorabies test and 
found negative; except that, if any swine are positive, the herd may 
maintain its status if the positive swine are isolated from the rest of 
the herd until they are found negative to a second approved differential 
pseudorabies test conducted within 30 days of the first. The requirement 
for annual testing of all swine in the herd over 6 months of age may be 
met by testing 25 percent of the swine over

[[Page 375]]

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 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

[[Page 376]]

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

    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

[[Page 377]]

in the official's State or his designated representative.
    State representative. A person regularly employed in animal health 
work of a State and who is authorized by such State to perform the 
function involved under a Cooperative Agreement with the United States 
Department of Agriculture.
    Swine not known to be infected with or exposed to pseudorabies. Any 
swine from a herd of swine in which no animal has been classified as a 
reactor to an official pseudorabies test, or has been diagnosed as 
having pseudorabies or suspected of having pseudorabies by a 
veterinarian; or any swine from a herd of swine which has been released 
from quarantine or has met the requirements of release from quarantine 
in accordance with the definition of known infected herd in 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]

    Editorial Note: For Federal Register citations affecting Sec.85.1, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfo.gov.



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]



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

[[Page 378]]

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. 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

[[Page 379]]

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 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(g) of this chapter, the swine are 
accompanied by an owner-shipper statement and are moved from a farm of 
origin directly to an approved livestock market; and
    (A) The owner-shipper statement is delivered to the consignee, and
    (B) The swine are identified at the approved livestock market to the 
farm of origin by the identification required by Sec.71.19 of this 
chapter.
    (ii) Unless the swine are moving interstate in a swine production 
system in compliance with Sec.71.19(g) of this chapter, the swine are 
accompanied by a certificate and such certificate is delivered to the 
consignee; the certificate, in addition to the information in 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

[[Page 380]]

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(g) of this chapter, the swine are 
accompanied by a certificate and such certificate is delivered to the 
consignee; and
    (2) The certificate, in addition to the information described in 
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; 69 FR 64651, Nov. 8, 2004]



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(g) of this chapter.
    (b) For all interstate movements other than those set forth in 
paragraph (a) of this section, the swine must be accompanied by a 
certificate, and the certificate must be delivered to the consignee. In 
addition to the information required by 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; 69 
FR 64651, Nov. 8, 2004]



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

[[Page 381]]

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 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 86_ANIMAL DISEASE TRACEABILITY--Table of Contents



Sec.
86.1 Definitions.
86.2 General requirements for traceability.
86.3 Recordkeeping requirements.
86.4 Official identification.
86.5 Documentation requirements for interstate movement of covered 
          livestock.
86.6-86.7 [Reserved]
86.8 Preemption.


[[Page 382]]


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

    Source: 78 FR 2071, Jan. 9, 2013, unless otherwise noted.



Sec.86.1  Definitions.

    Animal identification number (AIN). A numbering system for the 
official identification of individual animals in the United States that 
provides a nationally unique identification number for each animal. The 
AIN consists of 15 digits, with the first 3 being the country code (840 
for the United States or a unique country code for any U.S. territory 
that has such a code and elects to use it in place of the 840 code). The 
alpha characters USA or the numeric code assigned to the manufacturer of 
the identification device by the International Committee on Animal 
Recording may be used as an alternative to the 840 or other prefix 
representing a U.S. territory; however, only the AIN beginning with the 
840 or other prefix representing a U.S. territory will be recognized as 
official for use on AIN tags applied to animals on or after March 11, 
2015. The AIN beginning with the 840 prefix may not be applied to 
animals known to have been born outside the United States.
    Approved livestock facility. A stockyard, livestock market, buying 
station, concentration point, or any other premises under State or 
Federal veterinary inspection where livestock are assembled and that has 
been approved under Sec.71.20 of this chapter.
    Approved tagging site. A premises, authorized by APHIS, State, or 
Tribal animal health officials, where livestock may be officially 
identified on behalf of their owner or the person in possession, care, 
or control of the animals when they are brought to the premises.
    Commuter herd. A herd of cattle or bison moved interstate during the 
course of normal livestock management operations and without change of 
ownership directly between two premises, as provided in a commuter herd 
agreement.
    Commuter herd agreement. A written agreement between the owner(s) of 
a herd of cattle or bison and the animal health officials for the States 
or Tribes of origin and destination specifying the conditions required 
for the interstate movement from one premises to another in the course 
of normal livestock management operations and specifying the time 
period, up to 1 year, that the agreement is effective. A commuter herd 
agreement may be renewed annually.
    Covered livestock. Cattle and bison, horses and other equine 
species, poultry, sheep and goats, swine, and captive cervids.
    Dairy cattle. All cattle, regardless of age or sex or current use, 
that are of a breed(s) used to produce milk or other dairy products for 
human consumption, including, but not limited to, Ayrshire, Brown Swiss, 
Holstein, Jersey, Guernsey, Milking Shorthorn, and Red and Whites.
    Directly. Moved in a means of conveyance, without stopping to unload 
while en route, except for stops of less than 24 hours to feed, water, 
or rest the animals being moved, and with no commingling of animals at 
such stops.
    Flock-based number system. The flock-based number system combines a 
flock identification number (FIN) with a producer's unique livestock 
production numbering system to provide a nationally unique 
identification number for an animal.
    Flock identification number (FIN). A nationally unique number 
assigned by a State, Tribal, or Federal animal health authority to a 
group of animals that are managed as a unit on one or more premises and 
are under the same ownership.
    Group/lot identification number (GIN). The identification number 
used to uniquely identify a ``unit of animals'' of the same species that 
is managed together as one group throughout the preharvest production 
chain. When a GIN is used, it is recorded on documents accompanying the 
animals moving interstate; it is not necessary to have the GIN attached 
to each animal.
    Interstate certificate of veterinary inspection (ICVI). An official 
document issued by a Federal, State, Tribal, or accredited veterinarian 
certifying the inspection of animals in preparation for interstate 
movement.
    (a) The ICVI must show the species of animals covered by the ICVI; 
the number of animals covered by the ICVI; the

[[Page 383]]

purpose for which the animals are to be moved; the address at which the 
animals were loaded for interstate movement; the address to which the 
animals are destined; and the names of the consignor and the consignee 
and their addresses if different from the address at which the animals 
were loaded or the address to which the animals are destined. 
Additionally, unless the species-specific requirements for ICVIs provide 
an exception, the ICVI must list the official identification number of 
each animal, except as provided in paragraph (b) of this definition, or 
group of animals moved that is required to be officially identified, or, 
if an alternative form of identification has been agreed upon by the 
sending and receiving States, the ICVI must include a record of that 
identification. If animals moving under a GIN also have individual 
official identification, only the GIN must be listed on the ICVI. An 
ICVI may not be issued for any animal that is not officially identified 
if official identification is required. If the animals are not required 
by the regulations to be officially identified, the ICVI must state the 
exemption that applies (e.g., the cattle and bison do not belong to one 
of the classes of cattle and bison to which the official identification 
requirements of this part apply). If the animals are required to be 
officially identified but the identification number does not have to be 
recorded on the ICVI, the ICVI must state that all animals to be moved 
under the ICVI are officially identified.
    (b) As an alternative to typing or writing individual animal 
identification on an ICVI, if agreed to by the receiving State or Tribe, 
another document may be used to provide this information, but only under 
the following conditions:
    (1) The document must be a State form or APHIS form that requires 
individual identification of animals or a printout of official 
identification numbers generated by computer or other means;
    (2) A legible copy of the document must be stapled to the original 
and each copy of the ICVI;
    (3) Each copy of the document must identify each animal to be moved 
with the ICVI, but any information pertaining to other animals, and any 
unused space on the document for recording animal identification, must 
be crossed out in ink; and
    (4) The following information must be written in ink in the 
identification column on the original and each copy of the ICVI and must 
be circled or boxed, also in ink, so that no additional information can 
be added:
    (i) The name of the document; and
    (ii) Either the unique serial number on the document or, if the 
document is not imprinted with a serial number, both the name of the 
person who prepared the document and the date the document was signed.
    Interstate movement. From one State into or through any other State.
    Livestock. All farm-raised animals.
    Location-based numbering system. The location-based number system 
combines a State or Tribal issued location identification (LID) number 
or a premises identification number (PIN) with a producer's unique 
livestock production numbering system to provide a nationally unique and 
herd-unique identification number for an animal.
    Location identification (LID) number. A nationally unique number 
issued by a State, Tribal, and/or Federal animal health authority to a 
location as determined by the State or Tribe in which it is issued. The 
LID number may be used in conjunction with a producer's own unique 
livestock production numbering system to provide a nationally unique and 
herd-unique identification number for an animal. It may also be used as 
a component of a group/lot identification number (GIN).
    Move. To carry, enter, import, mail, ship, or transport; to aid, 
abet, cause, or induce carrying, entering, importing, mailing, shipping, 
or transporting; to offer to carry, enter, import, mail, ship, or 
transport; to receive in order to carry, enter, import, mail, ship, or 
transport; or to allow any of these activities.
    National Uniform Eartagging System (NUES). A numbering system for 
the official identification of individual animals in the United States 
that provides a nationally unique identification number for each animal.

[[Page 384]]

    Official eartag. An identification tag approved by APHIS that bears 
an official identification number for individual animals. Beginning 
March 11, 2014, all official eartags manufactured must bear an official 
eartag shield. Beginning March 11, 2015, all official eartags applied to 
animals must bear an official eartag shield. The design, size, shape, 
color, and other characteristics of the official eartag will depend on 
the needs of the users, subject to the approval of the Administrator. 
The official eartag must be tamper-resistant and have a high retention 
rate in the animal.
    Official eartag shield. The shield-shaped graphic of the U.S. Route 
Shield with ``U.S.'' or the State postal abbreviation or Tribal alpha 
code imprinted within the shield.
    Official identification device or method. A means approved by the 
Administrator of applying an official identification number to an animal 
of a specific species or associating an official identification number 
with an animal or group of animals of a specific species or otherwise 
officially identifying an animal or group of animals.
    Official identification number. A nationally unique number that is 
permanently associated with an animal or group of animals and that 
adheres to one of the following systems:
    (1) National Uniform Eartagging System (NUES).
    (2) Animal identification number (AIN).
    (3) Location-based number system.
    (4) Flock-based number system.
    (5) Any other numbering system approved by the Administrator for the 
official identification of animals.
    Officially identified. Identified by means of an official 
identification device or method approved by the Administrator.
    Owner-shipper statement. A statement signed by the owner or shipper 
of the livestock being moved stating the location from which the animals 
are moved interstate; the destination of the animals; the number of 
animals covered by the statement; the species of animal covered; the 
name and address of the owner at the time of the movement; the name and 
address of the shipper; and the identification of each animal, as 
required by the regulations, unless the regulations specifically provide 
that the identification does not have to be recorded.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, or joint stock company, or other legal entity.
    Premises identification number (PIN). A nationally unique number 
assigned by a State, Tribal, and/or Federal animal health authority to a 
premises that is, in the judgment of the State, Tribal, and/or Federal 
animal health authority a geographically distinct location from other 
premises. The PIN may be used in conjunction with a producer's own 
livestock production numbering system to provide a nationally unique and 
herd-unique identification number for an animal. It may be used as a 
component of a group/lot identification number (GIN).
    Recognized slaughtering establishment. Any slaughtering facility 
operating under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), 
the Poultry Products Inspection Act
    (21 U.S.C. 451 et seq.), or State meat or poultry inspection acts 
that is approved in accordance with 9 CFR 71.21.
    United States Department of Agriculture (USDA) approved backtag. A 
backtag issued by APHIS that provides a temporary unique identification 
for each animal.



Sec.86.2  General requirements for traceability.

    (a) The regulations in this part apply only to covered livestock, as 
defined in Sec.86.1.
    (b) No person may move covered livestock interstate or receive such 
livestock moved interstate unless the livestock meet all applicable 
requirements of this part.
    (c) The regulations in this part will apply to the movement of 
covered livestock onto and from Tribal lands only when the movement is 
an interstate movement; i.e., when the movement is across a State line.
    (d) In addition to meeting all applicable requirements of this part, 
all covered livestock moved interstate must

[[Page 385]]

be moved in compliance with all applicable provisions of APHIS program 
disease regulations (subchapter C of this chapter).
    (e) The interstate movement requirements in this part do not apply 
to the movement of covered livestock if:
    (1) The movement occurs entirely within Tribal land that straddles a 
State line and the Tribe has a separate traceability system from the 
States in which its lands are located; or
    (2) The movement is to a custom slaughter facility in accordance 
with Federal and State regulations for preparation of meat.



Sec.86.3  Recordkeeping requirements.

    (a) Official identification device distribution records. Any State, 
Tribe, accredited veterinarian, or other person or entity who 
distributes official identification devices must maintain for 5 years a 
record of the names and addresses of anyone to whom the devices were 
distributed.
    (b) Interstate movement records. Approved livestock facilities must 
keep any ICVIs or alternate documentation that is required by this part 
for the interstate movement of covered livestock that enter the facility 
on or after March 11, 2013. For poultry and swine, such documents must 
be kept for at least 2 years, and for cattle and bison, sheep and goats, 
cervids, and equines, 5 years.



Sec.86.4  Official identification.

    (a) Official identification devices and methods. The Administrator 
has approved the following official identification devices or methods 
for the species listed. The Administrator may authorize the use of 
additional devices or methods for a specific species if he or she 
determines that such additional devices or methods will provide for 
adequate traceability.
    (1) Cattle and bison. Cattle and bison that are required to be 
officially identified for interstate movement under this part must be 
identified by means of:
    (i) An official eartag; or
    (ii) Brands registered with a recognized brand inspection authority 
and accompanied by an official brand inspection certificate, when agreed 
to by the shipping and receiving State or Tribal animal health 
authorities; or
    (iii) Tattoos and other identification methods acceptable to a breed 
association for registration purposes, accompanied by a breed 
registration certificate, when agreed to by the shipping and receiving 
State or/Tribal animal health authorities; or
    (iv) Group/lot identification when a group/lot identification number 
(GIN) may be used.
    (2) Horses and other equine species. Horses and other equine species 
that are required to be officially identified for interstate movement 
under this part must be identified by one of the following methods:
    (i) A description sufficient to identify the individual equine 
including, but not limited to, name, age, breed, color, gender, 
distinctive markings, and unique and permanent forms of identification 
when present (e.g., brands, tattoos, scars, cowlicks, blemishes or 
biometric measurements). When the identity of the equine is in question 
at the receiving destination, the State or Tribal animal health official 
in the State or Tribe of destination or APHIS representative may 
determine if the description provided is sufficient; or
    (ii) Electronic identification that complies with ISO 11784/11785; 
or
    (iii) Non-ISO electronic identification injected to the equine on or 
before March 11, 2014; or
    (iv) Digital photographs sufficient to identify the individual 
equine; or
    (v) For equines being commercially transported to slaughter, a 
device or method authorized by 88 of this chapter.
    (3) Poultry. Poultry that are required to be officially identified 
for interstate movement under this part must be identified by one of the 
following methods:
    (i) Sealed and numbered leg bands in the manner referenced in the 
National Poultry Improvement Plan regulations (parts 145 through 147 of 
this chapter); or
    (ii) Group/lot identification when a group/lot identification number 
(GIN) may be used.
    (4) Sheep and goats. Sheep and goats that are required to be 
officially identified for interstate movement under

[[Page 386]]

this part must be identified by a device or method authorized by part 79 
of this chapter.
    (5) Swine. Swine that are required to be officially identified for 
interstate movement under this part must be identified by a device or 
method authorized by Sec.71.19 of this chapter.
    (6) Captive cervids. Captive cervids that are required to be 
officially identified for interstate movement under this part must be 
identified by a device or method authorized by part 77 of this chapter.
    (b) Official identification requirements for interstate movement--
(1) Cattle and bison. (i) All cattle and bison listed in paragraphs 
(b)(1)(iii)(A) through (b)(1)(iii)(D) of this section must be officially 
identified prior to the interstate movement, using an official 
identification device or method listed in paragraph (a)(1) of this 
section unless:
    (A) The cattle and bison are moved as a commuter herd with a copy of 
the commuter herd agreement or other documents as agreed to by the 
shipping and receiving States or Tribes. If any of the cattle or bison 
are shipped to a State or Tribe not included in the commuter herd 
agreement or other documentation, then these cattle or bison must be 
officially identified and documented to the original State of origin.
    (B) The cattle and bison are moved directly from a location in one 
State through another State to a second location in the original State.
    (C) The cattle and bison are moved interstate directly to an 
approved tagging site and are officially identified before commingling 
with cattle and bison from other premises or identified by the use of 
backtags or other methods that will ensure that the identity of the 
animal is accurately maintained until tagging so that the official 
eartag can be correlated to the person responsible for shipping the 
animal to the approved tagging site.
    (D) The cattle and bison are moved between shipping and receiving 
States or Tribes with another form of identification, as agreed upon by 
animal health officials in the shipping and receiving States or Tribes.
    (ii) Cattle and bison may also be moved interstate without official 
identification if they are moved directly to a recognized slaughtering 
establishment or directly to no more than one approved livestock 
facility and then directly to a recognized slaughtering establishment, 
where they are harvested within 3 days of arrival; and
    (A) They are moved interstate with a USDA-approved backtag; or
    (B) A USDA-approved backtag is applied to the cattle or bison at the 
recognized slaughtering establishment or federally approved livestock 
facility.
    (C) If a determination to hold the cattle or bison for more than 3 
days is made after the animals arrive at the slaughter establishment, 
the animals must be officially identified in accordance with Sec.
86.4(d)(4)(ii).
    (iii) Beginning on March 11, 2013, all cattle and bison listed below 
are subject to the official identification requirements of this section:
    (A) All sexually intact cattle and bison 18 months of age or over;
    (B) All female dairy cattle of any age and all dairy males born 
after March 11, 2013;
    (C) Cattle and bison of any age used for rodeo or recreational 
events; and
    (D) Cattle and bison of any age used for shows or exhibitions.
    (2) Sheep and goats. Sheep and goats moved interstate must be 
officially identified prior to the interstate movement unless they are 
exempt from official identification requirements under 9 CFR part 79 or 
are officially identified after the interstate movement, as provided in 
9 CFR part 79.
    (3) Swine. Swine moving interstate must be officially identified in 
accordance with Sec.71.19 of this chapter.
    (4) Horses and other equines. Horses and other equines moving 
interstate moved interstate must be officially identified prior to the 
interstate movement, using an official identification device or method 
listed in paragraph (a)(2) of this section unless:
    (i) They are used as the mode of transportation (horseback, horse 
and buggy) for travel to another location and then return direct to the 
original location.
    (ii) They are moved from the farm or stable for veterinary medical 
examination or treatment and returned to the same location without 
change in ownership.

[[Page 387]]

    (iii) They are moved directly from a location in one State through 
another State to a second location in the original State.
    (iv) They are moved between shipping and receiving States or Tribes 
with another form of identification as agreed upon by animal health 
officials in the shipping and receiving States or Tribes.
    (5) Poultry. Poultry moving interstate must be officially identified 
prior to interstate movement unless:
    (i) The shipment of poultry is from a hatchery to a redistributor or 
poultry grower and the person responsible for receiving the shipment 
maintains a record of the supplier; or
    (ii) The shipment is from a redistributor to a poultry grower and 
the person responsible for receiving the chicks maintains a record of 
the supplier of the chicks; or
    (iii) The poultry are identified as agreed upon by the States or 
Tribes involved in the movement.
    (6) Captive cervids. Captive cervids moving interstate must be 
officially identified prior to interstate movement in accordance with 
part 77 of this chapter.
    (c) Use of more than one official eartag. Beginning on March 13, 
2013, no more than one official eartag may be applied to an animal, 
except that:
    (1) Another official eartag may be applied providing it bears the 
same official identification number as an existing one.
    (2) In specific cases when the need to maintain the identity of an 
animal is intensified (e.g., such as for export shipments, quarantined 
herds, field trials, experiments, or disease surveys), a State or Tribal 
animal health official or an area veterinarian in charge may approve the 
application of an additional official eartag to an animal that already 
has one or more. The person applying the additional official eartag must 
record the following information about the event and maintain the record 
for 5 years: The date the additional official eartag is added; the 
reason for the additional official eartag device; and the official 
identification numbers of both the new official eartag and the one(s) 
already attached to the animal.
    (3) An eartag with an animal identification number (AIN) beginning 
with the 840 prefix (either radio frequency identification or visual-
only tag) may be applied to an animal that is already officially 
identified with one or more National Uniform Eartagging System tags and/
or an official vaccination eartag used for brucellosis. The person 
applying the AIN eartag must record the date the AIN tag is added and 
the official identification numbers of both official eartags and must 
maintain those records for 5 years.
    (4) A brucellosis vaccination eartag with a National Uniform 
Eartagging System number may be applied in accordance with part 78 of 
this chapter to an animal that is already officially identified with one 
or more official eartags under this part. The person applying the 
vaccination eartag must record the date the tag is added and the 
official identification numbers of both the existing official eartag(s) 
and the vaccination eartag and must maintain those records for 5 years.
    (d) Removal or loss of official identification devices. (1) Official 
identification devices are intended to provide permanent identification 
of livestock and to ensure the ability to find the source of animal 
disease outbreaks. Removal of these devices, including devices applied 
to imported animals in their countries of origin and recognized by the 
Administrator as official, is prohibited except at the time of 
slaughter, at any other location upon the death of the animal, or as 
otherwise approved by the State or Tribal animal health official or an 
area veterinarian in charge when a device needs to be replaced.
    (2) All man-made identification devices affixed to covered livestock 
unloaded at slaughter plants after moving interstate must be removed at 
the slaughter facility by slaughter-facility personnel with the devices 
correlated with the animal and its carcass through final inspection or 
condemnation by means approved by the Food Safety Inspection Service 
(FSIS). If diagnostic samples are taken, the identification devices must 
be packaged with the samples and be correlated with the carcasses 
through final inspection or condemnation by means approved by FSIS. 
Devices collected at slaughter

[[Page 388]]

must be made available to APHIS and FSIS by the slaughter plant.
    (3) All official identification devices affixed to covered livestock 
carcasses moved interstate for rendering must be removed at the 
rendering facility and made available to APHIS.
    (4) If an animal loses an official identification device and needs a 
new one: (i) A replacement tag with a different official identification 
number may be applied. The person applying a new official identification 
device with a different official identification number must record the 
following information about the event and maintain the record for 5 
years: The date the new official identification device was added; the 
official identification number on the device; and the official 
identification number on the old device if known.
    (ii) Replacement of a temporary identification device with a new 
official identification device is considered to be a retagging event, 
and all applicable information must be maintained in accordance with 
paragraph (d)(4)(i) of this section.
    (iii) A duplicate replacement eartag with the official number of the 
lost tag may be applied in accordance with APHIS' protocol for the 
administration of such tags.
    (e) Replacement of official identification devices for reasons other 
than loss. (1) Circumstances under which a State or Tribal animal health 
official or an area veterinarian in charge may authorize replacement of 
an official identification device include, but are not limited to:
    (i) Deterioration of the device such that loss of the device appears 
likely or the number can no longer be read;
    (ii) Infection at the site where the device is attached, 
necessitating application of a device at another location (e.g., a 
slightly different location of an eartag in the ear);
    (iii) Malfunction of the electronic component of a radio frequency 
identification (RFID) device; or
    (iv) Incompatibility or inoperability of the electronic component of 
an RFID device with the management system or unacceptable functionality 
of the management system due to use of an RFID device.
    (2) Any time an official identification device is replaced, as 
authorized by the State or Tribal animal health official or area 
veterinarian in charge, the person replacing the device must record the 
following information about the event and maintain the record for 5 
years:
    (i) The date on which the device was removed;
    (ii) Contact information for the location where the device was 
removed;
    (iii) The official identification number (to the extent possible) on 
the device removed;
    (iv) The type of device removed (e.g., metal eartag, RFID eartag);
    (v) The reason for the removal of the device;
    (vi) The new official identification number on the replacement 
device; and
    (vii) The type of replacement device applied.
    (f) Sale or transfer of official identification devices. Official 
identification devices are not to be sold or otherwise transferred from 
the premises to which they were originally issued to another premises 
without authorization by the Administrator or a State or Tribal animal 
health official.



Sec.86.5  Documentation requirements for interstate movement of 
covered livestock.

    (a) The persons responsible for animals leaving a premises for 
interstate movement must ensure that the animals are accompanied by an 
interstate certificate of veterinary inspection (ICVI) or other document 
required by this part for the interstate movement of animals.
    (b)(1) The APHIS representative, State or Tribal representative, or 
accredited veterinarian issuing an ICVI or other document required for 
the interstate movement of animals under this part must forward a copy 
of the ICVI or other document to the State or Tribal animal health 
official of the State or Tribe of origin within 7 calendar days from the 
date on which the ICVI or other document is issued. The State or Tribal 
animal health official in the State or Tribe of origin must forward a 
copy of the ICVI or other document to the State or Tribal animal health 
official the State or Tribe

[[Page 389]]

of destination within 7 calendar days from date on which the ICVI or 
other document is received.
    (2) The animal health official or accredited veterinarian issuing or 
receiving an ICVI or other interstate movement document in accordance 
with paragraph (b)(1) of this section must keep a copy of the ICVI or 
alternate documentation. For poultry and swine, such documents must be 
kept for at least 2 years, and for cattle and bison, sheep and goats, 
cervids, and equines, 5 years.
    (c) Cattle and bison. Cattle and bison moved interstate must be 
accompanied by an ICVI unless:
    (1) They are moved directly to a recognized slaughtering 
establishment, or directly to an approved livestock facility and then 
directly to a recognized slaughtering establishment, and they are 
accompanied by an owner-shipper statement.
    (2) They are moved directly to an approved livestock facility with 
an owner-shipper statement and do not move interstate from the facility 
unless accompanied by an ICVI.
    (3) They are moved from the farm of origin for veterinary medical 
examination or treatment and returned to the farm of origin without 
change in ownership.
    (4) They are moved directly from one State through another State and 
back to the original State.
    (5) They are moved as a commuter herd with a copy of the commuter 
herd agreement or other document as agreed to by the States or Tribes 
involved in the movement.
    (6) Additionally, cattle and bison may be moved between shipping and 
receiving States or Tribes with documentation other than an ICVI, e.g., 
a brand inspection certificate, as agreed upon by animal health 
officials in the shipping and receiving States or Tribes.
    (7) The official identification number of cattle or bison must be 
recorded on the ICVI or alternate documentation unless:
    (i) The cattle or bison are moved from an approved livestock 
facility directly to a recognized slaughtering establishment; or
    (ii) The cattle and bison are sexually intact cattle or bison under 
18 months of age or steers or spayed heifers; Except that: This 
exception does not apply to sexually intact dairy cattle of any age or 
to cattle or bison used for rodeo, exhibition, or recreational purposes.
    (d) Sheep and goats. Sheep and goats moved interstate must be 
accompanied by documentation as required by part 79 of this chapter.
    (e) Swine. Swine moved interstate must be accompanied by 
documentation in accordance with Sec.71.19 of this chapter or, if 
applicable, with part 85.
    (f) Horses and other equines. Horses and other equines moved 
interstate must be accompanied by an ICVI unless:
    (1) They are used as the mode of transportation (horseback, horse 
and buggy) for travel to another location and then return direct to the 
original location.
    (2) They are moved from the farm or stable for veterinary medical 
examination or treatment and returned to the same location without 
change in ownership.
    (3) They are moved directly from a location in one State through 
another State to a second location in the original State.
    (4) Additionally, equines may be moved between shipping and 
receiving States or Tribes with documentation other than an ICVI, e.g., 
an equine infectious anemia test chart, as agreed to by the shipping and 
receiving States or Tribes involved in the movement.
    (5) Equines moving commercially to slaughter must be accompanied by 
documentation in accordance with part 88 of this chapter. Equine 
infectious anemia reactors moving interstate must be accompanied by 
documentation as required by part 75 of this chapter.
    (g) Poultry. Poultry moved interstate must be accompanied by an ICVI 
unless:
    (1) They are from a flock participating in the National Poultry 
Improvement Plan (NPIP) and are accompanied by the documentation 
required under the NPIP regulations (parts 145 through 147 of this 
chapter) for participation in that program; or

[[Page 390]]

    (2) They are moved directly to a recognized slaughtering or 
rendering establishment; or
    (3) They are moved from the farm of origin for veterinary medical 
examination, treatment, or diagnostic purposes and either returned to 
the farm of origin without change in ownership or euthanized and 
disposed of at the veterinary facility; or
    (4) They are moved directly from one State through another State and 
back to the original State; or
    (5) They are moved between shipping and receiving States or Tribes 
with a VS Form 9-3 or documentation other than an ICVI, as agreed upon 
by animal health officials in the shipping and receiving States or 
Tribes.
    (6) They are moved under permit in accordance with part 82 of this 
chapter.
    (h) Captive cervids. Captive cervids moved interstate must be 
accompanied by documentation as required by part 77 of this chapter.



Sec. Sec.86.6-86.7  [Reserved]



Sec.86.8  Preemption.

    State, Tribal, and local laws and regulations may not specify an 
official identification device or method that would have to be used if 
multiple devices or methods may be used under this part for a particular 
species, nor may the State or Tribe of destination impose requirements 
that would otherwise cause the State or Tribe from which the shipments 
originate to have to develop a particular kind of traceability system or 
change its existing system in order to meet the requirements of the 
State or Tribe of destination.



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.
    Assembly point. Any facility, including auction markets, ranches, 
feedlots, and stockyards, in which equines are gathered in commerce.
    Commercial transportation. Movement for profit via conveyance on any 
highway or public road.
    Conveyance. Trucks, tractors, trailers, or semitrailers, or any 
combination of these, propelled or drawn by mechanical power.
    Equine. Any member of the Equidae family, which includes horses, 
asses, mules, ponies, and zebras.
    Equine for slaughter. Any member of the Equidae family being 
transferred to a slaughter facility, including an assembly point, 
feedlot, or stockyard.
    Euthanasia. The humane destruction of an animal by the use of an 
anesthetic agent or other means that causes painless loss of 
consciousness and subsequent death.
    Feedlot. Any facility which consolidates livestock for 
preconditioning, feeding, fattening, or holding before being sent to 
slaughter.
    Owner/shipper. Any individual, partnership, corporation, or 
cooperative association that engages in the commercial transportation of 
more than 20 equines per year to slaughtering facilities, except any 
individual or other entity who transports equines to slaughtering 
facilities incidental to his or her principal activity of production 
agriculture (production of food or fiber).
    Owner-shipper certificate. VS Form 10-13, \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.

[[Page 391]]

    Stallion. Any uncastrated male equine that is 1 year of age or 
older.
    Stockyard. Any place, establishment, or facility commonly known as 
stockyards, conducted, operated, or managed for profit or nonprofit as a 
public market for livestock producers, feeders, market agencies, and 
buyers, consisting of pens, or other enclosures, and their 
appurtenances, in which live cattle, sheep, swine, horses, mules, or 
goats are received, held, or kept for sale or shipment in commerce.
    USDA. The U.S. Department of Agriculture.
    USDA backtag. A backtag issued by APHIS that conforms to the eight-
character alpha-numeric National Backtagging System and that provides 
unique identification for each animal.
    USDA representative. Any employee of the USDA who is authorized by 
the Deputy Administrator for Veterinary Services of APHIS, USDA, to 
enforce this part.

[66 FR 63615, Dec. 7, 2001, as amended at 76 FR 55216, Sept. 7, 2011]



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 for slaughter is subject to the regulations in this 
part, a USDA representative may request from any individual or other 
entity who transported the equines information regarding the business of 
that individual or other entity. When such information is requested, the 
individual or other entity who transported the equines must provide the 
information within 30 days and in a format as may be specified by the 
USDA representative.

[66 FR 63615, Dec. 7, 2001, as amended at 76 FR 55216, Sept. 7, 2011]



Sec.88.3  Standards for conveyances.

    (a) The animal cargo space of conveyances used for the commercial 
transportation of equines for slaughter must:
    (1) Be designed, constructed, and maintained in a manner that at all 
times protects the health and well-being of the equines being 
transported (e.g., provides adequate ventilation, contains no sharp 
protrusions, etc.);
    (2) Include means of completely segregating each stallion and each 
aggressive equine on the conveyance so that no stallion or aggressive 
equine can come into contact with any of the other equines on the 
conveyance;
    (3) Have sufficient interior height to allow each equine on the 
conveyance to stand with its head extended to the fullest normal 
postural height; and
    (4) Be equipped with doors and ramps of sufficient size and location 
to provide for safe loading and unloading.
    (b) Equines for slaughter must not be transported in any conveyance 
that has the animal cargo space divided into two or more stacked levels, 
except that conveyances lacking the capability to convert from two or 
more stacked levels to one level may be used until December 7, 2006. 
Conveyances with collapsible floors (also known as ``floating decks'') 
must be configured to transport equines on one level only.

[66 FR 63615, Dec. 7, 2001, as amended at 76 FR 55216, Sept. 7, 2011]



Sec.88.4  Requirements for transport.

    (a) Prior to the commercial transportation of equines for slaughter, 
the owner/shipper must:
    (1) For a period of not less than 6 consecutive hours immediately 
prior to the equines being loaded on the conveyance, provide each equine 
appropriate food (i.e., hay, grass, or other food that would allow an 
equine in transit to maintain well-being), potable water, and the 
opportunity to rest;
    (2) Apply a USDA backtag \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

[[Page 392]]

slaughter and must include the following information, which must be 
typed or legibly completed in ink:
    (i) The owner/shipper's name, address, and telephone number;
    (ii) The receiver's (destination) name, address, and telephone 
number;
    (iii) The name of the auction/market, if applicable;
    (iv) A description of the conveyance, including the license plate 
number;
    (v) A description of the equine's physical characteristics, 
including such information as sex, breed, coloring, distinguishing 
markings, permanent brands, tattoos, and electronic devices that could 
be used to identify the equine;
    (vi) The number of the USDA backtag applied to the equine in 
accordance with paragraph (a)(2) of this section;
    (vii) A statement of fitness to travel at the time of loading, which 
will indicate that the equine is able to bear weight on all four limbs, 
able to walk unassisted, not blind in both eyes, older than 6 months of 
age, and not likely to give birth during the trip;
    (viii) A description of any preexisting injuries or other unusual 
condition of the equine, such as a wound or blindness in one eye, that 
may cause the equine to have special handling needs;
    (ix) The date, time, and place the equine was loaded on the 
conveyance; and
    (x) A statement that the equine was provided access to food, water, 
and rest prior to transport in accordance with paragraph (a)(1) of this 
section; and
    (4) Load the equines on the conveyance so that:
    (i) Each equine has enough floor space to ensure that no equine is 
crowded in a way likely to cause injury or discomfort; and
    (ii) Each stallion and any aggressive equines are completely 
segregated so that no stallion or aggressive equine can come into 
contact with any other equine on the conveyance.
    (b) During commercial transportation of equines for slaughter, the 
owner/shipper must:
    (1) Drive in a manner to avoid causing injury to the equines;
    (2) Observe the equines as frequently as circumstances allow, but 
not less than once every 6 hours, to check the physical condition of the 
equines and ensure that all requirements of this part are being 
followed. The owner/shipper must obtain veterinary assistance as soon as 
possible from an equine veterinarian for any equines in obvious physical 
distress. Equines that become nonambulatory en route must be euthanized 
by an equine veterinarian. If an equine dies en route, the owner/shipper 
must contact the nearest APHIS office as soon as possible and allow an 
APHIS veterinarian to examine the equine. If an APHIS veterinarian is 
not available, the owner/shipper must contact an equine veterinarian;
    (3) Offload from the conveyance any equine that has been on the 
conveyance for 28 consecutive hours and provide the equine appropriate 
food, potable water, and the opportunity to rest for at least 6 
consecutive hours; and
    (4) If offloading is required en route to the slaughtering facility, 
the owner/shipper must prepare another owner-shipper certificate as 
required by paragraph (a)(2) of this section and record the date, time, 
and location where the offloading occurred. In this situation, both 
owner-shipper certificates would need to accompany the equines for 
slaughter.
    (c) Handling of all equines for slaughter shall be done as 
expeditiously and carefully as possible in a manner that does not cause 
unnecessary discomfort, stress, physical harm, or trauma. Electric prods 
may not be used on equines for slaughter for any purpose, including 
loading or offloading on the conveyance, except when human safety is 
threatened.
    (d) At any point during the commercial transportation of equines for 
slaughter, a USDA representative may examine the equines, inspect the 
conveyance, or review the owner-shipper certificates required by 
paragraph (a)(3) of this section.
    (e) At any time during the commercial transportation of equines for 
slaughter, a USDA representative may direct the owner/shipper to take 
appropriate actions to alleviate the suffering of any equine. If deemed 
necessary by the USDA representative, such actions could include 
securing the services of

[[Page 393]]

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.

(Approved by the Office of Management and Budget under control numbers 
0579-0160 and 0579-0332)

[66 FR 63615, Dec. 7, 2001, as amended at 76 FR 55216, Sept. 7, 2011]



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)



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.

[[Page 394]]

 
\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 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 395]]



SUBCHAPTER D_EXPORTATION AND IMPORTATION OF ANIMALS (INCLUDING POULTRY) 
                           AND ANIMAL PRODUCTS





PART 91_EXPORTATION OF LIVE ANIMALS, HATCHING EGGS OR OTHER 
EMBRYONATED EGGS, ANIMAL SEMEN, ANIMAL EMBRYOS, AND GAMETES 
FROM THE UNITED STATES--Table of Contents



                      Subpart A_General Provisions

Sec.
91.1 Definitions.
91.2 Applicability.
91.3 General requirements.
91.4 Prohibited exports.

                           Subpart B_Livestock

91.5 Identification of livestock intended for export.
91.6 Cleaning and disinfection of means of conveyance, containers, and 
          facilities used during movement; approved disinfectants.
91.7 Pre-export inspection.
91.8 Rest, feed, and water at an export inspection facility associated 
          with the port of embarkation prior to export.
91.9 Ports.
91.10 Export inspection facilities.
91.11 Export isolation.
91.12 Ocean vessels.
91.13 Aircraft.
91.14 Other movements and conditions.

    Authority: 7 U.S.C. 8301-8317; 19 U.S.C. 1644a(c); 21 U.S.C. 136, 
136a, and 618; 7 CFR 2.22, 2.80, and 371.4.

    Source: 81 FR 2980, Jan. 20, 2016, unless otherwise noted.



                      Subpart A_General Provisions



Sec.91.1  Definitions.

    As used in this part, the following terms will have the meanings set 
forth in this section:
    Accredited veterinarian. A veterinarian approved by the 
Administrator in accordance with part 161 of this chapter to perform 
functions specified in parts 1, 2, 3, and 11 of subchapter A, and 
subchapters B, C, and D of this chapter, and to perform functions 
required by cooperative State-Federal disease control and eradication 
programs.
    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Animal. Any member of the animal kingdom (except a human).
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    APHIS representative. An individual who is authorized by APHIS to 
perform the function involved.
    Date of export. The date animals intended for export are loaded onto 
an ocean vessel or aircraft or, if moved by land to Canada or Mexico, 
the date the animals cross the border.
    Export health certificate. An official document issued in the United 
States that certifies that animals or other commodities listed on the 
certificate meet the export requirements of this part and the importing 
country.
    Export inspection facility. A facility that is affiliated with a 
port of embarkation and that has been approved by the Administrator as 
the location where APHIS will conduct health inspections of livestock 
before they are loaded onto ocean vessels or aircraft for export from 
the United States.
    Export isolation facility. A facility where animals intended for 
export are isolated from other animals for a period of time immediately 
before being moved for export.
    Horses. Horses, mules, and asses.
    Inspector. An individual authorized by APHIS to inspect animals and/
or animal products intended for export from the United States.
    Livestock. Horses, cattle (including American bison), captive 
cervids, sheep, swine, and goats, regardless of intended use.
    Premises of export. The premises where the animals intended for 
export are isolated as required by the importing country prior to export 
or, if the importing country does not require pre-export isolation, the 
farm or other premises where the animals are assembled for pre-export 
inspection and/or testing, or the germplasm is collected

[[Page 396]]

or stored, before being moved to a port of embarkation or land border 
port.
    Program diseases. Diseases for which there are cooperative State-
Federal programs and domestic regulations in subchapter C of this 
chapter.
    Program Handbook. A document that contains guidance and other 
information related to the regulations in this part. The Program 
Handbook is available on APHIS' import-export Web site (http://
www.aphis.usda.gov/ import_export/index.shtml).
    State of origin. The State in which the premises of export is 
located.



Sec.91.2  Applicability.

    You may not export any animal or animal germplasm from the United 
States except in compliance with this part.



Sec.91.3  General requirements.

    (a) Issuance of export health certificates. (1) Livestock must have 
an endorsed export health certificate in order to be eligible for export 
from the United States.
    (2) If APHIS knows that an importing country requires an export 
health certificate endorsed by the competent veterinary authority of the 
United States for any animal other than livestock or for any animal 
semen, animal embryos, hatching eggs, other embryonated eggs, or gametes 
intended for export to that country, the animal or other commodity must 
have an export health certificate endorsed by APHIS in order to be 
eligible for export from the United States.
    (b) Content of export health certificates--(1) Livestock; minimum 
requirements. Regardless of the requirements of the importing country, 
at a minimum, the following information must be contained on an export 
health certificate for livestock:
    (i) The species of each animal.
    (ii) The breed of each animal.
    (iii) The sex of each animal.
    (iv) The age of each animal.
    (v) The individual identification of the animals as required by 
Sec.91.5.
    (vi) The importing country.
    (vii) The consignor.
    (viii) The consignee.
    (ix) A certification that an accredited veterinarian inspected the 
livestock and found them to be fit for export.
    (x) A signature and date by an accredited veterinarian.
    (xi) An endorsement by the APHIS veterinarian responsible for the 
State of origin.
    (2) Livestock; additional requirements. In addition to the minimum 
requirements in paragraph (b)(1) of this section, the export health 
certificate must meet any other information or issuance requirements 
specified by the importing country.
    (3) Animals other than livestock, animal semen, animal embryos, 
hatching eggs, other embryonated eggs, and gametes. Export health 
certificates for animals other than livestock, animal semen, animal 
embryos, hatching eggs, other embryonated eggs, and gametes must meet 
any information requirements specified by the importing country.
    (c) Inspection requirements for livestock. In order to be eligible 
for export, livestock must be inspected within the timeframe required by 
the importing country. If the importing country does not specify a 
timeframe, the livestock must be inspected within 30 days prior to the 
date of export.
    (d) Testing requirements for livestock. All samples for tests of 
livestock that are required by the importing country must be taken by an 
APHIS representative or accredited veterinarian. The samples must be 
taken and tests made within the timeframe allowed by the importing 
country and, if specified, at the location required by the importing 
country. If the importing country does not specify a timeframe, the 
samples must be taken and tests made within 30 days prior to the date of 
export, except that tuberculin tests may be conducted within 90 days 
prior to the date of export. All tests for program diseases must be made 
in laboratories and using methods approved by the Administrator for 
those diseases. The Program Handbook contains a link to an APHIS Web 
site that lists laboratories approved to conduct tests for specific 
diseases. Approved methods are those specified or otherwise incorporated 
within the domestic regulations in subchapter C of this chapter.

[[Page 397]]

    (e) Movement of livestock, animals other than livestock, animal 
semen, animal embryos, hatching eggs, other embryonated eggs, or gametes 
with an export health certificate--(1) Livestock. An export health 
certificate for livestock must be issued and endorsed before the 
livestock move from the premises of export.
    (2) Animals other than livestock, animal semen, animal embryos, 
hatching eggs, other embryonated eggs, and gametes. When an export 
health certificate is required by the importing country for any animal 
other than livestock or for animal semen, animal embryos, hatching eggs, 
other embryonated eggs, or gametes, it must be issued and, if required 
by the importing country, endorsed by an APHIS representative prior to 
departure of the animal or other commodity from the port of embarkation 
or the crossing of the land border port. When presented for endorsement, 
the health certificate must be accompanied by reports for all laboratory 
tests specifically identified on the certificate. The laboratory reports 
must either be the originals prepared by the laboratory that performed 
the tests or must be annotated by the laboratory that performed the test 
to indicate how the reports may be verified.
    (f) Validity of export health certificate--(1) Livestock. Unless 
specified by the importing country, the export health certificate is 
valid for 30 days from the date of issuance, provided that the 
inspection and test results under paragraphs (c) and (d) of this section 
are still valid.
    (2) Animals other than livestock, animal semen, animal embryos, 
hatching eggs, other embryonated eggs, and gametes. Unless specified by 
the importing country, the export health certificate is valid for 30 
days from the date of issuance.

(Approved by the Office of Management and Budget under control number 
0579-0432)

[81 FR 2980, Jan. 20, 2016, as amended at 81 FR 74279, Oct. 26, 2016]



Sec.91.4  Prohibited exports.

    No animal, animal semen, animal embryos, hatching eggs, other 
embryonated eggs, or gametes under Federal, State, or local government 
quarantine or movement restrictions for animal health reasons may be 
exported from the United States unless the importing country issues an 
import permit or other written instruction allowing entry of the animal, 
animal semen, animal embryos, hatching eggs, other embryonated eggs, or 
gametes, and APHIS concurs with the export of the animal, animal semen, 
animal embryos, hatching eggs, other embryonated eggs, or gametes.



                           Subpart B_Livestock



Sec.91.5  Identification of livestock intended for export.

    Livestock that are intended for export must be identified in a 
manner that allows individual animals to be correlated to the animals 
listed in the export health certificate. If the importing country 
requires a specific or an additional form of identification, the 
livestock must also bear that form of identification.

(Approved by the Office of Management and Budget under control number 
0579-0432)



Sec.91.6  Cleaning and disinfection of means of conveyance,
containers, and facilities used during movement; approved
disinfectants.

    (a) All export health certificates for livestock must be accompanied 
by a statement issued by an APHIS representative and/or accredited 
veterinarian that the means of conveyance or container in which the 
livestock will be transported from the premises of export has been 
cleaned and disinfected prior to loading the livestock with a 
disinfectant approved by the Administrator for purposes of this section 
or by a statement that the means of conveyance or container was not 
previously used to transport animals.
    (b) Livestock moved for export may be unloaded only into a facility 
which has been cleaned and disinfected prior to such unloading with a 
disinfectant approved by the Administrator for purposes of this section, 
and has subsequently been inspected by an APHIS representative or 
accredited veterinarian. A statement certifying to such action must be 
attached to the export health certificate by the APHIS representative or 
accredited veterinarian.

[[Page 398]]

    (c) Approved disinfectants. The Administrator will approve a 
disinfectant for purposes of this section upon determining that the 
disinfectant is effective against pathogens that may be spread by the 
animals intended for export and, if the disinfectant is a chemical 
disinfectant, that it is registered or exempted for the specified use by 
the U.S. Environmental Protection Agency. The Program Handbook provides 
access to a list of disinfectants approved by the Administrator for use 
as required by this section. Other disinfectants may also be approved by 
the Administrator in accordance with this paragraph. The Administrator 
will withdraw approval of a disinfectant, and remove it from the list of 
approved disinfectants, if the disinfectant no longer meets the 
conditions for approval in this section.

(Approved by the Office of Management and Budget under control number 
0579-0432)



Sec.91.7  Pre-export inspection.

    (a) All livestock intended for export by air or sea must receive a 
visual health inspection from an APHIS veterinarian within 48 hours 
prior to embarkation, unless the importing country specifies otherwise. 
The purpose of the inspection is to determine whether the livestock are 
sound, healthy, and fit to travel. The APHIS veterinarian will reject 
for export any livestock that he or she finds unfit to travel. The owner 
of the animals or the owner's agent must make arrangements for any 
livestock found unfit to travel. Livestock that are unfit to travel 
include, but are not limited to:
    (1) Livestock that are sick, injured, weak, disabled, or fatigued;
    (2) Livestock that are unable to stand unaided or bear weight on 
each leg;
    (3) Livestock that are blind in both eyes;
    (4) Livestock that cannot be moved without causing additional 
suffering;
    (5) Newborn livestock with an unhealed navel;
    (6) Livestock that have given birth within the previous 48 hours and 
are traveling without their offspring;
    (7) Pregnant livestock that would be in the final 10 percent of 
their gestation period at the planned time of unloading in the importing 
country; and
    (8) Livestock with unhealed wounds from recent surgical procedures, 
such as dehorning.
    (b) The APHIS veterinarian must conduct the inspection at the export 
inspection facility associated with the port of embarkation of the 
livestock; at an export isolation facility, when authorized by the 
Administrator in accordance with paragraph (c) of this section; or at an 
export inspection facility other than the facility associated with the 
port of embarkation, when authorized by the Administrator in accordance 
with paragraph (d) of this section. Unless APHIS has authorized 
otherwise, any sorting, grouping, identification, or other handling of 
the livestock by the exporter must be done before this inspection. The 
APHIS veterinarian may also conduct clinical examination, including 
testing, of any livestock during or after this inspection if he or she 
deems it necessary in order to determine the animal's health. Any 
treatment related to this clinical examination performed on the animal 
must be performed by a licensed veterinarian. Finally, if the facility 
used to conduct the inspection is a facility other than the export 
inspection facility associated with the port of embarkation, it must be 
located within 28 hours driving distance under normal driving conditions 
from the port of embarkation; livestock must be afforded at least 48 
hours rest, with sufficient feed and water during that time period, 
prior to the pre-export inspection; and the exporter must maintain 
contact information for a veterinarian licensed in the State of 
embarkation to perform emergency medical services, as needed, on the 
animals intended for export.
    (c) Conditions for approval of pre-export inspection at an export 
isolation facility. (1) The Administrator may allow pre-export 
inspection of livestock to be conducted at an export isolation facility, 
rather than at an export inspection facility, when the exporter can show 
to the satisfaction of the Administrator that the livestock would suffer 
undue hardship if they had to be inspected at the export inspection 
facility, when the

[[Page 399]]

distance from the export isolation facility to the port of embarkation 
is significantly less than the distance from the export isolation 
facility to the export inspection facility associated with the port of 
embarkation, when inspection at the export isolation facility would be a 
more efficient use of APHIS resources, or for other reasons acceptable 
to the Administrator.
    (2) The Administrator's approval is contingent upon APHIS having 
personnel available to provide services at that location. Approval is 
also contingent upon the Administrator determining that the facility has 
space, lighting, and humane means of handling livestock sufficient for 
the APHIS personnel to safely conduct required inspections. The Program 
Handbook contains guidance on ways to meet these requirements. Owners 
and operators may submit alternative plans for meeting the requirements 
to APHIS for evaluation and approval. Alternatives must be at least as 
effective in meeting the requirements as those described in the Program 
Handbook in order to be approved. Alternate plans must be approved by 
APHIS before the facility may be used for purposes of this section.
    (d) The Administrator may allow pre-export inspection of livestock 
to be conducted at an export inspection facility other than the export 
inspection facility associated with the port of embarkation when the 
exporter can show to the satisfaction of the Administrator that the 
livestock would suffer undue hardship if they had to be inspected at the 
export inspection facility associated with the port of embarkation, when 
inspection at this different export inspection facility would be a more 
efficient use of APHIS resources, or for other reasons acceptable to the 
Administrator.
    (e) The APHIS veterinarian will maintain an inspection record that 
includes the date and place of the pre-export inspection, species and 
number of animals inspected, the number of animals rejected, a 
description of those animals, and the reasons for rejection.
    (f) If requested by the importing country or an exporter, the APHIS 
veterinarian who inspects the livestock will issue a certificate of 
inspection for livestock he or she finds to be sound, healthy, and fit 
to travel.



Sec.91.8  Rest, feed, and water at an export inspection facility
associated with the port of embarkation prior to export.

    All livestock that are intended for export by air or sea and that 
will be inspected for export at an export inspection facility associated 
with the port of embarkation must be allowed a period of at least 2 
hours rest at an export inspection facility prior to being loaded onto 
an ocean vessel or aircraft for export. Adequate food and water must be 
available to the livestock during the rest period. An inspector may 
extend the required rest period up to 5 hours, at his or her discretion 
and based on a determination that more rest is needed in order to have 
assurances that the animals are fit to travel prior to loading. Pre-
export inspection of the animals must take place at the conclusion of 
this rest period.



Sec.91.9  Ports.

    (a) Except as provided in paragraph (b) of this section, livestock 
exported by air or sea may be exported only through ports designated as 
ports of embarkation by the Administrator. Any port that has an export 
inspection facility that meets the requirements of Sec.91.10 
permanently associated with it is designated as a port of embarkation. 
The Program Handbook contains a list of designated ports of embarkation. 
A list may also be obtained from a Veterinary Services area office. 
Information on area offices is available on APHIS' import-export Web 
site (http://www.aphis.usda.gov/import _export/index.shtml).
    (b) The Administrator may approve other ports for the exportation of 
livestock on a temporary basis with the concurrence of the port 
director. The Administrator will grant such temporary approvals only for 
a specific shipment of livestock, and only if pre-export inspection of 
that shipment has occurred at an export isolation facility or an export 
inspection facility not associated with the port of embarkation, as 
provided in Sec.91.7.
    (c) Temporarily approved ports of embarkation will not be added to 
the

[[Page 400]]

list of designated ports of embarkation and are only approved for the 
time period and shipment conditions specified by APHIS at the time of 
approval.

(Approved by the Office of Management and Budget under control number 
0579-0432)



Sec.91.10  Export inspection facilities.

    (a) Export inspection facilities must be approved by the 
Administrator before they may be used for any livestock intended for 
export. The Administrator will approve an export inspection facility 
upon determining that it meets the requirements in paragraph (b) of this 
section. This approval remains in effect unless it is revoked in 
accordance with paragraph (c) of this section, or unless any of the 
following occur, in which case reapproval must be sought:
    (1) The owner of the facility changes.
    (2) Significant damage to the facility occurs or significant 
structural changes are made to the facility.
    (b)(1) Export inspection facilities must be constructed, equipped, 
and managed in a manner that prevents transmission of disease to and 
from livestock in the facilities, provides for the safe and humane 
handling and restraint of livestock, and provides sufficient offices, 
space, and lighting for APHIS veterinarians to safely conduct required 
health inspections of livestock and related business. The Program 
Handbook contains guidance on ways to meet these requirements. Owners 
and operators may submit alternative plans for meeting the requirements 
to APHIS for evaluation and approval; the address to which to submit 
such alternatives is contained in the Program Handbook. Alternatives 
must be at least as effective in meeting the requirements as the methods 
described in the Program Handbook in order to be approved. Alternatives 
must be approved by APHIS before being used for purposes of this 
section.
    (2) For the purposes of approval or a subsequent audit, APHIS 
representatives must have access to all areas of the facility during the 
facility's business hours to evaluate compliance with the requirements 
of this section.
    (3) The application for approval of an export inspection facility 
must be accompanied by a certification from the authorities having 
jurisdiction over environmental affairs in the locality of the facility. 
The certification must state that the facility complies with any 
applicable requirements of the State and local governments, and the U.S. 
Environmental Protection Agency regarding disposal of animal wastes.
    (c) The Administrator will deny or revoke approval of an export 
inspection facility for failure to meet the requirements in paragraph 
(b) of this section.
    (1) APHIS will conduct site inspections of approved export 
inspection facilities at least once a year for continued compliance with 
the standards. If a facility fails to pass the inspection, the 
Administrator may revoke its approval. If the Administrator revokes 
approval for a facility that serves a designated port of embarkation, 
the Administrator may also remove that port from the list of designated 
ports of embarkation.
    (2) APHIS will provide written notice of any proposed denial or 
revocation to the operator of the facility, who will be given an 
opportunity to present his or her views on the issues before a final 
decision is made. The notice will list any deficiencies in detail. APHIS 
will provide notice of pending revocations at least 60 days before the 
revocation is scheduled to take effect, but may suspend facility 
operations before that date and before any consideration of objections 
by the facility operator if the Administrator determines the suspension 
is necessary to protect animal health or public health, interest, or 
safety. The operator of any facility whose approval is denied or revoked 
may request another inspection after remedying the deficiencies.



Sec.91.11  Export isolation.

    If an importing country requires export isolation for livestock, 
such isolation must occur before the animals may be moved to a port of 
embarkation, and both the manner in which this isolation occurs and the 
facility at which it occurs must meet the requirements specified by the 
importing country.



Sec.91.12  Ocean vessels.

    (a) Inspection of the ocean vessel--(1) Certification to carry 
livestock. Ocean vessels must be certified by APHIS

[[Page 401]]

prior to initial use to transport any livestock from the United States. 
The owner or the operator of the ocean vessel must make arrangements 
prior to the vessel's arrival at a designated port of embarkation in the 
United States for an APHIS representative to inspect the vessel while it 
is at that port of embarkation. Alternatively, at the discretion of the 
Administrator and upon request of the exporter, transporting company, or 
their agent, the inspection may be done at a foreign port. If APHIS 
determines that the ocean vessel meets the requirements of paragraph (d) 
of this section, APHIS will certify the vessel to transport livestock 
from the United States. APHIS may certify a vessel that does not meet 
all of the requirements in paragraph (d), provided that an exemption 
from the requirements the vessel does not meet has been granted to the 
vessel pursuant to paragraph (e) of this section. The certification will 
specify the species of livestock for which the vessel is approved. The 
certification will be valid for up to 3 years; however, the ocean vessel 
must be recertified prior to transporting livestock any time significant 
changes are made to the vessel, including to livestock transport spaces 
or life support systems; any time a major life support system fails; any 
time species of livestock not covered by the existing certification are 
to be transported; and any time the owner or operator of the ocean 
vessel changes. The owner or operator of the vessel must present the 
following documentation to APHIS prior to its initial inspection for 
certification and when requested by APHIS prior to subsequent 
inspections for recertification:
    (i) General information about the vessel, including year built, 
length and breadth, vessel name history, port of registry, call sign, 
maximum and average speed, fresh water tank capacity and fresh water 
generation rate, and feed silo capacity (if the vessel has a silo);
    (ii) A notarized statement from an engineer concerning the rate of 
air exchange in each compartment of the vessel;
    (iii) The species of livestock that the vessel would transport;
    (iv) Scale drawings that provide details of the design, materials, 
and methods of construction and arrangement of fittings for the 
containment and movement of livestock; provisions for the storage and 
distribution of feed and water; drainage arrangements; primary and 
secondary sources of power; and lighting;
    (v) A photograph of the rails and gates of any pens;
    (vi) A description of the flooring surface on the livestock decks; 
and
    (vii) The following measurements: Width of the ramps; the clear 
height from the ramps to the lowest overhead structures; the incline 
between the ramps and the horizontal plane; the distance between 
footlocks on the ramps; the height of side fencing on the ramps; the 
height of the vessel's side doors through which livestock are loaded; 
the width of alleyways running fore and aft between livestock pens; and 
the distance from the floor of the livestock pens to the beams or lowest 
structures overhead.
    (2) Prior to each voyage. Prior to loading any livestock intended 
for export from the United States, an APHIS representative must inspect 
the vessel to confirm that the ocean vessel has been adequately cleaned 
and disinfected as required by paragraph (b) of this section, has 
sufficient food and water for the voyage as required by paragraph (c) of 
this section, and continues to meet the requirements of paragraph (d) of 
this section. APHIS will schedule the inspection after the owner or 
operator of the ocean vessel provides the following information:
    (i) The name of the ocean vessel;
    (ii) The port, date, and time the ocean vessel will be available for 
inspection, and estimated time that loading will begin;
    (iii) A description of the livestock to be transported, including 
the type, number, and estimated average weight of the livestock;
    (iv) Stability data for the ocean vessel with livestock on board;
    (v) The port of discharge; and
    (vi) The route and expected length of the voyage.

[[Page 402]]

    (3) The information in paragraphs (a)(2)(i) through (a)(2)(vi) must 
be provided at least 72 hours before the vessel will be available for 
inspection.
    (b) Cleaning and disinfection. (1) Any ocean vessel intended for use 
in exporting livestock, and all fittings, utensils, containers, and 
equipment (unless new) used for loading, stowing, or other handling of 
livestock aboard the vessel must be thoroughly cleaned and disinfected 
to the satisfaction of an APHIS representative prior to any livestock 
being loaded. The disinfectant must be approved by the Administrator. 
Guidance on cleaning and disinfecting ocean vessels may be found in the 
Program Handbook.
    (2) The Administrator will approve a disinfectant for the purposes 
of this paragraph upon determining that the disinfectant is effective 
against pathogens that may be spread by the animals and, if the 
disinfectant is a chemical disinfectant, that it is registered or 
exempted for the specified use by the U.S. Environmental Protection 
Agency. The Program Handbook provides access to a list of disinfectants 
approved by the Administrator. Other disinfectants may also be approved 
by the Administrator in accordance with this paragraph. The 
Administrator will withdraw approval of a disinfectant, and remove it 
from the list of approved disinfectants in the Program Handbook, if the 
disinfectant no longer meets the conditions for approval in this 
section.
    (3) All ocean vessels, upon docking at a U.S. port to load 
livestock, must have disinfectant foot baths at entryways where persons 
board and exit the ocean vessel, and require such baths before allowing 
any person to disembark.
    (c) Feed and water. Sufficient feed and water must be provided to 
livestock aboard the ocean vessel, taking into consideration the 
livestock's species, body weight, the expected duration of the voyage, 
and the likelihood of adverse climatic conditions during transport. 
Guidance on this requirement may be found in the Program Handbook. 
Livestock aboard the vessel must be provided feed and water within 28 
hours of the time they were last fed and watered within the United 
States.
    (d) Accommodations for the humane transport of livestock; general 
requirements. Ocean vessels used to transport livestock intended for 
export must be designed, constructed, and managed to reasonably assure 
the livestock are protected from injury and remain healthy during 
loading and transport to the importing country. Except as provided below 
in paragraph (e) of this section, no livestock may be loaded onto an 
ocean vessel unless, in the opinion of an APHIS representative, the 
ocean vessel meets the requirements of this section. The Program 
Handbook contains guidance on ways to meet the requirements. Owners and 
operators may submit alternative means and methods for meeting the 
requirements to APHIS for evaluation and approval. Alternatives must be 
at least as effective in meeting the requirements as those described in 
the Program Handbook in order to be approved. Alternatives must be 
approved by APHIS before being used for purposes of this section.
    (1) Pens. All pens, including gates and portable rails used to close 
access ways, must be designed and constructed of material of sufficient 
strength to securely contain the livestock. They must be properly 
formed, closely fitted, and rigidly secured in place. They must have 
smooth finished surfaces free from sharp protrusions. They must not have 
worn, decayed, unsound, or otherwise defective parts. Flooring must be 
strong enough to support the livestock to be transported and provide a 
satisfactory non-slip foothold. Pens on exposed upper decks must protect 
the livestock from the weather. Pens next to engine or boiler rooms or 
similar sources of heat must be fitted to protect the livestock from 
injury due to transfer of heat to the livestock or livestock transport 
spaces. Any fittings or protrusions from the vessel's sides that abut 
pens must be covered to protect the livestock from injury. Pens must be 
of appropriate size for the species, size, weight, and condition of the 
livestock being transported and take into consideration the vessel's 
route. Animals that may be hostile to each other may not be housed in 
the same pen.

[[Page 403]]

    (2) Positioning. Livestock must be positioned during transport so 
that an animal handler or other responsible person can observe each 
animal regularly and clearly to ensure the livestock's safety and 
welfare.
    (3) Resources for sick or injured animals. The vessel must have an 
adequate number of appropriately sized and located pens set aside to 
segregate livestock that become sick or injured from other animals. It 
must also have adequate veterinary medical supplies, including 
medicines, for the species, condition, and number of livestock 
transported.
    (4) Ramps, doors, and passageways. Ramps, doors, and passageways 
used for livestock must be of sufficient width and height for their use 
and allow the safe passage of the species transported. They must have 
secure, smooth fittings free from sharp protrusions and non-slip 
flooring, and must not have worn, decayed, unsound, or otherwise 
defective parts. Ramps must not have an incline that is excessive for 
the species of livestock transported and must be fitted with foot 
battens to prevent slippage at intervals suitable for the species. The 
sides of ramps must be of sufficient height and strength to prevent 
escape of the species of livestock transported.
    (5) Feed and water. The feeding and watering system must be designed 
to permit all livestock in each pen adequate access to feed and water. 
The system must also be designed to minimize soiling of pens and to 
prevent animal waste from contaminating feed and water. Similarly, feed 
must be loaded and stored aboard the vessel in a manner that protects it 
from weather and sea water and, if kept under animal transport spaces, 
protects it from spillage from animal watering and feeding and from 
animal waste. If the normal means of tending, feeding, and watering of 
livestock on board the ocean vessel is wholly or partially by automatic 
means, the vessel must have alternative arrangements for the 
satisfactory tending, feeding, and watering of the animals in the event 
of a malfunction of the automatic means.
    (6) Ventilation. Ventilation during loading, unloading, and 
transport must provide fresh air and remove excessive heat, humidity, 
and noxious fumes (such as ammonia and carbon dioxide). Ventilation must 
be adequate for variations in climate and weather and to meet the needs 
of the livestock being transported. Ventilation must be effective both 
when the vessel is stationary and when it is moving and must be turned 
on when the first animal is loaded. The vessel must have on board a 
back-up ventilation system (including emergency power supply) in good 
working order or replacement parts and the means, including qualified 
personnel, to make the repairs or replacements.
    (7) Waste management. The vessel must have a system or arrangements, 
including a backup system in working order or alternate arrangements, 
for managing waste to prevent excessive buildup in livestock transport 
spaces during the voyage.
    (8) Lighting. The vessel must have adequate illumination to allow 
clear observation of livestock during loading, unloading, and transport.
    (9) Bedding. Bedding must be loaded and stored aboard the vessel in 
a manner that protects it from weather and sea water and, if kept under 
animal transport spaces, protects it from spillage from animal watering 
and feeding and from animal waste.
    (10) Cleaning. The vessel must be designed and constructed to allow 
thorough cleaning and disinfection and to prevent feces and urine from 
livestock on upper levels from soiling livestock or their feed or water 
on lower levels.
    (11) Halters and ropes. Halters, ropes, or other equipment provided 
for the handling and tying of horses or other livestock must be 
satisfactory to ensure the humane treatment of the livestock.
    (12) Personnel. The owner or operator of the ocean vessel must have 
on board during loading, transport, and unloading at least 3 persons (or 
at least 1 person if fewer than 800 head of livestock will be 
transported) with previous experience with ocean vessels that have 
handled the kind(s) of livestock to be carried, as well as a sufficient 
number of personnel with the appropriate experience to be able to ensure 
proper care

[[Page 404]]

of the livestock. The APHIS representative assigned to inspect the ocean 
vessel prior to loading will determine whether the personnel aboard the 
vessel are sufficient and possess adequate experience, including, if 
necessary, veterinary experience, to ensure proper care of the 
livestock.
    (13) Vessel stability. The vessel must have adequate stability, 
taking into consideration the weight and distribution of livestock and 
fodder, as well as effects of high winds and seas. If requested by 
APHIS, the owner or operator of the vessel must present stability 
calculations for the voyage that have been independently verified for 
accuracy.
    (14) Means of humane euthanasia. Ocean vessels must maintain a means 
of humanely euthanizing sick or injured livestock aboard the vessel. One 
of the personnel aboard the vessel must be trained in humanely 
euthanizing livestock by using the means of euthanasia carried by the 
vessel.
    (15) Life support systems. The ocean vessel must maintain 
replacement parts for major life support systems aboard the vessel, and 
the means, including qualified personnel, to make the repairs or 
replacements.
    (16) Additional conditions. The vessel must meet any other condition 
the Administrator determines is necessary for approval, as dictated by 
specific circumstances and communicated to the owner and operator of the 
vessel, to protect the livestock and keep them healthy during loading, 
unloading, and transport to the importing country.
    (e) Accommodations for the humane transport of livestock; vessels 
using shipping containers. An inspector may exempt an ocean vessel that 
uses shipping containers to transport livestock to an importing country 
from requirements in paragraph (d) of this section that he or she 
specifies, if the inspector determines that the containers themselves 
are designed, constructed, and managed in a manner to reasonably assure 
the livestock are protected from injury and remain healthy during 
loading, unloading, and transport to the importing country. During such 
inspections, particular attention will be paid to the manner in which 
containers are constructed, the space the containers afford to livestock 
transported within them, the manner in which the vessel would provide 
feed and water to the animals in the containers, and the manner in which 
air and effluent are managed within the containers. The Program Handbook 
contains exemption guidance.
    (f) Operator's report. (1) The owner or operator of any ocean vessel 
used to export livestock (including vessels that use shipping 
containers) from the United States must submit a written report to APHIS 
within 5 business days after completing a voyage. The report must 
include the name of the ocean vessel; the name and address of all 
exporters of livestock transported on the vessel; the port of 
embarkation; dates of the voyage; the port where the livestock were 
discharged; the number of each species of livestock loaded; the number 
of each species that died and an explanation for those mortalities; and 
the number of animals that sustained injuries or sustained illnesses 
that were significant enough to require medical attention from the 
personnel entrusted with the care of the animals, as well as the nature 
of these injuries or illnesses. The report must also document any 
failure of any major life support system for the livestock, including, 
but not limited to, systems for providing feed and water, ventilation 
systems, and livestock waste management systems. Any such failure must 
be documented, regardless of the duration or whether the failure 
resulted in any harm to the livestock. The report must include the name, 
telephone number, and email address of the person who prepared the 
report and the date of the report. The report must be submitted to APHIS 
by facsimile or email. Contact numbers and addresses, as well as an 
optional template for the report, are provided in the Program Handbook.
    (2) If an ocean vessel used to export livestock experiences any 
failure of a major life support system for livestock during the voyage, 
the owner or operator of the ocean vessel must notify APHIS immediately 
by telephone, facsimile, or other electronic means. Contact numbers and 
addresses are provided in the Program Handbook.
    (3) Failure to provide timely reports as required by this section 
may result

[[Page 405]]

in APHIS disapproving future livestock shipments by the responsible 
owner or operator or revoking the vessel's certification under paragraph 
(a) of this section to carry livestock.

(Approved by the Office of Management and Budget under control number 
0579-0432)



Sec.91.13  Aircraft.

    (a) Prior to loading livestock aboard aircraft, the stowage area of 
the aircraft and any loading ramps, fittings, and equipment to be used 
in loading the animals must be cleaned and then disinfected with a 
disinfectant approved by the Administrator, to the satisfaction of an 
APHIS representative, unless the representative determines that the 
aircraft has already been cleaned and disinfected to his or her 
satisfaction.
    (1) The Administrator will approve a disinfectant for purposes of 
this section upon determining that the disinfectant is effective against 
pathogens that may be spread by the animals and, if the disinfectant is 
a chemical disinfectant, that it is registered or exempted for the 
specified use by the U.S. Environmental Protection Agency.
    (2) The Program Handbook provides access to a list of disinfectants 
approved by the Administrator for use as required by this section. Other 
disinfectants may also be approved by the Administrator in accordance 
with paragraph (a)(1) of this section.
    (3) The Administrator will withdraw approval of a disinfectant, and 
remove it from the list of approved disinfectants in the Program 
Handbook, if the disinfectant no longer meets the conditions for 
approval in this section.
    (b) The time at which the cleaning and disinfection are to be 
performed must be approved by the APHIS representative, who will give 
approval only if he or she determines that the cleaning and disinfection 
will be effective up to the projected time the livestock will be loaded. 
If the livestock are not loaded by the projected time, the APHIS 
representative will determine whether further cleaning and disinfection 
are necessary.
    (c) The cleaning must remove all garbage, soil, manure, plant 
materials, insects, paper, and other debris from the stowage area. The 
disinfectant solution must be applied with a device that creates an 
aerosol or mist that covers 100 percent of the surfaces in the stowage 
area, except for any loaded cargo and deck surface under it that, in the 
opinion of the APHIS representative, do not contain material, such as 
garbage, soil, manure, plant materials, insects, waste paper, or debris, 
that may harbor animal disease pathogens.
    (d) After cleaning and disinfection is performed, the APHIS 
representative will sign and deliver to the captain of the aircraft or 
other responsible official of the airline involved a document stating 
that the aircraft has been properly cleaned and disinfected, and stating 
further the date, the carrier, the flight number, and the name of the 
airport and the city and state in which it is located. If an aircraft is 
cleaned and disinfected at one airport, then flies to a subsequent 
airport, with or without stops en route, to load animals for export, an 
APHIS representative at the subsequent airport will determine, based on 
examination of the cleaning and disinfection documents, whether the 
previous cleaning and disinfection is adequate or whether to order a new 
cleaning and disinfection. If the aircraft has loaded any cargo in 
addition to animals, the APHIS representative at the subsequent airport 
will determine whether to order a new cleaning and disinfection, based 
on both examination of the cleaning and disinfection documents and on 
the inspection of the stowage area for materials, such as garbage, soil, 
manure, plant materials, insects, waste paper, or debris, that may 
harbor animal disease pathogens.
    (e) Cargo containers used to ship livestock must be designed and 
constructed of a material of sufficient strength to securely contain the 
animals and must provide sufficient space for the species being 
transported given the duration of the trip, as determined by APHIS.



Sec.91.14  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 or she may prescribe in each specific case to 
prevent the

[[Page 406]]

spread of livestock diseases and to ensure the humane treatment of the 
animals during transport to the importing country.



PART 92_IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: PROCEDURES FOR 
REQUESTING RECOGNITION OF REGIONS AND COMPARTMENTS--Table of Contents



Sec.
92.1 Definitions.

 Subpart A_Procedures for Requesting Recognition of Regions Other Than 
                                 for BSE

92.2 Application for recognition of the animal health status of a region 
          or a compartment.
92.3 Movement restrictions.
92.4 Reestablishment of a region or compartment's disease-free status.

Subpart B_Procedures for Requesting BSE Risk Status Classification With 
                            Regard to Bovines

92.5 Determination of the BSE risk classification of a region.
92.6 Determination of the date of effective enforcement of a ruminant-
          to-ruminant feed ban.
92.7 Incorporation by reference.

    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.
    Approved laboratory. A properly equipped institution in the 
exporting region, approved by the official authority who is responsible 
for animal health matters in that region, that is staffed by technically 
competent personnel under the control of a specialist in veterinary 
diagnostic methods who is responsible for the results.
    Bovine. Bos taurus, Bos indicus, and Bison bison.
    Communicable disease. Any contagious or infectious disease of 
animals. It can be transmitted either directly or indirectly to a 
susceptible animal from an infected animal, vector, inanimate source, or 
other sources.
    Compartment. Any defined animal subpopulation contained in one or 
more establishments under a common biosecurity management system for 
which surveillance, control, and biosecurity measures have been applied 
with respect to a specific disease.
    Contagious disease. Any communicable disease transmitted from one 
animal to another by direct contact or by feed, water, aerosol, or 
contaminated objects.
    Disease agent. A virus, bacterium, or other organism that causes 
disease in animals.
    Exporting region. A region from which shipments are sent to the 
United States.
    European Union. The organization of Member States consisting of 
Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, 
Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, 
Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, 
Romania, Slovakia, Slovenia, Republic of Ireland, Spain, Sweden, and

[[Page 407]]

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.
    OIE. The World Organization for Animal Health.
    OIE Code. The Terrestrial Animal Health Code of the World 
Organization for Animal Health.
    OIE Terrestrial Manual. The Manual of Diagnostic Tests and Vaccines 
for Terrestrial Animals of the World Organization for Animal Health.
    Passive surveillance. A surveillance system that does not depend on 
active participation by the responsible agency to seek out and monitor a 
restricted disease agent. The system relies on mandatory reporting, a 
pool of trained investigators, diagnostic submission procedures and 
laboratory support, and periodic public information and continuing 
education programs on diseases.
    Prevalence. The number of cases of a disease in existence at a given 
time in a designated area.
    Processed animal protein. Meat meal, bone meal, meat-and-bone meal, 
blood meal, dried plasma and other blood products, hydrolyzed protein, 
hoof meal, horn meal, poultry meal, feather meal, fish meal, and any 
other similar products.
    Region. Any defined geographic land region identifiable by 
geological, political or surveyed boundaries. A region may consist of 
any of the following:
    (1) A national entity (country);
    (2) Part of a national entity (zone, county, department, 
municipality, parish, Province, State, etc.);
    (3) Parts of several national entities combined into an area; or
    (4) A group of national entities (countries) combined into a single 
area.
    Region of controlled risk for bovine spongiform encephalopathy 
(BSE).\1\ A region for which a risk assessment has been conducted 
sufficient to identify the historical and existing BSE risk factors in 
the region and that:
---------------------------------------------------------------------------

    \1\ A list of regions classified by APHIS as regions of controlled 
risk for BSEs is available at http://www.aphis.usda.gov/import_ export/
animals/animal_ disease_status.shtml.
---------------------------------------------------------------------------

    (1) Has demonstrated that appropriate mitigations are being taken to 
manage all identified risks, but may not have been taken for the periods 
of time necessary to be classified as a region of negligible risk for 
BSE.
    (2) Is a region in which it can be demonstrated through an 
appropriate control and audit that neither meat-and-bone meal nor 
greaves derived from ruminants has been fed to ruminants.
    (3) Has demonstrated that Type A surveillance in accordance with 
Article 11.5.22 of the OIE Code, incorporated by reference in Sec.
92.7, or with equivalent guidelines recognized by the Administrator is 
in place and the relevant points target, in accordance with Table 1 of 
Article 11.5.22 of the OIE Code, or with equivalent guidelines 
recognized by the Administrator has been met. Type B surveillance in 
accordance with Article 11.5.22 of the OIE Code, or with equivalent 
guidelines recognized by the Administrator, is sufficient in place of 
Type A surveillance or its equivalent once the relevant points target 
for Type A surveillance or its equivalent has been met.
    (4) Meets one of the following conditions:
    (i) Has had no case of BSE in the region or every case has been 
demonstrated to have been imported and has been completely destroyed; or
    (ii) Has had at least one indigenous case, and all bovines described 
in either paragraph (4)(ii)(A) or (4)(ii)(B) of this definition, if 
still alive, are officially identified with unique individual 
identification that is traceable to the premises of origin of the 
animal, have their movements controlled, and, when slaughtered or at 
death, are completely destroyed:
    (A) All bovines that, during their first year of life, were reared 
with a bovine determined to be infected with BSE during its first year 
of life, and that investigation showed consumed the same potentially 
contaminated feed as the infected animal during that period; or
    (B) If the investigation was unable to determine whether the feed 
source that was used to feed the bovine known to be infected was also 
used to feed other bovines in the herd of the infected animal, all 
bovines born in the same herd

[[Page 408]]

as a BSE-infected bovine either within 12 months before or 12 months 
after the birth of the infected animal.
    (5) Meets the conditions in one of or both paragraphs (5)(i) or 
(5)(ii) of this definition:
    (i) Has met the following conditions, but not for at least the past 
7 years:
    (A) Conducted an ongoing awareness program for veterinarians, 
farmers, and workers involved in transportation, marketing, and 
slaughter of bovines to encourage reporting of bovines showing clinical 
signs that could be indicative of BSE;
    (B) Required notification and investigation of all bovines showing 
clinical signs consistent with BSE; and
    (C) Has carried out the examination, in accordance with 
internationally accepted diagnostic tests and procedures and in approved 
laboratories, of brain or other tissues collected as part of the 
surveillance and monitoring described in paragraphs (3) and (5)(i)(A) 
and (5)(i)(B) of this definition; or
    (ii) Has prohibited the feeding to ruminants in the region of meat-
and-bone meal and greaves derived from ruminants, but it cannot be 
demonstrated through an appropriate level of control and audit that the 
prohibited materials have not been fed to ruminants in the region for at 
least the past 8 years.
    Region of negligible risk for bovine spongiform encephalopathy 
(BSE).\2\ A region for which a risk assessment has been conducted 
sufficient to identify the historical and existing BSE risk factors in 
the region and that:
---------------------------------------------------------------------------

    \2\ A list of regions classified by APHIS as regions of negligible 
risk for BSEs is available at http://www.aphis.usda.gov/import_ export/
animals/animal_disease _status.shtml.
---------------------------------------------------------------------------

    (1) Has demonstrated that appropriate mitigations to manage all 
identified risks have been taken for each relevant period of time to 
meet each identified risk, as set forth in this definition.
    (2) Has demonstrated that Type B surveillance in accordance with 
Article 11.5.22 of the OIE Code, incorporated by reference in Sec.
92.7, or with equivalent guidelines recognized by the Administrator is 
in place and the relevant points target, in accordance with Table 1 of 
Article 11.5.22 of the OIE Code, or with equivalent guidelines 
recognized by the Administrator has been met.
    (3) Meets one of the following conditions:
    (i) Has had no case of BSE in the region or every case has been 
demonstrated to have been imported and has been completely destroyed; or
    (ii) Has had at least one indigenous case, but every indigenous case 
was born more than 11 years ago, and all bovines described in either 
paragraph (3)(ii)(A) or (3)(ii)(B) of this definition, if still alive, 
are officially identified with unique individual identification that is 
traceable to the premises of origin of the animal, have their movements 
controlled, and, when slaughtered or at death, are completely destroyed:
    (A) All bovines that, during their first year of life, were reared 
with a bovine determined to be infected with BSE during its first year 
of life, and that investigation showed consumed the same potentially 
contaminated feed as the infected animal during that period; or
    (B) If the investigation was unable to determine whether the feed 
source that was used to feed the bovine known to be infected was also 
used to feed other bovines in the herd of the infected animal, all 
bovines born in the same herd as a BSE-infected bovine either within 12 
months before or 12 months after the birth of the infected animal.
    (4) Has, for at least the past 7 years:
    (i) Conducted an ongoing awareness program for veterinarians, 
farmers, and workers involved in transportation, marketing, and 
slaughter of bovines to encourage reporting of bovines showing clinical 
signs that could be indicative of BSE;
    (ii) Required notification and investigation of all bovines showing 
clinical signs consistent with BSE; and
    (iii) Carried out the examination, in accordance with 
internationally accepted diagnostic tests and procedures and in approved 
laboratories, of brain or other tissues collected as part of the 
required surveillance and monitoring described in paragraphs (2) and 
(4)(i) and (4)(ii) of this definition.
    (5) Has demonstrated through an appropriate level of control and 
audit

[[Page 409]]

that, for at least the past 8 years, neither meat-and-bone meal nor 
greaves derived from ruminants have been fed to ruminants in the region.
    Region of undetermined risk for bovine spongiform encephalopathy 
(BSE). Any region that is not classified as either a region of 
negligible risk for BSE or a region of controlled risk for BSE.
    Restricted disease agent. Any communicable disease agent or its 
vector not known to exist in the United States or that is subject to a 
Federal or cooperative Federal/State control or eradication program 
within the United States.
    Specified risk materials (SRMs) from regions of controlled risk for 
BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a).
    Specified risk materials (SRMs) from regions of undetermined risk 
for BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a), except that the following bovine parts 
from regions of undetermined risk for BSE are considered SRMs if they 
are derived from bovines over 12 months of age: Brain, skull, eyes, 
trigeminal ganglia, spinal cord, vertebral column (excluding the 
vertebrae of the tail, the transverse processes of the thoracic and 
lumbar vertebrae, and the wings of the sacrum), and the dorsal root 
ganglia.
    Surveillance. Systems to find, monitor, and confirm the existence or 
absence of a restricted disease agent or agents in livestock, poultry 
and other animals. Surveillance may be passive or active.
    United States. All of the States of the United States, the District 
of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin 
Islands of the United States, and all other territories and possessions 
of the United States.
    Vector-borne disease. A disease transmitted to an animal through an 
intermediate arthropod vector, including ticks or insects.

[62 FR 56012, Oct. 28, 1997, as amended at 68 FR 16938, Apr. 7, 2003; 72 
FR 67232, Nov. 28, 2007; 78 FR 72993, Dec. 4, 2013; 85 FR 11835, Feb. 
28, 2020]



 Subpart A_Procedures for Requesting Recognition of Regions Other Than 
                                 for BSE

    Source: 78 FR 72994, Dec. 4, 2013, unless otherwise noted.



Sec.92.2  Application for recognition of the animal health status 
of a region or a compartment.

    (a) The representative of the national government(s) of any country 
or countries who has the authority to make such a request may request 
that APHIS recognize the animal health status of a region or a 
compartment.\1\ Such requests must be made in English and must be sent 
to the Administrator, c/o Strategy and Policy, VS, APHIS, 4700 River 
Road, Unit 38, Riverdale, MD 20737-1231. (Where possible, include a copy 
of the request and accompanying information in electronic format.)
---------------------------------------------------------------------------

    \1\ Additionally, APHIS may choose to initiate an evaluation of the 
animal health status of a foreign region or compartment on its own 
initiative. In such cases, APHIS will follow the same evaluation and 
notification procedures set forth in this section.
---------------------------------------------------------------------------

    (b) Requests for recognition of the animal health status of a 
region, other than requests submitted in accordance with paragraph (c) 
of this section, must include, in English, the information in paragraphs 
(b)(1) through (8) of this section about the region. More detailed 
information regarding the specific types of information that will enable 
APHIS to most expeditiously conduct an evaluation of the request is 
available at: https://www.aphis.usda.gov/ aphis/ourfocus/animalhealth/
export/ international-standard-setting-activities-oie /regionalization/
ct_ reg_request or by contacting the National Director, Regionalization 
Evaluation Services, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 
20737.
    (1) Scope of the evaluation being requested.
    (2) Veterinary control and oversight.

[[Page 410]]

    (3) Disease history and vaccination practices.
    (4) Livestock demographics and traceability.
    (5) Epidemiological separation from potential sources of infection.
    (6) Surveillance.
    (7) Diagnostic laboratory capabilities.
    (8) Emergency preparedness and response.
    (c) Requests for recognition that a region is historically free of a 
disease based on the amount of time that has elapsed since the disease 
last occurred in a region, if it has ever occurred, must include, in 
English, the information in paragraphs (c)(1) through (6) of this 
section about the region. More detailed information regarding the 
specific types of information that will enable APHIS to most 
expeditiously conduct an evaluation of the request is available 
at:https://www.aphis.usda.gov/aphis /ourfocus/animalhealth/export/ 
international-standard-setting-activities-oie/ regionalization/
ct_reg_request or by contacting the National Director, Regionalization 
Evaluation Services, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 
20737. For a region to be considered historically free of a disease, the 
disease must not have been reported in domestic livestock for at least 
the past 25 years and must not have been reported in wildlife for at 
least the past 10 years.
    (1) Scope of the evaluation being requested.
    (2) Veterinary control and oversight.
    (3) Disease history and vaccination practices.
    (4) Disease notification.
    (5) Disease detection.
    (6) Barriers to disease introduction.
    (d) Requests for recognition of the animal health status of a 
compartment must include, in English, the information in paragraphs 
(d)(1) through (8) of this section about the compartment. More detailed 
information regarding the specific types of information that will enable 
APHIS to most expeditiously conduct an evaluation of the request is 
available at: https://www.aphis.usda.gov/aphis/ourfocus/ animalhealth/
export/ international-standard-setting-activities-oie/regionalization/ 
ct_reg_request or by contacting the National Director, Regionalization 
Evaluation Services, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 
20737.
    (1) Scope of the evaluation being requested.
    (2) Veterinary control and oversight of the compartment.
    (3) Disease history and vaccination practices.
    (4) Livestock or poultry commodity movement and traceability.
    (5) Epidemiologic separation of the compartment from potential 
sources of infection.
    (6) Surveillance.
    (7) Diagnostic laboratory capabilities.
    (8) Emergency preparedness and response.
    (e) A list of those regions for which an APHIS recognition of their 
animal health status has been requested, the disease(s) under 
evaluation, and, if available, the animal(s) or product(s) the region 
wishes to export, is available at: https://www.aphis.usda.gov/ aphis/
ourfocus/animalhealth/export/ international-standard-setting-activities-
oie/regionalization/ ct_reg_request.
    (f) A list of countries that have requested an APHIS 
compartmentalization evaluation, and a description of the requested 
compartment is available at: https://www.aphis.usda.gov/ aphis/ourfocus/
animalhealth/ export/international-standard-setting-activities-oie/ 
regionalization/ct_reg_request.
    (g) If, after review and evaluation of the information submitted in 
accordance with paragraph (b), (c), or (d) of this section, APHIS 
believes the request can be safely granted, APHIS will indicate its 
intent and make its evaluation available for public comment through a 
document published in the Federal Register.
    (h) APHIS will provide a period of time during which the public may 
comment on its evaluation. During the comment period, the public will 
have access to the information upon which APHIS based its evaluation, as 
well as the evaluation itself. Once APHIS has reviewed all comments 
received, it will make a final determination regarding the request and 
will publish that determination in the Federal Register.

[[Page 411]]

    (i) If a region or compartment is granted animal health status under 
the provisions of this section, the representative of the national 
government(s) of any country or countries who has the authority to make 
a regionalization or compartmentalization request may be required to 
submit additional information pertaining to animal health status or 
allow APHIS to conduct additional information collection activities in 
order for that region or compartment to maintain its animal health 
status.

(Approved by the Office of Management and Budget under control number 
0579-0040)

[85 FR 11835, Feb. 28, 2020]



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]



Sec.92.4  Reestablishment of a region or compartment's disease-free 
status.

    This section applies to regions or compartments that are designated 
under this subchapter as free of a specific animal disease and then 
experience an outbreak of that disease.
    (a) Interim designation. If a region or a compartment recognized as 
free of a specified animal disease in this subchapter experiences an 
outbreak of that disease, APHIS will take immediate action to prohibit 
or restrict imports of animals and animal products from the entire 
region, a portion of that region, or the compartment. APHIS will inform 
the public as soon as possible of the prohibitions and restrictions by 
means of a notice in the Federal Register.
    (b) Reassessment of the disease situation. (1) Following removal of 
disease-free status from all or part of a region or a compartment, APHIS 
may reassess the disease situation in that region or compartment to 
determine whether it is necessary to continue the interim prohibitions 
or restrictions. In reassessing disease status, APHIS will take into 
consideration the standards of the World Organization for Animal Health 
(OIE) for reinstatement of disease-free status, as well as all relevant 
information obtained through public comments or collected by or 
submitted to APHIS through other means.
    (2) Prior to taking any action to relieve prohibitions or 
restrictions, APHIS will make information regarding its reassessment of 
the region's or compartment's disease status available to the public for 
comment. APHIS will announce the availability of this information by 
means of a notice in the Federal Register.
    (c) Determination. Based on the reassessment conducted in accordance 
with paragraph (b) of this section regarding the reassessment 
information, APHIS will take one of the following actions:
    (1) Publish a notice in the Federal Register of its decision to 
reinstate the disease-free status of the region, portion of the region, 
or compartment;
    (2) Publish a notice in the Federal Register of its decision to 
continue the prohibitions or restrictions on the imports of animals and 
animal products from that region or compartment; or
    (3) Publish another document in the Federal Register for comment.

[85 FR 11836, Feb. 28, 2020]



Subpart B_Procedures for Requesting BSE Risk Status Classification With 
                            Regard to Bovines

    Source: 78 FR 72994, Dec. 4, 2013, unless otherwise noted.



Sec.92.5  Determination of the BSE risk classification of a region.

    All countries of the world are considered by APHIS to be in one of 
three BSE risk categories--negligible risk, controlled risk, or 
undetermined risk. These risk categories are defined in Sec.92.1. Any 
region that is not classified by APHIS as presenting either negligible 
risk or controlled risk for BSE

[[Page 412]]

is considered to present an undetermined risk. The listing of those 
regions classified by APHIS as having either negligible risk or 
controlled risk can be accessed on the APHIS Web site at http://
www.aphis.usda.gov/import _export/animals/animal_ disease_status.shtml. 
The listing can also be obtained by writing to APHIS at National Import 
Export Services, 4700 River Road Unit 38, Riverdale, MD 20737. APHIS may 
classify a region for BSE according to either paragraph (a) or paragraph 
(b) of this section.
    (a) BSE risk classification based on OIE classification. If the OIE 
has classified a country as either BSE negligible risk or BSE controlled 
risk, APHIS will seek information to support concurrence with the OIE 
classification. This information could be publicly available 
information, or APHIS could request that countries supply the same 
information given to the OIE. APHIS will announce in the Federal 
Register, subject to public comment, each intent to concur with an OIE 
classification. APHIS will also post the summary of the BSE OIE ad hoc 
group conclusions for review during the comment period. The summaries 
would be available for review on the APHIS Web site at http://
www.aphis.usda.gov/ import_export/animals/reg_ request.shtml. Following 
review of any comments received, the Administrator will announce his or 
her final determination regarding classification of the country in the 
Federal Register, along with a discussion of and response to pertinent 
issues raised by commenters. If APHIS recognizes a country as either 
negligible risk or controlled risk for BSE, the Agency will include that 
country in a list of regions of negligible risk or controlled risk for 
BSE, as applicable, that APHIS will make available to the public on the 
Agency's Web site at http://www.aphis.usda.gov/ import_export/animals/
animal_ disease_status.shtml.
    (b) Regions seeking classification as negligible or controlled risk 
that have not been classified by the OIE. A region that has not received 
classification by OIE as either negligible risk or controlled risk for 
BSE and that wishes to be classified by APHIS as negligible risk or 
controlled risk must submit to the Administrator a request for 
classification, along with documentation sufficient to allow APHIS to 
conduct an evaluation of whether the region meets the criteria for 
classification. A list of the documentation required can be accessed on 
the APHIS Web site at http://www.aphis.usda.gov/import_ export/animals/
reg_ request.shtml. If, following evaluation of the information 
submitted, the Administrator determines that the region meets the 
criteria for classification as negligible risk or controlled risk, APHIS 
will announce that determination in the Federal Register and will make 
available to the public on the APHIS Web site the evaluation conducted 
by APHIS, as well as the information provided by the requesting region. 
APHIS will accept public comment on its intent. Following review of any 
comments received, the Administrator will announce his or her final 
determination regarding classification of the region in the Federal 
Register, along with a discussion of and response to pertinent issues 
raised by commenters.
    (c) Retention of classification as either negligible risk or 
controlled risk. (1) As required by the OIE for countries classified as 
either negligible risk or controlled risk by the OIE, regions evaluated 
by APHIS and classified as negligible or controlled risk would need to 
submit updated information to APHIS each year. The required information 
includes documentation of the following:
    (i) Relevant changes in BSE legislation, compared to the previous 
year;
    (ii) The importation into the region during the year of cattle, 
processed animal protein, and products containing processed animal 
protein;
    (iii) Audit findings in rendering plants and feed mills that process 
ruminant material or material from mixed species that contains ruminant 
material, related to the prohibition of the feeding to ruminants of 
processed animal protein;
    (iv) Audit findings in rendering plants and feed mills that process 
nonruminant material, related to the prohibition of the feeding to 
ruminants of processed animal protein;
    (v) Infractions at the types of facilities listed above;
    (vi) If and why, in light of the audit findings, there has been no 
significant

[[Page 413]]

exposure of cattle to the BSE agent through consumption of processed 
animal protein of bovine origin;
    (vii) Surveillance efforts;
    (viii) All clinical BSE suspects; and
    (ix) Any new cases of BSE.
    (2) If APHIS at any time determines that a region no longer meets 
the criteria for the risk classification it had previously received, 
APHIS will remove the region from its list of regions so classified. If 
the OIE determines the region no longer meets the criteria for the risk 
classification it had previously received, APHIS may concur with the OIE 
determination or may request updated information from the region and 
determine whether to concur with the OIE decision APHIS will announce 
its intent in the Federal Register and accept public comment regarding 
that intent. Following review of any comments received, the 
Administrator will announce in the Federal Register his or her final 
determination regarding classification of the region, along with a 
discussion of and response to pertinent issues raised by commenters.

(Approved by the Office of Management and Budget under control number 
0579-0393)



Sec.92.6  Determination of the date of effective enforcement of a 
ruminant-to-ruminant feed ban.

    (a) In order for APHIS to determine the eligibility of live bovines 
for importation from a region classified as BSE negligible risk or BSE 
controlled risk, APHIS must determine the date from which a ban on the 
feeding of ruminant material to ruminants has been effectively enforced 
in the region. APHIS will base its determination of the date of 
effective enforcement on the information included in the dossier the 
region submitted when it requested to be classified regarding BSE risk. 
The information APHIS will consider will include, but not be limited to:
    (1) Policies and infrastructure for feed ban enforcement, including 
an awareness program for producers and farmers;
    (2) Livestock husbandry practices;
    (3) Disposition of processed animal protein produced from domestic 
bovines, including the feeding of such material to any animal species;
    (4) Measures taken to control cross-contamination and mislabeling of 
feed; and
    (5) Monitoring and enforcement of the ruminant-to-ruminant feed ban, 
including audit findings in rendering plants and feed mills that process 
ruminant material.
    (b) After conducting its evaluation, APHIS will announce in the 
Federal Register for public comment the date APHIS considers to be the 
date of effective enforcement of a ruminant-to-ruminant feed ban in the 
requesting region, and will make available to the public the evaluation 
conducted by APHIS, as well as the supporting documentation. Following 
review of any comments received, the Administrator will announce his or 
her final determination in the Federal Register, along with a discussion 
of and response to pertinent issues raised by commenters.



Sec.92.7  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part 
with the approval of the Director of the Federal Register under 5 U.S.C. 
552(a) and 1 CFR part 51. To enforce any edition other than that 
specified in this section, USDA must publish notice of change in the 
Federal Register and the material must be available to the public. All 
approved material is available for inspection at the Animal and Plant 
Health Inspection Service (APHIS), and is available from the sources 
listed below. For information about the availability of this material at 
APHIS, call 301-851-3300 or write to National Import Export Services, 
4700 River Road Unit 38, Riverdale, MD 20737. It is also available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030 or go to http://www.archives.gov/federal _register/code_of 
_federal_regulations/ ibr_locations.html.
    (b) World Organization for Animal Health (OIE), 12, rue de Prony 
75017 Paris, France, or email [email protected], http://www.oie.int/eng/ 
normes/Mcode/en_sommaire.htm.
    (1) Terrestrial Animal Health Code, Chapter 11.5-Bovine Spongiform

[[Page 414]]

Encephalopathy, Article 11.5.22 (Surveillance activities), 22nd Edition, 
2013.
    (2) [Reserved]

(Approved by the Office of Management and Budget under control number 
0579-0393)



   PART 93_IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, 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 live poultry and hatching eggs.
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; payment information.
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.
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.

[[Page 415]]

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 Health certificate 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 and other bovines from Canada.
93.419 Sheep and goats from Canada.
93.420 Ruminants from Canada for immediate slaughter other than sheep 
          and goats.
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 and other bovines from Mexico.
93.428 Sheep and goats and wild ruminants from Mexico.
93.429 Ruminants for immediate slaughter.

                      Additional General Provisions

93.430-93.434 [Reserved]
93.435 Sheep and goats.
93.436 Bovines from regions of negligible risk, controlled risk, and 
          undetermined risk for BSE.
93.437 Tuberculosis status of foreign regions.
93.438 Process for requesting regional classification for tuberculosis.
93.439 Importation of ruminants from certain regions of the world; 
          tuberculosis.
93.440 Brucellosis status of foreign regions.
93.441 Process for requesting regional classification for brucellosis.
93.442 Importation of ruminants from certain regions of the world; 
          brucellosis.

                             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.

                                 Mexico

93.521 Declaration for swine.

                             Subpart F_Dogs

93.600 Importation of dogs.

[[Page 416]]

                     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.

                    Subpart I_Aquatic Animal Species

93.900 Definitions.
93.901 General restrictions; exceptions.
93.902 Ports designated for the importation of live fish, fertilized 
          eggs, and gametes.
93.903 Import permits for live fish, fertilized eggs, and gametes.
93.904 Health certificate for live fish, fertilized eggs, and gametes.
93.905 Declaration and other documents for live fish, fertilized eggs, 
          and gametes.
93.906 Inspection at the port of entry.

    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).
    Highly pathogenic avian influenza (HPAI). Highly pathogenic avian 
influenza is defined as follows:
    (1) Any influenza virus that kills at least 75 percent of eight 4- 
to 6-week-old susceptible chickens within 10 days following intravenous 
inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, 
infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-
week-old chickens resulting in an intravenous pathogenicity index (IVPI) 
of greater than 1.2;
    (2) Any H5 or H7 virus that does not meet the criteria in paragraph 
(1) of this definition, but has an amino acid sequence at the 
haemagglutinin cleavage site that is compatible with highly pathogenic 
avian influenza viruses; or
    (3) Any influenza virus that is not an H5 or H7 subtype and that 
kills one to five out of eight inoculated chickens and grows in cell 
culture in the absence of trypsin within 10 days.
    Inspector. An employee of the Animal and Plant Health Inspection 
Service authorized to perform duties required under this subpart.
    Licensed veterinarian. Any person licensed by any region or 
political subdivision thereof to practice veterinary medicine.
    Pen-raised. Cared for in a fenced enclosure, such that the ratites 
are kept

[[Page 417]]

apart from wild ratites, poultry, and other animals; can be readily 
observed, and be restrained for inspection and treatment. A flock is not 
considered to be pen-raised if ratites captured in the wild have been 
added to it after March 8, 1994.
    Performing or theatrical birds. Birds, except ratites, which are to 
be used in shows, theatrical acts or performances only.
    Persons. Any individual, corporation, company, association, firm, 
partnership, society or joint stock company.
    Pet birds. Birds, except ratites, which are imported for the 
personal pleasure of their individual owners and are not intended for 
resale.
    Port Veterinarian. A veterinarian employed by the Animal and Plant 
Health Inspection Service to perform duties required under this part at 
a port of entry.
    Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, 
partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys 
(including eggs for hatching).
    Production season. That period of time, usually approximately 9 
months each year, from the time ratites in a flock begin laying eggs 
until the ratites cease laying eggs.
    Quarantine facility. A USDA facility, or a private facility approved 
by APHIS, for the secure housing of imported birds, poultry, or other 
animals for specified periods.
    Ratites. Cassowaries, emus, kiwis, ostriches, and rheas.
    Region. Any defined geographic land area identifiable by geological, 
political, or surveyed boundaries. A region may consist of any of the 
following:
    (1) A national entity (country);
    (2) Part of a national entity (zone, county, department, 
municipality, parish, Province, State, etc.);
    (3) Parts of several national entities combined into an area; or
    (4) A group of national entities (countries) combined into a single 
area.
    Research birds. Birds which are to be used for research purposes 
only.
    Smuggled birds. Any bird which has been brought into the United 
States contrary to any Federal law or regulation and which has been 
seized by any official of any Department of the United States Government 
or which has been abandoned to the United States.
    United States. All of the States of the United States, the District 
of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin 
Islands of the United States, and all other Territories and Possessions 
of the United States.
    Veterinary Services. The Veterinary Services unit of the Department.
    Zoological birds. Birds intended for breeding or public display, for 
recreational or educational purposes, at a zoological park.
    Zoological park. A professionally operated zoo, park, garden or 
other place, maintained under the constant surveillance of a Doctor of 
Veterinary Medicine, for the exhibition of live animals, pigeons or 
birds, for the purpose of public recreation or education.

[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; 79 FR 71004, Dec. 1, 2014]



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. Unless otherwise indicated in 
the regulations, no live birds, and no hatching eggs from birds, shall 
be imported into the United States if the birds have originated from a 
region referenced in Sec.94.6(a) of this subchapter

[[Page 418]]

where highly pathogenic avian influenza or Newcastle disease is known to 
exist in commercial poultry populations, have transited highly 
pathogenic avian influenza- or Newcastle disease-affected regions, or 
have been vaccinated for the H5 or H7 subtype of avian influenza.
---------------------------------------------------------------------------

    \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 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

[[Page 419]]

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 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) Except for pet birds that have been in any region where 
highly pathogenic avian influenza exists, which are subject to the 
provisions of paragraph (c)(3) of this section, pet birds of United 
States origin that have not been outside the country for more than 60 
days may be offered for entry under the provisions of paragraph (c)(1) 
of this section if:
    (A) The pet birds are accompanied by an import permit issued by 
APHIS: Provided, that an import permit will not be required for pet 
birds returning from Canada or Mexico through a land border port; and
    (B) The birds are also accompanied by a United States veterinary 
health certificate issued prior to the departure of the birds from the 
United States and the certificate shows the number from the leg band, 
tattoo, or microchip affixed to the birds prior to departure; and

[[Page 420]]

    (C) During port of entry veterinary inspection it is determined that 
the number from the leg band, tattoo, or microchip on the bird is the 
same as the one listed on the health certificate.
    (ii) Except for pet birds that have been in any region where highly 
pathogenic avian influenza exists, which are subject to the provisions 
of paragraph (c)(3) of this section, pet birds of United States origin 
that have been outside the country for more than 60 days may be imported 
by their owner if:
    (A) The pet birds are accompanied by an import permit issued by 
APHIS: Provided, that an import permit will not be required for pet 
birds returning from Canada or Mexico through a land border port; and
    (B) The pet birds are found upon port of entry veterinary inspection 
to be free of poultry diseases; and
    (C) The pet birds are accompanied by a United States veterinary 
health certificate issued prior to the departure of the birds from the 
United States and the certificate shows the number from the leg band, 
tattoo, or microchip affixed to the birds prior to departure; and
    (D) During port of entry veterinary inspection it is determined that 
the number from the leg band, tattoo, or microchip on the bird is the 
same as the one listed on the health certificate; and
    (E) The owner importing the pet birds signs and furnishes to the 
Administrator the following:
    (1) A notarized declaration under oath or affirmation (or a 
statement signed by the owner and witnessed by a Department inspector) 
stating that the bird or birds have not been in contact with poultry or 
other birds while out of the region (for example, association with other 
avian species at exhibitions or at aviaries); and
    (2) An agreement on VS Form 17-8, obtainable from a Federal 
inspector at the port of entry, stating:
    (i) That the birds will be maintained in confinement in his or her 
personal possession separate and apart from all poultry and other birds 
for a minimum of 30 days following importation at the address where the 
birds are to be held and made available for health inspection and 
testing by Department inspectors upon request until released at the end 
of such period by such an inspector; and
    (ii) That appropriate Federal officials in the State of destination 
will be immediately notified if any signs of disease are noted in any of 
the birds or any bird dies during that period. The owner importing such 
birds must comply with the provisions of the aforementioned agreement 
before the birds may be released from confinement. Except for pet birds 
that have been in any region where highly pathogenic avian influenza 
exists, lots of pet birds of United States origin which do not otherwise 
meet the requirements of paragraphs (c)(1) or (2) of this section may be 
offered for entry under the provisions of paragraph (c)(4) of this 
section.
    (3) Any pet birds of United States origin that have been in any 
region identified in accordance with Sec.94.6(a)(2) of this subchapter 
as a region where highly pathogenic avian influenza exists, regardless 
of the length of time such birds have been outside of the United States, 
may only be imported through the port of Los Angeles, CA, Miami, FL, or 
New York, NY, and only under the following conditions:
    (i) The birds meet the requirements of paragraphs (c)(2)(ii)(A) 
through (D) of this section; and
    (ii) The birds are quarantined for a minimum of 30 days, and for 
such longer period as may be required by the Administrator in any 
specific case, at a USDA quarantine facility in accordance with Sec.
93.106.
    (4) Pet birds which are not known to be affected with or exposed to 
communicable diseases of poultry may be offered for entry at one of the 
ports of entry designated in 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 highly pathogenic avian influenza, Newcastle disease, chlamydiosis, 
and other communicable diseases of poultry, and that the birds were 
being exported in compliance

[[Page 421]]

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 of export from the region 
of origin, to communicable diseases of poultry, if an import permit \4\ 
has been obtained

[[Page 422]]

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 or by visiting http://
www.aphis.usda.gov/animal _health/permits/''. 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 returning to the United States. 
(1) Performing or theatrical birds of United States origin that are 
returning to the United States from Canada or Mexico may be imported if:
    (i) The birds are found upon port of entry veterinary inspection to 
be free of avian diseases; and
    (ii) The birds are accompanied by a United States veterinary health 
certificate issued prior to the departure of the birds from the United 
States and the certificate shows the number from the leg band, tattoo, 
or microchip affixed to the birds prior to departure; and
    (iii) During port of entry veterinary inspection it is determined 
that the number from the leg band, tattoo, or microchip on the birds is 
the same as the one listed on the health certificate.
    (2) Except for performing or theatrical birds that have been in any 
region where highly pathogenic avian influenza exists, which are subject 
to the

[[Page 423]]

provisions of paragraph (f)(3) of this section, performing or theatrical 
poultry of United States origin that have been outside the United States 
in a region other than Canada or Mexico may be imported if:
    (i) The birds meet the requirements of paragraphs (f)(1)(i) through 
(iii) of this section; and
    (ii) The birds are accompanied by an import permit issued by APHIS; 
and
    (iii) The owner importing the birds signs and furnishes to the 
Administrator the following:
    (A) A notarized declaration under oath or affirmation (or a 
statement signed by the owner and witnessed by a Department inspector) 
stating that the birds have not been in contact with other birds while 
out of the region (for example, association with other avian species at 
exhibitions or at aviaries); and
    (B) An agreement on VS Form 17-8, available electronically or 
through other authorized method, obtainable from a Federal inspector at 
the port of entry, stating:
    (1) That the birds will be maintained in confinement in his or her 
personal possession separate and apart from all birds and other birds 
for a minimum of 30 days following importation at the address where the 
birds are to be held and made available for health inspection and 
testing by Department inspectors upon request until released at the end 
of such period by such an inspector; and
    (2) That appropriate Federal officials in the State of destination 
will be immediately notified if any signs of disease are noted in any of 
the birds or any birds die during that period. The owner importing such 
poultry must comply with the provisions of the aforementioned agreement 
before the birds may be released from confinement. Except for performing 
or theatrical birds that have been in any region where highly pathogenic 
avian influenza exists, performing or theatrical birds of United States 
origin which do not otherwise meet the requirements of paragraphs (f)(1) 
or (2) of this section may be offered for entry under the provisions of 
Sec.93.101(c).
    (3) Any performing or theatrical birds of United States origin that 
have been in any region identified in accordance with Sec.94.6(a)(2) 
of this subchapter as a region where highly pathogenic avian influenza 
exists may only be imported through the port of Los Angeles, CA, Miami, 
FL, or New York, NY, and only under the following conditions:
    (i) The birds meet the requirements of paragraphs (f)(1)(i) through 
(iii) of this section; and
    (ii) The birds are accompanied by an import permit issued by APHIS; 
and
    (iii) The birds are quarantined for a minimum of 30 days, and for 
such longer period as may be required by the Administrator in any 
specific case, at a quarantine facility maintained by APHIS in 
accordance with paragraphs (c)(3)(ii) through (c)(3)(iv) of this 
section.
    (g) Any smuggled bird shall:
    (1) Be refused entry into the United States and be removed from the 
United States, \6\ or
---------------------------------------------------------------------------

    \6\ Birds that would require handfeeding will be refused entry.
---------------------------------------------------------------------------

    (2) Be quarantined in a USDA-operated quarantine facility pending 
negative results to two consecutive tests for highly pathogenic avian 
influenza and Newcastle disease \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 protocols for highly 
pathogenic avian influenza and Newcastle disease which are 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 highly pathogenic avian 
influenza and Newcastle disease isolation. Smuggled birds shall also be 
subject to such other tests and procedures to determine whether the 
birds are free from communicable diseases of poultry other than highly 
pathogenic avian influenza and Newcastle disease when the port 
veterinarian determine that the bird in question has shown physical 
symptoms of being affected with or exposed to communicable diseases of 
poultry. A lot of smuggled birds placed into the quarantine facility 
shall be handled on an ``all-in, all-out'' basis: Provided, That birds 
of endangered and threatened species, as determined by the Department of 
the Interior (16 U.S.C. 1533,

[[Page 424]]

as amended) shall be separated for quarantine and testing as separate 
lots. If highly pathogenic avian influenza or Newcastle disease or any 
other communicable disease of poultry is diagnosed in any smuggled bird 
at any point or if it is determined that any smuggled bird has been 
exposed to highly pathogenic avian influenza or Newcastle disease or any 
other such communicable disease, such birds shall not be released from 
quarantine and shall be disposed of in accordance with procedures 
established by the Administrator to prevent the entry of communicable 
diseases of livestock or poultry into the United States. However, if 
endangered or threatened species are determined to be exposed such birds 
shall be held in permanent quarantine in accordance with such conditions 
as the Deputy Administrator may prescribe to protect poultry of the 
United States. At the time any smuggled bird enters the quarantine 
facility, it shall be identified in a manner approved by the 
Administrator.
    (4) If the laboratory tests for highly pathogenic avian influenza 
and Newcastle disease are negative and as determined by the port 
veterinarian the birds are free of clinical evidence of diseases of 
poultry at the end of the quarantine period, the port veterinarian shall 
issue an agricultural release for entry of the birds through the United 
States Customs Service at the termination of the quarantine period. 
Providing that the sale of the smuggled birds is not contrary to any 
Federal law or regulation, expenses incurred by the Department for the 
handling of the smuggled birds under this paragraph shall be reimbursed 
from funds derived from the sale or disposition of the smuggled birds 
after their release from quarantine. Any smuggled bird which by law may 
not be sold, or so disposed, shall be quarantined in accordance with 
such procedures as the Deputy Administrator may establish to prevent the 
introduction of communicable diseases of livestock or poultry into the 
United States, in accordance with the law.

(Approved by the Office of Management and Budget under control numbers 
0579-0220 and 0579-0245)

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997]

    Editorial Note: For Federal Register citations affecting Sec.
93.101, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



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.
    (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

[[Page 425]]

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 or by visiting http://
www.aphis.usda.gov/ animal_health/permits/. 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 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

[[Page 426]]

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 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

[[Page 427]]

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 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.

[[Page 428]]

    (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 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

[[Page 429]]

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; 81 FR 40151, June 21, 2016]



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.
    (b) Birds other than ratites. The certificate for birds other than 
ratites must state:
    (1) That all birds covered by the certificate have been inspected by 
the veterinarian issuing the certificate;
    (2) That no evidence of Newcastle disease, highly pathogenic avian 
influenza, chlamydiosis, or other communicable disease of poultry was 
found among the birds;

[[Page 430]]

    (3) That insofar as has been possible to determine, the birds were 
not exposed to Newcastle disease, highly pathogenic avian influenza, 
chlamydiosis, or other communicable disease of poultry during the 90 
days immediately preceding their exportation;
    (4) That the birds have not been vaccinated with a vaccine for the 
H5 or H7 subtype of avian influenza; however, zoological birds that have 
been vaccinated for avian influenza subtypes H5 or H7 as part of an 
official program, using vaccine products approved and used under 
supervision by the veterinary authorities of the exporting country, may 
be imported under specific conditions as determined by the Administrator 
and specified in an import permit. Such birds must be exported with 
permanent individual identification and meet the other requirements for 
entry under this part, and will be subject to official testing and 
quarantine on arrival to the United States.
    (5) That highly pathogenic avian influenza or Newcastle disease did 
not occur anywhere on the premises from which the birds were to be 
exported or on adjacent premises during the 90 days immediately 
preceding the exportation of the birds;
    (6) That neither the premises from which the birds were to be 
exported nor any adjacent premises were located in any area under 
quarantine for poultry diseases at any time during the 90 days 
immediately preceding the exportation of the birds, and that the birds 
have not originated from or been moved through a region identified in 
accordance with Sec.94.6(a) of this subchapter as a region where 
highly pathogenic avian influenza exists; and
    (7) That the birds were placed into new or appropriately sanitized 
packaging materials at the premises from which the birds were to be 
exported.
    (c) Ratites other than hatching eggs. The certificate for ratites 
other than hatching eggs must state:
    (1) That, except as provided in paragraph (c)(13) of this section, 
all ratites covered by the certificate, and their flock of origin, have 
been inspected by the veterinarian issuing the certificate;
    (2) That, except when the certificate is for zoological birds or 
ratites imported from Canada in accordance with 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, highly pathogenic avian 
influenza, chlamydiosis, or other communicable disease of poultry was 
found in the flock of origin;
    (4) That insofar as has been possible to determine, the flock of 
origin was not exposed to Newcastle disease, highly pathogenic avian 
influenza, chlamydiosis, or other communicable disease of 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 or with a 
vaccine for the H5 or H7 subtype of avian influenza;
    (6) That highly pathogenic avian influenza or Newcastle disease did 
not occur anywhere on the premises where the flock of origin was kept or 
on adjacent premises during the 90 days immediately preceding the 
exportation;
    (7) That neither the premises where the flock of origin was kept nor 
any adjacent premises was located in any area under quarantine for 
poultry diseases at any time during the 90 days immediately preceding 
the exportation, and that the ratites have not originated from or been 
moved through a region identified in accordance with Sec.94.6(a) of 
this subchapter as a region where highly pathogenic avian influenza 
exists;
    (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

[[Page 431]]

or bedding materials with, any ratite not in the same shipment to the 
United States; and
    (11) That the ratites were placed in new or appropriately sanitized 
packaging materials for shipment to the United States at the premises 
where the flock of origin was kept.
    (12) The number of ratites contained in the shipment;
    (13) That the number of ratites and hatching eggs of ratites 
exported from the flock of origin has not exceeded the ceiling required 
to be established under 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;
    (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, highly pathogenic avian 
influenza, chlamydiosis, or other communicable disease of poultry was 
found in the flock of origin;
    (4) That insofar as has been possible to determine, the flock of 
origin was not exposed to Newcastle disease, highly pathogenic avian 
influenza, chlamydiosis, or other communicable disease of poultry during 
the 90 days immediately preceding the exportation of the hatching eggs;
    (5) That highly pathogenic avian influenza or Newcastle disease did 
not occur anywhere on the premises where the flock of origin was kept or 
on adjacent premises during the 90 days immediately preceding the 
exportation of the hatching eggs;
    (6) That neither the premises where the flock of origin was kept nor 
any adjacent premises were located in any area under quarantine for 
poultry diseases at any time during the 90 days immediately preceding 
the exportation of the hatching eggs; and
    (7) That the hatching eggs were placed into new or appropriately 
sanitized packaging materials for shipment to the United States at the 
premises where the flock of origin was kept.
    (8) The number of hatching eggs contained in the shipment;
    (9) That the number of ratites and hatching eggs of ratites exported 
from the flock of origin has not exceeded the ceiling required to be 
established under 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, Mar. 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; 76 FR 
4053, Jan. 24, 2011; 79 FR 71005, Dec. 1, 2014]



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

[[Page 432]]

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 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

[[Page 433]]

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 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 highly pathogenic avian influenza and Newcastle disease. If 
any of the ratites exhibit evidence of other communicable diseases, they 
will be subjected to such additional tests as may be required by the 
Administrator to determine their freedom from communicable diseases. 
Ratites other than those imported as hatching eggs also shall be treated 
for ectoparasites \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:

[[Page 434]]

    (A) Within the immediate metropolitan area of the port of entry to 
prevent the imported birds, while in transit to the quarantine facility, 
from introducing or disseminating disease to domestic poultry or 
livestock.
    (B) At least one-half mile from any concentration of avian species, 
such as, but not limited to, poultry processing plants, poultry or bird 
farms, pigeon lofts, or other bird quarantine facilities. Factors such 
as prevailing winds, the efficiency of the air filtration system of the 
quarantine facility, possible exposure to poultry or birds moving in 
local traffic, etc., shall be taken into consideration.
    (ii) Construction. Each quarantine facility shall consist of a 
single, self-contained building, which shall:
    (A) Be constructed only with material that can withstand continued 
cleaning and disinfection. All solid walls, floors, and ceilings must be 
constructed of impervious material. All openings to the outside must be 
double-screened, with an interior screen of metal or nylon mesh that is 
impervious to biting insects such as gnats or mosquitos, and an exterior 
metal screen that is rodent-proof and is made of wire, such as rabbit 
wire, hardware cloth, or smooth welded wire, with mesh size no larger 
than 1 inch x 1.5 inches (2.54 cm x 3.81 cm). The interior and exterior 
screens must be separated by at least 3 inches (7.62 cm);
    (B) Have a bird holding area of sufficient size to prevent 
overcrowding of the birds in quarantine. (All access into this holding 
area shall be from within the building and each entryway into such area 
shall be equipped with self-closing, double doors: Provided, That 
emergency exits to the outside may exist in the bird holding area if 
required by local fire ordinances. Such emergency exits shall be 
constructed so as to permit their opening from the inside of the 
facility only.);
    (C) Have a ventilation capacity sufficient to control moisture and 
odor at levels that are not injurious to the health of the birds in 
quarantine;
    (D) Have a vermin-proof feed storage area;
    (E) Have office space for recordkeeping;
    (F) Have a separate necropsy room which shall have refrigerated 
storage space for carcasses retained for laboratory examination and 
facilities adequate for specimen preparation and carcass disposal;
    (G) Have a separate area for washing facility equipment;
    (H) Have a shower at the entrance into the area comprised of the 
bird holding and necropsy rooms and a clothes storage and change area at 
each end of the shower area;
    (I) Have a storage area for equipment necessary for quarantine 
operations;
    (J) Have equipment necessary to maintain the facility in clean and 
sanitary condition, including insect and pest control equipment;
    (K) Have a receptacle for soiled and contaminated clothing in the 
clothes change area located nearest the entrance to the bird holding 
area;
    (L) All construction must be completed before any permit application 
is submitted in accordance with 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

[[Page 435]]

shall be of a size large enough to accommodate 75 percent of the 
incubator capacity, with a minimum of 10 square feet per egg.
    (P) If a facility for hatching eggs of ratites has a sun room, the 
sun room shall be connected to the chick holding area by a wall with a 
lockable door. This wall; the other walls, if any; and the flooring, 
must be impervious to water and able to withstand continued cleaning and 
disinfection. All walls of the sun room must be at least 8 feet high.
    (1) Any of the exterior walls may be replaced by a double-screened 
wall set in a concrete or concrete-block curb. The double screening 
shall be of wire mesh or wire mesh and nylon mesh, as provided in 
paragraph (c)(2)(ii)(A) of this section, with the interior and exterior 
screens of the sun room wall separated by at least 3 inches (7.62 cm); 
the concrete or concrete block curb must be at least 12 inches high, 
impermeable to water, and able to prevent the escape of water, manure, 
and debris.
    (2) The sun room shall have a roof, such as a double-mesh-screened 
roof or a glass roof, that is both impervious to free-flying birds and 
biting insects (such as gnats or mosquitoes) and capable of preventing 
contact between chicks and free-flying birds.
    (3) Be attended by personnel working in the bird (chick) holding 
area whenever chicks are in the sun room.
    (iii) Sanitation and security. Arrangements shall exist for:
    (A) A supply of water adequate to meet all watering and cleaning 
needs.
    (B) Disposal of wastes by incineration or a public sewer system 
which meets all applicable environmental quality control standards;
    (C) Control of surface drainage onto or from the facility to prevent 
any disease agent from entering or escaping;
    (D) Protective clothing and footwear adequate to insure that workers 
at the facility have clean clothing and footwear at the start of each 
workday and at any time such articles become soiled or contaminated;
    (E) Power cleaning and disinfecting equipment with adequate capacity 
to disinfect the facility and equipment;
    (F) Sufficient stocks of a disinfectant authorized in 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

[[Page 436]]

shall be taken out of the lot while it is in quarantine except for 
diagnostic purposes and if additional birds are added to a lot, the 
total quarantine period for that lot shall be extended so that all birds 
will have completed at least 30 consecutive days of quarantine before 
release for entry into the commerce of the United States. The quarantine 
period may be extended as provided in paragraph (a) of this section.
    (1) Hatching eggs of ratites comprising a single lot may be added to 
the facility in stages, provided the entire lot has been placed in the 
facility no later than 15 days after the arrival of the first shipment.
    (2) If hatching eggs of ratites begin to hatch in the incubator/
hatcher area while ratite chicks from the previously quarantined lot 
remain in the bird (chick) holding area, then the separate lots assume 
the status of a single lot, and will be released from quarantine in 
accordance with paragraph (c)(3)(ii)(A) of this section.
    (B) The birds may be vaccinated during quarantine only with a 
vaccine that has been approved by the Administrator, and is administered 
by a licensed veterinarian under the direct supervision of a 
veterinarian employed by the Animal and Plant Health Inspection Service. 
The Administrator will approve a vaccine if:
    (1) The vaccine is licensed by the Animal and Plant Health 
Inspection Service in accordance with 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 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 Newcastle disease or highly pathogenic avian 
influenza is found or detected among any birds in quarantine, all birds 
in the facility shall be destroyed or refused entry and the entire 
facility shall be thoroughly cleaned and then disinfected as directed 
under the supervision of an inspector.
    (F) The quarantine facility from which a lot of birds has been 
released shall be thoroughly cleaned and disinfected with a disinfectant 
authorized in 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

[[Page 437]]

the lot during the quarantine period, necropsy results, and laboratory 
findings on birds that died during the quarantine date of prescribed 
tests and results, Department import permit numbers of each lot, date 
lot was removed from the facility, and any other observations pertinent 
to the general health of the birds in the lot. The importer shall also 
make an identification record, at the time each psittacine bird is 
identified, containing the species of the bird, including the common and 
scientific name and the number of the identification device placed on 
each psittacine bird. The daily log and the identification record shall 
be maintained for 12 months following the date of release of the bird 
from quarantine and shall be made available to APHIS personnel upon 
request.
    (4) Additional requirements as to location, security, physical plant 
and facilities, sanitation, and other items may be imposed by the 
Administrator, in each specific case in order to assure that the 
quarantine of the birds in such facility will be adequate to enable 
determination of their health status, prevent spread of disease among 
birds in quarantine, and prevent escape of poultry disease agents from 
the facility.
    (5) Cooperative and Trust Fund Agreement for services required by 
importer at a privately owned bird quarantine facility.
    (i) When the Administrator determines that a privately owned bird 
quarantine facility meets the requirements set forth in paragraph (c) of 
this section, the Department and the importer shall execute a 
Cooperative and Trust Fund Agreement, as specified in paragraph 
(c)(5)(iii) of this section. In conjunction with the Cooperative and 
Trust Fund Agreement, the importer shall deposit with the Administrator 
a money order or cashier's check in an amount determined by the 
Administrator to cover all costs incurred by the Department in providing 
services in accordance with the provisions of the Cooperative and Trust 
Fund Agreement. Any unobligated funds will, upon request, be returned to 
the importer, after the birds' release from quarantine.
    (ii) The Administrator may provide services required by the importer 
at a privately owned quarantine facility for the importation of birds on 
a first come, first served basis, if adequate APHIS personnel are 
available to provide those services, upon determining that the importer 
has executed a Cooperative and Trust Fund Agreement, and has deposited 
funds in an amount determined by the Administrator to be sufficient to 
cover all costs incurred by the Department in providing services in 
accordance with that agreement, as specified in paragraph (c)(5)(iii) of 
this section.
    (iii) Cooperative and Trust Fund Agreement.

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.

[[Page 438]]

    (2) To provide a current list of designated personnel employed by 
the Importer who will be used to handle and care for birds during the 
quarantine period. The list will include the legal names, current 
residential addresses, and social security numbers of the designated 
personnel. The list will be furnished to the port veterinarian at the 
time an application for an import permit to import birds into the 
quarantine facility is submitted to the Service. The list will be 
updated for any changes in or additions to the designated personnel in 
advance of such personnel working in the quarantine facility.
    (3) To furnish to the Service a signed statement from each of the 
designated personnel employed by the Importer which provides that such 
personnel agree that for a period of 3 days from their most recent 
contact with birds in the quarantine facility, such personnel will 
refrain from having contact with other birds and poultry. This 
restriction ceases to apply on the date the birds are released from 
quarantine.
    (4) To not permit any designated personnel which the Service 
determines to be unfit to be employed at a quarantine facility upon 
written notice from the Service. Such determination shall be based upon 
such employee's committing or aiding and abetting in the commission of 
any violation of title 9, Code of Federal Regulations, part 93. The 
Importer further agrees to suspend any designated employee from working 
at a quarantine facility when the Service has reason to believe that 
such employee has violated any provision of title 9, Code of Federal 
Regulations, part 93, and the Administrator has determined that the 
actions of such employee constitute a severe threat to introduce or 
disseminate a communicable disease of poultry into the United States. 
Such action shall be made upon receipt of notice from the Service 
requiring such action by the Importer.
    (5) To allow the unannounced entry into the quarantine facility of 
Service personnel or other persons authorized by the Service for the 
purpose of inspecting birds in quarantine, the operations at the 
quarantine facility and to ascertain compliance with the Standards for 
quarantine facilities and handling procedures for importation of birds 
contained in title 9, Code of Federal Regulations, 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 highly pathogenic avian influenza 
or Newcastle disease is diagnosed in any of the birds in the quarantine 
facility, continuous guarding of the facility with personnel from a 
bonded security company shall be maintained by the Importer. The 
electronic security system if installed shall be of the ``silent type'' 
and shall be triggered to ring at the monitoring site and not at the 
facility. The electronic system shall be approved by Underwriter's 
Laboratories.

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.

[[Page 439]]

    (17) To decide what the disposition of a lot of birds will be within 
48 hours following official notification that such a lot is infected 
with or exposed to highly pathogenic avian influenza or Newcastle 
disease. Final disposition of the infected or exposed lot is to be 
accomplished within 4 working days following official notification. 
Disposition of the birds will be under the supervision of the Service.
    (18) To furnish a telephone number or numbers to the Service at 
which the Importer can be reached on a daily basis or furnish the same 
for an agent or representative that can act and make decisions on the 
Importer's behalf.
    (19) To deposit with the Service, upon execution of this agreement, 
a money order or cashier's check, in an amount determined by the 
Administrator to be sufficient to defray all costs incurred by the 
Service in providing services required. If such costs exceed the 
deposited amount, the importer will pay for additional costs incurred, 
based on official accounting records, within 14 days of receipt of the 
bill showing the balance due.
    (20) To provide for the maintenance and operation of the quarantine 
facility in accordance with standards for quarantine facilities and 
handling procedures for importation of birds contained in title 9, Code 
of Federal Regulations, 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 meet the 
Department's quarantine requirements before release into the United 
States.
    (2) To issue permits 3 working days following receipt of the permit 
application, depending upon the availability of personnel to provide the 
services required for quarantine and the results of an APHIS 
representative's inspection of the quarantine facility.
    (3) To provide the Importer within 30 days following receipt of a 
written request from the Importer, with an accounting of funds expended 
in providing services under paragraph (B)(1) of this agreement. Any 
unobligated balance upon termination or expiration of this agreement 
shall be returned to the Importer.
    (4) To inform the Importer when a diagnosis of highly pathogenic 
avian influenza or Newcastle disease has been made in any facility.
    (5) To promptly inform the Embassy or Consulate of the foreign 
region to which lots of birds, refused entry into the United States due 
to a diagnosis of highly pathogenic avian influenza or Newcastle 
disease, are to be shipped.
    (6) To notify in writing the Importer of any designated employee 
which the Service believes should be suspended from work at the 
quarantine facility and the basis for such action. Similar notice shall 
be afforded to the designated employee. Subsequent to such suspension, 
the designated employee shall have the right to request an immediate 
review of such action by the Administrator, including presenting his or 
her views to the Administrator in an informal conference. If the 
Administrator makes a final determination that grounds existed to 
suspend such employee, he or she shall notify the Importer and the 
suspended employee of his or her decision and such employee shall be 
discharged by the Importer.
    (7) Prior to any final determination being made by the Service 
concerning the discharge of any designated personnel employed by the 
Importer, the Service will inform, in writing, the Importer and the 
designated personnel of the basis for such action. If such person 
contests such action he or she shall be permitted to present his or her 
views to the Administrator, provided such request is made within 30 days 
of the receipt of the aforementioned written notice. If a final 
determination is made by the Administrator that such personnel should be 
discharged, he or she shall notify such personnel and the Importer of 
such determination.
    (C) It is mutually understood and agreed:
    (1) That a maximum capacity will be established for each quarantine 
lot. This will be based upon the capacity of the quarantine facility to 
handle the birds. The number of birds on the permits will not exceed 
this capacity.
    (2) If the seals referred to in paragraph (c)(5)(iii)(A)(16) of this 
section are broken by other than Service personnel, it will be 
considered a breach in security and an immediate accounting of all birds 
in the facility shall be made by the Service. If any birds are 
determined to be missing from the facility, the quarantine period will 
be extended for an additional 30-day period.
    (3) During the performance of this cooperative work, the Importer 
agrees to be bound by the equal opportunity and nondiscrimination 
provisions as set forth in exhibit B and nonsegregation of facilities 
provisions as set forth in exhibit C, \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.

[[Page 440]]

    (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.
    (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. Redesignated at 62 FR 56012, Oct. 28, 1997]

    Editorial Note: For Federal Register citations affecting Sec.
93.106, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.

                               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

[[Page 441]]

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.
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service or any other employee of the Animal and Plant Health 
Inspection Service, United States Department of Agriculture, to whom 
authority has been or may be delegated to act in the Administrator's 
stead.
    Animal and Plant Health Inspection Service. The Animal and Plant 
Health Inspection Service of the United States Department of Agriculture 
(APHIS or Service).
    Animals. Cattle, sheep, goats, other ruminants, swine, horses, 
asses, mules, zebras, dogs, and poultry.
    Commercial poultry. Chickens, doves, ducks, geese, grouse, guinea 
fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and 
turkeys (including eggs for hatching) which are imported for resale, 
breeding, public display, or any other commercial purpose.
    Communicable disease. Any contagious, infectious, or communicable 
disease of domestic livestock, poultry or other animals.
    Department. The United States Department of Agriculture (USDA).
    Fever tick. Boophilus annulatus, including, but not limited to, the 
varieties Americana and Australia.
    Highly pathogenic avian influenza (HPAI). Highly pathogenic avian 
influenza is defined as follows:
    (1) Any influenza virus that kills at least 75 percent of eight 4- 
to 6-week-old susceptible chickens within 10 days following intravenous 
inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, 
infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-
week-old chickens resulting in an intravenous pathogenicity index (IVPI) 
of greater than 1.2;
    (2) Any H5 or H7 virus that does not meet the criteria in paragraph 
(1) of this definition, but has an amino acid sequence at the 
haemagglutinin cleavage site that is compatible with highly pathogenic 
avian influenza viruses; or
    (3) Any influenza virus that is not an H5 or H7 subtype and that 
kills one to five out of eight inoculated chickens and grows in cell 
culture in the absence of trypsin within 10 days.
    Immediate slaughter. Consignment directly from the port of entry to 
a recognized slaughtering establishment \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.

[[Page 442]]

    Port veterinarian. A veterinarian employed by the Animal and Plant 
Health Inspection Service to perform duties required under this part at 
a port of entry.
    Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, 
partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys 
(including eggs for hatching).
    Quarantine facility. A USDA facility, or a private facility approved 
by APHIS, for the secure housing of imported birds, poultry, or other 
animals for specified periods.
    Region. Any defined geographic land area identifiable by geological, 
political, or surveyed boundaries. A region may consist of any of the 
following:
    (1) A national entity (country);
    (2) Part of a national entity (zone, county, department, 
municipality, parish, Province, State, etc.)
    (3) Parts of several national entities combined into an area; or
    (4) A group of national entities (countries) combined into a single 
area.
    Swine. The domestic hog and all varieties of wild hogs.
    United States. All of the States of the United States, the District 
of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin 
Islands of the United States, and all other Territories and Possessions 
of the United States.
    Veterinary services. The Veterinary Services unit of the Department.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56015, Oct. 28, 1997; 79 FR 71005, Dec. 1, 2014]



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. Unless otherwise 
indicated in the regulations, no live poultry, and no hatching eggs from 
poultry, shall be imported into the United States if the poultry have 
originated from a region referenced in Sec.94.6(a) of this subchapter 
where highly pathogenic avian influenza or Newcastle disease is known to 
exist in commercial poultry populations, have transited highly 
pathogenic avian influenza- or Newcastle disease-affected regions, or 
have been vaccinated for the H5 or H7 subtype of avian influenza.
---------------------------------------------------------------------------

    \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 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

[[Page 443]]

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 returning to the United States. 
(1) Performing or theatrical poultry of United States origin that are 
returning to the United States from Canada or Mexico may be imported if:
    (i) The poultry are found upon port of entry veterinary inspection 
to be free of poultry diseases; and
    (ii) The poultry are accompanied by a United States veterinary 
health certificate issued prior to the departure of the poultry from the 
United States and the certificate shows the number from the leg band, 
tattoo, or microchip affixed to the poultry prior to departure; and
    (iii) During port of entry veterinary inspection it is determined 
that the number from the leg band, tattoo, or microchip on the poultry 
is the same as the one listed on the health certificate.
    (2) Except for performing or theatrical poultry that have been in 
any region where highly pathogenic avian influenza exists, which are 
subject to the provisions of paragraph (c)(3) of this section, 
performing or theatrical poultry of United States origin that have been 
outside the United States in a region other than Canada or Mexico may be 
imported if:
    (i) The poultry meet the requirements of paragraphs (c)(1)(i) 
through (iii) of this section; and
    (ii) The poultry are accompanied by an import permit issued by 
APHIS; and
    (iii) The owner importing the poultry signs and furnishes to the 
Administrator the following:
    (A) A notarized declaration under oath or affirmation (or a 
statement signed by the owner and witnessed by a Department inspector) 
stating that the poultry have not been in contact with poultry or other 
birds while out of the region (for example, association with other avian 
species at exhibitions or at aviaries); and
    (B) An agreement on VS Form 17-8, obtainable from a Federal 
inspector at the port of entry, stating:
    (1) That the poultry will be maintained in confinement in his or her 
personal possession separate and apart from all poultry and other birds 
for a minimum of 30 days following importation at the address where the 
poultry

[[Page 444]]

are to be held and made available for health inspection and testing by 
Department inspectors upon request until released at the end of such 
period by such an inspector; and
    (2) That appropriate Federal officials in the State of destination 
will be immediately notified if any signs of disease are noted in any of 
the poultry or any poultry die during that period. The owner importing 
such poultry must comply with the provisions of the aforementioned 
agreement before the poultry may be released from confinement.
    (3) Any performing or theatrical poultry of United States origin 
that have been in any region listed in Sec.94.6(d) of this subchapter 
as a region where highly pathogenic avian influenza exists may only be 
imported through the port of Los Angeles, CA, Miami, FL, or New York, 
NY, and only under the following conditions:
    (i) The poultry meet the requirements of paragraphs (c)(1)(i) 
through (iii) of this section; and
    (ii) The poultry are accompanied by an import permit issued by 
APHIS; and
    (iii) The poultry are quarantined for a minimum of 30 days, and for 
such longer period as may be required by the Administrator in any 
specific case, at a quarantine facility maintained by APHIS in 
accordance with Sec. Sec.93.209 and 93.210.
    (d) The provisions in this part relating to poultry shall not be 
applicable to performing or theatrical poultry.
    (e) Pigeons, doves, and other Columbiform species that have 
originated from or transited regions where highly pathogenic avian 
influenza is considered to exist may be imported into the United States 
under permit and controlled conditions to approved establishments 
subject to all applicable requirements in this part.

(Approved by the Office of Management and Budget under control number 
0579-0245)

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 56012, 56015, 
Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 69 FR 25825, May 10, 2004; 76 
FR 4053, Jan. 24, 2011; 79 FR 71005, Dec. 1, 2014]



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 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 445]]

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 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

[[Page 446]]

concerning specific diseases to which the poultry are susceptible, as 
well as vaccinations or other precautionary treatments to which the 
poultry or poultry test specimens have been subjected. Notice of any 
such requirement will be given to the applicant in each case.
    (2) An application for permit to import poultry may also be denied 
because of: Communicable disease conditions in the area or region of 
origin, or in a region where the shipment has been or will be held or 
through which the shipment has been or will be transported; deficiencies 
in the regulatory programs for the control or eradication of animal 
diseases and the unavailability of veterinary services in the above 
mentioned regions; the importer's failure to provide satisfactory 
evidence concerning the origin, history, and health status of the 
poultry; the lack of satisfactory information necessary to determine 
that the importation will not be likely to transmit any communicable 
disease to livestock or poultry of the United States; or any other 
circumstances which the Administrator believes require such denial to 
prevent the dissemination of any communicable disease of livestock or 
poultry into the United States.
    (3)(i) The importer or importer's agent shall pay or ensure payment 
of a reservation fee for each lot of poultry to be quarantined in a 
facility maintained by USDA. For poultry, the reservation fee shall be 
100 percent of the cost of providing care, feed, and handling during 
quarantine, as estimated by the quarantine facility's veterinarian in 
charge.
    (ii) At the time the importer or the importer's agent requests a 
reservation of quarantine space, the importer or importer's agent shall 
pay the reservation fee by check or U.S. money order or ensure payment 
of the reservation fee by an irrevocable letter of credit from a 
commercial bank (the effective date on such letter of credit shall run 
to 30 days after the date the poultry are scheduled to be released from 
quarantine); except that anyone who issues a check to the Department for 
a reservation fee which is returned because of insufficient funds shall 
be denied any further request for reservation of a quarantine space 
until the outstanding amount is paid.
    (iii) Any reservation fee paid by check or U.S. money order shall be 
applied against the expenses incurred for services received by the 
importer or importer's agent in connection with the quarantine for which 
the reservation was made. Any part of the reservation fee which remains 
unused after being applied against the expenses incurred for services 
received by the importer or the importer's agent in connection with the 
quarantine for which the reservation was made, shall be returned to the 
individual who paid the reservation fee. If the reservation fee is 
ensured by a letter of credit, the Department will draw against the 
letter of credit unless payment for services received by the importer or 
importer's agent in connection with the quarantine is otherwise made at 
least 3 days prior to the expiration date of the letter of credit.
    (iv) Any reservation fee shall be forfeited if the importer or the 
importer's agent fails to present for entry, within 24 hours following 
the designated time of arrival, the lot of poultry for which the 
reservation was made: Except that a reservation fee shall not be 
forfeited if:
    (A) Written notice of cancellation from the importer or the 
importer's agent is received by the office of the veterinarian in charge 
of the quarantine facility \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

[[Page 447]]

of the poultry within the requested period are unavailable because of 
unforeseen circumstances as determined by the Administrator, (such as 
the closing of an airport due to inclement weather or the unavailability 
of the reserved space due to the extension of another quarantine).
    (v) If the reservation fee was ensured by a letter of credit and the 
fee is to be forfeited under paragraph (a)(3)(iv) of this section, the 
Department will draw against the letter of credit unless the reservation 
fee is otherwise paid at least 3 days prior to the expiration date of 
the letter of credit.
    (vi) When a reservation is cancelled in accordance with paragraph 
(a)(3)(iv)(A) of this section and the provisions of paragraph 
(a)(3)(iv)(B) of this section do not apply, a $40.00 cancellation fee 
shall be charged. If a reservation fee was paid, the cancellation fee 
shall be deducted from any reservation fee returned to the importer or 
the importer's agent. If the reservation fee was ensured by a letter of 
credit, the Department will draw the amount of the cancellation fee 
against the letter of credit unless the cancellation fee is otherwise 
paid at least 3 days prior to the expiration date of the letter of 
credit.
    (b) Permit. Except as provided in paragraph (c) of this section, 
when a permit is issued, the original and two copies will be sent to the 
importer. It shall be the responsibility of the importer to forward the 
original permit and one copy to the shipper in the region of origin, and 
it shall also be the responsibility of the importer to insure that the 
shipper presents the copy of the permit to the carrier and makes proper 
arrangements for the original permit to accompany the shipment to the 
specified U.S. port of entry for presentation to the collector of 
customs. Poultry and poultry test specimens for diagnostic screening 
purposes for poultry intended for importation into the United States for 
which a permit has been issued, will be received at the specified port 
of entry within the time prescribed in the permit which shall not exceed 
14 days from the first day that the permit is effective for all permits, 
except that the time prescribed in permits from the importation of 
poultry shall not exceed 30 days, and for performing or theatrical 
poultry shall not exceed 90 days. Poultry and poultry test specimens for 
which a permit is required by these regulations will not be eligible for 
entry if a permit has not been issued; if unaccompanied by such a 
permit; if shipment is from any port other than the one designated in 
the permit; if arrival in the United States is at any port other than 
the one designated in the permit; if the poultry or poultry test 
specimens offered for entry differ from those described in the permit; 
or if the poultry or poultry test specimens are not handled as outlined 
in the application for the permit and as specified in the permit issued.
    (c) Notwithstanding any other provisions in this part, importers are 
not required to obtain an import permit and provide the shipper with an 
original import permit for each individual shipment of poultry or 
pigeons transiting the port of Anchorage, Alaska, if the following 
conditions are met:
    (1) The importer applies for and obtains an import permit for 
multiple shipments of poultry or pigeons transiting the port of 
Anchorage, Alaska, in accordance with the provisions of this section and 
related requirements concerning application for the permit. However, the 
following information is not required on the application:
    (i) The species, breed, and number of poultry or pigeons to be 
imported;
    (ii) The individual poultry identification;
    (iii) The region of origin;
    (iv) The name and address of the exporter;
    (v) The port of embarkation in the foreign region;
    (vi) The mode of transportation and the route of travel;
    (vii) The proposed date of arrival of the poultry or pigeons; and
    (viii) The name and address of the person to whom the poultry or 
pigeons will be delivered.
    (2) The importer completes a copy of the import permit obtained 
under paragraph (c)(1) of this section for each separate shipment of 
poultry or pigeons

[[Page 448]]

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 live poultry and hatching eggs.

    (a) Live poultry. (1) All live poultry, except eggs for hatching, 
offered for importation from any region of the world shall be 
accompanied by a certificate stating that such poultry and their flock 
or flocks of origin were inspected on the premises of origin immediately 
before the date of movement from such region and that they were then 
found to be free of evidence of communicable diseases of poultry. The 
certificate shall also state that, as far as it has been possible to 
determine, during the 90 days prior to movement, the poultry were not 
exposed to communicable diseases of poultry and the premises were not in 
any area under quarantine. The certificate shall also state that the 
poultry have not been vaccinated with a vaccine for the H5 or H7 subtype 
of avian influenza. The certificate shall also state that the poultry 
have been kept in the region from which they are offered for importation 
since they were hatched, or for at least 90 days immediately preceding 
the date of movement, that the poultry have not originated from or have 
been moved through a region referenced in Sec.94.6(a) of this 
subchapter as a region where any form of highly pathogenic influenza 
exists, and that, as far as it has been possible to determine, no case 
of highly pathogenic avian influenza or Newcastle disease occurred on 
the premises where such poultry were kept, or on adjoining premises, 
during that 90-day period. The certificate must also state that the 
birds were placed into new or appropriately sanitized packaging 
materials at the premises from which the birds were to be exported.
    (2) Live poultry certificates accompanying pigeons, doves, and other 
Columbiform species that have originated from or been moved through 
regions where highly pathogenic avian influenza is considered to exist 
must additionally state that the Columbiform species have been moved and 
handled under conditions specified on the import permit ensuring that 
their movement and handling involved no direct or indirect exposure to 
other animals, birds, and poultry.
    (b) Hatching eggs. All eggs for hatching offered for importation 
from any part of the world shall be accompanied by a certificate stating 
that the flock or flocks of origin were found upon inspection to be free 
from evidence of communicable diseases of poultry, the hatching eggs are 
from poultry that have not been vaccinated with a vaccine for the H5 or 
H7 subtype of avian influenza, that during the 90 days prior to 
movement, the flock or flocks of origin were not exposed to communicable 
diseases of poultry and the premises were not in any area under 
quarantine, and that the hatching eggs and the flock or flocks of origin 
have not originated in or been moved through a region referenced in 
accordance with Sec.94.6(a) of this subchapter as a region where any 
form of highly pathogenic avian influenza exists. The certificate must 
also state that the hatching eggs

[[Page 449]]

were placed into new or appropriately sanitized packaging materials at 
the premises from which the hatching eggs were to be exported.
    (c) Nature of certificate. The certificate required by this section 
shall be issued by a salaried veterinary officer of the national 
government of the region of origin, or if the articles are exported from 
Mexico, may alternatively be issued by a veterinarian accredited by the 
National Government of Mexico and endorsed by a full-time salaried 
veterinary officer of the National Government of Mexico, thereby 
representing that the veterinarian issuing the certificate was 
authorized to do so.

[76 FR 4053, Jan. 24, 2011, as amended at 78 FR 19083, Mar. 29, 2013; 79 
FR 71006, Dec. 1, 2014]



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.
    (c) Any declaration, permit, or other document for poultry required 
under this subpart may be issued and presented using a U.S. Government 
electronic information exchange system or other authorized method.

[55 FR 31495, Aug. 2, 1990, as amended at 81 FR 40151, June 21, 2016]



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 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) of this subchapter as free of Newcastle 
disease and highly pathogenic avian influenza, shall be quarantined from 
time of arrival at the port of entry until hatched and the

[[Page 450]]

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; 76 FR 
4054, Jan. 24, 2011; 78 FR 19083, Mar. 29, 2013]



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 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

[[Page 451]]

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------



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).
    (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 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,

[[Page 452]]

except that the Administrator may permit their inspection at some other 
point when he or she finds that such action will not increase the risk 
that communicable disease of livestock and poultry will be disseminated 
to the livestock or poultry of the United States.
    (2) In-transit shipments through Canada. Poultry originating in the 
United States and transported directly through Canada may re-enter the 
United States without Canadian health or test certificates when 
accompanied by copies of the United States export health certificates 
properly issued and endorsed in accordance with regulations in part 91 
of this chapter: Provided, That, to qualify for entry, the date, time, 
port of entry, and signature of the Canadian Port Veterinarian that 
inspected the poultry for entry into Canada shall be recorded on the 
United States health certificate, or a document containing the 
information shall be included with the certificate that accompanies the 
poultry. In all cases it shall be determined by the veterinary inspector 
at the United States port of entry that the poultry are the identical 
poultry covered by said certificate.
    (b) Exhibition poultry. Poultry from the United States which have 
been exhibited at the Royal Agricultural Winter Fair at Toronto or other 
publicly recognized expositions in Canada, including racing, rodeo, 
circus, or stage exhibitions in Canada, and have not been in that region 
for more than 90 days are eligible for return to the United States 
without Canadian health or test certificates, if they are accompanied by 
copies of the United States health certificate, issued and endorsed in 
accordance with the export regulations contained in part 91 of this 
chapter for entry into Canada: Provided, That all poultry offered for 
re-entry upon examination by the veterinary inspector at the U.S. port 
of entry, are found by the inspector to be free of communicable diseases 
and exposure thereto and are determined to be the identical poultry 
covered by said certificates or that they otherwise qualified for entry 
into Canada under the Canadian regulations.

(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; 81 FR 
40151, June 21, 2016]



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\ 
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------



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.
    (b) For all poultry offered for importation from regions of Central 
America or of the West Indies, the importer or his or her agent shall 
present two copies of a declaration as provided in Sec.93.206.
    (c) All poultry offered for importation from regions of Central 
America and the West Indies shall also meet the

[[Page 453]]

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------



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.
    (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.
    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

[[Page 454]]

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.
    Lot. A group of horses that, while held on a premises or conveyance, 
have had opportunity for physical contact with other horses in the group 
or with their excrement or discharges at any time during their shipment 
to the United States.
    Lot-holding area. That area in a permanent, privately owned 
quarantine facility in which a single lot of horses is held at one time.
    Nonquarantine area. That area in a permanent, privately owned 
quarantine facility that includes offices, storage areas, and other 
areas outside the quarantine area, and that is off limits to horses, 
samples taken from horses, and any other objects or substances that have 
been in the quarantine area during the quarantine of horses.
    Operator. A person other than the Federal Government who owns or 
manages and has responsibility for the services provided by a temporary, 
privately owned quarantine facility or a permanent, privately owned 
quarantine facility.
    Permanent, privately owned quarantine facility. A facility that 
offers quarantine services for horses to the general public on a 
continuing basis and that is owned and operated by an entity other than 
the Federal Government (also permanent facility).
    Persons. Any individual, corporation, company, association, firm, 
partnership, society or joint stock company.
    Port Veterinarian. A veterinarian employed by the Animal and Plant 
Health Inspection Service to perform duties required under this part at 
a port of entry.
    Quarantine area. That area in a permanent, privately owned 
quarantine facility that comprises all of the lot-holding areas in the 
facility, and any other areas in the facility that horses have access 
to, including loading docks for receiving and releasing horses, and any 
areas used to conduct examinations of horses and take samples and where 
samples are processed or examined.
    Recognized slaughtering establishment. \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.
    Temporary, privately owned quarantine facility. A facility that 
offers quarantine services for horses imported for

[[Page 455]]

a specific event and that is owned and operated by an entity other than 
the Federal Government (also temporary facility).
    United States. All of the States of the United States, the District 
of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin 
Islands of the United States, and all other Territories and Possessions 
of the United States.
    Veterinarian in Charge. The veterinary official of the Animal and 
Plant Health Inspection Service, United States Department of 
Agriculture, who is assigned by the Administrator to supervise and 
perform the official animal health work of the Animal and Plant Health 
Inspection Service in the State concerned.
    Veterinary Services. The Veterinary Services unit of the Department.
    Weanling or yearling. Any horse, weaned from its dam, that was 
foaled not more than 731 days prior to its being offered for entry into 
the United States. A horse will not be considered to be a weanling or 
yearling if its first permanent incisors have erupted.

[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; 74 FR 31595, July 2, 2009]



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 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

[[Page 456]]

retained aboard such means of conveyance or in an approved holding 
facility during transshipment as required by this paragraph.
    (3) Provisions for the approval of facilities required in this 
paragraph are:
    (i) They must be sufficiently isolated to prevent direct or indirect 
contact with all other animals and birds while in the United States.
    (ii) They must be so constructed that they provide adequate 
protection against environmental conditions and can be adequately 
cleaned, washed and disinfected.
    (iii) They must provide for disposal of horse carcasses, manure, 
bedding, waste and any related shipping materials in a manner that will 
prevent dissemination of disease.
    (iv) They must have provisions for adequate sources of feed and 
water and for attendants for the care and feeding of horses in the 
facility.
    (v) They must comply with additional requirements as may be imposed 
by the Administrator if deemed applicable for a particular shipment.
    (vi) They must also comply with all applicable local, State and 
Federal requirements for environmental quality and with the provisions 
of the Animal Welfare Regulations in chapter I of this title, as 
applicable.
    (c) Specific prohibitions regarding contagious equine metritis; 
exceptions--(1) Importation prohibited. Except as provided in paragraph 
(c)(2) of this section, notwithstanding the other provisions of this 
part concerning the importation of horses into the United States, the 
importation of all horses from any region that APHIS considers to be 
affected with contagious equine metritis (CEM) and the importation of 
all horses that have been in any such region within the 12 months 
immediately preceding their being offered for entry into the United 
States is prohibited.
    (i) A list of regions that APHIS considers to be affected with CEM 
is maintained on the APHIS Web site at http://www.aphis.usda.gov/import 
_export/animals/animal_ disease_status.shtml. Copies of the list will 
also be available via postal mail, fax, or email upon request to the 
Sanitary Trade Issues Team, National Center for Import and Export, 
Veterinary Services, Animal and Plant Health Inspection Service, 4700 
River Road Unit 38, Riverdale, Maryland 20737.
    (ii) APHIS will add a region to the list upon determining that the 
disease exists in the region based on reports APHIS receives of 
outbreaks of the disease from veterinary officials of the exporting 
country, from the World Organization for Animal Health (OIE), or from 
other sources the Administrator determines to be reliable, or upon 
determining that the region trades horses freely with a region in which 
CEM exists without testing for CEM. APHIS will remove a region from the 
list after conducting an evaluation of the region in accordance with 
Sec.92.2 of this subchapter and finding that the disease is not 
present in the region. In the case of a region formerly not on this list 
that is added due to an outbreak, the region may be removed from the 
list in accordance with the procedures for reestablishment of a region's 
disease-free status in Sec.92.4 of this subchapter.
    (2) Exceptions. The provisions of paragraph (c)(1) of this section 
shall not apply to the following:
    (i) Wild (non-domesticated) species of equidae if captured in the 
wild or imported from a zoo or other facility where it would be unlikely 
that the animal would come in contact with domesticated horses used for 
breeding;
    (ii) Geldings;
    (iii) Weanlings or yearlings that have never been used for breeding, 
and whose age and breeding status are certified on the import health 
certificate required under 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

[[Page 457]]

more than 90 days to compete in specified events if the horses meet the 
requirements of paragraph (f)(1) of this section;
    (viii) Horses over 731 days of age imported into the United States 
for noncompetitive public exhibition and entertainment purposes if the 
horses meet the requirements of paragraph (f)(2) of this section; and
    (ix) Horses temporarily exported from the United States or from 
another region not known to be affected with CEM to a region listed 
under paragraph (c)(1) of this section within the 12 months immediately 
preceding their being offered for entry into the United States if the 
horses meet the requirements of paragraph (g) of this section.
    (d) Spanish Pure Breed horses from Spain and thoroughbred horses 
from France, Germany, 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: Asociacion National de Criadores de 
Caballos de Pura Raza Espanola 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;
    (3) For thoroughbred horses, that none of the premises where the 
horse has been since reaching 731 days of age are breeding premises; and
    (4) For Spanish Pure Breed horses from Spain, that since reaching 
731 days of age:
    (i) The horse has never been on a premises that is exclusively a 
breeding premises;
    (ii) The horse has never been bred;
    (iii) Breeding of the horse has never been attempted; and
    (iv) The horse has never been commingled and left unattended with 
adult horses of the opposite sex;
    (C) He or she has compared the records maintained by the approved 
breed association with the records kept by the trainer and has found the 
information in those two sets of records to be consistent and current;
    (D) For Spanish Pure Breed horses and thoroughbred horses over 731 
days of age, cultures negative for CEM were obtained from three sets of 
specimens collected within a 12-day period from the mucosal surfaces of 
the clitoral fossa and the clitoral sinuses, with one set of specimens 
including a specimen from the surfaces of the distal cervix or 
endometrium, of any female horses and from the surfaces of the prepuce, 
the urethral sinus, the distal urethra, and the fossa glandis, including 
the diverticulum of the fossa glandis, of any male horses. For both male 
and female horses, the sets of specimens must be taken within a 12-day 
period with no less than 72 hours between each set, and the last of 
these sets of specimens must be collected within 30 days prior to 
exportation. All specimens required by this paragraph must be collected 
by a licensed veterinarian who either is, or is acting in the presence 
of, the veterinarian signing the certificate; and
    (E) All specimens required by paragraph (d)(1)(ii)(D) of this 
section were received within 48 hours of collection

[[Page 458]]

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 under 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 under paragraph (c)(1) of this 
section if the horses meet the following requirements:
    (i) Each horse is accompanied at the time of importation by an 
import permit issued in accordance with 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 set of specimens consists of one culture 
swab from each location shall be taken from the prepuce, the urethral 
sinus, the distal urethra, and the fossa glandis, including the 
diverticulum of the fossa glandis; for mares, the specimens must be 
collected from the mucosal surfaces of the clitoral fossa, clitoral 
sinuses, and the distal cervix or endometrium in nonpregnant mares. All 
of the specimens collected must be cultured for CEM with negative 
results in a laboratory approved to culture for CEM by the national 
veterinary service of the region of origin;
    (iv) The horses described on the certificate must not have been used 
for natural breeding, for the collection of semen for artificial 
insemination in the case of stallions, or for artificial insemination in 
the case of mares, from the time the specimens were collected through 
the date of export;
    (v) All specimens required by paragraph (e)(1)(iii) of this section 
must be received within 48 hours of collection by a laboratory approved 
to culture for CEM by the national veterinary service of the region of 
export and must be accompanied by a statement indicating the date and 
time of their collection; and
    (vi) If any specimen collected in accordance with paragraph 
(e)(1)(iii) of this section is found to be positive for CEM, the 
stallion or mare must be treated for CEM in a manner approved by the 
national veterinary service of the region of export. After the treatment 
is completed, at least 21 days must pass before the horse will be 
eligible to be tested again in accordance with paragraph (e)(1)(ii) of 
this section. All treatments performed, and the dates of the treatments, 
must be recorded on the health certificate.
    (2) Post-entry. (i) Stallions and mares imported under paragraph 
(e)(1) of this section must complete the Federal quarantine required 
under Sec.93.308.

[[Page 459]]

Upon completion of the Federal quarantine, stallions must be sent to an 
approved State listed under paragraph (h)(6) of this section, and mares 
must be sent to an approved State listed under 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 Sec.71.22 of this chapter 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, the distal urethra, 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 three sets of specimens from the mucosal surfaces 
of the clitoral fossa and clitoral sinuses, with one set of specimens 
including a specimen from either the distal cervix or endometrium, 
between the third and fourteenth day after breeding, with negative 
results. The sets of specimens must be collected on three separate 
occasions within a 12-day period with no less than 72 hours between each 
set. A complement fixation test for CEM must be done with negative 
results between the twenty-first and twenty-eighth day after the 
breeding.
    (ii) If any culture or test required by this paragraph is positive 
for CEM, the stallion shall be treated as described in paragraph 
(e)(3)(i)(A) of this section and retested by being test bred to two 
mares no less than 21 days after the last day of treatment.
    (iii) A stallion may be released from State quarantine only if all 
cultures and tests of specimens from the mares used for test breeding 
are negative for CEM and all cultures performed on specimens taken from 
the stallion are negative for CEM.
    (4) Requirements for test mares. (i) Mares to be used to test 
stallions for CEM shall be permanently identified before the mares are 
used for such testing with the letter ``T.'' 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

[[Page 460]]

0.75 inch (1.9 cm) wide and shall be applied to the inside surface of 
the upper lip of the test mare.
    (ii) The test mares must be qualified prior to breeding as 
apparently free from CEM and may not be used for breeding from the time 
specimens are taken to qualify the mares as free from CEM. To qualify, 
each mare shall be tested with negative results by a complement fixation 
test for CEM, and specimens taken from each mare shall be cultured 
negative for CEM. Sets of specimens shall be collected on three separate 
occasions from the mucosal surfaces of the clitoral fossa and the 
clitoral sinuses, with one set of specimens including a specimen from 
either the distal cervix or endometrium, within a 12-day period with no 
less than 72 hours between each set.
    (iii) A test mare that has been used to test stallions for CEM may 
be released from quarantine only if:
    (A) The test mare is found negative for CEM on all cultures and 
tests required under paragraph (e)(3)(ii) of this section; or
    (B) The test mare is subjected to an ovariectomy by an accredited 
veterinarian under the direct supervision of a State or Federal 
veterinarian; or
    (C) The test mare is treated and handled in accordance with 
paragraph (e)(5) of this section; or
    (D) The test mare is moved directly to slaughter without unloading 
en route, is euthanized, or dies.
    (5) Testing and treatment requirements for mares. (i) Once the mare 
is in the approved State, a complement fixation test for CEM must be 
done, and three sets of specimens shall be collected from the mucosal 
surfaces of the clitoral fossa and clitoral sinuses, with one set of 
specimens including a specimen from the surfaces of the distal cervix or 
endometrium in nonpregnant mares. The sets of specimens must be 
collected on three separate occasions within a 12-day period with no 
less than 72 hours between each set. An accredited veterinarian shall 
collect specimens and shall submit each set of specimens to the National 
Veterinary Services Laboratories in Ames, IA, or to a laboratory 
approved by the Administrator in accordance with Sec.71.22 of this 
chapter to conduct CEM cultures and tests.
    (ii) After the three sets of specimens required by paragraph 
(e)(5)(i) of this section have been collected, an accredited 
veterinarian shall manually remove organic debris from the sinuses of 
each mare and then flush the sinuses with a cerumalytic agent. \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 performed on specimens taken from the mare are negative for 
CEM.
    (v) If any culture required by this paragraph is positive for CEM, 
the mare shall be treated as described in paragraphs (e)(5)(ii) and 
(e)(5)(iii) of this section. No less than 21 days after the last day of 
treatment, the mare shall be tested again in accordance with paragraph 
(e)(5)(i) of this section. If all specimens are negative for CEM, the 
mare may be released from quarantine.
    (f) Special provisions for temporary importation for competition or 
entertainment purposes. (1) Horses over 731 days of age may be imported 
into the United States for no more than 90 days to compete in specified 
events provided that the conditions in paragraphs (f)(3) through (f)(12) 
of this section are met.
    (2) Horses over 731 days of age may be temporarily imported into the 
United States solely for noncompetitive public exhibition and 
entertainment purposes

[[Page 461]]

provided that the conditions in paragraphs (f)(3) through (f)(12) of 
this section are met.
    (3) At the time of importation, each horse must be accompanied by an 
import permit in accordance with Sec.93.304 and a health certificate 
issued in accordance with Sec.93.314. For horses imported in 
accordance with paragraph (f)(2) of this section, the health certificate 
must also certify that cultures negative for CEM were obtained from 
three sets of specimens collected from the mucosal surfaces of the 
clitoral fossa and clitoral sinuses, with one set of specimens including 
a specimen from the surfaces of the distal cervix or endometrium, of any 
female horses and from the surfaces of the prepuce, the urethral sinus, 
the distal urethra, and the fossa glandis, including the diverticulum of 
the fossa glandis, of any male horses. For both female and male horses, 
the sets of specimens must be collected on three separate occasions 
within a 12-day period with no less than 72 hours between each set, and 
the last of these sets of specimens must be collected within 30 days 
prior to exportation. All specimens required by this paragraph must be 
collected by a licensed veterinarian who either is, or is acting in the 
presence of, the veterinarian signing the certificate.
    (4) Following the horse's arrival in the United States:
    (i) A horse imported in accordance with paragraph (f)(1) of this 
section may remain in the United States for not more than 90 days, 
except as provided in paragraph (f)(9) of this section.
    (ii) A horse imported in accordance with paragraph (f)(2) of this 
section may remain in the United States indefinitely, except as provided 
in paragraph (f)(9) of this section, as long as the conditions of 
paragraphs (f)(3) through (f)(12) of this section are met and the 
horse's owner or importer applies for and obtains from APHIS an import 
permit, as provided for in Sec.93.304, each year prior to the 
anniversary date of the horse's arrival in the United States.
    (5) While the horse is in the United States, the following 
conditions must be met:
    (i) A horse imported in accordance with paragraph (f)(2) of this 
section:
    (A) Must not be entered in competitions.
    (B) Must be regularly used in performances or exhibitions, unless 
sick or injured. A horse that is no longer performing or being exhibited 
must be exported or made eligible for permanent entry in accordance with 
paragraph (f)(9) of this section.
    (C) Must be kept with the other horses listed on the import permit, 
unless otherwise approved by an APHIS representative.
    (ii) Except as provided in paragraph (f)(5)(viii) of this section, 
the horse must be moved according to the itinerary and methods of 
transport specified in the import permit provided for in Sec.93.304.
    (iii) The horse must be monitored by an accredited veterinarian or 
APHIS representative to ensure that the provisions of paragraphs 
(f)(5)(ii), (f)(5)(vi), and (f)(5)(vii) of this section are met. If the 
monitoring is performed by an accredited veterinarian, the Veterinarian 
in Charge will ensure that the accredited veterinarian is familiar with 
the requirements of this section and spot checks will be conducted by an 
APHIS representative to ensure that the requirements of this section are 
being met. If an APHIS representative finds that requirements are not 
being met, the Administrator may require that all remaining monitoring 
be conducted by APHIS representatives to ensure compliance.
    (iv) Except when in transit, the horse must be kept on a premises 
that has been approved by an APHIS representative. For horses imported 
in accordance with paragraph (f)(1) of this section, such approval may 
be oral or in writing. If the approval is oral, it will be confirmed in 
writing by the Administrator as soon as circumstances permit. For horses 
imported in accordance with paragraph (f)(2) of this section, the 
approval will be in writing. To receive approval, the premises:
    (A) Must not be a breeding premises; and
    (B) Must be or contain a building or temporary structure in which 
the horse can be kept in a stall that is separated from other stalls 
that contain horses that are not listed on the import permit, either by 
an empty stall, by an

[[Page 462]]

open area across which horses cannot touch each other, or by a solid 
wall that is at least 8 feet (2.4 meters) high.
    (v) While in transit, the horse must be moved in either an aircraft 
or a sealed van or trailer. If the horse is moved in a sealed van or 
trailer, the seal may be broken only by an APHIS representative at the 
horse's destination, except in situations where the horse's life is in 
danger.
    (vi) Except when actually competing, performing, or being exhibited 
or exercised, the horse must be kept in a pasture approved by APHIS or 
in a stall that is separated from other stalls containing horses that 
are not listed on the import permit, either by an empty stall, by an 
open area across which horses cannot touch each other, or by a solid 
wall that is at least 8 feet (2.4 meters) high.
    (vii) The horse may not be used for breeding purposes (including 
artificial insemination or semen collection) and may not have any other 
sexual contact with other horses. The horse may not undergo any genital 
examinations, except that a horse imported in accordance with paragraph 
(f)(2) of this section may undergo genital examinations for diagnosis or 
treatment of a medical condition with the prior approval of an APHIS 
representative.
    (viii) The horse may be moved for diagnosis or treatment of a 
medical condition with the prior approval of an APHIS representative.
    (ix) After the horse is transported anywhere in the United States, 
any vehicle in which the horse was transported must be cleaned and 
disinfected in the presence of an APHIS representative, according to the 
procedures specified in Sec. Sec.71.7 through 71.12 of this chapter, 
before any other horse is transported in the vehicle.
    (x) The cleaning and disinfection specified in paragraph (f)(5)(ix) 
of this section must be completed before the vehicle is moved from the 
place where the horse is unloaded. In those cases where the facilities 
or equipment for cleaning and disinfection are inadequate at the place 
where the horse is unloaded, the Administrator may allow the vehicle to 
be moved to another location for cleaning and disinfection when the move 
will not pose a disease risk to other horses in the United States.
    (xi) The owner or importer of the horse must comply with any other 
provisions of this part applicable to him or her.
    (6) Except as provided in paragraph (f)(7) of this section, if the 
owner or importer wishes to change the horse's itinerary or the methods 
by which the horse is transported from that which he or she specified in 
the application for the import permit, the owner or importer must make 
the request for change in writing to the Administrator. Requests for 
change must be submitted to APHIS no less than 15 days before the 
proposed date of the change. Requests may be submitted to APHIS by 
postal mail, commercial delivery service, fax, or e-mail. The change in 
itinerary or method of transport may not be made without the written 
approval of the Administrator, who may grant the request for change when 
he or she determines that granting the request will not endanger other 
horses in the United States and that sufficient APHIS personnel are 
available to provide the services required by the owner or importer.
    (7) In response to an emergency or other unforeseen circumstances or 
events (e.g., weather-related transportation delays, vehicle breakdown, 
medical emergencies, etc.), the horse's itinerary or methods of 
transportation may be changed, with the prior approval of an APHIS 
representative, from that which is specified in the application for an 
import permit. Requests for such a change may be submitted to APHIS by 
telephone, postal mail, commercial delivery service, fax, or e-mail. 
Approval may be oral or in writing. If the approval is oral, it will be 
confirmed in writing by the Administrator as soon as circumstances 
permit.
    (8) The Administrator may cancel, orally or in writing, the import 
permit provided for under Sec.93.304 whenever the Administrator finds 
that the owner or importer of the horse has not complied with the 
provisions of paragraphs (f)(3) through (f)(7) of this section or any 
conditions imposed under those provisions. If the cancellation is oral, 
the

[[Page 463]]

Administrator will confirm the cancellation and the reasons for the 
cancellation in writing as soon as circumstances permit. Any person 
whose import permit is canceled may appeal the decision in writing to 
the Administrator within 10 days after receiving oral or written 
notification of the cancellation, whichever is earlier. If the appeal is 
sent by mail, it must be postmarked within 10 days after the owner or 
importer receives oral or written notification of the cancellation, 
whichever is earlier. The appeal must include all of the facts and 
reasons upon which the person relies to show that the import permit was 
wrongfully canceled. The Administrator will grant or deny the appeal in 
writing as promptly as circumstances permit, stating the reason for his 
or her decision. If there is a conflict as to any material fact, a 
hearing will be held to resolve the conflict. Rules of practice 
concerning the hearing will be adopted by the Administrator.
    (9) Except in those cases where an appeal is in process, any person 
whose import permit is canceled must move the horse identified in the 
import permit out of the United States within 10 days after receiving 
oral or written notification of cancellation, whichever is earlier. The 
horse is not permitted to enter competition, perform, or be exhibited 
from the date the owner or importer receives the notice of cancellation 
until the horse is moved out of the United States or until resolution of 
an appeal in favor of the owner or importer. Except when being 
exercised, the horse must be kept, at the expense of the owner or 
importer, in a stall on the premises where the horse is located when the 
notice of cancellation is received or, if the horse is in transit when 
the notice of cancellation is received, on the premises where it is next 
scheduled to compete, perform, or be exhibited according to the import 
permit. The stall in which the horse is kept must be separated from 
other stalls containing horses that are not listed on the import permit, 
either by an empty stall, by an open area across which horses cannot 
touch each other, or by a solid wall that is at least 8 feet (2.4 
meters) high. In cases where the owners of the above specified premises 
do not permit the horse to be kept on those premises, or when the 
Administrator determines that keeping the horse on the above specified 
premises will pose a disease risk to horses in the United States, the 
horse must be kept, at the expense of the owner or importer, on an 
alternative premises approved by the Administrator.
    (10) Stallions or mares over 731 days of age that are imported in 
accordance with paragraphs (f)(1) or (f)(2) of this section may be 
eligible to remain in the United States if the following is completed:
    (i) Following completion of the itinerary specified in the import 
permit provided for in Sec.93.304, the horse's owner or importer 
applies for and receives a new import permit that specifies that the 
stallion or mare will be moved to an approved State listed under 
paragraph (h)(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.
    (11) All costs and charges associated with the supervision and 
maintenance of a horse imported under paragraphs (f)(1) or (f)(2) of 
this section will be borne by the horse's owner or importer. The costs 
associated with the supervision and maintenance of the horse by an APHIS 
representative at his or her usual places of duty will be reimbursed by 
the horse's owner or importer through user fees payable under part 130 
of this chapter.
    (12) In the event that an APHIS representative must be temporarily 
detailed from his or her usual place of duty in connection with the 
supervision and maintenance of a horse imported under this paragraph 
(f), the owner or importer of the horse must execute a trust fund 
agreement with APHIS to reimburse all expenses (including travel costs, 
salary, per diem or subsistence, administrative expenses, and incidental 
expenses) incurred by the Department in connection with the temporary 
detail. Under

[[Page 464]]

the trust fund agreement, the horse's owner or importer must deposit 
with APHIS an amount equal to the estimated cost, as determined by 
APHIS, for the APHIS representative to inspect the premises at which the 
horse will compete, perform, or be exhibited; to conduct the monitoring 
required by paragraph (f)(5)(iii) of this section; and to supervise the 
cleaning and disinfection required by paragraph (f)(5)(ix) of this 
section. The estimated costs will be based on the following factors:
    (i) Number of hours needed for an APHIS representative to conduct 
the required inspection and monitoring;
    (ii) For services provided during regular business hours (8 a.m. to 
4:30 p.m., Monday through Saturday, except holidays), the average 
salary, per hour, for an APHIS representative;
    (iii) For services provided outside regular business hours, the 
applicable rate for overtime, night differential, or Sunday or holiday 
pay, based on the average salary, per hour, for an APHIS representative;
    (iv) Number of miles from the premises at which the horse competes, 
performs, or is exhibited to the APHIS office or facility that is 
monitoring the activities;
    (v) Government rate per mile for automobile travel or, if 
appropriate, cost of other means of transportation between the premises 
at which the horse competes, performs, or is exhibited and the APHIS 
office or facility;
    (vi) Number of trips between the premises at which the horse 
competes, performs, or is exhibited and the APHIS office or facility 
that APHIS representatives are required to make in order to conduct the 
required inspection and monitoring;
    (vii) Number of days the APHIS representative conducting the 
inspection and monitoring must be in ``travel status'';
    (viii) Applicable Government per diem rate; and
    (ix) Cost of related administrative support services.
    (13) If a trust fund agreement with APHIS has been executed by the 
owner or importer of a horse in accordance with paragraph (f)(12) of 
this section and APHIS determines, during the horse's stay in the United 
States, that the amount deposited will be insufficient to cover the 
services APHIS is scheduled to provide during the remainder of the 
horse's stay, APHIS will issue to the horse's owner or importer a bill 
to restore the deposited amount to a level sufficient to cover the 
estimated cost to APHIS for the remainder of the horse's stay in the 
United States. The horse's owner or importer must pay the amount billed 
within 14 days after receiving the bill. If the bill is not paid within 
14 days after its receipt, APHIS will cease to perform the services 
provided for in paragraph (f)(5) of this section until the bill is paid. 
The Administrator will inform the owner or importer of the cessation of 
services orally or in writing. If the notice of cessation is oral, the 
Administrator will confirm, in writing, the notice of cessation and the 
reason for the cessation of services as soon as circumstances permit. In 
such a case, the horse must be kept, at the expense of the owner or 
importer and until the bill is paid, in a stall either on the premises 
at which the horse is located when the notice of cessation of services 
is received or, if the horse is in transit when the notice of cessation 
of services is received, on the premises at which it is next scheduled 
to compete, perform, or be exhibited according to the import permit. The 
stall in which the horse is kept must be separated from other stalls 
containing horses that are not listed on the import permit, either by an 
empty stall, by an open area across which horses cannot touch each 
other, or by a solid wall that is at least 8 feet (2.4 meters) high. In 
cases where the owners of the premises where the horse would be kept 
following a cessation of services do not permit the horse to be kept on 
those premises, or when the Administrator determines that keeping the 
horse on the premises will pose a disease risk to other horses in the 
United States, the horse must be kept, at the expense of the owner or 
importer, on an alternative premises approved by the Administrator. 
Until the bill is paid, the horse is not permitted to enter competition, 
perform, or be exhibited. Any amount deposited in excess of the costs

[[Page 465]]

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 under 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 under paragraph (c)(1) of this section that are imported 
under paragraph (e) of this section, the State must meet the following 
conditions:
    (1) The State must enter into a written agreement with the 
Administrator, whereby the State agrees to enforce its laws and 
regulations to control CEM and to abide by the conditions of approval 
established by the regulations in this part.
    (2) The State must agree to quarantine all stallions and mares over 
731 days of age imported under the provisions of paragraph (e) of this 
section until the stallions have been treated in accordance with 
paragraph (e)(3) of this section and the mares have been treated in 
accordance with paragraph (e)(5) of this section.
    (3) The State must agree to quarantine all mares used to test 
stallions for CEM until the mares have been released from quarantine in 
accordance with paragraph (e)(4) of this section.
    (4) The State must 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

[[Page 466]]

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) A list of States approved by APHIS to receive stallions over 731 
days of age imported under paragraph (e) of this section is maintained 
on the APHIS Web site at http://www.aphis.usda.gov/ import_export/
animals/ downloads/states_app_ conduct_cem_testing.pdf. Copies of the 
list will also be available via postal mail, fax, or email upon request 
to the Sanitary Trade Issues Team, National Center for Import and 
Export, Veterinary Services, Animal and Plant Health Inspection Service, 
4700 River Road Unit 38, Riverdale, Maryland 20737.
    (7) A list of States approved by APHIS to receive mares over 731 
days of age imported under paragraph (e) of this section is maintained 
on the APHIS Web site at http://www.aphis.usda.gov/ import_export/
animals/ downloads/states_app_ conduct_cem_testing.pdf. Copies of the 
list will also be available via postal mail, fax, or email upon request 
to the Sanitary Trade Issues Team, National Center for Import and 
Export, Veterinary Services, Animal and Plant Health Inspection Service, 
4700 River Road Unit 38, Riverdale, Maryland 20737.
    (i) [Reserved]
    (j) Examination and treatment for screwworm. Horses from regions 
where APHIS considers screwworm to exist may be imported into the United 
States only if they meet the requirements in paragraphs (j)(1) through 
(7) of this section and all other applicable requirements of this part. 
APHIS will maintain a list of regions where screwworm is considered to 
exist on the APHIS Web site at http://www.aphis.usda.gov/ import_export/ 
animals/animal_disease _status.shtml. Copies of the list will also be 
available via postal mail, fax, or email upon request to the Sanitary 
Trade Issues Team, National Center for Import and Export, Veterinary 
Services, Animal and Plant Health Inspection Service, 4700 River Road 
Unit 38, Riverdale, Maryland 20737. APHIS will add a region to the list 
upon determining that screwworm exists in the region based on reports 
APHIS receives of detections of the pest from veterinary officials of 
the exporting country, from the World Organization for Animal Health 
(OIE), or from other sources the Administrator determines to be 
reliable. APHIS will remove a region from the list after conducting an 
evaluation of the region in accordance with Sec.92.2 of this 
subchapter and finding that screwworm is not present in the region. In 
the case of a region formerly not on this list that is added due to a 
detection, the region may be removed from the list in accordance with 
the procedures for reestablishment of a region's disease-free status in 
Sec.92.4 of this subchapter.
    (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.
    (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

[[Page 467]]

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, 0579-0165, and 0579-0324)

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56016, Oct. 28, 1997]

    Editorial Note: For Federal Register citations affecting Sec.
93.301, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



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 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.

[[Page 468]]

    (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 for horses to be quarantined at privately owned quarantine 
facilities. Horses, except horses from or which have transited any 
region in which African horsesickness is declared to exist, \10\ 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 
owned quarantine facilities 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.
---------------------------------------------------------------------------

    \10\ 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. Redesignated at 62 FR 56012, Oct. 28, 1997]

    Editorial Note: For Federal Register citations affecting Sec.
93.303, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



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 privately owned quarantine facility, 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

[[Page 469]]

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)(1) 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)(1) of this part, the horse's owner or importer must 
include the following information with the application for permit that 
is required by paragraph (a)(1)(i) of this section:
    (A) That the application is being made for a horse that will remain 
in the United States for no more than 90 days;
    (B) The names, dates, and locations of the events in which the horse 
will compete while in the United States;
    (C) The names and locations of the premises on which the horse will 
be kept while in the United States, and the dates the horse will be kept 
on each premises; and
    (D) The methods and routes by which the horse will be transported 
while in the United States.
    (iii) Horses intended for importation under Sec.93.301(f)(2) must 
meet the permit requirements of paragraph (a)(1)(i) of this section. 
Additionally, for horses intended for importation under Sec.
93.301(f)(2), the horse's owner or importer must include the following 
information with the application for permit that is required by 
paragraph (a)(1)(i) of this section:
    (A) The individual identifying information required in paragraph 
(a)(1)(i) of this section for all horses to be imported.
    (B) The permanent electronic identification of each horse to be 
imported, if applicable. In the event that a horse has permanent 
electronic identification, the horse must be accompanied by a compatible 
reader.
    (C) Photographs (head and lateral views) that are sufficient to 
identify each horse on an electronic medium approved by APHIS.
    (D) The proposed total length of stay in the United States.
    (E) A description of the shows or events in which the horse will 
perform while in the United States.
    (F) The names, dates, and locations of the venues in which the horse 
will perform while in the United States.
    (G) The names and locations of the premises on which the horse will 
be kept while in the United States, and the dates the horse will be kept 
on each premises.
    (H) The methods and routes by which the horse will be transported 
while in the United States.
    (I) A written plan for handling sick or injured horses that 
includes:
    (1) The name, address, and phone number of each accredited 
veterinarian who will provide veterinary services in the United States;
    (2) The name, address, and phone number of medical facilities to be 
used to diagnose or treat sick or injured horses while in the United 
States; and
    (3) A plan to return sick or injured horses to performance 
condition.
    (J) An application for a trust fund or escrow account agreement with 
APHIS in accordance with Sec.93.301(f)(12).
    (iv) 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) or horses intended for quarantine at a privately 
owned quarantine facility, may also be denied because of: Communicable 
disease conditions in the area or region of origin, or in a region where 
the shipment has been or will be held or through which the shipment has 
been or will be transported; deficiencies in the regulatory programs for 
the control or eradication

[[Page 470]]

of animal diseases and the unavailability of veterinary services in the 
above mentioned regions; the importer's failure to provide satisfactory 
evidence concerning the origin, history, and health status of the 
horses; the lack of satisfactory information necessary to determine that 
the importation will not be likely to transmit any communicable disease 
to livestock or poultry of the United States; or any other circumstances 
which the Administrator believes require such denial to prevent the 
dissemination of any communicable disease of livestock or poultry into 
the United States.
    (3)(i) The importer or importer's agent shall pay or ensure payment 
of a reservation fee for each lot of horses to be quarantined in a 
facility maintained by USDA. For horses, the reservation fee shall be 
100 percent of the cost of providing care, feed, and handling during 
quarantine, as estimated by the quarantine facility's veterinarian in 
charge.
    (ii) At the time the importer or the importer's agent requests a 
reservation of quarantine space, the importer or importer's agent shall 
pay the reservation fee by check or U.S. money order or ensure payment 
of the reservation fee by an irrevocable letter of credit from a 
commercial bank (the effective date on such letter of credit shall run 
to 30 days after the date the horses are scheduled to be released from 
quarantine); except that anyone who issues a check to the Department for 
a reservation fee which is returned because of insufficient funds shall 
be denied any further request for reservation of a quarantine space 
until the outstanding amount is paid.
    (iii) Any reservation fee paid by check or U.S. money order shall be 
applied against the expenses incurred for services received by the 
importer or importer's agent in connection with the quarantine for which 
the reservation was made. Any part of the reservation fee which remains 
unused after being applied against the expenses incurred for services 
received by the importer or the importer's agent in connection with the 
quarantine for which the reservation was made, shall be returned to the 
individual who paid the reservation fee. If the reservation fee is 
ensured by a letter of credit, the Department will draw against the 
letter of credit unless payment for services received by the importer or 
importer's agent in connection with the quarantine is otherwise made at 
least 3 days prior to the expiration date of the letter of credit.
    (iv) Any reservation fee shall be forfeited if the importer or the 
importer's agent fails to present for entry, within 24 hours following 
the designated time of arrival, the horse for which the reservation was 
made: Except that a reservation fee shall not be forfeited if the 
Administrator determines that services, other than provided by carriers, 
necessary for the importation of the horses within the required period 
are unavailable because of unforeseen circumstances as determined by the 
Administrator (such as the closing of an airport due to inclement 
weather or the unavailability of the reserved space due to the extension 
of another quarantine).
    (v) If the reservation fee was ensured by a letter of credit and the 
fee is to be forfeited under paragraph (a)(3)(iv) of this section, the 
Department will draw against the letter of credit unless the reservation 
fee is otherwise paid at least 3 days prior to the expiration date of 
the letter of credit.
    (vi) If a reservation is canceled, the importer or the importer's 
agent will be charged a fee according to the following schedule:

----------------------------------------------------------------------------------------------------------------
               Cancellation date                                               Fee
----------------------------------------------------------------------------------------------------------------
30 or more days before the scheduled            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.
----------------------------------------------------------------------------------------------------------------


[[Page 471]]

    (vii) If the reservation fee was ensured by a letter of credit, the 
Department will draw the amount of the cancellation fee against the 
letter of credit unless the cancellation fee is otherwise paid at least 
3 days prior to the expiration date of the letter of credit.
    (b) Permit. (1) When a permit is issued, the original and two copies 
will be sent to the importer. It shall be the responsibility of the 
importer to forward the original permit and one copy to the shipper in 
the region of origin, and it shall also be the responsibility of the 
importer to ensure that the shipper presents the copy of the permit to 
the carrier and makes the necessary arrangements for the original permit 
to accompany the shipment to the specified U.S. port of entry for 
presentation to the collector of customs.
    (2) Horses and horse test specimens for which a permit is required 
under paragraph (a) of this section will be received at the port of 
entry specified on the permit within the time prescribed in the permit, 
which shall not exceed 14 days from the first day that the permit is 
effective.
    (3) Horses and horse test specimens for which a permit is required 
under paragraph (a) of this section will not be eligible for entry if:
    (i) A permit has not been issued for the importation of the horse or 
horse test specimen;
    (ii) If the horse or horse test specimen is unaccompanied by the 
permit issued for its importation;
    (iii) If the horse or horse test specimen is shipped from any port 
other than the one designated in the permit;
    (iv) If the horse or horse test specimen arrives in the United 
States at any port other than the one designated in the permit;
    (v) If the horse or horse test specimen offered for entry differs 
from that described in the permit; or
    (vi) If the horse or horse test specimen is not handled as outlined 
in the application for the permit and as specified in the permit issued.

(Approved by the Office of Management and Budget under control numbers 
0579-0040 and 0579-0324)

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997]

    Editorial Note: For Federal Register citations affecting Sec.
93.304, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



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.
    (c) Any declaration, permit, or other document for horses required 
under this subpart may be issued and presented using a U.S. Government 
electronic information exchange system or other authorized method.

[55 FR 31495, Aug. 2, 1990,as amended at 81 FR 40151, June 21, 2016]



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

[[Page 472]]

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 in 
paragraph (a)(1)(i) of this section, 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.
    (i) Horses imported from regions of the Western Hemisphere that 
APHIS considers to be free of Venezuelan equine encephalomyelitis are 
exempt from the requirements of paragraph (a)(1) of this section. A list 
of regions that APHIS has declared free of Venezuelan equine 
encephalomyelitis is maintained on the APHIS Web site at http://
www.aphis.usda.gov/import _export/animals/animal_ import/equine/
equine_import _quarantine.shtml. Copies of the list will also be 
available via postal mail, fax, or email upon request to the Sanitary 
Trade Issues Team, National Center for Import and Export, Veterinary 
Services, Animal and Plant Health Inspection Service, 4700 River Road 
Unit 38, Riverdale, Maryland 20737.
    (ii) APHIS will add a region to the list of those it has declared 
free of Venezuelan equine encephalomyelitis after it conducts an 
evaluation of the region in accordance with Sec.92.2 of this 
subchapter and finds that the disease is not present. In the case of a 
region formerly on this list that is removed due to an outbreak, the 
region may be returned to the list in accordance with the procedures for 
reestablishment of a region's disease-free status in Sec.92.4 of this 
subchapter. APHIS will remove a region from the list of those it has 
declared free of Venezuelan equine encephalomyelitis upon determining 
that the disease exists in the region based on reports APHIS receives of 
outbreaks of the disease from veterinary officials of the exporting 
country, from the World Organization for Animal Health (OIE), or from 
other sources the Administrator determines to be reliable.
    (2) Horses intended for importation from regions APHIS considers to 
be affected with African horse sickness may enter the United States only 
at the port of New York, and must be quarantined at the New York Animal 
Import Center in Newburgh, New York, for at least 60 days. This 
restriction also applies to horses that have stopped in or transited a 
region considered affected with African horse sickness.
    (i) A list of regions that APHIS considers affected with African 
horse sickness is maintained on the APHIS Web site at http://
www.aphis.usda.gov/ import_export/animals/animal _disease_status.shtml. 
Copies of the list will also be available via postal mail, fax, or email 
upon request to the Sanitary Trade Issues Team, National Center for 
Import and Export, Veterinary Services, Animal and Plant Health 
Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 20737.
    (ii) APHIS will add a region to the list upon determining that the 
disease exists in the region based on reports

[[Page 473]]

APHIS receives of outbreaks of the disease from veterinary officials of 
the exporting country, from the World Organization for Animal Health 
(OIE), or from other sources the Administrator determines to be 
reliable. APHIS will remove a region from the list after conducting an 
evaluation of the region in accordance with Sec.92.2 of this 
subchapter and finding that the disease is not present in the region. In 
the case of a region formerly not on this list that is added due to an 
outbreak, the region may be removed from the list in accordance with the 
procedures for reestablishment of a region's disease-free status in 
Sec.92.4 of this subchapter.
    (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. \11\ 
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.
---------------------------------------------------------------------------

    \11\ 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) Temporary, privately owned quarantine facilities. Horses 
presented for entry into the United States as provided in Sec.
93.303(e) may be quarantined in temporary, privately owned quarantine 
facilities that meet the requirements of paragraphs (b)(1) and (b)(2) of 
this section and that have been approved by the Administrator for a 
specific importation.
    (1) Approval. Requests for approval and plans for proposed temporary 
facilities must be submitted no less than 15 days before the proposed 
date of entry of horses into the facility to APHIS, Veterinary Services, 
National Center for Import and Export, 4700 River Road Unit 39, 
Riverdale, MD 20737-1231. Before facility approval can be granted, a 
veterinary medical officer of APHIS must inspect the facility to 
determine whether it complies with the standards set forth in this 
section: Provided, however, that approval of any temporary facility and 
use of such facility will be contingent upon a determination made by the 
Administrator that adequate personnel are available to provide required 
services at the facility. Approval of any facility may be refused and 
approval of any quarantine facility may be withdrawn at any time by the 
Administrator, upon his or her determination that any requirements

[[Page 474]]

of this section are not being met. Before such action is taken, the 
operator of the facility will be informed of the reasons for the 
proposed action by the Administrator and afforded an opportunity to 
present his or her views. If there is a conflict as to any material 
fact, a hearing will be held to resolve the conflict. The cost of the 
facility and all maintenance and operational costs of the facility will 
be borne by the operator.
    (2) Standards and handling procedures. The facility must be 
maintained and operated in accordance with the following standards:
    (i) Inspection. Inspection and quarantine services must be arranged 
by the operator or his or her agent with the APHIS Veterinarian in 
Charge for the State in which the approved facility is located \12\ no 
less than 7 days before the proposed date of entry of the horses into 
the quarantine facility.
---------------------------------------------------------------------------

    \12\ The name and the address of the Veterinarian in Charge in any 
State is available from APHIS, Veterinary Services, National Center for 
Import and Export, 4700 River Road Unit 39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (ii) Physical plant requirements. (A) The facility must be located 
and constructed to prevent horses from having physical contact with 
animals outside the facility.
    (B) The facility must be constructed only with materials that can 
withstand repeated cleaning and disinfection. Disinfectants authorized 
in 9 CFR part 71 must be used. All walls, floors, and ceilings must be 
constructed of solid material that is impervious to moisture. Doors, 
windows, and other openings of the facility must be provided with double 
screens that will prevent insects from entering the facility.
    (iii) Sanitation and security. (A) The operator of the facility must 
arrange for a supply of water adequate to clean and disinfect the 
facility.
    (B) All feed and bedding must originate from an area not under 
quarantine because of splenetic or tick fever (see part 72 of this 
chapter) and must be stored within the facility.
    (C) Upon the death of any horse, the operator must arrange for the 
disposal of the horse's carcass by incineration. Disposal of all other 
waste removed from the facility during the time the horses are in 
quarantine or from horses that are refused entry into the United States 
must be either by incineration or in a public sewer system that meets 
all applicable environmental quality control standards. Following 
completion of the quarantine period and the release of the horses into 
the United States, all waste may be removed from the quarantine facility 
without further restriction.
    (D) The facility must be maintained and operated in accordance with 
any additional requirements the Administrator deems appropriate to 
prevent the dissemination of any communicable disease.
    (E) The facility must comply with all applicable local, State, and 
Federal requirements for environmental quality.
    (iv) Personnel. (A) Access to the facility will be granted only to 
persons working at the facility or to persons specifically granted such 
access by an APHIS representative.
    (B) The operator must provide attendants for the care and feeding of 
horses while in the quarantine facility.
    (C) Persons working in the quarantine facility may not come in 
contact with any horses outside the quarantine facility during the 
quarantine period for any horses in the facility.
    (v) Handling of horses in quarantine. Horses offered for importation 
into the United States that are quarantined in an approved temporary 
facility must be handled in accordance with paragraph (a) of this 
section while in quarantine.
    (c) Permanent, privately owned quarantine facilities. Horses 
presented for entry into the United States as provided in Sec.
93.303(e) may be quarantined in permanent, privately owned quarantine 
facilities approved by the Administrator as meeting the requirements of 
paragraphs (c)(1) through (c)(6) of this section.
    (1) APHIS approval--(i) Approval procedures. Persons seeking APHIS 
approval of a permanent, privately owned quarantine facility must write 
to the Administrator, c/o National Center for Import and Export, 
Veterinary Services, APHIS, 4700 River Road Unit 39, Riverdale, MD 
20737-1231. The application letter must include the full name and 
mailing address of the applicant;

[[Page 475]]

the location and street address of the facility for which approval is 
sought; blueprints of the facility; a description of the financial 
resources available for construction, operation, and maintenance of the 
facility; the anticipated source or origin of horses to be quarantined, 
as well as the expected size and frequency of shipments; a contingency 
plan for horses needing emergency veterinary care; and a contingency 
plan for the disposal of all the horses capable of being housed in the 
facility.
    (A) If APHIS determines that an application is complete and merits 
further consideration, the person applying for facility approval must 
enter into a service agreement with APHIS wherein the applicant agrees 
to pay the cost of all APHIS services associated with APHIS' evaluation 
of the application and facility. APHIS charges for the evaluation of the 
application and facility at hourly rates listed in Sec.130.30 of this 
chapter. This service agreement applies only to fees accrued during the 
application process. If the facility is approved by APHIS, facility 
owners must enter into a compliance agreement in accordance with 
paragraph (c)(2) of this section.
    (B) Requests for approval must be submitted to APHIS at least 120 
days prior to the date of application for local building permits. 
Requests for approval will be evaluated on a first-come, first-served 
basis.
    (ii) Criteria for approval. Before a facility may operate as a 
permanent, privately owned quarantine facility for horses, it must be 
approved by APHIS. To be approved:
    (A) The facility must meet all of the requirements of this section;
    (B) The facility must meet any additional requirements that may be 
imposed by the Administrator in each specific case, as specified in the 
compliance agreement required under paragraph (c)(2) of this section, to 
ensure that the quarantine of horses in the facility will be adequate to 
determine their health status, as well as to prevent the transmission of 
diseases into, within, and from the facility; and
    (C) The Administrator must determine that sufficient personnel, 
including one or more APHIS veterinarians and other professional, 
technical, and support personnel, are available to serve as APHIS 
representatives at the facility. If the facility is approved, APHIS 
representatives will be present at all import quarantine operations in 
order to monitor them and will be present in order to provide other 
technical services to ensure the biological security of the facility, 
including, but not limited to, those specified in paragraph (c)(4)(v)(H) 
of Sec.93.308. The Administrator's determination will be based on the 
expected size and frequency of shipments to the facility, as described 
in the application for approval of a permanent facility, as well as any 
other pertinent information in the application. APHIS will assign 
personnel to facilities requesting approval in the order that the 
facilities are approved. The Administrator has sole discretion on the 
number of APHIS personnel to be assigned to the facility.
    (iii) Maintaining approval. To maintain APHIS approval, the operator 
must continue to comply with all the requirements of paragraph (c) of 
this section and the terms of the compliance agreement executed in 
accordance with paragraph (c)(2) of this section.
    (iv) Denial or withdrawal of approval. Approval for a proposed 
permanent, privately owned quarantine facility may be denied or approval 
for a facility already in operation may be withdrawn at any time by the 
Administrator for any of the reasons provided in paragraph (c)(1)(iv)(C) 
of this section.
    (A) Before facility approval is denied or withdrawn, the operator of 
the facility will be informed of the reasons for the proposed action by 
the Administrator and afforded an opportunity to present his or her 
views. If there is a conflict as to any material fact, APHIS will afford 
the operator, upon request, the opportunity for a hearing with respect 
to the merits or validity of such action.
    (B) The Administrator may withdraw approval of an existing facility 
prior to a final determination in the hearing if the Administrator 
determines that such action is necessary to protect animal health or the 
public health, interest, or safety. Such withdrawal will be

[[Page 476]]

effective upon oral or written notification, whichever is earlier, to 
the operator of the facility. In the event of oral notification, APHIS 
will promptly give written confirmation to the operator of the facility. 
This withdrawal will continue in effect pending the completion of the 
hearing and any judicial review, unless otherwise ordered by the 
Administrator. In addition to withdrawal of approval for the reasons 
provided in paragraph (c)(1)(iv)(C) of this section, the Administrator 
will also automatically withdraw approval when the operator of any 
approved facility notifies the APHIS Veterinarian in Charge for the 
State in which the facility is located, in writing, that the facility is 
no longer in operation. \13\
---------------------------------------------------------------------------

    \13\ The name and address of the Veterinarian in Charge in any State 
is available from APHIS, Veterinary Services, National Center for Import 
and Export, 4700 River Road Unit 39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (C) The Administrator may deny or withdraw approval of a permanent, 
privately owned facility if:
    (1) Any requirement of this section or the compliance agreement is 
not complied with; or
    (2) The operator fails to remit any charges for APHIS services 
rendered; or
    (3) The operator or a person responsibly connected with the business 
of the quarantine facility acts as a paid agent (broker) for the 
importation or subsequent sale of horses; or
    (4) The operator or a person responsibly connected with the business 
of the quarantine facility is or has been found by a court of competent 
jurisdiction to have violated any law or regulation pertaining to the 
importation or quarantine of any animal; or
    (5) The operator or a person responsibly connected with the business 
of the quarantine facility is or has been convicted of any crime 
involving fraud, bribery, or extortion or any other crime involving a 
lack of the integrity needed for the conduct of operations affecting the 
importation of animals; or
    (6) The approved quarantine facility has not been in use to 
quarantine horses for a period of at least 1 year.
    (D) For the purposes of this section, a person is deemed to be 
responsibly connected with the business of the quarantine facility if 
such person has an ownership, mortgage, or lease interest in the 
facility's physical plant, or if such person is a partner, officer, 
director, holder, or owner of 10 percent or more of its voting stock, or 
is an employee in a managerial or executive capacity.
    (v) Approval for existing facilities. Any permanent, privately owned 
quarantine facility operating under APHIS authorization on August 3, 
2009 must be approved by APHIS to continue quarantine operations by 
August 3, 2010 or else must cease horse quarantine operations.
    (2) Compliance agreement. (i) All permanent, privately owned 
quarantine facilities for horses must operate in accordance with a 
compliance agreement executed by the operator or his or her agent and 
the Administrator, which must be renewed on an annual basis.
    (ii) The compliance agreement must provide that:
    (A) The facility must meet all applicable requirements of this 
section;
    (B) The operator agrees to have APHIS representatives present at all 
import quarantine operations at the facility in order to monitor the 
import quarantine operations;
    (C) The operator agrees to be responsible for the cost of the 
facility; all costs associated with its maintenance and operation; all 
costs associated with the hiring of employees and other personnel to 
attend to the horses as well as to maintain and operate the facility; 
all costs associated with the care of quarantined horses, such as feed, 
bedding, medicines, inspections, testing, laboratory procedures, and 
necropsy examinations; and all APHIS charges for the services of APHIS 
representatives in accordance with this section and part 130 of this 
chapter;
    (D) The operator agrees to bar from the facility any employee or 
other personnel at the facility who fails to comply with paragraph (c) 
of this section or other provisions of this part, any terms of the 
compliance agreement, or related instructions from APHIS 
representatives;
    (E) The operator agrees to demonstrate, to the satisfaction of the 
Administrator, that the routine cleaning and maintenance of the 
facility, the

[[Page 477]]

daily care of animals in quarantine, the disposal of wastes at the 
facility, the cleaning and disinfection procedures employed by the 
facility, the handling, washing, and disposal of soiled and contaminated 
clothing worn within the facility, and the disposal of dead horses, 
whether onsite or offsite, adhere to the best practices of biological 
security and animal care;
    (F) The operator agrees to random spot audits by APHIS 
representatives to determine whether employees and other personnel are 
complying with these practices; and
    (G) The operator of the facility allows the Administrator to amend 
the compliance agreement at any time after approval of the facility in 
order to incorporate related instructions issued by APHIS 
representatives while the facility is operational
    (3) Physical plant requirements. The facility must meet the 
following requirements as determined by an APHIS inspection prior to 
admitting horses into the facility:
    (i) Location. The quarantine facility must be located in proximity 
to a port authorized under Sec.93.303(e). The site and the specific 
routes for the movement of horses from the port to the site must be 
approved by the Administrator based on consideration of whether the site 
or routes would put the horses in a position that could result in the 
transmission of communicable diseases to domestic horses.
    (ii) Construction. The facility must be of sound construction, in 
good repair, and properly designed to prevent the escape of quarantined 
horses. It must have adequate capacity to receive and house shipments of 
horses as lots on an ``all in, all out'' basis, whereby separate lots of 
horses can be received and housed without contact with any other lots 
being quarantined at the facility. The facility must include the 
following:
    (A) Perimeter fencing. The facility must be surrounded by a security 
fence of sufficient height and design to prevent the entry of 
unauthorized people and animals from outside the facility and to prevent 
the escape of the horses in quarantine.
    (B) Entrances and exits. All entryways into the nonquarantine area 
of the facility must be equipped with a secure and lockable door. While 
horses are in quarantine, all access to the quarantine area for horses 
must be from within the building, and each such entryway to the 
quarantine area must be equipped with a series of solid self-closing 
double doors. Emergency exits to the outside are permitted in the 
quarantine area. Such emergency exits must be constructed so as to 
permit their being opened from the inside of the facility only.
    (C) Windows and other openings. The facility must be constructed so 
that any windows or other openings in the quarantine area are double-
screened with screening of sufficient gauge and mesh to prevent the 
entry or exit of insects and other vectors of diseases of horses and to 
provide ventilation sufficient to ensure the comfort and safety of all 
horses in the facility. The interior and exterior screens must be 
separated by at least 3 inches (7.62 cm). All screening of windows or 
other openings must be easily removable for cleaning, but must otherwise 
remain locked and secure at all times in a manner satisfactory to APHIS 
representatives in order to ensure the biological security of the 
facility.
    (D) Lighting. The entire facility, including its stalls and 
hallways, must have adequate lighting.
    (E) Loading docks. The facility must have separate docks for animal 
receiving and releasing and for general receiving and pickup, unless a 
single dock used for both purposes is cleaned and disinfected after each 
use in accordance with paragraph (c)(4)(iv)(F) of this section.
    (F) Surfaces. The facility must be constructed so that the floor 
surfaces with which horses have contact are nonslip and wear-resistant. 
All floor surfaces with which the horses, their excrement, or discharges 
have contact must provide for adequate drainage. All floor and wall 
surfaces with which the horses, their excrement, or discharges have 
contact must be impervious to moisture and be able to withstand frequent 
cleaning and disinfection without deterioration. Ceilings and wall 
surfaces with which the horses, their excrement, or discharges do not 
have contact must be able to

[[Page 478]]

withstand cleaning and disinfection between shipments of horses. All 
floor and wall surfaces must be free of sharp edges that could cause 
injury to horses.
    (G) Horse stalls. The stalls in which horses are kept must be large 
enough to allow each animal to make normal postural and social 
adjustments with adequate freedom of movement. Exercise equipment for 
horses may be kept in the stalls, provided that there will still be 
sufficient space within the stalls for the horses to move freely once 
the equipment is installed.
    (H) Aisleways. The aisleways through which horses are moved to and 
from stalls must be wide enough to provide for safe movement of horses, 
including allowing horses to turn around in the aisleway, preventing 
horses in facing stalls from coming into contact with horses in the 
aisleway, and adequately ventilating the stalls.
    (I) Means of isolation. Physical barriers must separate different 
lots of horses in the facility so that horses in one lot cannot have 
physical contact with horses in another lot or with their excrement or 
discharges. Stalls must be available that are capable of isolating any 
horses exhibiting signs of illness.
    (J) Showers. A shower must be located at each entrance to the 
quarantine area. If the facility has a necropsy area, a shower must be 
located at the entrance to the necropsy area. A clothes-storage and 
clothes-changing area must be provided with each shower area. There must 
also be one or more receptacles near each shower so that clothing that 
has been worn into the quarantine area can be deposited in a receptacle 
prior to entering the shower.
    (K) APHIS space. The facility must have adequate space for APHIS 
representatives to conduct examinations and testing of the horses in 
quarantine, prepare and package samples for mailing, and store the 
necessary equipment and supplies for duplicate samples. The space 
provided to conduct examinations and testing must include a 
refrigerator-freezer in which to store samples. The examination space 
must include equipment to provide for the safe inspection of horses. The 
facility must also include a secure, lockable office for APHIS use with 
enough room for a desk, chair, and filing cabinet.
    (L) Necropsy area. The facility must either include an area for 
conducting necropsies onsite or must have designated an alternate 
facility at which a suitable necropsy area is available. If the facility 
has a necropsy area, it must be of sufficient size to perform necropsies 
on horses and be equipped with adequate lighting, hot and cold running 
water, a drain, a cabinet for storing instruments, a refrigerator-
freezer for storing specimens, and an autoclave to sterilize veterinary 
equipment. If the facility does not have such an area, it must specify 
an alternate facility at which a suitable necropsy area is available, a 
route from the quarantine facility to the alternate facility's necropsy 
area, and the safeguards that will be in place to ensure that 
communicable diseases of horses are not spread during transit. This 
alternate facility and transport methodology must be approved by the 
Administrator under the procedures for requesting variances outlined in 
paragraph (c)(6) of this section.
    (M) Storage. The facility must have sufficient storage space for 
equipment and supplies used in import quarantine operations. Storage 
space must include separate, secure storage for pesticides and for 
medical and other biological supplies, as well as a separate vermin-
proof storage area for feed and bedding, if feed and bedding are stored 
at the facility. If the facility has multiple lot-holding areas, then 
separate storage space for any reusable supplies and equipment that are 
not disinfected after each use in accordance with part 71 of this 
chapter must be provided for each lot-holding area.
    (N) Additional space needs. The facility must have an area for 
washing and drying clothes, linens, and towels and an area for cleaning 
and disinfecting equipment used in the facility. The facility must also 
include a work area for the repair of equipment.
    (O) Restrooms. The facility must have permanent restrooms in both 
the quarantine and nonquarantine areas of the facility.
    (P) Ventilation and climate control. The facility must be 
constructed with

[[Page 479]]

an air handling system capable of controlling and maintaining the 
ambient temperature, air quality, humidity, and odor at levels that are 
not injurious or harmful to the health of horses in quarantine. Air 
supplied to the quarantine area must not be recirculated or reused for 
other ventilation needs. Air handling systems for lot-holding areas must 
be separate from air handling systems for other operational and 
administrative areas of the facility. In addition, if the facility is 
equipped to handle more than one lot of horses at a time, the air 
handling system must be adequate to ensure that there is no cross-
contamination of air between separate lot-holding areas.
    (Q) Fire protection. The facility, including the lot-holding areas, 
must have a fire alarm voice communication system.
    (R) Communication system. The facility must have a communication 
system between the nonquarantine and quarantine areas of the facility.
    (iii) Sanitation. To ensure that proper animal health and biological 
security measures are observed, the facility must have the following:
    (A) Equipment and supplies necessary to maintain the facility in 
clean and sanitary condition, including pest control equipment and 
supplies and cleaning and disinfecting equipment with adequate capacity 
to disinfect the facility and equipment.
    (B) Any reusable equipment and supplies that are not disinfected 
after each use in accordance with part 71 of this chapter maintained 
separately for each lot of horses.
    (C) Equipment and supplies used in the quarantine area maintained 
separately from equipment and supplies used in the nonquarantine area.
    (D) A supply of potable water adequate to meet all watering and 
cleaning needs, with water faucets for hoses located throughout the 
facility. An emergency supply of water for horses in quarantine must 
also be maintained.
    (E) A stock of disinfectant authorized in part 71 of this chapter or 
otherwise approved by the Administrator that is sufficient to disinfect 
the entire facility.
    (F) The capability to dispose of wastes, including manure, urine, 
and used bedding, by means of burial, incineration, or public sewer. 
Other waste material must be handled in such a manner that minimizes 
spoilage and the attraction of pests and must be disposed of by 
incineration, public sewer, or other preapproved manner that prevents 
the spread of disease. Disposal of wastes must be carried out in 
accordance with the terms of the compliance agreement, and is subject to 
spot audits by APHIS representatives.
    (G) The capability to dispose of horse carcasses in a manner 
approved by the Administrator and under conditions that minimize the 
risk of disease spread from carcasses.
    (H) For incineration to be carried out at the facility, the facility 
must have incineration equipment that is detached from other facility 
structures and is capable of burning animal waste and refuse. The 
incineration site must also include an area sufficient for solid waste 
holding. Incineration may also take place at a local site away from the 
facility premises. All incineration activities, whether onsite or 
offsite, must be carried out in accordance with the terms of the 
compliance agreement, and are subject to spot audits by APHIS 
representatives.
    (I) The capability to control surface drainage and effluent into, 
within, and from the facility in a manner that prevents the spread of 
disease into, within, or from the facility. If the facility is approved 
to handle more than one lot of horses at the same time, the drainage 
system must be adequate to ensure that there is no cross-contamination 
between lot-holding areas.
    (iv) Security. Facilities must provide the following security 
measures:
    (A) The facility and premises must be kept locked and secure at all 
times while horses are in quarantine.
    (B) The facility and premises must have signs indicating that the 
facility is a quarantine area and no visitors are allowed.
    (C) The facility and premises must be guarded at all times by one or 
more representatives of a bonded security company, or, alternatively, 
the facility

[[Page 480]]

must have an electronic security system that indicates the entry of 
unauthorized persons into the facility. Electronic security systems must 
be coordinated through or with the local police so that monitoring of 
the quarantine facility is maintained whenever APHIS representatives are 
not at the facility. The electronic security system must be of the 
``silent type'' and must be triggered to ring at the monitoring site and 
not at the facility. The electronic security system must be approved by 
Underwriter's Laboratories. The operator must provide written 
instructions to the monitoring agency stating that the police and a 
representative of APHIS designated by APHIS must be notified by the 
monitoring agency if the alarm is triggered. The operator must also 
submit a copy of those instructions to the Administrator. The operator 
must notify the designated APHIS representative whenever a breach of 
security occurs or is suspected of having occurred. In the event that 
disease is diagnosed in quarantined horses, the Administrator may 
require the operator to have the facility guarded by a bonded security 
company in a manner that the Administrator deems necessary to ensure the 
biological security of the facility.
    (D) The operator must furnish a telephone number or numbers to APHIS 
at which the operator or his or her agent can be reached at all times.
    (E) APHIS is authorized to place APHIS seals on any or all entrances 
and exits of the facility when determined necessary by APHIS and to take 
all necessary steps to ensure that such seals are broken only in the 
presence of an APHIS representative. If someone other than an APHIS 
representative breaks such seals, APHIS will consider the act a breach 
in security and APHIS representatives will make an immediate accounting 
of all horses in the facility. If a breach in security occurs, APHIS may 
extend the quarantine period as long as necessary to determine that the 
horses are free of communicable diseases.
    (4) Operating procedures. The following procedures must be observed 
at the facility at all times:
    (i) Oversight by APHIS representatives. (A) Import quarantine 
operations at a privately owned quarantine facility may only be 
conducted with the physical presence of and monitoring by APHIS 
representatives. APHIS representatives are also authorized to perform 
the services required by this section and by the compliance agreement.
    (B) If, as the result of a spot audit, or for any other reason, 
APHIS determines that the operator has failed to properly care for, 
feed, or handle quarantined horses as required in this paragraph (c) or 
in accordance with the terms of the compliance agreement, or has failed 
to maintain and operate the facility as provided in this paragraph (c) 
or in accordance with the terms of the compliance agreement, APHIS 
representatives will furnish such services, will make arrangements for 
the sale or disposal of quarantined horses at the quarantine facility 
owner's expense, or will begin the process for withdrawal of approval of 
the quarantine facility specified in paragraph (c)(1)(iv) of this 
section.
    (ii) Personnel. (A) The operator must provide adequate personnel to 
maintain the facility and care for the horses in quarantine, including 
attendants to care for and feed horses, and other personnel as needed to 
maintain, operate, and administer the facility.
    (B) The operator must provide APHIS with an up-to-date list of all 
personnel who have access to the facility. The list must include the 
names, current residential addresses, and employee identification 
numbers of each person. When the operator wishes to grant access to the 
facility to persons who have not previously had access to it, the 
operator must update the list prior to such persons having access to the 
quarantine facility.
    (C) The operator must provide APHIS with signed statements from each 
employee and any other personnel hired by the operator and working at 
the facility in which the person agrees to comply with paragraph (c) of 
this section and applicable provisions of this part, all terms of the 
compliance agreement, and any related instructions from APHIS 
representatives pertaining to import quarantine operations, including 
contact with animals both inside and outside the facility.

[[Page 481]]

    (iii) Authorized access. Access to the facility premises as well as 
inside the quarantine area will be granted only to APHIS 
representatives, authorized employees, and other personnel of the 
operator assigned to work at the facility. All other persons are 
prohibited from the premises unless specifically granted access by an 
APHIS representative. Any visitors granted access must be accompanied at 
all times by an APHIS representative while on the premises or in the 
quarantine area of the facility.
    (iv) Sanitary requirements. (A) All persons granted access to the 
quarantine area must:
    (1) Shower when entering and leaving the quarantine area;
    (2) Shower when leaving the necropsy area if a necropsy is in the 
process of being performed or has just been completed, or if all or 
portions of the examined animal remain exposed;
    (3) Wear clean protective work clothing and footwear upon entering 
the quarantine area;
    (4) Wear disposable gloves when handling sick horses and then wash 
hands after removing gloves; and
    (5) Change protective clothing, footwear, and gloves when they 
become soiled or contaminated.
    (B) The operator is responsible for providing a sufficient supply of 
clothing and footwear to ensure that all persons provided access to the 
quarantine area at the facility have clean, protective clothing, and 
footwear when they enter the quarantine area.
    (C) The operator is responsible for the handling, washing, and 
disposal of soiled and contaminated clothing worn within the quarantine 
facility in accordance with the terms of the compliance agreement. At 
the end of each workday, work clothing worn into the quarantine area 
must be collected and kept in a bag until the clothing is washed. Used 
footwear must either be left in the clothes-changing area or cleaned 
with hot water (148 [deg]F minimum) and detergent and disinfected in 
accordance with the terms of the compliance agreement. APHIS 
representatives may conduct spot audits of all handling, cleaning, and/
or disposal of used clothing or used footwear.
    (D) All equipment (including tractors) must be cleaned and 
disinfected prior to being used in the quarantine area of the facility 
with a disinfectant authorized in part 71 of this chapter or otherwise 
approved by the Administrator. The equipment must remain dedicated to 
the facility for the entire quarantine period. Any equipment used with 
quarantined horses (e.g., halters, floats, feed, water buckets, and 
exercise equipment) must remain dedicated to that particular lot of 
quarantined horses for the duration of the quarantine period or be 
cleaned and disinfected before coming in contact with horses from 
another lot. Prior to its removal from the quarantine premises, any 
equipment must be cleaned and disinfected in accordance with the terms 
of the compliance agreement. APHIS representatives may conduct spot 
audits of all cleaning and disinfection of equipment.
    (E) Any vehicle, before entering or leaving the quarantine area of 
the facility, must be cleaned and disinfected in accordance with the 
terms of the compliance agreement within a time period authorized by the 
APHIS representative and with a disinfectant authorized in part 71 of 
this chapter or otherwise approved by the Administrator. APHIS 
representatives may conduct spot audits of all cleaning and disinfection 
of vehicles.
    (F) If the facility has a single loading dock, the loading dock must 
be cleaned and disinfected after each use in accordance with the terms 
of the compliance agreement within a time period authorized by the APHIS 
representative and with a disinfectant authorized in part 71 of this 
chapter or otherwise approved by the Administrator. APHIS 
representatives may conduct spot audits of all cleaning and disinfection 
of the loading dock.
    (G) That area of the facility in which a lot of horses has been held 
or has had access to must be thoroughly cleaned and disinfected, with a 
disinfectant authorized in part 71 of this chapter or otherwise approved 
by the Administrator, in accordance with the terms of the compliance 
agreement, upon release of the horses before a new lot of horses is 
placed in that area of the facility. APHIS representatives may conduct 
spot audits of all cleaning and disinfection of lot-holding areas.

[[Page 482]]

    (v) Handling of the horses in quarantine. (A) All horses must be 
handled in accordance with paragraph (a) of this section.
    (B) Each lot of horses to be quarantined must be placed in the 
facility on an ``all-in, all out'' basis. No horse may be taken out of 
the lot while it is in quarantine, except for diagnostic purposes or as 
provided in paragraph (a)(4) of this section, and no horse may be added 
to the lot while the lot is in quarantine. Once import quarantine 
operations have been completed on a lot, but while the lot is still at 
the facility, a horse may be removed from that lot.
    (C) The facility must provide sufficient feed and bedding for the 
horses in quarantine, and it must be free of vermin and not spoiled. 
Feed and bedding must originate from an area that is not listed in part 
72 of this chapter as an area quarantined for splenetic or tick fever.
    (D) Breeding of horses or collection of germplasm from horses is 
prohibited during the quarantine period.
    (E) Horses in quarantine will be subjected to such tests and 
procedures as directed by an APHIS representative to determine whether 
they are free from communicable diseases of horses.
    (F) Any death or suspected illness of horses in quarantine must be 
reported immediately to APHIS. The affected horses must be disposed of 
as the Administrator may direct, or depending on the nature of the 
disease, must be cared for as directed by APHIS to prevent the spread of 
the disease.
    (G) Quarantined horses requiring specialized medical attention or 
additional postmortem testing may be transported off the quarantine 
site, if authorized by APHIS. A second quarantine site must be 
established to house the horses at the facility of destination (e.g., 
veterinary teaching hospital). In such cases, APHIS may extend the 
quarantine period for that horse and for its lot until the results of 
any outstanding tests or postmortem results are received.
    (H) Should a horse be determined to be infected with or exposed to a 
Federally regulated disease of horses, arrangements for the final 
disposition of the infected or exposed horse must be accomplished within 
10 days of the date that the importer is notified by the overseeing 
APHIS representative that the horse has been refused entry into the 
United States. APHIS representatives must be physically present at and 
directly monitor the subsequent disposition of the horse. The operator 
must have a preapproved contingency plan for the disposal of all horses 
housed at the facility prior to issuance of the import permit.
    (I) Vaccination of horses in quarantine is prohibited. However, once 
import quarantine operations have been completed on a lot, but while the 
lot is still at the facility, horses in that lot may be vaccinated.
    (vi) Records. (A) The facility operator must maintain a current 
daily record to record the entry and exit of all persons entering and 
leaving the quarantine facility.
    (B) The operator must maintain the daily record, along with any 
records kept by APHIS and deposited with the operator, for at least 2 
years following the date of release of the horses from quarantine and 
must make such records available to APHIS representatives upon request.
    (5) Environmental quality. If APHIS determines that a privately 
operated quarantine facility does not meet applicable local, State, or 
Federal environmental regulations, APHIS may deny or suspend approval of 
the facility until appropriate remedial measures have been applied.
    (6) Variances. The Administrator may grant variances to existing 
requirements relating to location, construction, and other design 
features of the physical facility, as well as to sanitation, security, 
operating procedures, recordkeeping, and other provisions of paragraph 
(c) of this section, but only if the Administrator determines that the 
variance causes no detrimental impact to the overall biological security 
of the import quarantine operations. The operator must submit a request 
for a variance from the requirements for the construction of the 
facility in paragraph (c)(3) of this section to the Administrator in 
writing prior to the construction of the facility. The operator must 
submit a request for a variance from the operational requirements in

[[Page 483]]

paragraph (c)(4) of this section to the Administrator in writing at 
least 30 days in advance of the arrival of horses to the facility. Any 
variance must also be expressly provided for in the compliance 
agreement.

(Approved by the Office of Management and Budget under control number 
0579-0313)

[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 at www.govinfo.gov.



Sec.93.309  Horse quarantine facilities; payment information.

    (a) Privately operated quarantine facilities. The importer, or his 
or her agent, of horses subject to quarantine under the regulations in 
this part shall arrange for acceptable transportation to the privately 
operated quarantine facility and for the care, feed, and handling of the 
horses from the time of unloading at the quarantine port to the time of 
release from quarantine. Such arrangements shall be agreed to in advance 
by the Administrator. All expenses resulting therefrom or incident 
thereto shall be the responsibility of the importer; APHIS assumes no 
responsibility with respect thereto. The quarantine facility must be 
suitable for the quarantine of such horses and must be approved by the 
Administrator prior to the issuance of any import permit. The facilities 
occupied by horses should be kept clean and sanitary to the satisfaction 
of the inspector assigned to supervise the quarantine. If for any cause 
the care, feed, or handling of horses, or the sanitation of the 
facilities, is neglected, in the opinion of the inspector assigned to 
supervise the quarantine, such services may be furnished by APHIS in the 
same manner as though arrangements had been made for such services as 
provided by paragraph (b) of this section, and/or the horses may be 
disposed of as the Administrator, may direct, including sale in 
accordance with the procedure described in paragraph (b) of this 
section. The importer, or his or her agent, shall request in writing 
such inspection and other services as may be required, and shall waive 
all claim against the United States and APHIS or any employee of APHIS 
for damages which may arise from such services. The Administrator, may 
prescribe reasonable rates for the services provided under this 
paragraph. When it is found necessary to extend the usual minimum 
quarantine period, the importer, or his or her agent, shall be so 
advised in writing and shall pay for such additional quarantine and 
other services required. Payment for all services received by the 
importer, or his or her agent, in connection with each separate lot of 
horses shall be made by certified check or U.S. money order prior to 
release of the horses. If such payment is not made, the horses may be 
sold in accordance with the procedure described in paragraph (b) of this 
section, or otherwise disposed of as directed by the Administrator.
    (b) Quarantine facilities maintained by APHIS. The importer, or his 
or her agent, of horses subject to quarantine under the regulations in 
this part shall arrange for acceptable transportation to the quarantine 
facility, and for the care, feed, and handling of the horses from the 
time they arrive at the quarantine port to the time of release from 
quarantine. Such arrangements shall be agreed to in advance by the 
Administrator. The importer or his or her agent shall request in writing 
such inspection and other services as may be required, and shall waive 
all claim against the United States and APHIS or any employee of APHIS, 
for damages which may arise from such services. All expenses resulting 
therefrom or incident thereto shall be the responsibility of the 
importer; APHIS assumes no responsibility with respect thereto. The 
Administrator may prescribe reasonable rates for the services provided 
under this paragraph. When it is found necessary to extend the usual 
minimum quarantine period, the importer, or his or her agent, shall be 
so advised in writing and shall pay for such additional quarantine and 
other services required. Payment for services received by the importer, 
or his or her agent, in connection with each separate lot of horses 
shall be made by certified check or U.S. money order prior to release of 
the horses. If such payment is not made, the horses may be sold in 
accordance with the procedure

[[Page 484]]

described in this paragraph or otherwise disposed of as directed by the 
Administrator. When payment is not made and the horses are to be sold to 
recover payment for services received, the importer, or his or her 
agent, will be notified by the inspector that if said charges are not 
immediately paid or satisfactory arrangements made for payment, the 
horses will be sold at public sale to pay the expense of care, feed, and 
handling during that period. The sale will be held after the expiration 
of the quarantine period, at such time and place as may be designated by 
the General Services Administration or other designated selling agent. 
The proceeds of the sale, after deducting the charges for care, feed, 
and handling of the horses and other expenses, including the expense of 
the sale, shall be held in a Special Deposit Account in the United 
States Treasury for 6 months from the date of sale. If not claimed by 
the importer, or his or her agent, within 6 months from the date of 
sale, the amount so held shall be transferred from the Special Deposit 
Account to the General Fund Account in the United States Treasury.
    (c) Amounts collected from the importer, or his or her agent, for 
service rendered shall be deposited so as to be available for defraying 
the expenses involved in this service.



Sec.93.310  Quarantine stations, visiting restricted; sales prohibited.

    Visitors are not permitted in the quarantine enclosure during any 
time that the horses are in quarantine unless an APHIS representative 
specifically grants access under such conditions and restrictions as may 
be imposed by APHIS. An importer (or his or her agent or accredited 
veterinarian) may be admitted to the lot-holding area(s) containing his 
or her quarantined horses at such intervals as may be deemed necessary, 
and under such conditions and restrictions as may be imposed, by an 
APHIS representative. On the last day of the quarantine period, owners, 
officers or registry societies, and others having official business or 
whose services may be necessary in the removal of the horses may be 
admitted upon written permission from an APHIS representative. No 
exhibition or sale shall be allowed within the quarantine grounds.

[74 FR 31601, July 2, 2009]



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;

[[Page 485]]

    (2) That each horse has been inspected on the premises of origin and 
found free of evidence of communicable disease and, insofar as can be 
determined, exposure thereto during the 60 days preceding exportation;
    (3) That each horse has not been vaccinated with a live or 
attenuated or inactivated vaccine during the 14 days preceding 
exportation: Provided, however, that in specific cases the Administrator 
may authorize horses that have been vaccinated with an inactivated 
vaccine to enter the United States when he or she determines that in 
such cases and under such conditions as he or she may prescribe such 
importation will not endanger the livestock in the United States, and 
such horses comply with all other applicable requirements of this part;
    (4) 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

[[Page 486]]

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 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

[[Page 487]]

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 
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]

[[Page 488]]



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.
    (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 Government and endorsed by a salaried 
veterinarian of the Mexican Government, thereby representing that the 
veterinarian issuing the certificate was authorized to do so, stating 
that he or she has inspected such horses on the premises of origin and 
found them free of evidence of communicable disease, and that, so far as 
it has been possible to determine, they have not been exposed to any 
such disease common to animals of their kind during the preceding 60 
days, and if the horses are shipped by

[[Page 489]]

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]



                           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 for brucellosis. A herd that meets APHIS' standards 
for accreditation for brucellosis status. Standards for accreditation 
are specified in import protocols.
    Accredited herd for tuberculosis. A herd that meets APHIS' standards 
for accreditation for bovine tuberculosis status. Standards for 
accreditation are specified in import protocols.
    Accredited veterinarian. A veterinarian approved by the 
Administrator in accordance with the provisions of part 161 of this 
title to perform functions specified in parts 1, 2, 3, and 11 of 
subchapter A, and subchapters B, C, and D of this chapter, and to 
perform functions required by cooperative state-federal disease control 
and eradication programs.
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service or any other employee of the Animal and Plant Health 
Inspection Service, United States Department of Agriculture, to whom 
authority has been or may be delegated to act in the Administrator's 
stead.
    Animal and Plant Health Inspection Service. Animal and Plant Health 
Inspection Service of the United States Department of Agriculture (APHIS 
or Service).
    Animals. Cattle, sheep, goats, other ruminants, swine, horses, 
asses, mules, zebras, dogs, and poultry.
    APHIS representative. A veterinarian or other individual employed by 
the Animal and Plant Health Inspection Service, United States Department 
of Agriculture, who is authorized to perform the services required by 
this part.
    Area veterinarian in charge (AVIC). The veterinary official of APHIS 
who is assigned by the Administrator to supervise and perform the 
official animal health work of APHIS in the State concerned.
    As a group. Collectively, in such a manner that the identity of the 
animals as a unique group is maintained.
    Authorized USDA representative. An APHIS Veterinary Services 
employee, a USDA Food Safety and Inspection Service inspector, a State 
representative, an accredited veterinarian, or an employee of an 
accredited veterinarian, slaughtering establishment, or feedlot who is 
designated by the accredited veterinarian or management of the 
slaughtering establishment or feedlot to perform the function involved. 
In order to designate an employee to break official seals, an accredited 
veterinarian or the management of a slaughtering establishment or 
feedlot must first supply in writing the name of the designated 
individual to the APHIS AVIC in the State where the seals will be 
broken. Additionally, the management of a slaughtering establishment or 
feedlot must enter into an agreement with Veterinary Services in which 
the management of the facility agrees that only designated individuals 
will break the seals, that the facility will contact an APHIS 
representative or USDA Food Safety and Inspection Service inspector 
immediately if the seals are not intact when the means of conveyance 
arrives or if the animals being transported appear to be sick or injured 
due to transport conditions, and that the facility will cooperate with 
APHIS representatives, USDA Food Safety and Inspection Service 
inspectors, and State representatives in

[[Page 490]]

maintaining records of sealed shipments received.
    Bovine. Bos taurus, Bos indicus, and Bison bison.
    Bovine spongiform encephalopathy (BSE) minimal risk region. A region 
listed in Sec.94.18(a)(3) of this subchapter.
    Brucellosis. Infection with or disease caused by Brucella abortus.
    Brucellosis certified free herd. A herd in which all eligible cattle 
in the herd were negative to brucellosis tests under the Canadian 
requirements and which is officially certified by the Canadian 
Government as a brucellosis free listed herd.
    Camelid. All species of the family Camelidae, including camels, 
guanacos, llamas, alpacas, and vicunas.
    Cattle. Animals of the bovine species.
    Cervid. All members of the family Cervidae and hybrids, including 
deer, elk, moose, caribou, reindeer, and related species.
    Communicable disease. Any contagious, infectious, or communicable 
disease of domestic livestock, poultry or other animals.
    Department. The United States Department of Agriculture (USDA).
    Designated feedlot. A feedlot that has been designated by the 
Administrator as one that is eligible to receive sheep and goats 
imported from a BSE minimal-risk region and whose owner or legally 
responsible representative has signed an agreement in accordance with 
Sec.93.419(d)(8) of this subpart to adhere to, and is in compliance 
with, the requirements for a designated feedlot.
    Exporting region. A region from which shipments are sent to the 
United States.
    Federal veterinarian. A veterinarian employed and authorized by the 
Federal Government to perform the tasks required by this subpart.
    Fever tick. Rhipicephalus annulatus, Rhipicephalus microplus, and 
any other species of tick determined by the Administrator to be a vector 
of bovine babesiosis and specified on the Internet at http://
www.aphis.usda.gov/wps/ portal/aphis/ourfocus/importexport.
    Flock. Any group of one or more sheep maintained on common ground; 
or two or more groups of sheep 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. Any group of one or more animals maintained on common ground; 
or two or more groups of animals under common ownership or supervision 
on two or more premises that are geographically separated, but among 
which there is an interchange or movement of animals.
    Herd of origin. A herd of one or more sires and dams and their 
offspring from which animals in a consignment presented for export to 
the United States originate. The herd of origin may be the birth herd or 
the herd where the animal has resided for a minimum 4-month period 
immediately prior to movement, unless otherwise specified in an import 
criteria. Additional animals can be moved into a herd of origin during 
or after the 4-month qualifying period only if they:
    (1) Originate from an accredited herd; or
    (2) Originate from a herd of origin that tested negative to a whole 
herd test conducted within the last 12 months and the individual animals 
being moved into the herd also tested negative to any additional 
individual tests for tuberculosis and brucellosis required by the 
Administrator.
    Immediate slaughter. Consignment directly from the port of entry to 
a recognized slaughtering establishment \1\ and slaughtered within 2 
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 for 
the State of destination of the shipment. The name and address of the 
area veterinarian in charge in any State is available from the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Center for Import and Export, 4700 River Road Unit 39, Riverdale, MD 
20737-1231.
---------------------------------------------------------------------------

    Import protocol. A document issued by APHIS and provided to 
officials of the competent veterinary authority of an exporting region 
that specifies in detail the mitigation measures that will comply with 
the regulations in this part regarding the import of certain animals or 
commodities.
    Individual test. A test for brucellosis or tuberculosis that is 
approved by the

[[Page 491]]

Administrator and that is administered individually in accordance with 
this part to ruminants that are susceptible to brucellosis or 
tuberculosis.
    Inspector. Any individual authorized by the Administrator of APHIS 
or the Commissioner of Customs and Border Protection, Department of 
Homeland Security, to enforce the regulations in this subpart.
    Lot. A group of ruminants that, while held on a conveyance or 
premises, has opportunity for physical contact with each other or with 
each other's excrement or discharges at any time between arrival at the 
quarantine facility and 60 days prior to export to the United States.
    Lot-holding area. That area in a privately owned medium or minimum 
security quarantine facility in which a single lot of ruminants is held 
at one time.
    Moved directly. Moved without unloading and without stopping except 
for refueling, or for traffic conditions such as traffic lights or stop 
signs.
    Moved directly by land. Moved by rail, truck, or other land vehicle 
without unloading and without stopping except for refueling, or for 
traffic conditions such as traffic lights or stop signs.
    Non-negative test results. Any test results for tuberculosis or 
brucellosis within the suspect, reactor, or positive range parameters of 
a pathogen assay that has been approved by the Administrator.
    Nonquarantine area. That area of a privately owned medium or minimum 
security quarantine facility that includes offices, storage areas, and 
other areas outside the quarantine area, and that is off limits to 
ruminants, samples taken from ruminants, and any other objects or 
substances that have been in the quarantine area during the quarantine 
of ruminants.
    Notifiable disease. A disease for which confirmed or suspected 
occurrences within a region must be reported to the competent veterinary 
authority or other competent authority of that region.
    Official identification device or method. A means of officially 
identifying an animal or group of animals using devices or methods 
approved by the Administrator, including, but not limited to, official 
tags, tattoos, and registered brands when accompanied by a certificate 
of inspection from a recognized brand inspection authority. For animals 
intended for importation into the United States, the device or method of 
identification used must have been approved by the Administrator for 
that type of import before the animal is exported to the United States.
    Officially identified. Individually identified by means of an 
official identification device or method.
    Operator. A person other than the Federal Government who owns or 
operates, subject to APHIS' approval and oversight, a privately owned 
medium or minimum security quarantine facility.
    Permitted dip. A dip permitted by the Administrator to be used in 
the official dipping of cattle for fever ticks and for dipping cattle 
and sheep for scabies.
    Persons. Any individual, corporation, company, association, firm, 
partnership, society or joint stock company.
    Port Veterinarian. A veterinarian employed by the Animal and Plant 
Health Inspection Service to perform duties required under this part at 
a port of entry.
    Positive for a transmissible spongiform encephalopathy. A sheep or 
goat for which a diagnosis of a transmissible spongiform encephalopathy 
has been made.
    Premises of origin. Except as otherwise used in Sec.93.423 of this 
subpart, the premises where the animal was born.
    Prevalence. The number of affected herds occurring during the period 
specified in Sec. Sec.93.437 and 93.440. In some instances, the 
Administrator may allow calculation of prevalence based on affected 
herd-years to avoid penalizing regions with small herd numbers.
    Privately owned medium security quarantine facility (medium security 
facility). A facility that:
    (1) Is owned, operated, and financed by a person other than the 
Federal Government;
    (2) Is subject to the strict oversight of APHIS representatives;
    (3) Is constructed, operated, and maintained in accordance with the 
requirements for medium security facilities in Sec.93.412(d); and

[[Page 492]]

    (4) Provides the necessary level of quarantine services for the 
holding of ruminants in an indoor, vector-proof environment prior to the 
animals' entry into the United States. Quarantine services would have to 
include testing or observation for any OIE listed diseases and other 
livestock diseases exotic to the United States, as well as any other 
diseases, as necessary, to be determined by the Administrator.
    Privately owned minimum security quarantine facility (minimum 
security facility). A facility that:
    (1) Is owned, operated, and financed by a person other than the 
Federal Government;
    (2) Is subject to the strict oversight of APHIS representatives;
    (3) Is constructed, operated, and maintained in accordance with the 
requirements for minimum security facilities in Sec.93.412(d);
    (4) Is used for the quarantine of ruminants that pose no significant 
risk, as determined by the Administrator, of introducing or transmitting 
to the U.S. livestock population any livestock disease that is 
biologically transmissible by vectors; and
    (5) Provides the necessary level of quarantine services for the 
outdoor holding of ruminants, prior to the animals' entry into the 
United States. Quarantine services would have to include testing or 
observation for any OIE listed diseases and other livestock diseases 
exotic to the United States, as well as any other diseases, as 
necessary, to be determined by the Administrator.
    Processed animal protein. Meat meal, bone meal, meat-and-bone meal, 
blood meal, dried plasma and other blood products, hydrolyzed protein, 
hoof meal, horn meal, poultry meal, feather meal, fish meal, and any 
other similar products.
    Quarantine area. That area of a privately owned medium or minimum 
security quarantine facility that comprises all of the lot-holding areas 
in the facility and any other areas in the facility that ruminants have 
access to, including loading docks for receiving and releasing 
ruminants, and any areas used to conduct examinations of ruminants and 
take samples and any areas where samples are processed or examined.
    Recognized slaughtering establishment. Any slaughtering 
establishment operating under the provisions of the Federal Meat 
Inspection Act (21 U.S.C. 601 et seq.) or a State meat inspection act. 
\2\
---------------------------------------------------------------------------

    \2\ See footnote 1.
---------------------------------------------------------------------------

    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.
    Spayed heifer. A female bovine that has been neutered in a manner 
otherwise approved by the Administrator and specified in an import 
protocol.
    State representative. A veterinarian or other person employed in 
livestock sanitary work by a State or political subdivision of a State 
who is authorized by such State or political subdivision of a State to 
perform the function involved under a memorandum of understanding with 
APHIS.
    State veterinarian. A veterinarian employed and authorized by a 
State or political subdivision of a State to perform the tasks required 
by this subpart.
    Steer. A sexually neutered male bovine.
    Suspect for a transmissible spongiform encephalopathy. (1) A sheep 
or goat that has tested positive for a transmissible spongiform 
encephalopathy or for the proteinase resistant protein associated with a 
transmissible spongiform encephalopathy, unless the animal is designated 
as positive for a transmissible spongiform encephalopathy; or
    (2) A sheep or goat that exhibits any of the following signs and 
that has been determined to be suspicious for a transmissible spongiform 
encephalopathy by a veterinarian:

[[Page 493]]

Weight loss despite retention of appetite; behavior abnormalities; 
pruritus (itching); wool pulling; biting at legs or side; lip smacking; 
motor abnormalities such as incoordination, high stepping gait of 
forelimbs, bunny hop movement of rear legs, or swaying of back end; 
increased sensitivity to noise and sudden movement; tremor, ``star 
gazing,'' head pressing, recumbency, or other signs of neurological 
disease or chronic wasting.
    Swine. The domestic hog and all varieties of wild hogs.
    Temporary inspection facility. A temporary facility that is 
constructed of metal panels that can be erected and broken down 
alongside the transportation vessel carrying ruminants that are imported 
into the United States in accordance with Sec.93.408 of this subpart 
and that will be quarantined at a minimum or medium security quarantine 
facilities located more than 1 mile from the port of entry.
    Tuberculosis. Infection with or disease caused by Mycobacterium 
bovis.
    United States. All of the States of the United States, the District 
of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin 
Islands of the United States, and all other Territories and Possessions 
of the United States.
    Veterinary Services. The Veterinary Services unit of the Department.
    Wether. A castrated male sheep or goat.
    Whole herd test for brucellosis. A brucellosis test that has been 
approved by APHIS of all sexually intact bovines in a herd of origin 
that are 6 months of age or older, and of all sexually intact bovines in 
the herd of origin that are less than 6 months of age and were not born 
into the herd of origin, except those sexually intact bovines that are 
less than 6 months of age and originate directly from a currently 
accredited herd for brucellosis.
    Whole herd test for tuberculosis. A tuberculosis test that has been 
approved by APHIS of all bovines in a herd of origin that are 6 months 
of age or older, and of all bovines in the herd of origin that are less 
than 6 months of age and were not born into the herd of origin, except 
those bovines that are less than 6 months of age and originate directly 
from a currently accredited herd for tuberculosis.
    World Organization for Animal Health (OIE). The international 
organization recognized by the World Trade Organization for setting 
animal health standards, reporting global animal situations and disease 
status, and presenting guidelines and recommendations on sanitary 
measures related to animal health.
    Zoological park. A professionally operated zoo, park, garden or 
other place, maintained under the constant surveillance of a Doctor of 
Veterinary Medicine, for the exhibition of live animals, pigeons or 
birds, for the purpose of public recreation or education.

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997]

    Editorial Note: For Federal Register citations affecting Sec.
93.400, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



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 non-bovine ruminant that has been in a region listed 
in Sec.94.24(a) 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.

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

[[Page 494]]

    (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 
by the Administrator if deemed applicable for a particular shipment.
    (vi) They must also comply with all applicable local, State and 
Federal requirements for environmental quality and with the provisions 
of the Animal Welfare Regulations in chapter I of this title, as 
applicable.
    (c) Removal and loss of official identification devices. Official 
identification devices are intended to provide permanent identification 
of livestock and to ensure the ability to find the source of animal 
disease outbreaks. Removal of these devices is prohibited except at the 
time of slaughter. If an official identification device is lost, and it 
is necessary to retag an animal with a new official number, every effort 
should be made to correlate the new official number with the previous 
official number of the animal.
    (d) Cleaning and disinfection prior to shipment. A means of 
conveyance used to transport an animal to the United States in 
accordance with this subpart must be cleaned and disinfected in a

[[Page 495]]

manner specified within an import protocol prior to transport, unless an 
exemption has been granted by the Administrator.

[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; 69 FR 64651, Nov. 8, 
2004; 78 FR 72996, Dec. 4, 2013; 85 FR 57952, Sept. 17, 2020]



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 Wells, 
Columbus, and Santa Teresa, New Mexico.

[[Page 496]]

    (d) Special ports. Charlotte Amalie, St. Thomas, and Christiansted, 
St. Croix, in the United States Virgin Islands, are hereby designated as 
quarantine stations for the entry of ruminants from the British Virgin 
Islands into the United States Virgin Islands for immediate slaughter.
    (e) Limited ports. The following ports are designated as having 
inspection facilities for the entry of ruminants and ruminant products 
such as ruminant test specimens which do not appear to require restraint 
and holding inspection facilities: Anchorage and Fairbanks, Alaska; San 
Diego, California; Jacksonville, St. Petersburg-Clearwater, and Tampa, 
Florida; Atlanta, Georgia; Honolulu, Hawaii, Chicago, Illinois; New 
Orleans, Louisiana; Portland, Maine; Baltimore, Maryland; Boston, 
Massachusetts; Minneapolis, Minnesota; Great Falls, Montana; Portland, 
Oregon; San Juan, Puerto Rico; Memphis, Tennessee (no live animals); El 
Paso, Galveston, and Houston, Texas; and Seattle, Spokane, and Tacoma, 
Washington.
    (f) Designation of other ports. The Secretary of the Treasury has 
approved the designation as quarantine stations of the ports specified 
in this section. In special cases other ports may be designated as 
quarantine stations under this section by the Administrator, with the 
concurrence of the Secretary of the Treasury.
    (g) Ports and privately owned quarantine facilities. Ruminants may 
be imported into the United States at any port specified in paragraph 
(a) of this section, or at any other port designated as an international 
port or airport by the Bureau of Customs and Border Protection, and 
quarantined at an APHIS-approved privately owned quarantine facility, 
provided the applicable provisions of Sec. Sec.93.401, 93.404(a), 
93.407, 93.408, and 93.412 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; 71 FR 29773, May 24, 2006]



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 name and 
address of the quarantine facility, if the ruminants are to be 
quarantined at a privately owned quarantine facility; the proposed date 
of arrival of the ruminants or ruminant test specimens to be imported; 
and the name of the person to whom the ruminants or ruminant test 
specimens will be delivered and the location of the place in the United 
States to which delivery will be made from the port of entry. Additional 
information may be required in the form of certificates concerning 
specific diseases to which the ruminants are susceptible, as well as 
vaccinations or other precautionary treatments to which the ruminants or 
ruminant test specimens have been subjected. Notice of any such 
requirement will be given to the applicant in each case.

[[Page 497]]

    (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 where 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

[[Page 498]]

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)(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 exists. 
This paragraph (c) applies to the importation of wild ruminants, such 
as, but not limited to, giraffes, deer and antelopes, from regions 
designated in part 94 of this subchapter as countries in which foot-and-
mouth disease exists.
    (1) Permits for the importation of wild ruminants will be issued 
only for importations through the Port of New York, and only if the 
animals are imported for exhibition in a PEQ Zoo. A PEQ Zoo is a 
zoological park or other place maintained for the exhibition of live 
animals for recreational or educational purposes that:
    (i) Has been approved by the Administrator in accordance with 
paragraph (c)(2) of this section to receive and maintain imported wild 
ruminants; and
    (ii) Has entered into the agreement with APHIS set forth in 
paragraph (c)(4) of this section for the maintenance and handling of 
imported wild ruminants.
    (2) Approval of a PEQ Zoo shall be on the basis of an inspection, by 
an authorized representative of the Department, of the physical 
facilities of the establishment and its methods of operation. Standards 
for acceptable physical facilities shall include satisfactory pens, 
cages, or enclosures in which the imported ruminants can be maintained 
so as not to be in contact with the general public and free from contact 
with domestic livestock; natural or established drainage from the PEQ 
Zoo which will avoid contamination of land areas where domestic 
livestock are kept or with which domestic livestock may otherwise come 
in contact; provision for the disposition of manure, other wastes, and 
dead ruminants within the PEQ Zoo; and other reasonable

[[Page 499]]

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 exists and 
being subject to restrictions under regulations contained in part 93, 
title 9, Code of Federal Regulations.
    In making this request, it is understood and agreed that:
    1. The animals for which an import permit is requested will be held 
in isolation at a port of embarkation in the region of origin, approved 
by the Administrator as a port having facilities which are adequate for 
maintaining wild animals in isolation from all other animals and having 
veterinary supervision by officials of the region of origin of the 
animals. Such animals will be held in such isolation for not less than 
60 days under the supervision of the veterinary service of that region 
to determine whether the animals show any clinical evidence of foot-and-
mouth disease, or other communicable disease that is exotic to the 
United States or for which APHIS has an eradication or control program 
in 9 CFR chapter I, and to assure that the animals will not have been 
exposed to such a disease within the 60 days next before their 
exportation from that region.
    2. Shipment will be made direct from such port of embarkation to the 
port of New York as the sole port of entry in the United States. If 
shipment is made by ocean vessel the animals will not be unloaded in any 
foreign port en route. If shipment is made by air, the animals will not 
be unloaded at any port or other place of landing, except at a port 
approved by the Administrator as a port not located in a region where 
foot-and-mouth disease exists or as a port in such a region having 
facilities and inspection adequate for maintaining wild animals in 
isolation from all other animals.
    3. No ruminants or swine will be aboard the transporting vehicle, 
vessel or aircraft, except those for which an import permit has been 
issued.
    4. The animals will be quarantined for not less than 30 days in the 
Department's Animal Import Center in Newburgh, New York.
    5. Upon release from quarantine the animals will be delivered to the 
zoological park named in this agreement to become the property of the 
park and they will not be sold, exchanged or removed from the premises 
without the prior consent of APHIS. If moved to another zoological park 
in the United States, the receiving zoological park must be approved by 
the Administrator in accordance with paragraph 6 of this agreement.
    6. The Administrator will approve the movement of an imported animal 
subject to this agreement if the Administrator determines that the 
animal has spent at least one year in quarantine in a PEQ Zoo following

[[Page 500]]

importation without showing clinical evidence of foot-and-foot mouth 
disease, or other communicable disease that is exotic to the United 
States or for which APHIS has an eradication or control program in 9 CFR 
chapter I, and determines that the receiving zoological park is 
accredited by the American Zoo and Aquarium Association (AZA), or the 
receiving zoological park has facilities and procedures in place related 
to preventing the spread of communicable animal diseases (including but 
not limited to procedures for animal identification, record keeping, and 
veterinary care) that are equivalent to those required for AZA 
accreditation. The Administrator will approve the movement of a carcass, 
body part, or biological specimen derived from an imported animal 
subject to this agreement if the Administrator determines that the 
animal has spent at least one year in quarantine in a PEQ Zoo following 
importation without showing clinical evidence of foot-and-foot mouth 
disease, or other communicable disease that is exotic to the United 
States or for which APHIS has an eradication or control program in 9 CFR 
chapter I, and determines that the carcass, body part, or biological 
specimen will be moved only for scientific research or museum display 
purposes.

________________________________________________________________________
(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; 71 FR 29773, May 24, 2006; 83 FR 15492, Apr. 11, 2018]



Sec.93.405  Health certificate for ruminants.

    (a) All ruminants intended for importation from any part of the 
world, except as provided in Sec. Sec.93.423(c) and 93.428(d), shall 
be accompanied by a certificate issued by a full-time salaried 
veterinary officer of the national government of the region of origin, 
or issued by a veterinarian designated or accredited by the national 
government of the region of origin and endorsed by a full-time salaried 
veterinary officer of the national government of the region of origin, 
representing that the veterinarian issuing the certificate was 
authorized to do so. The certificate shall state:
    (1) That the ruminants have been kept in that region during the last 
60 days immediately preceding the date of shipment to the United States, 
and that during this time the region has been entirely free from foot-
and-mouth disease, contagious pleuropneumonia, and surra; provided, 
however, that for wild ruminants for exhibition purposes, the 
certificate need specify only that the district of origin has been free 
from the listed diseases; and provided further, that for sheep and 
goats, with respect to contagious pleuropneumonia, the certificate may 
specify only that the district of origin has been free from this 
disease;
    (2) That the ruminants are not in quarantine in the region of 
origin; and
    (3) If the ruminants are from any region where screwworm is 
considered to exist, the ruminants may be imported into the United 
States only if they meet the requirements of paragraphs (a)(3)(i) 
through (iv) of this section and all other applicable requirements of 
this part. APHIS will maintain a list of regions where screwworm is 
considered to exist on the APHIS Web site at http://www.aphis.usda.gov/ 
import_export/animals/animal _disease_status.shtml. Copies of the list 
will also be available via postal mail, fax, or email upon request to 
the Sanitary Trade Issues Team, National Center for Import and Export, 
Veterinary Services, Animal and Plant Health Inspection Service, 4700 
River Road Unit 38, Riverdale, Maryland 20737. APHIS will add a region 
to the list upon determining that screwworm exists in the region based 
on reports APHIS receives of detections of the pest from veterinary 
officials of the exporting country, from the World Organization for 
Animal Health (OIE), or from other sources the Administrator

[[Page 501]]

determines to be reliable. APHIS will remove a region from the list 
after conducting an evaluation of the region in accordance with Sec.
92.2 of this subchapter and finding that screwworm is not present in the 
region. In the case of a region formerly not on this list that is added 
due to a detection, the region may be removed from the list in 
accordance with the procedures for reestablishment of a region's 
disease-free status in Sec.92.4 of this subchapter.
    (i) A veterinarian must treat the ruminants with ivermectin 3 to 5 
days prior to the date of export to the United States according to the 
recommended dose prescribed on the product's label.
    (ii) The ruminants must be fully examined for screwworm by a full-
time salaried veterinary official of the exporting country within 24 
hours prior to shipment to the United States. If ruminants are found to 
be infested with screwworm, they must be treated until free from 
infestation.
    (iii) At the time ruminants are loaded onto a means of conveyance 
for export, a veterinarian must treat any visible wounds on the animals 
with a solution of coumaphos dust at a concentration of 5 percent active 
ingredient.
    (iv) The ruminants must be accompanied to the United States by a 
certificate signed by a full-time salaried veterinary official of the 
exporting country. The certificate must state that the ruminants have 
been thoroughly examined and found free of screwworm and that the 
ruminants have been treated in accordance with paragraphs (a)(3)(i) and 
(a)(3)(iii) of this section.
    (4) If the ruminants are sheep or goats from Canada, the certificate 
must also include the name and address of the importer; the species, 
breed, number or quantity of ruminants to be imported; the purpose of 
the importation; individual ruminant identification, which includes the 
official identification required under Sec.93.419(c) of this 
subchapter, and any other identification present on the animal, 
including registration number, if any; a description of the ruminant, 
including age, color, and markings, if any; region of origin; the 
address of or other means of identifying the premises of origin and any 
other premises where the ruminants resided immediately prior to export, 
including the State or its equivalent, the municipality or nearest city, 
or an equivalent method, approved by the Administrator, of identifying 
the location of the premises, and the specific physical location of the 
destination where the ruminants are to be moved after importation; the 
name and address of the exporter; the port of embarkation in the foreign 
region; and the mode of transportation, route of travel, and port of 
entry in the United States.
    (b) Goats. (1) In addition to the statements required by paragraph 
(a) of this section, the certificate accompanying goats from any part of 
the world, except for goats imported from Canada for immediate 
slaughter, 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 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

[[Page 502]]

    (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 infectious or 
contagious disease during the 60 days immediately preceding shipment to 
the United States.
    (2) In addition, except for sheep imported from Canada for immediate 
slaughter, the certificate accompanying sheep intended for importation 
from any part of the world except Australia 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 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, 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, 0579-0165, 0579-0234, and 0579-0393)

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56018, Oct. 28, 1997]

    Editorial Note: For Federal Register citations affecting Sec.
93.405, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.93.406  Diagnostic tests.

    (a) [Reserved]
    (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,

[[Page 503]]

method of testing, names of consignor and consignee, and a description 
of the goats, including breed, ages, markings, and tattoo and eartag 
numbers.
    (c)-(d) [Reserved]

[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; 
69 FR 21042, Apr. 20, 2004; 85 FR 57952, Sept. 17, 2020]



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.
    (c) Any declaration, permit, or other document for ruminants 
required under this subpart may be issued and presented using a U.S. 
Government electronic information exchange system or other authorized 
method.

[55 FR 31495, Aug. 2, 1990, as amended at 81 FR 40151, June 21, 2016]



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.93.421. 
All ruminants found to be free from communicable disease and not to have 
been exposed thereto within 60 days prior to their exportation to the 
United States shall be admitted subject to the other provisions in this 
part; all other ruminants except as provided in 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; 85 FR 57952, Sept. 17, 
2020]



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

[[Page 504]]

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 owned quarantine facilities. The operator of a 
privately owned medium or minimum security quarantine facility subject 
to the regulations in this subpart shall arrange for acceptable 
transportation from the port to the privately owned quarantine facility 
and for the care, feeding, and handling of the ruminants from the time 
of unloading at the port to the time of release from the quarantine 
facility. Such arrangements shall be agreed to in advance by the 
Administrator. All expenses related to these activities shall be the 
responsibility of the operator. The privately owned quarantine facility 
must be suitable for the quarantine of the ruminants and must be 
approved by the Administrator prior to the issuance of any import 
permit. The facilities occupied by the ruminants should be kept clean 
and sanitary to the satisfaction of the APHIS representatives. If for 
any cause, the care, feeding, or handling of ruminants, or the 
sanitation of the facilities is neglected, in the opinion of the 
overseeing APHIS representative, such services may be furnished by APHIS 
in the same manner as though arrangements had been made for such 
services as provided by paragraph (b) of this section. The operator must 
request in writing inspection and other services as may be required, and 
shall waive all claims against the United States and APHIS or any 
employee of APHIS for damages which may arise from such services. The 
Administrator may prescribe reasonable rates for the services provided 
under this paragraph. When APHIS finds it necessary to extend the usual 
minimum quarantine period, APHIS shall advise the operator in writing, 
and the operator must pay for such additional quarantine and other 
services required. The operator must pay for all services received in 
connection with each separate lot of ruminants as specified in the 
compliance agreement required under paragraph (d)(2) of this section.
    (b) Quarantine facilities maintained by APHIS. The importer, or his 
or her agent, of ruminants subject to quarantine under the regulations 
in this part shall arrange for acceptable transportation to the 
quarantine facility, and for the care, feed, and handling of the 
ruminants from the time they arrive at the quarantine port to the time 
of release from quarantine. Such arrangements shall be agreed to in 
advance by the Administrator. The importer or his or her agent shall 
request in writing such inspection and other services as may be 
required, and shall waive all claim against the United States and APHIS 
or any employee of APHIS, for damages which may arise from such 
services. All expenses resulting therefrom or incident thereto shall be 
the responsibility of the importer; APHIS assumes no responsibility with 
respect thereto. The Administrator may prescribe reasonable rates for 
the services provided under this paragraph. When it is found necessary 
to extend the usual minimum quarantine period, the importer, or his or 
her agent, shall be so advised in writing and shall pay for such 
additional quarantine and other services required. Payment for services 
received by the importer, or his or her agent, in connection with each 
separate lot of ruminants shall be made by certified check or U.S. money 
order prior to release of the ruminants. If such payment is not made, 
the ruminants may be sold in accordance with the procedure described in 
this paragraph or otherwise disposed of as directed by the 
Administrator. When payment is not made and the

[[Page 505]]

ruminants are to be sold to recover payment for services received, the 
importer, or his or her agent, will be notified by the inspector that if 
said charges are not immediately paid or satisfactory arrangements made 
for payment, the ruminants will be sold at public sale to pay the 
expense of care, feed, and handling during that period. The sale will be 
held after the expiration of the quarantine period, at such time and 
place as may be designated by the General Services Administration or 
other designated selling agent. The proceeds of the sale, after 
deducting the charges for care, feed, and handling of the ruminants and 
other expenses, including the expense of the sale, shall be held in a 
Special Deposit Account in the United States Treasury for 6 months from 
the date of sale. If not claimed by the importer, or his or her agent, 
within 6 months from the date of sale, the amount so held shall be 
transferred from the Special Deposit Account to the General Fund Account 
in the United States Treasury.
    (c) APHIS collection of payments from the importer, or his or her 
agent, or the operator, for service rendered shall be deposited so as to 
be available for defraying the expenses involved in this service.
    (d) Standards for privately owned quarantine facilities for 
ruminants--(1) APHIS approval of facilities--(i) Approval procedures. 
Persons seeking APHIS approval of a privately owned medium or minimum 
security quarantine facility for ruminants must make written application 
to the Administrator, c/o National Center for Import and Export, 
Veterinary Services, APHIS, 4700 River Road Unit 39, Riverdale, MD 
20737-1231. The application must include the full name and mailing 
address of the applicant; the location and street address of the 
facility for which approval is sought; blueprints of the facility; a 
description of the financial resources available for construction, 
operation and maintenance of the facility; copies of all approved State 
permits for construction and operation of the facility (but not local 
building permits), as well as copies of all approved Federal, State, and 
local environmental permits; the anticipated source(s) or origin(s) of 
ruminants to be quarantined, as well as the expected size and frequency 
of shipments, and a contingency plan for the possible destruction and 
disposal of all ruminants capable of being held in the facility.
    (A) If APHIS determines that an application is complete and merits 
further consideration, the person applying for facility approval must 
agree to pay the costs of all APHIS services associated with APHIS' 
evaluation of the application and facility. APHIS charges for evaluation 
services at hourly rates are listed in Sec.130.30 of this chapter. If 
the facility is approved by APHIS, the operator must enter into a 
compliance agreement in accordance with paragraph (d)(2) of this 
section.
    (B) Requests for approval must be submitted at least 120 days prior 
to the date of application for local building permits. Requests for 
approval will be evaluated on a first-come, first-served basis.
    (ii) Criteria for approval. Before a facility may be built to 
operate as a privately owned medium or minimum security quarantine 
facility for ruminants, it must be approved by APHIS. To be approved:
    (A) APHIS must find, based on an environmental assessment, and based 
on any required Federal, State, and local environmental permits or 
evaluations secured by the operator and copies of which are provided to 
APHIS, that the operation of the facility will not have significant 
environmental effects;
    (B) The facility must meet all the requirements of paragraph (d) of 
this section;
    (C) The facility must meet any additional requirements that may be 
imposed by the Administrator in each specific case, as specified in the 
compliance agreement required under paragraph (d)(2) of this section, to 
ensure that the quarantine of ruminants in the facility will be adequate 
to enable determination of their health status, as well as to prevent 
the transmission of livestock diseases into, within, and from the 
facility; and
    (D) The Administrator must determine whether sufficient personnel, 
including one or more APHIS veterinarians and other professional, 
technical, and support personnel, are available to serve as APHIS 
representatives at the

[[Page 506]]

facility and provide continuous oversight and other technical services 
to ensure the biological security of the facility, if approved. APHIS 
will assign personnel to facilities requesting approval in the order 
that the facilities meet all of the criteria for approval. The 
Administrator has sole discretion on the number of APHIS personnel to be 
assigned to the facility.
    (iii) Maintaining approval. To maintain APHIS approval, the operator 
must continue to comply with all the requirements of paragraph (d) of 
this section as well as the terms of the compliance agreement executed 
in accordance with paragraph (d)(2) of this section.
    (iv) Withdrawal or denial of approval. Approval of a proposed 
privately owned medium or minimum security quarantine facility may be 
denied or approval of a facility already in operation may be withdrawn 
at any time by the Administrator for any of the reasons provided in 
paragraph (d)(1)(iv)(C) of this section.
    (A) Before facility approval is denied or withdrawn, APHIS will 
inform the operator of the proposed or existing facility and include the 
reasons for the proposed action. If there is a conflict as to any 
material fact, APHIS will afford the operator, upon request, the 
opportunity for a hearing with respect to the merits or validity of such 
action in accordance with rules of practice that APHIS adopts for the 
proceeding.
    (B) Withdrawal of approval of an existing facility will become 
effective pending final determination in the proceeding when the 
Administrator determines that such action is necessary to protect the 
public health, interest, or safety. Such withdrawal will be effective 
upon oral or written notification, whichever is earlier, to the operator 
of the facility. In the event of oral notification, APHIS will give 
written confirmation to the operator of the facility as promptly as 
circumstances allow. This withdrawal will continue in effect pending the 
completion of the proceeding and any judicial review, unless otherwise 
ordered by the Administrator. In addition to withdrawal of approval for 
the reasons provided in paragraph (d)(1)(iv)(C) of this section, the 
Administrator will also automatically withdraw approval when the 
operator of any approved facility notifies the area veterinarian in 
charge for the State in which the facility is located, in writing, that 
the facility is no longer in operation. \7\
---------------------------------------------------------------------------

    \7\ The name and address of the area veterinarian in charge in any 
State is available from the Animal and Plant Health Inspection Servcie, 
Veterinary Services, National Center for Import and Export, 4700 River 
road Unit 39, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (C) The Administrator may deny or withdraw the approval of a 
privately owned medium or minimum security quarantine facility if:
    (1) Any requirement of paragraph (d) of this section or the 
compliance agreement is not met; or
    (2) The facility has not been in use to quarantine ruminants for a 
period of at least 1 year; or
    (3) The operator fails to remit any charges for APHIS services 
rendered; or
    (4) The operator or a person responsibly connected with the business 
of the facility is or has been convicted of any crime under any law 
regarding the importation or quarantine of any animal; or
    (5) The operator or a person responsibly connected with the business 
of the facility is or has been convicted of a crime involving fraud, 
bribery, extortion, or any other crime involving a lack of integrity 
needed for the conduct of operations affecting the importation of 
animals; or
    (6) Any other requirement under the Animal Health Protection Act (7 
U.S.C. 8301-8317) or the regulations thereunder are not met.
    (D) For the purposes of paragraph (d)(1)(iv) of this section, a 
person is deemed to be responsibly connected with the business of the 
facility if such person has an ownership, mortgage, or lease interest in 
the facility, or if such person is a partner, officer, director, holder, 
or owner of 10 percent or more of its voting stock, or an employee in a 
managerial or executive capacity.
    (2) Compliance agreement. (i) A privately owned medium or minimum 
security quarantine facility must operate in accordance with a 
compliance agreement executed by the operator or other

[[Page 507]]

designated representative of the facility and by the Administrator. The 
compliance agreement must be signed by both parties before a facility 
may commence operations. The compliance agreement must provide that:
    (A) The facility must meet all applicable requirements of paragraph 
(d) of this section;
    (B) The facility's quarantine operations are subject to the strict 
oversight of APHIS representatives;
    (C) The operator agrees to be responsible for the cost of building 
the facility; all costs associated with its maintenance and operation; 
all costs associated with the hiring of personnel to attend to the 
ruminants, as well as to maintain and operate the facility; all costs 
associated with the care of quarantined ruminants, such as feed, 
bedding, medicines, inspections, testing, laboratory procedures, and 
necropsy examinations; all costs associated with the death or 
destruction and disposition of quarantined ruminants; and all APHIS 
charges for the services of APHIS representatives in accordance with 
this section and part 130 of this chapter;
    (D) The operator obtained, prior to execution of this agreement, a 
financial instrument (insurance or surety bond) approved by APHIS that 
financially guarantees the operator's ability to cover all costs and 
other financial liabilities and obligations of the facility, including a 
worst case scenario in which all quarantined ruminants must be destroyed 
and disposed of because of an animal health emergency, as determined by 
the Administrator.
    (E) The operator will deposit with the Administrator, prior to 
commencing quarantine operations, a certified check or U.S. money order 
to cover the estimated costs, as determined by the Administrator, of 
professional, technical, and support services to be provided by APHIS at 
the facility over the duration of the quarantine. If actual costs 
incurred by APHIS over the quarantine period exceed the deposited 
amount, the operator will pay for any additional costs incurred by 
APHIS, based on official accounting records. Payment for all services 
received in connection with each lot of ruminants in quarantine shall be 
made prior to release of the ruminants. The operator must pay for any 
other costs incurred by APHIS with respect to the quarantine following 
the release of the ruminants, based on official records, within 14 days 
of receipt of the bill showing the balance due. APHIS will return to the 
operator any unobligated funds deposited with APHIS, after the release 
of the lot of ruminants from the facility and termination or expiration 
of the compliance agreement, or, if requested, credit to the operator's 
account such funds to be applied towards payment of APHIS services at a 
future date.
    (ii) Prior to the entry of each subsequent lot of ruminants into the 
medium or minimum security facility, a new compliance agreement must be 
executed, and a certified check or U.S. money order to the Administrator 
must be deposited to cover the estimated costs, as determined by the 
Administrator, of professional, technical, and support services to be 
provided by APHIS at the facility over the duration of the quarantine.
    (3) Physical plant requirements. A privately owned medium or minimum 
security quarantine facility must meet the following requirements as 
determined by an APHIS inspection before ruminants may be admitted to 
it.
    (i) Location. (A) The medium or minimum security facility must be 
located at a site approved by the Administrator, and the specific routes 
for the movement of ruminants from the port must be approved in advance 
by the Administrator, based on consideration of whether the site or 
routes would put the animals in a position that could result in their 
transmitting communicable livestock diseases.
    (B) In the case of a medium security facility, the facility must be 
located at least one-half mile from any premises holding livestock. In 
the case of a minimum security facility, the Administrator will 
establish the required minimum distance between the facility and other 
premises holding livestock on a case-by-case basis.
    (C) If the medium or minimum security facility is to be located more 
than 1 mile from a designated port, the operator must make arrangements 
for the imported ruminants to be held in a

[[Page 508]]

temporary inspection facility to allow for the inspection of the 
imported ruminants by a Federal or State veterinarian prior to the 
animals' movement to the medium or minimum security facility.
    (1) The temporary inspection facility must have adequate space for 
Federal or State veterinarians to conduct examinations and testing of 
the imported ruminants.
    (2) The examination space of the temporary inspection facility must 
be equipped with appropriate animal restraining devices for the safe 
inspection of ruminants.
    (3) The temporary inspection facility may not hold more than one lot 
of animals at the same time.
    (4) In seeking APHIS approval of the temporary inspection facility, 
the operator must provide APHIS with the following information: The port 
of entry; a description of the temporary inspection facility; and the 
anticipated source(s) of the materials to be used for the facility.
    (5) If the ruminants, upon inspection at the temporary inspection 
facility, are determined to be infected with or exposed to a disease 
that precludes their entry into the United States, the animals will be 
refused entry. Ruminants refused entry remain the responsibility of the 
operator, but subject to further handling or disposition as directed by 
the Administrator in accordance with Sec.93.408 of this subpart.
    (6) APHIS' approval to build and operate a medium or minimum 
security facility outside the immediate vicinity of a designated port is 
contingent upon APHIS' approval of the temporary inspection facility at 
the port, as well as approval of the routes for the movement of 
ruminants from the port to the medium or minimum security facility.
    (ii) Construction. The medium or minimum security facility must be 
of sound construction, in good repair, and properly designed to prevent 
the escape of quarantined ruminants. It must have adequate capacity to 
receive and hold a shipment of ruminants as a lot on an ``all-in, all-
out'' basis and must include the following:
    (A) Loading docks. The facility must include separate docks for 
animal receiving and releasing and for general receiving and pickup, or, 
alternatively, a single dock may be used for both purposes if the dock 
is cleaned and disinfected after each use in accordance with paragraph 
(d)(4)(iv)(D) of this section.
    (B) Perimeter fencing. The facility must be surrounded by double-
security perimeter fencing separated by at least 30 feet and of 
sufficient height and design to prevent the entry of unauthorized 
persons and animals from outside the facility and to prevent the escape 
of any ruminants in quarantine.
    (C) Means of isolation. The facility must provide pens, chutes, and 
other animal restraining devices, as appropriate, for inspection and 
identification of each animal, as well as for segregation, treatment, or 
both, of any ruminant exhibiting signs of illness. The medium or minimum 
security facility must also have lot-holding areas of sufficient size to 
prevent overcrowding. A medium security facility may hold more than one 
lot of ruminants as long as the lots are separated by physical barriers 
such that ruminants in one lot do not have physical contact with 
ruminants in another lot or with their excrement or discharges. A 
minimum security facility may not hold more than one lot of animals at 
the same time.
    (D) APHIS space. The facility must have adequate space for APHIS 
representatives to conduct examinations and draw samples for testing of 
ruminants in quarantine, prepare and package samples for mailing, and 
store duplicate samples and the necessary equipment and supplies for 
each lot of ruminants. The examination space must be equipped with 
appropriate animal restraining devices for the safe inspection of 
ruminants. The facility must also provide a secure, lockable office for 
APHIS use with enough room for a desk, chair, and filing cabinet.
    (E) Storage. The facility must have sufficient storage space for 
equipment and supplies used in quarantine operations. Storage space must 
include separate, secure storage for pesticides and for medical and 
other biological supplies, as well as a separate storage area for feed 
and bedding, if feed and bedding are stored at the facility.

[[Page 509]]

    (F) Other work areas. The facility must include work areas for the 
repair of equipment and for cleaning and disinfecting equipment used in 
the facility.
    (iii) Additional construction requirements for medium security 
facilities. For medium security facilities only, the following 
requirements must also be met:
    (A) Self-contained building. The medium security facility must be 
constructed so that the quarantine area is located in a secure, self-
contained building that contains appropriate control measures against 
the spread of livestock diseases biologically transmissible by vectors. 
All entryways into the nonquarantine area of the building must be 
equipped with a secure and lockable door. While ruminants are in 
quarantine, all access to the quarantine area must be from within the 
building. Each entryway to the quarantine area must be equipped with a 
solid self-closing door. Separate access must be provided within the 
quarantine area to each lot-holding area so that it is not necessary to 
move through one lot-holding area to gain access to another lot-holding 
area. Entryways to each lot-holding area within the quarantine area 
would also have to be equipped with a solid lockable door. Emergency 
exits to the outside may exist in the quarantine area if required by 
local fire ordinances. Such emergency exits must be constructed so as to 
permit their opening from the inside of the facility only.
    (B) Windows and other openings. Any windows or other openings in the 
quarantine area must be double-screened with screening of sufficient 
gauge and mesh to prevent the entry or exit of insects and other vectors 
of livestock diseases and to provide ventilation sufficient to ensure 
the comfort and safety of all ruminants in the facility. The interior 
and exterior screens must be separated by at least 3 inches (7.62 cm). 
All screening of windows or other openings must be easily removable for 
cleaning, yet otherwise remain locked and secure at all times in a 
manner satisfactory to APHIS representatives in order to ensure the 
biological security of the facility.
    (C) Surfaces. The medium security facility must be constructed so 
that the floor surfaces with which ruminants have contact are nonslip 
and wear-resistant. All floor surfaces with which the ruminants, their 
excrement, or discharges have contact must slope gradually to the 
center, where one or more drains of at least 8 inches in diameter are 
located for adequate drainage, or, alternatively, must be of slatted or 
other floor design that allows for adequate drainage. All floor and wall 
surfaces with which the ruminants, their excrement, or discharges have 
contact must be impervious to moisture and be able to withstand frequent 
cleaning and disinfection without deterioration. Other ceiling and wall 
surfaces with which the ruminants, their excrement, or discharges do not 
have contact must be able to withstand cleaning and disinfection between 
shipments of ruminants. All floor and wall surfaces must be free of 
sharp edges that could cause injury to ruminants.
    (D) Ventilation and climate control. The medium security facility 
must be constructed with a heating, ventilation, and air conditioning 
(HVAC) system capable of controlling and maintaining the ambient 
temperature, air quality, moisture, and odor at levels that are not 
injurious or harmful to the health of ruminants in quarantine. Air 
supplied to lot-holding areas must not be recirculated or reused for 
other ventilation needs. HVAC systems for lot-holding areas must be 
separate from air handling systems for other operational and 
administrative areas of the facility. In addition, if the facility is 
approved to handle more than one lot of ruminants at a time, each lot-
holding area must have its own separate HVAC system that is designed to 
prevent cross-contamination between the separate lot-holding areas.
    (E) Lighting. The medium security facility must have adequate 
lighting throughout, including in the lot-holding areas and other areas 
used to examine ruminants and conduct necropsies.
    (F) Fire protection. The medium security facility, including the 
lot-holding areas, must have a fire alarm and voice communication 
system.
    (G) Monitoring system. The medium security facility must have a 
television

[[Page 510]]

monitoring system or other arrangement sufficient to provide a full view 
of the lot-holding areas.
    (H) Communication system. The medium security facility must have a 
communication system between the nonquarantine and quarantine areas of 
the facility.
    (I) Necropsy area. The medium security facility must have an area 
that is of sufficient size to perform necropsies on ruminants and that 
is equipped with adequate lighting, hot and cold running water, a drain, 
a cabinet for storing instruments, a refrigerator-freezer for storing 
specimens, and an autoclave to sterilize veterinary equipment.
    (J) Additional storage requirements. Feed storage areas in the 
medium security facility must be vermin-proof. Also, if the medium 
security facility has multiple lot-holding areas, then separate storage 
space for supplies and equipment must be provided for each lot-holding 
area.
    (K) Showers. In a medium security facility, there must be a shower 
at the entrance to the quarantine area. A shower also must be located at 
the entrance to the necropsy area. A clothes-storage and clothes-
changing area must be provided at each end of each shower area. There 
also must be one or more receptacles near each shower so that clothing 
that has been worn in a lot-holding area or elsewhere in the quarantine 
area can be deposited in the receptacle(s) prior to entering the shower.
    (L) Restrooms. The medium security facility must have permanent 
restrooms in both the nonquarantine and quarantine areas of the 
facility.
    (M) Break room. The medium security facility must have an area 
within the quarantine area for breaks and meals.
    (N) Laundry area. The medium security facility must have an area for 
washing and drying clothes, linens, and towels.
    (iv) Sanitation. To ensure that proper animal health and biological 
security measures are observed, a privately owned medium or minimum 
security quarantine facility must provide the following:
    (A) Equipment and supplies necessary to maintain the facility in a 
clean and sanitary condition, including pest control equipment and 
supplies and cleaning and disinfecting equipment with adequate capacity 
to disinfect the facility and equipment.
    (B) Separately maintained sanitation and pest control equipment and 
supplies for each lot-holding area if the facility will hold more than 
one lot of ruminants at a time (applicable to medium security facilities 
only).
    (C) A supply of potable water adequate to meet all watering and 
cleaning needs, with water faucets for hoses located throughout the 
facility. An emergency supply of water for ruminants in quarantine also 
must be maintained.
    (D) A stock of disinfectant authorized in Sec.71.10(a)(5) of this 
chapter or otherwise approved by the Administrator that is sufficient to 
disinfect the entire facility.
    (E) The capability to dispose of wastes, including manure, urine, 
and used bedding, by means of burial, incineration, or public sewer. 
Other waste material must be handled in such a manner that minimizes 
spoilage and the attraction of pests and must be disposed of by 
incineration, public sewer, or other preapproved manner that prevents 
the spread of disease. Disposal of wastes must be carried out under the 
direct oversight of APHIS representatives.
    (F) The capability to dispose of ruminant carcasses in a manner 
approved by the Administrator and under conditions that prevent the 
spread of disease from the carcasses.
    (G) For incineration to be carried out at the facility, incineration 
equipment that is detached from other facility structures and is capable 
of burning wastes or carcasses as required. The incineration site must 
include an area sufficient for solid waste holding. Incineration may 
also take place at a local site away from the facility premises. All 
incineration activities must be carried out under the direct oversight 
of an APHIS representative.
    (H) The capability to control surface drainage and effluent into, 
within, and from the facility in a manner that prevents the spread of 
disease into, within, and from the facility. If the facility is approved 
to handle more than one lot of ruminants at the same time,

[[Page 511]]

there must be separate drainage systems for each lot-holding area in 
order to prevent cross contamination.
    (v) Security. (A) A privately owned medium or minimum security 
quarantine facility must provide the following security measures:
    (1) The facility and premises must be kept locked and secure at all 
times while the ruminants are in quarantine.
    (2) The facility and premises must have signs indicating that the 
facility is a quarantine area and no visitors are allowed.
    (3) The operator must furnish a telephone number or numbers to APHIS 
at which the operator or his or her agent can be reached at all times.
    (4) APHIS is authorized to place seals on any or all entrances and 
exits of the facility, when determined necessary by APHIS to ensure 
security, and to take all necessary steps to ensure that the seals are 
broken only in the presence of an APHIS representative. If the seals are 
broken by someone other than an APHIS representative, it will be 
considered a breach in security, and an immediate accounting of all 
ruminants in the facility will be made by an APHIS representative. If a 
breach in security occurs, APHIS may extend the quarantine period as 
long as necessary to determine that the ruminants are free of 
communicable livestock diseases.
    (5) In the event that a communicable livestock disease is diagnosed 
in quarantined ruminants, the Administrator may require that the 
operator have the facility guarded by a bonded security company, at the 
expense of the operator of the facility, in a manner that the 
Administrator deems necessary to ensure the biological security of the 
facility.
    (B) A privately owned medium security facility also must provide the 
following security measures:
    (1) The medium security facility and premises must be guarded at all 
times by one or more representatives of a bonded security company, or, 
alternatively, the medium security facility must have an electronic 
security system that prevents the entry of unauthorized persons into the 
facility and prevents animals outside the facility from having contact 
with ruminants in quarantine;
    (2) If an electronic security system is used, the electronic 
security system must be coordinated through or with the local police so 
that monitoring of the facility is maintained whenever APHIS 
representatives are not at the facility. The electronic security system 
must be of the ``silent type'' and must be triggered to ring at the 
monitoring site and, if the operator chooses, at the facility. The 
operator must provide written instructions to the monitoring agency 
stating that the police and an APHIS representative designated by APHIS 
must be notified by the monitoring agency if the alarm is triggered. The 
operator also must submit a copy of those instructions to the 
Administrator. The operator must notify the designated APHIS 
representative whenever a break in security occurs or is suspected of 
occurring.
    (4) Operating procedures. The following procedures must be followed 
at a privately owned medium or minimum security quarantine facility at 
all times:
    (i) APHIS oversight. (A) The quarantine of ruminants at the facility 
will be subject to the strict oversight of APHIS representatives 
authorized to perform the services required by this subpart.
    (B) If, for any reason, the operator fails to properly care for, 
feed, or handle the quarantined ruminants as required in paragraph (d) 
of this section, or in accordance with animal health and husbandry 
standards provided elsewhere in this chapter, or fails to maintain and 
operate the facility as provided in paragraph (d) of this section, APHIS 
representatives are authorized to furnish such neglected services at the 
operator's expense, as authorized in paragraph (a) of this section.
    (ii) Personnel. (A) The operator must provide adequate personnel to 
maintain the facility and care for the ruminants in quarantine, 
including attendants to care for and feed ruminants, and other personnel 
as needed to maintain, operate, and administer the facility.
    (B) The operator must provide APHIS with an updated list of all 
personnel who have access to the facility. The list must include the 
names, current

[[Page 512]]

residential addresses, and identification numbers of each person, and 
must be updated with any changes or additions in advance of such person 
having access to the quarantine facility.
    (C) The operator must provide APHIS with signed statements from all 
personnel having access to the facility in which the person agrees to 
comply with paragraph (d) of this section and applicable provisions of 
this part, all terms of the compliance agreement, and any related 
instructions from APHIS representatives pertaining to quarantine 
operations, including contact with animals both inside and outside the 
facility.
    (iii) Authorized access. (A) Access to the facility premises as well 
as inside the quarantine area will be granted only to APHIS 
representatives and other persons specifically authorized to work at the 
facility. All other persons are prohibited from the premises unless 
specifically granted access by an APHIS representative. Any visitors 
granted access must be accompanied at all times by an APHIS 
representative while on the premises.
    (B) All visitors, except veterinary practitioners who enter the 
facility to provide emergency care, must sign an affidavit before 
entering the quarantine area, if determined necessary by the overseeing 
APHIS representative, declaring that they will not have contact with any 
susceptible animals outside the facility for at least 5 days after 
contact with the ruminants in quarantine, or for a period of time 
determined by the overseeing APHIS representative as necessary to 
prevent the transmission of communicable livestock diseases of 
ruminants.
    (iv) Sanitary practices. (A) All persons granted access to the 
quarantine area must:
    (1) Wear clean protective work clothing and footwear upon entering 
the quarantine area.
    (2) Wear disposable gloves when handling sick animals and then wash 
hands after removing gloves.
    (3) Change protective clothing, footwear, and gloves when they 
become soiled or contaminated.
    (4) Be prohibited, if determined necessary by the overseeing APHIS 
representative, from having contact with any susceptible animals outside 
the facility for at least 5 days after the last contact with ruminants 
in quarantine, or for a longer period of time determined necessary by 
the overseeing APHIS representative to prevent the transmission of 
livestock diseases.
    (B) All equipment (including tractors) must be cleaned and 
disinfected prior to being used in the quarantine area of the facility 
with a disinfectant that is authorized in Sec.71.10(a)(5) of this 
chapter or that is otherwise approved by the Administrator. The 
equipment must remain dedicated to the facility for the entire 
quarantine period. Any equipment used with quarantined ruminants must 
remain dedicated to that particular lot of ruminants for the duration of 
the quarantine period or be cleaned and disinfected before coming in 
contact with ruminants from another lot. Prior to its use on another lot 
of ruminants or its removal from the quarantine area, such equipment 
must be cleaned and disinfected to the satisfaction of an APHIS 
representative.
    (C) Any vehicle, before entering or leaving the quarantine area of 
the facility, must be immediately cleaned and disinfected under the 
oversight of an APHIS representative with a disinfectant that is 
authorized in Sec.71.10(a)(5) of this chapter or that is otherwise 
approved by the Administrator.
    (D) If the facility has a single loading dock, the loading dock must 
be immediately cleaned and disinfected after each use under the 
oversight of an APHIS representative with a disinfectant that is 
authorized in Sec.71.10(a)(5) of this chapter or that is otherwise 
approved by the Administrator.
    (E) That area of the facility in which a lot of ruminants had been 
held or had access must be thoroughly cleaned and disinfected under the 
oversight of an APHIS representative upon release of the ruminants, with 
a disinfectant that is authorized in Sec.71.10(a)(5) of this chapter 
or that is otherwise approved by the Administrator, before a new lot of 
ruminants is placed in that area of the facility.
    (F) For medium security facilities only, the following additional 
sanitary practices also must be followed:

[[Page 513]]

    (1) All persons granted access to the quarantine area, must:
    (i) Shower when leaving the quarantine area.
    (ii) Shower before entering a lot-holding area if previously exposed 
from access to another lot-holding area.
    (iii) Shower when leaving the necropsy area if a necropsy is in the 
process of being performed or has just been completed, or if all or 
portions of the examined animal remain exposed.
    (iv) Be prohibited, unless specifically allowed otherwise by the 
overseeing APHIS representative, from having contact with any ruminants 
in the facility, other than the lot or lots of ruminants to which the 
person is assigned or is granted access.
    (2) The operator is responsible for providing a sufficient supply of 
clothing and footwear to ensure that workers and others provided access 
to the quarantine area of the facility have clean, protective clothing 
and footwear before entering the facility.
    (3) The operator is responsible for the proper handling, washing, 
and disposal of soiled and contaminated clothing worn in the quarantine 
area in a manner approved by an APHIS representative as adequate to 
preclude the transmission of disease within and from the facility. At 
the end of each workday, work clothing worn into each lot-holding area 
and elsewhere in the quarantine area must be collected and kept in bags 
until the clothing is washed. Used footwear must either be left in the 
clothes changing area or cleaned with hot water (148 [deg]F minimum) and 
detergent and disinfected as directed by an APHIS representative.
    (v) Handling of ruminants in quarantine. (A) Each lot of ruminants 
to be quarantined must be placed in the facility on an ``all-in, all-
out'' basis. No ruminant may be taken out of a lot while the lot is in 
quarantine, except for diagnostic purposes, and no ruminant may be added 
to a lot while in quarantine.
    (B) The facility must provide sufficient feed and bedding for the 
ruminants in quarantine, and it must be free of vermin and not spoiled. 
Feed and bedding must originate from a region that has been approved by 
APHIS as a source for feed and bedding.
    (C) Breeding of ruminants or collection of germ plasm from ruminants 
is prohibited during the quarantine period unless necessary for a 
required import testing procedure.
    (D) Ruminants in quarantine will be subjected to such tests and 
procedures as directed by an APHIS representative to determine whether 
the ruminants are free of communicable livestock diseases. While in 
quarantine, ruminants may be vaccinated only with vaccines that have 
been approved by the APHIS representative and licensed in accordance 
with Sec.102.5 of this chapter. \8\ Vaccines must be administered 
either by an APHIS veterinarian or an accredited veterinarian under the 
direct oversight of an APHIS representative.
---------------------------------------------------------------------------

    \8\ A list of approved vaccines is available from the Center for 
Veterinary Biologics, USDA, APHIS, VS, 510 south 17th Street6, Suite 
104, Ames, IA 50010.
---------------------------------------------------------------------------

    (E) Any death or suspected illness of ruminants in quarantine must 
be reported immediately to the overseeing APHIS representative. The 
affected ruminants must be disposed of as the Administrator may direct 
or, depending on the nature of the disease, must be cared for as 
directed by APHIS to prevent the spread of disease.
    (F) Quarantined ruminants requiring specialized medical attention or 
additional postmortem testing may be transported off the quarantine 
site, if authorized by APHIS. A second quarantine site must be 
established to house the ruminants at the facility of destination (e.g., 
veterinary college hospital). In such cases, APHIS may extend the 
quarantine period until the results of any outstanding tests or 
postmortems are received.
    (G) Should the Administrator determine that an animal health 
emergency exists at the facility, arrangements for the final disposition 
of the infected or exposed lot of ruminants must be accomplished within 
4 workdays following disease confirmation. Subsequent disposition of the 
ruminants must occur under the direct oversight of APHIS 
representatives.
    (vi) Recordkeeping. (A) The operator must maintain a current daily 
log, to record the entry and exit of all persons entering and leaving 
the facility.

[[Page 514]]

    (B) The operator must retain the daily log, along with any logs kept 
by APHIS and deposited with the operator, for at least 2 years following 
the date of release of the ruminants from quarantine and must make such 
logs available to APHIS representatives upon request.
    (5) Environmental quality. If APHIS determines that a privately 
owned medium or minimum security quarantine facility does not meet 
applicable local, State, or Federal environmental regulations, APHIS may 
deny or suspend approval of the facility until appropriate remedial 
measures have been applied.
    (6) Other laws. A privately owned medium or minimum security 
quarantine facility must comply with other applicable Federal laws and 
regulations, as well as with all applicable State and local codes and 
regulations.
    (7) Variances. The Administrator may grant variances to existing 
requirements relating to location, construction, and other design 
features of a privately owned medium security quarantine facility or 
minimum security quarantine facility as well as to sanitation, security, 
operating procedures, recordkeeping, and other provisions in paragraph 
(d) of this section, but only if the Administrator determines that the 
variance causes no detrimental impact to the health of the ruminants or 
to the overall biological security of the quarantine operations. The 
operator must submit a request for a variance to the Administrator in 
writing at least 30 days in advance of the arrival of the ruminants to 
the facility. Any variance also must be expressly provided for in the 
compliance agreement.

(Approved by the Office of Management and Budget under control number 
0579-0232)

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997, 
as amended at 71 FR 29773, May 24, 2006]



Sec.93.413  Quarantine stations, visiting restricted; sales prohibited.

    Visitors are not permitted in the quarantine enclosures during any 
time that ruminants are in quarantine unless the APHIS representative or 
inspector in charge specifically grants access under such conditions and 
restrictions as may be imposed by the APHIS representative or inspector 
in charge. An importer (or his or her accredited agent or veterinarian) 
may be admitted to the yards and buildings containing his or her 
quarantined ruminants at such intervals as may be deemed necessary, and 
under such conditions and restrictions as may be imposed, by the APHIS 
representative or the inspector in charge of the quarantine facility or 
station. On the last day of the quarantine period, owners, officers, or 
registry societies, and others having official business or whose 
services may be necessary in the removal of the ruminants may be 
admitted upon written permission from the APHIS representative or 
inspector in charge. No exhibition or sale shall be allowed within the 
quarantine grounds.

[71 FR 29779, May 24, 2006]



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 APHIS representative or 
inspector in charge of the quarantine station and subject to such 
restrictions as he or she may consider necessary to each instance. No 
milk or cream shall be removed from the quarantine premises except in 
compliance with all State and local regulations.

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997, 
as amended at 71 FR 29779, May 24, 2006]



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.

[[Page 515]]

The affected ruminants shall be disposed of as the Administrator may 
direct, depending upon the nature of the disease.

                               Canada \9\
---------------------------------------------------------------------------

    \9\ 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 and other bovines from Canada.

    (a) Health certificates. Cattle intended for importation from Canada 
must be accompanied by a certificate issued in accordance with Sec.
93.405(a). The certificate must state that the cattle have been 
inspected and were found to be free from any evidence of communicable 
disease and that, as far as can be determined, they have not been 
exposed to any such disease during the preceding 60 days. Cattle found 
unqualified upon inspection at the port of entry will be refused entry 
into the United States.
    (b)-(c) [Reserved]
    (d) Conditions for importation. In addition to meeting the other 
requirements of this section, bovines may be imported from Canada only 
under the following conditions:
    (1) The bovines are imported for immediate slaughter under Sec.
93.420; or
    (2) The bovines are imported for other than immediate slaughter 
under the following conditions:
    (i) The bovines were born after March 1, 1999, the date determined 
by APHIS to be the date of effective enforcement of a ruminant-to-
ruminant feed ban in Canada;
    (ii) The bovines are imported only through a port of entry listed in 
Sec.93.403(b) or as provided for in Sec.93.403(f);
    (iii) The bovines were officially identified prior to arriving at 
the port of entry in the United States with unique individual 
identification that is traceable to each bovine's premises of origin. No 
person may alter, deface, remove, or otherwise tamper with the official 
identification while the animal is in the United States or moving into 
or through the United States, except that the identification may be 
removed at slaughter; and
    (iv) The bovines are permanently and humanely identified using one 
of the following additional methods:
    (A) A ``C[Lambda]N'' mark properly applied with a freeze brand, hot 
iron, or other method, and easily visible on the live animal and on the 
carcass before skinning. Such a mark must be not less than 2 inches nor 
more than 3 inches high, and must be applied to each animal's right hip, 
high on the tail-head (over the junction of the sacral and first 
coccygeal vertebrae); or
    (B) A tattoo with the letters ``C[Lambda]N'' applied to the inside 
of one ear of the animal; or
    (C) Other means of permanent identification upon request if deemed 
adequate by the Administrator to humanely identify the animal in a 
distinct and legible way as having been imported from Canada.
    (3) The bovines are accompanied by a certificate issued in 
accordance with

[[Page 516]]

Sec.93.405 that states, in addition to the statements required by 
Sec.93.405, that the conditions of paragraph (d)(2) of this section, 
as applicable, have been met.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[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; 
71 FR 12997, Mar. 14, 2006; 78 FR 72996, Dec. 4, 2013; 78 FR 73993, Dec. 
10, 2013; 85 FR 57952, Sept. 17, 2020]



Sec.93.419  Sheep and goats from Canada.

    (a) Sheep and goats intended for importation from Canada must be 
accompanied by a certificate issued in accordance with Sec.93.405.
    (b) If the 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 or exposed to a 
communicable disease, they shall be refused entry and shall be handled 
or quarantined, or otherwise disposed of, as the Administrator may 
direct.
    (c) Any sheep or goats imported from Canada must not be pregnant, 
must be less than 12 months of age when imported into the United States 
and when slaughtered, must be from a flock or herd subject to a ruminant 
feed ban equivalent to the requirements established by the U.S. Food and 
Drug Administration at 21 CFR 589.2000, and, before the animal's arrival 
at the port of entry into the United States, must be officially 
identified with unique individual identification that is traceable to 
the premises of origin of the animal. No person may alter, deface, 
remove, or otherwise tamper with the official identification while the 
animal is in the United States or moving into or through the United 
States, except that the identification may be removed at the time of 
slaughter. The animals must be accompanied by the certification issued 
in accordance with Sec.93.405 that states, in addition to the 
statements required by Sec.93.405, that the conditions of this 
paragraph have been met. Additionally, for sheep and goats imported for 
immediate slaughter, the certificate must state that the conditions of 
paragraphs (d)(1) through (d)(3) of this section have been met, and, for 
sheep and goats imported for other than immediate slaughter, the 
certificate must state that the conditions of paragraphs (e)(1) and 
(e)(2) of this section have been met.
    (d) Sheep and goats imported for immediate slaughter. Sheep and 
goats imported from Canada for immediate slaughter must be imported only 
through a port of entry listed in Sec.93.403(b) or as provided for in 
Sec.93.403(f) in a means of conveyance sealed in Canada with seals of 
the Canadian Government, and must be moved directly as a group from the 
port of entry to a recognized slaughtering establishment for slaughter 
as a group. The sheep and goats shall be inspected at the port of entry 
and otherwise handled in accordance with Sec.93.408. The seals on the 
means of conveyance must be broken only at the port of entry by the 
APHIS port veterinarian or at the recognized slaughtering establishment 
by an authorized USDA representative. If the seals are broken by the 
APHIS port veterinarian at the port of entry, the means of conveyance 
must be resealed with seals of the U.S. Government before being moved to 
the recognized slaughtering establishment. The shipment must be 
accompanied from the port of entry to the recognized slaughtering 
establishment by APHIS Form VS 17-33, which must include the location of 
the recognized slaughtering establishment. Additionally, the sheep and 
goats must meet the following conditions:
    (1) The animals have not tested positive for and are not suspect for 
a transmissible spongiform encephalopathy;
    (2) The animals have not resided in a flock or herd that has been 
diagnosed with BSE; and
    (3) The animals' movement is not restricted within Canada as a 
result of exposure to a transmissible spongiform encephalopathy.
    (e) Imported for feeding. Any sheep or goats imported from Canada 
for feeding at a feedlot must be imported only through a port of entry 
listed in Sec.93.403(b) or as provided for in Sec.93.403(f) in a 
means of conveyance sealed in the region of origin with seals of the 
national government of the region of origin, must be moved directly as a 
group

[[Page 517]]

from the port of entry to a designated feedlot, must not be commingled 
with any sheep or goats that are not being moved directly to slaughter 
from the designated feedlot at less than 12 months of age, and must meet 
the following conditions:
    (1) The sheep and goats must be permanently and humanely identified 
before arrival at the port of entry with a distinct and legible ``C'' 
mark, properly applied with a freeze brand, hot iron, or other method, 
and easily visible on the live animal and on the carcass before 
skinning. The mark must be not less than 1 inch or more than 1\1/4\ 
inches high. Other means of permanent identification may be used upon 
request if deemed adequate by the Administrator to humanely identify the 
animal in a distinct and legible way as having been imported from 
Canada;
    (2) The animals may be moved from the port of entry only to a 
feedlot designated in accordance with paragraph (e)(7) of this section 
and must be accompanied from the port of entry to the designated feedlot 
by APHIS Form VS 17-130 or other movement documentation deemed 
acceptable by the Administrator, which must identify the physical 
location of the feedlot, the individual responsible for the movement of 
the animals, and the individual identification of each animal, which 
includes the official identification required under paragraph (c) of 
this section and any other identification present on the animal, 
including registration number, if any:
    (3) The seals of the national government of Canada must be broken 
only at the port of entry by the APHIS port veterinarian or at the 
designated feedlot by an authorized USDA representative. If the seals 
are broken by the APHIS port veterinarian at the port of entry, the 
means of conveyance must be resealed with seals of the U.S. Government 
before being moved to the designated feedlot;
    (4) The animals must remain at the designated feedlot until 
transported to a recognized slaughtering establishment. The animals must 
be moved directly to the recognized slaughtering establishment in a 
means of conveyance sealed with seals of the U.S. Government by an 
accredited veterinarian, a State representative, or an APHIS 
representative. The seals must be broken at the recognized slaughtering 
establishment only by an authorized USDA representative;
    (5) The animals must be accompanied to the recognized slaughtering 
establishment by APHIS Form VS 1-27 or other documentation deemed 
acceptable by the Administrator, which must identify the physical 
location of the recognized slaughtering establishment, the individual 
responsible for the movement of the animals, and the individual 
identification of each animal, which includes the official 
identification required under paragraph (c) of this section and any 
other identification present on the animal, including registration 
number, if any;
    (6) The animals must be less than 12 months of age when slaughtered;
    (7) To be approved to receive sheep or goats imported for feeding, a 
feedlot must have signed a written agreement with the Administrator 
stating that the feedlot:
    (i) Will not remove official identification from animals unless 
medically necessary, in which case new official identification will be 
applied and cross referenced in the records;
    (ii) Will monitor all incoming imported feeder animals to ensure 
that they have the required ``C'' brand;
    (iii) Will maintain records of the acquisition and disposition of 
all imported sheep and goats entering the feed lot, including the 
official identification number and all other identifying information, 
the age of each animal, the date each animal was acquired and the date 
each animal was shipped to slaughter, and the name and location of the 
plant where each animal was slaughtered. For Canadian animals that die 
in the feedlot, the feedlot will remove the official identification 
device if affixed to the animal, or will record any other official 
identification on the animal and place the official identification 
device or record of official identification in a file with a record of 
the disposition of the carcass;
    (iv) Will maintain copies of the APHIS Forms VS 17-130 and VS 1-27 
or other movement documentation

[[Page 518]]

deemed acceptable by the Administrator that have been issued for 
incoming animals and for animals moved to slaughter and that list the 
official identification of each animal;
    (v) Will allow State and Federal animal health officials access to 
inspect its premises and animals and to review inventory records and 
other required files upon request;
    (vi) Will keep required records for at least 5 years;
    (vii) Will designate either the entire feedlot or pens within the 
feedlot as terminal for sheep and goats to be moved only directly to 
slaughter at less than 12 months of age, and
    (viii) Agrees that if inventory cannot be reconciled or if animals 
are not moved to slaughter as required the approval of the feedlot will 
be immediately withdrawn.

(Approved by the Office of Management and Budget under control numbers 
0579-0040, 0579-0234, and 0579-0277)

[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; 70 FR 547, Jan. 4, 2005; 70 FR 
71217, Nov. 28, 2005; 71 FR 12997, Mar. 14, 2006; 72 FR 53376, Sept. 18, 
2007; 73 FR 3383, Jan. 18, 2008]



Sec.93.420  Ruminants from Canada for immediate slaughter other than
sheep and goats.

    (a) General requirements. The requirements for the importation of 
sheep and goats from Canada for immediate slaughter are contained in 
Sec.93.419. There are no BSE-related restrictions on the importation 
of cervids or camelids from Canada. All other ruminants imported from 
Canada for immediate slaughter, in addition to meeting all other 
applicable requirements of this part, may be imported only under the 
following conditions:
    (1) The ruminants must be imported only through a port of entry 
listed in Sec.93.403(b) or as provided for in Sec.93.403(f) and be 
inspected at the port of entry and otherwise handled in accordance with 
Sec.93.408.
    (2) The ruminants must be moved directly from the port of entry to a 
recognized slaughtering establishment in conveyances that are sealed 
with seals of the U.S. Government at the port of entry. The seals may be 
broken only at the recognized slaughtering establishment by an 
authorized USDA representative.
    (3) The ruminants must be accompanied from the port of entry to the 
recognized slaughtering establishment by APHIS Form VS 17-33, which must 
include the location of the recognized slaughtering establishment.
    (b) Bovines. In addition to meeting the requirements of paragraph 
(a) of this section, bovines may be imported from Canada for immediate 
slaughter only under the following conditions:
    (1) The bovines must have been born after March 1, 1999, the date 
determined by APHIS to be the date of effective enforcement of a 
ruminant-to-ruminant feed ban in Canada;
    (2) Before the animal's arrival at the port of entry into the United 
States, each bovine imported into the United States from Canada must be 
officially identified with unique individual identification that is 
traceable to the premises of origin of the animal. No person may alter, 
deface, remove, or otherwise tamper with the official identification 
while the animal is in the United States or moving into or through the 
United States, except that the identification may be removed at 
slaughter; and
    (3) The bovines must be accompanied by a certificate issued in 
accordance with Sec.93.405 that states, in addition to the statements 
required by Sec.93.405, that the conditions of paragraphs (b)(1) and 
(b)(2) of this section have been met.

(Approved by the Office of Management and Budget under control numbers 
0579-0234 and 0579-0393)

[78 FR 72996, Dec. 4, 2013]



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

[[Page 519]]

(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 point when he or she finds 
that such action will not increase the risk that communicable diseases 
of livestock and poultry will be disseminated to the livestock or 
poultry of the United States.
    (2) In-transit shipments through Canada. Ruminants originating in 
the United States and transported directly through Canada may re-enter 
the United States without Canadian health or test certificates when 
accompanied by copies of the United States export health certificates 
properly issued and endorsed in accordance with regulations in part 91 
of this chapter: Provided, That, to qualify for entry, the date, time, 
port of entry, and signature of the Canadian Port Veterinarian that 
inspected the ruminants for entry into Canada shall be recorded on the 
United States health certificate, or a document containing information 
shall be included with the certificate that accompanies the ruminants. 
In all cases it shall be determined by the veterinary inspector at the 
United States port of entry that the ruminants are the identical 
ruminants covered by said certificate.
    (b) Exhibition ruminants. Ruminants from the United States which 
have been exhibited at the Royal Agricultural Winter Fair at Toronto or 
other publicly recognized expositions in Canada, including racing, 
rodeo, circus, or stage exhibitions in Canada, and have not been in that 
region for more than 90 days are eligible for return to the United 
States without Canadian health or test certificates, if they are 
accompanied by copies of the United States health certificate, issued 
and endorsed in accordance with the export regulations contained in part 
91 of this chapter for entry into Canada: Provided, That all ruminants 
offered for re-entry upon examination by the veterinary inspector at the 
U.S. port of entry, are found by the inspector to be free of 
communicable diseases and exposure thereto and are determined to be the 
identical ruminants covered by said certificates or are the natural 
increase of such ruminants born after official test dates certified on 
the dam's health certificate.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56018, Oct. 28, 1997; 81 FR 40151, June 21, 2016]

                  Central America and West Indies \10\
---------------------------------------------------------------------------

    \10\ 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.
---------------------------------------------------------------------------



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.
    (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) In addition to all other applicable requirements of the 
regulations in this part, ruminants intended for importation from 
Central America and the

[[Page 520]]

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 
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 bovine 
babesiosis, during the 60 days preceding their movement to the United 
States Virgin Islands.
    (d) If ruminants are unaccompanied by the certificate or affidavit 
as required by paragraphs (a), (b), or (c) of this section, or if they 
are found upon inspection at the port of entry to be affected with a 
communicable disease or to have been exposed thereto, they shall be 
refused entry, except as provided in paragraph (c) of this section. 
Ruminants refused entry shall be handled or quarantined, or otherwise 
disposed of as the Administrator may direct.
    (e) In addition to meeting all other applicable requirements of this 
part, bovines from Central America and the West Indies may be imported 
only in accordance with Sec.93.436.

(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; 78 FR 72997, Dec. 4, 2013; 80 FR 10324, Feb. 26, 
2015; 85 FR 57952, Sept. 17, 2020]

                               Mexico \11\
---------------------------------------------------------------------------

    \11\ 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.
---------------------------------------------------------------------------



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

[[Page 521]]

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:
    (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 mutual satisfactory arrangements for the 
orderly inspection of the animals. The veterinary inspector at the port 
of entry will provide the importer or his or her agent with a written 
statement assigning a date when the animals may be presented for import 
inspection.

[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; 85 FR 57952, Sept. 17, 2020]



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 and other bovines from Mexico.

    (a) Cattle and other ruminants from Mexico. Cattle and other 
ruminants from Mexico, except animals being transported in bond for 
immediate return to Mexico or animals imported for immediate slaughter, 
may be detained at the port of entry, and there subjected to such 
disinfection, blood tests, other tests, and dipping as required in this 
part to determine their freedom from any communicable disease or 
infection of such disease. The importer shall be responsible for the 
care, feed, and handling of the animals during the period of detention. 
In addition, each steer or spayed heifer imported into the United States 
from Mexico shall be identified with a distinct, permanent, and legible 
``M'' mark applied with a freeze brand, hot iron, or other method prior 
to arrival at a port of entry, unless the steer or spayed heifer is 
being transported in bond for immediate return to Mexico or imported for 
slaughter in accordance with Sec.93.429. The ``M'' mark shall be 
between 3 inches (7.5 cm) and 5 inches (12.5 cm) high and wide, and 
shall be applied to each animal's right hip, within 4 inches (10 cm) of 
the midline of the tailhead (that is, the top of the brand should be 
within 4 inches (10 cm) of the midline of the tailhead, and placed above 
the hook and pin bones). The brand should also be within 18 inches (45.7 
cm) of the anus.
    (b)(1) Cattle from regions of Mexico that APHIS has determined to be 
free from fever ticks. APHIS has evaluated certain regions of Mexico in 
accordance with Sec.92.2 of this chapter, and determined that they are 
free from fever ticks; a list of all such regions is found on the 
Internet http://www.aphis.usda.gov/wps/ portal/aphis/

[[Page 522]]

ourfocus/importexport. Copies of the list are also available by 
contacting APHIS at the following address: Regionalization Evaluation 
Services, National Import Export Services, Veterinary Services, Animal 
and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, 
MD 20737. Regions may be removed from the list based on a determination 
by APHIS that fever ticks exist in the region, on the discovery of tick-
infested cattle from the region at a port of entry into the United 
States, or on information provided by a representative of the government 
of that region that fever ticks exist in the region. Cattle from regions 
of Mexico that APHIS has determined to be free from fever ticks may be 
imported into the United States subject to the following conditions:
    (i) The cattle are accompanied by a certificate issued in accordance 
with Sec.93.405 that states that the cattle originate from a region of 
Mexico that APHIS has determined to be free from fever ticks.
    (ii) If the cattle will transit to the United States through an area 
of Mexico that APHIS has not determined to be free from fever ticks, 
they are moved in a sealed means of conveyance, and that seal remains 
intact throughout such transit.
    (iii) The cattle are presented for entry into the United States at a 
land border port of entry listed in Sec.93.403(c).
    (iv) The cattle are segregated at the U.S. port of entry from cattle 
from regions of Mexico that APHIS has not determined to be free from 
fever ticks.
    (v) The importer, or his or her agent, executes and delivers to the 
inspector at the port of entry an application for inspection or 
supervised dipping. In this application, the importer, or his or her 
agent, waive all claims against the United States for any loss or damage 
to the cattle occasioned by or resulting from inspection or dipping or 
from the fact that the cattle are later found still to be tick infested, 
and for any loss or damage to any other cattle in the importer's 
possession or control that come in contact with the dipped cattle.
    (vi) The cattle are either inspected by an APHIS inspector at the 
port of entry for evidence of tick infestation or are treated with a 
tickicidal dip that is listed in Sec.72.13 of this chapter under the 
supervision of an inspector at the port of entry.
    (vii) If any cattle are determined to be infested with fever ticks, 
the lot of cattle is refused entry and may only be imported into the 
United States subject to the requirements in paragraph (b)(2) of this 
section.
    (2) Cattle from regions of Mexico that APHIS has not determined to 
be free from fever ticks. Cattle from regions of Mexico that APHIS has 
not determined to be free from fever ticks may only be imported into the 
United States subject to the following conditions:
    (i) The cattle have been inspected by a veterinarian in Mexico and, 
in the determination of the veterinarian, are free from fever ticks and 
all evidence of communicable diseases, and have not been exposed to 
communicable diseases, other than bovine babesiosis, during the 60 days 
prior to movement to a port of entry into the United States.
    (ii) The cattle have been treated in Mexico with a tickicidal dip 
that is listed in Sec.72.13 of this chapter within 7 to 14 days before 
being offered for entry into the United States.
    (iii) The cattle are accompanied by a certificate issued in 
accordance with Sec.93.405 that states that this inspection and 
dipping have occurred.
    (iv) The cattle are presented for entry into the United States at 
the port of entry at Santa Teresa, NM, or a port of entry within Texas 
that is listed in Sec.93.403(c).
    (v) The importer, or his or her agent, executes and delivers to the 
inspector at the port of entry an application for inspection and 
supervised dipping. In this application, the importer, or his or her 
agent, agrees to waive all claims against the United States for any loss 
or damage to the cattle occasioned by or resulting from this dipping or 
from the fact that the cattle are later found to still be infested with 
ticks, and for any loss or damage to any other cattle in the importer's 
possession or control that come in contact with the dipped cattle.
    (vi) When offered for entry, the cattle receive an inspection by an 
inspector. If free from fever ticks, the cattle are treated once with a 
tickicidal dip that

[[Page 523]]

is listed in Sec.72.13 of this chapter 7 to 14 days after the dipping 
required in paragraph (b)(2)(ii) of this section. If found to be 
infested with fever ticks, the cattle are refused entry and may not be 
inspected again at a port of entry until they are again dipped and 7 to 
14 days have elapsed.
    (vii) The cattle are not imported into an area of Texas that is 
quarantined in accordance with Sec.72.5 of this chapter for bovine 
babesiosis, or for tick infestation.
    (c) Importation of Holsteins from Mexico. The importation of 
Holstein steers, Holstein spayed heifers, Holstein cross steers, and 
Holstein cross spayed heifers from Mexico is prohibited.
    (d) [Reserved]
    (e) BSE. In addition to meeting the requirements of this section and 
all other applicable requirements of this part, bovines may be imported 
from Mexico only under the following conditions:
    (1) The bovines were born after November 30, 2007, the date 
determined by APHIS to be the date of effective enforcement of a 
ruminant-to-ruminant feed ban in Mexico.
    (2) The bovines were officially identified prior to arriving at the 
port of entry in the United States with unique individual identification 
that is traceable to each bovine's premises of origin. No person may 
alter, deface, remove, or otherwise tamper with the official 
identification while the animal is in the United States or moving into 
or through the United States, except that the identification may be 
removed at slaughter.
    (3) The bovines, if sexually intact, are permanently and humanely 
identified using one of the following additional methods:
    (i) An ``M'' mark properly applied with a freeze brand, hot iron, or 
other method, and easily visible on the live animal and on the carcass 
before skinning. Such a mark must be between 3 inches (7.5 cm) and 5 
inches (12.5 cm) high and wide, and must be applied to the upper right 
front shoulder of each animal; or
    (ii) A tattoo with the letters ``MX'' applied to the inside of one 
ear of the animal; or
    (iii) Other means of permanent identification upon request if deemed 
adequate by the Administrator to humanely identify the animal in a 
distinct and legible way as having been imported from Mexico.
    (4) The bovines are accompanied by a certificate issued in 
accordance with Sec.93.405 that states, in addition to the statements 
required by Sec.93.405, that the conditions of paragraphs (e)(1) 
through (e)(3) of this section have been met.

(Approved by the Office of Management and Budget under control numbers 
0579-0040, 0579-0224, 0579-0393, and 0579-0425)

[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; 69 
FR 9750, Mar. 2, 2004; 74 FR 5, Jan. 2, 2009; 78 FR 72997, Dec. 4, 2013; 
80 FR 10324, Feb. 26, 2015; 83 FR 64225, Dec. 14, 2018; 85 FR 57952, 
Sept. 17, 2020]

    Effective Date Note: At 74 FR 5, Jan. 2, 2009, as corrected at 74 FR 
22091, May 12, 2009, Sec.93.427 was amended by revising paragraph 
(b)(2) introductory text, effective date delayed indefinitely. For the 
convenience of the user, the revised text is set forth as follows:



Sec.93.427  Cattle from Mexico.

                                * * * * *

    (b) * * *
    (2) Cattle that have been exposed to splenetic, southern, or tick 
fever, or that have been infested with or exposed to fever ticks, may be 
imported from Mexico for admission into the United States, except into 
areas of Texas quarantined because of said disease or tick infestation 
as specified in Sec.72.5 of this chapter, at one of the land border 
ports in Texas listed in Sec.93.403(c), the port of Santa Teresa, NM, 
or the port of San Luis, AZ, provided that the following conditions are 
strictly observed and complied with:

                                * * * * *



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

[[Page 524]]

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 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]

                      Additional General Provisions



Sec. Sec.93.430-93.434  [Reserved]



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

[[Page 525]]

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, 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

[[Page 526]]

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 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]



Sec.93.436  Bovines from regions of negligible risk, controlled risk,
and undetermined risk for BSE.

    The importation of bovines is prohibited, unless the conditions of 
this section and any other applicable conditions of this part are met. 
Once the bovines are imported, if they do not meet the conditions of 
this section, they must be disposed of as the Administrator may direct.
    (a) Bovines from a region of negligible risk for BSE in which there 
has been no indigenous case of BSE. Bovines from a region of negligible 
risk for BSE, as defined in Sec.92.1 of this subchapter, in which 
there has been no indigenous case of BSE, may be imported only if the 
bovines are accompanied by an original certificate issued by a full-time 
salaried veterinary officer of the national government of the exporting 
region, or issued by a veterinarian designated or accredited by the 
national government of the exporting region and endorsed by a full-time 
salaried veterinary officer of the national government of the exporting 
region, representing that the veterinarian issuing the certificate was 
authorized to do so, and the certificate attests that the exporting 
region of the bovines is classified by APHIS as a negligible-risk region 
for BSE in which there has been no indigenous case of BSE.
    (b) Bovines from a region of negligible risk for BSE in which there 
has been an indigenous case of BSE and bovines from a region of 
controlled risk for BSE. Bovines from a region of negligible risk for 
BSE, as defined in Sec.92.1 of this subchapter, in which there has 
been an indigenous case of BSE, and bovines from a region of controlled 
risk for BSE, as defined in Sec.92.1 of this subchapter, may be 
imported only under the following conditions:
    (1) Prior to importation into the United States, each bovine is 
officially identified with unique individual identification that is 
traceable to the premises of origin of the animal. No person may alter, 
deface, remove, or otherwise tamper with the official identification 
while the animal is in the United States or moving into or through the 
United States, except that the identification may be removed at 
slaughter.
    (2) The bovines are permanently and humanely identified before 
arrival at the port of entry with a distinct and legible mark 
identifying the exporting country. Acceptable means of permanent 
identification include the following:
    (i) A mark properly applied with a freeze brand, hot iron, or other 
method, and easily visible on the live animal and on the carcass before 
skinning. Such a mark must be not less than 2 inches nor more than 3 
inches high, and must be applied to each animal's right hip, high on the 
tail-head (over the junction of the sacral and first coccygeal 
vertebrae);
    (ii) A tattoo with letters identifying the exporting country must be 
applied to the inside of one ear of the animal; or
    (iii) Other means of permanent identification upon request if deemed 
adequate by the Administrator to humanely identify the animal in a 
distinct and legible way as having been imported from a region of 
negligible risk for BSE in which there has been an indigenous case of 
BSE or from a region of controlled risk for BSE.
    (3) The bovines were born after the date from which the ban on the 
feeding of ruminants meat-and-bone meal or

[[Page 527]]

greaves derived from ruminants has been effectively enforced.
    (4) The bovines are accompanied by an original certificate issued by 
a full-time salaried veterinary officer of the national government of 
the exporting region, or issued by a veterinarian designated or 
accredited by the national government of the exporting region and 
endorsed by a full-time salaried veterinary officer of the national 
government of the exporting region, representing that the veterinarian 
issuing the certificate was authorized to do so, and the certificate 
attests to the BSE risk classification of the exporting region and that 
the conditions of paragraphs (b)(1) through (b)(3) of this section have 
been met.
    (5) If there has been an indigenous case of BSE in the exporting 
region, the following restrictions apply:
    (i) Bovines that, during their first year of life, were reared with 
a bovine determined to be infected with BSE during its first year of 
life, and that an investigation showed consumed the same potentially 
contaminated feed as the infected animal during that period are not 
eligible for importation into the United States; and
    (ii) If the investigation was unable to determine whether the feed 
source that was used to feed the bovine known to be infected was also 
used to feed other bovines in the herd of the infected animal, all 
bovines born in the same herd as a BSE-infected bovine either within 12 
months before or 12 months after the birth of the infected animal are 
not eligible for importation into the United States.
    (c) Bovines from a region of undetermined risk for BSE. Importation 
of bovines from a region of undetermined risk for BSE, as defined in 
Sec.92.1 of this subchapter, is prohibited; Except that: The 
Administrator may allow such imports on a case-by-case basis if the live 
bovines are imported for specific uses, including, but not limited to, 
show or exhibition, and under conditions determined by the Administrator 
to be adequate to prevent the spread of BSE.

(Approved by the Office of Management and Budget under control number 
0579-0234)

[78 FR 72997, Dec. 4, 2013]



Sec.93.437  Tuberculosis status of foreign regions.

    (a) Level I regions. APHIS considers certain regions of the world to 
have a program that meets APHIS requirements for tuberculosis 
classification in accordance with Sec.93.438, and a prevalence of 
tuberculosis in their domestic bovine herds of less than 0.001 percent 
over at least the previous 2 years (24 consecutive months).
    (b) Level II regions. APHIS considers certain regions of the world 
to have a program that meets APHIS requirements for tuberculosis 
classification in accordance with Sec.93.438, and a prevalence of 
tuberculosis in their domestic bovine herds equal to or greater than 
0.001 percent, but less than 0.01 percent, over the previous 2 years (24 
consecutive months).
    (c) Level III regions. APHIS considers certain regions of the world 
to have a program that meets APHIS requirements for tuberculosis 
classification in accordance with Sec.93.438, and a prevalence of 
tuberculosis in their domestic bovine herds equal to or greater than 
0.01 percent, but less than 0.1 percent, over the previous year (12 
consecutive months).
    (d) Level IV regions. APHIS considers certain regions of the world 
to have a program that meets APHIS requirements for tuberculosis 
classification in accordance with Sec.93.438, and a prevalence of 
tuberculosis in their domestic bovine herds equal to or greater than 0.1 
percent, but less than 0.5 percent, over the previous year (12 
consecutive months).
    (e) Level V regions. APHIS considers certain regions of the world 
not to have a program that meets APHIS requirements for tuberculosis 
classification in accordance with Sec.93.438, to have a prevalence of 
tuberculosis in their domestic bovine herds equal to or greater than 0.5 
percent, or to be unassessed by APHIS with regard to tuberculosis.
    (f) Listing of regions. Lists of all Level I regions, Level II 
regions, Level III regions, Level IV regions, and Level V regions for 
tuberculosis are found online, at http://www.aphis.usda.gov/ 
import_export/animals/live_animals.shtml.

[[Page 528]]

Changes to the lists will be made in accordance with Sec.93.438.

[85 FR 57953, Sept. 17, 2020]



Sec.93.438  Process for requesting regional classification 
for tuberculosis.

    (a) Request for regional classification; requirements. A 
representative of the national government(s) of any country or countries 
who has the authority to make such a request may request that APHIS 
classify a region for tuberculosis. Requests for classification or 
reclassification must be submitted to APHIS electronically or through 
the mail as provided at http://www.aphis.usda.gov/ import_export/
animals/ live_animals.shtml. Guidance regarding how to complete a 
request in a manner that will allow APHIS to review it expeditiously is 
available at http://www.aphis.usda.gov/ import_export/animals/reg_ 
request.shtml, and may also be obtained by contacting the National 
Director, Regionalization Evaluation Services, Strategy and Policy Unit, 
VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737. At a minimum, 
in order for APHIS to consider the request complete, it must define the 
boundaries of the region, specify the prevalence level for tuberculosis 
within the region, and demonstrate the following:
    (1) That there is effective veterinary control and oversight within 
the region;
    (2) That tuberculosis is a notifiable disease within the region; and
    (3) That the region has a program in place for tuberculosis that 
includes, at a minimum:
    (i) Epidemiological investigations following the discovery of any 
infected animals or affected herds, or any animals or herds that have 
had non-negative test results following a test for tuberculosis, and 
documentation of these investigations;
    (ii) Management of affected herds in a manner designed to eradicate 
tuberculosis from those herds in a timely manner, and documentation 
regarding this management;
    (iii) Regulatory controls on the movement of livestock into, within, 
and from the region that correspond to the risk of dissemination of 
tuberculosis associated with such movement; and
    (iv) Access to, oversight of, and quality controls for diagnostic 
testing for tuberculosis within the region.
    (4) That the region has surveillance in place that is equivalent to 
or exceeds Federal standards for surveillance within the United States.
    (b) APHIS evaluation. If, after reviewing and evaluating the request 
for classification, APHIS believes the region can be accurately 
classified for tuberculosis, APHIS will publish a notice in the Federal 
Register proposing to classify the region according to Sec.93.437, and 
making the information upon which this proposed classification is based 
available to the public for review and comment. The notice will request 
public comment.
    (c) APHIS determination. (1) If no comments are received on the 
notice, or if comments are received but do not affect APHIS' proposed 
classification, APHIS will publish a subsequent notice in the Federal 
Register announcing that classification to be final and adding the 
region to the appropriate list on the APHIS website.
    (2) If comments received on the notice suggest that the region be 
classified according to a different tuberculosis classification, and 
APHIS agrees with the comments, APHIS will publish a subsequent notice 
in the Federal Register making the information supplied by commenters 
available to the public, and proposing to classify the region according 
to this different classification. The notice will request public 
comment.
    (3) If comments received on the notice suggest that insufficient 
information was supplied on which to base a tuberculosis classification, 
and APHIS agrees with the comments, APHIS will publish a subsequent 
notice in the Federal Register specifying the additional information 
needed before APHIS can classify the region.
    (d) Maintaining classification and reclassification initiated by 
APHIS. If a region is classified under the provisions of this section, 
that region may be required to submit additional information or allow 
APHIS to conduct additional information collection activities in order 
for that region to maintain its

[[Page 529]]

classification. Moreover, if APHIS determines that a region's 
classification for tuberculosis is no longer accurate, APHIS will 
publish a notice in the Federal Register announcing the revised 
classification and setting forth the reasons for this reclassification.

(Approved by the Office of Management and Budget under control number 
0579-0442)

[85 FR 57953, Sept. 17, 2020]



Sec.93.439  Importation of ruminants from certain regions of the 
world; tuberculosis.

    (a) Importation of certain ruminants prohibited. Notwithstanding any 
other provisions of this section, ruminants that are known to be 
infected with or exposed to tuberculosis and ruminants that have had a 
non-negative response to any test for tuberculosis at any time are 
prohibited importation into the United States.
    (b) Identification of bovines imported for any purpose. Unless 
otherwise specified by the Administrator, bovines imported into the 
United States for any purpose must be officially identified and 
accompanied by a certificate, issued in accordance with Sec.93.405(a), 
that lists the official identification of the animals presented for 
import.
    (c) Importation of bovines from a Level I region. Unless specified 
otherwise by the Administrator, bovines may be imported into the United 
States from a Level I region for tuberculosis in accordance with 
paragraph (b) of this section.\12\
---------------------------------------------------------------------------

    \12\ The importation of such bovines, as well as that of all other 
bovines covered by this section, is still subject to all other relevant 
restrictions of this part.
---------------------------------------------------------------------------

    (d) Importation of bovines from a Level II region. (1) Sexually 
intact bovines may be imported into the United States from a Level II 
region for tuberculosis for purposes other than immediate slaughter 
provided that the bovines are subjected to an individual test for 
tuberculosis at the port of entry into the United States or during post-
arrival quarantine in accordance with Sec.93.411, with negative 
results.
    (2) Steers or spayed heifers may be imported into the United States 
from a Level II region for tuberculosis for purposes other than 
immediate slaughter in accordance with paragraph (b) of this section.
    (e) Importation of bovines from a Level III region. (1) Bovines 
directly from currently accredited herds for tuberculosis. Bovines may 
be imported into the United States for purposes other than immediate 
slaughter directly from a currently accredited herd for tuberculosis in 
a Level III region for tuberculosis, provided that:
    (i) The bovines are accompanied by a certificate, issued in 
accordance with Sec.93.405(a), with an additional statement that the 
bovines originate directly from a currently accredited herd for 
tuberculosis; and
    (ii) If sexually intact, the bovines are subjected to an individual 
test for tuberculosis at the port of entry into the United States or 
during post-arrival quarantine in accordance with Sec.93.411, with 
negative results.
    (2) Sexually intact bovines that do not originate directly from a 
currently accredited herd for tuberculosis may be imported into the 
United States from a Level III region for tuberculosis for purposes 
other than immediate slaughter, provided that:
    (i) The bovines originate from a herd that was subjected to a whole 
herd test for tuberculosis on its premises of origin no more than 1 year 
prior to the export of the bovines to the United States, with negative 
results; and
    (ii) The bovines are subjected to an individual test for 
tuberculosis at the port of entry into the United States or during post-
arrival quarantine in accordance with Sec.93.411, with negative 
results; and
    (iii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.93.405(a), with an additional statement that the 
animals meet the conditions for importation in paragraph (e)(2)(i) of 
this section.
    (3) Steers or spayed heifers that do not originate directly from a 
currently accredited herd for tuberculosis may be imported into the 
United States from a Level III region for tuberculosis for purposes 
other than immediate slaughter provided that:
    (i) The steers or spayed heifers are subjected to an individual test 
for tuberculosis no more than 60 days prior

[[Page 530]]

to export of the bovines to the United States, with negative results; 
and
    (ii) The steers or spayed heifers are accompanied by a certificate, 
issued in accordance with Sec.93.405(a), with an additional statement 
that the animals meet the conditions for importation in paragraph 
(e)(3)(i) of this section.
    (f) Importation of bovines from a Level IV region. (1) Bovines may 
be imported into the United States for purposes other than immediate 
slaughter directly from a currently accredited herd for tuberculosis in 
a Level IV region for tuberculosis, provided that:
    (i) The bovines are accompanied by a certificate, issued in 
accordance with Sec.93.405(a), with an additional statement that the 
bovines originate directly from a currently accredited herd for 
tuberculosis and, if steers or spayed heifers, meet the conditions for 
importation in paragraph (f)(1)(iii) of this section; and
    (ii) If sexually intact, the bovines are subjected to an individual 
test for tuberculosis at the port of entry into the United States or 
during post-arrival quarantine in accordance with Sec.93.411, with 
negative results; and
    (iii) If steers and spayed heifers, the bovines are subjected to an 
individual test for tuberculosis no more than 60 days prior to export of 
the bovines to the United States, with negative results.
    (2) Sexually intact bovines that do not originate directly from a 
currently accredited herd for tuberculosis may be imported into the 
United States from a Level IV region for tuberculosis for purposes other 
than immediate slaughter, provided that:
    (i) The bovines originate from a herd that was subjected to two 
whole herd tests for tuberculosis on its premises of origin and 
conducted no less than 9 months and no more than 15 months apart, with 
the second whole herd test conducted no less than 60 days and no more 
than 12 months prior the export of the bovines to the United States, 
with negative results each time; and
    (ii) The bovines are subjected to an additional individual test for 
tuberculosis at the port of entry into the United States or during post-
arrival quarantine in accordance with Sec.93.411, with negative 
results; and
    (iii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.93.405(a), with an additional statement that the 
bovines meet the requirements in paragraph (f)(2)(i) of this section.
    (3) Steers or spayed heifers that do not originate directly from a 
currently accredited herd for tuberculosis may be imported into the 
United States from a Level IV region for tuberculosis for purposes other 
than immediate slaughter provided that:
    (i) The bovines originate from a herd that was subjected to a whole 
herd test for tuberculosis on its premises of origin no more than 1 year 
prior to the export of the bovines, with negative results; and
    (ii) The bovines are subjected to an additional individual test for 
tuberculosis no more than 60 days prior to export of the bovines to the 
United States, with negative results, except that the individual test is 
not required if the bovines are exported within 60 days of the whole 
herd test and were included in that test; and
    (iii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.93.405(a), with an additional statement that the 
bovines meet the requirements in this paragraph (f)(3).
    (g) Importation of bovines from a Level V region. At the discretion 
of the Administrator, bovines may be imported into the United States 
from a Level V region for tuberculosis for purposes other than immediate 
slaughter, provided that:
    (1) The bovines are subject to a pre-clearance program administered 
by APHIS and detailed in an import protocol published on the APHIS 
website; and
    (2) The bovines are subjected to an additional individual test for 
tuberculosis at the port of entry into the United States or during post-
arrival quarantine in accordance with Sec.93.411, with negative 
results; and
    (3) The bovines are accompanied by a certificate, issued in 
accordance with

[[Page 531]]

Sec.93.405(a), with an additional statement that bovines meet the 
requirements in paragraphs (g)(1) and (2) of this section.

(Approved by the Office of Management and Budget under control number 
0579-0442)

[85 FR 57954, Sept. 17, 2020]



Sec.93.440  Brucellosis status of foreign regions.

    (a) Level I regions. APHIS considers certain regions of the world to 
have a program that meets APHIS requirements for brucellosis 
classification in accordance with Sec.93.441, and a prevalence of 
brucellosis in their domestic bovine herds of less than 0.001 percent 
over at least the previous 2 years (24 consecutive months).
    (b) Level II regions. APHIS considers certain regions of the world 
to have a program that meets APHIS requirements for brucellosis 
classification in accordance with Sec.93.441, and a prevalence of 
brucellosis in their domestic bovine herds equal to or greater than 
0.001 percent, but less than 0.01 percent over at least the previous 2 
years (24 consecutive months).
    (c) Level III regions. APHIS considers certain regions of the world 
not to have a program that meets APHIS requirements for brucellosis 
classification in accordance with Sec.93.441, to have a herd 
prevalence equal to or greater than 0.01 percent, or to be unassessed by 
APHIS with regard to brucellosis prevalence.
    (d) Listing of regions. Lists of all Level I, Level II, and Level 
III regions for brucellosis are found online, at http://
www.aphis.usda.gov/ import_export/animals/live_ animals.shtml. Changes 
to the lists will be made in accordance with Sec.93.441.

[85 FR 57955, Sept. 17, 2020]



Sec.93.441  Process for requesting regional classification for 
brucellosis.

    (a) Request for regional classification; requirements. A 
representative of the national government(s) of any country or countries 
who has the authority to make such a request may request that APHIS 
classify a region for brucellosis. Requests for classification or 
reclassification must be submitted to APHIS electronically or through 
the mail as provided at http://www.aphis.usda.gov/ import_export/
animals/live _animals.shtml. Guidance regarding how to complete a 
request in a manner that will allow APHIS to review it expeditiously is 
available at http://www.aphis.usda.gov/ import_export/animals/reg_ 
request.shtml, and may also be obtained by contacting the National 
Director, Regionalization Evaluation Services, Strategy and Policy Unit, 
VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737. At a minimum, 
in order for APHIS to consider the request complete, it must define the 
boundaries of the region, specify the prevalence level for brucellosis 
within the region, and demonstrate the following:
    (1) That there is effective veterinary control and oversight within 
the region;
    (2) That brucellosis is a notifiable disease within the region;
    (3) That the region has a program for brucellosis in place that 
includes, at a minimum:
    (i) Epidemiological investigations following the discovery of any 
infected animals or affected herds, or any animals or herds that have 
had non-negative test results following a test for brucellosis, and 
documentation of these investigations;
    (ii) Management of affected herds in a manner designed to eradicate 
brucellosis from those herds, and documentation regarding this 
management;
    (iii) Regulatory controls on the movement of livestock into, within, 
and from the region that correspond to the risk of dissemination of 
brucellosis associated with such movement; and
    (iv) Access to, oversight of, and quality controls on diagnostic 
testing for brucellosis within the region;
    (4) That the region has surveillance in place that is equivalent to 
or exceeds Federal standards for brucellosis surveillance within the 
United States; and
    (5) That, if the region vaccinates for brucellosis, it is in a 
manner that has been approved by APHIS.
    (b) APHIS evaluation. If, after reviewing and evaluating the request 
for classification, APHIS believes the region can be accurately 
classified for brucellosis, APHIS will publish a notice in

[[Page 532]]

the Federal Register proposing to classify the region according to Sec.
93.440, and making available to the public the information upon which 
this proposed classification is based. The notice will request public 
comment.
    (c) APHIS determination. (1) If no comments are received on the 
notice, or if comments are received but do not affect APHIS' proposed 
classification, APHIS will publish a subsequent notice in the Federal 
Register announcing that classification to be final and adding the 
region to the appropriate list on the internet.
    (2) If comments received on the notice suggest that the region be 
classified according to a different brucellosis classification, and 
APHIS agrees with the comments, APHIS will publish a subsequent notice 
in the Federal Register making the information supplied by commenters 
available to the public, and proposing to classify the region according 
to this different classification. The notice will request public 
comment.
    (3) If comments received on the notice suggest that insufficient 
information was supplied on which to base a brucellosis classification, 
and APHIS agrees with the comments, APHIS will publish a subsequent 
notice in the Federal Register specifying the additional information 
needed before APHIS can classify the region.
    (d) Maintaining classification and reclassification initiated by 
APHIS. If a region is classified under the provisions of this section, 
that region may be required to submit additional information or allow 
APHIS to conduct additional information collection activities in order 
for that region to maintain its classification. Moreover, if APHIS 
determines that a region's classification for brucellosis is no longer 
accurate, APHIS will publish a notice in the Federal Register announcing 
the revised classification and setting forth the reasons for this 
reclassification.

(Approved by the Office of Management and Budget under control number 
0579-0442)

[85 FR 57955, Sept. 17, 2020]



Sec.93.442  Importation of ruminants from certain regions of the 
world; brucellosis.

    (a) Importation of certain ruminants prohibited. Notwithstanding any 
other provisions of this section, ruminants that are known to be 
infected with or exposed to brucellosis are prohibited importation into 
the United States.
    (b) Identification of bovines imported for any purpose. Unless 
otherwise specified by the Administrator, bovines imported into the 
United States for any purpose must be officially identified and 
accompanied by a certificate, issued in accordance with Sec.93.405(a), 
that lists the official identification of the animals presented for 
import.
    (c) Importation of steers and spayed heifers. Unless otherwise 
specified by the Administrator, steers and spayed heifers may be 
imported into the United States from a region in accordance with 
paragraph (b) of this section, without further restrictions under this 
part.
    (d) Importation of sexually intact bovines from Level I regions. 
Unless specified otherwise by the Administrator, sexually intact bovines 
may be imported into the United States from a Level I region for 
brucellosis in accordance with paragraph (b) of this section.\13\
---------------------------------------------------------------------------

    \13\ The importation of such bovines, as well as that of all other 
bovines covered by this section, is still subject to all other relevant 
restrictions of this chapter.
---------------------------------------------------------------------------

    (e) Importation of sexually intact bovines from a Level II region. 
(1) Sexually intact bovines directly from currently accredited herds for 
brucellosis. Sexually intact bovines may be imported into the United 
States for purposes other than immediate slaughter from a currently 
accredited herd for brucellosis in a Level II region for brucellosis, 
provided that the bovines are accompanied by a certificate, issued in 
accordance with Sec.93.405(a), with an additional statement that the 
bovines originate directly from a currently accredited herd for 
brucellosis.
    (2) Sexually intact bovines that do not originate directly from a 
currently

[[Page 533]]

accredited herd for brucellosis. Sexually intact bovines that do not 
originate directly from a currently accredited herd for brucellosis may 
be imported into the United States from a Level II region for 
brucellosis for purposes other than immediate slaughter, provided that:
    (i) The bovines originate from a herd that was subjected to a whole 
herd test for brucellosis on its premises of origin no more than 90 days 
and no less than 30 days prior to the export of the bovines to the 
United States, with negative results; and
    (ii) The bovines are subjected to an additional individual test for 
brucellosis at the port of entry into the United States or during post-
arrival quarantine in accordance with Sec.93.411, with negative 
results; and
    (iii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.93.405(a), with an additional statement that the 
bovines meet the requirements in paragraph (d)(2)(i) of this section.
    (f) Importation of sexually intact bovines from a Level III region. 
(1) Sexually intact bovines directly from currently accredited herds for 
brucellosis. Sexually intact bovines may be imported into the United 
States for purposes other than immediate slaughter from a currently 
accredited herd for brucellosis in a Level III region for brucellosis, 
provided that:
    (i) The bovines are subjected to an individual test for brucellosis 
at the port of entry into the United States or during post-arrival 
quarantine in accordance with Sec.93.411, with negative results; and
    (ii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.93.405(a), with an additional statement that the 
bovines originate directly from a currently accredited herd for 
brucellosis.
    (2) Sexually intact bovines that do not originate directly from a 
currently accredited herd for brucellosis. Sexually intact bovines that 
do not originate directly from a currently accredited herd for 
brucellosis may be imported into the United States from a Level III 
region for brucellosis for purposes other than immediate slaughter, 
provided that:
    (i) The bovines originate from a herd that was subjected to two 
whole herd tests for brucellosis on its premises of origin conducted no 
less than 9 months and no more than 15 months apart, with the second 
test taking place no more than 90 days and no less than 30 days prior to 
the export of the bovines to the United States, with negative results 
each time; and
    (ii) The bovines are subjected to an additional individual test for 
brucellosis at the port of entry into the United States or during post-
arrival quarantine in accordance with Sec.93.411, with negative 
results; and
    (iii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.93.405(a), with an additional statement that the 
bovines meet the requirements in paragraph (e)(2)(i) of this section.

(Approved by the Office of Management and Budget under control number 
0579-0442)

[85 FR 57956, Sept. 17, 2020]



                             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).

[[Page 534]]

    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.
    Official identification device or method. A means of officially 
identifying an animal or group of animals using devices or methods 
approved by the Administrator, including, but not limited to, official 
tags, tattoos, and registered brands when accompanied by a certificate 
of inspection from a recognized brand inspection authority.
    Port veterinarian. A veterinarian employed by the Animal and Plant 
Health Inspection Service to perform duties required under this part at 
a port of entry.
    Recognized slaughtering establishment. \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 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; 69 FR 64651, Nov. 8, 2004; 71 FR 29070, May 19, 
2006; 72 FR 67232, Nov. 28, 2007; 76 FR 70039, Nov. 10, 2011; 77 FR 
1391, Jan. 10, 2012]



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,

[[Page 535]]

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.
    (iii) They must provide for disposal of swine carcasses, manure, 
bedding, waste and any related shipping materials in a manner that will 
prevent dissemination of disease.
    (iv) They must have provisions for adequate sources of feed and 
water and for attendants for the care and feeding of swine in the 
facility.
    (v) They must comply with additional requirements as may be imposed 
by the Administrator if deemed applicable for a particular shipment.
    (vi) They must also comply with all applicable local, State and 
Federal requirements for environmental quality and with the provisions 
of the Animal Welfare Regulations in chapter I of this title, as 
applicable.
    (c) Removal and loss of official identification devices. Official 
identification devices are intended to provide permanent identification 
of livestock and to ensure the ability to find the source of animal 
disease outbreaks. Removal of these devices is prohibited except at the 
time of slaughter. If an official identification device is lost and it 
is necessary to retag an animal with a new official number, every effort

[[Page 536]]

should be made to correlate the new official number with the previous 
official number of the animal.

[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; 69 FR 64651, Nov. 8, 2004]



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 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.

[[Page 537]]

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 foot-and-mouth disease exists.
    (3) An application for permit to import swine may also be denied 
because of: Communicable disease conditions in the area or region of 
origin, or in a region where the shipment has been or will be held or 
through which the shipment has been or will be transported; deficiencies 
in the regulatory programs for the control or eradication of animal 
diseases and the unavailability of veterinary services in the above 
mentioned regions; the importer's failure to provide satisfactory 
evidence concerning the origin, history, and health status of the swine; 
the lack of satisfactory information necessary to determine that the 
importation will not be likely to transmit any communicable disease to 
livestock or poultry of the United States; or any other circumstances 
which the Administrator believes require such denial to prevent the 
dissemination of any communicable disease of livestock or poultry into 
the United States.
    (4)(i) The importer or importer's agent shall pay or ensure payment 
of a reservation fee for each lot of swine to be quarantined in a 
facility maintained by USDA. For swine the reservation fee

[[Page 538]]

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 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

[[Page 539]]

shipper in the region of origin, and it shall also be the responsibility 
of the importer to insure that the shipper presents the copy of the 
permit to the carrier and makes proper arrangements for the original 
permit to accompany the shipment to the specified U.S. port of entry for 
presentation to the collector of customs. Swine and swine test specimens 
for diagnostic screening purposes for swine intended for importation 
into the United States for which a permit has been issued, will be 
received at the specified port of entry within the time prescribed in 
the permit which shall not exceed 14 days from the first day that the 
permit is effective for all permits. Swine and swine test specimens for 
which a permit is required by these regulations will not be eligible for 
entry if a permit has not been issued; if unaccompanied by such a 
permit; if shipment is from any port other than the one designated in 
the permit; if arrival in the United States is at any port other than 
the one designated in the permit; if the swine or swine test specimens 
offered for entry differ from those described in the permit; if the 
swine or swine test specimens are not handled as outlined in the 
application for the permit and as specified in the permit issued; or if 
ruminants or swine other than those covered by import permits are aboard 
the transporting carrier.
    (c) Wild swine from regions where foot-and-mouth disease exists. 
This paragraph (c) applies to the importation of wild swine from 
countries designated in part 94 of this subchapter as regions in which 
foot-and-mouth disease exists.
    (1) Permits for the importation of wild swine will be issued only 
for importations through the Port of New York, and only if the animals 
are imported for exhibition in a PEQ Zoo. A PEQ Zoo is a zoological park 
or other place maintained for the exhibition of live animals for 
recreational or educational purposes that:
    (i) Has been approved by the Administrator in accordance with 
paragraph (c)(2) of this section to receive and maintain imported wild 
swine; and
    (ii) Has entered into the agreement with APHIS set forth in 
paragraph (c)(4) of this section for the maintenance and handling of 
imported wild swine.
    (2) Approval of a PEQ Zoo shall be on the basis of an inspection, by 
an authorized representative of the Department, of the physical 
facilities of the establishment and its methods of operation. Standards 
for acceptable physical facilities shall include satisfactory pens, 
cages, or enclosures in which the imported swine can be maintained so as 
not to be in contact with the general public and free from contact with 
domestic livestock; natural or established drainage from the PEQ Zoo 
which will avoid contamination of land areas where domestic livestock 
are kept or with which domestic livestock may otherwise come in contact; 
provision for the disposition of manure, other wastes, and dead swine 
within the PEQ Zoo; and other reasonable facilities considered necessary 
to prevent the dissemination of diseases from the PEQ Zoo. The operator 
of the PEQ Zoo shall have available the services of a full-time or part-
time veterinarian, or a veterinarian on a retainer basis, who shall make 
periodic examinations of all animals maintained at the PEQ Zoo for 
evidence of disease; who shall make a post-mortem examination of each 
animal that dies; and who shall make a prompt report of suspected cases 
of contagious or communicable diseases to appropriate state or federal 
livestock sanitary officials.
    (3) Manure and other animal wastes must be disposed of within the 
PEQ Zoo park for a minimum of one year following the date an imported 
wild swine enters the zoo. If an APHIS veterinarian determines that an 
imported swine shows no signs of any communicable disease during this 1-
year period, its manure and other wastes need not be disposed of within 
the zoo after the 1-year period. If, however, an APHIS veterinarian 
determines that the swine does show signs of any communicable disease 
during this 1-year period, an APHIS veterinarian will investigate the 
disease and determine whether the swine's manure and other wastes may 
safely be disposed of outside the zoo after the 1-year period has ended.
    (4) Prior to the issuance of an import permit under this section, 
the operator

[[Page 540]]

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 exists and 
being subject to restrictions under regulations contained in part 93, 
title 9, Code of Federal Regulations.
    In making this request, it is understood and agreed that:
    1. The animals for which an import permit is requested will be held 
in isolation at a port of embarkation in the region of origin, approved 
by the Administrator as a port having facilities which are adequate for 
maintaining wild animals in isolation from all other animals and having 
veterinary supervision by officials of the region of origin of the 
animals. Such animals will be held in such isolation for not less than 
60 days under the supervision of the veterinary service of that region 
to determine whether the animals show any clinical evidence of foot-and-
mouth disease, or other communicable disease that is exotic to the 
United States or for which APHIS has an eradication or control program 
in 9 CFR chapter I, and to assure that the animals will not have been 
exposed to such a disease within the 60 days next before their 
exportation from that region.
    2. Shipment will be made direct from such port of embarkation to the 
port of New York as the sole port of entry in this region. If shipment 
is made by ocean vessel, the animals will not be unloaded in any foreign 
port en route. If shipment is made by air, the animals will not be 
unloaded at any port or other place of landing, except at a port 
approved by the Administrator as a port not located in a region where 
foot-and-mouth disease exists or as a port in such a region having 
facilities and inspection adequate for maintaining wild animals in 
isolation from all other animals.
    3. No ruminants or swine will be aboard the transporting vehicle, 
vessel or aircraft, except those for which an import permit has been 
issued.
    4. The animals will be quarantined for not less than 30 days in the 
Department's Animal Import Center in Newburgh, New York.
    5. Upon release from quarantine the animals will be delivered to the 
zoological park named in this agreement to become the property of the 
park and they will not be sold, exchanged or removed from the premises 
without the prior consent of APHIS. If moved to another zoological park 
in the United States, the receiving zoological park must be approved by 
the Administrator in accordance with paragraph 6 of this agreement.
    6. The Administrator will approve the movement of an imported animal 
subject to this agreement if the Administrator determines that the 
animal has spent at least one year in quarantine in a PEQ Zoo following 
importation without showing clinical evidence of foot-and-mouth disease, 
or other communicable disease that is exotic to the United States or for 
which APHIS has an eradication or control program in 9 CFR chapter I, 
and determines that the receiving zoological park is accredited by the 
American Zoo and Aquarium Association (AZA), or the receiving zoological 
park has facilities and procedures in place related to preventing the 
spread of communicable animal diseases (including but not limited to 
procedures for animal identification, record keeping, and veterinary 
care) that are equivalent to those required for AZA accreditation. The 
Administrator will approve the movement of a carcass, body part, or 
biological specimen derived from an imported animal subject to this 
agreement if the Administrator determines that the animal has spent at 
least one year in quarantine in a PEQ Zoo following importation without 
showing clinical evidence of foot-and-foot mouth disease, or other 
communicable disease that is exotic to the United States or for which 
APHIS has an eradication or control program in 9 CFR chapter I, and 
determines that the carcass, body part, or biological specimen will be 
moved only for scientific research or museum display purposes.

________________________________________________________________________
(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 __,__


[[Page 541]]


________________________________________________________________________
(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; 83 FR 15492, Apr. 11, 2018]



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, contagious pleuropneumonia, 
and surra: Provided, however, That certificates for wild swine for 
exhibition purposes need specify freedom from the said diseases of the 
district of origin only: And provided further, That in the case of swine 
the certificate, as far as it relates to contagious pleuropneumonia, may 
specify freedom from such disease of the district of origin only. For 
domestic swine, the certificate shall also show that the entire region 
of origin is free of African swine fever and swine vesicular disease and 
that, for 60 days immediately preceding the time of movement from the 
premises of origin, no swine erysipelas or swine plague has existed on 
such premises or on adjoining premises. Additionally, except for the 
APHIS-defined European CSF region, as defined in Sec.94.0 of this 
subchapter, for which additional certification is required under Sec.
94.24(b)(6), for domestic swine the certificate shall show that the 
entire region of origin is free of classical swine fever.
    (b) Swine from any region where screwworm is considered to exist may 
only be imported into the United States if they meet the requirements of 
paragraphs (b)(1) through (b)(4) of this section and all other 
applicable requirements of this part. APHIS will maintain a list of 
regions where screwworm is considered to exist on the APHIS Web site at 
http://www.aphis.usda.gov/ import_export/animals/animal_ 
disease_status.shtml. Copies of the list will also be available via 
postal mail, fax, or email upon request to the Sanitary Trade Issues 
Team, National Center for Import and Export, Veterinary Services, Animal 
and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, 
Maryland 20737. APHIS will add a region to the list upon determining 
that screwworm exists in the region based on reports APHIS receives of 
detections of the pest from veterinary officials of the exporting 
country, from the World Organization for Animal Health (OIE), or from 
other sources the Administrator determines to be reliable. APHIS will 
remove a region from the list after conducting an evaluation of the 
region in accordance with Sec.92.2 of this subchapter and finding that 
screwworm is not present in the region. In the case of a region formerly 
not on this list that is added due to a detection, the region may be 
removed from the list in accordance with the procedures for 
reestablishment of a region's disease-free status in Sec.92.4 of this 
subchapter.
    (1) A veterinarian must treat the swine with ivermectin 3 to 5 days 
prior to the date of export to the United States according to the 
recommended dose prescribed on the product's label.
    (2) The swine must be fully examined for screwworm by a full-time 
salaried veterinary official of the exporting country within 24 hours 
prior to shipment to the United States. If swine are found to be 
infested with screwworm, they must be treated until free from 
infestation.
    (3) At the time swine are loaded onto a means of conveyance for 
export, a veterinarian must treat any visible wounds on the animals with 
a solution

[[Page 542]]

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; 71 FR 29070, May 19, 2006; 71 FR 31069, 
June 1, 2006; 72 FR 67232, Nov. 28, 2007; 73 FR 50878, Aug. 29, 2008; 76 
FR 70039, Nov. 10, 2011; 77 FR 1391, Jan. 10, 2012; 83 FR 15492, Apr. 
11, 2018]



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.
    (c) Any declaration, permit, or other document for swine required 
under this subpart may be issued and presented using a U.S. Government 
electronic information exchange system or other authorized method.

[55 FR 31495, Aug. 2, 1990, as amended at 81 FR 40151, June 21, 2016]



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

[[Page 543]]

the quarantine grounds in boats, cars, or vehicles approved by the 
inspector in charge at the port of entry. Such cars, boats, or vehicles 
shall be cleaned and disinfected under APHIS supervision immediately 
after such use, by the carrier moving the same. The railway cars so used 
shall be either cars reserved for this exclusive use or box cars not 
otherwise employed in the transportation of swine or their fresh 
products. When movement of the aforesaid swine upon or across a public 
highway is unavoidable, it shall be under such careful supervision and 
restrictions as the inspector in charge at the port of entry and the 
local authorities may direct.



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

[[Page 544]]

the importer; APHIS assumes no responsibility with respect thereto. The 
Administrator may prescribe reasonable rates for the services provided 
under this paragraph. When it is found necessary to extend the usual 
minimum quarantine period, the importer, or his or her agent, shall be 
so advised in writing and shall pay for such additional quarantine and 
other services required. Payment for services received by the importer, 
or his or her agent, in connection with each separate lot of swine shall 
be made by certified check or U.S. money order prior to release of the 
swine. If such payment is not made, the swine may be sold in accordance 
with the procedure described in this paragraph or otherwise disposed of 
as directed by the Administrator. When payment is not made and the swine 
are to be sold to recover payment for services received, the importer, 
or his or her agent, will be notified by the inspector that if said 
charges are not immediately paid or satisfactory arrangements made for 
payment, the swine will be sold at public sale to pay the expense of 
care, feed, and handling during that period. The sale will be held after 
the expiration of the quarantine period, at such time and place as may 
be designated by the General Services Administration or other designated 
selling agent. The proceeds of the sale, after deducting the charges for 
care, feed, and handling of the swine and other expenses, including the 
expense of the sale, shall be held in a Special Deposit Account in the 
United States Treasury for 6 months from the date of sale. If not 
claimed by the importer, or his or her agent, within 6 months from the 
date of sale, the amount so held shall be transferred from the Special 
Deposit Account to the General Fund Account in the United States 
Treasury.
    (c) Amounts collected from the importer, or his or her agent, for 
service rendered shall be deposited so as to be available for defraying 
the expenses involved in this service.



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.

[[Page 545]]

                               Canada \7\ 
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------



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:
    (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

[[Page 546]]

inspected the swine for entry into Canada shall be recorded on the 
United States health certificate, or a document containing the 
information shall be included with the certificate that accompanies the 
swine. In all cases it shall be determined by the veterinary inspector 
at the United States port of entry that the swine are the identical 
swine covered by said certificate.
    (b) Exhibition swine. Swine from the United States which have been 
exhibited at the Royal Agricultural Winter Fair at Toronto or other 
publicly recognized expositions in Canada, including racing, rodeo, 
circus, or stage exhibitions in Canada, and have not been in that region 
for more than 90 days are eligible for return to the United States 
without Canadian health or test certificates, if they are accompanied by 
copies of the United States health certificate, issued and endorsed in 
accordance with the export regulations contained in Part 91 of this 
chapter for entry into Canada: Provided, That all swine offered for re-
entry upon examination by the veterinary inspector at the U.S. port of 
entry, are found by the inspector to be free of communicable diseases 
and exposure thereto and are determined to be the identical swine 
covered by said certificates or are the natural increase of such swine 
born after official test dates certified on the dam's health 
certificate.

(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; 81 FR 
40151, June 21, 2016]

                   Central America and West Indies \8\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------



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.

[55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 
56020, Oct. 28, 1997]

                               Mexico \9\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------



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.

[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 any region of the world where screwworm is 
considered to exist may only be imported into the United States if they 
meet the requirements of paragraphs (a)(1) and (2) of this section and 
all other applicable requirements of this part. APHIS will maintain a 
list of regions where screwworm is considered to exist on the APHIS Web 
site at http://www.aphis.usda.gov/ import_export/animals/animal_ 
disease_status.shtml. Copies of the list will also be available via 
postal mail, fax, or email upon request to the Sanitary Trade Issues 
Team, National Center for Import and Export, Veterinary Services, Animal 
and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, 
Maryland 20737. APHIS will add a region to the list upon determining 
that screwworm exists in the region based on reports APHIS receives of 
detections of the pest from veterinary officials of the exporting 
country, from the World Organization for Animal Health (OIE), or from 
other sources the Administrator determines to be reliable. APHIS will 
remove a region from the list after conducting an evaluation of the 
region in accordance with Sec.92.2 of this subchapter and finding that 
screwworm is not present in the region. In the case of a region formerly 
not on this list that is added due to a detection, the region

[[Page 547]]

may be removed from the list in accordance with the procedures for 
reestablishment of a region's disease-free status in Sec.92.4 of this 
subchapter.
    (1) Dogs must be accompanied by a certificate signed by a full-time 
salaried veterinary official of the region of origin stating that the 
dog has been inspected for screwworm within 5 days preceding its 
shipment to the United States.
    (2) The certificate must state that the dog is either free from 
screwworm or was found to be infested with screwworm and was held in 
quarantine and treated until free from screwworm prior to leaving the 
region of origin.
    (b) Dogs for handling livestock. Collie, Shepherd, and other dogs 
that are imported from any part of the world except Canada, Mexico, and 
regions of Central America and the West Indies and that are to be used 
in the handling of sheep or other livestock must be inspected and 
quarantined at the port of entry for a sufficient time to determine 
their freedom from tapeworm (Taenia spp.). If found to be infested with 
tapeworm, dogs must be treated under the supervision of an inspector at 
the port of entry until they are free from infestation.

(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; 
73 FR 50878, Aug. 29, 2008; 77 FR 1391, Jan. 10, 2012]



                     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.

[[Page 548]]

    (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:
    (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 FR 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 submit an application (VS Form 17-129) for an 
import permit. Applications are available from the Import-Export Animals 
Staff, National Center for Import-Export, Veterinary Services, APHIS, 
4700 River Road Unit 39, Riverdale, MD 20737-1231 or by visiting http://
www.aphis.usda.gov/ animal_health/permits/. 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.

[[Page 549]]

    (11) The name, mailing address, and telephone number of the person 
to whom the hedgehog or tenrec will be delivered in the United States.
    (12) The location of the place where delivery will be made in the 
United States.
    (13) Any remarks regarding the shipment.
    (d) Issuance of an import permit. Upon receipt of the application, 
APHIS will review the application. If the hedgehog or tenrec appears to 
be eligible to be imported into the United States, APHIS will issue an 
import permit indicating the applicable requirements under this subpart 
for the importation of the hedgehog or tenrec. Even though an import 
permit has been issued for the importation of a hedgehog or tenrec, the 
animal may enter the United States only if all other applicable 
requirements of this subpart have been met.

(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; 81 FR 40151, June 21, 2016]



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.

[[Page 550]]

    (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.



       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]

[[Page 551]]



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 may be obtained from the 
Import-Export Animals Staff, National Center for Import-Export, 
Veterinary Services, APHIS, 4700 River Road Unit 38, Riverdale, MD 
20737-1231 or by visiting http://www.aphis.usda.gov/ animal_health/
permits/.
    (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; 81 
FR 40151, June 21, 2016]



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

[[Page 552]]

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 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 or by visiting http://www.aphis.usda.gov/animal_health/permits/.) 
Forms may be provided to the inspector using a U.S. Government 
electronic information exchange system or other authorized method. The 
completed form must state:
    (a) The port of entry;
    (b) The date of arrival;
    (c) The import permit number;
    (d) The name of the carrier and identification of the means of 
conveyance;
    (e) The name and address of the importer;
    (f) The name and address of the broker;
    (g) The region from which the elephant, hippopotamus, rhinoceros, or 
tapir was shipped;
    (h) The number, species, and purpose of importation of the elephant, 
hippopotamus, rhinoceros, or tapir; and
    (i) The name and address of the person to whom the elephant, 
hippopotamus, rhinoceros, or tapir will be delivered.

[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, as amended at 81 FR 40151, 
June 21, 2016]



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:

[[Page 553]]

    (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:
    (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

[[Page 554]]

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:
    (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, Apr. 30, 1999]



                    Subpart I_Aquatic Animal Species

    Source: 71 FR 51435, Aug. 30, 2006, unless otherwise noted.



Sec.93.900  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, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Animal and Plant Health Inspection Service. The Animal and Plant 
Health Inspection Service of the United States Department of Agriculture 
(APHIS).
    APHIS representative. A veterinarian or other individual employed by 
the Animal and Plant Health Inspection Service, United States Department 
of Agriculture, who is authorized to perform the services required by 
this part.
    Certifying official. An individual authorized by the competent 
authority of a country to sign health certificates for aquatic animals.
    Competent authority. The national veterinary services or other 
authority of a country, having the responsibility and competence for 
ensuring or supervising the implementation of aquatic animal health 
measures.
    Container. A transport receptacle that is specially constructed to 
facilitate transportation of aquatic animals or aquatic animal products 
by one or several means of transport.
    Department. The United States Department of Agriculture (USDA).
    Fertilized egg. A viable fertilized ovum of an aquatic animal.
    Gamete. The sperm or unfertilized egg of aquatic animals that is 
held or transported separately.
    Inspector. An employee of the Animal and Plant Health Inspection 
Service authorized to perform duties required under this subpart.
    Person. Any individual, corporation, company, association, firm, 
partnership, society or joint stock company.
    Port veterinarian. A veterinarian employed by the Animal and Plant 
Health Inspection Service to perform duties required under this subpart 
at a port of entry.
    Region. Any defined geographic land area identifiable by geological, 
political, or surveyed boundaries. A region may consist of any of the 
following:
    (1) A national entity (country);

[[Page 555]]

    (2) Part of a national entity (zone, county, department, 
municipality, parish, Province, State, etc.);
    (3) Parts of several national entities combined into an area; or
    (4) A group of national entities (countries) combined into a single 
area.
    Spring viremia of carp (SVC). A disease caused by infection with 
spring viremia of carp virus, a rhabodivrus capable of infecting several 
carp species, in addition to some other cyprinid and ictalurid fish 
species.
    SVC-susceptible species. Common carp (Cyprinus carpio), grass carp 
(Ctenopharyngodon idellus), silver carp (Hypophthalmichthys molitrix), 
bighead carp (Aristichthys nobilis), Crucian carp (Carassius carassius), 
goldfish (Carassius auratus), tench (Tinca tinca), and sheatfish 
(Silurus glanis).
    United States. All of the States of the United States, the District 
of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin 
Islands of the United States, and all other territories and possessions 
of the United States.



Sec.93.901  General restrictions; exceptions.

    (a) No live fish, fertilized eggs, or gametes of SVC-susceptible 
species may be imported into the United States except in accordance with 
this subpart, \11\ nor shall any such live fish, fertilized eggs, or 
gametes be moved from the port of entry after arrival until released by 
the port veterinarian; provided that the Administrator may, upon request 
in specific cases, allow the importation of SVC-susceptible live fish, 
fertilized eggs, or gametes under conditions other than those set forth 
in this subpart when the Administrator determines that such movement 
will not result in the introduction of SVC into the United States.
---------------------------------------------------------------------------

    \11\ The importation of live cultures of SVC virus, preserved SVC 
virus viral RNA or DNA, tissue samples containing viable SVC virus, or 
other specimens intended for diagnostic or research purposes and which 
contain viable SVC virus may be imported only under permit in accordance 
with 9 CFR part 122.
---------------------------------------------------------------------------

    (b) Other provisions of this subpart relating to the importation of 
live fish, fertilized eggs, and gametes shall not apply to shipments of 
SVC-susceptible species of live fish, fertilized eggs, or gametes in 
transit through the United States if an import permit has been obtained 
under Sec.93.903 and all conditions of the permit are observed; and if 
the live fish, fertilized eggs, and gametes are handled as follows:
    (1) They are maintained under continuous confinement while in 
transit through the United States aboard an aircraft, ocean vessel, or 
other means of conveyance; or
    (2) They are unloaded, in the course of such transit, into a holding 
facility \12\ that is provided by the carrier or its agent and has been 
approved by the Administrator in accordance with paragraph (b)(4) of 
this section as adequate to prevent the spread within the United States 
of any finfish disease; 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.
---------------------------------------------------------------------------

    \12\ Requests for approval of such facilities should be made to the 
Animal and Plant Health Inspection Service at the address provided in 
Sec.93.903 for permit applications.
---------------------------------------------------------------------------

    (3) They are moved in accordance with any additional conditions 
prescribed in the permit and determined by the Administrator to be 
necessary to ensure that the live fish, fertilized eggs, or gametes 
through the United States do not introduce SVC into the United States.
    (4) For a holding facility to be approved by the Administrator:
    (i) The holding facility must be sufficiently isolated to prevent 
direct or indirect contact of the live fish, fertilized eggs, or gametes 
it contains with any other SVC-susceptible species in the United States;
    (ii) The holding facility must be constructed to provide adequate 
protection against environmental conditions and so that it can be 
adequately cleaned, washed and disinfected;
    (iii) Provision must be made for disposal of fish carcasses, 
shipping water, waste and any associated shipping materials in a manner 
that will prevent dissemination of disease;

[[Page 556]]

    (iv) Provision must be made for adequate sources of feed and water 
and for attendants for the care and feeding of live fish, fertilized 
eggs, or gametes in the facility;
    (v) The holding facility must comply with all applicable local, 
State and Federal requirements for environmental quality.
    (vi) The holding facility must comply with any additional 
requirements that may be imposed by the Administrator for a particular 
shipment if necessary to prevent the dissemination of disease.

(Approved by the Office of Management and Budget under control number 
0579-0301)

[71 FR 51435, Aug. 30, 2006; 71 FR 54552, Sept. 15, 2006]



Sec.93.902  Ports designated for the importation of live fish, 
fertilized eggs, and gametes.

    (a) The following ports are designated as ports of entry for live 
fish, fertilized eggs, and gametes of SVC-susceptible species imported 
under this subpart:
    (1) Air and ocean ports. Los Angeles and San Francisco, CA; Miami 
and Tampa, FL; Atlanta, GA; Honolulu, HI; Chicago, IL; Boston, MA; 
Newark, NJ; New York, NY; Portland, OR; Dallas-Ft. Worth, TX; and San 
Juan, PR.
    (2) Canadian border ports. Detroit, MI; Buffalo-Niagara, NY; and 
Blaine and Seattle, WA.
    (3) Mexican border ports. Otay Mesa, CA.
    (b) Designation of other ports. Other ports may be designated by the 
Administrator in specific cases with the concurrence of the Secretary of 
the Department of Homeland Security.



Sec.93.903  Import permits for live fish, fertilized eggs, and gametes.

    (a) Live fish, fertilized eggs, or gametes of SVC-susceptible 
species imported into the United States must be accompanied by an import 
permit issued by APHIS and must be imported within 30 days after the 
proposed date of arrival stated in the import permit.
    (b) An application for an import permit must be submitted for each 
shipment of live fish, fertilized eggs, or gametes of SVC-susceptible 
species to the Animal and Plant Health Inspection Service, Veterinary 
Services, National Center for Import and Export, 4700 River Road Unit 
38, Riverdale, MD 20737-1231. Application forms for import permits may 
be obtained from this address.
    (c) A completed application shall include the following information:
    (1) The name and address of the person intending to export live 
fish, fertilized eggs, or gametes of SVC-susceptible species to the 
United States;
    (2) The proposed date of shipment to the United States;
    (3) The name and address of the person intending to import live 
fish, fertilized eggs, or gametes of SVC-susceptible species into the 
United States;
    (4) The species and number of live fish, fertilized eggs, or gametes 
of SVC-susceptible species to be imported into the United States;
    (5) The purpose of the importation;
    (6) The port of embarkation;
    (7) The mode of transportation;
    (8) The route of travel, including all carrier stops en route;
    (9) The port of entry in the United States;
    (10) The proposed date of arrival in the United States; and
    (11) The name and address of the person to whom the live fish, 
fertilized eggs, or gametes of SVC-susceptible species will be delivered 
in the United States.
    (d) If APHIS determines that the live fish, fertilized eggs, or 
gametes are eligible for importation, APHIS will issue an import permit 
indicating the applicable conditions for importation. An import permit 
does not guarantee that any live fish, fertilized eggs, or gametes will 
be allowed entry into the United States; the fish, fertilized eggs, or 
gametes will be allowed to enter the United States only if they meet all 
applicable requirements of the permit and regulations.

(Approved by the Office of Management and Budget under control number 
0579-0301)



Sec.93.904  Health certificate for live fish, fertilized eggs, 
and gametes.

    (a) General. All live fish, fertilized eggs, and gametes of SVC-
susceptible species that are imported from any region of the world must 
be accompanied by a health certificate issued by a full-

[[Page 557]]

time salaried veterinarian of the national government of the exporting 
region, or issued by a certifying official and endorsed by the competent 
authority of that country. The health certificate must be written in 
English or contain an English translation. The health certificate will 
be valid for 30 days from the date of issuance. The health certificate 
for the live fish, fertilized eggs, or gametes must state that:
    (1) The live fish, fertilized eggs, or gametes were inspected by the 
veterinarian or certifying official who issued the certificate within 72 
hours prior to shipment, and were found to be free of any clinical signs 
of disease consistent with SVC; and
    (2) The live fish, fertilized eggs, or gametes covered by the health 
certificate meet the requirements of this section.
    (b) Surveillance. The live fish, fertilized eggs, or gametes must 
meet the following conditions to be eligible for importation into the 
United States:
    (1) The live fish, fertilized eggs, or gametes must originate in a 
region or establishment which conducts a surveillance program for SVC 
under the supervision of the competent authority.
    (2) The region or establishment must demonstrate freedom from SVC 
through a minimum of 2-years' continuous health history, supported by 
laboratory testing by a pathogen detection facility approved for SVC 
viral assays by the competent authority.
    (3) SVC-susceptible fish populations in the region or establishment 
must be tested at least twice annually, with at least 3 months between 
the tests and at times or under environmental conditions that would 
facilitate the detection of SVCV if it were present. Sampling procedures 
must utilize an assumed pathogen prevalence of 2 percent, with a 
corresponding confidence level of 95 percent. Samples must be collected 
and submitted by a certifying official or veterinarian recognized by the 
competent authority. The standard screening method for SVC must include 
isolation of SVCV in cell culture, using either the epithelioma 
papulosum cyprini (EPC) or fathead minnow (FHM) cell lines. However, the 
Administrator may authorize other assays for SVCV detection in lieu of 
virus isolation through cell culture, if the Administrator determines 
that such assays provide equivalent assurance of the SVC status of an 
exporting region or establishment. All viral testing results must be 
negative.
    (c) Shipping containers. All live fish, fertilized eggs, and gametes 
must be shipped to the United States in new containers or in used 
containers that have been cleaned and disinfected in accordance with 
this section.
    (1) Cleaning and disinfection of shipping containers must take place 
under the supervision of the veterinarian or certifying official who 
issues the health certificate.
    (2) Cleaning and disinfection must be sufficient to neutralize any 
SVC virus to which shipping containers may have been exposed. Acceptable 
disinfection procedures include individual or combination treatments 
with: Solutions having a pH of 12 or higher or 3 or lower with a contact 
time of at least 10 minutes; heat at or above 56 [deg]C for at least 15 
minutes; chlorine solutions having a concentration of at least 500 ppm 
with a contact time of at least 10 minutes; iodine solutions having a 
concentration of at least 100 ppm with a contact time of at least 10 
minutes; ultraviolet exposure (254 nm; min exposure of 10,000 microwatt 
seconds/cm \2\); or other disinfectants such as Virkon used according to 
the manufacturer's directions. The Administrator may authorize other 
procedures if the Administrator determines they are adequate to 
neutralize the SVC virus.
    (3) Cleaning and disinfection protocols must be referenced in the 
health certificate or in a separate cleaning and disinfection 
certificate accompanying the shipment to the U.S. port of entry.

(Approved by the Office of Management and Budget under control number 
0579-0301)



Sec.93.905  Declaration and other documents for live fish, fertilized
eggs, and gametes.

    (a) For all live fish, fertilized eggs, and gametes offered for 
importation under this subpart, the importer or his or her agent must 
submit the following documents to the collector of customs for use by 
the port veterinarian:

[[Page 558]]

    (1) All permits, certificates, or other documentation required by 
this subpart; and
    (2) Two copies of a declaration that lists the port of entry, the 
name and address of the importer, the name and address of the broker, 
the origin of the live fish, fertilized eggs, or gametes, the number, 
species, and the purpose of the importation, the name of the person to 
whom the fish will be delivered, and the location of the place to which 
such delivery will be made.
    (b) Any declaration, permit, or other document for live fish, 
fertilized eggs, and gametes required under this subpart may be issued 
and presented using a U.S. Government electronic information exchange 
system or other authorized method.

(Approved by the Office of Management and Budget under control number 
0579-0301)

[71 FR 51435, Aug. 30, 2006, as amended at 81 FR 40152, June 21, 2016]



Sec.93.906  Inspection at the port of entry.

    (a) All live fish, fertilized eggs, and gametes of SVC-susceptible 
species imported from any part of the world must be presented for 
inspection at a port of entry designated under Sec.93.902. The APHIS 
port veterinarian must be notified at least 72 hours in advance of the 
arrival in the United States of a shipment of live fish, fertilized 
eggs, or gametes of SVC-susceptible species. Any shipment of live SVC-
susceptible fish species that the port veterinarian determines to 
exhibit clinical signs consistent with SVCV infection or disease, or any 
shipments of live fish, fertilized eggs, and gametes of SVC-susceptible 
species that otherwise do not meet the requirements of this subpart, 
shall be refused entry.
    (b) Shipments refused entry, unless exported within a time fixed in 
each case by the Administrator, and in accordance with other provisions 
he or she may require in each case for their handling, shall be disposed 
of as the Administrator may direct.

(Approved by the Office of Management and Budget under control number 
0579-0301)



 PART 94_FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE, HIGHLY PATHOGENIC 
 AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE 
 VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED 
 AND RESTRICTED IMPORTATIONS--Table of Contents



Sec.
94.0 Definitions.
94.1 Regions where foot-and-mouth disease exists; importations 
          prohibited.
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 foot-and-mouth disease 
          exists.
94.5 Regulation of certain garbage.
94.6 Carcasses, meat, parts or products of carcasses, and eggs (other 
          than hatching eggs) of poultry, game birds, or other birds; 
          importations from regions where Newcastle disease or highly 
          pathogenic avian influenza 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, 
          African swine fever, classical swine fever, or swine vesicular 
          disease exists.
94.18 Bovine spongiform encephalopathy; importation of edible products 
          derived from bovines.
94.19 Importation of meat, meat byproducts, and meat food products 
          derived from bovines from regions of negligible risk for BSE.
94.20 Importation of meat, meat byproducts, and meat food products 
          derived

[[Page 559]]

          from bovines from regions of controlled risk for BSE.
94.21 Importation of meat, meat byproducts, and meat food products 
          derived from bovines from regions of undetermined risk for 
          BSE.
94.22 Meat or dressed carcasses of hunter-harvested bovines.
94.23 Importation of gelatin derived from bovines.
94.24 Restrictions on importation of meat and edible products from 
          ovines and caprines due to bovine spongiform encephalopathy.
94.25 Restrictions on the importation from Canada of meat and edible 
          products from ovines and caprines other than gelatin.
94.26 Gelatin derived from horses or swine or from ovines or caprines 
          that have not been in a region restricted because of BSE.
94.27 Transit shipment of articles.
94.28 Restrictions on the importation of poultry meat and products, and 
          live birds and poultry, from the APHIS-defined EU Poultry 
          Trade Region.
94.29 Restrictions on importation of fresh (chilled or frozen) beef and 
          ovine meat from specified regions.
94.30 Importation of poultry meat and other poultry products from 
          Sinaloa and Sonora, Mexico.
94.31 Restrictions on the importation of pork, pork products, and swine 
          from the APHIS-defined European CSF region.
94.32 Restrictions on the importation of live swine, pork, or pork 
          products from certain regions free of classical swine fever.
94.33 Restrictions on importation of live poultry, poultry meat, and 
          other poultry products from specified regions.

    Authority: 7 U.S.C. 1633, 7701-7772, 7781-7786, 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.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 
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.
    APHIS-defined EU Poultry Trade Region. The European Union Member 
States of Austria, Belgium, Cyprus, the Czech Republic, Denmark, 
Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, 
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, 
Slovakia, Slovenia, Spain, Sweden, and the United Kingdom (England, 
Scotland, Wales, the Isle of Man, and Northern Ireland).
    APHIS-defined European CSF region. A single region of Europe 
recognized by APHIS as low risk for classical swine fever.
    (1) A list of areas included in the region is maintained on the 
APHIS Web site at http://www.aphis.usda.gov/ import_export/animals/
animal _disease_status.shtml. Copies of the list will also be available 
via postal mail, fax, or email upon request to the Sanitary Trade Issues 
Team, National Center for Import and Export, Veterinary Services, Animal 
and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, 
Maryland 20737.
    (2) APHIS will add an area to the region after it conducts an 
evaluation of the area to be added in accordance with Sec.92.2 of this 
subchapter and finds that the risk profile for the area is equivalent 
with respect to classical swine fever to the risk profile for the region 
it is joining.
    Approved establishment means an establishment authorized by 
Veterinary Services for the receipt and handling of restricted imported 
animal carcasses, products, and byproducts.
    Authorized inspector. Any individual authorized by the Administrator 
of APHIS or the Commissioner of Customs and Border Protection, 
Department of Homeland Security, to enforce the regulations in this 
part.
    Birds. All members of the class Aves (other than poultry or game 
birds).
    Bovine. Bos taurus, Bos indicus, and Bison bison.
    Bovine spongiform encephalopathy (BSE) minimal-risk region. A region 
that:
    (1) Maintains, and, in the case of regions where BSE was detected, 
had in place prior to the detection of BSE in an indigenous ruminant, 
risk mitigation measures adequate to prevent

[[Page 560]]

widespread exposure and/or establishment of the disease. Such measures 
include the following:
    (i) Restrictions on the importation of animals sufficient to 
minimize the possibility of infected ruminants being imported into the 
region, and on the importation of animal products and animal feed 
containing ruminant protein sufficient to minimize the possibility of 
ruminants in the region being exposed to BSE;
    (ii) Surveillance for BSE at levels that meet or exceed 
recommendations of the World Organization for Animal Health (Office 
International des Epizooties) for surveillance for BSE; and
    (iii) A ruminant-to-ruminant feed ban that is in place and is 
effectively enforced.
    (2) In regions where BSE was detected, conducted an epidemiological 
investigation following detection of BSE sufficient to confirm the 
adequacy of measures to prevent the further introduction or spread of 
BSE, and continues to take such measures.
    (3) In regions where BSE was detected, took additional risk 
mitigation measures, as necessary, following the BSE outbreak based on 
risk analysis of the outbreak, and continues to take such measures.
    Cold spot. The area in a flexible plastic cooking tube or other type 
of container loaded with meat product, or the areas at various points 
along the belt in an oven chamber, slowest to reach the required 
temperature during the cooking process. The cold spot(s) for each 
container is experimentally determined before the cooking process 
begins, and once identified, remains constant.
    Commercial birds. Birds that are imported for resale, breeding, 
public display, or any other purpose, except pet birds, zoological 
birds, research birds, or performing or theatrical birds.
    Commercial poultry. Chickens, doves, ducks, geese, grouse, guinea 
fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and 
turkeys (including eggs for hatching) which are imported for resale, 
breeding, public display, or any other commercial purpose.
    Contact. Known or potential commingling of products during 
processing or storage, or while being transported from any point to any 
other point. Contact includes the simultaneous processing in the same 
room, locker, or container, but not necessarily the same storage 
facility or conveyance, as long as adequate security measures are taken 
to prevent commingling, as determined by an authorized APHIS 
representative.
    Container. For the purposes of 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).
    Direct transloading. The transfer of cargo directly from one means 
of conveyance to another.
    Exporting region. A region from which shipments are sent to the 
United States.
    Farm equipment. Equipment used in the production of livestock or 
crops, including, but not limited to, mowers, harvesters, loaders, 
slaughter machinery, agricultural tractors, farm engines, farm trailers, 
farm carts, and farm wagons, but excluding automobiles and trucks.
    Flock of origin. The flock in which the eggs were produced.
    Food Safety and Inspection Service. The Food Safety and Inspection 
Service (FSIS) of the United States Department of Agriculture.
    FSIS inspector. An individual authorized by the Administrator, Food 
Safety and Inspection Service, United States Department of Agriculture, 
to perform the function involved.
    Game birds. Migratory birds, including certain ducks, geese, 
pigeons, and doves (``migratory'' refers to seasonal flight to and from 
the United States); free-flying quail, wild grouse, wild pheasants (as 
opposed to those that are commercial, domestic, or pen-raised).
    Highly pathogenic avian influenza (HPAI). Highly pathogenic avian 
influenza is defined as follows:
    (1) Any influenza virus that kills at least 75 percent of eight 4- 
to 6-week-old susceptible chickens within 10 days following intravenous 
inoculation with

[[Page 561]]

0.2 mL of a 1:10 dilution of a bacteria-free, infectious allantoic fluid 
or inoculation of 10 susceptible 4- to 8-week-old chickens resulting in 
an intravenous pathogenicity index (IVPI) of greater than 1.2;
    (2) Any H5 or H7 virus that does not meet the criteria in paragraph 
(1) of this definition, but has an amino acid sequence at the 
haemagglutinin cleavage site that is compatible with highly pathogenic 
avian influenza viruses; or
    (3) Any influenza virus that is not an H5 or H7 subtype and that 
kills one to five out of eight inoculated chickens and grows in cell 
culture in the absence of trypsin within 10 days.
    House. A structure, enclosed by walls and a roof, in which poultry 
are raised.
    Immediate export. The period of time determined by APHIS, based on 
shipping routes and timetables, to be the shortest practicable interval 
of time between the arrival in the United States of an incoming carrier 
and the departure from the United States of an outgoing carrier, to 
transport a consignment of products.
    Import (imported, importation) into the United States. To bring into 
the territorial limits of the United States.
    Indicator piece. A cube or slice of meat to be used for the pink 
juice test, required to meet minimum size specifications.
    Mechanically separated meat. A finely comminuted product resulting 
from the mechanical separation and removal of most of the bone from 
attached skeletal muscle of bovine carcasses that meets the FSIS 
specifications contained in 9 CFR 319.5.
    Newcastle disease. Newcastle disease is an acute, rapidly spreading, 
and usually fatal viral infection of poultry caused by an avian 
paramyxovirus serotype 1 that meets one of the following criteria for 
virulence: The virus has an intracerebral pathogenicity index (ICPI) in 
day-old chicks (Gallus gallus) of 0.7 or greater; or multiple basic 
amino acids have been demonstrated in the virus (either directly or by 
deduction) at the C-terminus of the F2 protein and phenylalanine at 
residue 117, which is the N-terminus of the F1 protein. The term 
``multiple basic amino acids'' refers to at least three arginine or 
lysine residues between residues 113 and 116. In this definition, amino 
acid residues are numbered from the N-terminus of the amino acid 
sequence deduced from the nucleotide sequence of the F0 gene; 113-116 
corresponds to residues -4 to -1 from the cleavage site. Failure to 
demonstrate the characteristic pattern of amino acid residues as 
described above may require characterization of the isolated virus by an 
ICPI test. A failure to detect a cleavage site that is consistent with 
virulent strains does not confirm the absence of a virulent virus.
    Operator. The operator responsible for the day-to-day operations of 
a facility.
    Personal use. Only for personal consumption or display and not 
distributed further or sold.
    Pink juice test. Determination of whether meat has been thoroughly 
cooked by observation of whether the flesh and juices have lost all red 
and pink color.
    Port of arrival. Any place in the United States at which a product 
or article arrives, unless the product or article remains on the means 
of conveyance on which it arrived within the territorial limits of the 
United States.
    Positive for a transmissible spongiform encephalopathy. A sheep or 
goat for which a diagnosis of a transmissible spongiform encephalopathy 
has been made.
    Poultry. Chickens, turkeys, swans, partridges, guinea fowl, pea 
fowl; nonmigratory ducks, geese, pigeons, and doves; commercial, 
domestic, or pen-raised grouse, pheasants, and quail.
    Processed animal protein. Meat meal, bone meal, meat-and-bone meal, 
blood meal, dried plasma and other blood products, hydrolyzed protein, 
hoof meal, horn meal, poultry meal, feather meal, fish meal, and any 
other similar products.
    Premises of origin. The premises where the flock of origin is kept.
    Region. Any defined geographic land area identifiable by geological, 
political, or surveyed boundaries. A region may consist of any of the 
following:
    (1) A national entity (country);
    (2) Part of a national entity (zone, county, department, 
municipality, parish, Province, State, etc.)

[[Page 562]]

    (3) Parts of several national entities combined into an area; or
    (4) A group of national entities (countries) combined into a single 
area.
    Region of origin. For meat and meat products, the region in which 
the animal from which the meat or meat products were derived was born, 
raised and slaughtered; and for eggs, the region in which the eggs were 
laid.
    Restricted zone for classical swine fever. An area, delineated by 
the relevant competent veterinary authorities of the region in which the 
area is located, that surrounds and includes the location of an outbreak 
of classical swine fever in domestic swine or detection of the disease 
in wild boar, and from which the movement of domestic swine is 
prohibited.
    Ruminants. All animals that chew the cud, such as cattle, buffaloes, 
sheep, goats, deer, antelopes, camels, llamas and giraffes.
    Sentinel bird. A chicken that has been raised in an environment free 
of pathogens that cause communicable diseases of poultry and that has 
not been infected with, exposed to, or immunized with any strain of 
virus that causes Newcastle disease.
    Specified risk materials (SRMs) from regions of controlled risk for 
BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a).
    Specified risk materials (SRMs) from regions of undetermined risk 
for BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a), except that the following bovine parts 
from regions of undetermined risk for BSE are considered SRMs if they 
are derived from bovines over 12 months of age: Brain, skull, eyes, 
trigeminal ganglia, spinal cord, vertebral column (excluding the 
vertebrae of the tail, the transverse processes of the thoracic and 
lumbar vertebrae, and the wings of the sacrum), and the dorsal root 
ganglia.
    State. Any of the several States of the United States, the 
Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto 
Rico, the District of Columbia, Guam, the Virgin Islands of the United 
States, or any other territory or possession of the United States.
    Suspect for a transmissible spongiform encephalopathy. (1) A sheep 
or goat that has tested positive for a transmissible spongiform 
encephalopathy or for the proteinase resistant protein associated with a 
transmissible spongiform encephalopathy, unless the animal is designated 
as positive for a transmissible spongiform encephalopathy; or
    (2) A sheep or goat that exhibits any of the following signs and 
that has been determined to be suspicious for a transmissible spongiform 
encephalopathy by a veterinarian: Weight loss despite retention of 
appetite; behavior abnormalities; pruritus (itching); wool pulling; 
biting at legs or side; lip smacking; motor abnormalities such as 
incoordination, high stepping gait of forelimbs, bunny hop movement of 
rear legs, or swaying of back end; increased sensitivity to noise and 
sudden movement; tremor, ``star gazing,'' head pressing, recumbency, or 
other signs of neurological disease or chronic wasting.
    Temperature indicator device (TID). A precalibrated temperature-
measuring instrument containing a chemical compound activated at a 
specific temperature (the melting point of the chemical compound) 
identical to the processing temperature that must be reached by the meat 
being cooked. The Administrator will approve a TID for use after 
determining that the chemical compound in the device is activated at the 
specific temperature required.
    Thoroughly cooked. Heated sufficiently to inactivate any pathogen 
that may be present, as indicated by the required TID or pink juice 
test.
    United States. All of the States.
    Veterinarian in Charge. The veterinary official of the Animal and 
Plant Health Inspection Service, United States Department of 
Agriculture, who is assigned by the Administrator to supervise and 
perform the official animal health work of the Animal and Plant Health 
Inspection Service in the State or area concerned.
    Wild swine. Any swine which are allowed to roam outside an 
enclosure.

[52 FR 33801, Sept. 8, 1987]

[[Page 563]]


    Editorial Note: For Federal Register citations affecting Sec.94.0, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfo.gov.



Sec.94.1  Regions where foot-and-mouth disease exists; importations 
prohibited.

    (a) APHIS considers foot-and-mouth disease to exist in all regions 
of the world except those declared free of the disease by APHIS.
    (1) A list of regions that APHIS has declared free of foot-and-mouth 
disease is maintained on the APHIS Web site at http://
www.aphis.usda.gov/ import_export/animals/ animal_disease_status.shtml. 
Copies of the list will also be available via postal mail, fax, or email 
upon request to the Sanitary Trade Issues Team, National Center for 
Import and Export, Veterinary Services, Animal and Plant Health 
Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 20737.
    (2) APHIS will add a region to the list of those it has declared 
free of foot-and-mouth disease after it conducts an evaluation of the 
region in accordance with Sec.92.2 of this subchapter and finds that 
the disease is not present. In the case of a region formerly on this 
list that is removed due to an outbreak, the region may be returned to 
the list in accordance with the procedures for reestablishment of a 
region's disease-free status in Sec.92.4 of this subchapter. APHIS 
will remove a region from the list of those it has declared free of 
foot-and-mouth disease upon determining that the disease exists in the 
region based on reports APHIS receives of outbreaks of the disease from 
veterinary officials of the exporting country, from the World 
Organization for Animal Health (OIE), or from other sources the 
Administrator determines to be reliable.
    (b) The importation of any ruminant or swine or any fresh (chilled 
or frozen) meat of any ruminant or swine \1\ that originates in any 
region where 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 foot-and-mouth disease exists, is prohibited:
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (1) Except as provided in part 93 of this chapter for wild ruminants 
and wild swine;
    (2) Except as provided in paragraph (d) of this section for fresh 
(chilled or frozen) meat of ruminants or swine that is otherwise 
eligible for importation under this part but that enters a port or 
otherwise transits a region where foot-and-mouth disease exists; and
    (3) Except as provided in Sec.94.4 of this part for cooked or 
cured meat from regions where foot-and-mouth disease exists.
    (4) Except as provided in Sec.94.29 for fresh (chilled or frozen) 
beef and ovine meat.
    (c) The importation of any used farm equipment that originates in 
any region where foot-and-mouth disease exists, as designated in 
paragraph (a) of this section, is prohibited, unless the equipment is 
accompanied by an original certificate signed by an authorized official 
of the national animal health service of the exporting region that 
states that the equipment, after its last use and prior to export, was 
steam-cleaned free of all exposed dirt and other particulate matter. 
Such farm equipment is subject to APHIS inspection at the port of 
arrival. If it is found during such inspection to contain any exposed 
dirt or other particulate matter, it will be denied entry into the 
United States, unless, in the judgment of the APHIS inspector, the 
amount of exposed soil is minimal enough to allow cleaning at the port 
of arrival, and there are adequate facilities and personnel at the port 
to conduct such cleaning without risk of disease contamination.
    (d) Except as otherwise provided in this part, fresh (chilled or 
frozen) meat of ruminants or swine raised and slaughtered in a region 
free of foot-and-mouth disease, as designated in paragraph (a) of this 
section, and fresh (chilled or frozen) beef and ovine meat exported in 
accordance with Sec.94.29, which during shipment to the United

[[Page 564]]

States enters a port or otherwise transits a region where foot-and-mouth 
disease exists, may be imported provided that all of the following 
conditions are met:
    (1) The meat is accompanied by the foreign meat inspection 
certificate required by 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 
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 at www.govinfo.gov.



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 affected with 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 affected with 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; 
77 FR 1392, Jan. 10, 2012; 83 FR 15493, Apr. 11, 2018]



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 foot-and-mouth disease exists, as designated in Sec.
94.1, except for pharmaceutical or biological purposes under

[[Page 565]]

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; 83 FR 15493, Apr. 
11, 2018]



Sec.94.4  Cured or cooked meat from regions where foot-and-mouth
disease exists.

    (a) The importation of cured meats derived from ruminants or swine, 
originating in any region where 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 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 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

[[Page 566]]

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 than two indicator pieces or pieces containing 
TID's. All indicator pieces and pieces containing TID's must be 
individually sealed, properly labeled, and enclosed together in one 
sealed box that accompanies the shipment. Any indicator pieces or pieces 
containing TID's that are not used to accompany a shipment to the United 
States must be destroyed following loading of the batch into a 
container; and
    (ii) After removing the indicator piece or piece containing a TID, 
all remaining meat from the same batch may be cut into smaller cubes and 
sealed in plastic or other material approved by the U.S. Food and Drug 
Administration. After being processed into smaller cubes once, the meat 
may not be further processed before shipment to the United States. The 
cubes of meat and the indicator piece or piece containing a TID must be 
accompanied to the United States by a certificate as provided in 
paragraph (b)(8) of this section.
    (7) Any TID used in accordance with paragraph (b)(4) or (b)(5) of 
this section must remain in the meat, as originally inserted, and must 
accompany the cooked meat whose temperature it has gauged when that meat 
is shipped to the United States.
    (8) Pork rind pellets (pork skins). Pork rind pellets (pork skins) 
must be cooked in one of the following ways:
    (i) One-step process. The pork skins must be cooked in oil for at 
least 80 minutes when oil temperature is consistently maintained at a 
minimum of 114 [deg]C.

[[Page 567]]

    (ii) Two-step process. The pork skins must be dry-cooked at 260 
[deg]C for approximately 210 minutes after which they must be cooked in 
hot oil (deep-fried) at 104 [deg]C for an additional 150 minutes.
    (9) Certificate. (i) The cooked meat must be accompanied by a 
certificate issued by an official of the National Government of the 
region of origin who is authorized to issue the foreign meat inspection 
certificate required under 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)(9)(i) of this section: ``No more than two tubes were 
randomly selected per batch per cooker for cutting an indicator piece or 
obtaining a piece containing a TID. The indicator piece or piece 
containing a TID represents a shipment of (describe form of processed 
product--e.g., diced cubes of a particular size). A piece containing a 
TID or a piece 3.8 cm (1.5 in) or larger in each dimension was cut from 
the cold spot of the tube, and was sealed and marked with the following 
cooking date, cooker, and batch: _____ and the following date of 
selection of the tube_____. The total number of indicator pieces or 
pieces containing TID's enclosed in a sealed box is_____.''
    (10) The meat is inspected by an FSIS inspector at a port of arrival 
in a defrost facility approved by the Administrator \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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (ii) The Administrator may deny approval of any defrost facility if 
the Administrator determines that the defrost facility does not meet the 
conditions for approval. If approval is denied, the operator of the 
defrost facility will be informed of the reasons for denial and be given 
an opportunity to respond. The operator will be afforded an opportunity 
for a hearing with respect to any disputed issues of fact. The hearing 
will be conducted in accordance with rules of practice that will be 
adopted for the proceeding.
    (iii) The Administrator may withdraw approval of any defrost 
facility as follows: (A) When the operator of the defrost facility 
notifies the Administrator in writing that the defrost facility no 
longer performs the required services; or (B) when the Administrator 
determines that the defrost facility does not meet the conditions for 
approval. Before the Administrator withdraws approval from any defrost 
facility, the operator of the defrost facility will be informed of the 
reasons for the proposed withdrawal and given an opportunity to respond. 
The operator will be afforded a hearing with respect to any disputed 
issues of fact. The hearing will be conducted in accordance with rules 
of practice that will be adopted for the proceeding. If approval of a 
defrost facility is withdrawn, the Administrator will remove its name 
from the list of approved defrost facilities.
    (c) Meat processing establishment; standards. (1) Before the 
Administrator

[[Page 568]]

will approve a meat processing establishment for export shipment of 
cooked meat to the United States, the Administrator must determine:
    (i) That the meat processing establishment has furnished APHIS with 
a description of the process used to inactivate FMD virus that may be 
present in meat intended for export to the United States, and with 
blueprints of the facilities where this meat is cooked and packaged;
    (ii) That an APHIS representative has inspected the establishment 
and found that it meets the standards set forth in paragraph (c)(2) of 
this section;
    (iii) That the operator of the establishment has signed a 
cooperative service agreement with APHIS, stating:
    (A) That all cooked meat processed for importation into the United 
States will be processed in accordance with the requirements of this 
part;
    (B) that a full-time, salaried meat inspection official of the 
National Government of the exporting region will supervise the 
processing (including certification of the cold spot) and examination of 
the product, and certify that it has been processed in accordance with 
this section; and
    (C) that APHIS personnel or other persons authorized by the 
Administrator may enter the establishment, unannounced, to inspect the 
establishment and its records; and
    (iv) That the operator of the establishment has entered into a trust 
fund agreement with APHIS and is current in paying all costs for an 
APHIS representative to inspect the establishment for initial 
evaluation, and periodically thereafter, including travel, salary, 
subsistence, administrative overhead, and other incidental expenses 
(including an excess baggage provision up to 150 pounds). In accordance 
with the terms of the trust fund agreement, before the APHIS 
representative's site inspection, the operator of the processing 
establishment must deposit with the Administrator an amount equal to the 
approximate cost of one inspection by an APHIS representative, including 
travel, salary, subsistence, administrative overhead, and other 
incidental expenses (including an excess baggage provision up to 150 
pounds). As funds from that amount are obligated, a bill for costs 
incurred based on official accounting records will be issued, to restore 
the deposit to the original level, revised as necessary to allow for 
inflation or other changes in estimated costs. To be current, bills must 
be paid within 14 days of receipt.
    (2) Establishment. An APHIS representative will conduct an on-site 
evaluation, and subsequent inspections, as provided in 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, 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

[[Page 569]]

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]

    Editorial Note: For Federal Register citations affecting Sec.94.4, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfo.gov.



Sec.94.5  Regulation of certain garbage.

    (a) General restrictions--(1) Interstate movements of garbage from 
Hawaii and U.S. territories and possessions to the continental United 
States. Hawaii, Puerto Rico, American Samoa, the Commonwealth of the 
Northern Mariana Islands, the Federated States of Micronesia, Guam, the 
U.S. Virgin Islands, Republic of the Marshall Islands, and the Republic 
of Palau are hereby quarantined, and the movement of garbage therefrom 
to any other State is hereby prohibited except as provided in this 
section in order to prevent the introduction and spread of exotic plant 
pests and diseases.
    (2) Imports of garbage. In order to protect against the introduction 
of exotic animal and plant pests, the importation of garbage from all 
foreign countries except Canada is prohibited except as provided in 
paragraph (c)(2) of this section.
    (b) Definitions--Agricultural waste. Byproducts generated by the 
rearing of animals and the production and harvest of crops or trees. 
Animal waste, a large component of agricultural waste, includes waste 
(e.g., feed waste, bedding and litter, and feedlot and paddock runoff) 
from livestock, dairy, and other animal-related agricultural and farming 
practices.
    Approved facility. A facility approved by the Administrator, Animal 
and Plant Health Inspection Service, upon his determination that it has 
equipment and uses procedures that are adequate to prevent the 
dissemination of plant pests and livestock or poultry diseases, and that 
it is certified by an appropriate Government official as currently 
complying with the applicable laws for environmental protection.
    Approved sewage system. A sewage system approved by the 
Administrator, Animal and Plant Health Inspection Service, upon his 
determination that the system is designed and operated in such a way as 
to preclude the discharge of sewage effluents onto land surfaces or into 
lagoons or other stationary waters, and otherwise is adequate to prevent 
the dissemination of plant pests and livestock or poultry diseases, and 
that is certified by an appropriate Government official as currently 
complying with the applicable laws for environmental protection.
    Carrier. The principal operator of a means of conveyance.
    Continental United States. The 49 States located on the continent of 
North America and the District of Columbia.
    Garbage. All waste material that is derived in whole or in part from 
fruits, vegetables, meats, or other plant or animal (including poultry) 
material, and other refuse of any character whatsoever that has been 
associated with any such material.
    Incineration. To reduce garbage to ash by burning.
    Inspector. A properly identified employee of the U.S. Department of 
Agriculture or other person authorized by the Department to enforce the 
provisions of applicable statutes, quarantines, and regulations.
    Interstate. From one State into or through any other State.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, or joint stock company.
    Shelf-stable. The condition achieved in a product, by application of 
heat, alone or in combination with other ingredients and/or other 
treatments, of being rendered free of microorganisms capable of growing 
in the product under nonrefrigerated conditions (over 50 [deg]F or 10 
[deg]C).
    Sterilization. Cooking garbage at an internal temperature of 212 
[deg]F for 30 minutes.
    Stores. The food, supplies, and other provisions carried for the 
day-to-day operation of a conveyance and the care and feeding of its 
operators.
    Yard waste. Solid waste composed predominantly of grass clippings,

[[Page 570]]

leaves, twigs, branches, and other garden refuse.
    (c) Garbage generated onboard a conveyance--(1) Applicability. This 
section applies to garbage generated onboard any means of conveyance 
during international or interstate movements as provided in this section 
and includes food scraps, table refuse, galley refuse, food wrappers or 
packaging materials, and other waste material from stores, food 
preparation areas, passengers' or crews' quarters, dining rooms, or any 
other areas on the means of conveyance. This section also applies to 
meals and other food that were available for consumption by passengers 
and crew on an aircraft but were not consumed.
    (i) Not all garbage generated onboard a means of conveyance is 
regulated for the purposes of this section. Garbage regulated for the 
purposes of this section is defined as ``regulated garbage'' in 
paragraphs (c)(2) and (c)(3) of this section.
    (ii) Garbage that is commingled with regulated garbage is also 
regulated garbage.
    (2) Garbage regulated because of movements outside the United States 
or Canada. For purposes of this section, garbage on or removed from a 
means of conveyance is regulated garbage, if, when the garbage is on or 
removed from the means of conveyance, the means of conveyance has been 
in any port outside the United States and Canada within the previous 2-
year period. There are, however, two exceptions to this provision. These 
exceptions are as follows:
    (i) Exception 1: Aircraft. Garbage on or removed from an aircraft is 
exempt from requirements under paragraph (c)(4) of this section if the 
following conditions are met when the garbage is on or removed from the 
aircraft:
    (A) The aircraft had previously been cleared of all garbage and of 
all meats and meat products, whatever the country of origin, except 
meats that are shelf-stable; all fresh and condensed milk and cream from 
countries designated in Sec.94.1 as those in which foot-and-mouth 
disease exists; all fresh fruits and vegetables; and all eggs; and the 
items previously cleared from the aircraft as prescribed by this 
paragraph have been disposed of according to the procedures for 
disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) 
and (c)(4)(iii) of this section.
    (B) After the garbage and stores referred to in paragraph 
(c)(2)(i)(A) of this section were removed, the aircraft has not been in 
a non-Canadian foreign port.
    (ii) Exception 2: Other conveyances. Garbage on or removed in the 
United States from a means of conveyance other than an aircraft is 
exempt from requirements under paragraph (c)(4) of this section if the 
following conditions are met when the garbage is on or removed from the 
means of conveyance:
    (A) The means of conveyance is accompanied by a certificate from an 
inspector stating the following:
    (1) That the means of conveyance had previously been cleared of all 
garbage and of all meats and meat products, whatever the country of 
origin, except meats that are shelf-stable; all fresh and condensed milk 
and cream from countries designated in Sec.94.1 as those in which 
foot-and-mouth disease exists; all fresh fruits and vegetables; and all 
eggs; and the items previously cleared from the means of conveyance as 
prescribed by this paragraph have been disposed of according to the 
procedures for disposing of regulated garbage, as specified in 
paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.
    (2) That the means of conveyance had then been cleaned and 
disinfected in the presence of the inspector; and
    (B) Since being cleaned and disinfected, the means of conveyance has 
not been in a non-Canadian foreign port.
    (3) Garbage regulated because of certain movements to or from 
Hawaii, territories, or possessions. For purposes of this section, 
garbage on or removed from a means of conveyance is regulated garbage, 
if at the time the garbage is on or removed from the means of 
conveyance, the means of conveyance has moved during the previous 1-year 
period, either directly or indirectly, to the continental United States 
from any territory or possession or from Hawaii, to any territory or 
possession from any other territory or possession or from Hawaii, or to 
Hawaii from any territory or possession. There are, however,

[[Page 571]]

two exceptions to this provision. These exceptions are as follows:
    (i) Exception 1: Aircraft. Garbage on or removed from an aircraft is 
exempt from requirements under paragraph (c)(4) of this section if the 
following two conditions are met when the garbage is on or removed from 
the aircraft:
    (A) The aircraft had been previously cleared of all garbage and all 
fresh fruits and vegetables, and the items previously cleared from the 
aircraft as prescribed by this paragraph have been disposed of according 
to the procedures for disposing of regulated garbage, as specified in 
paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.
    (B) After the garbage and stores referred to in paragraph 
(c)(3)(i)(A) of this section were removed, the aircraft has not moved to 
the continental United States from any territory or possession or from 
Hawaii, to any territory or possession from any other territory or 
possession or from Hawaii, or to Hawaii from any territory or 
possession.
    (ii) Exception 2: Other conveyances. Garbage on or removed from a 
means of conveyance other than an aircraft is exempt from requirements 
under paragraph (c)(4) of this section if the following two conditions 
are met when the garbage is on or removed from the means of conveyance:
    (A) The means of conveyance is accompanied by a certificate from an 
inspector stating that the means of conveyance had been cleared of all 
garbage and all fresh fruits and vegetables, and the items previously 
cleared from the means of conveyance as prescribed by this paragraph 
have been disposed of according to the procedures for disposing of 
regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) 
of this section.
    (B) After being cleared of the garbage and stores referred to in 
paragraph (c)(3)(ii)(A) of this section, the means of conveyance has not 
moved to the continental United States from any territory or possession 
or from Hawaii; to any territory or possession from any other territory 
or possession or from Hawaii; or to Hawaii from any territory or 
possession.
    (4) Restrictions on regulated garbage. (i) Regulated garbage may not 
be disposed of, placed on, or removed from a means of conveyance except 
in accordance with this section.
    (ii) Regulated garbage is subject to general surveillance for 
compliance with this section by inspectors and to disposal measures 
authorized by the Plant Protection Act and the Animal Health Protection 
Act to prevent the introduction and dissemination of pests and diseases 
of plants and livestock.
    (iii) All regulated garbage must be contained in tight, covered, 
leak-proof receptacles during storage on board a means of conveyance 
while in the territorial waters, or while otherwise within the territory 
of the United States. All such receptacles shall be contained inside the 
guard rail if on a watercraft. Such regulated garbage shall not be 
unloaded from such means of conveyance in the United States unless such 
regulated garbage is removed in tight, covered, leak-proof receptacles 
under the direction of an inspector to an approved facility for 
incineration, sterilization, or grinding into an approved sewage system, 
under direct supervision by such an inspector, or such regulated garbage 
is removed for other handling in such manner and under such supervision 
as may, upon request in specific cases, be approved by the Administrator 
as adequate to prevent the introduction and dissemination of plant pests 
and animal diseases and sufficient to ensure compliance with applicable 
laws for environmental protection. Provided that, a cruise ship may 
dispose of regulated garbage in landfills at Alaskan ports only, if and 
only if the cruise ship does not have prohibited or restricted meat or 
animal products on board at the time it enters Alaskan waters for the 
cruise season, and only if the cruise ship, except for incidental travel 
through international waters necessary to navigate safely between ports, 
remains in Canadian and U.S. waters off the west coast of North America, 
and calls only at continental U.S. and Canadian ports during the entire 
cruise season.
    (A) Application for approval of a facility or sewage system may be 
made

[[Page 572]]

in writing by the authorized representative of any carrier or by the 
official having jurisdiction over the port or place of arrival of the 
means of conveyance to the Administrator, Animal and Plant Health 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250. The application must be endorsed by the operator of the facility 
or sewage system.
    (B) Approval will be granted if the Administrator determines that 
the requirements set forth in this section are met. Approval may be 
denied or withdrawn at any time, if the Administrator determines that 
such requirements are not met, after notice of the proposed denial or 
withdrawal of the approval and the reasons therefor, and an opportunity 
to demonstrate or achieve compliance with such requirements, has been 
afforded to the operator of the facility or sewage system and to the 
applicant for approval. However, approval may also be withdrawn without 
such prior procedure in any case in which the public health, interest, 
or safety requires immediate action, and in such case, the operator of 
the facility or sewage system and the applicant for approval shall 
promptly thereafter be given notice of the withdrawal and the reasons 
therefore and an opportunity to show cause why the approval should be 
reinstated.
    (iv) The Plant Protection and Quarantine Programs and Veterinary 
Services, Animal, and Plant Health Inspection Service, will cooperate 
with other Federal, State, and local agencies responsible for enforcing 
other statutes and regulations governing disposal of the regulated 
garbage to the end that such disposal shall be adequate to prevent the 
dissemination of plant pests and livestock or poultry diseases and 
comply with applicable laws for environmental protection. The 
inspectors, in maintaining surveillance over regulated garbage movements 
and disposal, shall coordinate their activities with the activities of 
representatives of the U.S. Environmental Protection Agency and other 
Federal, State, and local agencies also having jurisdiction over such 
regulated garbage.
    (d) Garbage generated in Hawaii--(1) Applicability. This section 
applies to garbage generated in households, commercial establishments, 
institutions, and businesses prior to interstate movement from Hawaii, 
and includes used paper, discarded cans and bottles, and food scraps. 
Such garbage includes, and is commonly known as, municipal solid waste.
    (i) Industrial process wastes, mining wastes, sewage sludge, 
incinerator ash, or other wastes from Hawaii that the Administrator 
determines do not pose risks of introducing animal or plant pests or 
diseases into the continental United States are not regulated under this 
section.
    (ii) The interstate movement from Hawaii to the continental United 
States of agricultural wastes and yard waste (other than incidental 
amounts (less than 3 percent) that may be present in municipal solid 
waste despite reasonable efforts to maintain source separation) is 
prohibited.
    (iii) Garbage generated onboard any means of conveyance during 
interstate movement from Hawaii is regulated under paragraph (c) of this 
section.
    (2) Restrictions on interstate movement of garbage. The interstate 
movement of garbage generated in Hawaii to the continental United States 
is regulated as provided in this section.
    (i) The garbage must be processed, packaged, safeguarded, and 
disposed of using a methodology that the Administrator has determined is 
adequate to prevent the introduction and dissemination of plant pests 
into noninfested areas of the United States.
    (ii) The garbage must be moved under a compliance agreement in 
accordance with paragraph (e) of this section. APHIS will only enter 
into a compliance agreement when the Administrator is satisfied that the 
Agency has first satisfied all its obligations under the National 
Environmental Policy Act and all applicable Federal and State statutes 
to fully assess the impacts associated with the movement of garbage 
under the compliance agreement.
    (iii) All such garbage moved interstate from Hawaii to any of the 
continental United States must be moved in compliance with all 
applicable laws for environmental protection.
    (e) Compliance agreement and cancellation--(1) Any person engaged in 
the business of handling or disposing of

[[Page 573]]

garbage in accordance with this section must first enter into a 
compliance agreement with the Animal and Plant Health Inspection Service 
(APHIS). Compliance agreement forms (PPQ Form 519) are available without 
charge from local USDA/APHIS/Plant Protection and Quarantine offices, 
which are listed in telephone directories.
    (2) A person who enters into a compliance agreement, and employees 
or agents of that person, must comply with the following conditions and 
any supplemental conditions which are listed in the compliance 
agreement, as deemed by the Administrator to be necessary to prevent the 
introduction and dissemination into or within the United States of plant 
pests and livestock or poultry diseases:
    (i) Comply with all applicable provisions of this section;
    (ii) Allow inspectors access to all records maintained by the person 
regarding handling or disposal of garbage, and to all areas where 
handling or disposal of garbage occurs;
    (iii)(A) If the garbage is regulated under paragraph (c) of this 
section, remove garbage from a means of conveyance only in tight, 
covered, leak-proof receptacles;
    (B) If the garbage is regulated under paragraph (d) of this section, 
transport garbage interstate in sealed, leak-proof packaging approved by 
the Administrator;
    (iv) Move the garbage only to a facility approved by the 
Administrator; and
    (v) At the approved facility, dispose of the garbage in a manner 
approved by the Administrator and described in the compliance agreement.
    (3) Approval for a compliance agreement may be denied at any time if 
the Administrator determines that the applicant has not met or is unable 
to meet the requirements set forth in this section. Prior to denying any 
application for a compliance agreement, APHIS will provide notice to the 
applicant thereof, and will provide the applicant with an opportunity to 
demonstrate or achieve compliance with requirements.
    (4) Any compliance agreement may be canceled, either orally or in 
writing, by an inspector whenever the inspector finds that the person 
who has entered into the compliance agreement has failed to comply with 
this section. If the cancellation is oral, the cancellation and the 
reasons for the cancellation will be confirmed in writing as promptly as 
circumstances allow. Any person whose compliance agreement has been 
canceled may appeal the decision, in writing, within 10 days after 
receiving written notification of the cancellation. The appeal must 
state all of the facts and reasons upon which the person relies to show 
that the compliance agreement was wrongfully canceled. As promptly as 
circumstances allow, the Administrator will grant or deny the appeal, in 
writing, stating the reasons for the decision. A hearing will be held to 
resolve any conflict as to any material fact. Rules of practice 
concerning a hearing will be adopted by the Administrator. This 
administrative remedy must be exhausted before a person can file suit in 
court challenging the cancellation of a compliance agreement.
    (5) Where a compliance agreement is denied or canceled, the person 
who entered into or applied for the compliance agreement may be 
prohibited, at the discretion of the Administrator, from handling or 
disposing of regulated garbage.

(Approved by the Office of Management and Budget under control numbers 
0579-0015, 0579-0054, and 0579-0292)

[71 FR 49317, Aug. 23, 2006]



Sec.94.6  Carcasses, meat, parts or products of carcasses, and eggs
(other than hatching eggs) of poultry, game birds, or other birds;
importations from regions where Newcastle disease or highly 
pathogenic avian influenza is considered to exist.

    (a) Disease status of regions for Newcastle disease and highly 
pathogenic avian influenza (HPAI)--(1) Regions in which Newcastle 
disease is not considered to exist. (i) A list of such regions is 
maintained on the APHIS National Import Export Services Web site at 
http://www.aphis.usda.gov/ import_export/animals/ 
animal_disease_status.shtml. Copies of the list will also be available 
upon request to Regional Evaluation Services, National Import Export 
Services, Veterinary Services, Animal and Plant Health Inspection 
Service, 4700

[[Page 574]]

River Road Unit 38, Riverdale, Maryland 20737; fax: (301) 851-3300; 
email: [email protected].
    (ii) APHIS will remove a region from the list referenced in 
paragraph (a)(1)(i) of this section upon determining that Newcastle 
disease exists there based on reports APHIS receives of outbreaks of the 
disease in commercial birds or poultry from veterinary officials of the 
exporting country, from the World Organization for Animal Health (OIE), 
or from other sources the Administrator determines to be reliable. APHIS 
will add a region to this list after it conducts an evaluation of the 
region and finds that Newcastle disease is not likely to be present in 
its commercial bird or poultry populations. In the case of a region 
formerly on this list that is removed due to an outbreak, the region may 
be returned to the list in accordance with the procedures for 
reestablishment of a region's disease-free status in Sec.92.4 of this 
subchapter.
    (2) Regions in which HPAI is considered to exist. (i) A list of such 
regions is maintained on the APHIS National Center for Import and Export 
Web site at http://www.aphis.usda.gov/ import_export/animals/ 
animal_disease_status.shtml. Copies of the list will also be available 
via postal mail, fax, or e-mail upon request to Sanitary Trade Issue 
Team, National Center for Import and Export, Veterinary Services, Animal 
and Plant Health Inspection Service, 4700 River Road, Unit 38, 
Riverdale, Maryland 20737.
    (ii) APHIS will consider a region to have HPAI and add it to this 
list referenced in paragraph (a)(2)(i) of this section upon determining 
that HPAI exists in commercial birds or poultry in the region based on 
reports APHIS receives of outbreaks of the disease from veterinary 
officials of the exporting country, from the OIE, or from other sources 
the Administrator determines to be reliable. APHIS will remove a region 
from this list only after it conducts an evaluation of the region and 
finds that HPAI is not likely to be present in its commercial bird or 
poultry populations.
    (b) Carcasses, and parts or products of carcasses, including meat, 
from regions where Newcastle disease or HPAI is considered to exist. 
This paragraph applies to carcasses, and parts or products of carcasses, 
\4\ including meat, of poultry, game birds, or other birds that were 
raised or slaughtered in any region where Newcastle disease or any 
subtype of HPAI is considered to exist (see paragraph (a) of this 
section); are imported from any such region; or are moved into or 
through any such region at any time before importation or during 
shipment to the United States.
---------------------------------------------------------------------------

    \4\ Animal byproducts are regulated under part 95 of this 
subchapter.
---------------------------------------------------------------------------

    (1) Carcasses of game birds, if eviscerated with heads and feet 
removed, may be imported from regions where Newcastle disease is 
considered to exist. Carcasses of game birds may not be imported from 
regions where any subtype of HPAI is considered to exist. Viscera, 
heads, and feet removed from game birds in any of these regions are 
ineligible for entry into the United States.
    (2) Carcasses, or parts or products of carcasses, of poultry, game 
birds, and other birds from regions where Newcastle disease or HPAI are 
considered to exist may be imported for consignment to any museum, 
educational institution or other establishment which has provided the 
Administrator with evidence that it has the equipment, facilities, and 
capabilities to store, handle, process, or disinfect such articles so as 
to prevent the introduction or dissemination of Newcastle disease or 
HPAI into the United States, and which is approved by the Administrator. 
\5\
---------------------------------------------------------------------------

    \5\ The names and addresses of approved establishments may be 
obtained from, and requests for approval may be made to the National 
Center for Import-Export, Veterinary Services, APHIS, 4700 River Road, 
Unit 38, Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (3) Carcasses, or parts or products of carcasses, including meat, of 
poultry, game birds, or other birds, may be imported if packed in 
hermetically sealed containers and if cooked by a commercial method 
after such packing to produce articles that are shelf stable without 
refrigeration.
    (4) Carcasses and parts or products of carcasses, including meat, of 
poultry, game birds, or other birds, may be imported if they are 
accompanied by a

[[Page 575]]

certificate that is signed by a full-time, salaried veterinarian of the 
government agency responsible for animal health in the region and that 
specifies that the articles were cooked throughout to reach a minimum 
internal temperature of 74 [deg]C (165 [deg]F).
    (5) Carcasses, and parts or products of carcasses, including meat, 
of poultry, game birds, or other birds, that originated in a region 
considered to be free of Newcastle disease and any subtype of HPAI, and 
that are processed (cut, packaged, or other processing) in a region 
where Newcastle disease or HPAI is considered to exist, may be imported 
under the following conditions:
    (i) Shipment to processing establishments. All poultry, game bird, 
or other bird products from such regions shall be shipped from the 
Newcastle disease and HPAI-free region where they originated to a 
processing establishment \6\ in the region where Newcastle disease or 
HPAI is considered to exist 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 a 
full-time, salaried veterinarian of the government agency responsible 
for animal health in the region and that specifies the products' region 
of origin, the processing establishment to which the carcasses or parts 
or products are consigned, and the numbers of the seals applied to the 
shipping containers.
---------------------------------------------------------------------------

    \6\ As a condition of entry into the United States, poultry species 
and poultry products addressed by the Poultry Products Inspection Act 
(PPIA, 21 U.S.C. 451 et seq.) and regulations thereunder (9 CFR, chapter 
III, part 381), must also meet all of the requirements of the PPIA and 
part 381, including requirements that the poultry or poultry products be 
prepared only in establishments approved by FSIS. Species subject to 
these requirements include chickens, turkeys, ducks, geese, guineas, 
ratites, or squabs.
---------------------------------------------------------------------------

    (A) The poultry, game bird, or other bird carcasses or parts or 
products may be removed from containers at the processing establishment 
in the region where Newcastle disease or HPAI is considered to exist 
only after an official of the national government has determined that 
the seals are intact and free of any evidence of tampering. The official 
must attest to this fact by signing the certificate accompanying the 
shipment.
    (B) [Reserved]
    (ii) Handling of poultry, game bird, or other bird carcasses or 
parts or products. Establishments in regions where Newcastle disease or 
HPAI is considered to exist that process poultry, game bird, or other 
bird carcasses or parts or products for export to the United States:
    (A) May not receive or handle any live poultry or birds.
    (B) Must keep any records required by this section on file at the 
facility for a period of at least 2 years after export of processed 
products to the United States, and must make those records available to 
USDA inspectors during inspections.
    (C) May process carcasses or parts or products that originate in any 
region, provided that:
    (1) All areas, utensils, and equipment likely to contact the 
carcasses or parts or products to be processed, including skinning, 
deboning, cutting, and packing areas, are cleaned and disinfected 
between processing carcasses or parts or products from regions where 
Newcastle disease or HPAI is considered to exist and processing those 
from Newcastle disease and HPAI-free regions.
    (2) Carcasses or parts or products intended for export to the United 
States are not handled, cut, or otherwise processed at the same time as 
any carcasses or parts or products not eligible for export to the United 
States.
    (3) Carcasses or parts or products intended for export to the United 
States are packed in clean new packaging that is clearly distinguishable 
from that containing any carcasses or parts or products not eligible for 
export to the United States.
    (4) Carcasses or parts or products are stored in a manner that 
ensures that no cross-contamination occurs.
    (iii) Cooperative service agreement. Operators of processing 
establishments must enter into a cooperative service agreement with 
APHIS to pay all expenses incurred by APHIS in inspecting the 
establishment. APHIS anticipates that such inspections will occur once a 
year. The cooperative service account

[[Page 576]]

must always contain a balance that is at least equal to the cost of one 
inspection. APHIS will charge the cooperative service account for 
travel, salary, and subsistence of APHIS employees, as well as 
administrative overhead and other incidental expenses (including excess 
baggage charges up to 150 pounds).
    (iv) Shipment to the United States. Poultry, game bird, or other 
bird carcasses or parts or products to be imported into the United 
States must be shipped from the region where they were processed in 
closed containers sealed with serially numbered seals applied by an 
official of the national government of that region. The shipments must 
be accompanied by a certificate signed by an official of the national 
government of the region where articles were processed that lists the 
numbers of the seals applied and states that all of the conditions of 
this section have been met. A copy of this certificate must be kept on 
file at the processing establishment for at least 2 years.
    (6) Poultry, game bird, or other bird carcasses or parts or products 
that do not otherwise qualify for importation under paragraphs (b)(1) 
through (5) of this section may be imported only if the importer applies 
to, and is granted a permit by, the Administrator, authorizing such 
importation. A permit will be given only when the Administrator 
determines that such importation will not constitute a risk of 
introduction or dissemination of Newcastle disease or HPAI into the 
United States. Application for a permit may be made in accordance with 
paragraph (d) of this section.
    (c) Eggs (other than hatching eggs) from regions where Newcastle 
disease or HPAI is considered to exist. Eggs (other than hatching eggs 
\7\) 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 Newcastle disease or 
HPAI is considered to exist (see paragraph (a) of this section); are 
imported from any region where Newcastle disease or HPAI is considered 
to exist; or are moved into or through any region where Newcastle 
disease or HPAI is considered to exist at any time before importation or 
during shipment to the United States.
---------------------------------------------------------------------------

    \7\ 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 veterinary officer of 
the national government of the region of origin or, if exported from 
Mexico, accompanied either by such a certificate or by a certificate 
issued by a veterinarian accredited by the national government of Mexico 
and endorsed by a full-time salaried veterinary officer of the national 
government of Mexico, thereby representing that the veterinarian issuing 
the certificate was authorized to do so, and:
    (i) The eggs are imported in cases marked with the identity of the 
flock of origin and sealed with the seal of the national government of 
the region of origin.
    (ii) The certificate accompanying the eggs is presented to an 
authorized inspector when the eggs reach the port of arrival in the 
United States.
    (iii) The certificate identifies the flock of origin and shows the 
region of origin, the port of embarkation, the port of arrival, the name 
and address of the exporter and importer, the total number of eggs, and 
cases of eggs, shipped with the certificate, and the date the 
certificate was signed.
    (iv) The certificate states that the eggs qualify for importation in 
accordance with this section.
    (v) The certificate states that no more than 90 days before the 
certificate was signed, a salaried veterinary officer of the national 
government of the region of origin or, if exported from Mexico, by a 
veterinarian accredited by the national government of Mexico, inspected 
the flock of origin and found no evidence of communicable diseases of 
poultry.
    (vi) The eggs were washed, to remove foreign material from the 
surface of the shells, and sanitized on the premises of origin with a 
hypochlorite solution of from 100 ppm to 200 ppm available chlorine.

[[Page 577]]

    (vii) The eggs were packed on the premises of origin in previously 
unused cases.
    (viii) Before leaving the premises of origin, the cases in which the 
eggs were packed were sealed with a seal of the national government of 
the region of origin by the salaried veterinarian of the national 
government of the region of origin who signed the certificate or, if 
exported from Mexico, by the veterinarian accredited by the national 
government of Mexico who signed the certificate.
    (ix) In addition, if the eggs were laid in any region where 
Newcastle disease or HPAI is considered to exist (see paragraph (a) of 
this section), the certificate must also state:
    (A) No Newcastle disease or HPAI occurred on the premises of origin 
or on adjoining premises during the 90 days before the certificate was 
signed.
    (B) There is no evidence that the flock of origin was exposed to 
Newcastle disease or HPAI during the 90 days before the certificate was 
signed.
    (C) The eggs are from a region free of HPAI, or from a flock of 
origin found free of Newcastle disease as follows: On the seventh and 
fourteenth days of the 21-day period before the certificate is signed, 
at least 1 cull bird (a sick or dead bird, not a healthy bird that was 
killed) for each 10,000 live birds occupying each poultry house 
certified for exporting table eggs was tested for Newcastle disease 
virus using embryonated egg inoculation technique. The weekly cull rate 
of birds of every exporting poultry house within the exporting farm does 
not exceed 0.1 percent. The tests present no clinical or immunological 
evidence of Newcastle disease by embryonated egg inoculation technique 
from tissues of birds that were culled and have been collected by a 
salaried veterinary officer of the national government of the region of 
origin or by a veterinarian accredited by the national government of 
Mexico. All examinations and embryonated egg inoculation tests were 
conducted in a laboratory located in the region of origin, and the 
laboratory was approved to conduct the examinations and tests by the 
veterinary services organization of the national government of that 
region. All results were negative for Newcastle disease.
    (D) Egg drop syndrome is notifiable in the region of origin and 
there have been no reports of egg drop syndrome in the flocks of origin 
of the eggs, or within a 50 kilometer radius of the flock of origin, for 
the 90 days prior to the issuance of the certificate.
    (2) To an approved establishment for breaking and pasteurization. 
The eggs may be imported if they are moved from the port of arrival in 
the United States, under seal of the United States Department of 
Agriculture, to an approved establishment for breaking and 
pasteurization. Establishments will be approved when the Administrator 
determines that pasteurization and sanitation procedures for handling 
the eggs, and for disposing of egg shells, cases, and packing materials, 
are adequate to prevent the introduction of Newcastle disease and HPAI 
into the United States.
    (3) For scientific, educational, or research purposes. The eggs may 
be imported if they are imported for scientific, educational, or 
research purposes and the Administrator has determined that the 
importation can be made under conditions that will prevent the 
introduction of Newcastle disease and HPAI into the United States. The 
eggs must be accompanied by a permit obtained from APHIS prior to the 
importation in accordance with paragraph (d) of this section, and they 
must be moved and handled as specified on the permit to prevent the 
introduction of Newcastle disease and HPAI into the United States.
    (4) Other. The eggs may be imported when the Administrator 
determines that the eggs have been cooked or processed or will be 
handled in a manner that will prevent the introduction of Newcastle 
disease and HPAI into the United States. The eggs must be accompanied by 
a permit obtained from APHIS prior to the importation in accordance with 
paragraph (d) of this section, and they must be moved and handled as 
specified on the permit to prevent the introduction of Newcastle disease 
and HPAI into the United States.
    (d) To apply for a permit, contact the Animal and Plant Health 
Inspection Service, Veterinary Services, National

[[Page 578]]

Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 
20737-1231 or visit http://www.aphis.usda.gov/ animal_health/permits/.

(Approved by the Office of Management and Budget under control numbers 
0579-0015, 0579-0245, 0579-0328, and 0579-0367)

[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 at www.govinfo.gov.



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 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.

    (a) African swine fever exists or the Administrator has reason to 
believe that African swine fever exists in the regions listed under 
paragraph (a)(2) of this section.
    (1) The Administrator bases the reason to believe African swine 
fever exists in a region on the following factors:
    (i) When a region allows the importation of host animals, pork or 
pork products, or vectors of African swine fever from a region in which 
African swine fever exists under conditions which the Administrator has 
determined are less stringent than those prescribed by this chapter for 
importing host animals, pork or pork products, or vectors of African 
swine fever into the United States from a region in which African swine 
fever exists; or
    (ii) When a region allows the importation or use of African swine 
fever virus or cultures under conditions which the Administrator has 
determined are less stringent than those prescribed by this chapter for 
the importation or use of African swine fever

[[Page 579]]

virus or cultures into or within the United States; or
    (iii) When a region has a contiguous border with, or is subject to 
commercial exchange or natural spread of African swine fever host 
animals, host materials, or vectors with, another region with known 
outbreaks of African swine fever; or
    (iv) A region's lack of a disease detection, control, or reporting 
system capable of detecting or controlling African swine fever and 
reporting it to the United States in time to allow the United States to 
take appropriate action to prevent the introduction of African swine 
fever into the United States; or
    (v) Any other fact or circumstance found to exist which constitutes 
a risk of introduction of African swine fever into the United States.
    (2) A list of regions where African swine fever exists or the 
Administrator has reason to believe that African swine fever exists is 
maintained on the APHIS Web site at http://www.aphis.usda.gov/ 
import_export/animals/ animal_disease_status.shtml. Copies of the list 
will also be available via postal mail, fax, or email upon request to 
the Sanitary Trade Issues Team, National Center for Import and Export, 
Veterinary Services, Animal and Plant Health Inspection Service, 4700 
River Road Unit 38, Riverdale, Maryland 20737.
    (3) APHIS will add a region to the list upon determining that the 
disease exists in the region based on reports APHIS receives of 
outbreaks of the disease from veterinary officials of the exporting 
country, from the World Organization for Animal Health (OIE), or from 
other sources the Administrator determines to be reliable, or upon 
determining that there is reason to believe the disease exists in the 
region. APHIS will remove a region from the list after conducting an 
evaluation of the region in accordance with Sec.92.2 of this 
subchapter and finding that the disease is not present and that there is 
no reason to believe the disease is present. In the case of a region 
formerly not on this list that is added due to an outbreak, the region 
may be removed from the list in accordance with the procedures for 
reestablishment of a region's disease-free status in Sec.92.4 of this 
subchapter.
    (b) No pork or pork products may be imported into the United States 
from any region listed in this section unless:
    (1) Such pork or pork product has been fully cooked by a commercial 
method in a container hermetically sealed promptly after filling but 
before such cooking, so that such cooking and sealing produced a fully-
sterilized product which is shelf-stable without refrigeration; or
    (2) Such pork or pork product is not otherwise prohibited 
importation under this part and is consigned directly from the port of 
arrival in the United States to a meat processing establishment 
operating under Federal meat inspection, approved by the Administrator, 
for further processing of such pork or pork product by heat.
    (3) Such pork or pork product:
    (i) Was processed in a single establishment that meets the 
requirements in paragraph (b)(5) of this section.
    (ii) Was heated by other than a flash-heating method to an internal 
temperature of at least 69 [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.
    (4) The pork product is pork rind pellets (pork skins) that were 
cooked in one of the following ways in an establishment that meets the 
requirements in paragraph (b)(5) of this section:
    (i) One-step process. The pork skins must be cooked in oil for at 
least 80 minutes when oil temperature is consistently maintained at a 
minimum of 114 [deg]C.
    (ii) Two-step process. The pork skins must be dry-cooked at a 
minimum of

[[Page 580]]

260 [deg]C for approximately 210 minutes after which they must be cooked 
in hot oil (deep-fried) at a minimum of 104 [deg]C for an additional 150 
minutes.
    (5) The processing establishment \8\ in a region listed in this 
section must comply with the following requirements:
---------------------------------------------------------------------------

    \8\ 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.
    (c) Pork or pork products consigned from the port of arrival to an 
approved establishment under the provisions of paragraph (b)(2) of this 
section shall be moved from the port of arrival to the approved 
establishment under Customs seals or seals of the Administrator, and 
shall be otherwise handled as the Administrator, may direct in order to 
guard against the introduction and dissemination of the contagion of 
African swine fever. Seals applied under this section shall not be 
broken except by persons authorized to do so by the Administrator.
    (d) Pork or pork products imported into the United States from a 
region listed in this section which do not meet the requirements 
specified in this section shall be seized, quarantined, and disposed of 
as the Administrator, may direct in order to guard against the 
introduction and dissemination of the contagion of the disease.

(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 at www.govinfo.gov.



Sec.94.9  Pork and pork products from regions where classical swine 
fever exists.

    (a) APHIS considers classical swine fever to exist in all regions of 
the world except those declared free of the disease by APHIS.
    (1) A list of regions that APHIS has declared free of classical 
swine fever is maintained on the APHIS Web site at http://
www.aphis.usda.gov/ import_export/animals/animal _disease_status.shtml. 
Copies of the list will also be available via postal mail, fax, or email 
upon request to the Sanitary Trade Issues Team, National Center for 
Import and Export, Veterinary Services, Animal and Plant Health 
Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 20737.
    (2) APHIS will add a region to the list of those it has declared 
free of classical swine fever after it conducts an evaluation of the 
region in accordance with Sec.92.2 of this subchapter and finds that 
the disease is not present. In the case of a region formerly on this 
list that is removed due to an outbreak, the region may be returned to 
the list in accordance with the procedures for reestablishment of a 
region's disease-free status in Sec.92.4 of this subchapter. APHIS 
will remove a region from the list of those it has declared free of 
classical swine fever upon determining that the disease exists in the 
region based on reports APHIS receives of outbreaks of the disease from 
veterinary officials of the exporting country, from the World 
Organization for Animal Health (OIE), or from other sources the 
Administrator determines to be reliable.

[[Page 581]]

    (b) The APHIS-defined European CSF region is a single region of low-
risk for CSF.
    (c) Except as provided in Sec.94.31 for the APHIS-defined European 
CSF region, no fresh pork or pork product may be imported into the 
United States from any region where classical swine fever is known to 
exist unless it complies with the following requirements: \9\
---------------------------------------------------------------------------

    \9\ 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 the importation of swine and swine products.
---------------------------------------------------------------------------

    (1) Such pork or pork product has been treated in accordance with 
one of the following procedures:
    (i) Such pork and pork product has been fully cooked by a commercial 
method in a container hermetically sealed promptly after filling but 
before such cooking, so that such cooking and sealing produced a fully 
sterilized product which is shelf-stable without refrigeration;
    (ii) Such pork or pork product is in compliance with the following 
requirements:
    (A) All bones were completely removed prior to cooking; and
    (B) Such pork or pork product was heated by other than a flash-
heating method to an internal temperature of 69 [deg]C. (156 [deg]F.) 
throughout;
    (iii) Such pork or pork product is in compliance with the following 
requirements:
    (A) All bones have been completely removed in the region of origin, 
and
    (B) The meat has been held in an unfrozen, fresh condition for at 
least 3 days immediately following the slaughter of the animals from 
which it was derived, and
    (C) The meat has been thoroughly cured and fully dried for a period 
of not less than 90 days so that the product is shelf stable without 
refrigeration: Provided, That the period of curing and drying shall be 
45 days if the pork or pork product is accompanied to the processing 
establishment by a certificate of an official of the national government 
of a classical swine fever free region which specifies that:
    (1) The pork involved originated in that region and the pork or pork 
product was consigned to a processing establishment in ______ (a region 
not listed under paragraph (a) of this section as free of classical 
swine fever), in a closed container sealed by the national veterinary 
authorities of the classical swine fever free region by seals of a 
serially numbered type; and
    (2) The numbers of the seals used were entered on the meat 
inspection certificate of the classical swine fever free region which 
accompanied the shipment from such free region: And, provided further, 
That the certificate required by paragraph (c)(3) of this section also 
states that: The container seals specified in paragraph 
(c)(1)(iii)(C)(1) of this section were found intact and free of any 
evidence of tampering on arrival at the processing establishment by a 
national veterinary inspector; and the processing establishment from 
which the pork or pork product is shipped to the United States does not 
receive or process any live swine, and uses only pork or pork product 
which originates in regions listed under paragraph (a) of this section 
as free of classical swine fever and processes all such pork or pork 
products in accordance with paragraph (c)(1)(i), (ii), or (iii) of this 
section; or
    (iv) Pork rind pellets (pork skins) originating in regions where 
classical swine fever is known to exist may be imported into the United 
States provided they have been cooked in one of the following ways:
    (A) One-step process. The pork skins must be cooked in oil for at 
least 80 minutes when oil temperature is consistently maintained at a 
minimum of 114 [deg]C.
    (B) Two-step process. The pork skins must be dry-cooked at a minimum 
of 260 [deg]C for approximately 210 minutes after which they must be 
cooked in hot oil (deep-fried) at a minimum of 104 [deg]C for an 
additional 150 minutes.
    (2) Articles under paragraph (c)(1)(ii), (iii), or (iv) of this 
section were prepared in an inspected establishment that is eligible to 
have its products imported into the United States under the Federal Meat 
Inspection Act and 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

[[Page 582]]

prepared under paragraph (c)(1)(ii), (iii), or (iv) of this section 
shall be accompanied by a certificate that states that the provisions of 
paragraph (c)(1)(ii), (iii), or (iv) of this section have been met. This 
certificate shall be issued by an official of the national government of 
the region of origin who is authorized to issue the foreign meat 
inspection certificate required by Sec.327.4 of this title. \10\ 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.
---------------------------------------------------------------------------

    \10\ 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.
    (d) Thoroughly cured and fully dried pork and pork products from 
regions where both classical swine fever and swine vesicular disease are 
known or considered to exist need not comply with paragraph (c)(1)(iii) 
of this section if they are in compliance with the provisions of Sec.
94.12(b)(1)(iii) of this part.
    (e) Uncooked pork or pork products that originated in a region 
considered to be free of classical swine fever (CSF) and are processed 
in a region where CSF exists may be imported into the United States 
under the following conditions:
    (1) Shipment to approved establishments. (i) The uncooked pork or 
pork products must be shipped from the CSF-free region of origin in 
closed containers sealed with serially numbered seals applied by an 
official of the national government of that region. They must be 
accompanied by a certificate that is signed by an official of that 
region's national government and that specifies the product's region of 
origin, the name and number of the establishment of origin, and the 
processing establishment to which the uncooked pork or pork products are 
consigned, and the numbers of the seals applied to the shipping 
containers.
    (ii) The uncooked pork or pork products may be removed from 
containers at the processing establishment in the region where CSF is 
considered to exist only after an official of that region's national 
government has determined that the seals are intact and free of any 
evidence of tampering.
    (2) Handling of uncooked pork and pork products. Establishments \11\ 
in regions where CSF is considered to exist that process uncooked pork 
or pork products for export to the United States:
---------------------------------------------------------------------------

    \11\ See footnote 9.
---------------------------------------------------------------------------

    (i) May not receive or handle any live swine;
    (ii) May not receive, handle, or process uncooked pork or pork 
products that originate in regions affected with CSF;
    (iii) Must keep the certificate required by paragraph (e)(1)(i) of 
this section on file at the facility for a period of at least 2 years 
after export of processed products to the United States, and must make 
those records available to USDA inspectors during inspections; and
    (iv) Must be evaluated and approved by APHIS through a site 
inspection.
    (3) Compliance agreement. The operators of the processing 
establishment must sign a compliance agreement with APHIS, stating that:
    (i) All meat processed for importation to the United States will be 
processed in accordance with the requirements of this part; and
    (ii) A full-time, salaried meat inspection official of the national 
government of the region in which the processing facility is located 
will supervise the processing and examination of the product, and 
certify that it has been processed in accordance with this section; and
    (iii) APHIS personnel or other persons authorized by the 
Administrator may enter the establishment, unannounced, to inspect the 
establishment and its records.

[[Page 583]]

    (4) Cooperative service agreement. The processing establishment, or 
a party on its behalf, must enter into a cooperative service agreement 
with APHIS to pay all expenses incurred by APHIS for the initial 
evaluation of the processing establishment and periodically thereafter, 
including travel, salary, subsistence, administrative overhead, and 
other incidental expenses, including excess baggage up to 150 pounds. In 
accordance with the terms of the cooperative service agreement, before 
the APHIS representative's site inspection, the operator of the 
processing establishment or the party acting on their behalf must 
deposit with the Administrator an amount equal to the approximate cost 
of one inspection by an APHIS representative, including travel, salary, 
subsistence, administrative overhead, and other incidental expenses, 
including excess baggage up to 150 pounds. As funds from that amount are 
obligated, a bill for costs incurred based on official accounting 
records will be issued to restore the deposit to the original level, 
revised as necessary to allow for inflation or other changes in 
estimated costs. To be current, bills must be paid within 14 days of 
receipt.
    (5) Shipment to the United States. Uncooked pork or pork products to 
be imported into the United States must be shipped from the region where 
they were processed in closed containers sealed with serially numbered 
seals applied by an official of the national government of that region. 
The shipments must be accompanied by a certificate signed by an official 
of the national government of the region where the pork or pork products 
were processed that lists the numbers of the seals applied and states 
that all of the conditions of this paragraph (e) have been met. The 
certificate shall also state that the container seals specified in 
paragraph (e)(1)(i) and (ii) of this section were found by an official 
of the region's national government to be intact and free of any 
evidence of tampering on arrival at the processing establishment in the 
CSF-affected region. A copy of this certificate must be kept on file at 
the processing establishment for at least 2 years.

(Approved by the Office of Management and Budget under control numbers 
0579-0015 and 0579-0333)

[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 at www.govinfo.gov.



Sec.94.10  Swine from regions where classical swine fever exists.

    (a) APHIS considers classical swine fever to exist in all regions of 
the world except those declared free of the disease by APHIS.
    (1) A list of regions that APHIS has declared free of classical 
swine fever is maintained on the APHIS Web site at http://
www.aphis.usda.gov/ import_export/animals/animal_ disease_status.shtml. 
Copies of the list will also be available via postal mail, fax, or email 
upon request to the Sanitary Trade Issues Team, National Center for 
Import and Export, Veterinary Services, Animal and Plant Health 
Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737.
    (2) APHIS will add a region to the list of those it has declared 
free of classical swine fever after it conducts an evaluation of the 
region in accordance with Sec.92.2 of this subchapter and finds that 
the disease is not present. In the case of a region formerly on this 
list that is removed due to an outbreak, the region may be returned to 
the list in accordance with the procedures for reestablishment of a 
region's disease-free status in Sec.92.4 of this subchapter. APHIS 
will remove a region from the list of those it has declared free of 
classical swine fever upon determining that the disease exists in the 
region based on reports APHIS receives of outbreaks of the disease from 
veterinary officials of the exporting country, from the World 
Organization for Animal Health (OIE), or from other sources the 
Administrator determines to be reliable.
    (b) The APHIS-defined European CSF region is a single region of low-
risk for CSF.

[[Page 584]]

    (c) Except as provided in Sec.94.31 for the APHIS-defined European 
CSF region, no swine that are moved from or transit any region where 
classical swine fever is known to exist may be imported into the United 
States, except for wild swine imported into the United States in 
accordance with paragraph (d) of this section.
    (d) Wild swine may be allowed importation into the United States by 
the Administrator upon request in specific cases under Sec.93.501 or 
Sec.93.504(c) of this chapter.

[71 FR 29070, May 19, 2006, as amended at 71 FR 31070, June 1, 2006; 72 
FR 30470, June 1, 2007; 72 FR 67232, Nov. 28, 2007; 75 FR 69857, Nov. 
16, 2010; 76 FR 70039, Nov. 10, 2011; 77 FR 1393, Jan. 10, 2012; 78 FR 
72998, Dec. 4, 2013]



Sec.94.11  Restrictions on importation of meat and other animal
products from specified regions.

    (a) The meat of ruminants or swine, and other animal products, and 
ship stores, airplane meals, and baggage containing such meat or animal 
products originating in any region listed as provided in paragraph 
(a)(2) of this section may not be imported into the United States unless 
the requirements in this section, in addition to other applicable 
requirements of chapter III of this title, are met. However, meat and 
meat products that meet the requirements of 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 part 96 of this chapter.
    (1) The regions listed under paragraph (a)(2) of this section have 
been declared free of foot-and-mouth disease by APHIS as provided in 
Sec.94.1(a) but supplement their national meat supply by the 
importation of fresh (chilled or frozen) meat of ruminants or swine from 
regions that APHIS considers to be affected with foot-and-mouth disease 
as provided in Sec.94.1(a); or have a common land border with regions 
considered to be affected with foot-and-mouth disease; or import 
ruminants or swine from regions considered to be affected with foot-and-
mouth disease under conditions less restrictive than would be acceptable 
for importation into the United States. Thus, the meat may be commingled 
with the fresh (chilled or frozen) meat of animals from an affected 
region, resulting in an undue risk of introducing foot-and-mouth disease 
into the United States.
    (2) A list of regions whose products are regulated under this 
section is maintained on the APHIS Web site at http://
www.aphis.usda.gov/ import_export/animals/ animal_disease_status.shtml. 
Copies of the list will also be available via postal mail, fax, or email 
upon request to the Sanitary Trade Issues Team, National Center for 
Import and Export, Veterinary Services, Animal and Plant Health 
Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 20737.
    (3) APHIS will add a region to the list of those whose products are 
regulated under this section after conducting an evaluation of the 
region and determining that one or more of the circumstances described 
in paragraph (a)(1) of this section exists. APHIS will remove a region 
from the list upon conducting an evaluation of the region and 
determining that the circumstances in paragraph (a)(1) of this section 
no longer exist or upon determining that foot-and-mouth disease exists 
in the region.
    (b) All meat or other animal product from such regions, whether in 
personal-use amounts or commercial lots (except that which has been 
fully cooked by a commercial method in a container hermetically sealed 
promptly after filling but before such cooking and sealing produced a 
fully sterilized product which is shelf-stable without refrigeration) 
shall have been prepared only in an inspected establishment that is 
eligible to have its products imported into the United States under the 
Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations 
in 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.

[[Page 585]]

    (c) Additional certification. Meat of ruminants or swine or other 
animal products from any region listed under paragraph (a)(2) of this 
section must be accompanied by additional certification by a full-time 
salaried veterinary official of the agency in the national government 
that is responsible for the health of the animals within that region. 
Upon arrival of the meat of ruminants or swine or other animal product 
in the United States, the certification must be presented to an 
authorized inspector at the port of arrival. The certification must give 
the name and official establishment number of the establishment where 
the animals were slaughtered, and shall state that:
    (1) The slaughtering establishment is not permitted to receive 
animals that originated in, or have ever been in, or that have been 
aboard a means of conveyance at the time such means of conveyance called 
at or landed at a port in, a region designated under Sec.94.1(a) as a 
region where foot-and-mouth disease exists;
    (2) The slaughtering establishment is not permitted to receive meat 
or other animal products derived from ruminants or swine which 
originated in such a foot-and-mouth disease affected region, or meat or 
other animal products from a foot-and-mouth disease free region 
transported through a foot-and-mouth disease affected region except in 
containers sealed with serially numbered seals of the National 
Government of the noninfected region of origin;
    (3) The meat or other animal product covered by the certificate was 
derived from animals born and raised in a region listed under Sec.
94.1(a) as free of foot-and-mouth disease and the meat or other animal 
product has never been in any region in which foot-and-mouth disease 
existed;
    (4) The meat or other animal product has been processed, stored, and 
transported to the means of conveyance that will bring the article to 
the United States in a manner to preclude its being commingled or 
otherwise in contact with meat or other animal products that do not 
comply with the conditions contained in this certificate.

(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 at www.govinfo.gov.



Sec.94.12  Pork and pork products from regions where swine vesicular
disease exists.

    (a) APHIS considers swine vesicular disease to exist in all regions 
of the world except those declared free of the disease by APHIS.
    (1) A list of regions that APHIS has declared free of swine 
vesicular disease is maintained on the APHIS Web site at http://
www.aphis.usda.gov/ import_export/animals/animal _disease_status.shtml. 
Copies of the list will also be available via postal mail, fax, or email 
upon request to the Sanitary Trade Issues Team, National Center for 
Import and Export, Veterinary Services, Animal and Plant Health 
Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 20737.
    (2) APHIS will add a region to the list of those it has declared 
free of swine vesicular disease after it conducts an evaluation of the 
region in accordance with Sec.92.2 of this subchapter and finds that 
the disease is not present. In the case of a region formerly on this 
list that is removed due to an outbreak, the region may be returned to 
the list in accordance with the procedures for reestablishment of a 
region's disease-free status in Sec.92.4 of this subchapter. APHIS 
will remove a region from the list of those it has declared free of 
swine vesicular disease upon determining that the disease exists in the 
region based on reports APHIS receives of outbreaks of the disease from 
veterinary officials of the exporting country, from the World 
Organization for Animal Health (OIE), or from other sources the 
Administrator determines to be reliable.
    (b) No pork or pork product may be imported into the United States 
from

[[Page 586]]

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 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 affected region by a certificate signed 
by an official of the National Government of the swine vesicular disease 
free region of origin specifying that the pork or pork product involved 
originated in that region and the pork or pork product was consigned to 
a processing establishment in ______ (a region not listed under 
paragraph (a)(1) of this section as free of swine vesicular disease), in 
a closed container sealed by the national veterinary authorities of the 
swine vesicular disease free region of origin by seals of a serially 
numbered type. The numbers of these seals shall be entered on this 
certificate; and
    (2) The certificate required by paragraph (b)(3) of this section 
shall also state that:
    (i) The container seals specified in paragraph (b)(1)(iv)(B)(1) of 
this section were found intact and free of any evidence of tampering on 
arrival at the processing establishment in the swine vesicular disease 
affected region by a national veterinary inspector of that region,
    (ii) The processing establishment from which the pork or pork 
product was shipped to the United States does not receive or process any 
live swine, and uses only pork or pork products which originate in 
regions listed under paragraph (a)(1) of this section as free of swine 
vesicular disease; and

[[Page 587]]

    (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.).
    (vi) Pork rind pellets (pork skins) must be cooked in one of the 
following ways:
    (A) One-step process. The pork skins must be cooked in oil for at 
least 80 minutes when oil temperature is consistently maintained at a 
minimum of 114 [deg]C.
    (B) Two-step process. The pork skins must be dry-cooked at a minimum 
of 260 [deg]C for approximately 210 minutes after which they must be 
cooked in hot oil (deep-fried) at a minimum of 104 [deg]C for an 
additional 150 minutes.
    (2) Articles under paragraph (b)(1)(ii), (iii) or (iv) of this 
section were prepared in an inspected establishment that is eligible to 
have its products imported into the United States under the Federal Meat 
Inspection Act and the regulations in 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.
---------------------------------------------------------------------------

    (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

[[Page 588]]

excess baggage provision up to 150 pounds), and, as funds from that 
amount are obligated, bills for costs incurred based on official 
accounting records will be issued to restore the deposit to its original 
level. Amounts to restore the deposit to its original level must be paid 
within 14 days of receipt of such bills.
    (3) At the pasta processing establishment, pork intended to be used 
for pork-filled pasta products for export to the United States must be 
stored apart from any meat or meat products not eligible for export to 
the United States, either in a separate storage room or facility or in a 
separate area of the same storage room. Any storage room area reserved 
for pork or pork products eligible for export to the United States must 
be separated by at least 1 meter from any storage room area where meat 
or meat products ineligible for export to the United States are stored 
and must be marked by signs and by having its borders outlined on the 
floor.
    (4) Prior to handling pork used for pork-filled pasta products 
intended for export to the United States, workers at the processing 
facility who handle pork or pork products in the facility must shower 
and put on a full set of clean clothes, or wait 24 hours after handling 
pork or pork products that are not eligible for importation into the 
United States.
    (5) All equipment and machinery that will come in contact with the 
pork or other ingredients of pork-filled pasta products intended for 
export to the United States must be cleaned and disinfected before each 
use.
    (6) Processing lines working with pork-filled pasta products for 
export to the United States must be totally dedicated to the production 
of such products for the time needed to complete a given lot. When any 
processing line in a facility is working with pork-filled pasta products 
intended for export to the United States, no other processing lines in 
the same facility may work on products using meat that is not eligible 
for export to the United States.
    (7) Processing facilities that are completely dedicated to producing 
only pork-filled pasta products for export to the United States and do 
not receive, handle, or process any animal product not intended for 
export to the United States are exempt from the requirements of 
paragraphs (c)(3) through (c)(6) of this section.
    (8) During processing, the pork-filled pasta must be steam-heated to 
a minimum internal temperature of 90 [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

[[Page 589]]

Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.94.13  Restrictions on importation of pork or pork products 
from specified regions.

    (a) Pork or pork products and ship's stores, airplane meals, and 
baggage containing pork or pork products, other than those articles 
regulated under part 95 or part 96 of this chapter, produced in any 
region listed under paragraph (a)(2) of this section may not be imported 
into the United States unless the requirements of this section, in 
addition to other applicable requirements of part 327 of this title, are 
met.
    (1) The regions listed under paragraph (a)(2) of this section have 
been declared free of swine vesicular disease as provided in Sec.
94.12(a) but supplement their national pork supply by the importation of 
fresh (chilled or frozen) meat of animals from regions where swine 
vesicular disease is considered to exist, or have a common border with 
such regions, or have trade practices that are less restrictive than are 
acceptable to the United States. Thus, the pork or pork products may be 
commingled with fresh (chilled or frozen) meat of animals from a region 
where swine vesicular disease is considered to exist, resulting in an 
undue risk of swine vesicular disease introduction into the United 
States.
    (2) A list of regions whose products are regulated under this 
section is maintained on the APHIS Web site at http://
www.aphis.usda.gov/ import_export/animals/animal_ disease_status.shtml. 
Copies of the list will also be available via postal mail, fax, or email 
upon request to the Sanitary Trade Issues Team, National Center for 
Import and Export, Veterinary Services, Animal and Plant Health 
Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 20737.
    (3) APHIS will add a region to the list of those whose products are 
regulated under this section after conducting an evaluation of the 
region and determining that one or more of the circumstances listed in 
paragraph (a)(1) of this section exists. APHIS will remove a region from 
the list upon conducting an evaluation of the region and determining 
that the circumstances in paragraph (a)(1) of this section no longer 
exist or upon determining that swine vesicular disease exists in the 
region.
    (b) All such pork or pork products, except those treated in 
accordance with 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.
    (c) 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 a region considered to have swine vesicular 
disease or that have ever been in a region in which swine vesicular 
disease existed.
    (2) The slaughtering establishment is not permitted to receive pork 
derived from swine which originated in such a region or pork from swine 
from a swine vesicular disease free region which has been transported 
through a region where swine vesicular disease is considered to exist 
except pork which was transported in containers sealed with serially 
numbered seals of the National Government of a region of origin listed 
under Sec.94.12(a) as a region considered free of the disease.
    (3) The pork has been processed, stored, and transported to the 
means of

[[Page 590]]

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 at www.govinfo.gov.



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 under Sec.94.12(a) of this part. No swine 
which are moved from or transit any region in which swine vesicular 
disease is known to exist may be imported into the United States except 
wild swine imported in accordance with paragraph (b) of this section.
    (b) Wild swine may be allowed importation into the United States by 
the Administrator upon request in specific cases under 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; 77 FR 1394, Jan. 
10, 2012]



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 or by visiting http://www.aphis.usda.gov/ 
animal_health/permits/.)
    (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

[[Page 591]]

    (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 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 or by visiting http://
www.aphis.usda.gov/ animal_health/permits/ .
    (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

[[Page 592]]

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; 81 FR 40152, June 21, 2016]



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 where foot-and-mouth disease is considered to exist under Sec.
94.1(a) may be imported into the United States if they meet the 
requirements of paragraphs (b)(1), (2), or (3) of this section:
    (1) They are in a concentrated liquid form and have been processed 
by heat by a commercial method in a container hermetically sealed 
promptly after filling but before such heating, so as to be shelf stable 
without refrigeration.
    (2) They are dry milk or dry milk products, including dry whole 
milk, nonfat dry milk, dried whey, dried buttermilk, and formulations 
which contain any such dry milk products, and are consigned directly to 
an approved establishment \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.

[[Page 593]]

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, long-life milks such as 
sterilized milk, casein and caseinates, lactose, and lactalbumin.
    (4) Small amounts of milk and milk products subject to the 
restrictions of this part may in specific cases be imported for purposes 
of examination, testing, or analysis, if the importer applies to and 
receives written approval for such importation from the Administrator. 
Approval will be granted only when the Administrator determines that 
such action will not endanger the health of the livestock of the United 
States.
    (c) Milk and milk products originating in and shipped from regions 
listed under Sec.94.1(a) as free of foot-and-mouth disease but which 
have entered a port or otherwise transited a region where APHIS 
considers the disease to exist may not be imported into the United 
States unless:
    (1) The product was transported under serially numbered official 
seals applied at the point of origin of the shipment by an authorized 
representative of the region of such origin; except that, if any seal 
applied at the point of origin was broken by any foreign official to 
inspect the shipment, an authorized representative of that region 
applied a new serially numbered official seal to the hold, compartment, 
or container in which the milk or milk products were transported; and if 
any member of a ship's crew broke a seal, the serial number of the seal, 
the location of the seal, and the reason for breaking the seal were 
recorded in the ship's log.
    (2) The numbers of such seals are listed on, or are on a list 
attached to, the bill of lading or similar document accompanying the 
shipment.
    (3) Upon arrival of the carrier at the United States port, an 
inspector of the Animal and Plant Health Inspection Service determines 
that the seals are intact and that their numbers are in agreement with 
the numbers appearing on the accompanying document; Provided, That, if 
the representative finds that any seal has been broken or has a 
different number than is recorded on the accompanying document, then the 
milk or milk products may remain eligible for entry into the United 
States only if APHIS personnel are available to inspect the hold, 
compartment, or container, the cartons or other containers of milk or 
milk products, and all accompanying documentation; and the importer 
furnishes additional documentation (either copies of pages from the 
ship's log signed by the officer-in-charge, or certification from a 
foreign government that the original seal was removed and the new seal 
applied by officials of the government) that demonstrates to the 
satisfaction of the Administrator that the milk or milk products were 
not contaminated or exposed to contamination during movement from the 
region of origin to the United States.
    (d) Except for milk and milk products imported from Canada, and 
except as provided in this paragraph, milk or milk products imported 
from a region listed under Sec.94.1(a) as free of foot-and-mouth 
disease must be accompanied by a certificate endorsed by a full-time, 
salaried veterinarian employed by the region of export. The certificate 
must state that the milk was produced and processed in a region listed 
under Sec.94.1(a) as free of foot-and-mouth disease, or that the milk 
product was processed in one such region from milk produced in another 
such region. The certificate must name the region in which the milk was 
produced and the

[[Page 594]]

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 a region 
in which foot-and-mouth disease exists. Milk or milk products from a 
region listed under Sec.94.1(a) as free of foot-and-mouth disease and 
that were processed in whole or in part from milk or milk products from 
a region not listed under Sec.94.1(a) as free of foot-and-mouth 
disease may be imported into the United States only in accordance with 
paragraph (b)(3) of this section.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[40 FR 44123, Sept. 25, 1975]

    Editorial Note: For Federal Register citations affecting Sec.
94.16, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.94.17  Dry-cured pork products from regions where foot-and-mouth
disease, 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, African Swine fever, classical swine fever, or swine 
vesicular disease;
    (c) The ham, pork shoulder, or pork loin came from a swine that was 
not on any premises where foot-and-mouth disease, African swine fever, 
classical swine fever, or swine vesicular disease exists or had existed 
within 60 days prior to slaughter;
    (d) The whole ham, pork shoulder, or pork loin was accompanied from 
the slaughtering facility to the processing establishment by a numbered 
certificate issued by a person authorized by the government of the 
region of origin stating that the provisions of paragraphs (a) and (c) 
of this section have been met;
    (e) The ham, pork shoulder, or pork loin was processed whole as set 
forth in paragraph (i) of this section in only one processing 
establishment;\15\
---------------------------------------------------------------------------

    \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

[[Page 595]]

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-cured pork product must have had no contact 
with any other meat or animal product during processing.
    (1) Italian-type hams. The ham was processed for a period of not 
less than 400 days in accordance with the following conditions: after 
slaughter the ham was held at a temperature of 0-3 [deg]C. (32-34.7 
[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 0-4 [deg]C. (32-39.2 [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 0-4 [deg]C. (32-39.2 [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 1-6 [deg]C. (33.8-42.8 [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 15-23 [deg]C. (59-73.4 [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 15-20 [deg]C. (59-68 [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;

[[Page 596]]

    (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 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):

[[Page 597]]

    (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.
    (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

[[Page 598]]

by the veterinary services of the national government of the region of 
origin to conduct activities under this paragraph, maintained original 
records (which shall be kept for a minimum of two years) identifying the 
dry-cured ham, pork shoulder, or pork loin by the date it entered the 
processing establishment, by the slaughtering facility from which it 
came, and by the number of the certificate which accompanied the dry-
cured ham, pork shoulder, or pork loin from the slaughtering facility to 
the processing establishment, and where such original records are 
maintained under lock and key by such person, with access to such 
original records restricted to officials of the government of the region 
of origin, officials of the United States Government, and such person 
maintaining the records;
    (l) The whole dry-cured ham, pork shoulder, or pork loin came from a 
processing establishment which allows the unannounced entry into the 
establishment of APHIS personnel, or other persons authorized by the 
Administrator, for the purpose of inspecting the establishment and 
records of the establishment;
    (m) The dry-cured ham, pork shoulder, or pork loin was processed in 
accordance with one of the following criteria:
    (1) The ham, if it is an Italian-type ham processed in accordance 
with paragraph (i)(1) of this section, was processed in a region which 
has submitted, through its veterinary services, to the Administrator, a 
written statement stating that it conducts a program to authorize 
persons to supervise activities specified under this section;
    (2) The Serrano ham, processed in accordance with paragraph (i)(2) 
of this section, and came from any breed of large, white swine, 
including but not limited to Landrace, Pietrain, Duroc, Jersey, 
Hampshire, and Yorkshire breeds, and crosses of such breeds;
    (3) The Iberian ham, processed in accordance with paragraph (i)(3) 
of this section, and came from a swine of the Iberico breed of pigs;
    (4) The Iberian pork shoulder, processed in accordance with 
paragraph (i)(4) of this section, and came from a swine of the Iberico 
breed of pigs;
    (5) The Iberian pork loin, if processed in accordance with paragraph 
(i)(5) of this section, and came from a swine of the Iberico breed of 
pigs.
    (n) The whole dry-cured ham, pork shoulder, or pork loin came from a 
processing establishment that has entered into a cooperative service 
agreement executed by the operator of the establishment or a 
representative of the establishment and APHIS, and that pursuant to the 
cooperative service agreement is current in paying all costs for a 
veterinarian of APHIS to inspect the establishment (it is anticipated 
that such inspections will occur up to four times per year), including 
travel, salary, subsistence, administrative overhead, and other 
incidental expenses (including an excess baggage provision up to 150 
pounds). In accordance with the terms of the cooperative service 
agreement, the operator of the processing establishment shall deposit 
with the Administrator, an amount equal to the approximate costs for a 
veterinarian to inspect the establishment one time, including travel, 
salary, subsistence, administrative overhead and other incidental 
expenses (including an excess baggage provision up to 150 pounds), and 
as funds from that amount are obligated, bills for costs incurred based 
on official accounting records will be issued to restore the deposit to 
its original level. Amounts to restore the deposit to its original level 
shall be paid within 14 days of receipt of such bills.
    (o) The dry-cured ham, pork shoulder, or pork loin is accompanied at 
the time of importation into the United States by a certificate issued 
by a person authorized to issue such certificates by the veterinary 
services of the national government of the region of origin, stating:
    (1) That all the provisions of this section have been complied with, 
including paragraphs (i) and (m) of this section;
    (2) The paragraph of this section under which the dry-cured ham, 
pork shoulder, or pork loin was processed; and stating further that, if 
the product covered by the certificate:
    (i) Is an Italian-type ham processed under paragraph (i)(1) of this 
section, it

[[Page 599]]

was processed for a minimum of 400 days;
    (ii) Is a Serrano ham processed under paragraph (i)(2) of this 
section, it was:
    (A) Processed for a minimum of 190 days in a region free of swine 
vesicular disease, in a facility authorized by the veterinary services 
of the national government of that region to process only meat from 
regions free of swine vesicular disease; or,
    (B) Processed for a minimum of 560 days in any region, in a facility 
that may also process meat from regions where swine vesicular disease 
exists;
    (iii) Is an Iberian ham processed under paragraph (i)(3) of this 
section, it was:
    (A) Processed for a minimum of 365 days in a region free of swine 
vesicular disease, in a facility authorized by the veterinary services 
of the national government of that region to process only meat from 
regions free of swine vesicular disease; or,
    (B) Processed for a minimum of 560 days in any region, in a facility 
that may also process meat from regions where swine vesicular disease 
exists;
    (iv) Is a dry-cured pork shoulder, it was processed in accordance 
with paragraph (i)(4) of this section for a minimum of 240 days; or
    (v) Is a dry-cured pork loin, it was processed in accordance with 
paragraph (i)(5) of this section for a minimum of 130 days.
    (p) Whole hams, pork shoulders, and pork loins that have been dry-
cured in accordance with paragraph (i) of this section may be 
transported to a facility in the same region for slicing and packaging 
in accordance with this paragraph.
    (1) The slicing/packaging facility. (i) The slicing/packaging 
facility \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.
---------------------------------------------------------------------------

    (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.

[[Page 600]]

    (vi) The operator of the slicing/packaging facility must have signed 
a cooperative service agreement with APHIS prior to receipt of the whole 
dry-cured hams, pork shoulders, or pork loins for slicing and packaging, 
stating that all hams, pork shoulders, or pork loins sliced and packaged 
at the facility for importation into the United States will be sliced 
and packaged only in accordance with this section.
    (vii) The operator of the slicing/packaging facility must be 
current, in accordance with the terms of the cooperative service 
agreement signed with APHIS, in paying all costs for an APHIS 
representative to inspect the establishment, including travel, salary, 
subsistence, administrative overhead, and other incidental expenses.
    (viii) The slicing/packaging facility must allow the unannounced 
entry into the establishment of APHIS representatives, or other persons 
authorized by the Administrator, for the purpose of inspecting the 
establishment and records of the establishment.
    (ix) Workers at the slicing/packaging facility who handle pork or 
pork products in the facility must shower and put on a full set of clean 
clothes, or wait 24 hours after handling pork or pork products that are 
not eligible for importation into the United States, before handling 
dry-cured hams, pork shoulders, or pork loins in the slicing/packaging 
facility that are intended for importation into the United States.
    (x) Pork products intended for importation into the United States 
may not be in the slicing/packaging facility at the same time as pork 
products not intended for exportation to the United States.
    (2) Slicing and packaging and labeling procedures. (i) A full-time 
salaried veterinarian employed by the national government of the region 
of origin must inspect each lot of whole dry-cured hams, pork shoulders, 
and pork loins at the slicing/packaging facility, before slicing is 
begun, and must certify in English that it is eligible for importation 
into the United States in accordance with this section; and
    (ii) Either a full-time salaried veterinarian employed by the 
national government of the region of origin, or, if the national 
government of the region of origin recognizes a local consortium as 
responsible for product quality, a representative of that local 
consortium, must certify in English that he or she personally supervised 
the entire process of slicing and packaging each lot of dry-cured hams, 
pork shoulders, and pork loins at the slicing/packaging facility; that 
each lot of dry-cured hams, pork shoulders, and pork loins was sliced 
and packaged in accordance with the requirements of this paragraph; and 
that the sliced and packaged pork ham, shoulder, or loin is the same 
dry-cured ham, pork shoulder, or pork loin certified under paragraph 
(p)(2)(i).
    (iii) The sliced and packaged dry-cured pork ham, pork shoulder, or 
pork loin must be labeled with the date that processing of the meat 
under paragraph (i) of this section began, and with the date the meat 
was sliced and packaged.

(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; 73 FR 17885, Apr. 2, 2008; 74 FR 18288, Apr. 22, 2009; 76 FR 4054, 
4055, Jan. 24, 2011; 77 FR 1395, Jan. 10, 2012; 83 FR 15493, Apr. 11, 
2018]



Sec.94.18  Bovine spongiform encephalopathy; importation of edible
products derived from bovines.

    (a) The importation of meat, meat products, and other edible 
products derived from bovines is prohibited with regard to BSE, except 
as provided in this section and in Sec. Sec.94.19, 94.20, 94.21, 
94.22, 94.23, and 94.27.
    (b) The following commodities derived from bovines may be imported 
into the United States without restriction regarding BSE, provided that 
all other applicable requirements of this part are met:
    (1) Milk and milk products;
    (2) Boneless skeletal muscle meat (excluding mechanically separated 
meat) that:
    (i) Is derived from bovines that were not, prior to slaughter, 
subjected to a pithing process or to stunning with a device injecting 
compressed air or gas into the cranial cavity, and that passed

[[Page 601]]

ante-mortem and post-mortem inspection;
    (ii) Has been prepared in a manner to prevent contamination with 
SRMs; and
    (iii) Is accompanied to the United States by an original certificate 
stating that the conditions of paragraphs (b)(2)(i) and (b)(2)(ii) of 
this section have been met. The certificate must be issued and signed by 
a full-time salaried veterinary officer of the national government of 
the exporting region or signed by a person authorized to issue such 
certificates by the veterinary services of the national government of 
the exporting region.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[78 FR 72998, Dec. 4, 2013]



Sec.94.19  Importation of meat, meat byproducts, and meat food 
products derived from bovines from regions of negligible risk for BSE.

    Meat, meat byproducts, and meat food products, as defined by FSIS in 
9 CFR 301.2-except that those terms as applied to bison shall have a 
meaning comparable to those provided in 9 CFR 301.2 with regard to 
cattle, and other than boneless skeletal meat that meets the conditions 
of Sec.94.18(b)(2)--may be imported from a region of negligible risk 
for BSE, as defined in Sec.92.1 of this subchapter, if the following 
conditions and all other applicable requirements of this part are met:
    (a) The commodities were exported from a region of negligible risk 
for BSE.
    (b) If BSE has been diagnosed in one or more indigenous bovines in 
the region of negligible risk, the commodities were derived from bovines 
subject to a ban on the feeding to ruminants of meat-and-bone meal or 
greaves derived from ruminants.
    (c) The commodities were derived from bovines that passed ante-
mortem and post-mortem inspections.
    (d) The commodities are accompanied by an original certificate 
stating that the exporting region is classified by APHIS as a region of 
negligible risk for BSE and that the conditions of paragraphs (a) 
through (c) of this section, as applicable, have been met. The 
certificate must be issued and signed by a full-time salaried veterinary 
officer of the national government of the exporting region, or signed by 
a person authorized to issue such certificates by the veterinary 
services of the national government of the exporting region.
    Note: To be eligible to export meat, meat byproducts, and meat food 
products under the conditions of this section for human consumption, a 
region must also be one that has demonstrated to FSIS in accordance with 
9 CFR 310.22 that its BSE risk status can reasonably be expected to 
provide the same level of protection from human exposure to the BSE 
agent as does prohibiting specified risk materials for use as human food 
in the United States.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 72999, Dec. 4, 2013]



Sec.94.20  Importation of meat, meat byproducts, and meat food 
products derived from bovines from regions of controlled risk 
for BSE.

    Meat, meat byproducts, and meat food products, as defined by FSIS in 
9 CFR 301.2--except that those terms as applied to bison shall have a 
meaning comparable to those provided in 9 CFR 301.2 with regard to 
cattle, and other than boneless skeletal meat that meets the conditions 
of Sec.94.18(b)(2)--may be imported from a region of controlled risk 
for BSE, as defined in Sec.92.1 of this subchapter, if the following 
conditions and all other applicable requirements of this part are met:
    (a) The commodities were exported from a region of controlled risk 
for BSE.
    (b) The commodities were derived from bovines that passed ante-
mortem and post-mortem inspections.
    (c) The commodities were derived from bovines that were not 
subjected to a stunning process, prior to slaughter, with a device 
injecting compressed air or gas into the cranial cavity, or to a pithing 
process.
    (d) The commodities were produced and handled in a manner that 
ensured that such commodities do not contain and are not contaminated 
with either of the following:
    (1) SRMs from regions of controlled risk for BSE; or
    (2) Mechanically separated meat from the skull and vertebral column 
from bovines 30 months of age or older.

[[Page 602]]

    (e) The commodities are accompanied by an original certificate 
stating that the exporting region is classified by APHIS as a region of 
controlled risk for BSE, and that the conditions of this section have 
been met. The certificate must be issued and signed by a full-time 
salaried veterinary officer of the national government of the exporting 
region, or signed by a person authorized to issue such certificates by 
the veterinary services of the national government of the exporting 
region.

(Approved by the Office of Management and Budget under control numbers 
0579-0015 and 0579-0393)

[78 FR 72999, Dec. 4, 2013]



Sec.94.21  Importation of meat, meat byproducts, and meat food
products derived from bovines from regions of undetermined risk 
for BSE.

    Meat, meat byproducts, and meat food products, as defined by FSIS in 
9 CFR 301.2-except that those terms as applied to bison shall have a 
meaning comparable to those provided in 9 CFR 301.2 with regard to 
cattle, and other than boneless skeletal meat that meets the conditions 
of Sec.94.18(b)(2)--may be imported from regions of undetermined risk 
for BSE, as defined in Sec.92.1 of this subchapter, if the following 
conditions and all other applicable requirements of this part are met:
    (a) The commodities were derived from bovines that have never been 
fed meat-and-bone meal or greaves derived from ruminants.
    (b) The commodities were derived from bovines that passed ante-
mortem and post-mortem inspections.
    (c) The commodities were derived from bovines that were not 
subjected to a stunning process, prior to slaughter, with a device 
injecting compressed air or gas into the cranial cavity, or to a pithing 
process.
    (d) The commodities were produced and handled in a manner that 
ensured that such commodities do not contain and are not contaminated 
with any of the following:
    (1) SRMs from regions of undetermined risk for BSE; or
    (2) Mechanically separated meat from the skull and vertebral column 
from bovines over 12 months of age.
    (e) The commodities are accompanied by an original certificate 
stating that the exporting region is a region of undetermined risk for 
BSE and that the conditions of this section have been met. The 
certificate must be issued and signed by a full-time salaried veterinary 
officer of the national government of the exporting region, or signed by 
a person authorized to issue such certificates by the veterinary 
services of the national government of the exporting region.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 72999, Dec. 4, 2013]



Sec.94.22  Meat or dressed carcasses of hunter-harvested bovines.

    The meat or dressed carcass (eviscerated and the head is removed) is 
derived from a wild bovine that has been legally harvested in the wild, 
as verified by proof such as a hunting license, tag, or the equivalent 
that the hunter must show to the authorized inspector.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 72999, Dec. 4, 2013]



Sec.94.23  Importation of gelatin derived from bovines.

    (a) The importation of gelatin derived from bovines is prohibited 
because of BSE, unless:
    (1) The gelatin meets the requirements of either paragraph (b), (c), 
or (d), as well as the requirements of paragraph (e) of this section and 
all other applicable requirements of this part; or
    (2) The gelatin is authorized importation under paragraph (f) of 
this section and meets all other applicable requirements of this part.
    (b) The gelatin is derived from hides and skins, provided the 
gelatin has not been commingled with materials ineligible for entry into 
the United States.
    (c) The gelatin is derived from the bones of bovines and originates 
in a region of negligible risk for BSE.
    (d) The gelatin is derived from the bones of bovines, originates in 
a region of controlled risk or undetermined risk for BSE, and meets the 
requirements of paragraphs (d)(1) through (d)(4) of this section:

[[Page 603]]

    (1) The bones from which the gelatin was derived were derived from 
bovines that passed ante-mortem and post-mortem inspection.
    (2) The bones from which the gelatin was derived did not include the 
skulls of bovines or the vertebral column of bovines 30 months of age or 
older.
    (3) The bones were subjected to a process that includes all of the 
following steps, or to a process at least as effective in reducing BSE 
infectivity:
    (i) Degreasing;
    (ii) Acid demineralization;
    (iii) Acid or alkaline treatment;
    (iv) Filtration; and
    (v) Sterilization at 138 [deg]C (280.4 [deg]F) or greater for a 
minimum of 4 seconds; and
    (4) The gelatin has not been commingled with materials ineligible 
for entry into the United States.
    (e) The gelatin is accompanied to the United States by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the exporting region, or issued by a veterinarian 
designated by the national government of the exporting region and 
endorsed by a full-time salaried veterinary officer of the national 
government of the exporting region, representing that the veterinarian 
issuing the certificate was authorized to do so. The certificate must 
state that the requirements of paragraph (b), (c), or (d) of this 
section, as applicable, have been met and, for gelatin other than that 
described in paragraph (b) of this section, must indicate the BSE risk 
classification of the exporting region.
    (f) The Administrator determines that the gelatin will not come into 
contact with ruminants in the United States and can be imported under 
conditions that will prevent the introduction of BSE into the United 
States, and the person importing the gelatin has obtained a United 
States Veterinary Permit for Importation and Transportation of 
Controlled Materials and Organisms and Vectors. To apply for a permit, 
file a permit application on VS Form 16-3 (available from APHIS, 
Veterinary Services, National Center for Import and Export, 4700 River 
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://
www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the gelatin and name and address 
of the consignee in the United States.

[78 FR 72999, Dec. 4, 2013]



Sec.94.24  Restrictions on importation of meat and edible products
from ovines and caprines due to bovine spongiform encephalopathy.

    (a) Except as provided in paragraph (b) of this section and in Sec.
94.25, the importation of meat, meat products, and edible products other 
than meat (excluding milk and milk products) from ovines and caprines 
that have been in any of the following regions is prohibited: Albania, 
Andorra, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Canada, 
Croatia, the Czech Republic, Denmark, the Federal Republic of 
Yugoslavia, Finland, France, Germany, Greece, Hungary, the Republic of 
Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, the Former 
Yugoslav Republic of Macedonia, Monaco, Norway, Oman, the Netherlands, 
Poland, Portugal, Romania, San Marino, Slovakia, Slovenia, Spain, 
Sweden, Switzerland, and the United Kingdom.
    (b) The importation of gelatin derived from ovines or caprines that 
have been in any region listed in paragraph (a) of this section is 
prohibited unless the following conditions have been met:
    (1) The gelatin is 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 obtains a United States 
Veterinary Permit for Importation and Transportation of Controlled 
Materials and Organisms and Vectors by filing a permit application on VS 
Form 16-3. Permit applications are available from APHIS, Veterinary 
Services, National Center for Import and Export, 4700 River Road Unit 
38, Riverdale, MD 20737-1231, or at http://www.aphis.usda.gov/
animal_health/permits/. Forms may be submitted using a U.S. Government 
electronic information exchange system or

[[Page 604]]

other authorized method. The application for such a permit must state 
the intended use of the gelatin and name and address of the consignee in 
the United States.

[78 FR 72999, Dec. 4, 2013, as amended at 81 FR 40152, June 21, 2016]



Sec.94.25  Restrictions on the importation from Canada of meat and
edible products from ovines and caprines other than gelatin.

    The commodities listed in paragraphs (a) and (b) of this section may 
be imported from Canada if the conditions of this section are met.
    (a) Meat, carcasses, meat byproducts, and meat food products from 
ovines or caprines. (1) The meat, carcass, meat byproduct, or meat food 
product, as defined by FSIS in 9 CFR 301.2, is derived from ovines or 
caprines that are from a flock or herd subject to a ruminant feed ban 
equivalent to the requirements established by the U.S. Food and Drug 
Administration at 21 CFR 589.2000, and the ovines or caprines:
    (i) Were less than 12 months of age when slaughtered;
    (ii) Were slaughtered at a facility that either slaughters only 
ovines or caprines less than 12 months of age or complies with a 
segregation process approved by the national veterinary authority of the 
region of origin and the Administrator as adequate to prevent 
contamination or commingling of the meat with products not eligible for 
importation into the United States;
    (iii) Did not test positive for and were not suspect for a 
transmissible spongiform encephalopathy;
    (iv) Never resided in a flock or herd that has been diagnosed with 
BSE; and
    (v) Were not subject to any movement restrictions within Canada as a 
result of exposure to a transmissible spongiform encephalopathy.
    (2) The commodities are accompanied by an original certificate of 
such compliance issued by a full-time salaried veterinary officer of 
Canada, or issued by a veterinarian designated by the Canadian 
government and endorsed by a full-time salaried veterinary officer of 
the Government of Canada, representing that the veterinarian issuing the 
certificate was authorized to do so; and if all other applicable 
requirements of this part are met.
    (b) Meat or dressed carcasses of hunter-harvested ovines or 
caprines. (1) The meat or dressed carcass (eviscerated and the head is 
removed) is derived from a wild ovine or caprine that has been legally 
harvested in the wild, as verified by proof such as a hunting license, 
tag, or the equivalent that the hunter must show to the United States 
Customs and Border Protection official; and
    (2) The animal from which the meat is derived was harvested within a 
jurisdiction specified by the Administrator for which the game and 
wildlife service of the jurisdiction has informed the Administrator 
either that the jurisdiction conducts no type of game feeding program, 
or has complied with, and continues to comply with, a ruminant feed ban 
equivalent to the requirements established by the U.S. Food and Drug 
Administration at 21 CFR 589.2000.
    (c) Ports. All products to be brought into the United States under 
this section must, if arriving at a land border port, arrive at one of 
the following ports: Eastport, ID; Houlton, ME; Detroit (Ambassador 
Bridge), Port Huron, and Sault St. Marie, MI; International Falls, MN; 
Sweetgrass, MT; Alexandria Bay, Buffalo (Lewiston Bridge and Peace 
Bridge), and Champlain, NY; Pembina and Portal, ND; Derby Line and 
Highgate Springs, VT; and Blaine (Pacific Highway and Cargo Ops), 
Lynden, Oroville, and Sumas (Cargo), WA.

[78 FR 72999, Dec. 4, 2013]



Sec.94.26  Gelatin derived from horses or swine or from ovines or
caprines that have not been in a region restricted because of BSE.

    Gelatin derived from horses or swine, or from ovines or caprines 
that have not been in any region listed in Sec.94.24(a) 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 ovines or caprines, certify

[[Page 605]]

that the gelatin is not derived from ovines or caprines that have been 
in any region listed in Sec.94.24(a).

[78 FR 72999, Dec. 4, 2013]



Sec.94.27  Transit shipment of articles.

    Meat, meat products, and other edible products derived from bovines, 
ovines, or caprines that are otherwise prohibited importation into the 
United States in accordance with Sec.94.18 through Sec.94.26 may 
transit air and ocean ports in the United States for immediate export if 
the conditions of paragraphs (a) through (c) this section are met. Meat, 
meat products, and other edible products derived from bovines, ovines, 
or caprines are eligible to transit the United States by overland 
transportation if the requirements of paragraphs (a) through (d) of this 
section are met:
    (a) 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.
    (b) The person moving the articles must notify, in writing, the 
inspector at both the place in the United States where the articles will 
arrive and the port of export before such transit. Notification may be 
made using a U.S. Government electronic information exchange system or 
other authorized method. The notification must include the:
    (1) Times and dates of arrival in the United States;
    (2) Times and dates of exportation from the United States;
    (3) Mode of transportation; and
    (4) Serial numbers of the sealed containers.
    (c) The articles must transit the United States in Customs bond.
    (d) The commodities must be eligible to enter the United States in 
accordance with the provisions of this part and must be accompanied by 
the certification required by that section. Additionally, the following 
conditions must be met:
    (1) The shipment must be exported from the United States within 7 
days of its entry; and
    (2) The commodities may not be transloaded while in the United 
States, except for direct transloading under the supervision of an 
authorized inspector, who must break the seals of the national 
government of the region of origin on the means of conveyance that 
carried the commodities into the United States and seal the means of 
conveyance that will carry the commodities out of the United States with 
seals of the U.S. Government.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 72999, Dec. 4, 2013, as amended at 81 FR 40152, June 21, 2016]



Sec.94.28  Restrictions on the importation of poultry meat and 
products, and live birds and poultry, from the APHIS-defined EU
Poultry Trade Region.

    (a) Poultry meat and products. In addition to meeting all other 
applicable provisions of this part, poultry meat and poultry products, 
including eggs and egg products (other than hatching eggs) imported from 
the APHIS-defined EU Poultry Trade Region must meet the following 
conditions:
    (1) The poultry meat and products must not have been derived from 
birds and poultry that were in any of the following regions or zones, 
unless the birds and poultry were slaughtered after the periods 
described, or unless the poultry meat and products are accompanied by a 
certificate specifying that the articles were cooked and processed in 
accordance with the regulations in Sec.94.6(b)(3) or (b)(4):
    (i) Any region when the region was classified in Sec.94.6(a)(1)(i) 
as one in which Newcastle disease is considered to exist, or any region 
when the region was listed in accordance with Sec.94.6(a)(2)(i) as one 
in which HPAI is considered to exist, except for the APHIS-defined EU 
Poultry Trade Region;
    (ii) A restricted zone in the APHIS-defined EU Poultry Trade Region 
established because of detection of Newcastle disease or HPAI in 
commercial poultry, from the time of detection until the designation of 
the zone as a restricted zone is removed by the competent veterinary 
authority of the Member State or until 3 months (90 days) following 
depopulation of the

[[Page 606]]

poultry on affected premises in the restricted zone and the cleaning and 
disinfection of the last affected premises in the zone, whichever is 
later; or
    (iii) A restricted zone in the APHIS-defined EU Poultry Trade Region 
established because of detection of Newcastle disease or HPAI in racing 
pigeons, backyard flocks, or wild birds, from the time of detection 
until the designation of the zone as a restricted zone is removed by the 
competent veterinary authority of the Member State.
    (2) The poultry meat and products must not have been commingled with 
poultry meat and products derived from other birds and poultry that were 
in any of the regions or zones described in paragraphs (a)(1)(i) through 
(a)(1)(iii) of this section. Additionally, the poultry meat and products 
must not have been derived from poultry that were commingled with other 
poultry that were in any of the regions or zones described in paragraphs 
(a)(1)(i) through (a)(1)(iii) of this section.
    (3) No equipment or materials used in transporting the birds or 
poultry from which the poultry meat and products were derived from the 
farm of origin to the slaughtering establishment may have been used 
previously for transporting live birds or poultry that do not meet the 
requirements of Sec.94.28(b), unless the equipment and materials have 
first been cleaned and disinfected.
    (4) The poultry meat and products, including eggs and egg products 
(other than hatching eggs) must be accompanied by a certificate issued 
by an official of the competent veterinary authority of the APHIS-
defined EU Poultry Trade Region Member State who is authorized to issue 
the inspection certificate required by Sec.93.205 of this subchapter, 
stating that the applicable provisions of paragraphs (a)(1) through 
(a)(3) of this section have been met. The certification for poultry meat 
and products may be placed on the foreign meat inspection certificate 
required by Sec.381.196 of this title or may be contained in a 
separate document.
    (b) Live birds and poultry. In addition to meeting all other 
applicable provisions of this title, live birds and poultry, except 
hatching eggs, imported from the APHIS-defined EU Poultry Trade Region 
must meet the following conditions:
    (1) The birds and poultry must not have been in any of the following 
regions or zones, unless the birds and poultry are exported to the 
United States after the periods described.
    (i) Any region when the region was classified in Sec.94.6(a)(1)(i) 
as one in which Newcastle disease is considered to exist, or any region 
when the region was listed in accordance with Sec.94.6(a)(2)(i) as one 
in which HPAI is considered to exist, except for the APHIS-defined EU 
Poultry Trade Region;
    (ii) A restricted zone in the APHIS-defined EU Poultry Trade Region 
established because of detection of Newcastle disease or HPAI in 
commercial poultry, from the time of detection until the designation of 
the zone as a restricted zone is removed by the competent veterinary 
authority of the Member State or until 3 months (90 days) following 
depopulation of the poultry on affected premises in the restricted zone 
and the cleaning and disinfection of the last affected premises in the 
zone, whichever is later; or
    (iii) A restricted zone in the APHIS-defined EU Poultry Trade Region 
established because of detection of Newcastle disease or HPAI in racing 
pigeons, backyard flocks, and wild birds, from the time of detection 
until the designation of the zone as a restricted zone is removed by the 
competent veterinary authority of the Member State.
    (2) The birds and poultry must not have been commingled with other 
birds or poultry that have at any time been in any of the regions or 
zones described in paragraphs (b)(1)(i) through (b)(1)(iii) of this 
section.
    (3) No equipment or materials used in transporting the birds and 
poultry may have been used previously for transporting birds or poultry 
that do not meet the requirements of this paragraph, unless the 
equipment and materials have first been cleaned and disinfected.
    (4) The birds and poultry must be accompanied by a certificate 
issued by an official of the competent veterinary authority of the 
Member State who is

[[Page 607]]

authorized to issue the inspection certificate required by Sec.93.205 
of this subchapter, stating that the applicable provisions of paragraphs 
(b)(1) through (b)(3) of this section have been met. The certification 
may be placed on the foreign meat inspection certificate required by 
Sec.381.196 of this title or may be contained in a separate document.
    (c) Hatching eggs. Hatching eggs intended for import from the APHIS-
defined EU Poultry Trade Region are subject to all applicable provisions 
of paragraph (b) of this section, except that such hatching eggs may be 
moved through zones established because of detection of HPAI within the 
APHIS-defined EU Poultry Trade Region provided that the hatching eggs 
are transported under official seal and accompanied by a certificate as 
indicated in paragraph (b)(4) of this section stating that the 
applicable provisions of paragraph (b) have been met. The import permit 
will require the seal number to be listed on the health certificate that 
accompanies the shipment and the veterinarian who places the seal will 
be required to sign his or her name under the seal number. Seals must 
not be broken until the shipment reaches its U.S. port of entry. 
Hatching egg shipment with seals that are not intact will be rejected 
upon inspection at the U.S. port of entry.
    (d) Presentation of certificates. The certificates required by 
paragraphs (a)(4), (b)(4), and (c) of this section must be presented by 
the importer to an authorized inspector at the port of arrival, upon 
arrival of the birds, poultry, hatching eggs, or poultry meat and 
products at the port.

[78 FR 19084, Mar. 29, 2013, as amended at 79 FR 7568, Feb. 10, 2014]



Sec.94.29  Restrictions on importation of fresh (chilled or frozen)
beef and ovine meat from specified regions.

    Notwithstanding any other provisions of this part, fresh (chilled or 
frozen) beef from a region in Argentina located north of Patagonia South 
and Patagonia North B, referred to as Northern Argentina (the region 
sometimes referred to as Patagonia North A is included in Northern 
Argentina); fresh (chilled or frozen) beef from a region in Brazil 
composed of the States of Bahia, Distrito Federal, Esp[iacute]rito 
Santo, Goi[aacute]s, Mato Grosso, Mato Grosso do Sul, Minas Gerais, 
Paran[aacute], Rio Grande do Sul, Rio de Janeiro, Rond[ocirc]nia, 
S[atilde]o Paulo, Sergipe, and Tocantins; and fresh (chilled or frozen) 
beef and ovine meat from Uruguay may be exported to the United States 
under the following conditions:
    (a) The meat is:
    (1) Beef from animals that have been born, raised, and slaughtered 
in the exporting regions of Argentina or Brazil; or
    (2) Beef or ovine meat from Uruguay derived from animals that have 
been born, raised, and slaughtered in Uruguay.
    (b) Foot-and-mouth disease has not been diagnosed in the exporting 
region of Argentina (for beef from Argentina), the exporting region of 
Brazil (for beef from Brazil), or in Uruguay (for beef or ovine meat 
from Uruguay) within the previous 12 months.
    (c) The meat comes from bovines or sheep that originated from 
premises where foot-and-mouth disease has not been present during the 
lifetime of any bovines and sheep slaughtered for the export of beef and 
ovine meat to the United States.
    (d) The meat comes from bovines or sheep that were moved directly 
from the premises of origin to the slaughtering establishment without 
any contact with other animals.
    (e) The meat comes from bovines or sheep that received ante-mortem 
and post-mortem veterinary inspections, paying particular attention to 
the head and feet, at the slaughtering establishment, with no evidence 
found of vesicular disease.
    (f) The meat consists only of bovine parts or ovine parts that are, 
by standard practice, part of the animal's carcass that is placed in a 
chiller for maturation after slaughter and before removal of any bone, 
blood clots, or lymphoid tissue. The bovine and ovine parts that may not 
be imported include all parts of the head, feet, hump, hooves, and 
internal organs.
    (g) All bone and visually identifiable blood clots and lymphoid 
tissue have been removed from the meat; except that bone-in ovine meat 
from Uruguay

[[Page 608]]

may be exported to the United States under the following conditions:
    (1) The meat must be derived from select lambs that have never been 
vaccinated for FMD;
    (2) The select lambs must be maintained in a program approved by the 
Administrator. Lambs in the program must:
    (i) Be segregated from other FMD-susceptible livestock at a select 
lamb facility operated under the authority of the national veterinary 
authority of Uruguay;
    (ii) Be subjected to an FMD testing scheme approved by the 
Administrator; and
    (iii) Be individually identified with official unique identification 
that is part of a national traceability system sufficient to ensure that 
only the products of select lambs meeting all required criteria are 
exempt from the deboning requirement.
    (3) Select lambs and their products must not be commingled with 
other animals and their products within the slaughter facility.
    (h) The meat has not been in contact with meat from regions other 
than those listed in Sec.94.1(a).
    (i) The meat came from carcasses that were allowed to maturate at 40 
to 50 [deg]F (4 to 10 [deg]C) for a minimum of 24 hours after slaughter 
and that reached a pH below 6.0 in the loin muscle at the end of the 
maturation period. Measurements for pH must be taken at the middle of 
both longissimus dorsi muscles. Any carcass in which the pH does not 
reach less than 6.0 may be allowed to maturate an additional 24 hours 
and be retested, and, if the carcass still has not reached a pH of less 
than 6.0 after 48 hours, the meat from the carcass may not be exported 
to the United States.
    (j) An authorized veterinary official of the government of the 
exporting region certifies on the foreign meat inspection certificate 
that the above conditions have been met.
    (k) The establishment in which the bovines and sheep are slaughtered 
allows periodic on-site evaluation and subsequent inspection of its 
facilities, records, and operations by an APHIS representative.


(Approved by the Office of Management and Budget under control numbers 
0579-0372, 0579-0414, 0579-0428, and 0579-0449)

[80 FR 37952, July 2, 2015; 82 FR 6212, Jan. 19, 2017; 82 FR 42732, 
Sept. 12, 2017]



Sec.94.30  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 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

[[Page 609]]

listed in Sec.94.6 as a region where Newcastle disease is not known to 
exist, unless:
    (1) The poultry meat or other poultry products arrive at the U.S. 
port of entry in shipping containers bearing intact, serially numbered 
seals that were applied at the federally inspected slaughter plant by a 
full-time salaried veterinarian of the Government of Mexico, and the 
seal numbers correspond with the seal numbers listed on the foreign meat 
inspection certificate; or
    (2) The poultry meat or other poultry products arrive at the U.S. 
port of entry in shipping containers bearing seals that have different 
numbers than the seal numbers on the foreign meat inspection 
certificate, but, upon inspection of the hold, compartment, or container 
and all accompanying documentation, an APHIS representative is satisfied 
that the poultry containers were opened and resealed en route by an 
appropriate official of the Government of Mexico and the poultry meat or 
other poultry products were not contaminated or exposed to contamination 
during movement from Sinaloa or Sonora to the United States.

[65 FR 15526, Mar. 23, 2000. Redesignated at 70 FR 550, Jan. 4, 2005, as 
amended at 78 FR 19084, Mar. 29, 2013. Redesignated at 78 FR 72999, Dec. 
4, 2013]



Sec.94.31  Restrictions on the importation of pork, pork products,
and swine from the APHIS-defined European CSF region.

    (a) Pork and pork products. In addition to meeting all other 
applicable provisions of this part, fresh pork and pork products 
imported from the APHIS-defined European CSF region must meet the 
following conditions:
    (1) The pork or pork products must not have been derived from swine 
that were in any of the following regions or zones, unless the swine 
were slaughtered after the periods described:
    (i) Any region when the region was classified under Sec. Sec.
94.9(a) and 94.10(a) as a region in which classical swine fever is known 
to exist, except for the APHIS-defined European CSF region;
    (ii) A restricted zone in the APHIS-defined European CSF region 
established because of detection of classical swine fever in domestic 
swine, from the time of detection until the designation of the zone as a 
restricted zone is removed by the competent veterinary authority or 
until 6 months following depopulation of the swine on affected premises 
in the restricted zone and the cleaning and disinfection of the last 
affected premises in the zone, whichever is later; or
    (iii) A restricted zone in the APHIS-defined European CSF region 
established because of the detection of classical swine fever in wild 
boar, from the time of detection until the designation of the zone as a 
restricted zone is removed by the competent veterinary authority.
    (2) The pork and pork products must not have been commingled with 
pork or pork products derived from other swine that were in any of the 
regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) 
of this section, unless the other swine were slaughtered after the 
periods described. Additionally, the pork and pork products must not 
have been derived from swine that were commingled with other swine that 
were in any of the regions or zones described in paragraphs (a)(1)(i) 
through (a)(1)(iii) of this section, unless the swine from which the 
pork or pork products were derived were slaughtered after the periods 
described.
    (3) The swine from which the pork or pork products were derived must 
not have transited any region or zone described in paragraphs (a)(1)(i) 
through (a)(1)(iii) of this section, unless the swine were moved 
directly through the region or zone in a sealed means of conveyance with 
the seal determined to be intact upon arrival at the point of 
destination, or unless the swine were slaughtered after the periods 
described.
    (4) No equipment or materials used in transporting the swine from 
which the pork or pork products were derived from the farm of origin to 
the slaughtering establishment may have been used previously for 
transporting swine that do not meet the requirements of this section, 
unless the equipment and materials have first been cleaned and 
disinfected.
    (5) The pork and pork products must be accompanied by a certificate 
issued

[[Page 610]]

by an official of the competent veterinary authority who is authorized 
to issue the foreign meat inspection certificate required by Sec.327.4 
of this title, stating that the applicable provisions of paragraphs 
(a)(1) through (a)(4) 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. In addition to meeting all other applicable 
provisions of this title, live swine imported from the APHIS-defined 
European CSF region must meet the following conditions:
    (1) The swine must be breeding swine.
    (2) The swine must not have been in any of the following regions or 
zones, unless the swine are exported to the United States after the 
periods described:
    (i) Any region when the region was classified under Sec. Sec.
94.9(a) and 94.10(a) as a region in which classical swine fever is known 
to exist, except for the APHIS-defined European CSF region;
    (ii) A restricted zone in the APHIS-defined European CSF region 
established because of the detection of classical swine fever in 
domestic swine, from the time of detection until the designation of the 
zone as a restricted zone is removed by the competent veterinary 
authority or until 6 months following depopulation of the swine on 
affected premises in the restricted zone and the cleaning and 
disinfection of the last affected premises in the zone, whichever is 
later; or
    (iii) A restricted zone in the APHIS-defined European CSF region 
established because of the detection of classical swine fever in wild 
boar, from the time of detection until the designation of the zone as a 
restricted zone is removed by the competent veterinary authority.
    (3) The swine must not have been commingled with other swine that 
have at any time been in any of the regions or zones described in 
paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the 
swine are exported after the periods described.
    (4) The swine must not have transited any region or zone described 
in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the 
swine were moved directly through the region or zone in a sealed means 
of conveyance with the seal determined to be intact upon arrival at the 
point of destination, or unless the swine are exported after the periods 
described;
    (5) No equipment or materials used in transporting the swine may 
have been used previously for transporting swine that do not meet the 
requirements of this section, unless the equipment and materials have 
first been cleaned and disinfected.
    (6) The swine must be accompanied by a certificate issued by a 
salaried veterinary officer of the competent veterinary authority, 
stating that the conditions of paragraphs (b)(1) through (b)(5) of this 
section have been met. \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)(5) and (b)(6) of 
this section must be presented by the importer to an authorized 
inspector at the port of arrival, upon arrival of the swine, pork, or 
pork products at the port.

(Approved by the Office of Management and Budget under control numbers 
0579-0218 and 0579-0265)

[71 FR 29071, May 19, 2006. Redesignated at 71 FR 31070, June 1, 2006, 
as amended at 72 FR 67232, Nov. 28, 2007; 74 FR 18288, Apr. 22, 2009; 76 
FR 4054, Jan. 24, 2011; 76 FR 70039, Nov. 10, 2011; 77 FR 1395, Jan. 10, 
2012. Redesignated at 78 FR 72999, Dec. 4, 2013]



Sec.94.32  Restrictions on the importation of live swine, pork, 
or pork products from certain regions free of classical swine 
fever.

    (a) Live swine, pork, or pork products and ship stores, airplane 
meals, and baggage containing pork or pork products, other than those 
articles regulated under part 95 or part 96 of this chapter, may not be 
imported into the United States from a region listed under paragraph 
(a)(2) of this section unless the requirements in this section, in 
addition to other applicable requirements of part 93 of this chapter and 
part 327 of this title, are met.
    (1) The regions listed under paragraph (a)(2) of this section have 
been declared free of classical swine fever (CSF) by APHIS in accordance 
with

[[Page 611]]

Sec. Sec.94.9(a) and 94.10(a) but either supplement their pork 
supplies with fresh (chilled or frozen) pork imported from regions 
considered to be affected by CSF, or supplement their pork supplies with 
pork from CSF-affected regions that is not processed in accordance with 
the requirements of this part, or share a common land border with CSF-
affected regions, or import live swine from CSF-affected regions under 
conditions less restrictive than would be acceptable for importation 
into the United States. Thus, the live swine, pork, or pork products 
from those regions may be commingled with live swine, pork, or pork 
products from CSF-affected regions, resulting in a risk of CSF 
introduction into the United States.
    (2) A list of regions whose live swine, pork, and pork products are 
regulated under this section is maintained on the APHIS Web site at 
http://www.aphis.usda.gov/ import_export/animals/animal 
_disease_status.shtml. Copies of the list will also be available via 
postal mail, fax, or email upon request to the Sanitary Trade Issues 
Team, National Center for Import and Export, Veterinary Services, Animal 
and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, 
Maryland 20737.
    (3) APHIS will add a region to the list of those whose live swine, 
pork, and pork products are regulated under this section after 
conducting an evaluation of the region and determining that one or more 
of the circumstances described in paragraph (a)(1) of this section 
exists. APHIS will remove a region from the list upon conducting an 
evaluation of the region and determining that the circumstances in 
paragraph (a)(1) of this section no longer exist or upon determining 
that classical swine fever exists in the region.
    (b) Live swine. The swine must be accompanied by a certification 
issued by a full-time salaried veterinary officer of the national 
government of the region of export. Upon arrival of the swine in the 
United States, the certification must be presented to an authorized 
inspector at the port of arrival. The certification must identify both 
the exporting region and the region of origin as a region listed under 
Sec. Sec.94.9 and 94.10 as free of CSF at the time the swine were in 
the region and must state that:
    (1) The swine have not lived in a region classified under Sec. Sec.
94.9 and 94.10 as a region in which CSF is known to exist;
    (2) The swine have never been commingled with swine that have been 
in a region that is classified under Sec. Sec.94.9 and 94.10 as a 
region in which CSF is known to exist;
    (3) The swine have not transited a region classified under 
Sec. Sec.94.9 and 94.10 as a region in which CSF is known to exist 
unless moved directly through the region to their destination in a 
sealed means of conveyance with the seal intact upon arrival at the 
point of destination; and
    (4) The conveyances or materials used in transporting the swine, if 
previously used for transporting swine, have been cleaned and 
disinfected in accordance with the requirements of Sec.93.502 of this 
chapter.
    (c) Pork or pork products. The pork or pork products must be 
accompanied by a certification issued by a full-time salaried veterinary 
officer of the national government of the region of export. Upon arrival 
of the pork or pork products in the United States, the certification 
must be presented to an authorized inspector at the port of arrival. The 
certification must identify both the exporting region and the region of 
origin of the pork or pork products as a region listed under Sec. Sec.
94.9 and 94.10 as free of CSF at the time the pork or pork products were 
in the region and must state that:
    (1) The pork or pork products were derived from swine that were born 
and raised in a region listed under Sec. Sec.94.9 and 94.10 as free of 
CSF and were slaughtered in such a region at a federally inspected 
slaughter plant that is under the direct supervision of a full-time 
salaried veterinarian of the national government of that region and that 
is eligible to have its products imported into the United States under 
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the 
regulations in Sec.327.2 of this title;
    (2) The pork or pork products were derived from swine that have not 
lived in a region classified under Sec. Sec.94.9 and

[[Page 612]]

94.10 as a region in which CSF is known to exist;
    (3) The pork or pork products have never been commingled with pork 
or pork products that have been in a region that is classified under 
Sec. Sec.94.9 and 94.10 as a region in which CSF is known to exist;
    (4) The pork or pork products have not transited through a region 
classified under Sec. Sec.94.9 and 94.10 as a region in which CSF is 
known to exist unless moved directly through the region to their 
destination in a sealed means of conveyance with the seal intact upon 
arrival at the point of destination; and
    (5) If processed, the pork or pork products were processed in a 
region listed under Sec. Sec.94.9 and 94.10 as free of CSF in a 
federally inspected processing plant that is under the direct 
supervision of a full-time salaried veterinary official of the national 
government of that region.

(Approved by the Office of Management and Budget under control numbers 
0579-0230 and 0579-0235)

[71 FR 31070, June 1, 2006, as amended at 72 FR 30470, June 1, 2007; 76 
FR 15211, Mar. 21, 2011; 77 FR 1395, Jan. 10, 2012. Redesignated at 78 
FR 72999, Dec. 4, 2013]



Sec.94.33  Restrictions on importation of live poultry, poultry meat,
and other poultry products from specified regions.

    Argentina and the Mexican States of Campeche, Quintana Roo, and 
Yucatan, which are declared in Sec.94.6(a)(1) to be free of Newcastle 
disease, supplement their meat supply by the importation of fresh 
(chilled or frozen) poultry meat from regions designated in Sec.
94.6(a) as regions where Newcastle disease is considered to exist, have 
a common land border with regions where Newcastle disease is considered 
to exist, or import live poultry from regions where Newcastle disease is 
considered to exist under conditions less restrictive than would be 
acceptable for importation into the United States. Thus, even though the 
Department has declared such regions to be free of Newcastle disease, 
live poultry originating in such free regions may be commingled with 
live poultry originating in an Newcastle disease-affected region and the 
meat and other animal products produced in such free regions may be 
commingled with the fresh (chilled or frozen) meat of animals from an 
Newcastle disease-affected region, resulting in an undue risk of 
introducing Newcastle disease into the United States. Therefore, live 
poultry, poultry meat and other poultry products, and ship stores, 
airplane meals, and baggage containing such meat or animal products 
originating in the free regions listed in this section may not be 
imported into the United States unless the following requirements, in 
addition to all other applicable requirements of part 93 of this chapter 
and of chapter III of this title, are met:
    (a) Additional certification. Live poultry, poultry meat, and other 
poultry products from any region designated in this section must be 
accompanied by an additional certification by a full-time salaried 
veterinary officer of the national Government of the exporting region. 
Upon arrival of the live poultry, poultry meat, or other poultry product 
in the United States, the certification must be presented to an 
authorized inspector at the port of arrival.
    (b) Live poultry. The certification accompanying live poultry must 
identify the exporting region of the poultry as a region designated in 
Sec.94.6(a) as free of Newcastle disease and highly pathogenic avian 
influenza at the time the poultry were in the region and must state 
that:
    (1) The poultry have not been in contact with poultry or poultry 
products from any region where Newcastle disease is considered to exist;
    (2) The poultry have not lived in a region where Newcastle disease 
is considered to exist; and
    (3) The poultry have not transited through a region where Newcastle 
disease is considered to exist unless moved directly through the region 
in a sealed means of conveyance with the seal intact upon arrival at the 
point of destination.
    (c) Poultry meat or other poultry products. The certification 
accompanying poultry meat or other poultry products must state that:
    (1) The poultry meat or other poultry products are derived from 
poultry that meet all requirements of this section

[[Page 613]]

and that have been slaughtered in a region designated in Sec.94.6(a) 
as free of Newcastle disease and highly pathogenic avian influenza at a 
federally inspected slaughter plant that is under the direct supervision 
of a full-time salaried veterinarian of the national Government of the 
exporting region and that is approved to export poultry meat and other 
poultry products to the United States in accordance with Sec.381.196 
of this title;
    (2) The poultry meat or other poultry products have not been in 
contact with poultry meat or other poultry products from any region 
where Newcastle disease is considered to exist;
    (3) The poultry meat or other poultry products have not transited 
through a region where Newcastle disease is considered to exist unless 
moved directly through the region in a sealed means of conveyance with 
the seal intact upon arrival at the point of destination; and
    (4) If processed, the poultry meat or other poultry products were 
processed in a region designated in Sec.94.6(a) as free of Newcastle 
disease and highly pathogenic avian influenza in a federally inspected 
processing plant that is under the direct supervision of a full-time 
salaried veterinarian of the national Government of the exporting 
region.

(Approved by the Office of Management and Budget under control number 
0579-0228)

[69 FR 3823, Jan. 27, 2004. Redesignated at 70 FR 550, Jan. 4, 2005, as 
amended at 71 FR 4813, Jan. 30, 2006; 76 FR 4055, Jan. 24, 2011; 78 FR 
19084, Mar. 29, 2013. Redesignated at 78 FR 72999, Dec. 4, 2013]



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 Processed animal protein derived from ruminants.
95.6 Offal derived from bovines.
95.7 Collagen derived from bovines.
95.8 Tallow derived from bovines.
95.9 Derivatives of tallow derived from bovines.
95.10 Dicalcium phosphate derived from bovines.
95.11 Specified risk materials.
95.12 Blood and blood products derived from bovines.
95.13 Importation from regions of negligible risk for BSE of processed 
          animal protein derived from animals other than ruminants.
95.14 Importation from regions of controlled risk or undetermined risk 
          for BSE of processed animal protein derived from animals other 
          than ruminants.
95.15 Transit shipment of articles.
95.16 Untanned hides and skins and bird trophies; requirements for 
          entry.
95.17 Untanned hides, skins, and bird trophies; importations permitted 
          subject to restrictions.
95.18 Wool, hair, and bristles; requirements for unrestricted entry.
95.19 Wool, hair, and bristles; importations permitted subject to 
          restrictions.
95.20 Glue stock; requirements for unrestricted entry.
95.21 Glue stock; importations permitted subject to restrictions.
95.22 Bones, horns, and hoofs for trophies or museums; disinfected 
          hoofs.
95.23 Bones, horns, and hoofs; importations permitted subject to 
          restrictions.
95.24 Bone meal for use as fertilizer or as feed for domestic animals; 
          requirements for entry.
95.25 Blood meal, tankage, meat meal, and similar products, for use as 
          fertilizer or animal feed; requirements for entry.
95.26 Blood meal, blood albumin, intestines, and other animal byproducts 
          for industrial use; requirements for unrestricted entry.
95.27 Blood meal, blood albumin, intestines, and other animal byproducts 
          for industrial use; importations permitted subject to 
          restrictions.
95.28 Glands, organs, ox gall, and like materials; requirements for 
          unrestricted entry.
95.29 Glands, organs, ox gall, and like materials; importations 
          permitted subject to restrictions.
95.30 Animal stomachs.
95.31 Animal manure.
95.32 Hay and straw; requirements for unrestricted entry.
95.33 Hay and straw; importations permitted subject to restrictions.
95.34 Previously used meat covers; importations permitted subject to 
          restrictions.
95.35 Methods for disinfection of hides, skins, and other materials.

[[Page 614]]

95.36 Transportation of restricted import products; placarding cars and 
          marking billing; unloading enroute.
95.37 Railroad cars, trucks, boats, aircraft and other means of 
          conveyance, equipment or containers, yards, and premises; 
          cleaning and disinfection.
95.38 Regulations applicable to products from Territorial possessions.
95.39 Hay or straw and similar material from tick-infested areas.
95.40 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 contagion of foot-and-mouth disease.
    Approved establishment means an establishment approved by Veterinary 
Services for the receipt and handling of restricted import animal 
byproducts.
    Approved sewerage system means a drainage system equipped and 
operated so as to carry and dispose of sewage without endangering 
livestock through the contamination of streams or fields and approved by 
the Veterinary Services.
    Approved warehouse means a warehouse having facilities approved by 
Veterinary Services for the handling and storage, apart from other 
merchandise, of restricted import products.
    Bird trophy. A carcass or part of a carcass of a wild bird taken as 
game during a hunting expedition for the purpose of processing into 
taxidermy mounts for personal exhibition.
    Blood meal means dried blood of animals.
    Bone meal means ground animal bones and hoof meal and horn meal.
    Bovine. Bos taurus, Bos indicus, and Bison bison.
    Bovine spongiform encephalopathy (BSE) minimal-risk region. A region 
listed in Sec.94.18(a)(3) of this subchapter.
    Department means the United States Department of Agriculture.
    Deputy Administrator of Veterinary Services means the Deputy 
Administrator of Veterinary Services.
    Direct transloading. The transfer of cargo directly from one means 
of conveyance to another.
    Exporting region. A region from which shipments are sent to the 
United States.
    Glue stock means fleshings, hide cuttings and parings, tendons, or 
other collagenous parts of animal carcasses.
    Hay and straw means dried grasses, clovers, legumes, and similar 
materials or stalks or stems of various grains, such as barley, oats, 
rice, rye, and wheat.
    Highly pathogenic avian influenza (HPAI). Highly pathogenic avian 
influenza is defined as follows:
    (1) Any influenza virus that kills at least 75 percent of eight 4- 
to 6-week-old susceptible chickens within 10 days following intravenous 
inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, 
infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-
week-old chickens resulting in an intravenous pathogenicity index (IVPI) 
of greater than 1.2;
    (2) Any H5 or H7 virus that does not meet the criteria in paragraph 
(1) of this definition, but has an amino acid sequence at the 
haemagglutinin cleavage site that is compatible with highly pathogenic 
avian influenza viruses; or
    (3) Any influenza virus that is not an H5 or H7 subtype and that 
kills one to five out of eight inoculated chickens and grows in cell 
culture in the absence of trypsin within 10 days.
    Inspector. Any individual authorized by the Administrator of APHIS 
or the

[[Page 615]]

Commissioner of Customs and Border Protection, Department of Homeland 
Security, to enforce the regulations in this part.
    Meat meal or tankage means the rendered and dried carcasses or parts 
of the carcasses of animals.
    Offal. The inedible parts of a butchered animal.
    Positive for a transmissible spongiform encephalopathy. A sheep or 
goat for which a diagnosis of a transmissible spongiform encephalopathy 
has been made.
    Processed animal protein means meat meal, bone meal, meat and bone 
meal, blood meal, dried plasma and other blood products, hydrolyzed 
proteins, hoof meal, horn meal, poultry meal, feather meal, fish meal, 
and any other similar products.
    Region. Any defined geographic land area identifiable by geological, 
political, or surveyed boundaries. A region may consist of any of the 
following:
    (1) A national entity (country);
    (2) Part of a national entity (zone, county, department, 
municipality, parish, Province, State, etc.)
    (3) Parts of several national entities combined into an area; or
    (4) A group of national entities (countries) combined into a single 
area.
    Specified risk materials (SRMs) from regions of controlled risk for 
BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a).
    Specified risk materials (SRMs) from regions of undetermined risk 
for BSE. Those bovine parts considered to be at particular risk of 
containing the BSE agent in infected animals, as listed in the FSIS 
regulations at 9 CFR 310.22(a), except that the following bovine parts 
from regions of undetermined risk for BSE are considered SRMs if they 
are derived from bovines over 12 months of age: Brain, skull, eyes, 
trigeminal ganglia, spinal cord, vertebral column (excluding the 
vertebrae of the tail, the transverse processes of the thoracic and 
lumbar vertebrae, and the wings of the sacrum), and the dorsal root 
ganglia.
    Suspect for a transmissible spongiform encephalopathy. (1) A sheep 
or goat that has tested positive for a transmissible spongiform 
encephalopathy or for the proteinase resistant protein associated with a 
transmissible spongiform encephalopathy, unless the animal is designated 
as positive for a transmissible spongiform encephalopathy; or
    (2) A sheep or goat that exhibits any of the following signs and 
that has been determined to be suspicious for a transmissible spongiform 
encephalopathy by a veterinarian: Weight loss despite retention of 
appetite; behavior abnormalities; pruritus (itching); wool pulling; 
biting at legs or side; lip smacking; motor abnormalities such as 
incoordination, high stepping gait of forelimbs, bunny hop movement of 
rear legs, or swaying of back end; increased sensitivity to noise and 
sudden movement; tremor, ``star gazing,'' head pressing, recumbency, or 
other signs of neurological disease or chronic wasting.
    Tallow derivative. Any chemical obtained through initial hydrolysis, 
saponification, or transesterification of tallow; chemical conversion of 
material obtained by hydrolysis, saponification, or transesterification 
may be applied to obtain the desired product.
    United States means the several States, the District of Columbia, 
Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of 
the United States, and all other territories and possessions of the 
United States.
    Veterinary Services means the Veterinary Services unit of the Animal 
and Plant Health Inspection Service, United States Department of 
Agriculture.

[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; 70 FR 551, Jan. 4, 2005; 70 FR 71218, Nov. 28, 2005; 74 FR 
66226, Dec. 15, 2009; 78 FR 73001, Dec. 4, 2013; 79 FR 71007, Dec. 1, 
2014; 83 FR 15493, Apr. 11, 2018]



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

[[Page 616]]

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, highly pathogenic 
avian influenza, or Newcastle disease is prohibited.

[83 FR 15493, Apr. 11, 2018]



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), (d), (e), (f), or (g) of 
this section or in Sec.95.15, any of the materials listed in paragraph 
(b) of this section derived from animals, or products containing such 
materials, are prohibited importation into the United States if 
paragraph (a)(1), (a)(2), or (a)(3) of this section applies:
    (1) The animals have been in any region listed in paragraph (a)(4) 
of this section;
    (2) The materials have been stored, rendered, or otherwise processed 
in a region listed in paragraph (a)(4) of this section; or
    (3) The materials have otherwise been associated with a facility in 
a region listed in paragraph (a)(4) of this section.
    (4) Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina, 
Bulgaria, Canada, Croatia, the Czech Republic, Denmark, the Federal 
Republic of Yugoslavia, Finland, France, Germany, Greece, Hungary, the 
Republic of Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, 
the Former Yugoslav Republic of Macedonia, Monaco, Norway, Oman, the 
Netherlands, Poland, Portugal, Romania, San Marino, Slovakia, Slovenia, 
Spain, Sweden, Switzerland, and the United Kingdom.
    (b) Restricted materials: (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;
    (2) Glands, unprocessed fat tissue, and blood and blood products;
    (3) Processed fats and oils, and derivatives of processed animal 
protein, tankage, and offal; or
    (4) Derivatives of glands and blood and blood products.
    (c) The import prohibition in paragraph (a) of this section does not 
apply if the following conditions are met prior to importation:
    (1) The material is derived from one of the following:
    (i) A nonruminant species and the material is not ineligible for 
importation under Sec.95.13 or Sec.95.14;
    (ii) Cervids or camelids;
    (iii) Bovines, and the material is not ineligible for importation 
under the conditions of Sec.95.5, Sec.95.6, Sec.95.7, Sec.95.8, 
Sec.95.9, Sec.95.10, or Sec.95.12; or
    (iv) Ovines or caprines that have never been in any region listed in 
paragraph (a)(4) of this section.
    (2) In any region other than Canada that is listed in paragraph 
(a)(4) of this section, all steps of processing and storing the material 
are carried out in a facility that has not been used for the processing 
and storage of materials derived from ovines or caprines that have been 
in any region that is listed in paragraph (a)(4) of this section.
    (3) In Canada, all steps of processing and storing the material are 
carried out in a facility that has not been used for the processing and 
storage of materials derived from ovines and caprines that have been in 
any region other than Canada that is listed in paragraph (a)(4) of this 
section.
    (4) 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.
    (5) If the facility processes or handles any material derived from 
mammals,

[[Page 617]]

inspection of the facility for compliance with the provisions of this 
section is conducted at least annually by a representative of the 
government agency responsible for animal health in the region, unless 
the region chooses to have such inspection conducted by APHIS. If APHIS 
conducts the inspections required by this section, the facility has 
entered into a cooperative service agreement executed by the operator of 
the facility and APHIS. In accordance with the cooperative service 
agreement, the facility must be current in paying all costs for a 
veterinarian of APHIS to inspect the facility (it is anticipated that 
such inspections will occur approximately once per year), including 
travel, salary, subsistence, administrative overhead, and other 
incidental expenses (including excess baggage provisions up to 150 
pounds). In addition, the facility must have on deposit with APHIS an 
unobligated amount equal to the cost for APHIS personnel to conduct one 
inspection. As funds from that amount are obligated, a bill for costs 
incurred based on official accounting records will be issued to restore 
the deposit to the original level, revised as necessary to allow for 
inflation or other changes in estimated costs. To be current, bills must 
be paid within 14 days of receipt.
    (6) The facility allows periodic APHIS inspection of its facilities, 
records, and operations.
    (7) Each shipment to the United States is accompanied by an original 
certificate signed by a full-time, salaried veterinarian of the 
government agency responsible for animal health in the exporting region 
certifying that the conditions of paragraphs (c)(1) through (c)(5) of 
this section have been met.
    (8) 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 and 
Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or 
electronically at http://www.aphis.usda.gov/animal_health/permits/.)
    (d) Except as provided in paragraph (e) of this section and in Sec.
95.15, serum from ovines or caprines that have been in any region listed 
in paragraph (a)(4) of this section is prohibited importation into the 
United States, except for scientific, educational, or research purposes 
if the Administrator determines that the importation can be made under 
conditions that will prevent the introduction of BSE into the United 
States. Such serum 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.
    (e) The importation of serum albumin, serocolostrum, amniotic 
liquids or extracts, and placental liquids derived from ovines or 
caprines that have been in any region listed in paragraph (a)(4) of this 
section, and collagen and collagen products that are derived from ovines 
or caprines and that would otherwise be prohibited under paragraphs (a) 
and (b) 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 and Export, 4700 River Road Unit 38, 
Riverdale, MD 20737-1231, or electronically at http://
www.aphis.usda.gov/animal_health/permits/.); and
    (3) The permit application states the intended use of the article 
and the name and address of the consignee in the United States.
    (f) Insulin otherwise prohibited under paragraphs (a) and (b) of 
this section may be imported if the insulin is for the personal medical 
use of the person importing it and if the person importing the shipment 
has applied for and obtained from APHIS a United States Veterinary 
Permit for Importation and Transportation of Controlled Materials and 
Organisms and Vectors. To apply

[[Page 618]]

for a permit, file a permit application on VS Form 16-3 (available from 
APHIS, Veterinary Services, National Center for Import and Export, 4700 
River Road Unit 38, Riverdale, MD 20737-1231, or electronically at 
http://www.aphis.usda.gov/animal_health/permits/). The application for 
such a permit must state the intended use of the insulin and the name 
and address of the consignee in the United States.
    Note to paragraph (f):
    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.
    (g) Offal that is otherwise prohibited under paragraphs (a) and (b) 
of this section because it is derived from ovines or caprines that have 
been in a region listed in paragraph (a)(4) of this section may be 
imported into the United States if the offal is derived from ovines or 
caprines from Canada that have not been in a region listed in paragraph 
(a)(4) of this section other than Canada, and the following conditions 
are met:
    (1) The offal:
    (i) Is derived from ovines or caprines that were less than 12 months 
of age when slaughtered and that are from a flock or herd subject to a 
ruminant feed ban equivalent to the requirements established by the U.S. 
Food and Drug Administration at 21 CFR 589.2000;
    (ii) Is not derived from ovines or caprines that have tested 
positive for or are suspect for a transmissible spongiform 
encephalopathy;
    (iii) Is not derived from animals that have resided in a flock or 
herd that has been diagnosed with BSE; and
    (iv) Is derived from ovines or caprines whose movement was not 
restricted in the BSE minimal-risk region as a result of exposure to a 
transmissible spongiform encephalopathy.
    (2) Each shipment to the United States is accompanied by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the exporting region, or issued by a veterinarian 
designated by the exporting region and endorsed by a full-time salaried 
veterinary officer of the national government of the exporting region, 
representing that the veterinarian issuing the certificate was 
authorized to do so. The certificate must state that the requirements of 
paragraph (g)(1) of this section have been met; and
    (3) The shipment, if arriving at a U.S. land border port, arrives at 
a port listed in Sec.94.25(c) of this subchapter.

(Approved by the Office of Management and Budget under control numbers 
0579-0015, 0579-0234, and 0579-0393)

[78 FR 73001, Dec. 4, 2013]



Sec.95.5  Processed animal protein derived from ruminants.

    The importation of ruminant-derived processed animal protein, or any 
commodities containing such products, is prohibited unless the 
conditions of this section are met:
    (a) The exporting region is a region of negligible risk for BSE; and
    (1) The product has not been commingled or contaminated with 
ruminant meat-and-bone meal or greaves from a region of controlled or 
undetermined risk for BSE; and
    (2) The product must be derived from ruminants that were subject to 
a ban on the feeding of ruminants with meat-and-bone meal or greaves 
derived from ruminants if it is either:
    (i) Exported from a region of negligible risk for BSE in which there 
has been at least one indigenous case of BSE; or
    (ii) Derived from ruminants that were in a region of negligible risk 
for BSE in which there has been at least one indigenous case of BSE.
    (b) The exporting region is a region of controlled or undetermined 
risk, the product is ruminant-derived processed animal protein other 
than ruminant meat-and-bone meal or greaves, and it has been 
demonstrated that the product has not been commingled or contaminated 
with ruminant meat-and-bone meal or greaves from a controlled or 
undetermined risk region.
    (c) Each shipment to the United States is accompanied by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the exporting region, or issued by a veterinarian 
designated by the national government of the exporting region and 
endorsed by a full-time

[[Page 619]]

salaried veterinary officer of the national government of the exporting 
region, representing that the veterinarian issuing the certificate was 
authorized to do so. The certificate must state the exporting region and 
that the requirements of this section, as applicable, have been met.
    (d) The person importing the processed animal protein obtains a 
United States Veterinary Permit for Importation and Transportation of 
Controlled Materials and Organisms and Vectors by filing a permit 
application on VS Form 16-3. To apply for a permit, file a permit 
application on VS Form 16-3 (available from APHIS, Veterinary Services, 
National Center for Import and Export, 4700 River Road Unit 38, 
Riverdale, MD 20737-1231, or electronically at http://
www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the processed animal protein and 
name and address of the consignee in the United States.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 73003, Dec. 4, 2013]



Sec.95.6  Offal derived from bovines.

    Offal derived from bovines is prohibited importation into the United 
States unless it meets the requirements for the importation of meat, 
meat products, and meat byproducts in either Sec.94.19, Sec.94.20, 
or Sec.94.21, with the exception of the requirements in Sec.
94.19(c), Sec.94.20(b), and Sec.94.21(b), respectively. The person 
importing the offal must obtain a United States Veterinary Permit for 
Importation and Transportation of Controlled Materials and Organisms and 
Vectors by filing a permit application on VS Form 16-3. To apply for a 
permit, file a permit application on VS Form 16-3 (available from APHIS, 
Veterinary Services, National Center for Import and Export, 4700 River 
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://
www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the offal and name and address of 
the consignee in the United States.

[78 FR 73003, Dec. 4, 2013]



Sec.95.7  Collagen derived from bovines.

    (a) The importation of collagen derived from bovines is prohibited 
because of BSE unless:
    (1) The collagen meets the requirements of either paragraph (b), 
(c), or (d), as well as the requirements of paragraph (e) of this 
section and all other applicable requirements of this part; or
    (2) The collagen is authorized importation under paragraph (f) of 
this section and meets all other applicable requirements of this part:
    (b) The collagen is derived from hides and skins, provided the 
collagen has not been commingled with materials ineligible for entry 
into the United States.
    (c) The collagen is derived from the bones of bovines that 
originated from a region of negligible risk for BSE.
    (d) The collagen is derived from the bones of bovines that 
originated from a region of controlled or undetermined risk for BSE and 
meets the requirements of paragraphs (d)(1) through (d)(4) of this 
section:
    (1) The bones from which the collagen was derived were derived from 
bovines that passed ante-mortem and post-mortem inspection;
    (2) The bones from which the collagen was derived did not include 
the skulls of bovines or the vertebral column of bovines 30 months of 
age or older;
    (3) The bones were subjected to a process that includes all of the 
following steps, or to a process at least as effective in reducing BSE 
infectivity:
    (i) Degreasing;
    (ii) Acid demineralization;
    (iii) Acid or alkaline treatment;
    (iv) Filtration; and
    (v) Sterilization at 138 [deg]C (280.4 [deg]F) or greater for a 
minimum of 4 seconds; and
    (4) The collagen has not been commingled with materials ineligible 
for entry into the United States.
    (e) The collagen is accompanied to the United States by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the exporting region, or issued by a veterinarian 
designated by the national government of the exporting region and 
endorsed by a full-time

[[Page 620]]

salaried veterinary officer of the national government of the exporting 
region, representing that the veterinarian issuing the certificate was 
authorized to do so. The certificate must state that the requirements of 
paragraph (b), (c), or (d) of this section, as applicable, have been met 
and, for collagen other than that described in paragraph (b) of this 
section, must indicate the BSE risk classification of the exporting 
region.
    (f) The Administrator determines that the collagen will not come 
into contact with ruminants in the United States and can be imported 
under conditions that will prevent the introduction of BSE into the 
United States, and the person importing the collagen has obtained a 
United States Veterinary Permit for Importation and Transportation of 
Controlled Materials and Organisms and Vectors. To apply for a permit, 
file a permit application on VS Form 16-3 (available from APHIS, 
Veterinary Services, National Center for Import and Export, 4700 River 
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://
www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the collagen and the name and 
address of the consignee in the United States.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 73003, Dec. 4, 2013]



Sec.95.8  Tallow derived from bovines.

    (a) The importation of bovine-derived tallow is prohibited unless:
    (1) The requirements of either paragraph (b), (c), or (d), as well 
as the requirements of paragraph (e) of this section are met; or
    (2) The requirements of paragraph (f) of this section are met.
    (b) The tallow is composed of a maximum level of insoluble 
impurities of 0.15 percent in weight; or
    (c) The tallow originates from a region of negligible risk for BSE; 
or
    (d) The tallow originates from a region of controlled risk for BSE, 
is derived from bovines that have passed ante-mortem and post-mortem 
inspections, and has not been prepared using SRMs as defined for regions 
of controlled risk for BSE in Sec.92.1 of this subchapter.
    (e) The tallow is accompanied to the United States by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the exporting region, or issued by a veterinarian 
designated by the national government of the exporting region and 
endorsed by a full-time salaried veterinary officer of the national 
government of the exporting region, representing that the veterinarian 
issuing the certificate was authorized to do so. The certificate must 
state that the requirements of paragraph (b), (c), or (d) of this 
section, as applicable, have been met and, for tallow other than that 
described in paragraph (b) of this section, must indicate the BSE risk 
classification of the exporting region.
    (f) The Administrator determines that the tallow will not come into 
contact with ruminants in the United States and can be imported under 
conditions that will prevent the introduction of BSE into the United 
States, and the person importing the tallow has obtained a United States 
Veterinary Permit for Importation and Transportation of Controlled 
Materials and Organisms and Vectors. To apply for a permit, file a 
permit application on VS Form 16-3 (available from APHIS, Veterinary 
Services, National Center for Import and Export, 4700 River Road Unit 
38, Riverdale, MD 20737-1231, or electronically at http://
www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the tallow and the name and 
address of the consignee in the United States.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 73003, Dec. 4, 2013]



Sec.95.9  Derivatives of tallow derived from bovines.

    (a) The importation of derivatives of tallow from bovines is 
prohibited unless the commodity meets the conditions of either paragraph 
(b), (c), (d), or (e) of this section as well as paragraph (f) of this 
section, or, alternatively, meets the conditions of paragraph (g) of 
this section.

[[Page 621]]

    (b) The commodity meets the definition of tallow derivative in Sec.
95.1.
    (c) The derivative is from tallow composed of a maximum level of 
insoluble impurities of 0.15 percent in weight.
    (d) The derivative is from tallow that originates from a region of 
negligible risk for BSE.
    (e) The derivative is from tallow that originates from a region of 
controlled risk for BSE, is derived from bovines that have passed ante-
mortem and post-mortem inspections, and does not contain SRMs as defined 
for regions of controlled risk for BSE in Sec.92.1 of this subchapter.
    (f) The tallow derivative is accompanied to the United States by an 
original certificate signed by a full-time salaried veterinary officer 
of the national government of the exporting region, or issued by a 
veterinarian designated by the national government of the exporting 
region and endorsed by a full-time salaried veterinary officer of the 
national government of the exporting region, representing that the 
veterinarian issuing the certificate was authorized to do so. The 
certificate must state that the requirements of paragraph (b), (c), (d), 
or (e) of this section, as applicable, have been met and, for tallow 
derivatives other than those described in paragraph (b) or (c) of this 
section, must indicate the BSE risk classification of the exporting 
region.
    (g) The Administrator determines that the tallow derivative will not 
come into contact with ruminants in the United States and can be 
imported under conditions that will prevent the introduction of BSE into 
the United States, and the person importing the tallow derivative has 
obtained a United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors. To 
apply for a permit, file a permit application on VS Form 16-3 (available 
from APHIS, Veterinary Services, National Center for Import and Export, 
4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at 
http://www.aphis.usda.gov/animal_health/permits/). The application for 
such a permit must state the intended use of the tallow derivative and 
the name and address of the consignee in the United States.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 73003, Dec. 4, 2013]



Sec.95.10  Dicalcium phosphate derived from bovines.

    (a) The importation of dicalcium phosphate derived from bovines is 
prohibited unless:
    (1) The requirements of either paragraph (b), (c), or (d) and the 
requirements of paragraph (e) of this section are met; or
    (2) The requirements of paragraph (f) of this section are met.
    (b) The dicalcium phosphate contains no trace of protein or fat; or
    (c) The dicalcium phosphate originates from a region of negligible 
risk for BSE; or
    (d) The dicalcium phosphate originates from a region of controlled 
risk for BSE, is derived from bovines that have passed ante-mortem and 
post-mortem inspections, and does not contain SRMs as defined for 
regions of controlled risk for BSE in Sec.92.1 of this subchapter.
    (e) The dicalcium phosphate is accompanied by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the exporting region, or issued by a veterinarian 
designated by the national government of the exporting region and 
endorsed by a full-time salaried veterinary officer of the national 
government of the exporting region, representing that the veterinarian 
issuing the certificate was authorized to do so. The certificate must 
indicate the BSE risk classification of the exporting region and state 
that the requirements of paragraph (b) (c), or (d) of this section, as 
applicable, have been met.
    (f) The Administrator determines that the dicalcium phosphate will 
not come into contact with ruminants in the United States and can be 
imported under conditions that will prevent the introduction of BSE into 
the United States, and the person importing the dicalcium phosphate has 
obtained a United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms

[[Page 622]]

and Vectors. To apply for a permit, file a permit application on VS Form 
16-3 (available from APHIS, Veterinary Services, National Center for 
Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or 
electronically at http://www.aphis.usda.gov/animal_health/permits/). The 
application for such a permit must state the intended use of the 
dicalcium phosphate and the name and address of the consignee in the 
United States.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 73003, Dec. 4, 2013]



Sec.95.11  Specified risk materials.

    Notwithstanding any other provisions of this part, the importation 
of specified risk materials from controlled-risk regions or 
undetermined-risk regions for BSE, and any commodities containing such 
materials, is prohibited, unless the Administrator determines that the 
materials or other commodities will not come into contact with ruminants 
in the United States and can be imported under conditions that will 
prevent the introduction of BSE into the United States, and the person 
importing the materials or other commodities has obtained a United 
States Veterinary Permit for Importation and Transportation of 
Controlled Materials and Organisms and Vectors. To apply for a permit, 
file a permit application on VS Form 16-3 (available from APHIS, 
Veterinary Services, National Center for Import and Export, 4700 River 
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://
www.aphis.usda.gov/animal_health/permits/). The application for such a 
permit must state the intended use of the materials and other 
commodities and the name and address of the consignee in the United 
States.

[78 FR 73003, Dec. 4, 2013]



Sec.95.12  Blood and blood products derived from bovines.

    The importation of bovine blood and products derived from bovine 
blood is prohibited unless the following conditions and the conditions 
of all other applicable parts of this chapter are met:
    (a) For blood collected at slaughter and for products derived from 
blood collected at slaughter:
    (1) The blood was collected in a hygienic manner, as determined by 
the Administrator, that prevents contamination of the blood with SRMs; 
and
    (2) The slaughtered animal passed ante-mortem inspection and was not 
subjected to a pithing process or to a stunning process with a device 
injecting compressed air or gas into the cranial cavity.
    (b) For blood collected from live donor bovines and for products 
derived from blood collected from live donor bovines:
    (1) The blood was collected in a hygienic manner, as determined by 
the Administrator, that prevents contamination of the blood with SRMs; 
and
    (2) The donor animal was free of clinical signs of disease.
    (c) The blood and blood products are accompanied to the United 
States by an original certificate that states that the conditions of 
this section have been met. The certificate must be issued by a full-
time salaried veterinary officer of the national government of the 
exporting region, or issued by a veterinarian designated by the national 
government of the exporting region and endorsed by a full-time salaried 
veterinary officer of the exporting region, representing that the 
veterinarian issuing the certificate was authorized to do so.

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 73003, Dec. 4, 2013]



Sec.95.13  Importation from regions of negligible risk for BSE of
processed animal protein derived from animals other than ruminants.

    The importation from regions of negligible risk for BSE of processed 
animal protein derived from animals other than ruminants is prohibited 
importation into the United States unless the following conditions are 
met:
    (a) The processed animal protein is not prohibited importation under 
Sec.95.4;
    (b) The processed animal protein imported into the United States in 
accordance with this section is accompanied by an original certificate 
signed

[[Page 623]]

by a full-time salaried veterinary officer of the national government of 
the exporting region, or issued by a veterinarian designated by the 
national government of the exporting region and endorsed by a full-time 
salaried veterinary officer of the national government of the exporting 
region, representing that the veterinarian issuing the certificate was 
authorized to do so, that indicates that the material is derived from 
animals other than ruminants.
    (c) The person importing the shipment has applied for and obtained 
from APHIS a United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors. To 
apply for a permit, file a permit application on VS Form 16-3 (available 
from APHIS, Veterinary Services, National Center for Import and Export, 
4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at 
http://www.aphis.usda.gov/animal_health/permits/).

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 73003, Dec. 4, 2013]



Sec.95.14  Importation from regions of controlled risk or undetermined
risk for BSE of processed animal protein derived from animals other
than ruminants.

    The importation from regions of controlled risk or undetermined risk 
for BSE of processed animal protein derived from animals other than 
ruminants is prohibited importation into the United States unless the 
following conditions are met:
    (a) The processed animal protein is not prohibited importation under 
Sec.95.4;
    (b) Except as provided in paragraph (c) of this section, the 
processed animal protein does not contain and was not commingled with 
material derived from ruminants originating in a BSE controlled- or 
undetermined-risk region;
    (c) For blood meal, blood plasma, and other blood products, the 
material does not contain and was not commingled with ruminant blood or 
blood products prohibited importation into the United States under this 
part.
    (d) Inspection of the facility for compliance with the provisions of 
this section is conducted at least annually by a competent authority of 
the government agency responsible for animal health in the region, 
unless the region chooses to have such inspections conducted by APHIS. 
The inspections must verify either that:
    (1) All steps of processing and storing the material are carried out 
in a facility that has not been used for the processing or storage of 
materials derived from ruminants originating in a BSE controlled- or 
undetermined-risk region; or
    (2) The material is produced in a manner that prevents contamination 
of the processed animal protein with materials prohibited importation 
into the United States.
    (e) If APHIS conducts the inspections required by paragraph (d) of 
this section, the facility has entered into a cooperative service 
agreement executed by the operator of the facility and APHIS. In 
accordance with the cooperative service agreement, the facility must be 
current in paying all costs for a veterinarian of APHIS to inspect the 
facility (it is anticipated that such inspections will occur 
approximately once per year), including travel, salary, subsistence, 
administrative overhead, and other incidental expenses (including excess 
baggage provisions up to 150 pounds). In addition, the facility must 
have on deposit with APHIS an unobligated amount equal to the cost for 
APHIS personnel to conduct one inspection. As funds from that amount are 
obligated, a bill for costs incurred based on official accounting 
records will be issued to restore the deposit to the original level, 
revised as necessary to allow for inflation or other changes in 
estimated costs. To be current, bills must be paid within 14 days of 
receipt.
    (f) The facility allows periodic APHIS inspection of its facilities, 
records, and operations.
    (g) The processed animal protein imported into the United States in 
accordance with this section is accompanied by an original certificate 
signed by a full-time, salaried veterinary officer of the national 
government of the

[[Page 624]]

exporting region, or issued by a veterinarian designated by the national 
government of the exporting region and endorsed by a full-time, salaried 
veterinary officer of the national government of the exporting region, 
representing that the veterinarian issuing the certificate was 
authorized to do so, that states that the processed animal protein is 
not of ruminant origin and that conditions of this section have been 
met.
    (h) The person importing the shipment has applied for and obtained 
from APHIS a United States Veterinary Permit for Importation and 
Transportation of Controlled Materials and Organisms and Vectors. To 
apply for a permit, file a permit application on VS Form 16-3 (available 
from APHIS, Veterinary Services, National Center for Import and Export, 
4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at 
http://www.aphis.usda.gov/animal_health/permits/).

(Approved by the Office of Management and Budget under control number 
0579-0393)

[78 FR 73003, Dec. 4, 2013]



Sec.95.15  Transit shipment of articles.

    Articles that are otherwise prohibited importation into the United 
States in accordance with Sec. Sec.95.4 through 95.14 may transit air 
and ocean ports in the United States for immediate export if the 
conditions of paragraphs (a) through (c) of this section are met. 
Articles are eligible to transit the United States by overland 
transportation if the requirements of paragraphs (a) through (e) of this 
section are met.
    (a) 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.
    (b) Before such transit, the person moving the articles must notify, 
in writing, the inspector at both the place in the United States where 
the articles will arrive and the port of export. The notification must 
include the:
    (1) Times and dates of arrival in the United States;
    (2) Times and dates of exportation from the United States; and
    (3) Serial numbers of the sealed containers.
    (c) The articles must transit the United States under Customs bond.
    (d) The person moving the articles must obtain a United States 
Veterinary Permit for Importation and Transportation of Controlled 
Materials and Organisms and Vectors. To apply for a permit, file a 
permit application on VS Form 16-3 (available from APHIS, Veterinary 
Services, National Center for Import and Export, 4700 River Road Unit 
38, Riverdale, MD 20737-1231, or electronically at http://
www.aphis.usda.gov/animal_health/permits/).
    (e) The commodities must be eligible to enter the United States in 
accordance with Sec. Sec.95.4 through 95.14 and must be accompanied by 
the certification required by that section. Additionally, the following 
conditions must be met:
    (1) The shipment must be exported from the United States within 7 
days of its entry;
    (2) The commodities may not be transloaded while in the United 
States, except for direct transloading under the supervision of an 
authorized inspector, who must break the seals of the national 
government of the exporting region on the means of conveyance that 
carried the commodities into the United States and seal the means of 
conveyance that will carry the commodities out of the United States with 
seals of the U.S. Government; and
    (3) A copy of the import permit required under paragraph (d) of this 
section must be presented to the inspector at the port of arrival and 
the port of export in the United States.

[78 FR 73003, Dec. 4, 2013]



Sec.95.16  Untanned hides and skins and bird trophies; requirements
for entry.

    Untanned hides and skins and bird trophies \1\ may be imported into 
the United States if they meet the requirements of this section. Except 
for ruminant hides or skins from Mexico,

[[Page 625]]

untanned hides and skins and bird trophies may also be imported if 
handled at an approved establishment as set forth in Sec.95.17.
---------------------------------------------------------------------------

    \1\ The importation of bird trophies is also subject to restrictions 
under Sec.95.17.
---------------------------------------------------------------------------

    (a) Untanned hides and skins. (1) Except for ruminant hides or skins 
from Mexico, any untanned hides or skins of ruminants from regions free 
of foot-and-mouth disease and any untanned hides or skins of swine from 
regions free of foot-and-mouth disease and African swine fever may be 
imported without further restriction.
    (2) Untanned ruminant hides or skins may be imported from any region 
without other restriction if an inspector determines, based on 
inspection and upon examination of a shipper or importer certificate, 
that they are hard dried hides or skins.
    (3) Except for ruminant hides or skins from Mexico, untanned 
abattoir hides or skins of ruminants may be imported from any region 
without other restriction if the following requirements are met:
    (i) The ruminants from which the hides or skins were taken have been 
slaughtered under national government inspection in a region \2\ and in 
an abattoir in which is maintained an inspection service that meets the 
requirements and has been approved pursuant to part 327 of this title; 
and
---------------------------------------------------------------------------

    \2\ Names of these regions will be furnished upon request to the 
Animal and Plant Health Inspection Service, Veterinary Services, 
National Center for Import and Export, 4700 River Road Unit 38, 
Riverdale, Maryland 20737-1231.
---------------------------------------------------------------------------

    (ii) The hides or skins are accompanied by a certificate bearing the 
seal of the proper department of that national government and signed by 
an official veterinary inspector of the region in which the ruminants 
were slaughtered. The certificate must state that the hides or skins 
were taken from ruminants slaughtered in an abattoir that meets the 
requirements of paragraph (a)(3)(i) of this section and that the hides 
or skins are free from anthrax and foot-and-mouth disease.
    (4) Untanned ruminant hides or skins from any region may be imported 
without other restriction if an inspector determines, based on 
inspection and upon examination of a shipper or importer certificate, 
that they have been pickled in a solution of salt containing mineral 
acid and packed in barrels, casks, or tight cases while still wet with 
such solution. The solution must be determined by the inspector to have 
a pH of less than or equal to 5.
    (5) Untanned ruminant hides or skins from any region may be imported 
without other restriction if an inspector determines, based on 
inspection and upon examination of a shipper or importer certificate, 
that they have been treated with lime in such manner and for such period 
as to have obviously been processed, to have become dehaired, and to 
have reached the stage of preparation for immediate manufacture into 
products ordinarily made from rawhide.
    (b) Ruminant hides and skins from Mexico. Ruminant hides and skins 
from Mexico may enter the United States without other restriction if:
    (1) They are free of ticks and have been subjected to any one of the 
treatments specified in paragraphs (a)(2), (a)(4), or (a)(5) of this 
section; or
    (2) They are inspected and found to have been frozen solid for 24 
hours by an inspector and are accompanied by a certificate attesting to 
that fact issued by the shipper or importer that is reviewed by the 
inspector, and are free from ticks; or
    (3) They are free from ticks and are accompanied by a certificate 
issued by a full-time salaried veterinary officer of the Government of 
Mexico stating that they have been treated with an acaricide; or
    (4) They are bovine hides taken from cattle that were subjected to a 
tickicidal dip in one of the permitted dips listed in Sec.72.13(b) of 
this chapter at a Mexican facility 7 to 12 days prior to slaughter, and 
are free from ticks.
    (c) Bird trophies. Bird trophies from regions designated in Sec.
94.6 of this subchapter as free of Newcastle disease and free of HPAI 
may be imported without further restriction if accompanied by a 
certificate of origin issued

[[Page 626]]

by the national government of the region of export.

(Approved by the Office of Management and Budget under control numbers 
0579-0015 and 0579-0307)

[74 FR 66226, Dec. 15, 2009, as amended at 76 FR 28887, May 19, 2011; 78 
FR 19085, Mar. 29, 2013. Redesignated and amended at 78 FR 73003, 73006, 
Dec. 4, 2013; 79 FR 71007, Dec. 1, 2014; 83 FR 15493, Apr. 11, 2018]



Sec.95.17  Untanned hides, skins, and bird trophies; importations 
permitted subject to restrictions.

    Except for ruminant hides or skins from Mexico, hides or skins or 
bird trophies offered for importation which do not meet the conditions 
or requirements of Sec.95.16 shall be handled and treated in the 
following manner after arrival at the port of entry:
    (a) They shall be consigned from the coast or border port of arrival 
to an approved establishment and shall be subject to disinfection by 
such method or methods as the Deputy Administrator, Veterinary Services 
may prescribe unless the said establishment discharges drainage into an 
approved sewerage system or has an approved chlorinating equipment 
adequate for the proper disinfection of effluents: Provided, however, 
That upon permission of the Deputy Administrator, Veterinary Services 
such hides or skins or bird trophies may be stored for a temporary 
period in approved warehouses under bond, and under the supervision of 
an inspector: And provided further, That I. T. or inbound shipments of 
hides or skins or bird trophies may go forward under customs seals from 
a coast or border port of arrival, with the approval of an inspector at 
said port, to another port in the United States for consumption entry 
subject to the other provisions of this section.
    (b) They shall be moved from the coast or border port of arrival or, 
in case of I. T. or in-bound shipments, from the interior port to the 
approved establishment in cars or trucks or in vessel compartments with 
no other materials contained therein, sealed with seals of the 
Department, which shall not be broken except by inspectors or other 
persons authorized by the Deputy Administrator, Veterinary Services so 
to do, or without sealing as aforesaid and with other freight when 
packed in tight cases or casks acceptable to the inspector in charge at 
the port of entry.
    (c) They shall be handled at the approved establishment under the 
direction of an inspector in a manner approved by the Deputy 
Administrator, Veterinary Services to guard against the dissemination of 
foot-and-mouth disease, African swine fever, highly pathogenic avian 
influenza, and Newcastle disease. They shall not be removed therefrom 
except upon special permission of the Deputy Administrator, Veterinary 
Services and upon compliance with all the conditions and requirements of 
this section relative to the movement of the said hides and skins or 
bird trophies from the port of arrival to the said establishment.

(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; 74 
FR 66227, Dec. 15, 2009; 76 FR 28887, May 19, 2011; 78 FR 19085, Mar. 
29, 2013. Redesignated and amended at 78 FR 73003, 73006, Dec. 4, 2013; 
79 FR 71007, Dec. 1, 2014; 83 FR 15494, Apr. 11, 2018]



Sec.95.18  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.95.19 after 
their arrival at the port of entry: Provided, however, That no 
bloodstained wool, hair, or bristles shall be imported under any 
condition:
    (a) Such wool, hair, or bristles may be imported without other 
restriction if originating in and shipped directly from a region not 
declared by the Secretary of Agriculture to be infected with foot-and-
mouth disease.
    (b) Wool or hair clipped from live animals or pulled wool or hair 
may be imported without other restriction if the said wool or hair is 
reasonably free from animal manure in the form of dung locks or 
otherwise.
    (c) Wool, hair, or bristles taken from sheep, goats, cattle, or 
swine, when such animals have been slaughtered under national government 
inspection

[[Page 627]]

in a region \3\ 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 and foot-and-mouth disease, 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 and foot-and-mouth disease.
---------------------------------------------------------------------------

    \3\ See footnote 2 in Sec.95.16.
---------------------------------------------------------------------------

    (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; 74 FR 66226, Dec. 15, 2009. Redesignated and 
amended at 78 FR 73003, 73006, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]



Sec.95.19  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.95.18 shall be handled and 
treated in the following manner after arrival at the port of entry:
    (a) Such wool, hair, or bristles shall be consigned from the coast 
or border port of arrival to an approved establishment: Provided, 
however, That upon permission by the Deputy Administrator, Veterinary 
Services such wool, hair, or bristles may be stored for a temporary 
period in approved warehouses under bond and under the supervision of an 
inspector: And provided further, That I. T. on in-bond shipments of 
wool, hair, or bristles may go forward under customs seals from a coast 
or border port of arrival, with the approval of an inspector at said 
port, to another port for consumption entry, subject to the other 
provisions of this section.
    (b) Such wool, hair, or bristles shall be moved from the coast or 
border port of arrival or, in the case of I. T. or in-bond shipments, 
from the interior port to the establishment in cars or trucks or in 
vessel compartments with no other materials contained therein, sealed 
with seals of the Department, which shall not be broken except by 
inspectors or other persons authorized by the Deputy Administrator, 
Veterinary Services so to do, or without sealing as aforesaid and with 
other freight when packed in tight cases acceptable to an inspector.
    (c) Such wool, hair, or bristles shall be handled at the 
establishment under the direction of an inspector in a manner approved 
by the Deputy Administrator, Veterinary Services to guard against the 
dissemination of foot-and-mouth disease. Such products shall not be 
removed therefrom except upon special permission of the Deputy 
Administrator, Veterinary Services and upon compliance with all the 
conditions and requirements of this section relative to the movement of 
the said wool, hair, or bristles from the port of arrival to the said 
establishment.

(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. 
Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 
15494, Apr. 11, 2018]



Sec.95.20  Glue stock; requirements for unrestricted 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.95.21 after arrival at the port of entry:
    (a) Glue stock originating in and shipped directly from a region not 
declared by the Secretary of Agriculture to be infected with foot-and-
mouth disease may be imported without other restriction.

[[Page 628]]

    (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 \4\ 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 
and foot-and-mouth disease, 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 and foot-and-mouth 
disease.
---------------------------------------------------------------------------

    \4\ See footnote 2 in Sec.95.16.

(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; 74 FR 66226, Dec. 15, 2009. Redesignated and 
amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]



Sec.95.21  Glue stock; importations permitted subject to restrictions.

    Glue stock offered for importation which does not meet the 
conditions or requirements of Sec.95.20 shall be handled and treated 
in the following manner after arrival at the port of entry:
    (a) It shall be consigned from the coast or border port of arrival 
to an approved establishment and shall be subject to disinfection by 
such method or methods as the Deputy Administrator, Veterinary Services 
may prescribe unless the said establishment discharges drainage into an 
approved sewerage system or has an approved chlorinating equipment 
adequate for the proper disinfection of effluents: Provided, however, 
That upon permission by the Deputy Administrator, Veterinary Services 
glue stock may be stored for a temporary period in approved warehouses 
under bond and under the supervision of an inspector: And provided 
further, That I. T. or in-bond shipments of glue stock may go forward 
under customs seals from a coast or border port of arrival with the 
approval of an inspector at said port to another port for consumption 
entry, subject, after arrival at the latter port, to the other 
provisions of this section.
    (b) It shall be moved from the coast or border port of arrival or, 
in case of I. T. or in-bond shipments, from the interior port to the 
establishment in cars or trucks or in vessel compartments with no other 
materials contained therein, sealed with seals of the Department, which 
shall not be broken except by inspectors or other persons authorized by 
the Deputy Administrator, Veterinary Services so to do, or without 
sealing as aforesaid and with other freight when packed in tight cases 
or casks acceptable to an inspector at port of entry.
    (c) It shall be handled at the establishment under the direction of 
an inspector in a manner approved by the Deputy Administrator, 
Veterinary Services to guard against the dissemination of foot-and-mouth 
disease. It shall not be removed therefrom except upon special 
permission of the Deputy Administrator, Veterinary Services and upon 
compliance with all the conditions and requirements of this section 
relative to the movement of the said glue stock from the port of arrival 
to the said establishment.

(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. 
Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 
15494, Apr. 11, 2018]



Sec.95.22  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

[[Page 629]]

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. Redesignated at 78 FR 73003, Dec. 4, 2013]



Sec.95.23  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.95.22 shall be handled and 
treated in the following manner after arrival at the port of entry:
    (a) They shall be consigned from the coast or border port of arrival 
to an approved establishment having facilities for their disinfection or 
their conversion into products customarily made from bones, horns, or 
hoofs: Provided, however, That I. T. or in-bond shipments of bones, 
horns, or hoofs may go forward under customs seals from a coast or 
border port of arrival, with the approval of an inspector at said port, 
to another port for consumption entry subject to the other provisions of 
this section.
    (b) They shall be moved from the coast or border port of arrival or, 
in case of I. T. or in-bond shipments, from the interior port to the 
establishment in cars or trucks with no other materials contained 
therein, sealed with seals of the Department, which shall not be broken 
except by inspectors or other persons authorized by the Deputy 
Administrator, Veterinary Services so to do, or without sealing as 
aforesaid and with other freight when packed in tight cases or casks 
acceptable to an inspector at the port of entry.
    (c) They shall be handled at the establishment under the direction 
of an inspector in a manner to guard against the dissemination of 
anthrax, foot-and-mouth disease, highly pathogenic avian influenza, and 
Newcastle disease, and the bags, burlap, or other containers thereof, 
before leaving the establishment, shall be disinfected by heat or 
otherwise, as directed by the Deputy Administrator, Veterinary Services 
or burned at the establishment. They shall not be removed therefrom 
except upon special permission of the Deputy Administrator, Veterinary 
Services and upon compliance with all the conditions and requirements of 
this section relative to the movement of the said bones, horns, and 
hoofs.

(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. 
Redesignated at 78 FR 73003, 73007, Dec. 4, 2013; 79 FR 71007, Dec. 1, 
2014; 83 FR 15494, Apr. 11, 2018]



Sec.95.24  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.

[28 FR 5981, June 13, 1963. Redesignated at 78 FR 73003, Dec. 4, 2013]

[[Page 630]]



Sec.95.25  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.95.27, unless:
    (a) Such products originated in and were shipped directly from a 
region not declared by the Secretary of Agriculture to be infected with 
foot-and-mouth disease; or
    (b) The inspector at the port of entry finds that such products have 
been fully processed by tanking under live steam or by dry rendering.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997. 
Redesignated at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 15494, Apr. 11, 
2018]



Sec.95.26  Blood meal, blood albumin, intestines, and other animal 
byproducts for industrial use; requirements for unrestricted 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.95.27, 
unless such products originated in and were shipped directly from a 
region not declared by the Secretary of Agriculture to be infected with 
foot-and-mouth disease.

(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; 62 
FR 56024, Oct. 28, 1997. Redesignated and amended at 78 FR 73003, 73007, 
Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]



Sec.95.27  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.95.26 shall be handled and treated 
in the following manner after arrival at the port of entry.
    (a) They shall be consigned from the coast or border port of arrival 
to an approved establishment: Provided, however, That upon permission by 
the Deputy Administrator, Veterinary Services they may be stored for a 
temporary period in approved warehouses under bond and under the 
supervision of an inspector: And provided further, That I. T. or in-bond 
shipments of such products may go forward under customs seals from a 
coast or border port of arrival, with the approval of an inspector at 
said port, to another port of consumption entry, subject after arrival 
at the latter port to the other provisions of this section.
    (b) They shall be moved from the coast or border port of arrival or, 
in the case of I. T. or in-bond shipments, from the interior port to the 
establishment in cars or trucks or in vessel compartments with no other 
materials contained therein, sealed with seals of the Department, which 
shall not be broken except by Veterinary Services inspectors or other 
persons authorized by the Deputy Administrator, Veterinary Services so 
to do, or without sealing as aforesaid and with other freight when 
packed in tight cases or casks acceptable to an inspector at the port of 
entry.
    (c) They shall be handled at the establishment under the direction 
of an inspector in a manner to guard against the dissemination of foot-
and-mouth disease. They shall not be removed therefrom except upon 
special permission of the Deputy Administrator, Veterinary Services and 
upon compliance with all the conditions and requirements of this section 
relative to the movement of the said products from the port of arrival 
to the said establishment.

(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. 
Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 
15494, Apr. 11, 2018]



Sec.95.28  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

[[Page 631]]

swine, intended for use in the manufacture of pharmaceutical products 
shall not be imported except subject to handling and treatment in 
accordance with Sec.95.29, unless such glands, organs, or materials 
originated in and were shipped directly from a region not declared by 
the Secretary of Agriculture to be infected with foot-and-mouth disease.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997. 
Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 
15494, Apr. 11, 2018]



Sec.95.29  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.95.28 may be imported for pharmaceutical 
purposes if in tight containers and consigned to an approved 
establishment: Provided, however, That upon special permission of the 
Deputy Administrator, Veterinary Services they may be stored for a 
temporary period in approved warehouses under bond and under the 
supervision of an inspector. They shall be handled and processed at the 
said establishment in a manner approved by the Deputy Administrator, 
Veterinary Services and the containers shall be destroyed or disinfected 
as prescribed by him. They shall not be removed therefrom except upon 
special permission of the Deputy Administrator, Veterinary Services and 
upon compliance with all the conditions and requirements of this section 
relative to the movement of the said glands, organs, ox gall, and like 
materials from the port of arrival to the said establishment.

(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. 
Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013]



Sec.95.30  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 at 59 FR 67134, Dec. 29, 1994. 
Redesignated at 78 FR 73003, Dec. 4, 2013]



Sec.95.31  Animal manure.

    Manure of horses, cattle, sheep, other ruminants, and swine shall 
not be imported except upon permission from the Deputy Administrator, 
Veterinary Services. Importations permitted shall be subject to such 
restrictions as he may deem necessary in each instance: Provided, 
however, That manure produced by animals while in transit to the United 
States shall be subject only to the requirements of the Department 
regulations governing the importation of domestic livestock and other 
animals.

(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. 
Redesignated at 78 FR 73003, Dec. 4, 2013]



Sec.95.32  Hay and straw; requirements for unrestricted entry.

    Except as provided in Sec.95.39, hay or straw shall not be 
imported except subject to handling and treatment in accordance with 
Sec.95.33 after arrival at the port of entry, unless such hay or straw 
originated in and was shipped directly from a region not declared by the 
Secretary of Agriculture to be infected with foot-and-mouth disease.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997. 
Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 
15494, Apr. 11, 2018]



Sec.95.33  Hay and straw; importations permitted subject to 
restrictions.

    Except as provided in Sec.95.39, hay or straw which does not meet 
the conditions or requirements of Sec.95.32 shall be handled and 
treated in the following manner upon arrival at the port of entry:

[[Page 632]]

    (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.

[28 FR 5981, June 13, 1963. Redesignated and amended at 78 FR 73003, 
73007, Dec. 4, 2013]



Sec.95.34  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 foot-and-mouth disease exists, shall not be imported 
except under the following conditions:
    (a) The cloth or burlap shall be consigned from the coast or border 
port of arrival to an establishment specifically approved for the 
purpose by the Deputy Administrator, Veterinary Services.
    (b) The cloth or burlap shall be immediately moved from the coast or 
border port of arrival, or in case of I. T. or in-bond shipments from 
the interior port, to the establishment, in railroad cars or trucks, or 
in vessel compartments, with no other material contained therein, sealed 
with seals of the Department, which shall not be broken except by 
inspectors or other persons authorized by the Deputy Administrator, 
Veterinary Services: Provided, however, That upon permission of the 
Deputy Administrator, Veterinary Services, such cloth or burlap may be 
stored for a temporary period in approved warehouses at the port of 
arrival under bond and under the supervision of an inspector.
    (c) The material shall be disinfected and otherwise handled at the 
establishment under the direction of an inspector in a manner approved 
by the Deputy Administrator, Veterinary Services to guard against the 
dissemination of foot-and-mouth disease, and the material shall not be 
removed therefrom, except upon special permission of the Deputy 
Administrator, Veterinary Services, until all of the conditions and 
requirements of this section have been complied with.

(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; 62 
FR 56024, Oct. 28, 1997. Redesignated at 78 FR 73003, Dec. 4, 2013; 83 
FR 15494, Apr. 11, 2018]



Sec.95.35  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.

[28 FR 5981, June 13, 1963. Redesignated at 78 FR 73003, Dec. 4, 2013]



Sec.95.36  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

[[Page 633]]

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.95.37.
    (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.95.37, and the said carrier shall 
immediately report the matter, by telegraph, to the Deputy 
Administrator, Veterinary Services, Washington, DC 20251. Such report 
shall include the following information: Nature of emergency; place 
where product or material was unloaded; original points of shipment and 
destination; number and materials of the original car or truck; and 
number and initials of the car, truck or other vehicle into which the 
product or material is reloaded in case the original car or truck is not 
used.

(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. 
Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013]



Sec.95.37  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 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

[[Page 634]]

other parts of the boat with a permitted disinfectant approved for use 
in this part.
    (3) Buildings, sheds, and premises required by this part to be 
disinfected shall be treated in the following manner: Collect all litter 
and other refuse therefrom and destroy the same by burning or other 
approved methods, and saturate the entire surface of the fencing, 
chutes, floors, walls, and other parts with a permitted disinfectant 
approved for use in this part.
    (c) Permitted disinfectants. The disinfectants permitted for use in 
disinfecting railroad cars, trucks, boats, aircraft and other means of 
conveyance, equipment or containers, yards, and premises against 
infection of foot-and-mouth disease are freshly prepared solutions of:
    (1) Sodium carbonate (4 percent) in the proportion of 1 pound to 3 
gallons of water.
    (2) Sodium carbonate (4 percent) plus sodium silicate (0.1 percent) 
in the proportion of 1 pound of sodium carbonate plus sodium silicate to 
3 gallons of water.
    (3) Sodium hydroxide (Lye) prepared in a fresh solution in the 
proportion of not less than 1 pound avoirdupois of sodium hydroxide of 
not less than 95 percent purity to 6 gallons of water, or one 13\1/2\-
ounce can to 5 gallons of water. \5\
---------------------------------------------------------------------------

    \5\ 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 foot-and-mouth disease and 
tick infestation; or other disinfectants or treatments approved by the 
Deputy Administrator, Veterinary Services.

[28 FR 5981, June 13, 1963, as amended at 32 FR 19157, Dec. 20, 1967; 74 
FR 66226, Dec. 15, 2009. Redesignated at 78 FR 73003, Dec. 4, 2013; 83 
FR 15494, Apr. 11, 2018]



Sec.95.38  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.

[28 FR 5981, June 13, 1963. Redesignated at 78 FR 73003, Dec. 4, 2013]



Sec.95.39  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 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).

[28 FR 5981, June 13, 1963. Redesignated at 78 FR 73003, Dec. 4, 2013]



Sec.95.40  Certification for certain materials.

    (a) In addition to meeting any other certification or permit 
requirements of this chapter, the following articles, if derived from 
ovines or caprines, may be imported into the United States from any 
region not listed in Sec.95.4(a)(4) 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;
    (2) Glands and unprocessed fat tissue;
    (3) Processed fats and oils, and derivatives of processed animal 
protein, tankage, and offal;

[[Page 635]]

    (4) Derivatives of glands; 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.95.4(a)(4), with the regions listed 
in Sec.95.4(a)(4) specifically named;
    (4) That the material did not originate in, and was never stored, 
rendered, or processed in, or otherwise associated with, a facility in a 
region listed in Sec.95.4(a)(4); 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.95.4(a)(4).
    (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 
0579-0234)

[78 FR 73007, Dec. 4, 2013]



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 cattle, sheep, swine, or goats that are used to encase processed 
meats in foods such as sausage.
    APHIS representative. An individual employed by APHIS who is 
authorized to perform the function involved.
    Authorized inspector. Any individual authorized by the Administrator 
of APHIS or the Commissioner of Customs and Border Protection, 
Department of Homeland Security, to enforce the regulations in this 
subpart.
    Department. The United States Department of Agriculture.
    Food and Drug Administration. The Food and Drug Administration of 
the United States Department of Health and Human Services.
    Food Safety and Inspection Service. The Food Safety and Inspection 
Service of the United States Department of Agriculture.
    Import (imported, importation) into the United States. To bring into 
the territorial limits of the United States.
    Region. Any defined geographic land area identifiable by geological, 
political, or surveyed boundaries. A region may consist of any of the 
following:
    (1) A national entity (country);

[[Page 636]]

    (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; 70 FR 553, Jan. 4, 
2005; 72 FR 53379, Sept. 18, 2007]



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 under Sec.94.8(a) of this subchapter, is prohibited, with the 
following exception: Swine casings that are processed in a region where 
African swine fever exists may be imported into the United States under 
the following conditions:
    (1) Origin of casings. The swine casings were derived from swine 
raised and slaughtered in a region not listed under 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 under Sec.
94.8(a) of this subchapter in a closed container sealed with serially 
numbered seals applied by an official of the national government of the 
region of origin.
    (3) Origin certificate. The casings were accompanied from the region 
of origin to the processing establishment by a certificate written in 
English and signed by an official of the national government of the 
region of origin specifying the region of origin, the processing 
establishment to which the swine casings were consigned, and the numbers 
of the seals applied.
    (4) Integrity of seals. The casings were taken out of the container 
at the processing establishment only after an official of the national 
government of the region where the processing establishment is located 
determined that the seals were intact and free of any evidence of 
tampering and had so stated on the certificate referred to in paragraph 
(a)(3) of this section.
    (5) The processing establishment. The casings were processed at a 
single processing establishment \1\ in a region listed under Sec.
94.8(a) 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 under Sec.94.8(a) 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 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).

[[Page 637]]

    (8) Compliance agreement cancellation. Any compliance agreement may 
be canceled orally or in writing by the inspector who is supervising its 
enforcement whenever the authorized inspector finds that such person has 
failed to comply with the provisions of this section or any conditions 
imposed by this section. If the cancellation is oral, the decision and 
the reasons will be confirmed in writing, as promptly as circumstances 
allow. Any person whose compliance agreement has been canceled may 
appeal the decision to the Administrator, in writing, within 10 days 
after receiving written notification of the cancellation. The appeal 
should state all of the facts and reasons upon which the person relies 
to show that the compliance agreement was wrongfully canceled. The 
Administrator will grant or deny the appeal, in writing, stating the 
reasons for such decision, as promptly as circumstances allow. If there 
is a conflict as to any material fact, a hearing will be held to resolve 
such conflict. Rules of Practice governing such a hearing will be 
adopted by the Administrator.
    (9) Export certification. The casings are accompanied to the United 
States by an original certificate stating that all of the requirements 
of this section have been met. The certificate must be written in 
English. The certificate must be issued by an official of the national 
government of the region in which the processing establishment is 
located. The official must be authorized to issue the foreign meat 
inspection certificate required by part 327 in chapter III of this 
title. Upon arrival of the swine casings in the United States, the 
certificate must be presented to an authorized inspector at the port of 
arrival.
    (b) Casings from ovines or caprines. The importation of casings, 
except stomachs, derived from ovines or caprines that originated in or 
were processed in any region listed in Sec.95.4(a)(4) are prohibited, 
unless the following conditions are met:
    (1) The casings are derived from sheep that were slaughtered in 
Canada at less than 12 months of age and that were from a flock subject 
to a ruminant feed ban equivalent to the requirements established by the 
U.S. Food and Drug Administration at 21 CFR 589.2000; and
    (2) The casings are accompanied by an original certificate that 
meets the requirements of Sec.96.3 and:
    (i) States that the casings meet the conditions of this section;
    (ii) Is written in English;
    (iii) Is signed by an individual eligible to issue the certificate 
required under Sec.96.3; and
    (iv) Is presented to an authorized inspector at the port of entry.
    (c) Casings from bovines. The importation of casings derived from 
bovines is prohibited, unless the following conditions are met:
    (1) If the casings are derived from bovines from a region of 
negligible risk for BSE, as defined in Sec.92.1 of this subchapter, 
the certificate required under Sec.96.3 indicates the APHIS BSE risk 
classification of the region in which the bovines were slaughtered and 
the casings were collected.
    (2) If the casings are derived from bovines from a region of 
controlled risk for BSE or a region of undetermined risk for BSE, as 
defined in Sec.92.1 of this subchapter, the casings are not derived 
from the small intestine or, if the casings are derived from the small 
intestine, the casings are derived from that part of the small intestine 
that is eligible for use as human food in accordance with the 
requirements established by the Food Safety and Inspection Service at 9 
CFR 310.22 and the Food and Drug Administration at 21 CFR 189.5.
    (3) The casings are accompanied by an original certificate that 
meets the requirements of Sec.96.3 and paragraphs (b)(2)(i) through 
(b)(3)(iv) of this section.

(Approved by the Office of Management and Budget under control number 
0579-0015)

[65 FR 1307, Jan. 10, 2000, as amended at 70 FR 553, Jan. 4, 2005; 72 FR 
53379, Sept. 18, 2007; 77 FR 1395, Jan. 10, 2012; 78 FR 73007, Dec. 4, 
2013]



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

[[Page 638]]

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) ____

    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:_________________________________________________________
    (d) In addition to meeting the requirements of this section, the 
certificate accompanying sheep casings from Canada must state that the 
casings meet the requirements of Sec.96.2(b) and the certificate 
accompanying bovine casings must state that the casings meet the 
requirements of either Sec.96.2(c)(1) or (c)(2) as applicable.

(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; 70 
FR 553, Jan. 4, 2005; 72 FR 53379, Sept. 18, 2007; 78 FR 73008, Dec. 4, 
2013]



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

[[Page 639]]

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]



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]

[[Page 640]]



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 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

[[Page 641]]

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]



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 resistant coating.
    (c) Not more than 175 pounds casings shall be treated with each 100 
gallons of the solution. After the treatment of 175 pounds of casings, 
or at the end of the day if less than 175 pounds of casings are 
disinfected in any one day, the solution shall be discarded unless means 
are provided for accurately determining the loss of strength. In event 
means for accurately determining loss of strength are provided it will 
be permissible to restore the strength of the solution with fresh acid 
and use it repeatedly.
    (d) Shake as much of the adherent salt as possible from the casings 
and weigh them. Bundles must be separated but individual hanks need not 
be untied. Place the casings in the disinfecting solution a few hanks at 
a time with vigorous agitation to insure the fullest possible contact of 
the solution with them. Then keep the casings completely submerged in 
the solution for not less than three-fourths of an hour.
    (e) Remove the casings from the solution, rinse them with water, and 
place them in a solution containing 8\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]

[[Page 642]]



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 unsatisfactory results. After removing the 
casings from the testing vat, it will be found advantageous to submerge 
them in another vat containing cold brine solution or cold water in 
order to remove the extra heat from the casings as promptly as possible, 
but of course this is optional with the importer. In order to obtain the 
most satisfactory results, the hanks, rings, and similar units must be 
separated as much as possible without untying, but ``dolls'' will not be 
permitted to be disinfected by this heating method. In order to keep the 
temperature of the brine in the testing vat of a uniform degree, it is 
necessary to agitate the solution occasionally by moving the casings. 
The tip of the recording thermometer should be located at a point which 
would be approximately at the bottom of the volume of casings being 
disinfected.

[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 or U.S. Customs and Border Protection on a Sunday or holiday, or 
at any other time outside the regular tour of duty of the employee, 
shall sufficiently in advance of the period of Sunday, holiday, or 
overtime service request the Animal and Plant Health Inspection Service 
or U.S. Customs and Border Protection inspector in charge to furnish the 
service and shall pay the Government at the rate listed in the following 
table, except as provided in paragraphs (a)(1), (a)(2), (a)(3), and 
(a)(4) of this section:

  Overtime for Inspection, Laboratory Testing, Certification, or Quarantine of Plant, Plant Products, Animals,
                                 Animal Products or Other Regulated Commodities
----------------------------------------------------------------------------------------------------------------
                                                                        Overtime rates (per hour)
                                                        --------------------------------------------------------
       Outside the employee's normal tour of duty          Nov. 2, 2015-      Oct. 1, 2016-
                                                           Sept. 30, 2016     Sept. 30, 2017    Beginning  Oct.
                                                                                                    1, 2017
----------------------------------------------------------------------------------------------------------------
Monday through Saturday and holidays...................                $75                $75                $75
Sundays................................................                 99                 99                100
----------------------------------------------------------------------------------------------------------------


[[Page 643]]

    (1) For any services performed on a Sunday or holiday, or at any 
time after 5 p.m. or before 8 a.m. on a weekday, in connection with the 
arrival in or departure from the United States of a private aircraft or 
private vessel, the total amount payable shall not exceed $25 for all 
inspection services performed by the U.S. Customs and Border Protection 
, Public Health Service, and the Department of Agriculture;
    (2) Owners and operators of aircraft will be provided service 
without reimbursement during regularly established hours of service on a 
Sunday or holiday; and
    (3) The overtime rate to be charged owners or operators of aircraft 
at airports of entry or other places of inspection as a consequence of 
the operation of the aircraft, for work performed outside of the 
regularly established hours of service is listed in the following table:

                             Overtime for Commercial Airline Inspection Services \1\
----------------------------------------------------------------------------------------------------------------
                                                                        Overtime rates (per hour)
                                                        --------------------------------------------------------
       Outside the employee's normal tour of duty          Nov. 2, 2015-      Oct. 1, 2016-
                                                           Sept. 30, 2016     Sept. 30, 2017    Beginning  Oct.
                                                                                                    1, 2017
----------------------------------------------------------------------------------------------------------------
Monday through Saturday and holidays...................                $64                $65                $65
Sundays................................................                 85                 86                 86
----------------------------------------------------------------------------------------------------------------
\1\ These charges exclude administrative overhead costs.

    (4) The overtime rate and all other charges, including minimum and 
commute compensation charges, to be billed for services provided by an 
employee of U.S. Customs and Border Protection shall be charged 
according to the provisions of this section, 5 CFR part 551, or 19 CFR 
24.16.
    (b) A minimum charge of 2 hours shall be made for any Sunday or 
holiday or unscheduled overtime duty performed by an employee on a day 
when no work was scheduled for him or her, or which is performed by an 
employee on his or her regular workday beginning either at least 1 hour 
before his or her scheduled tour of duty or which is not in direct 
continuation of the employee's regular tour of duty. In addition, each 
such period of Sunday or holiday or unscheduled overtime work to which 
the 2-hour minimum charge applies may include a commuted traveltime 
period (CTT) the amount of which shall be prescribed in administrative 
instructions to be issued by the Administrator, Animal and Plant Health 
Inspection Service or U.S. Customs and Border Protection for the areas 
in which the Sunday or holiday or overtime work is performed and such 
period shall be established as nearly as may be practicable to cover the 
time necessarily spent in reporting to and returning from the place at 
which the employee performs such Sunday, holiday or overtime duty. With 
respect to places of duty within the metropolitan area of the employee's 
headquarters, such CTT period shall not exceed 3 hours. It shall be 
administratively determined from time to time which days constitute 
holidays. The circumstances under which such CTT periods shall be 
charged and the percentage applicable in each circumstance are as 
reflected in the following table:

------------------------------------------------------------------------
                                 Actual time
                                \1\ charge--     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.

[[Page 644]]

 
    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 transport persons or property for compensation or hire, or (ii) 
in fishing operations or in processing of fish or fish products.
    (d)(1) Any principal, or any person, firm, partnership, corporation, 
or other legal entity acting as an agent or broker by requesting Sunday, 
holiday, or overtime services of an Animal and Plant Health Inspection 
Service or U.S. Customs and Border Protection inspector on behalf of any 
other person, firm, partnership, corporation, or other legal entity 
(principal), and who has not previously requested such service from an 
Animal and Plant Health Inspection Service inspector, must pay the 
inspector before service is provided.
    (2) Since the payment must be collected before service can be 
provided, the Animal and Plant Health Inspection Service or U.S. Customs 
and Border Protection inspector will estimate the amount to be paid. Any 
difference between the inspector's estimate and the actual amount owed 
to the Animal and Plant Health Inspection Service will be resolved as 
soon as reasonably possible following the delivery of service, with the 
Animal and Plant Health Inspection Service or U.S. Customs and Border 
Protection either returning the difference to the agent, broker, or 
principal, or billing the agent, broker, or principal for the 
difference.
    (3) The prepayment must be in some guaranteed form, such as money 
order, certified check, or cash. Prepayment in guaranteed form will 
continue until the Animal and Plant Health Inspection Service or U.S. 
Customs and Border Protection determines that the agent, broker, or 
principal has established an acceptable credit history.
    (4) For security reasons, cash payments will be accepted only from 7 
a.m. to 5 p.m., and only at a location designated by the Animal and 
Plant Health Inspection Service inspector or U.S. Customs and Border 
Protection.
    (e)(1) Any principal, or any person, firm, partnership, corporation, 
or other legal entity requesting Sunday, holiday, or overtime services 
of an Animal and Plant Health Inspection Service inspector, and who has 
a debt to the Animal and Plant Health Inspection Service or U.S. Customs 
and Border Protection more than 60 days delinquent, must pay the 
inspector before service is provided.
    (2) Since the payment must be collected before service can be 
provided, the Animal and Plant Health Inspection Service or U.S. Customs 
and Border Protection inspector will estimate the amount to be paid. Any 
difference between the inspector's estimate and the actual amount owed 
to the Animal and Plant Health Inspection Service or U.S. Customs and 
Border Protection will be resolved as soon as reasonably possible 
following the delivery of service, with the Animal and Plant Health 
Inspection Service or U.S. Customs and Border Protection either 
returning the difference to the agent, broker, or principal, or billing 
the agent, broker, or principal for the difference.

[[Page 645]]

    (3) The prepayment must be in some guaranteed form, such as money 
order, certified check, or cash. Prepayment in guaranteed form will 
continue until the debtor pays the delinquent debt.
    (4) For security reasons, cash payments will be accepted only from 7 
a.m. to 5 p.m., and only at a location designated by the Animal and 
Plant Health Inspection Service or U.S. Customs and Border Protection 
inspector.
    (f) Reimbursable Sunday, holiday, or overtime services will be 
denied to any principal, or any person, firm, partnership, corporation, 
or other legal entity who has a debt to the Animal and Plant Health 
Inspection Service or U.S. Customs and Border Protection more than 90 
days delinquent. Services will be denied until the delinquent debt is 
paid.

[38 FR 28814, Oct. 17, 1973]

    Editorial Note: For Federal Register citations affecting Sec.97.1, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.govinfo.gov.



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
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

[[Page 646]]

 
   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
   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\
   Do...........................  Eagle Pass, TX....  ........         3
   Do...........................  Laredo, TX........  ........         6
   Do...........................  Pleasanton, TX....  ........         6
  Juarez........................  El Paso, TX.......  ........         1
  Nuevo Laredo..................  Del Rio, TX.......  ........         4
   Do...........................  Eagle Pass, TX....  ........         5

[[Page 647]]

 
   Do...........................  Laredo, TX........  ........    1\1/2\
   Do...........................  Pharr, TX.........  ........         6
   Do...........................  Pleasanton, TX....  ........         5
  Ojinaga.......................  El Paso, TX.......  ........         6
   Do...........................  Presidio, TX......  ........         1
  Piedras Negras................  Eagle Pass, TX....  ........         1
   Do...........................  Laredo, TX........  ........         5
   Do...........................  Pharr, TX.........  ........        10
   Do...........................  Pleasanton, TX....  ........         5
  Reynosa (Pharr International    Eagle Pass, TX....  ........        12
   Bridge).
   Do...........................  Hidalgo, TX.......  ........         1
   Do...........................  Laredo, TX........  ........         5
   Do...........................  Mission, TX.......  ........         1
   Do...........................  Pharr, TX.........  ........         1
  San Jeronimo..................  El Paso, TX.......  ........         2
   Do...........................  Presidio, TX......  ........         6
   Do...........................  Santa Theresa, NM.  ........         1
Michigan:
  Detroit.......................  ..................         3
   Do...........................  Beaverton.........  ........         6
   Do...........................  Chelsea...........  ........         3
   Do...........................  Clara.............  ........         6
   Do...........................  Kalamazoo.........  ........         5
   Do...........................  Lansing...........  ........         4
   Do...........................  Port Huran........  ........         4
  Port Huron....................  ..................         1
   Do...........................  Beaverton.........  ........         6
   Do...........................  Chelsea...........  ........         6
   Do...........................  Clara.............  ........         6
   Do...........................  Detroit...........  ........         3
   Do...........................  Lansing...........  ........         5
   Do...........................  Kalamazoo.........  ........         6
Minnesota:
  Minneapolis/St. Paul            ..................         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
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

[[Page 648]]

 
   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               Decatur...........  ........         2
   International Airport.
  Do............................  Ft. Worth or               2
                                   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).
  Do............................  Bellville, TX.....  ........         4
  Do............................  Bryan, TX.........  ........         4
  Do............................  Georgetown, TX....  ........         8
  Do............................  Pleasanton, TX....  ........         8
  Laredo........................  ..................         1
   Do...........................  Brownsville or San  ........         6
                                   Antonio.
   Do...........................  Eagle Pass........  ........         5
   Do...........................  McAllen, Edinburg   ........         6
                                   or Mission.
  Presidio......................  ..................         1
   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 at www.govinfo.gov.

[[Page 649]]



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 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 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.
98.37 [Reserved]
98.38 Restrictions on the importation of swine semen from the APHIS-
          defined European CSF region.

    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 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

[[Page 650]]

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 be imported into the United States unless it is from a region listed 
under Sec.94.1(a) of this chapter as being free of foot-and-mouth 
disease, and:
    (a) The embryo is exported to the United States from the region in 
which it was conceived;
    (b) The embryo was conceived as a result of artificial insemination 
with semen collected from a donor sire at an approved artificial 
insemination center, or the embryo as conceived as a result of natural 
breeding by a donor sire at an approved embryo transfer unit;
    (c) If artificially inseminated, the donor dam conceived the embryo 
after being inseminated in an approved embryo transfer unit with semen 
collected at an approved artificial insemination center;
    (d) At the time of collection of the semen used to conceive the 
embryo or at the time of natural breeding, the donor sire met all 
requirements the donor sire would have to meet under part 93 of this 
chapter for a health certificate required as a condition of importation 
into the United States;
    (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

[[Page 651]]

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; 77 FR 1396, Jan. 10, 2012; 83 FR 15494, Apr. 11, 2018]



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 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

[[Page 652]]

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
    (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]

[[Page 653]]



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 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;

[[Page 654]]

    (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 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.
    Camelid. All species of the family Camelidae, including camels, 
guanacos, llamas, alpacas, and vicunas.
    Cervid. All members of the family Cervidae and hybrids, including 
deer, elk, moose, caribou, reindeer, and related species.
    Collection of embryos. Embryos removed from a single donor dam in 
one operation.
    Embryo. The initial stages of development of an animal, after 
collection from the natural mother and while it is capable of being 
transferred to a recipient dam, but not after it has been transferred to 
a recipient dam.
    Embryo collection unit. Area or areas where the donor dam will be 
bred to produce embryos for importation into the United States, and 
where the embryos will be collected, processed, and stored pending 
shipment to the United States.
    Foreign Animal Disease Diagnostic Laboratory. The Foreign Animal 
Disease Diagnostic Laboratory of the Animal and Plant Health Inspection 
Service.
    Herd of origin. The herd in which the donor dam is kept during the 
60 days before the donor dam is required to be housed in an embryo 
collection unit, in accordance with 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.);

[[Page 655]]

    (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; 78 FR 73008, Dec. 4, 2013]



Sec.98.12  General prohibitions.

    (a) Ruminant and swine embryos may not be imported from regions 
where foot-and-mouth disease exists except in accordance with this 
subpart.
    (b) Ruminant and swine embryos may not be imported into the United 
States from any region other than the region in which they were 
conceived and collected.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 
FR 56025, Oct. 28, 1997; 83 FR 15494, Apr. 11, 2018]



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 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;
    (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; 83 FR 15494, Apr. 
11, 2018]



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 veterinarian who collected the 
embryos;
    (3) The date of embryo collection;
    (4) The identification and breed of the donor dam and donor sire;
    (5) The number of ampules or straws covered by the health 
certificate and the identification number or code on each ampule or 
straw;
    (6) The dates, types, and results of all examinations and tests 
performed on

[[Page 656]]

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 foot-
and-mouth disease exists only if all of the following conditions are 
met:
    (a) The donor dam is determined to be free of communicable diseases 
based on tests, examinations, and other requirements, as follows, except 
that, with regard to bovine spongiform encephalopathy, the following 
does not apply to bovines, cervids, or camelids.
    (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 
pleuropneumonia, foot-and-mouth disease, Rift Valley fever, or vesicular 
stomatitis; or
    (ii) Swine: African swine fever, foot-and-mouth disease, classical 
swine fever, pseudorabies, swine vesicular disease, or vesicular 
stomatitis.
    (2) During the year before embryo collection, no case of the 
following diseases occurred within 5 kilometers of the embryo collection 
unit or in any herd in which the donor dam was present:
    (i) Ruminant: Bovine spongiform encephalopathy, contagious bovine 
pleuropneumonia, foot-and-mouth disease, Rift Valley fever, or vesicular 
stomatitis; or
    (ii) Swine: African swine fever, foot-and-mouth disease, classical 
swine fever, pseudorabies, swine vesicular disease, or vesicular 
stomatitis.
    (3) During the 60 days before embryo collection, the donor dam did 
not receive a vaccination for foot-and-mouth disease.
    (4) During the 60 days before the donor dam was required to be in 
the embryo collection unit, in accordance with 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:

[[Page 657]]

    (A) Ruminant: Contagious bovine pleuropneumonia, Rift Valley fever, 
or vesicular stomatitis; or
    (B) Swine: African swine fever, classical swine fever, pseudorabies, 
swine vesicular disease, or vesicular stomatitis.
    (iii) If the donor dam was in any herd during the year before embryo 
collection that was not certified free of brucellosis by the national 
government of the region of origin, the donor dam was determined to be 
free of brucellosis based on tests of the serum samples.
    (iv) The only official test results will be those provided by the 
Foreign Animal Disease Diagnostic Laboratory.
    (6) If the donor dam was in any herd during the year before embryo 
collection that was not certified free of tuberculosis by the national 
government of the region of origin, the donor dam was determined to be 
free of tuberculosis by an official veterinarian based on an intradermal 
tuberculin test. The test must have been administered to the donor dam 
by an official veterinarian not less than 30 days nor more than 120 days 
after embryo collection, and not less than 60 days after any previously 
administered intradermal test for tuberculosis.
    (7)(i) Not less than 30 days nor more than 120 days after embryo 
collection, the donor dam was examined by an official veterinarian and 
found free of clinical evidence of the following diseases:
    (A) Ruminant: Bovine spongiform encephalopathy, brucellosis, 
contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley 
fever, tuberculosis, and vesicular stomatitis; or
    (B) Swine: African swine fever, brucellosis, foot-and-mouth disease, 
classical swine fever, pseudorabies, swine vesicular disease, 
tuberculosis, and vesicular stomatitis.
    (ii) All signs of any other communicable disease must be listed on 
the health certificate that accompanies the embryos to the United 
States.
    (8)(i) Between the time the embryos were collected and all 
examinations and tests required by this subpart were completed, no 
animals in the embryo collection unit with the donor dam, or in the 
donor dam's herd of origin, exhibited any clinical evidence of:
    (A) Ruminant: Bovine spongiform encephalopathy, brucellosis, 
contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley 
fever, tuberculosis, and vesicular stomatitis; or
    (B) Swine: African swine fever, brucellosis, foot-and-mouth disease, 
classical swine fever, pseudorabies, swine vesicular disease, 
tuberculosis, and vesicular stomatitis.
    (ii) All signs of any other communicable disease must be listed on 
the health certificate that accompanies the embryos to the United 
States.
    (b) The donor dam or donor sire is determined to be free of 
communicable diseases based on other testing or certifications if 
required by the Administrator. The Administrator may require additional 
testing or certifications if he or she determines that they are 
necessary to determine either the donor dam's or the donor sire's 
freedom from communicable diseases. Circumstances that may result in 
additional testing or certifications include, but are not limited to:
    (1) The existence of communicable diseases of livestock, other than 
those diseases specifically listed, in the region of origin;
    (2) A high prevalence or an increase in the incidence of a 
communicable disease in the region of origin;
    (3) The use of natural breeding, rather than artificial insemination 
to conceive the embryos;
    (4) The use of fresh, rather than frozen semen, for artificial 
insemination; and
    (5) The use of semen collected at a site other than an artificial 
insemination center approved by the national government of the region of 
origin.
    (c) Embryos produced by any donor dam or sire that dies before being 
examined and tested as required under this subpart will not be eligible 
for importation into the United States.

[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; 78 FR 73008, Dec. 4, 
2013; 83 FR 15494, Apr. 11, 2018]

[[Page 658]]



Sec.98.16  The embryo collection unit.

    Ruminant and swine embryos may be imported into the United States 
from a region where foot-and-mouth disease exists only if they were 
conceived, collected, processed, and stored prior to importation at an 
embryo collection unit. The embryo collection unit may be located on the 
premises where the donor dam's herd of origin is kept, or at any other 
location, provided that the embryo collection unit has been inspected 
and approved by an APHIS veterinarian and that the following 
requirements are met:
    (a) Animal holding and breeding area(s). The embryo collection unit 
must have an area or areas for holding the donor dams and for breeding 
them (either natural breeding or artificial insemination).
    (b) Embryo collection area. The embryo collection must have a room 
or outdoor area for collection of embryos that contains a device or 
devices for restraining embryo donors during embryo collection. If a 
room, the floor, walls, and ceiling must be impervious to moisture and 
constructed of materials that can withstand repeated cleaning and 
disinfection. If an outdoor area, the area must have a floor that is 
impervious to moisture and is constructed of materials that can 
withstand repeated cleaning and disinfection. If the outdoor area also 
has walls or a roof, the walls or roof also must be impervious to 
moisture and be constructed of materials that can withstand repeated 
cleaning and disinfection.
    (c) Embryo processing area. The embryo collection unit must have an 
enclosed room, which may be mobile, that is used only for processing 
embryos. The walls, floor, and ceiling of the room must be impervious to 
moisture and constructed of materials that can withstand repeated 
cleaning and disinfection. The room must contain a work surface for 
handling the embryos, such as a table or countertop that is impervious 
to moisture. The room also must contain a microscope with a minimum of 
50x magnification, and equipment for freezing the embryos.
    (d) Embryo storage area. The embryo collection unit must have one 
lockable area that is used only for storing frozen embryos intended for 
importation into the United States.
    (e) Area for cleaning and disinfecting or sterilizing equipment. The 
embryo collection unit must have an enclosed room used for cleaning and 
disinfecting or sterilizing equipment used for artificial insemination 
or for collection, processing, or storage of embryos. The walls, floor, 
and ceiling of the room must be impervious to moisture and constructed 
of materials that can withstand repeated cleaning and disinfection.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15184, Apr. 5, 1996; 62 
FR 56025, Oct. 28, 1997; 83 FR 15494, Apr. 11, 2018]



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,

[[Page 659]]

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 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

[[Page 660]]

next transfer. Embryos from different donors may not be washed together.
    (4) After the last wash, each embryo must be microscopically 
examined over its entire surface at not less than 50 x magnification. An 
embryo may not be imported into the United States unless its zona 
pellucida is found to be intact and free from any adherent material.
    (5) After washing and examination of the zona pellucida, embryos 
must be individually packaged in sterile ampules or straws and frozen in 
liquid nitrogen. The donor dam's and sire's identifications and breed, 
the date of embryo collection, the name and address of the place where 
the embryos were collected, and an identification number for the straw 
or ampule must be recorded with indelible markings on each ampule or 
straw. If any of this information is provided in code, deciphering 
information must be attached to the health certificate for the embryos.
    (6) The Administrator may require additional measures to be taken in 
processing embryos after collection (for example, adding trypsin to the 
washes) if he or she determines that such measures are necessary to 
ensure the embryos freedom from infectious agents that may cause 
communicable diseases. Circumstances that may result in such additional 
measures being required include, but are not limited to:
    (i) The existence of communicable diseases of livestock, other than 
those diseases specifically listed, in the region of origin; and
    (ii) A high prevalence or an increase in the incidence of a 
communicable disease in the region of origin.
    (g) Preparation of test samples; tests. (1) All nontransferrable 
embryos and unfertilized eggs from each collection of embryos intended 
for importation into the United States must be pooled, frozen in liquid 
nitrogen, and sent to the Foreign Animal Disease Diagnostic Laboratory 
for testing under the personal supervision of an APHIS veterinarian. The 
collection and last two wash fluids from the collection of embryos must 
be frozen and sent to the Foreign Animal Disease Diagnostic Laboratory 
for testing under the personal supervision of an APHIS veterinarian. 
Samples from different collections may not be mixed.
    (2) All samples collected in accordance with paragraph (g)(1) of 
this section must be tested and found negative for viral contamination. 
The wash fluids also must be found negative for bacterial contamination. 
The only official results for these tests will be those provided by the 
Foreign Animal Disease Diagnostic Laboratory.
    (h) Storage of embryos. (1) Frozen embryos to be imported into the 
United States must be stored in a locked area or must remain in the 
custody of an official veterinarian until they are sealed in accordance 
with paragraph (h)(2) of this section and released for shipment to the 
United States in accordance with 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

[[Page 661]]

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:
    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

[[Page 662]]

required under this part at a port of entry.
    Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, 
partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys 
(including eggs for hatching).
    Region. Any defined geographic land area identifiable by geological, 
political, or surveyed boundaries. A region may consist of any of the 
following:
    (1) A national entity (country);
    (2) Part of a national entity (zone, county, department, 
municipality, parish, Province, State, etc.)
    (3) Parts of several national entities combined into an area; or
    (4) A group of national entities (countries) combined into a single 
area.
    Restricted zone for classical swine fever. An area, delineated by 
the relevant competent veterinary authorities of the region in which the 
area is located, that surrounds and includes the location of an outbreak 
of classical swine fever in domestic swine or detection of the disease 
in wild boar, and from which the movement of domestic swine is 
prohibited.
    Ruminants. All animals which chew the cud, such as cattle, 
buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.
    Swine. The domestic hog and all varieties of wild hogs.
    United States. All of the States of the United States, the District 
of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin 
Islands of the United States, and all other Territories and Possessions 
of the United States.

[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; 71 FR 29071, May 19, 2006; 72 FR 67233, Nov. 28, 2007; 
76 FR 70039, Nov. 10, 2011; 77 FR 1396, Jan. 10, 2012]



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 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

[[Page 663]]

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 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, Nov. 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

[[Page 664]]

exporter; the port of embarkation in the foreign region; the mode of 
transportation, route of travel, and the port of entry in the United 
States; the proposed date of arrival of the animal semen to be imported; 
and the name of the person to whom the animal semen will be delivered 
and the location of the place in the United States to which delivery 
will be made from the port of entry. Additional information may be 
required in the form of certificates concerning specific diseases to 
which the animals are susceptible, as well as vaccinations or other 
precautionary treatments to which the animals or animal semen have been 
subjected. Notice of any such requirements will be given to the 
applicant in each case.
    (2) An application for permit to import will be denied for semen 
from ruminants or swine from any region where it has been declared, 
under section 306 of the Act of June 17, 1930, that foot-and-mouth 
disease has been determined to exist, except as provided in paragraph 
(c) of this section.
    (3) An application for permit to import poultry semen or animal 
semen may also be denied because of: Communicable disease conditions in 
the area or region of origin, or in a region through which the shipment 
has been or will be transported; deficiencies in the regulatory programs 
for the control or eradication of animal diseases and the unavailability 
of veterinary services in the above mentioned regions; the importer's 
failure to provide satisfactory evidence concerning the origin, history, 
and health status of the animals or animal semen; the lack of 
satisfactory information necessary to determine that the importation 
will not be likely to transmit any communicable disease to livestock or 
poultry of the United States; or any other circumstances which the 
Administrator believes require such denial to prevent the dissemination 
of any communicable disease of livestock or poultry into the United 
States.
    (b) Permit. When a permit is issued, the original and two copies 
will be sent to the importer. It shall be the responsibility of the 
importer to forward the original permit and one copy to the shipper in 
the region of origin, and it shall also be the responsibility of the 
importer to insure that the shipper presents the copy of the permit to 
the carrier and makes proper arrangements for the original permit to 
accompany the shipment to the specified U.S. port of entry for 
presentation to the collector of customs. Animal semen intended for 
importation into the United States for which a permit has been issued, 
will be received at the specified port of entry within the time 
prescribed in the permit which shall not exceed 14 days from the first 
day that the permit is effective for all permits. Poultry semen and 
animal semen for which a permit is required by these regulations will 
not be eligible for entry if a permit has not been issued; if 
unaccompanied by such a permit; if shipment is from any port other than 
the one designated in the permit; if arrival in the United States is at 
any port other than the one designated in the permit; if the animal 
semen offered for entry differs from that described in the permit; or if 
the animal semen is not handled as outlined in the application for the 
permit and as specified in the permit issued.
    (c) Animal semen from regions where foot-and-mouth disease exists. 
Importation of semen of ruminants or swine, originating in any region 
designated in paragraph (a) of Sec.94.1 of this subchapter as a region 
where foot-and-mouth disease is determined to exist, is prohibited, 
except that semen from ruminants or swine originating in such a region 
may be offered for entry into the United States at the port of New York 
and later released from such port provided the following conditions have 
been fulfilled:
    (1) The importer has applied for and obtained an import permit for 
the semen in accordance with the provisions of this section and related 
requirements concerning application therefor, which permit is in effect 
at the time of importation, and has deposited with the Department prior 
to the issuance of the permit sufficient funds so as to be available for 
defraying estimated expenses to be incurred in connection with the 
proposed semen importation and following the issuance of the permit has 
deposited such other amounts as may be required from time to time to 
defray unanticipated costs

[[Page 665]]

or increased expenses. Such an import permit may be denied for the 
reasons specified in paragraph (a)(3) of this section. Furthermore, an 
import permit will be revoked unless the following conditions have been 
complied with:
    (i) The donor animal shall have been inspected on the farm of origin 
or on another premises (the inspection may be on another premises only 
if a veterinarian of the Department has traced the donor animal back to 
its farm of origin) by a veterinarian of the United States Department of 
Agriculture who, in cooperation with the veterinary service of the 
region of origin of the donor animal, shall have determined, insofar as 
possible, that the donor animal was never infected with foot-and-mouth 
disease; that the donor animal was never on a farm or other premises 
where foot-and-mouth disease then existed; that the donor animal has not 
been on a premises that had an animal that was susceptible to the virus 
of foot-and-mouth disease and that was exposed to the disease during the 
12 months immediately prior to the date of inspection of the donor 
animal; that the donor animal, if a swine, has never been vaccinated 
against foot-and-mouth disease; and that the donor animal was free from 
evidence of other communicable disease;
    (ii) The donor animal shall have been permanently identified in a 
manner satisfactory to a veterinarian of this Department; a blood sample 
and an oesophageal-pharyngeal tissue sample (O-P sample) from such a 
donor ruminant and a blood sample from such a donor swine for tests as 
specified in paragraph (c)(1)(iv) of this section or other tests shall 
have been collected by a veterinarian of the United States Department of 
Agriculture and transported by air to the New York Port Veterinarian for 
delivery to the Foreign Animal Disease Diagnostic Laboratory, Greenport, 
New York, in containers approved by a veterinarian of this Department, 
sealed in the region of origin by a veterinarian of this Department; and 
pending the results of the tests, the donor animal shall have been kept 
in isolation on the farm of origin or other acceptable location under 
the supervision of a veterinarian of this Department, and during such 
isolation period no animal susceptible to foot-and-mouth disease shall 
have been permitted to enter such farm or location and no other source 
of exposure to foot-and-mouth disease shall have been present;
    (iii) The blood samples from the donor animal shall have been 
negative to the tests specified in paragraph (c)(1)(iv) of this section 
made at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New 
York, and to any other test for foot-and-mouth disease or other 
communicable disease prescribed by the Administrator.
    (iv) In the case of a ruminant, each blood sample collected pursuant 
to paragraph (c)(1)(ii) or (vi) of this section shall have been tested 
for foot-and-mouth disease using the virus infection associated (VIA) 
test and each O-P sample collected pursuant to paragraph (c)(1)(ii) or 
(iv) of this section shall have been tested for foot-and-mouth disease 
using the virus isolation test. In the case of a swine, each blood 
sample collected pursuant to paragraph (c)(1)(ii) or (vi) of this 
section shall have been tested for foot-and-mouth disease using the 
virus infection associated (VIA) test and the virus neutralization 
test.'' \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 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

[[Page 666]]

this Department (any number of collections may be made); such 
veterinarian shall take a 0.5 ml sample of semen from each semen 
collection; and all handling procedures, such as examination, dilution, 
refrigeration, and preparation of the semen for shipment, shall have 
been under the direct supervision of a veterinarian of this Department. 
In the case of a ruminant, a blood sample and an O-P sample shall have 
been taken from the donor animal by a veterinarian of the Department 
within 7 days after the final semen collection, and between 21 to 28 
days after the taking of these samples another blood sample shall have 
been taken from the donor animal by a veterinarian of the Department. In 
the case of a swine, a blood sample shall have been taken from the donor 
animal by a veterinarian of the Department within 7 days after the final 
semen collection, and between 21 to 28 days after the taking of the 
sample, another blood sample shall have been taken from the donor animal 
by a veterinarian of the Department.
    (2) The semen collected at the approved isolation facility shall 
have been at all times, except during air transportation to New York, in 
the custody of a veterinarian of this Department.
    (3) The semen for which an import permit has been issued shall have 
been transported by air to the port of New York in liquid nitrogen 
containers approved by a veterinarian of this Department; sealed in the 
region of origin by a veterinarian of this Department; and accompanied 
by a statement by such veterinarian showing the identification of the 
donor animal and the dates the semen was collected, along with a 
certificate regarding the health status of the donor animal as of the 
date of shipment of the semen to the port of New York. All semen 
received at the port of New York shall be held under quarantine in 
liquid nitrogen storage at such port in the custody of APHIS until 
released or otherwise disposed of as provided in this section.
    (4) The donor animal shall have been retained at the approved 
isolation facility in the region where the semen was collected until all 
of the applicable samples referred to in paragraph (c)(1)(vi) of this 
section have been collected by a veterinarian of the Department for 
tests as specified in paragraph (c)(1)(iv) of this section at the 
Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, and 
any other tests as required by the Administrator.
    (5) The semen sample from each collection shall have consisted of 
unprocessed semen without any added substances, and shall have been 
tested at the Foreign Animal Disease Diagnostic Laboratory, Greenport, 
New York. Such tests shall have been performed by injecting the semen 
samples into test animals which are susceptible to foot-and-mouth 
disease. The semen collected at the approved isolation facility, other 
than the semen samples, may be held in the region of origin or at the 
port of New York, at the option of the importer, until all of the 
testing required to be conducted under this section is completed.
    (6) If it is determined that the requirements set forth in this 
paragraph have been complied with and there are no indications that the 
donor animal or the semen from the donor animal harbors the virus of 
foot-and-mouth disease or any other communicable disease and if the 
donor animal, blood samples from the donor animal, O-P samples (if 
applicable) from the donor animal, and semen samples from the donor 
animal are negative to all other tests required, the semen shall be 
released for shipment to the consignee listed by the importer; otherwise 
the semen shall be destroyed or disposed of as the Administrator, may 
direct.
    (7) Porcine semen from the People's Republic of China. In addition 
to the other requirements of this part, porcine semen may be imported 
into the United States from the People's Republic of China (PRC) only 
after the official veterinary organization (OVO) of the PRC has 
certified that the PRC is free of African swine fever, and Teschen's 
disease, and after the following conditions have been fulfilled:
    (i) The donor boars must pass a 60-day isolation/collection period 
in a facility jointly approved by the OVO of the PRC and the USDA as 
adequate to prevent exposure of the donor boars to infectious diseases. 
Any other swine at the isolation facility, such as teaser

[[Page 667]]

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 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.

[[Page 668]]

    (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.
    (d) Sheep and goat semen from regions where scrapie exists. 
Importation of semen of sheep and goats is subject to the requirements 
in Sec.98.35(e). Applications for a permit to import sheep and goat 
semen must include statements that:
    (1) All first generation (F1) progeny resulting from imported semen 
will be identified with a permanent official identification consistent 
with the provisions of Sec.79.2 of this chapter; and
    (2) Records of any sale of F1 progeny, including the name and 
address of the buyer, will be kept for a period of 5 years. APHIS may 
view and copy these records during normal business hours.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, 
as 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; 72 FR 64128, Nov. 
15, 2007; 83 FR 15494, Apr. 11, 2018]



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 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:

[[Page 669]]

    (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 donor animals:
    (i) Are permanently identified, to enable traceback to their 
establishment of origin; and
    (ii) Have been kept since birth in establishments in which no case 
of scrapie had been confirmed during their residency; and
    (iii) Neither showed clinical signs of scrapie at the time of semen 
collection nor developed scrapie between the time of semen collection 
and the export of semen to the United States; and
    (iv) The dam of the semen donor is not, nor was not, affected with 
scrapie.
    (2) In the region where the semen originates:
    (i) Scrapie is a compulsorily notifiable disease; and
    (ii) An effective surveillance and monitoring system for scrapie is 
in place; and
    (iii) Affected sheep and goats are slaughtered and completely 
destroyed; and
    (iv) The feeding of sheep and goats with meat-and-bone meal or 
greaves derived from ruminants has been banned and the ban effectively 
enforced in the whole region; and
    (3) Semen originating in regions other than Australia and New 
Zealand is to be transferred to females in a flock that is listed in the 
Scrapie National Database as part of the Scrapie Program in the United 
States. Imported semen may be further distributed to any other listed 
flock with written notification to the APHIS Veterinary Services area 
office.
    (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; 72 FR 64128, Nov. 15, 2007]



Sec.98.36  Animal semen from Canada.

    (a) General importation requirements for animal semen from Canada.

[[Page 670]]



------------------------------------------------------------------------
   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 671]]

 
(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  [Reserved]



Sec.98.38  Restrictions on the importation of swine semen from the 
APHIS-defined European CSF region.

    In addition to meeting all other applicable provisions of this part, 
swine semen imported from the APHIS-defined European CSF region, as 
defined in Sec.94.0 of this subchapter, must meet the following 
conditions:
    (a) The semen must come from a semen collection center approved for 
export by the competent veterinary authority.
    (b) The semen must not have been collected from a donor boar that 
was in any of the following regions or zones, unless the semen was 
collected after the periods described:
    (1) Any region when the region was classified under Sec. Sec.
94.9(a) and 94.10(a) of this chapter as a region in which classical 
swine fever is known to exist, except for the APHIS-defined European CSF 
region;
    (2) A restricted zone in the APHIS-defined European CSF region 
established because of the detection of classical swine fever in 
domestic swine, from the time of detection until the designation of the 
zone as a restricted zone is removed by the competent veterinary 
authority or until 6 months following depopulation of the swine on 
affected premises in the restricted zone and the cleaning and 
disinfection of the last affected premises in the zone, whichever is 
later; or
    (3) A restricted zone in the APHIS-defined European CSF region 
established because of the detection of classical swine fever in wild 
boar, from the time of detection until the designation of the zone as a 
restricted zone is removed by the competent veterinary authority.
    (c) The semen must not have been collected from a donor boar that 
was commingled with swine that at any time were in any of the regions or 
zones described in paragraphs (b)(1) through (b)(3) of this section, 
unless the semen was collected after the periods described.
    (d) The semen must not have been collected from a donor boar that 
transited any region or zone described in paragraphs (b)(1) through 
(b)(3) of this section during the periods described, unless the donor 
boar was moved directly through the region or zone in a sealed means of 
conveyance with the seal determined to be intact upon arrival at the 
point of destination, or unless the semen was collected after the 
periods described;
    (e) The donor boar must be held in isolation for at least 30 days 
prior to entering the semen collection center.
    (f) No more than 30 days prior to being held in isolation as 
required by

[[Page 672]]

paragraph (e) of this section, the donor boar must be tested with 
negative results with a classical swine fever test approved by the World 
Organization for Animal Health.
    (g) No equipment or materials used in transporting the donor boar 
from the farm of origin to the semen collection center may have been 
used previously for transporting swine that do not meet the requirements 
of this section, unless such equipment or materials have first been 
cleaned and disinfected.
    (h) The semen must be accompanied by a certificate issued by a 
salaried veterinary officer of the competent veterinary authority, 
stating that the provisions of paragraphs (a) through (g) of this 
section have been met. \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 numbers 
---------------------------------------------------------------------------
0579-0218 and 0579-0265)

[71 FR 29072, May 19, 2006, as amended at 72 FR 67233, Nov. 28, 2007; 76 
FR 70040, Nov. 10, 2011; 77 FR 1396, Jan. 10, 2012; 77 FR 74558, Dec. 
17, 2012]



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 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 673]]



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.
    Adverse event. Any observation in animals, whether or not the cause 
of the event is known, that is unfavorable and unintended, and that 
occurs after any use (as indicated on the label or any off-label use) of 
a biological product, including events related to a suspected lack of 
expected efficacy. For products intended to diagnose disease, adverse 
events refer to a failure in product performance that hinders an 
expected discovery of the correct diagnosis.
    Adverse event report. Direct communication concerning the occurrence 
of an adverse event from an identifiable first-hand reporter which 
includes the following information:
    (1) An identifiable reporter;
    (2) An identifiable animal;
    (3) An identifiable biologic product; and
    (4) One or more adverse events.
    Animal and Plant Health Inspection Service. The agency in the 
Department of Agriculture responsible for administering the Virus-Serum-
Toxin Act.
    Biological products. The term biological products, also referred to 
in this subchapter as biologics, biologicals, or products, shall mean 
all viruses, serums, toxins (excluding substances that are selectively 
toxic to microorganisms, e.g., antibiotics), or analogous products at 
any stage of production, shipment, distribution, or sale, which are 
intended for use in the treatment of animals and which act primarily 
through the direct stimulation, supplementation, enhancement, or 
modulation of the immune system or immune response. The term 
``biological products'' includes but is not limited to vaccines, 
bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, 
certain cytokines, antigenic or immunizing components of live organisms, 
and diagnostic components, that are of natural or synthetic origin, or 
that are derived from synthesizing or altering various substances or 
components of substances such as microorganisms, genes or genetic 
sequences, carbohydrates, proteins, antigens, allergens, or antibodies.
    (1) A product's intended use shall be determined through an 
objective standard and not a subjective one, and would be dependent on 
factors such as representations, claims (either oral or written), 
packaging, labeling, or appearance.
    (2) The term analogous products shall include:
    (i) Substances, at any stage of production, shipment, distribution, 
or sale, which are intended for use in the treatment of animals and 
which are similar in function to biological products in that they act, 
or are intended to act, through the stimulation, supplementation, 
enhancement, or modulation of the immune system or immune response; or
    (ii) Substances, at any stage of production, shipment, distribution, 
or

[[Page 674]]

sale, which are intended for use in the treatment of animals through the 
detection or measurement of antigens, antibodies, nucleic acids, or 
immunity; or
    (iii) Substances, at any stage of production, shipment, 
distribution, or sale, which resemble or are represented as biological 
products intended for use in the treatment of animals through 
appearance, packaging, labeling, claims (either oral or written), 
representations, or through any other means.
    (3) The term treatment shall mean the prevention, diagnosis, 
management, or cure of diseases of animals.
    Department. The U.S. Department of Agriculture.
    Distributor. A person who sells, distributes, or otherwise places in 
channels of trade, one or more biological products he does not produce 
or import.
    Division. A marketing unit established by the licensee which may be 
named on labels, advertisements and promotional material in addition to 
the name and address of the producer.
    Domestic animals. All animals, other than man, including poultry.
    Establishment. One or more premises designated on the establishment 
license.
    Guidelines. Guidelines establish principles or practices related to 
test procedures, manufacturing practices, product standards, scientific 
protocols, labeling, and other technical or policy considerations. 
Guidelines contain procedures or standards of general applicability that 
are usually not regulatory in nature, but that are related to matters 
that fall under the Virus-Serum-Toxin Act. Guidelines issued by the 
agency include Veterinary Biologics Licensing Considerations, Memoranda, 
Notices, and Supplemental Assay Methods.
    Herd. Any group of animals, including birds, fish, and reptiles, 
maintained at a common location (e.g. lot, farm or ranch) for any 
purpose. The herd (or flock) includes all animals subsequently housed at 
the common location. If the principal animals of a group are moved to a 
different location, the group is still considered the same herd.
    Herd of origin. The herd from which the microorganism used as seed 
for production of an autogenous biologic is isolated. Offspring and 
excess breeding stock (not the principal animals) moved or sold from one 
group of animals to another have changed herds and are no longer 
considered part of the herd they originated from. Groups of animals 
under the same ownership but at different locations are separate herds.
    Inspection. An examination made by an inspector to determine the 
fitness of animals, establishments, facilities, and procedures used in 
connection with the preparation, testing, and distribution of biological 
products and the examination or testing of biological products.
    Inspector. Any officer or employee of Animal and Plant Health 
Inspection Service who is authorized by the Administrator to do 
inspection work.
    Licensed establishment. An establishment operated by a person 
holding an unexpired, unsuspended, and unrevoked U.S. Veterinary 
Biologics Establishment License.
    Licensee. A person to whom an establishment license and at least one 
product license has been issued.
    Microorganisms. Microscopic or submicroscopic organisms, which are 
sometimes referred to as organisms, which may introduce or disseminate 
disease of animals.
    Nonadjacent herd. Nonadjacent herds are all herds other than the 
herd of origin and other than herds adjacent to the herd of origin. 
Herds adjacent to the herd of origin but in a different State from the 
herd of origin are also considered nonadjacent herds.
    Permittee. A person who resides in the United States or operates a 
business establishment within the United States, to whom a permit to 
import biological products has been issued.
    Person. Any individual, firm, partnership, corporation, company, 
association, educational institution, State or local governmental 
agency, or other organized group of any of the foregoing, or any agent, 
officer, or employee of any thereof.
    Premises. All buildings, appurtenances, and equipment used to 
produce and store biological products located within a particular land 
area

[[Page 675]]

shown on building plans or drawings furnished by the applicant or the 
licensee and designated by an address adequate for identification.
    Prepare or preparation. Sometimes referred to as manufacture or 
produce, means the steps and procedures used in the processing, testing, 
packaging, labeling, and storing of a biological product.
    Regulations. The provisions in parts 101 through 118 of this 
subchapter.
    Research investigator or research sponsor. A person who has 
requested authorization to ship an experimental biological product for 
the purpose of evaluating such product, or has been granted such 
authorization.
    Secretary. The Secretary of Agriculture of the United States or any 
officer or employee of the Department to whom authority has heretofore 
been delegated, or to whom authority may hereafter be delegated, to act 
in his stead.
    Subsidiary. A corporation in which a corporate licensee owns in 
excess of 50 percent of the voting stock.
    Veterinary Services. Veterinary Services unit of Animal and Plant 
Health Inspection Service of the Department.
    Virus-Serum-Toxin Act. The Act of March 4, 1913, 37 Stat. 832-833; 
as amended December 23, 1985, Public Law 99-198, 99 Stat. 1654-1655; and 
as further amended September 28, 1988, Public Law 100-449, 102 Stat. 
1868; 21 U.S.C. 151-159.
    U.S. Veterinary Biological Product License. A document, sometimes 
referred to as a product license, which is issued pursuant to part 102 
of this subchapter to the holder of an establishment license, as a part 
of and ancillary to the establishment license, and which authorizes 
production of a specified biological product in the designated licensed 
establishment.
    U.S. Veterinary Biological Product Permit. A document, sometimes 
referred to as a permit, issued to a person authorizing the importation 
of specified biological products subject to restrictions and controls as 
provided in the regulations.
    U.S. Veterinary Biologics Establishment License. A document referred 
to as an establishment license, which is issued pursuant to part 102 of 
this subchapter, authorizing the use of designated premises for 
production of biological products specified in one or more unexpired, 
unsuspended, and unrevoked product license(s).

[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; 83 FR 22835, May 17, 2018]



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

[[Page 676]]

times or under different conditions such as, but not limited to, being 
desiccated in different size final containers and/or at different times.
    (j) Outline of production. A detailed protocol of methods of 
manufacture to be followed in the preparation of a biological product 
and which may sometimes be referred to as an outline.
    (k) Product Code Number. A number assigned by Animal and Plant 
Health Inspection Service to each type of licensed biological product.
    (l) Harvest date. Unless otherwise specified in a filed Outline of 
Production, the harvest date shall be the date blood or tissues are 
collected for production or the date cultures of living microorganisms 
are removed from production incubators.
    (m) Bacterin. An inactivated bacterial product consisting of an 
antigenic suspension of organisms or particulate parts of organisms, 
representing a whole culture or a concentrate thereof, with or without 
the unevaluated growth products, which has been inactivated as 
demonstrated by acceptable tests written into the filed Outline of 
Production for the product.
    (n) Toxoid. An inactivated bacterial product which consists of a 
sterile, antigenic toxin or toxic growth product, which has resulted 
from the growth of bacterial organisms in a culture medium from which 
the bacterial cells have been removed, which has been inactivated 
without appreciable loss of antigenicity as measured by suitable tests, 
and which is nontoxic as demonstrated by acceptable tests written into 
the filed Outline of Production.
    (o) Bacterin-toxoid. An inactivated bacterial product which is 
either:
    (1) A suspension of organisms, representing a whole culture or a 
concentrate thereof, with the toxic growth products from the culture 
which has been inactivated without appreciable loss of antigenicity as 
measured by suitable tests, the inactivation of organisms and toxins 
being demonstrated by acceptable tests written into the filed Outline of 
Production: Provided, That it shall contain cellular antigens and shall 
stimulate the development of antitoxin; or
    (2) A combination product in which one or more toxoids or bacterin-
toxoids is combined with one or more bacterins or one or more bacterin-
toxoids.
    (p) Bacterial extract. An inactivated bacterial product which 
consists of the sterile, nontoxic, antigenic derivatives extracted from 
bacterial organisms or from culture medium in which bacterial organisms 
have grown.
    (q) Combination package. Biological product consisting of two or 
more licensed biological products. Each completed product in final 
container is packaged together and mixed prior to administration. A 
combination package is issued a separate U.S. Veterinary Biological 
Product License and assigned a product code number to distinguish it 
from its component products, which also may be marketed individually 
unless otherwise restricted.

[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; 81 FR 59433, Aug. 30, 2016]



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.

[[Page 677]]

    (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:
    (a) Standard Requirement. Test methods, procedures, and criteria 
established by Animal and Plant Health Inspection Service for evaluating 
biological products to be pure, safe, potent, and efficacious, and not 
to be worthless, contaminated, dangerous, or harmful under the Act.
    (b) Log. Logarithm computed to the base 10.
    (c) Pure or purity. Quality of a biological product prepared to a 
final form relatively free of extraneous micro-organisms and extraneous 
material (organic or inorganic) as determined by test methods or 
procedures established by Animal and Plant Health Inspection Service in 
Standard Requirements or in the approved Outline of Production for such 
product, but free of extraneous microorganisms or material which in the 
opinion of the Administrator adversely affects the safety, potency, or 
efficacy of such product.
    (d) Safe or safety. Freedom from properties causing undue local or 
systemic reactions when used as recommended or suggested by the 
manufacturer.
    (e) Sterile or sterility. Freedom from viable contaminating 
microorganisms as demonstrated by procedures prescribed in part 113 of 
this subchapter, Standard Requirements, and approved Outlines of 
Production.
    (f) Potent or potency. Relative strength of a biological product as 
determined by test methods or procedures as established by Animal and 
Plant Health Inspection Service in Standard Requirements or in the 
approved Outline of Production for such product.
    (g) Efficacious or efficacy. Specific ability or capacity of the 
biological product to effect the result for which it is offered when 
used under the conditions recommended by the manufacturer.
    (h) Dose. The amount of a biological product recommended on the 
label to be given to one animal at one time.
    (i) Vaccinate. An animal which has been inoculated, injected, or 
otherwise administered a biological product being evaluated.
    (j) Control animal. An animal, which may be referred to as a 
control, used in a test procedure for purposes of comparison or to add 
validity to the results.
    (k) Day. Time elapsing between any regular working hour of one day 
and any regular working hour of the following day.
    (l) Test results. Terms used to designate testing results are as 
follows:
    (1) No Test. Designation used when a deficiency in the test system 
has rendered a test unsuitable for drawing a valid conclusion.
    (2) Satisfactory. Designation is a final conclusion given to a valid 
test with results that meet the release criteria stated in the filed 
Outline of Production or Standard Requirement.
    (3) Unsatisfactory. Designation is a final conclusion given to a 
valid test with results that do not meet the release criteria stated in 
the filed Outline of Production or Standard Requirement.
    (4) Inconclusive. Designation used for an initial test when a 
sequential test design established in the filed Outline of Production or 
Standard Requirement allows further testing if a valid initial test is 
not satisfactory.
    (m) Healthy. Apparently normal in all vital functions and free of 
signs of disease.

[[Page 678]]

    (n) Unfavorable reactions. Overt adverse changes which occur in 
healthy test animals subsequent to initiation of a test and manifested 
during the observation period prescribed in the test protocol which are 
attributable either to the biological product being tested or to factors 
unrelated to such product as determined by the responsible individual 
conducting the test.
    (o) Master reference. A Master Reference is a reference whose 
potency is correlated, directly or indirectly, to host animal 
immunogenicity. The Master Reference may be used as the working 
reference in in vitro tests for relative potency. The Master Reference 
may also be used to establish the relative potency of a serial of 
product used in requalification studies and to establish the relative 
potency of working references. The preparation of a Master Reference as 
described in a filed Outline of Production may be:
    (1) A completed serial of vaccine or bacterin prepared in accordance 
with a filed Outline of Production;
    (2) A purified preparation of a protective immunogen or antigen; or
    (3) A nonadjuvanted harvested culture of microorganisms.
    (p) Working reference. A Working Reference is the reference 
preparation that is used in the in vitro test for the release of serials 
of product. Working References may be:
    (1) Master References; or
    (2) Serials of product that have been prepared and qualified, in a 
manner acceptable to Animal and Plant Health Inspection Service for use 
as reference preparations.
    (q) Qualifying serial. (1) A serial of biological product used to 
test for immunogenicity when the Master or Working Reference is a 
purified antigen or nonadjuvanted harvest material. Qualifying serials 
shall be produced in accordance with the filed Outline of Production, 
tested for immunogenicity in accordance with methods deemed appropriate 
by the Animal and Plant Health Inspection Service, and have a geometric 
mean relative potency, when compared to the Master Reference, of not 
greater than 1.0 as established by: independent parallel line assays 
with five or more replicates; or other valid assay methods for 
determining relative antigen content which demonstrate linearity, 
specificity, and reproducibility at least equivalent to the parallel 
line assay and are acceptable to the Animal and Plant Health Inspection 
Service.
    (2) Qualifying serials used to requalify or extend the dating period 
of a Master Reference shall be determined to be immunogenic in 
accordance with methods deemed appropriate by the Animal and Plant 
Health Inspection Service as provided in paragraph (a)(1) of this 
section, and, in addition, shall be within their permitted dating period 
and have been prepared in accordance with the production method 
described in the currently filed Outline of Production.
    (r) Immunogenicity. The ability of a biological product to elicit an 
immune response in animals as determined by test methods or procedures 
acceptable to the Animal and Plant Health Inspection Service.
    (s) Stability-indicating assay. A stability-indicating assay is a 
validated quantitative analytical procedure that can detect changes over 
time in a pertinent property of the product.

[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; 79 FR 55969, Sept. 18, 2014; 
83 FR 11143, Mar. 14, 2018]



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]

[[Page 679]]



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]



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.

[[Page 680]]

    (b) U.S. Veterinary Biological Product License. (1) The licensee of 
each establishment or applicant for an establishment license shall make 
written application to the Administrator for a U.S. Veterinary 
Biological Product License for each biological product to be prepared in 
the licensed establishment.
    (2) Each application for a U.S. Veterinary Biological Product 
License shall be supported by:
    (i) At least two copies of an Outline of Production prepared in 
accordance with 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; 75 FR 20772, Apr. 21, 2010]



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:
    (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

[[Page 681]]

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.
    (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, Policy, Evaluation, and Licensing, 1920 
Dayton Avenue, P.O. Box 844, Ames, IA 50010. Requests must specify the 
restriction(s) being requested and must explain why the restrictions are 
needed. Copies of any supporting documents, such as scientific 
literature, published or unpublished articles, or data from tests, 
should be attached to the request. When a decision is reached

[[Page 682]]

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; 75 FR 20772, Apr. 21, 
2010]



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]



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

[[Page 683]]

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 of the United States any unlicensed biological product for 
experimental use in animals. For the benefit of license applicants and 
to permit and encourage research, a person may be authorized by the 
Administrator to ship unlicensed biological products for the purpose of 
evaluating such experimental products by treating limited numbers of 
animals, Provided, that, the Administrator determines that the 
conditions under which the experiment is to be conducted are adequate to 
prevent the spread of disease and approves the procedures set forth in 
the request for such authorization. Special restrictions or tests may be 
imposed, especially in the case of products containing live organisms, 
when they are deemed necessary or advisable by the Administrator. A 
request for authorization to ship an unlicensed biological product for 
experimental study and evaluation shall be accompanied by the following:
    (a) One copy of a permit or letter of permission from the proper 
State or foreign animal health authorities of each State or foreign 
country involved.
    (b) Two copies of a tentative list of the names of the proposed 
recipients and quantity of experimental product that is to be shipped to 
each individual. In the event of subsequent changes, additional 
information shall be furnished when such facts are known;
    (c) Two copies of a description of the product, recommendations for 
use, and results of preliminary research work;
    (d) A copy of the labels or label sketches which show the name or 
identification of the product and bear the statement ``Notice! For 
experimental use only-Not For Sale'' or equivalent. Such statement shall 
appear on final container labels, except that it may appear on the 
carton in the case of very small final container labels and labeling for 
diagnostic test kits. The U.S. Veterinary License legend shall not 
appear on such labels; and
    (e) Two copies of a proposed general plan covering the methods and 
procedures for evaluating the product and for maintaining records of the 
quantities of experimental product prepared, shipped and used. At the 
conclusion of field studies, results shall be obtained, summarized, and 
submitted to

[[Page 684]]

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; 75 FR 20772, 
Apr. 21, 2010; 81 FR 59433, Aug. 30, 2016]



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 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, highly pathogenic avian influenza, swine 
vesicular disease, Newcastle disease, and African swine fever, if in the 
opinion of the Administrator, such products may endanger the livestock 
or poultry of this country.
    (c) A permit shall not be issued until an inspector has determined 
the condition of the equipment and facilities of the producer, of the 
applicant, or of both if such a determination is considered necessary by 
the Administrator.
    (d) A permit shall not be issued for a biological product prepared 
in the United States, exported, and presented for reentry except as 
provided in 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; 78 FR 19085, Mar. 29, 2013; 83 FR 15495, 
Apr. 11, 2018]

[[Page 685]]



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. Application forms are available on the Internet at (http://
www.aphis.usda.gov/ animal_health/vet_biologics/vb_forms.shtml) and 
application for a permit to import a veterinary biologic for research 
and evaluation or transit shipment may be made on the Internet at 
(http://www.aphis.usda.gov/ animal_health/permits/
vet_bio_permits.shtml).
    (b) The application shall specify the type of permit required, the 
port of entry at which the product shall be cleared through Customs, the 
estimated quantity involved, and the anticipated date on which the 
importation shall be made.

(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; 75 FR 20772, Apr. 21, 2010]



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 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) Two copies of blueprints of the producing foreign establishment 
shall be submitted with the application unless satisfactory plans are on 
file with Animal and Plant Health Inspection Service from a previous 
application. The production facilities to be used for each product 
prepared at the establishment shall be designated.
    (2) The manufacturer shall submit written authorization for properly 
accredited inspectors to inspect without previous notification, and at 
such times as may be demanded by the aforesaid inspectors, all parts of 
the establishment in which biological products shall be prepared, all 
processes of

[[Page 686]]

preparation, and all records relative to such preparation.
    (3) The manufacturer shall furnish written assurance that a 
biological product to be imported for Distribution and Sale shall be 
prepared under the supervision of a person competent by education and 
experience to handle all matters pertaining to the preparation of such 
product and that each biological product shall be prepared in accordance 
with the regulations applicable to the product or in a manner acceptable 
to the Administrator so as to carry out the purposes of the Act.
    (4) The methods to be used in the preparation of each biological 
product shall be written into an approved Outline of Production prepared 
in accordance with the applicable provisions of part 114 of this 
subchapter. Two copies of such Outlines of Production shall be submitted 
to Animal and Plant Health Inspection Service and be approved before the 
permit is issued.
    (5) Data shall be furnished by the applicant which establishes that 
the product involved complies with the provisions of the Act and the 
regulations issued pursuant thereto. When deemed necessary to obtain 
required information, Animal and Plant Health Inspection Service may 
require that the product be tested under field conditions within or 
outside the United States as the occasion demands.
    (b) The permittee shall furnish the following:
    (1) Adequate facilities for storing all imported biological 
products. An inspection of such facilities shall be made by inspectors 
before a permit is issued and additional inspections shall be made at 
any time subsequent to the importation of the biological products if 
deemed necessary by the Administrator;
    (2) Information regarding all claims to be made on labels and 
advertising matter used in connection with or related to the biological 
product to be imported;
    (3) Mounted copies of final container labels, carton labels, and 
enclosures to be used with the imported product as provided in part 112 
of this subchapter; and
    (4) Samples of each serial from each shipment of biological products 
imported or offered for importation. Such samples shall be collected, 
examined, and tested in a manner specified by the Administrator. The 
biological products being sampled shall not be further distributed by 
the permittee until released by Animal and Plant Health Inspection 
Service.

(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; 75 FR 20772, Apr. 
21, 2010]



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,

[[Page 687]]

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;
    (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

[[Page 688]]

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.
    (c) When notified to stop distribution and sale of a serial or 
subserial of a veterinary biological product under the provisions of 
paragraph (a) or (b) of this section, veterinary biologics licensees or 
permittees shall:
    (1) Stop the preparation, distribution, sale, barter, exchange, 
shipment, or importation of the affected serial(s) or subserial(s) of 
any veterinary biological product pending further instructions from 
APHIS.
    (2) Immediately, but no later than 2 days, send stop distribution 
and sale notifications to any wholesalers, jobbers, dealers, foreign 
consignees, or other persons known to have any such veterinary 
biological product in their possession, which instruct them to stop the 
preparation, distribution, sale, barter, exchange, shipment, or 
importation of any such veterinary biological product. All notifications 
shall be documented in writing by the licensee or permittee.
    (3) Account for the remaining quantity of each serial(s) or 
subserial(s) of any such veterinary biological product at each location 
in the distribution channel known to the manufacturer (licensee) or 
importer (permittee).
    (4) When required by the Administrator, submit complete and accurate 
reports of all notifications concerning stop distribution and sale 
actions to the Animal and Plant Health Inspection Service pursuant to 
Sec.116.5 of this subchapter.

(Approved by the Office of Management and Budget under control number 
0579-0318)

[38 FR 23512, Aug. 31, 1973, as amended at 56 FR 66783, Dec. 26, 1991; 
72 FR 17798, Apr. 10, 2007]



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.



Sec.106.1  Biological products; exemption.

    The Administrator may exempt any biological product from one or more 
of the requirements of this subchapter if

[[Page 689]]

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 facilities in which such products are prepared, shall be 
exempt from preparation pursuant to unsuspended and unrevoked 
establishment and product licenses. Persons exempt from licensure under 
this part shipping products which contain live organisms shall provide 
any information the Administrator may require prior to shipment, or at 
any other time deemed necessary, in order to assess the products' safety 
and effect on the environment. The shipment or delivery for shipment 
anywhere in or from the United States of any exempted product which is 
worthless, contaminated, dangerous, or harmful is prohibited, and any 
person shipping such product, or delivering such product for shipment, 
shall be subject to sanctions under the Act.
    (a)(1) Products prepared by a veterinary practitioner (veterinarian) 
solely for administration to animals in the course of a State licensed 
professional practice of veterinary medicine by such veterinarian under 
a veterinarian-client-patient relationship and facilities in which such 
products are prepared shall be exempt from licensing under the Act and 
regulations. Such a relationship is considered to exist when:
    (i) The veterinarian has assumed the responsibility for making 
medical judgments regarding the health of the animal(s) and the need for 
medical treatment, and the client (owner or other caretaker) has agreed 
to follow the instructions of the veterinarian; and when
    (ii) There is sufficient knowledge of the animal(s) by the 
veterinarian to initiate at least a general or preliminary diagnosis of 
the medical condition of the animal(s). This means that the veterinarian 
has recently seen and is personally acquainted with the keeping and care 
of the animal(s), and/or by medically appropriate and timely visits to 
the premises where the animal(s) are kept; and when
    (iii) The practicing veterinarian is readily available for followup 
in case of adverse reactions or failure of the regimen.
    (2) All steps in the preparation of product being prepared under the 
exemption in paragraph (a)(1) of this section must be performed at the 
facilities that the veterinarian utilizes for the day-to-day activities 
associated with the treatment of animals in the course of his/her State-
licensed professional practice of veterinary medicine. A veterinary 
assistant employed by the veterinary practitioner and working at the 
veterinary practice's facility under the veterinarian's direct 
supervision may perform the steps in the preparation of product. Such 
preparation may not be consigned to any other party or sub-contracted to 
a commercial laboratory/manufacturing facility.
    (3) Veterinarians preparing products subject to the exemption for 
products under this section shall maintain and make available for 
inspection by Animal and Plant Health Inspection Service representatives 
or other Federal employees designated by the Secretary such records as 
are necessary to establish that a valid veterinarian-client-patient 
relationship exists and that there is a valid basis for the exemption 
under this section.
    (b) Products prepared by a person solely for administration to 
animals owned by that person shall be exempt from the requirement that 
preparation

[[Page 690]]

be pursuant to an unsuspended and unrevoked license.

[52 FR 30131, Aug. 13, 1987, as amended at 56 FR 66783, Dec. 26, 1991; 
80 FR 26821, May 11, 2015]



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 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

[[Page 691]]

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 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:

[[Page 692]]

    (1) A listing of all rooms by identifying letters or numbers and the 
fractions prepared in each. Exceptions may be listed for general purpose 
areas or rooms. Functions performed in each area and room shall be 
described, whether the licensed or unlicensed products. In rooms where 
products are exposed to the surroundings, a description of 
decontamination procedures and other precautions against cross 
contamination shall be included.
    (2) A listing of the coded stationary equipment.
    (3) A general listing of other essential biological equipment such 
as mills, centrifuges, mixing tanks, bottling and sealing equipment, and 
the like, which are not regarded as stationary but are maintained in 
certain rooms.

[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.

    Two copies of all plot plans, blueprints, and legends, including 
revisions, shall be submitted to Animal and Plant Health Inspection 
Service for review and filing. When the reviewer takes exception to a 
submitted item, such item shall be returned with appropriate comments 
for correction and resubmission. Acceptable submissions shall be stamped 
as filed and the date noted. One stamped copy shall be returned and two 
copies retained for Animal and Plant Health Inspection Service files.

[39 FR 16854, May 10, 1974, as amended at 56 FR 66783, Dec. 26, 1991; 75 
FR 20772, Apr. 21, 2010]



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

[[Page 693]]

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, 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]

[[Page 694]]



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]



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.

[[Page 695]]

    (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 complete true name of the biological product which name 
shall be identical with that shown in the product license under which 
such product is prepared or the permit under which it is imported, shall 
be prominently lettered and placed giving equal emphasis to each word 
composing it. Descriptive terms used in the true name on the product 
license or permit shall also appear. Abbreviations of the descriptive 
terms may be used on the final container label if complete descriptive 
terms appear on the carton label and enclosure. The following exceptions 
are applicable to small final containers, and containers of 
interchangeable reagents included in diagnostic test kits:
    (i) For small final containers, an abbreviated true name of the 
biological product, which shall be identical with that shown in the 
product license under which the product is prepared or the permit under 
which it is imported, may be used: Provided, That the complete true name 
of the product must appear on the carton label and enclosures;
    (ii) In addition to the true name of the kit, the functional and/or 
chemical name of the reagent must appear on labeling for small final 
containers of reagents included in diagnostic kits: Provided, That the 
true name is not required on labeling for small final containers of 
interchangeable (non-critical) components of diagnostic kits.
    (2) For biological product prepared in the United States or in a 
foreign country, the name and address of the producer (licensee, or 
subsidiary) or permittee and of the foreign producer, and an appropriate 
consumer contact telephone number: Provided, That in the case of a 
biological product exported from the United States in labeled final 
containers, a consumer contact telephone number is not required; 
however, small single dose containers marketed in the United States must 
include contact telephone information on carton and enclosures.
    (3) The United States Veterinary Biologics Establishment License 
Number (VLN) or the United States Veterinary Biological Product Permit 
Number (VPN), and the Product Code Number (PCN) assigned by the 
Department, which shall be shown only as ``VLN/PCN'' and ``VPN/PCN,'' 
respectively, except that:
    (i) Only the VLN or VPN is required on container labels of 
interchangeable (non-critical) components of diagnostic kits and 
container labels for individual products packaged together for co-
administration.
    (ii) The PCN may be used in lieu of the true name of the kit on 
small container labels for critical components of diagnostic kits.
    (iii) Container labels for individually licensed biological 
products, when marketed as components of combination packages, must 
include a statement referring the consumer to the carton or enclosure 
for the PCN of the combination package.
    (4) Storage temperature recommendation for the biological product 
stated as 2 to 8 [deg]C or 35 to 46 [deg]F, or both.
    (5) Full instructions for the proper use of the product, including 
indications for use, target species, minimum age of administration, 
route of administration, vaccination schedule, product license 
restriction(s) that bear on product use, warnings, cautions, and any 
other vital information for the product's use; except that in the case 
of limited space on final container labels, a statement as to where such 
information is to be found, such as ``See enclosure for complete 
directions,'' ``Full directions on carton,'' or comparable statement.
    (6) In the case of a multiple-dose final container, a warning to use 
entire contents when first opened: Provided,

[[Page 696]]

That a diagnostic or a desensitizing antigen packaged in a multiple-dose 
final container is exempt.
    (7) The following warning statements, or equivalent statements, 
shall appear on the labeling as applicable:
    (i) Products other than diagnostic kits: ``Do not mix with other 
products, except as specified on this label.''
    (ii) Injectable products and other products containing hazardous 
components: ``In case of human exposure, contact a physician.''
    (iii) Products containing viable organisms: ``Inactivate unused 
contents before disposal.''
    (8) In the case of a biological product recommended for use in 
domestic animals, the edible portion of which may be used for food 
purposes, a withholding statement of not less than 21 days to read: ``Do 
not vaccinate within (insert number) days before slaughter'' or ``Do not 
vaccinate food-producing animals within (insert number) days before 
slaughter'': Provided, That longer periods shall be stated when deemed 
necessary by the Administrator. Very small final container labels are 
exempted from this requirement.
    (9) The following information shall appear on the final container 
label and carton label, if any, but need not appear on the enclosure:
    (i) A permitted expiration date;
    (ii) The number of doses where applicable;
    (iii) The recoverable quantity of the content of each final 
container stated in cubic centimeters (cc.) or milliliters (ml.) or 
units.
    (iv) A serial number by which the product can be identified with the 
manufacturer's records of preparation: Provided, That when a liquid 
antigenic fraction is to be used instead of a water diluent for one or 
more desiccated antigenic fractions in a combination package, a 
hyphenated serial number composed of a serial number for the desiccated 
fraction and the serial number for the liquid fraction shall be used on 
the carton.
    (v) A statement similar to ``For more information regarding efficacy 
and safety data, go to productdata.aphis.usda.gov.
    (10) In the case of a product that contains a preservative that is 
added during the production process and is not reduced to undetectable 
levels in the completed product through the production process, the 
statement ``Contains [name of preservative] as a preservative'' or an 
equivalent statement must appear on cartons and enclosures, if used. If 
cartons are not used, such information must appear on the final 
container label.
    (11) The number of final containers of biological product and the 
number of doses in each final container shall be stated on each carton 
label for all cartons containing more than one final container of 
biological product. The number of final containers of diluent, if any, 
and the quantity in each shall also be stated on each carton label.
    (12) An indications statement to read, ``This product has been shown 
to be effective for the vaccination of healthy (insert name of species) 
__ weeks of age or older against __.'' Provided, That in the case of 
very small final container labels or carton, a statement as to where 
such information is to be found, such as ``See enclosure for complete 
directions,'' ``Full directions on carton,'' or comparable statement.
    (b) Labels may also include any other statement which is not false 
or misleading and may include factual statements regarding variable 
response of different animals when vaccinated as directed but may not 
include disclaimers of merchantability, fitness for the purpose offered, 
or responsibility for the product.
    (c) Labels of biological products prepared at licensed 
establishments or imported shall not include any statement, design, or 
device, which overshadows the true name of the product as licensed or 
which is false or misleading in any particular or which may otherwise 
deceive the purchaser.
    (d) Carton labels and enclosures shall be subject to paragraph 
(d)(1), (d)(2), and (d)(3) of this section.
    (1) The statement, ``Restricted to use by or under the direction of 
a veterinarian'' or ``Restricted to use by a veterinarian,'' shall be 
used on all carton

[[Page 697]]

labels and enclosures when such restriction is prescribed on the product 
license.
    (2) If the licensee states on the carton labels and enclosures of a 
product that its sales are restricted to veterinarians, then the entire 
production of that particular product in the licensed establishment 
shall be so restricted by the licensee.
    (3) The statement ``For use in animals only'' may appear on the 
labeling as appropriate for a product to indicate that the product is 
recommended specifically for animals and not for humans.
    (e) When label requirements of a foreign country differ from the 
requirements as prescribed in this part, special labels may be approved 
by APHIS for use on biological products to be exported to such country 
upon receipt of written authorization, acceptable to APHIS, from 
regulatory officials of the importing country, provided that:
    (1) If the labeling contains claims or indications for use not 
supported by data on file with APHIS, the special labels for export 
shall not bear the VLN.
    (2) All other labels for export shall bear the VLN unless the 
importing country provides documentation that the VLN is specifically 
prohibited. When laws, regulations, or other requirements of foreign 
countries require exporters of biological products prepared in a 
licensed establishment to furnish official certification that such 
products have been prepared in accordance with the Virus-Serum-Toxin Act 
and regulations issued pursuant to the Act, such certification may be 
made by APHIS.
    (f) Multiple-dose final containers of liquid biological product and 
carton tray covers showing required labeling information are subject to 
the requirements in this paragraphs.
    (1) If a carton label or an enclosure is required to complete the 
labeling for a multiple-dose final container of liquid biological 
product, only one final container, with a container of diluent if 
applicable, shall be packaged in each carton: Provided, That if the 
multiple-dose final container is fully labeled without a carton label or 
enclosure, two or more final containers, and a corresponding number of 
diluent containers, may be packaged in a single carton which shall be 
considered a shipping box. Labels or stickers for shipping boxes shall 
not contain false or misleading information, but need not be submitted 
to APHIS for approval.
    (2) When required labeling information is shown on a carton tray 
cover, it must be printed on the outside face of such tray cover where 
it may be read without opening the carton. The inside face of the tray 
cover may contain information suitable for an enclosure.

(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; 80 FR 39674, July 10, 2015; 81 FR 59433, Aug. 30, 
2016; 81 FR 78500, Nov. 8, 2016]



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

[[Page 698]]

    (2) The biological product is composed of viable or dangerous 
organisms or viruses, the notice, ``Inactivate unused contents before 
disposal.''
    (g) The establishment license number or the permit number, as the 
case may be, in one of the forms provided in 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; 81 FR 59434, Aug. 30, 2016]



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 (d) of this section and under the 
master label system provided in paragraph (e) of this section.
    (a) Transmittal forms, available on the APHIS Web page at http://
www.aphis.usda.gov/ animalhealth/cvb/forms, shall be used with each 
submission of sketches (including proofs) and labels. Separate forms 
shall be used for each biological product but only one copy of the form 
shall be used for all sketches and labels submitted at the same time for 
the same biological product.
    (b) A data summary, available on the Internet at 
productdata.aphis.usda.gov, shall be used with each submission of 
efficacy and safety data in support of a label claim. Manufacturers will 
submit the efficacy and safety data information with either the efficacy 
and safety studies or at the time of label submission. This information 
will be posted at

[[Page 699]]

productdata.aphis.usda.gov to allow public disclosure of product 
performance.
    (c) Sketches may be submitted for comment to Animal and Plant Health 
Inspection Service by the licensee or permittee before preparing the 
finished label. Such sketches shall be returned to the licensee or 
permittee with comments, if any. Failure of the reviewer to take 
exception to a sketch shall not constitute approval of a finished label 
subsequently prepared.
    (d)(1) Labels must be submitted to the Animal and Plant Health 
Inspection Service for review and written approval. Only labels which 
are approved as provided in paragraph (e) of this section may be used. 
When changes are made in approved labels, the new labels shall be 
subject to review and approval before use: Provided, That certain minor 
changes may be made in labels for products with approved labels or 
master labels, and the revised labels may be used prior to review by 
APHIS, with the provision that a new label or master label bearing these 
changes is submitted to APHIS for review and written approval within 60 
days of label use, and that such minor changes do not render the product 
mislabeled or the label false and misleading in any particular.
    (2) Minor label changes that may be made under the provision for 
products with approved labels or master labels are:
    (i) Changes in the physical dimensions of the label provided that 
such change does not affect the legibility of the label;
    (ii) Changes in the color of label print or background, provided 
that such changes do not affect the legibility of the label;
    (iii) The addition or deletion of a Trade Mark (TM) or Registered 
(R) symbol;
    (iv) The correction of typographical errors;
    (v) Adding, changing, deleting, or repositioning label control 
numbers, universal product codes, or other inventory control numbers;
    (vi) Revising or updating logos;
    (vii) Changing the telephone contact number;
    (viii) Adding, changing, or deleting an email and/or Web site 
address;
    (ix) Changing the establishment license or permit number assigned by 
APHIS, and/or changing the name and/or address of the manufacturer or 
permittee, provided that such changes are identical to information on 
the current establishment license or permit; and
    (x) Adding or changing the name and/or address of a distributor.
    (e) Labels and sketches submitted shall be prepared in the number 
and manner prescribed in this paragraph.
    (1) Copies required:
    (i) For label sketches, submit two copies of each sketch of a final 
container label, carton label, and enclosure. Sketches must be legible, 
and must include all information specified in 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 paragraph 
(e)(1)(iii) of this section: Provided, That master label sketches 
submitted in support of an application for license or permit shall be 
held as long as the application is considered active.
    (iii) For finished labels, submit two copies of each finished final 
container label, carton label, and enclosure: Provided, That when an 
enclosure is to be used with more than one product, one extra copy shall 
be submitted for each additional product. One copy of each finished 
label will be retained by APHIS. One copy will be stamped and returned 
to the licensee or permittee. Labels to which exceptions are taken

[[Page 700]]

shall be marked as sketches and handled under paragraph (e)(1)(i) of 
this section.
    (iv) For finished master labels, submit for each product two copies 
each of the enclosure and the labels for the smallest size final 
container and carton. Labels for larger sizes of containers or cartons 
of the same product that are identical, except for physical dimensions, 
need not be submitted. Such labels become eligible for use concurrent 
with the approval of the appropriate finished master label, provided 
that the marketing of larger size final containers is approved in the 
filed Outline of Production, and the appropriate larger sizes of 
containers or cartons are identified on the label mounting sheet. When a 
master label enclosure is to be used with more than one product, one 
extra copy for each additional product shall be submitted. One copy of 
each finished master label will be retained by APHIS. One copy will be 
stamped and returned to the licensee or permittee. Master labels to 
which exception are taken will be marked as sketches and handled under 
paragraph (e)(1)(ii) of this section.
    (2) Mounting:
    (i) Each label or sketch shall be securely fastened to a separate 
sheet of heavy bond paper (8\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 in the lower left hand 
corner, if applicable:
    (i) The dose size(s) to which the master label applies.
    (ii) The APHIS assigned number for the label or sketch to be 
replaced.
    (iii) The APHIS assigned number for the label to be used as a 
reference for reviewing the submitted label.
    (f) Special requirements for foreign language labels:
    (1) An accurate English translation must accompany each foreign 
language label submitted for approval. A statement affirming the 
accuracy of the translation must also be included.
    (2) Foreign language portion of a bilingual label shall be a true 
translation of the English portion. Reference to additional information 
on the enclosure shall not be made unless that enclosure is also 
bilingual.
    (g) When a request is received from Animal and Plant Health 
Inspection Service, the licensee or permittee shall submit a list of all 
approved labels currently being used. Each label listed shall be 
identified as to:
    (1) Name and product code number as it appears on the product 
license or permit for the product; and
    (2) Where applicable, the size of the package (doses, ml., cc., or 
units) on which the label shall be used; and

[[Page 701]]

    (3) Label number and date assigned; and
    (4) Name of licensee or subsidiary appearing on the label as the 
producer.
    (h) At the time of an inspection, or when requested by APHIS, 
licensees or permittees shall make all labels and master labels, 
including labels approved for use but exempted from filing under the 
master label system, available for review by authorized inspectors. Such 
labels shall be identical to the approved label or master label except 
for physical dimensions, reference to recoverable volume or doses and/or 
certain minor differences permitted in accordance with paragraph (d) of 
this section.

(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; 75 FR 20772, Apr. 21, 2010; 80 FR 39675, July 10, 
2015; 81 FR 47005, July 20, 2016; 81 FR 59435, Aug. 30, 2016]



Sec.112.6  Packaging biological products.

    (a) Multiple-dose final containers of a biological product with 
final container labeling including all information required under the 
regulations may be packaged one or more per carton with a container(s) 
of the proper volume of diluent, if required, for that dose as specified 
in the filed Outline of Production: Provided, That cartons containing 
more than one final container of product must comply with the conditions 
set forth in paragraphs (c)(1) through (4) of this section. Multiple-
dose final containers of a product that require a carton or enclosure in 
order to provide all information required under the regulations shall be 
packaged one container per carton with the proper volume of diluent, if 
required, for that dose as specified in the filed Outline of Production.
    (b) Single-dose final containers of a product need not be packaged 
one per carton. For single-dose products which require a diluent for 
administration, the number of containers of the proper amount of diluent 
specified in the filed Outline of Production for the number of doses 
contained in the carton shall be included in each carton.
    (c) Poultry products for mass administration (including but not 
limited to administration through drinking water and spray) and products 
used in automatic vaccinating systems (including but not limited to 
pneumatic beak injectors and automated needle injectors) may be packaged 
in multiple-dose final containers as specified in the filed Outline of 
Production. Poultry products for manual administration to individual 
birds shall not exceed 1,000 doses in each final container. Diluent need 
not be packaged with the final container(s) of the product, but the 
licensee shall provide the required number of containers of diluent as 
specified in the filed Outline of Production. The following requirements 
apply to cartons containing more than one final container of poultry 
product:
    (1) They shall be sealed prior to leaving the licensed 
establishment.
    (2) The contents may not be repackaged.
    (3) The contents of such cartons may not be sold in fractional 
units.
    (4) The following statement must appear in a prominent place on the 
carton label: ``Federal regulations prohibit the repackaging or sale of 
the contents of this carton in fractional units. Do not accept if seal 
is broken.''
    (d) Diluent for the following products need not be packaged with the 
final container(s) of the product, but the licensee shall provide the 
consumer with the required number of containers of the proper amount of 
diluent as specified in the filed Outline of Production:
    (1) Marek's Disease Vaccine.
    (2) Poultry vaccines administered to individual birds using 
automatic vaccinating equipment.
    (e) Final containers of biological product prepared at a licensed 
establishment, or imported, in cartons or other containers shall not be 
removed from such cartons or containers for sale or distribution, unless 
each final container bears, or is packaged in a carton with, complete 
and approved labeling which is affixed to or included with each 
container by the licensed establishment producing the product or by the 
producer in the case of imported product: Provided, That this paragraph

[[Page 702]]

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; 81 FR 59435, Aug. 
30, 2016]



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.
    (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) Labeling for all products for use in mammals must bear an 
appropriate statement concerning use in pregnant animals.
    (1) For bovine rhinotracheitis vaccine or bovine virus diarrhea 
vaccine containing modified live virus, all labeling except small final 
container labels shall bear the following statement: ``Do not use in 
pregnant cows or in calves nursing pregnant cows.'': Provided, That such 
vaccines which have been shown to be safe for use in pregnant cows may 
be excepted from this label requirement by the Administrator.
    (2) For other modified live and inactivated vaccine, labeling shall 
bear a statement appropriate to the level of safety that has been 
demonstrated in pregnant animals.
    (i) Products known to be unsafe in pregnant animals shall include 
statements such as ``Do not use in pregnant animals,'' or ``Unsafe for 
use in pregnant animals,'' or an equivalent statement acceptable to 
APHIS.
    (ii) Products without safety documentation acceptable to APHIS, but 
not known to be unsafe, labeling shall include the statement ``This 
product has not been tested in pregnant animals'' or an equivalent 
statement acceptable to APHIS.

[[Page 703]]

    (3) For modified live vaccines containing agents with potential 
reproductive effects but having acceptable pregnant animal safety data 
on file with APHIS, labeling still must bear the following statement 
concerning residual risk: ``Fetal health risks associated with the 
vaccination of pregnant animals with this vaccine cannot be 
unequivocally determined during clinical trials conducted for licensure. 
Appropriate strategies to address the risks associated with vaccine use 
in pregnant animals should be discussed with a veterinarian.''
    (f) For biological products recommending annual booster 
vaccinations, such recommendations must be supported by data acceptable 
to APHIS. In the absence of data that establish the need for booster 
vaccination, labeling must bear the following statement: ``The need for 
annual booster vaccinations has not been established for this product; 
consultation with a veterinarian is recommended.''
    (g) In the case of a liquid product authorized in a filed Outline of 
Production to be used as a diluent in a combination package, the carton 
labels and enclosures used for serials which are either not tested for 
bactericidal or viricidal activity or have been found unsatisfactory by 
such test shall contain the statement: ``CAUTION: DO NOT USE AS DILUENT 
FOR LIVE VACCINES.''
    (h) In the case of wart vaccine, recommendations shall be limited to 
use in cattle. Indications for use shall be for prophylactic use only, 
as an aid in the control of viral papillomas (warts). All labels shall 
include a dosage recommendation of at least 10 ml to be given 
subcutaneously and the dose repeated in 3 to 5 weeks.
    (i) All but very small final container labels for feline 
panleukopenia vaccines shall contain the following recommendations for 
use:
    (1) Killed virus vaccines. Vaccinate healthy cats with one dose, 
except that if the animal is less than 12 weeks of age, a second dose 
should be given no earlier than 16 weeks of age.
    (2) Modified live virus vaccines. Vaccinate healthy cats with one 
dose, except that if the animal is less than 12 weeks of age, a second 
dose should be given no earlier than16 weeks of age.
    (j) In the case of normal serum, antiserum, or antiserum 
derivatives, the type of preservative used shall be indicated on all 
labels.
    (k) Unless acceptable data has been filed with Animal and Plant 
Health Inspection Service, to show that development of corneal opacity 
is not associated with the product, carton labels and enclosures used 
with biological products containing modified live canine hepatitis virus 
or modified live canine adenovirus Type 2 shall bear the following 
statement: ``Occasionally, transient corneal opacity may occur following 
the administration of this product.''
    (l) All labels for autogenous biologics must specify the name of the 
microorganism(s) or antigen(s) that they contain, and shall bear the 
following statement: ``Potency and efficacy of autogenous biologics have 
not been established. This product is prepared for use only by or under 
the direction of a veterinarian or approved specialist.''
    (m) In the case of biological products containing Marek's disease 
virus, all labels shall specify the Marek's disease virus serotype(s) 
used in the product.
    (n) All labels for conditionally licensed products shall bear the 
following statement: ``This product license is conditional; efficacy and 
potency have not been fully demonstrated.''

(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 at www.govinfo.gov.



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

[[Page 704]]

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.
    (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.

[[Page 705]]

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.
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.
113.201-203 [Reserved]
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 [Reserved]
113.212 Bursal Disease Vaccine, Killed Virus.
113.213-113.214 [Reserved]
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.

[[Page 706]]

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.

    Editorial Note: Nomenclature changes to part 113 appear at 79 FR 
55969, Sept. 18, 2014.

                              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 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

[[Page 707]]

samples of biological product in the number prescribed in paragraph (b) 
of this section. Each sample shall be marked for identification by the 
person making the selection after which they shall be packaged by the 
licensee or permittee, as the case may be, and forwarded to National 
Veterinary Services Laboratories; except that an employee of the 
Department may forward or deliver the samples to National Veterinary 
Services Laboratories if such action deemed advisable by the 
Administrator.
    (1) Selection shall be made as follows:
    (i) Nonviable liquid biological products--either bulk or final 
container samples of completed product shall be selected for purity, 
safety, or potency tests. Biological product in final container shall be 
selected to test for viable bacteria and fungi.
    (ii) Viable liquid biological products; samples shall be in final 
containers and shall be randomly selected at the end of the filling 
operation. Bulk containers of completed product may be sampled when 
authorized by the Administrator.
    (iii) Desiccated biological products; samples shall be in final 
containers and shall be randomly selected if desiccated in the final 
container. Biological products desiccated in bulk shall be sampled at 
the end of the filling operation.
    (iv) Representative samples of each serial or subserial in each 
shipment of imported biological products shall be selected.
    (2) Comparable samples shall be used by Animal and Plant Health 
Inspection Service, the licensee, and the permittee for similar tests.
    (3) When bulk samples of completed product in liquid form are to be 
tested as prescribed in paragraph (a)(1) of this section, the number of 
such samples from each serial and the minimum quantity of product to be 
provided in each sample shall be stated in the filed Outline of 
Production.
    (b) Unless otherwise prescribed by the Administrator, the number of 
final container samples to be selected from each serial and subserial 
shall be:
    (1) Vaccines:
    (i) Six multiple-dose samples of Brucella Abortus Vaccine;
    (ii) Twelve samples of all other live bacterial vaccines;
    (iii) Two samples of Coccidiosis Vaccine;
    (iv) Eighteen samples of Rabies Vaccine, Modified Live Virus;
    (v) Sixteen samples of all other vaccines consisting of live 
microorganisms;
    (vi) Thirty single-dose or 14 multiple-dose samples of Equine 
Encephalomyelitis Vaccine, Killed Virus;
    (vii) Twenty-two single-dose or 14 multiple-dose samples of Rabies 
Vaccine, Killed Virus;
    (viii) Sixteen single-dose or 12 multiple-dose samples of all other 
vaccines consisting of killed microorganisms.
    (2) Bacterins and bacterin-toxoids:
    (i) Twelve samples of single-fraction products;
    (ii) Thirteen samples of two-fraction products;
    (iii) Fourteen samples of products consisting of 3 or more 
fractions.
    (3) Antiserums: Twelve samples of antiserum recommended for large 
animals or 14 samples of antiserum recommended for small animals or the 
number of reagent serum samples prescribed in the filed Outline of 
Production for the product.
    (4) Antitoxins:
    (i) Fourteen single-dose or 12 multiple dose samples of Tetanus 
Antitoxin;
    (ii) Twelve samples of all other antitoxins.
    (5) Toxoids:
    (i) Eighteen single-dose or 12 multiple dose samples of all toxoids.
    (6) Antigens: Twelve samples of poultry antigens or 20 samples of 
tuberculin or four samples of all other diagnostic antigens.
    (7) Diagnostic test kits: Two samples of diagnostic test kits. The 
licensee or permittee will hold one of these selected samples at the 
storage temperature recommended on the label while awaiting a request by 
the animal and Plant Health Inspection Service to submit the additional 
sample. If submission is not requested by the Animal and Plant Health 
Inspection Service, the additional sample may be returned

[[Page 708]]

to the serial inventory after the serial is released. In the case of 
diagnostic test kits in which final packaging consists of multiple 
microtiter test plates or strips, the licensee or permittee may submit a 
specified number of test plates or strips along with all other test 
reagents as prescribed in a filed Outline of Production and retain a 
similar amount as a second sample for submission upon request. When the 
initial sample is not representative of final packaging by the licensee 
of permittee, e.g., does not consist of all the microtiter test plates 
or strips, the second sample is not eligible to be returned to serial 
inventory after the serial is released.
    (8) Autogenous biologics: With the exception of the first serial or 
subserial, 10 samples must be selected and submitted to the Animal and 
Plant Health Inspection Service from each serial or subserial of an 
autogenous biologic eligible to be shipped that consists of more than 50 
containers. For first serials or subserials eligible for shipment 
consisting of more than 50 containers, 10 samples from each serial or 
subserial must be selected and held for submission to the Animal and 
Plant Health Inspection Service upon request in accordance with 
paragraph (e)(4) of this section. For serials or subserials of 
autogenous biologic with 50 or fewer containers, no samples, other than 
those required by paragraph (e) of this section, are required.
    (9) Miscellaneous: The number of samples from products not in the 
categories provided for in paragraphs (b)(1) through (b)(8) of this 
section shall be prescribed in the filed Outline of Production for the 
product.
    (c) Prelicensing and Outline of Production changes: Samples needed 
to support a license application or a change in the Outline of 
Production for a licensed product shall be submitted only upon request 
from the animal and Plant Health Inspection Service. Except for 
miscellaneous products specified in paragraph (b)(9) of this section, 
the number of such samples shall be at least one and one-half times the 
number prescribed for such product in paragraph (b) of this section. 
Samples of Master Seeds and Master Cell Stocks with a minimum individual 
volume of 1 ml shall be submitted as follows:
    (1) Ten samples of Bacterial Master Seeds.
    (2) Thirteen samples of viral Master Seeds or nonviral Master Seeds 
requiring cell culture propagation. For Master Seeds isolated or passed 
in a cell line different from the species of intended use, an additional 
2 samples are required for each additional species. For Master Seeds 
grown in cell culture and intended for use in more than one species, an 
additional 2 samples are required for each additional species.
    (3) Thirty-six samples of at least 1 ml each or six samples of at 
least 1 ml each, one sample of at least 20 ml, and one sample of at 
least 10 ml of Master Cell Stocks. In the case of Master Cell Stocks 
which are persistently infected with a virus, an additional four samples 
of at least 1 ml each are required. If these persistently infected cell 
stocks are intended for use in more than one species, an additional two 
samples of at least 1 ml each are required for each additional species.
    (4) Four samples of the Master Cell Stock + n (highest passage) 
cells.
    (d) Sterile diluent: A sample of Sterile Diluent shall accompany 
each sample of product, other than Marek's Disease Vaccine, if such 
diluent is required to rehydrate or dilute the product before use. The 
volume of diluent shall be an appropriate amount to rehydrate or dilute 
the product. Samples of Sterile Diluent prepared for use with Marek's 
Disease Vaccine shall be submitted upon request from the Animal and 
Plant Health Inspection Service.
    (e) Reserve samples shall be selected from each serial and subserial 
of biological product. Such samples shall be selected at random from 
final containers of completed product by an employee of the Department, 
of the licensee, or of the permittee, as designated by the 
administrator. Each sample shall:
    (1) Consist of 5 single-dose packages, 2 multiple-dose packages, or 
2 diagnostic test kits, except that, in the case of diagnostic test kits 
in which final packaging consists of multiple microtiter test plates or 
strips, a sample may consist of a specified number of test plates or 
strips along with all

[[Page 709]]

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 prescribed in the filed 
Outline of Production or the Standard Requirements for the product shall 
be submitted to Animal and Plant Health Inspection Service. Blank forms 
shall be furnished upon request to Animal and Plant Health Inspection 
Service.
    (d) When the initial or any subsequent test is declared a No Test, 
the reasons shall be reported in the test records, the results shall not 
be considered as final, and the test may be repeated. When a test is 
declared satisfactory, the test designation is considered to be a final 
conclusion. When a test is declared unsatisfactory, the test designation 
is considered to be a final conclusion. When the initial or any 
subsequent test is declared inconclusive, the reasons shall be reported 
in the test records, the result shall not be considered as final, and 
the test may be repeated as established in the filed Outline of 
Production or Standard Requirement. If a test is designated inconclusive 
or No Test and the biological product is not further tested, the test 
designation of unsatisfactory is the final conclusion.
    (e) When new test methods are developed and approved by Animal and 
Plant Health Inspection Service, biological products tested thereafter 
shall be evaluated by such methods, and if not found to be satisfactory 
when so tested shall not be released.

(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; 79 FR 
55969, Sept. 18, 2014]



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.

[[Page 710]]

    (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:
    (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.

[[Page 711]]

    (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. Firms currently using 
immunoassays which do not satisfy this requirement shall have 2 years 
from the effective date of the final rule to update their filed Outlines 
of Production to be in compliance with this requirement unless granted 
an extension by the Administrator based on a showing by the firm seeking 
the extension that they have made a good faith effort with due diligence 
to achieve compliance. On the basis of the results of such test 
procedures, each serial that meets the required minimum potency shall be 
released to the firm for marketing; each serial not meeting the required 
minimum potency shall be withheld from the market. The evaluation of 
such products shall be made in accordance with the following criteria:
    (1) A test that results in no valid lines is considered a ``no 
test'' and may be repeated.
    (2) An initial test (test 1) that results in valid lines that are 
not parallel is considered a valid equivocal test. Release of the serial 
may not be based on such test since the result cannot be termed 
``satisfactory'' or ``unsatisfactory.''
    (3) If the initial test (test 1) shows that potency equals or 
exceeds the required minimum potency, the serial is satisfactory without 
additional testing.
    (4) If the initial test (test 1) is an equivocal test due to lack of 
parallelism, the serial may be retested up to three times (tests 2, 3, 
and 4) with disposition to be as specified in paragraphs (c)(4)(i) and 
(ii) of this section; Provided, That, if the serial is not retested or 
the other provisions of this section are not satisfied, the serial shall 
be deemed unsatisfactory.
    (i) If: The first retest (test 2) following an initial equivocal 
test; the second retest (test 3) following two consecutive equivocal 
tests (tests 1 and 2); or the third retest (test 4) following three 
consecutive equivocal tests (tests 1, 2, and 3) shows that the potency 
equals or exceeds the required minimum potency, the serial is 
satisfactory.
    (ii) If the first retest (test 2) following an initial equivocal 
test shows that potency is less than the required minimum potency, 
disposition of the serial will be based on the outcome of

[[Page 712]]

retests 2 and 3 (tests 3 and 4) as follows: if either retest (test 3 or 
4) shows that potency is less than the required minimum potency, the 
serial is unsatisfactory. If either retest 2 or retest 3 (tests 3 or 4) 
is an equivocal test, or in the event that each retest (tests 2, 3, and 
4) following an initial equivocal test is also an equivocal test, the 
accumulated test results shall be considered indicative of a lack of 
potency and release of the serial withheld. In which case, the licensee 
may submit data confirming the continued validity of the test system to 
APHIS for review and approval. If the data are acceptable to APHIS, the 
potency test may be repeated by the firm, subject to the provisions 
specified in paragraphs (i) and (ii) and confirmatory testing by APHIS.
    (5) If the initial test (test 1) shows that potency is less than the 
required minimum potency, the serial may be retested a minimum of two 
times (tests 2 and 3) but not more than three times (tests 2, 3, and 4) 
with disposition as specified in paragraphs (c)(5) (i) and (ii) of this 
section; Provided, That, if the serial is not retested or the other 
provisions of this section are not satisfied, the serial shall be deemed 
unsatisfactory.
    (i) If two consecutive retests (tests 2 and 3) show that potency of 
the serial equals or exceeds the required minimum potency, the serial is 
satisfactory. If one of the two retests (test 2 or 3) shows that the 
potency is less than the required minimum potency, the serial is 
unsatisfactory.
    (ii) If one of the retests (tests 2 or 3) shows that the potency 
equals or exceeds the required minimum potency and the other retest 
(test 2 or 3) is an equivocal test, a third retest (test 4) may be 
performed. If the third retest (test 4) shows that the potency of the 
serial equals or exceeds the required minimum potency, the serial is 
deemed satisfactory. If both retests (tests 2 and 3) or if the third 
retest (test 4) is an equivocal test, the accumulated test results shall 
be considered indicative of a lack of potency and release of the serial 
withheld, in which case the licensee may submit data confirming the 
continued validity of the test system to APHIS for review and approval. 
If the data are acceptable to APHIS, the potency test may be repeated by 
the firm, subject to the provisions specified in paragraphs (c)(4) (i) 
and (ii) and (c)(5) (i) and (ii) of this section, and confirmatory 
testing by APHIS.
    (d) Extending the dating of a reference. All determinations of 
relative antigen content using parallel line immunoassays or equivalent 
methods shall be conducted with an unexpired reference. The lot of 
reference used to determine antigenic content shall have an initial 
dating period equal to the dating of the product or as supported by data 
acceptable to APHIS, except that frozen references may have an initial 
dating of up to 5 years, Provided, That the request for dating of the 
frozen references beyond the dating of the product is supported by 
preliminary data acceptable to APHIS and includes provisions for 
monitoring the stability of the reference to determine when the potency 
starts to decline and for taking the appropriate steps to requalify a 
reference with declining potency either by testing a Qualifying Serial 
in host animals or by providing other evidence of immunogenicity, e.g., 
antibody titers or laboratory animal test data previously correlated to 
host animal protection in a manner acceptable to APHIS. Prior to the 
expiration date, such reference may be granted an extension of dating, 
Provided, That its immunogenicity has been confirmed using a Qualifying 
Serial of product in a manner acceptable to APHIS. The dating period of 
the Master Reference and Working Reference may be extended by data 
acceptable to APHIS if the minimum potency of the Master Reference is 
determined to be adequately above the minimum level needed to provide 
protection in the host animal. If a new Master Reference is established, 
it shall be allowed an initial dating period equal to the dating of the 
product or as supported by data acceptable to APHIS, except that frozen 
references may have an initial dating period of 5 years, or as supported 
by data acceptable to APHIS. Prior to the expiration date, such 
reference may be granted an extension of dating by confirming its 
immunogenicity using a Qualifying Serial of product.

[[Page 713]]

    (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 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; 72 FR 72564, Dec. 21, 2007; 79 FR 
31021, May 30, 2014]



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

[[Page 714]]

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]



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.

[[Page 715]]

    (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 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.

[[Page 716]]

    (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 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.

[[Page 717]]

    (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.
    (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

[[Page 718]]

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 60 x 15 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 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]

[[Page 719]]



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 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.

[[Page 720]]

    (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 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

[[Page 721]]

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 by inoculating eight mice intraperitoneally or subcutaneously 
with 0.5 mL (the inoculation volume may be divided among more than one 
injection site), and the animals observed for 7 days.
    (2) If unfavorable reactions attributable to the product occur in 
any of the mice during the observation period, the serial or subserial 
is unsatisfactory. If unfavorable reactions which are not attributable 
to the product occur, the test shall be declared a No Test and may be 
repeated: Provided, That, if the test is not repeated, the serial or 
subserial shall be declared unsatisfactory.
    (b) Bulk or final container samples of completed product from liquid 
products, such as but not limited to antiserums and bacterins, shall be 
tested for safety in accordance with the test provided in this 
paragraph.
    (1) Unless otherwise prescribed in the Standard Requirement or 
approved in a filed Outline of Production for the product, a 0.5 ml dose 
shall be injected intraperitoneally or subcutaneously into eight mice 
and the animals observed for 7 days.
    (2) If unfavorable reactions attributable to the product occur in 
any of the mice during the observation period, the serial or subserial 
is unsatisfactory. If unfavorable reactions which are not attributable 
to the product occur, the test shall be declared a No Test and may be 
repeated: Provided, That, if the test is not repeated, the serial or 
subserial shall be declared unsatisfactory.

[38 FR 34727, Dec. 18, 1973, as amended at 39 FR 16857, May 10, 1974; 72 
FR 72564, Dec. 21, 2007]



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

[[Page 722]]

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 
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

[[Page 723]]

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 a No Test 
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.
    (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,

[[Page 724]]

a 2 ml dose shall be injected either intramuscularly or subcutaneously 
into each of two guinea pigs and the animals observed for 7 days.
    (b) If unfavorable reactions attributable to the product occur in 
either of the guinea pigs during the observation period, the serial or 
subserial is unsatisfactory. If unfavorable reactions which are not 
attributable to the product occur, the test shall be declared a No Test 
and may be repeated: Provided, That, if the test is not repeated, the 
serial or subserial shall be declared unsatisfactory.

[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 not 
attributable to the Master Seed Virus, the test shall be declared a No 
Test and repeated: Provided, That, if not repeated, the Master Seed 
Virus shall be unsatisfactory.
    (b) The cat safety test provided in this paragraph shall be used 
when a serial of vaccine is tested for safety before release.
    (1) Each of two healthy cats shall be administered 10 cat doses by 
the method recommended on the label and the cats observed each day for 
14 days.
    (2) If unfavorable reactions attributable to the biological product 
occur during the observation period, the serial is unsatisfactory. If 
unfavorable reactions occur which are not attributable to the product, 
the test shall be declared a No Test and repeated: Provided, That, if 
not repeated, the serial shall be unsatisfactory.

[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

[[Page 725]]

unfavorable reactions occur which are not attributable to the Master 
Seed Virus, the test shall be declared a No Test and may be repeated: 
Provided: That, if the test is not repeated, the Master Seed Virus shall 
be considered unsatisfactory.
    (b) The dog safety test provided in this paragraph shall be used 
when a serial of vaccine is tested for safety before release.
    (1) Each of two healthy dogs shall be administered 10 dog doses by 
the method recommended on the label and the dogs shall be observed each 
day for 14 days.
    (2) If unfavorable reactions attributable to the biological product 
occur during the observation period, the serial is unsatisfactory. If 
unfavorable reactions occur which are not attributable to the biological 
product, the test shall be declared a No Test and may be repeated: 
Provided, That, if the test is not repeated, the serial shall be 
considered unsatisfactory.

[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 a 
No Test 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.
    (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

[[Page 726]]

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 a 
No Test 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 a 
No Test 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.113.46  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

[[Page 727]]

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.
    (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

[[Page 728]]

production purposes are exempt from having to produce positive rabies 
virus control monolayers. Fixed positive rabies virus control monolayers 
will be provided by the National Veterinary Services Laboratories.
    (c) After staining, each group of monolayers shall be examined for 
the presence of specific fluorescence attributable to the presence of 
extraneous viruses.
    (1) If the material under test shows any evidence of specific viral 
fluorescence, it is unsatisfactory and may not be used; Provided, That, 
if specific fluorescence attributable to the virus being tested for is 
absent in the positive control monolayers, the test is a No Test and may 
be repeated.
    (2) If the fluorescence of the monolayers inoculated with the 
specific virus as positive controls is equivocal, or if the negative 
monolayers show equivocal fluorescence indicating possible viral 
contamination, or both, the test shall be declared a No Test, and may be 
repeated; Provided, That, if the test is not repeated, the material 
under test shall be regarded as unsatisfactory for use in the production 
of biologics.

[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 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.

[[Page 729]]

    (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 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

[[Page 730]]

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 2,000 x g for no more 
than 15 minutes to remove cellular debris. Divide the supernatant into 
equal aliquots and dispense 1.0 ml onto each of at least one monolayer 
(at least 75 cm \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),

[[Page 731]]

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;
    (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 80,000 x g, 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

[[Page 732]]

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 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;

[[Page 733]]

    (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.
    (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

[[Page 734]]

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 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

[[Page 735]]

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 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) 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).

[[Page 736]]

    (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; 72 
FR 72564, Dec. 21, 2007]



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. 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 a No Test: Provided, That 
control pigs which meet the criteria requirements for susceptibility 
except for high body temperature shall be considered susceptible if 
sacrificed and organisms identified as Erysipelothrix rhusiopathiae can 
be isolated from the blood, spleen, or other organs.
    (6) To demonstrate immunity after challenge, the vaccinates shall 
remain free of clinical signs and the body temperature shall not exceed 
104.6 [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) An Outline of Production change shall be made before authority 
for use of a new Master Seed shall be granted

[[Page 737]]

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; 72 
FR 72564, Dec. 21, 2007]



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 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

[[Page 738]]

Plant Health Inspection Service, the Master Seed is unsatisfactory.
    (6) An Outline of Production change must be made before authority 
for use of a new lot of Master Seed is granted by the Animal and Plant 
Health Inspection Service.
    (c) Test requirements for release. Each serial and subserial shall 
meet the applicable general requirements prescribed in 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 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, as amended at 72 FR 72564, Dec. 21, 2007]



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

[[Page 739]]

substantial weight loss; or any combination of these symptoms.
    (5) Lung lesion response to challenge will be assessed in all 
calves. Lung lesions will be assessed at necropsy in calves that succumb 
to challenge. Surviving calves will be euthanized on day 4 to 10 
following challenge and lung lesions assessed at necropsy. Lung lesion 
scores will be used in the assessment of the response to challenge 
exposure. If a significant difference in lung lesion scores cannot be 
demonstrated between vaccinates and controls using a scoring system 
approved by the Animal and Plant Health Inspection Service, the Master 
Seed is unsatisfactory.
    (6) An Outline of Production change must be made before authority 
for use of a new lot of Master Seed is granted by the Animal and Plant 
Health Inspection Service.
    (c) Test requirements for release. Each serial and subserial shall 
meet the applicable general requirements prescribed in 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 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 72 FR 72564, Dec. 21, 2007]



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

[[Page 740]]

valid. If at least 16 of 20 of the vaccinates do not survive the 14-day 
postchallenge period, the Master Seed is unsatisfactory at the selected 
bacterial count.
    (c) Test requirements for release. Each serial and subserial shall 
meet the applicable requirements in 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.
    (iii) If unfavorable reactions occur which are not attributable to 
the test vaccine, the test is a No Test and may be repeated. If the 
results of the next test are not satisfactory, or if the test is not 
repeated, the serial shall be considered unsatisfactory.
    (2) Bacterial count requirements. Final container samples of 
completed product shall be tested for bacterial count using the method 
used in paragraph (b)(2) of this section. Two replicate titrations shall 
be conducted on each serial and subserial. Each sample shall be 
rehydrated with accompanying sterile diluent to the volume indicated on 
the label. To be eligible for release, each serial and subserial shall 
have a bacterial count sufficiently greater than that of the vaccine 
used in the immunogenicity test count per dose established to assure 
that, when tested at any time within the expiration period, each serial 
and subserial shall have a bacterial count at least two times greater 
than that used in the immunogenicity test.

[55 FR 35560, Aug. 31, 1990, as amended at 59 FR 19633, Apr. 25, 1994; 
64 FR 43044, Aug. 9, 1999; 72 FR 72564, Dec. 21, 2007]



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

[[Page 741]]

days postchallenge. The rectal temperature of each animal shall be taken 
and the presence or absence of clinical signs noted and recorded each 
day.
    (i) If less than 8 of 10 controls show clinical signs of feline 
pneumonitis infection other than fever, the test is a No Test and may be 
repeated.
    (ii) If a significant difference in clinical signs other than fever 
or chlamydia shedding cannot be demonstrated between vaccinates and 
controls using a scoring system approved by the Animal and Plant Health 
Inspection Service, the Master Seed is unsatisfactory.
    (4) An Outline of Production change must be made before authority 
for use of a new lot of Master Seed is granted by the Animal and Plant 
Health Inspection Service.
    (c) Test requirements for release: Except for 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; 
72 FR 72564, Dec. 21, 2007]

                     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

[[Page 742]]

below the species level, adequate testing must be used to identify the 
bacteria to that level. Tests which may be used to identify Master Seed 
Bacteria include, but are not limited to:
    (1) Cultural characteristics,
    (2) Staining reaction,
    (3) Biochemical reactivity,
    (4) Fluorescent antibody tests,
    (5) Serologic tests,
    (6) Toxin typing,
    (7) Somatic or flagellar antigen characterization, and
    (8) Restriction endonuclease analysis.
    (d) Ingredient requirements. Ingredients used for the growth and 
preparation of Master Seed Bacteria and of final product shall meet the 
requirements provided in 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. \1\ 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.
---------------------------------------------------------------------------

    \1\ 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; 79 
FR 31021, May 30, 2014]



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:

[[Page 743]]



----------------------------------------------------------------------------------------------------------------
                                                                           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]



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.

[[Page 744]]

    (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 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:

[[Page 745]]



                                                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]



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


[[Page 746]]


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, 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:

[[Page 747]]

    (i) International antitoxin unit. (I.U.) That quantity of Alpha 
Antitoxin which reacts with Lo and L + doses of Standard Toxin according 
to their definitions.
    (ii) Lo dose. The largest quantity of toxin which can be mixed with 
one unit of Standard Antitoxin and not cause sickness or death in 
injected mice.
    (iii) L + dose. The smallest quantity of toxin which can be mixed 
with one unit of Standard Antitoxin and cause death in at least 80 
percent of injected mice.
    (iv) Standard antitoxin. The Alpha Antitoxin preparation which has 
been standardized as to antitoxin unitage on the basis of the 
International Clostridium novyi Alpha Antitoxin Standard and which is 
either supplied by or acceptable to the Animal and Plant Health 
Inspection Service. The antitoxin unit value shall be stated on the 
label.
    (v) Standard toxin. The Alpha toxin preparation which is supplied by 
or is acceptable to the Animal and Plant Health Inspection Service.
    (vi) Diluent. The solution used to make proper dilutions prescribed 
in this test. Such solutions shall be made by dissolving 1 gram of 
peptone and 0.25 gram of sodium chloride in each 100 ml of distilled 
water; adjusting the pH to 7.2; autoclaving at 121 [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 a No Test and shall be 
repeated: Provided, That, if the test is not repeated, the serial shall 
be declared unsatisfactory.
    (ii) If less than 80 percent of the mice inoculated with the mixture 
of 0.1 International Unit of Standard Antitoxin and 0.1 L + doses of 
Standard Toxin die, the results of the serum neutralization test are a 
No Test and shall be repeated: Provided, That, if the test is not 
repeated, the serial shall be declared unsatisfactory.

[[Page 748]]

    (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 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 a No 
Test and shall be repeated: Provided, That, if the test is not repeated, 
the serial shall be declared unsatisfactory.
    (4) The antitoxin content of the rabbit serums shall be determined 
by the serum neutralization test as follows:
    (i) Make a dilution of Standard Antitoxin to contain 1.0 
international unit of antitoxin per ml.
    (ii) Make a dilution of Standard Toxin in which 1.0 Lo dose is 
contained in a volume of 1 ml or less. Make a second dilution of 
Standard Toxin in which 1.0 L + dose is contained in a volume of 1 ml or 
less.
    (iii) Combine 1.0 International Unit Standard Antitoxin with 1.0 Lo 
dose of

[[Page 749]]

diluted Standard Toxin and combine 1.0 International Unit of Standard 
Antitoxin with 1.0 L + dose of diluted Standard Toxin. Each mixture is 
adjusted to a final volume of 2.0 ml with diluent.
    (iv) Combine 1.0 Lo dose of diluted Standard Toxin with a 1.0 ml 
volume of undiluted serum. This mixture is adjusted to a final volume of 
2.0 ml with diluent.
    (v) Neutralize all toxin-antitoxin mixtures at room temperature for 
1 hour and hold in ice water until injections of mice can be made.
    (vi) Five Swiss white mice, each weighing 16-20 grams, shall be used 
for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected 
intravenously into each mouse. Conclude the test 72 hours post injection 
and record all deaths.
    (5) Test Interpretation shall be as follows:
    (i) If any mice inoculated with the mixture of 1.0 International 
Unit of Standard Antitoxin and 1.0 Lo doses of Standard Toxin die, the 
results of the serum neutralization test are a No Test and shall be 
repeated: Provided, That, if the test is not repeated, the serial shall 
be declared unsatisfactory.
    (ii) If less than 80 percent of the mice inoculated with the mixture 
of 1.0 International Unit of Standard Antitoxin and 1.0 L + doses of 
Standard Toxin die, the results of the serum neutralization test are a 
No Test and shall be repeated: Provided, That, if the test is not 
repeated, the serial shall be declared unsatisfactory.
    (iii) If any mice inoculated with the mixture of 1.0 ml undiluted 
serum with 1.0 Lo dose of Standard Toxin die, the serum is considered to 
contain less than 1.0 International Units per ml.
    (iv) If the single pooled serum from seven or more rabbits contains 
less than 1.0 International Unit per ml, the serial is unsatisfactory.

[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; 79 FR 55969, 
Sept. 18, 2014]



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]

[[Page 750]]



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.
    (1) When used in this test, the following words and terms shall 
mean:
    (i) International antitoxin unit. (I.U.) That quantity of Beta 
Antitoxin which reacts with L 0 and L \+\ doses of Standard 
Toxin according to their definitions.
    (ii) L 0 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 a No 
Test and shall be repeated: Provided, That, if the test is not repeated, 
the serial shall be declared unsatisfactory.
    (4) The antitoxin content of the rabbit serums shall be determined 
as follows:
    (i) Make a dilution of Standard Antitoxin to contain 10 
International Units of antitoxin per ml.
    (ii) Make one dilution of Standard Toxin to contain 10 L 
0 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 L 
0 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.

[[Page 751]]

    (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 a No Test and shall be repeated: 
Provided, That, if the test is not repeated, the serial shall be 
declared unsatisfactory.
    (ii) If less than 80 percent of the mice inoculated with mixture of 
10 International Units of Standard Antitoxin and 10 L+ doses 
of Standard Toxin die, the results of the test are a No Test and shall 
be repeated: Provided, That, if the test is not repeated, the serial 
shall be declared unsatisfactory.
    (iii) If any mice inoculated with the mixture of serum with 10 
L0 doses of 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; 
79 FR 55969, Sept. 18, 2014]



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 a No 
Test and

[[Page 752]]

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 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 a No Test and shall be repeated: Provided, 
That, if the test is not repeated, the serial shall be declared 
unsatisfactory.
    (ii) If less than 80 percent of the mice inoculated with mixture of 
1 International Unit of Standard Antitoxin and 10 L+ doses of 
Standard Toxin die, the results of the test area No Test and shall be 
repeated: Provided, That, if the test is not repeated, the serial shall 
be declared unsatisfactory.
    (iii) If any mice inoculated with the mixture of 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; 
79 FR 55969, Sept. 18, 2014]



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, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) the 
following information. (If any of the data are unavailable, the 
applicant for authorization

[[Page 753]]

should indicate that such data are unavailable and why.)
    (i) Name, address, and phone number of the owner of the herd of 
origin.
    (ii) Attending veterinarian's name, address, and phone number.
    (iii) Animal species and number in herd of origin.
    (iv) Identification of microorganism(s), at least to genus.
    (v) Diagnosis or clinical signs of the disease observed.
    (vi) Name and address of the person who isolated the 
microorganism(s) and the date of isolation.
    (vii) Number of doses of autogenous biologic requested and 
vaccination schedule.
    (viii) Each adjacent herd owner's name, address, and phone number.
    (ix) Number of animals and species in each adjacent herd.
    (x) The attending veterinarian's or approved specialist's assessment 
of the involvement of the adjacent herd(s) with the disease observed.

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, 
1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) for authorization to 
prepare a product for use in herds not adjacent to the herd of origin. 
Because the recipient herd involved may not be known when autogenous 
biologics are to be used in other geographic areas, the following data 
may be used in place of the data required in paragraphs (a)(2)(viii) and 
(a)(2)(ix) of this section.
    (i) Names and addresses of practitioners in the area in place of the 
name, address, and phone number of the adjacent herd owner.
    (ii) The geographic designations of the area involved.
    (iii) A summary of the epidemiology of the disease situation that 
links the designated geographic areas with the herd of origin.

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

[[Page 754]]

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 test cultures or if any of the test animals used 
to demonstrate product safety, sicken, or die during the observation 
period.
    (iv) Test summaries must be submitted to the Administrator (in c/o 
the Director, Center for Veterinary Biologics, Inspection and 
Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) on a 
quarterly basis by the 21st day of January, April, July, and October or 
more often as required by the Administrator.
    (2) Each serial or subserial of autogenous bacterial product other 
than the first serial or subserial produced from an isolate shall meet 
the applicable general requirements prescribed in 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, Policy, Evaluation, and Licensing, 1920 Dayton 
Avenue, P.O. Box 844, Ames, IA 50010 for review. Microorganisms not 
shown to be antigenic (that is, not shown to induce a significant 
serological response) or immunogenic by such approved tests shall not be 
used for the preparation of such product.

[[Page 755]]

    (B) Bulk or final container samples of completed product from each 
serial of such autogenous biologics containing fractions for which 
standard requirement potency test procedures have been established shall 
be tested for potency in accordance with applicable standard requirement 
potency tests provided in 9 CFR part 113. If the culture of 
microorganisms used to produce such fractions is shown to be of a 
different strain or serotype than the reagent or challenge 
microorganisms used in the standard requirement potency test, reagents 
or challenges of the same strain or serotype as the microorganism used 
for production may be used.
    (C) If no standard requirement potency test procedures have been 
established for a fraction(s) in the autogenous biologic, such 
fraction(s) of each serial of product shall be tested for potency using 
a developmental potency test described in the filed outline of 
production or shall at least be standardized to contain an antigenic 
mass for such fraction(s) that has been shown to be antigenic or 
immunogenic in accordance with paragraph (c)(2)(iv)(A) of this section.

[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; 75 FR 20773, Apr. 
21, 2010]



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]

[[Page 756]]



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 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.

[[Page 757]]

    (a) Purity test. Final container samples of completed product shall 
be tested for viable bacteria and fungi as provided in 9 CFR 113.26.
    (b) Safety test. Observation of the vaccinated turkeys during the 
prechallenge period of the potency test provided in paragraph (c) of 
this section shall constitute the safety test. If unfavorable reactions 
that are attributable to the product occur, the serial is 
unsatisfactory. If unfavorable reactions that are not attributable to 
the product occur in one turkey, test results shall be determined by 
observing the remaining 20 turkeys. The test is a No Test and may be 
repeated if unfavorable reactions that are not attributable to the 
product occur in two or more turkeys, but the serial is unsatisfactory 
if the test is not repeated.
    (c) Potency test. Bulk or final container samples of completed 
product shall be tested for potency of the Type 4 strain, using the two-
stage test provided in this paragraph. Turkeys at least 6 weeks old 
obtained from the same source and hatch shall be properly identified and 
used as provided in this paragraph.
    (1) Vaccinates. Each of not more than 21 turkeys shall be vaccinated 
with the dose and by the route recommended on the label. A second dose 
shall be given after 3 weeks and the turkeys observed for an additional 
2-week prechallenge period.
    (2) Unvaccinated controls. Each of not more than 11 turkeys shall be 
held as controls.
    (3) Challenge. Not less than 14 days after the second dose, each of 
20 vaccinates, and each of 10 unvaccinated controls shall be challenged 
intramuscularly with virulent Pasteurella multocida, Strain P-1662, Type 
4 (Little and Lyons classification) and observed daily for a 14-day 
postchallenge period. Only dead birds shall be considered in evaluating 
the product.
    (4) Validity requirements. Eight or more unvaccinated controls must 
die for the test to be valid. If this requirement is met, the potency 
test results are evaluated according to stage one of the following 
table. The test is a No Test and may be repeated if the validity 
requirement is not met, but the serial is unsatisfactory if the test is 
not repeated.

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

[[Page 758]]

the product occur in one chicken, test results shall be determined by 
observing the remaining 20 chickens. The test is a No Test and may be 
repeated if unfavorable reactions that are not attributable to the 
product occur in two or more chickens, but the serial is unsatisfactory 
if the test is not repeated.
    (c) Potency test. Bulk or final container samples of completed 
product shall be tested for potency of the Type 1 strain, using the two-
stage test provided in this paragraph. Chickens, at least 12 weeks of 
age, obtained from the same source and hatch, shall be properly 
identified and used as provided in this paragraph.
    (1) Vaccinates. Each of not more than 21 chickens shall be injected 
with the dose and by the route recommended on the label. A second dose 
shall be injected after 3 weeks and the chickens observed for an 
additional 2 week prechallenge period.
    (2) Unvaccinated controls. Each of not more than 11 chickens shall 
be held as controls.
    (3) Challenge. Not less than 14 days after the second injection, 
each of 20 vaccinates, and each of 10 unvaccinated controls shall be 
challenged intramuscularly with a minimum of 250 colony-forming units of 
virulent Pasteurella multocida, Strain X-73, Type 1 (Little and Lyons 
classification) and observed daily for a 14-day postchallenge period. 
Only dead birds shall be considered in evaluating the product.
    (4) Validity requirements. Eight or more unvaccinated controls must 
die for the test to be valid. If these requirement are met, the potency 
test results are evaluated according to stage one of the following 
table. The test is a No Test and may be repeated if the validity 
requirements are not met, but the serial is unsatisfactory if the test 
is not repeated.

----------------------------------------------------------------------------------------------------------------
                                                                  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 a No Test and may be 
repeated if unfavorable reactions that are not attributable to the 
product occur in two or more turkeys, but the serial is unsatisfactory 
if the test is not repeated.
    (c) Potency test. Bulk or final container samples of completed 
product

[[Page 759]]

shall be tested for potency of the Type 3 strain, using the two-stage 
test provided in this paragraph. Turkeys, at least 6 weeks of age, 
obtained from the same source and hatch, shall be properly identified 
and used as provided in this paragraph.
    (1) Vaccinates. Each of not more than 21 turkeys shall be injected 
with the dose and by the route recommended on the label. A second dose 
shall be injected after 3 weeks and the turkeys observed for an 
additional 2 week prechallenge period.
    (2) Unvaccinated controls. Each of not more than 11 turkeys shall be 
held as controls.
    (3) Challenge. Not less than 14 days after the second injection, 
each of 20 vaccinates, and each of 10 unvaccinated controls shall be 
challenged intramuscularly with a minimum of 150 colony-forming units of 
virulent Pasteurella multocida, Strain P-1059, Type 3 (Little and Lyons 
Classification) and observed daily for a 14-day postchallenge period. 
Only dead birds shall be considered in evaluating the product.
    (4) Validity requirements. Eight or more unvaccinated controls must 
die for the test to be valid. If these requirements are met, the potency 
test results are evaluated according to stage one of the following 
table. The test is a No Test and may be repeated if the validity 
requirements are not met, but the serial is unsatisfactory if the test 
is not repeated.

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

[[Page 760]]

    (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:
[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.

[[Page 761]]

    (1) The ability of the bacterin being tested (Unknown) to protect 
mice shall be compared with a Standard Reference Bacterin (Standard) 
which is either supplied by or acceptable to Animal and Plant Health 
Inspection Service.
    (2) At least three tenfold dilutions shall be made with the Standard 
and the same tenfold dilutions shall be made for each Unknown. The 
dilutions shall be made in Phosphate Buffered Saline.
    (3) For each dilution of the Standard and each dilution of an 
Unknown, a group of at least 20 mice, each weighing 16-22 grams, shall 
be used. Each mouse in a group shall be injected intraperitoneally with 
one mouse dose of the appropriate dilution. Each mouse shall be 
revaccinated on day 14, using the same schedule.
    (4) Each of 20 vaccinated mice per group shall be challenged 
intraperitoneally 7-10 days after the second vaccination with a 0.25 ml 
dose containing 100-10,000 mouse 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

[[Page 762]]

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.
    (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

[[Page 763]]

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 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

[[Page 764]]

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 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:

[[Page 765]]

[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 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.

[[Page 766]]

    (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.
    (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. \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.

[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; 79 FR 31021, May 30, 2014]



Sec. Sec.113.201-113.203  [Reserved]



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 a No Test and may be repeated: 
Provided, That, if the test is not repeated, the serial is 
unsatisfactory.
    (b) Potency test. Bulk or final container samples of completed 
product shall be tested for potency using 10 mink enteritis susceptible 
mink (five vaccinates and five controls) as follows:
    (1) Vaccination. Each of the five vaccinates shall be injected with 
one dose of vaccine as recommended on the label and observed each day 
for 14 days.
    (2) Challenge. At least 2 weeks after the last inoculation, the five 
vaccinates and the five controls shall be challenged with virulent mink 
enteritis virus and observed each day for 12 days. Fecal material shall 
be collected on one day between days 4-8 (inclusive) postchallenge from 
each test animal that remains free of enteric signs and tested for the 
presence of mink enteritis virus by cell culture with fluorescent 
antibody examination.
    (3) Interpretation. A serial is satisfactory if at least 80 percent 
of the vaccinates remain free of enteric signs and do not shed virus in 
the feces, while at least 80 percent of the controls develop clinical 
signs of mink enteritis or shed virus in the feces. If at least 80 
percent of the vaccinates remain free of enteric signs and do not shed 
virus in the feces, while less than 80 percent of the controls develop 
clinical signs of mink enteritis or shed virus in the feces, the test is 
considered a No Test and may be repeated: Provided, That, if at least 80 
percent of the vaccinates do not remain well and free of detectable 
virus in the feces, the serial is unsatisfactory.

[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-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

[[Page 767]]

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 a 
No Test and may be repeated: Provided, That, if the test is not 
repeated, the serial shall be declared unsatisfactory.
    (b) Potency test. A vaccination-challenge test shall be conducted 
using susceptible chickens 2 to 6 weeks of age at time of vaccination, 
properly identified and obtained from the same source and hatch.
    (1) Ten or more chickens shall be vaccinated as recommended on the 
label and kept isolated under observation for at least 14 days.
    (2) After at least 14 days post-vaccination, the vaccinates and at 
least 10 unvaccinated chickens that have been kept isolated as controls 
shall be challenged with a virulent strain of Newcastle disease virus 
supplied by or approved by Veterinary Services and the vaccinates 
observed each day for 14 days.
    (3) If at least 90 percent of the controls do not show typical signs 
of Newcastle disease or die, the test is a No Test and may be repeated. 
If at least 90 percent of the vaccinates do not remain normal, the 
serial is unsatisfactory.

[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(h).

[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; 81 FR 59436, Aug. 30, 2016]



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, the serial is 
unsatisfactory. If unfavorable reactions not attributable to the product 
occur, the test is a No Test and

[[Page 768]]

may be repeated: Provided, That, if the test is not repeated, the serial 
is unsatisfactory.
    (b) Potency test. Bulk or final container samples of completed 
product from each serial shall be tested for potency in accordance with 
the two-stage test provided in this paragraph. For each fraction 
contained in the product--Eastern type, Western type, or Venezuelan 
type--the serological interpretations required in this test shall be 
made independently. A serial or subserial found unsatisfactory for any 
of the fractions shall not be released.
    (1) For this test, a guinea pig dose shall be one-half the amount 
recommended on the label for a horse and shall be administered as 
recommended for a horse. Each of 10 healthy guinea pigs (vaccinates) 
shall be injected with two guinea pig doses with an interval of 14 to 21 
days between doses. Two additional guinea pigs from the same source 
shall be held as controls.
    (2) Fourteen to 21 days after the second injection, serum samples 
from each vaccinate and each control shall be tested by a plaque 
reduction, serum neutralization test using Vero 76 cells.
    (3) If the control serum samples show a titer of 1:4 or greater for 
any fraction, the test is a No Test for that fraction and may be 
repeated: Provided, That, if four or more of the vaccinate serum samples 
show a titer of less than 1:40 for the Eastern type fraction, less than 
1:40 for the Western type fraction, or less than 1:4 for the Venezuelan 
type fraction, the serial or subserial is unsatisfactory without further 
testing.
    (4) If two or three of the vaccinate serum samples show a titer of 
less than 1:40 for the Eastern type fraction, less than 1:40 for the 
Western type fraction, or less than 1:4 for the Venezuelan type 
fraction, the second stage of the test may be used for the relevant 
fraction(s): Provided, That, if a fraction is found acceptable by the 
first stage of the test, the second stage need not be conducted for that 
fraction.
    (5) If the second stage is used and four or more of the vaccinate 
serum samples show a titer of less than 1:40 for the Eastern type 
fraction or the Western type fraction, or less than 1:4 for the 
Venezuelan type fraction, the serial or subserial is unsatisfactory.
    (6) The results shall be evaluated according to the following table:

                                                Cumulative Totals
----------------------------------------------------------------------------------------------------------------
                Stage                         Vaccinates        Failures for acceptance   Failures for rejection
----------------------------------------------------------------------------------------------------------------
1....................................  10.....................  1 or less..............  4 or more.
2....................................  20.....................  3 or less..............   Do.
----------------------------------------------------------------------------------------------------------------


[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 of the 5 embryos shall show 
evidence of AE virus infection during the 11 to 13

[[Page 769]]

day PI period or the test shall be considered a No Test and repeated: 
Provided, That, if the test is not repeated, the serial shall be 
declared unsatisfactory.
    (ii) Chicken test. Each of 10 or more AE susceptible 7 day old 
chickens shall be injected intracerebrally with 0.1 ml vaccine each. The 
chickens shall be observed each day for 28 days. If any chickens show 
clinical signs of AE, the serial is unsatisfactory. Concurrently, 5 
additional chickens from the same source shall be injected 
intracerebrally with live AE virus of the production strain to serve as 
positive controls. At least 4 of the 5 controls shall show evidence of 
AE virus infection during the observation period or the test shall be a 
No Test and may be repeated: Provided, That, if the test is not 
repeated, the serial shall be unsatisfactory.
    (b) Potency test. Bulk or final container samples of completed 
product from each serial or one subserial shall be tested. Ten or more 
AE-susceptible chickens (vaccinates), 4 weeks or older, properly 
identified and obtained from the same source and hatch, shall be 
injected as recommended on the label. At least 10 additional AE-
susceptible chickens, properly identified and obtained from the same 
source and hatch shall be kept in isolation as controls.
    (1) At least 28 days post-injection, the vaccinates and the controls 
shall be challenged intramuscularly with a virulent AE virus and the 
chickens observed each day for 21 days.
    (2) If at least 80 percent of the controls do not show clinical 
signs of or die from AE infection, the test is a No Test and may be 
repeated.
    (3) If at least 80 percent of the vaccinates do not remain normal, 
the serial is unsatisfactory.

[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 and are incorporated by reference.

[[Page 770]]

These provisions state that the challenge virus standard to be used as 
the challenge in the NIH test and the reference vaccine for the test are 
available from the national control authority. In the United States, 
that authority is the Animal and Plant Health Inspection Service's 
Center for Veterinary Biologics Laboratory, located at 1920 Dayton 
Avenue, P.O. Box 844, Ames, IA 50010; phone (515) 337-6100; fax (515) 
337-6120. This incorporation by reference was approved by the Director 
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from the World Health Organization 
Publications Center USA, 49 Sheridan Avenue, Albany, NY 12210. Copies 
may be inspected at the Animal and Plant Health Inspection Service, 
Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 
Dayton Avenue, P.O. Box 844, Ames, IA 50010, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/ federal_register/code_ of_federal_regulations/ 
ibr_locations.html.
    (2) The dose of vaccine to be used in the immunogenicity test shall 
be no more than the amount which, on the basis of The NIH Test For 
Potency, has been diluted to the proposed minimum acceptable potency 
value. \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

[[Page 771]]

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.113.200 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; 69 FR 18803, Apr. 9, 2004; 75 
FR 20773, Apr. 21, 2010]



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

[[Page 772]]

not attributable to the vaccine, the test is inconclusive and may be 
repeated. If the test is not repeated, the serial is unsatisfactory.
    (2) Potency. Bulk or final container samples of completed product 
shall be treated for potency as follows:
    (i) Eight feline calicivirus susceptible cats (five vaccinates and 
three controls) shall be used as test animals. Throat and nasal swabs 
shall be collected from each cat and individually tested on susceptible 
cell cultures for the presence of feline calicivirus. Blood samples 
shall be drawn and individual serum samples tested for neutralizing 
antibody. The cats shall be considered suitable for use if all swabs are 
negative for virus isolation and all serums are negative for calicivirus 
antibody at the 1:2 final dilution in a 50 percent plaque reduction test 
or other test of equal sensitivity.
    (ii) The five cats used as vaccinates shall be administered one dose 
of vaccine by the method recommended on the label. If two doses are 
recommended, the second dose shall be given after the interval 
recommended on the label.
    (iii) Fourteen or more days after the final dose of vaccine, the 
vaccinates and controls shall each be challenged intranasally with 
virulent feline calicivirus furnished or approved by Animal and Plant 
Health Inspection Service and observed each day for 14 days 
postchallenge. The rectal temperature of each animal shall be taken and 
the presence or absence of clinical signs, particularly lesions on the 
oral mucosa, noted and recorded each day.
    (iv) If three of three controls do not show clinical signs of feline 
calicivirus infection other than fever, the test is inconclusive and may 
be repeated.
    (v) If a significant difference in clinical signs cannot be 
demonstrated between vaccinates and controls using a scoring system 
approved by Animal and Plant Health Inspection Service and prescribed in 
the Outline of Production, the serial is unsatisfactory.

[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  [Reserved]



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 a No Test 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 a No Test and may be 
repeated. If the test is not repeated, the serial is unsatisfactory.

[[Page 773]]

    (2) Potency. Bulk or final container samples of completed product 
from each serial shall be tested for potency using the two-stage potency 
test provided in this paragraph.
    (i) Vaccinates. Inject each of 21 susceptible chickens 14 to 28 days 
of age, properly identified and obtained from the same source and hatch, 
with one dose of vaccine by the route recommended on the label and 
observe for at least 21 days.
    (ii) Controls. Retain at least 10 additional chickens from the same 
source and hatch as unvaccinated controls.
    (iii) Challenge. Twenty-one to 28 days postvaccination, challenge 20 
vaccinates and 10 controls by eyedrop with a virulent infectious bursal 
disease virus furnished or approved by Animal and Plant Health 
Inspection Service.
    (iv) Postchallenge period. Four days postchallenge, necropsy all 
chickens and examine each for gross lesions of bursal disease. For 
purposes of this test, gross lesions shall include peribursal edema and/
or edema and/or macroscopic hemorrhage in the bursal tissue. Vaccinated 
chickens showing gross lesions shall be counted as failures. If at least 
80 percent of the controls do not have gross lesions of bursal disease 
in a stage of the test, that stage is considered inconclusive and may be 
repeated. In a valid test, the results shall be evaluated according to 
the following table:

----------------------------------------------------------------------------------------------------------------
                                                    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; 79 FR 55969, Sept. 18, 
2014]



Sec. Sec.113.213-113.214  [Reserved]



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 section shall be observed each day during the prechallenge 
period. If unfavorable reactions occur, including respiratory signs, 
which are attributable to the vaccine, the serial is unsatisfactory. If 
unfavorable reactions occur which are not attributable to the vaccine, 
the test is a No Test and may be

[[Page 774]]

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 a No Test 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 section shall be observed each day during the prechallenge 
period. If unfavorable reactions occur, which are attributable to the 
vaccine, the serial is unsatisfactory. If unfavorable reactions occur 
which are not attributable to the vaccine, the test is a No Test and may 
be repeated one time. If the results of the second test are not 
satisfactory, or if the test is not repeated, the serial is 
unsatisfactory.

[[Page 775]]

    (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 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

[[Page 776]]

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 a 
No Test and may be repeated.
    (4) If the vaccinates do not show a typical immune reaction, the 
serial is unsatisfactory: Provided, That, an initial active reaction 
with hyperemia which resolves progressively and disappears within 2 
weeks, may be characterized as a typical immune reaction.

[39 FR 27430, July 29, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66786, Dec. 26, 1991]

[[Page 777]]



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 a No Test and may be repeated.
    (ii) If at least 19 of 20, 27 of 30, or 36 of 40 of the vaccinates 
do not survive without showing clinical signs of distemper during the 
observation period, the Master Seed Virus is unsatisfactory.
    (4) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be authorized by Animal 
and Plant Health Inspection Service.
    (d) Test requirements for release: Each serial and subserial shall 
meet the general requirements prescribed in 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 manner recommended on the label. The mink shall be 
observed each day for 21 days. If unfavorable reactions attributable to 
the product occur in either of the mink during the observation period, 
the serial or subserial is unsatisfactory. If unfavorable reactions 
which are not attributable to the product occur, the test shall be 
declared a No Test and may be repeated: Provided, That if the test is 
not repeated, the serial or subserial shall be declared unsatisfactory.
    (2) Potency Test. An in vitro potency test shall be conducted. To be 
eligible for release, each serial and subserial shall have a virus titer 
sufficiently greater than the titer of vaccine virus

[[Page 778]]

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; 72 FR 72564, Dec. 21, 2007]



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 a No Test 
and may be repeated.
    (ii) If at least 19 of the 20 vaccinates tested as prescribed in 
paragraph (c)(3) of this section do not have bluetongue neutralizing 
antibody titers of 1:4 final serum dilution or higher, or if more than 
one of the vaccinates shows a temperature rise of 3 [deg]F or higher 
than its prechallenge mean temperature for 2 or more days, or if more 
than one of the vaccinates exhibits clinical signs of bluetongue, the 
Master Seed is unsatisfactory.
    (5) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed shall be granted by Animal and Plant 
Health Inspection Service.
    (d) Test requirements for release. Each serial and subserial shall 
meet the applicable general requirements prescribed in Sec.113.300 and 
the requirements in this paragraph. Final container samples of completed 
product shall be tested. Any serial or subserial

[[Page 779]]

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; 72 FR 72564, Dec. 21, 
2007]



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 cats held as uninjected controls. To confirm the dosage 
calculations, five replicate virus titrations shall be conducted on a 
sample of the vaccine virus dilution used.
    (3) Fourteen days post-injection, the vaccinates and the controls 
shall be challenged with virulent feline panleukopenia virus furnished 
by Animal and Plant Health Inspection Service and the cats observed each 
day for 14 days.
    (i) If at least 80 percent of the controls do not show clinical 
signs of feline panleukopenia during the observation period, the test is 
a No Test and may be repeated. Clinical signs of feline panleukopenia 
shall include a pronounced leukopenia wherein the white cell count drops 
to 4,000 or less per cubic mm, or the white cell count drops to less 
than 25 percent of the normal level established by an average of three 
or more counts taken prior to challenge.

[[Page 780]]

    (ii) If at least 19 of the 20 vaccinates do not survive the 
observation period without showing clinical signs of feline 
panleukopenia as described in paragraph (c)(3)(i) of this section, the 
Master Seed Virus is unsatisfactory.
    (4) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (d) Test requirements for release. Each serial and subserial shall 
meet the requirements prescribed in 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 a No Test and repeated: Provided, That, if 
not repeated, the serial shall be unsatisfactory.
    (2) Virus titer requirements. Final container samples of completed 
product shall be tested for virus titer using the titration method used 
in paragraph (c)(2) of this section. To be eligible for release, each 
serial and each subserial shall have a virus titer sufficiently greater 
than the titer of vaccine virus used in the immunogenicity test 
prescribed in paragraph (c) of this section to assure that when tested 
at any time within the expiration period, each serial and subserial 
shall have a virus titer of 10 \0.7\ greater than that used in 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; 72 FR 
72564, Dec. 21, 2007]



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 a No Test and may be 
repeated.

[[Page 781]]

    (B) If at least 19 of the 20 vaccinates do not survive without 
showing clinical signs of infectious canine hepatitis during the 
observation period, the Master Seed Virus is unsatisfactory.
    (2) Immunogenicity for canine adenovirus Type 2. Thirty canine 
adenovirus type 2 susceptible dogs shall be used as test animals (20 
vaccinates and 10 controls). Blood samples shall be drawn from these 
animals and individual serum samples tested. The dogs shall be 
considered susceptible if the results are negative at a 1:2 final serum 
dilution in a varying serum-constant virus neutralization test using 50 
to 300 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 a No 
Test and may be repeated.
    (B) If a significant difference in clinical signs in a valid test 
cannot be demonstrated between vaccinates and controls using a scoring 
system approved by the Animal and Plant Health Inspection Service, the 
Master Seed Virus is unsatisfactory.
    (iii) An Outline of Production change shall be made before 
authorization for use of a new lot of Master Seed Virus shall be granted 
by the Animal and Plant Health Inspection Service.
    (c) Test requirements for release. Each serial and subserial shall 
meet the requirements prescribed in 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, as amended at 72 FR 72564, Dec. 21, 2007]



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 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

[[Page 782]]

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 a No Test and may be repeated.
    (ii) If at least 19 of the 20 vaccinates do not survive without 
showing clinical signs of canine distemper during the observation 
period, the Master Seed Virus is unsatisfactory.
    (4) An Outline of Production change shall be made before 
authorization for use of a new lot of Master Seed Virus shall be granted 
by the Animal and Plant Health Inspection Service.
    (c) Test requirements for release. Except for 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) 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, as amended at 72 FR 72564, Dec. 21, 2007]



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:

[[Page 783]]

    (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) 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.
    (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; 72 FR 72564, Dec. 21, 
2007]



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

[[Page 784]]

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.
    (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) 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 785]]

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; 72 FR 72564, Dec. 21, 2007]



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.
    (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 a 
No Test and may be repeated.
    (6) If less than 19 of the post-injection serum samples tested as 
prescribed in paragraph (c)(3) of this section show neutralization in 
all tubes of the 1:2 final serum dilution, or if more than one of the 
vaccinates show a temperature of 103.5 [deg]F. or higher for 2 or more

[[Page 786]]

days, or if more than one of the vaccinates exhibit respiratory or other 
clinical signs of infectious bovine rhinotracheitis, or both, the Master 
Seed Virus is unsatisfactory.
    (7) A sequential test procedure may be used in lieu of the 20 calf 
requirement. A beta value of .05 and a tolerance level of .78 shall be 
required.
    (8) An outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (d) Test requirements for release: Each serial and subserial shall 
meet the applicable general requirements prescribed in 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 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; 72 FR 72564, 
Dec. 21, 2007]



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

[[Page 787]]

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 a No Test and may be repeated.
    (5) If less than 19 of the post-injection serum samples, tested as 
prescribed in paragraph (c)(3) of this section, show neutralization in 
all tubes of the 1:8 dilution; or if more than one of the vaccinates 
exhibits respiratory or other clinical signs of bovine virus diarrhea 
post-challenge; or both, the Master Seed Virus is unsatisfactory.
    (6) A sequential test procedure may be used in lieu of the 20 calf 
requirement. A beta value of .05 and a tolerance level of .78 shall be 
required.
    (7) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (d) Test requirements for release: Each serial and subserial shall 
meet the applicable general requirements prescribed in 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; 72 FR 72564, Dec. 21, 2007]



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.

[[Page 788]]

    (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 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

[[Page 789]]

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 
for a satisfactory test without further challenge. If one or more of the 
vaccinates die from rabies, all the remaining vaccinates, regardless of 
titer, along with the five controls shall be challenged. The cumulative 
results from the two challenges shall be evaluated for acceptance as 
specified in paragraph (b)(3)(v) of this section.
    (5) An outline of Production change shall be made before authority 
for use of a new lot of Master Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (c) If more than 1 year duration of immunity is to be claimed, a 
duration of immunity test for the additional time shall be conducted and 
interpreted as prescribed in paragraph (b) of this section for the 1 
year test. The test animals shall be monitored serologically at least 
every 180 days. The time of challenge may be adjusted accordingly.
    (d) Test requirements for release: Each serial and each subserial 
shall meet the general requirements prescribed in 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 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.

[[Page 790]]

    (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; 72 FR 72564, Dec. 21, 2007]



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 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

[[Page 791]]

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 a No Test and may be repeated.
    (ii) If at least 19 of the 20 vaccinates do not survive without 
showing a temperature of 104.0 [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) 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; 72 FR 72564, Dec. 21, 
2007]



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 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

[[Page 792]]

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 a No Test and may be 
repeated.
    (ii) If a significant difference in clinical signs cannot be 
demonstrated between vaccinates and controls using a scoring system 
approved by Animal and Plant Health Inspection Service and prescribed in 
the Outline of Production, the Master Seed Virus is unsatisfactory.
    (4) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (d) Test requirements for release. Each serial and subserial shall 
meet the requirements prescribed in 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; 72 FR 72564, Dec. 21, 
2007]



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 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

[[Page 793]]

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 a No Test and 
may be repeated.
    (ii) If a significant difference in clinical signs cannot be 
demonstrated between vaccinates and controls using a scoring system 
approved by Veterinary Services and prescribed in the Outline of 
Production, the Master Seed Virus is unsatisfactory.
    (4) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (d) Test requirements for release. Each serial and subserial shall 
meet the requirements prescribed in 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; 72 FR 72564, Dec. 21, 2007]



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

[[Page 794]]

shall be administered a predetermined quantity of vaccine virus. Five 
replicate virus titrations shall be conducted on a sample of the vaccine 
virus dilution used to confirm the dosage administered. If two doses are 
used, five replicate confirming titrations shall be conducted on each 
dose.
    (3) Three to 4 weeks after the final dose of vaccine, all dogs shall 
be bled for serum antibodies and nasal swabs shall be collected for 
canine parainfluenza virus isolation. On the same day, all vaccinates 
and controls shall be challenged with canine parainfluenza virus 
furnished or approved by Animal and Plant Health Inspection Service.
    (4) The rectal temperature of each dog shall be taken and the 
presence of respiratory or other clinical signs of canine parainfluenza 
virus infection noted and recorded each day for 14 consecutive days 
postchallenge. Nasal swabs shall be collected from each dog each day for 
at least 10 consecutive days postchallenge. Individual swabs shall be 
tested for virus isolation by culture in canine parainfluenza virus 
susceptible cells for at least 7 days. Results shall be evaluated 
according to the following criteria:
    (i) If five of five controls have not remained seronegative at a 
final serum dilution of 1:2 during the prechallenge period, the test is 
a No Test and may be repeated.
    (ii) If more than one vaccinate shows febrile response, respiratory 
or other clinical signs of canine parainfluenza virus infection; or, if 
less than 19 of 20 vaccinates show serum neutralization titers of 1:4 or 
greater; or, if there is not a significant reduction in virus isolation 
rate in vaccinates when compared with controls, the Master Seed is 
unsatisfactory.
    (5) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed shall be granted by Animal and Plant 
Health Inspection Service.
    (c) Test requirements for release. Each serial and subserial shall 
meet the applicable general requirements prescribed in 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 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; 72 FR 72564, Dec. 21, 
2007]



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

[[Page 795]]

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 a No Test and may be repeated.
    (ii) If at least 19 of the 20 vaccinates do not survive the 
observation period without showing more than one criterion of infection 
described in paragraph (c)(3)(i), of this section, the Master Seed is 
unsatisfactory.
    (4) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed shall be granted by Animal and Plant 
Health Inspection Service.
    (d) Test requirements for release. Each serial and subserial shall 
meet the applicable general requirements prescribed in 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; 72 FR 72564, Dec. 21, 
2007]



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

[[Page 796]]

from the Master Seed shall be established before the immunogenicity test 
is conducted. The 20 pigs used as vaccinates shall be administered a 
predetermined quantity of vaccine virus by the method recommended on the 
label. To confirm the dosage administered, five replicate virus 
titrations shall be conducted on a sample of the vaccine virus dilution 
used.
    (3) Fourteen to 28 days postvaccination, the vaccinates and controls 
shall be challenged with virulent pseudorabies virus furnished or 
approved by Animal and Plant Health Inspection Service and observed each 
day for 14 days.
    (i) If at least four of the five controls do not develop severe 
central nervous system signs or die, the test is a No Test and may be 
repeated.
    (ii) If at least 19 of the 20 vaccinates in a valid test do not 
remain free of signs of pseudorabies, the Master Seed is unsatisfactory.
    (4) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed shall be granted by Animal and Plant 
Health Inspection Service.
    (c) Test requirements for release. Each serial and subserial shall 
meet the applicable general requirements prescribed in 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; 72 FR 72564, Dec. 21, 
2007]



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 a No Test because of a vaccine virus override, the 
test may be repeated and if the repeat test is inconclusive for the same 
reason, the chicken inoculation test prescribed in 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 797]]

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 a No Test and may be 
repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the 
vaccinates in each group do not remain free from clinical signs of avian 
encephalomyelitis during the observation period, the Master Seed Virus 
is unsatisfactory.
    (5) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (d) After a lot of Master Seed Virus has been established as 
prescribed in paragraphs (a), (b), and (c) of this section, each serial 
and subserial shall meet the applicable requirements in 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 a No Test 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 a No Test and repeated, except that, if the 
test is not repeated, the serial shall be unsatisfactory.
    (3) Virus titer requirements. Final container samples of completed 
product shall be tested for virus titer using the titration method used 
in paragraph (c)(2) of this section. To be eligible for release, each 
serial and each subserial shall have a virus titer sufficiently greater 
than the titer of vaccine virus used in the immunogenicity test 
prescribed in paragraph (c) of this section to assure that when tested 
at any time within the expiration period, each serial and subserial 
shall have a virus titer of 10 \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; 72 FR 72564, Dec. 21, 2007; 79 FR 
55969, Sept. 18, 2014]



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

[[Page 798]]

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 a No Test and may be 
repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the 
vaccinates in each group do not remain free from clinical signs of fowl 
pox during the observation period, the Master Seed Virus is 
unsatisfactory.
    (5) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (d) After a lot of Master Seed Virus has been established as 
prescribed in paragraphs (a), (b), and (c) of this section, each serial 
and subserial shall meet the requirements in 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.
    (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:

[[Page 799]]



                                                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 a No Test and may be repeated 
or, in lieu thereof, the serial declared unsatisfactory.
    (iv) Vaccines not recommended for use in birds 10 days of age or 
younger shall be tested for safety as follows: Each of twenty-five 3- to 
5-week-old, fowl-pox susceptible birds shall be vaccinated with the 
equivalent of 10 doses of vaccine by each of all routes recommended on 
the label and observed each day for 14 days. If any of the birds show 
severe clinical signs of disease or death during the observation period 
due to causes attributable to the product, the serial is unsatisfactory. 
If unfavorable reactions occur which are not attributable to the 
product, the test shall be declared a No Test and may be repeated or, in 
lieu thereof, the serial declared unsatisfactory.
    (2) Virus titer requirements. Final container samples of completed 
product shall be tested for virus titer using the titration method used 
in paragraph (c)(2) of this section. To be eligible for release, each 
serial and each subserial shall have a virus titer sufficiently greater 
than the titer of vaccine virus used in the immunogenicity test 
prescribed in paragraph (c) of this section to assure that when tested 
at any time within the expiration period, each serial and subserial 
shall have a virus titer of 10 \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; 72 FR 72564, Dec. 21, 2007]



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 a No Test because of a vaccine virus override, the 
test may be repeated and if the repeat test is a No Test for the same 
reason, the chicken inoculation test prescribed in 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 
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

[[Page 800]]

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 a 
No Test. A tracheal swab shall be positive for virus recovery when any 
of the embryos in a valid test show typical infectious bronchitis virus 
lesions, such as but not limited to, stunting, curling, kidney urates, 
clubbed down, or death during the 4 to 7 day post-inoculation period. If 
less than 20 percent of the embryos which survive the third day post-
inoculation die during the 4 to 7 day post-inoculation period and show 
no gross lesions typical of infectious bronchitis, they may be 
disregarded.
    (iii) If less than 90 percent of the controls are positive for virus 
recovery, the test is a No Test and may be repeated.
    (iv) If less than 90 percent of the vaccinates are negative for 
virus recovery, the Master Seed Virus is unsatisfactory.
    (4) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (d) After a lot of Master Seed Virus has been established as 
prescribed in paragraphs (a), (b), and (c) of this section, each serial 
and subserial shall meet the applicable requirements in 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 a No Test 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 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.
----------------------------------------------------------------------------------------------------------------


[[Page 801]]


If unfavorable reactions occur which are not attributable to the 
product, the test shall be declared a No Test and repeated or, in lieu 
thereof, the serial declared unsatisfactory.
    (3) Virus titer requirements. Final container samples of completed 
product shall be tested for virus titer using the 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; 72 FR 
72564, Dec. 21, 2007]



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 a No Test because of vaccine virus override, the 
test may be repeated and if the repeat test is a No Test for the same 
reason, the chicken inoculation test prescribed in 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 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.

[[Page 802]]

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 a No Test and may be repeated. If at least 19 of 20, 27 of 
30, or 36 of 40 of the vaccinates in each group do not remain free of 
clinical signs of fowl laryngotracheitis during the observation period, 
the Master Seed Virus is unsatisfactory.
    (6) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (d) After a lot of Master Seed Virus has been established as 
prescribed in paragraphs (a), (b), and (c) of this section, each serial 
and subserial shall meet the applicable requirements in 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 a No Test 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 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 a No Test and repeated or in 
lieu thereof, the serial declared unsatisfactory.
    (3) Virus titer requirements. Final container samples of completed 
product shall be tested for virus titer using the titration method 
provided in paragraphs (c)(2) or (3) of this section. To be eligible for 
release, each serial and each subserial shall have a virus titer 
sufficiently greater than the titer of vaccine virus used in the

[[Page 803]]

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; 72 FR 72564, 
Dec. 21, 2007]



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 a No Test because of a vaccine virus override, the 
test may be repeated and if the repeat test is a No Test for the same 
reason, the chicken inoculation test prescribed in 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 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 a 
No Test and may be repeated. If at least 19 of 20, or 27 of 30, or 36 of 
40 of the vaccinates in each group do not remain free from clinical 
signs of Newcastle disease during the observation period, the Master 
Seed Virus is unsatisfactory.
    (5) A strain identity test acceptable to Animal and Plant Health 
Inspection Service shall be conducted.

[[Page 804]]

    (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, 
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 a No Test 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 a No Test and may be repeated.
    (iv) Vaccines not recommended for use in chickens 10 days of age or 
younger shall be tested for safety as follows:
    Each of twenty-five 3 to 5 week old Newcastle disease susceptible 
chickens shall be vaccinated as recommended on the label with the 
equivalent of ten doses and observed each day for 21 days. If any of the 
birds show severe clinical signs of disease or death during the 
observation period due to causes attributable to the product, the serial 
is unsatisfactory.
    (3) Virus titer requirements. Final container samples of completed 
product shall be tested for virus titer using the titration method used 
in paragraph (c)(2) of this section. To be eligible for release, each 
serial and each subserial shall have a virus titer per dose sufficiently 
greater than the titer of vaccine virus used in the immunogenicity test 
prescribed in paragraph (c) of this section to assure that when tested 
at any time within the expiration period, each serial and subserial 
shall have a virus titer of 10 \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; 72 FR 72564, 
Dec. 21, 2007]



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 a No Test because of a vaccine virus override, the 
chicken inoculation

[[Page 805]]

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 a No 
Test and may be repeated.
    (ii) At 120 days of age, the remaining chickens in groups 1, 3, and 
4 shall be weighed, killed, and necropsied. If less than 30 of the 
chickens in group 3 survive the 120 day period, or if any of the 
chickens in group 3 have gross lesions of Marek's disease at necropsy, 
the test is declared a No Test. If less than 30 chickens in groups 1 and 
4 survive the 120 day period; or if any of the chickens in groups 1 and 
4 have gross lesions of Marek's disease at necropsy; or if the average 
body weight of the chickens in groups 1 or 4 is significantly 
(statistically) different from the average in group 3 at the end of the 
120 days, the lot of Master Seed Virus is unsatisfactory.
    (3) For tests involving in ovo inoculation, hatchability results 
shall also be reported for each group.
    (c) Immunogenicity. Each lot of Master Seed Virus used for vaccine 
production shall be tested for immunogenicity at the highest passage 
level allowed for the product, and the virus dose to be used shall be 
established as follows:
    (1) Specific pathogen free chickens or embryos, negative for Marek's 
disease antibodies, and from the same source, shall be isolated into the 
following groups:
    (i) Group 1. A minimum of 35 test subjects shall be inoculated with 
the vaccine, using the recommended route, at 1 day of age for chicks or 
18 days of embryonation for embryos. The dose used shall be established 
by 5 replicate virus titrations conducted by a cell culture system or 
other titration method acceptable to APHIS.
    (ii) Group 2. A minimum of 35 nonvaccinated test subjects shall be 
held as challenge controls.
    (iii) Group 3. A minimum of 25 nonvaccinated test subjects shall be 
held as nonchallenge controls.
    (iv) Group 4. Except for studies evaluating vaccines which contain 
only a Serotype 3 virus as the Marek's disease fraction, a minimum of 35 
chicks shall be vaccinated at 1 day of age with a licensed Serotype 3 
vaccine, in order to document the severity of the very virulent 
challenge.
    (2) At least 30 chickens in groups 1, 2, and 4, and at least 20 
chickens in group 3, shall survive to 5 days of age. All chickens in 
groups 1, 2, and 4 shall be challenged at 5 days of age in the following 
manner:
    (i) For studies evaluating vaccines which contain only a Serotype 3 
virus as the Marek's disease fraction, groups 1 and 2 shall be 
inoculated with a standard virulent challenge virus provided or approved 
by APHIS.
    (ii) For all other Marek's disease vaccines, groups 1, 2, and 4 
shall be inoculated with a very virulent challenge virus provided or 
approved by APHIS.

[[Page 806]]

    (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 a No Test 
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 a No Test.
    (ii) If lesions of any disease or cause of death are directly 
attributable to the vaccine, the serial is unsatisfactory.
    (iii) If less than 20 chicks survive the observation period and 
there are no deaths or lesions attributable to the vaccine, the test may 
be repeated one time, Provided, that if the test is not repeated, the 
serial shall be declared unsatisfactory.
    (3) Potency test. The samples shall be titrated using a cell culture 
system or other titration method acceptable to APHIS. For vaccines 
composed of more than one Marek's disease virus serotype, each fraction 
shall be titrated in a serotype-specific manner.
    (i) Samples of desiccated vaccine shall be incubated at 37 [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

[[Page 807]]

(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 a No Test 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 a No Test 
and may be repeated.
    (iii) Twenty-one days postvaccination, the vaccinates and the 
controls shall be necropsied and examined for gross lesions of bursal 
disease. If more than two of the vaccinates have such lesions, the 
Master Seed Virus is unsatisfactory, except that, if any of the negative 
controls or less than four of the positive controls have such lesions, 
the test is a No Test and may be repeated. For purposes of this test, 
gross lesions shall include obvious pathological processes and/or 
obvious reduction in size of the bursa from normal.
    (2) Each of thirty-five 3- to 4-week-old bursal disease susceptible 
chickens (vaccinates) shall be vaccinated with approximately one minimum 
protective dose of vaccine virus as determined in paragraph (c) of this 
section. Each of 10 chickens of the same source and hatch shall be 
administered at least 10 \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, the 10 
positive controls, and 10 of the negative controls shall be necropsied 
and examined for gross lesions of bursal disease. If any of the 
vaccinates have such lesions, the Master Seed Virus is unsatisfactory, 
except that, if any of the negative controls or less than 8 of the 
positive controls have such lesions, the test is a No Test and may be 
repeated. For purposes of this test, gross lesions shall include peri-
bursal edema and/or edema and/or macroscopic hemorrhage in the bursal 
tissue.
    (ii) Fourteen days post-vaccination, the remaining vaccinates and 
negative controls shall be necropsied and examined for obvious bursal 
atrophy. If any of the vaccinates have such atrophy, the Master Seed 
Virus is unsatisfactory, except that, if any of the negative controls 
have such atrophy, the test is a No Test and may be repeated.
    (c) Each lot of Master Seed Virus shall be tested for immunogenicity 
and the selected virus dose to be used shall be established as follows:
    (1) Bursal Disease susceptible chickens, all of the same age (3 
weeks or younger) and from the same source, shall be used. Twenty or 
more chickens shall be used as vaccinates for each method of 
administration recommended on the label. Ten additional chickens of the 
same age and from the same source shall be held as unvaccinated 
controls.
    (2) A geometric mean titer of the vaccine produced from the highest 
passage of the Master Seed Virus shall be established before the 
immunogenicity

[[Page 808]]

test is conducted. Each vaccinate shall receive a predetermined quantity 
of vaccine virus. Five replicate virus titrations shall be conducted on 
an aliquot of the vaccine virus to confirm the amount of virus 
administered to each chicken used in the test. At least three 
appropriate (not to exceed tenfold) dilutions shall be used to conduct 
the titrations by a method acceptable to Animal and Plant Health 
Inspection Service.
    (3) When the test chickens are 28 to 35 days of age but not less 
than 14 days postvaccination, each vaccinate and each control shall be 
challenged by eye-drop with a virulent bursal disease virus provided or 
approved by Animal and Plant Health Inspection Service.
    (i) Three to five days postchallenge, all vaccinates and controls 
shall be necropsied and examined for gross lesions of bursal disease as 
described in paragraph (b)(2)(i) of this section.
    (ii) If at least 19 of 20, or 27 of 30, or 36 of 40 vaccinates in 
each group are not free from such lesions, the Master Seed Virus is 
unsatisfactory, except that, if less than 90 percent of the controls 
have such lesions, the test is a No Test and may be repeated.
    (4) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed Virus shall be granted by Animal and 
Plant Health Inspection Service.
    (d) After a lot of Master Seed Virus has been established as 
prescribed in paragraphs (a), (b), and (c) of this section, each serial 
and subserial shall meet the applicable requirements in 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 a No Test 
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 
twenty-five 4- to 5-week-old bursal disease susceptible chickens shall 
be vaccinated orally with the equivalent of 10 doses.
    (C) Ten chickens of the same source and hatch shall be maintained in 
isolation as negative controls. The vaccinates and controls shall be 
observed each day for 21 days.
    (ii) If unfavorable reactions which are attributable to the 
biological product occur during the observation period, the serial is 
unsatisfactory. If unfavorable reactions occur in more than one of the 
controls or if unfavorable reactions which are not attributable to the 
biological product occur in more than two of the vaccinates, the test 
shall be declared a No Test and repeated, except that, if the test is 
not repeated, the serial shall be unsatisfactory.
    (3) Virus titer requirements. Final container samples of completed 
product shall be tested for virus titer using the titration method used 
in paragraph (c)(2) of this section. To be eligible for release, each 
serial and each subserial shall have a virus titer sufficiently greater 
than the titer of vaccine virus used in the immunogenicity test 
prescribed in paragraph (c) of this section to assure that when tested 
at any time within the expiration period, each serial and subserial 
shall have a virus titer of 10 \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; 72 FR 72564, Dec. 21, 2007]



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

[[Page 809]]

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 known 
antigen, or the Master Seed is unsatisfactory.
    (4) Safety using the following chicken test:
    (i) For vaccines intended for use in chickens less than 14 days of 
age, Master Seed equal to 10 label doses shall be administered 
subcutaneously to each of 25 1-day-old tenosynovitis susceptible 
chickens.
    (ii) For vaccines intended for use only in chickens 14 days of age 
or older, Master Seed equal to 10 label doses shall be administered 
subcutaneously to each of 25 4-week-old or older tenosynovitis 
susceptible chickens.
    (iii) The vaccinates shall be observed each day for 21 days. If 
unfavorable reactions occur which are attributable to the vaccine, the 
Master Seed is unsatisfactory. If unfavorable reactions occur which are 
not attributable to the vaccine, the test is a No Test and may be 
repeated.
    (c) Each lot of Master Seed shall be tested for immunogenicity. The 
selected virus dose shall be established as follows:
    (1) Tenosynovitis susceptible chickens, of the same age and from the 
same source shall be used as test birds. Vaccines intended for use in 
very young chickens shall be administered to chickens of the youngest 
age for which the vaccine is recommended. Vaccines intended for use in 
older chickens shall be administered to 4-week-old or older chickens. 
Twenty or more vaccinates shall be used for each method of 
administration recommended on the label. Ten or more chickens shall be 
held as unvaccinated controls.
    (2) A geometric mean titer of the vaccine produced at the highest 
passage from the Master Seed shall be established using a method 
acceptable to Animal and Plant Health Inspection Service before the 
immunogenicity test is conducted. A predetermined

[[Page 810]]

quantity of vaccine virus shall be administered to each vaccinate. Five 
replicate virus titrations shall be conducted on an aliquot of the 
vaccine virus to confirm the dose.
    (3) Twenty-one to 28 days postvaccination, each vaccinate and 
control shall be challenged by injecting virulent virus furnished or 
approved by Animal and Plant Health Inspection Service into one foot 
pad. The vaccinates and controls shall be observed each day for 14 days. 
If at least 90 percent of the controls do not develop swelling and 
discoloration in the phalangeal joint area of the injected foot pad 
typical of infection with tenosynovitis virus, the test is a No Test and 
may be repeated. If at least 19 of 20, 27 of 30, or 36 of 40 vaccinates 
do not remain free from these signs, disregarding transient swelling 
which subsides within 5 days postchallenge, the Master Seed is 
unsatisfactory.
    (4) An Outline of Production change shall be made before authority 
for use of a new lot of Master Seed shall be granted by Animal and Plant 
Health Inspection Service.
    (d) Test requirements for release. Each serial and subserial shall 
meet the applicable general requirements prescribed in 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 not attributable to the product, the test is a 
No Test and may be repeated. If the test is not repeated, the serial is 
unsatisfactory.
    (3) Virus titer requirements. Final container samples of completed 
product shall be titrated by the method used in paragraph (c)(2) of this 
section. To be eligible for release, each serial and subserial shall 
have a virus titer sufficiently greater than the titer of the vaccine 
virus used in the immunogenicity test prescribed in paragraph (c) of 
this section to assure that, when tested at any time within the 
expiration period, each serial and subserial shall have a virus titer 10 
\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; 
72 FR 72564, Dec. 21, 2007]

                        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

[[Page 811]]

microscopically for the presence of acidfast (Ziehl-Nielsen stain) or 
other microorganisms (Gram stain). A serial which contains 
microorganisms is unsatisfactory for release.
    (b) Safety test. Final container samples of completed product from 
each serial shall be tested for safety. Two mature guinea pigs shall be 
injected subcutaneously with 1 ml and observed for 10 days. If 
unfavorable reactions attributable to the product occur during the 
observation period, the serial is unsatisfactory. If unfavorable 
reactions occur which are not attributable to the product, the test 
shall be declared a No Test and repeated: Provided, That if the test is 
not repeated, the serial shall be declared unsatisfactory.
    (c) Potency test. Bulk or final container samples of completed 
product from each serial shall be subjected to a comparison test using a 
Reference Tuberculin supplied by Animal and Plant Health Inspection 
Service. Test animals shall be 10 sensitized white female guinea pigs 
from one source which weigh 500-700 grams at the beginning of the test 
and which have not been used in a previous test. The comparison test 
shall be conducted in accordance with the procedures prescribed in 
paragraphs (c)(1), (2), (3), (4), (5), (6), (7), and (8) of this 
section.
    (1) The guinea pigs shall be sensitized with a sterile heat-killed 
suspension of equal amounts of strains Pn, C, and Dt of Mycobacterium 
tuberculosis. The heat-killed sensitizing agent shall be injected in a 
volume of 0.5 ml per guinea pig. The guinea pigs shall be considered 
sensitized for testing not less than 30 days nor more than 120 days 
post-injection.
    (2) The guinea pigs shall be prepared for sensitivity testing at 
least 4 hours prior to the injection of tuberculin. The entire abdominal 
and flank areas shall be clipped, a depilatory agent applied for 5-10 
minutes, the area rinsed with warm water, and dried.
    (3) Dilutions of 1:100, 1:200, and 1:400 shall be prepared with the 
Reference Tuberculin and the unknown tuberculin. Three test sites on 
each side of and equidistant from the abdominal midline shall be chosen 
on each guinea pig. Using a tuberculin syringe and needle, 0.05 ml of 
each dilution shall be injected intradermally at one of the test sites 
which has been randomly selected for the dilution.
    (4) The sensitivity of the tuberculins shall be determined 24 hours 
after injected by measuring the area of erythema. Measurements in 
millimeters shall be made anterior of the greatest diameter and 
perpendicular to the first measurement. The square millimeter shall be 
calculated by multiplying the two measurements.
    (5) The total area of response for each tuberculin tested shall be 
determined by adding the areas of erythema for each dilution of each of 
the test animals in a group. The sums of the areas of erythema for all 
three dilutions of each tuberculin shall be added to give the total area 
of tuberculin response.
    (6) The total tuberculin response area of the serial being tested 
shall be expressed as a percentage of the total tuberculin response area 
of the Reference Tuberculin. (The total response area of the serial 
divided by the total response area of the Reference Tuberculin times 
100.)
    (7) If the total tuberculin response area of the serial being tested 
does not fall between 75 percent and 125 percent of the total tuberculin 
response area of the Reference Tuberculin, the serial is unsatisfactory.
    (8) Two unsensitized guinea pigs are given 0.05 ml intradermal 
injections of 1:4 and 1:10 dilutions of both the serial being tested and 
the Reference Tuberculin as a control for nonspecific positive 
reactions. If positive reactions are observed with the Reference 
Tuberculin, the test is considered a ``No Test'' and repeated. If 
positive reactions are observed with the serial being tested only, the 
serial is unsatisfactory.
    (d) Special chemical tests and requirements. Final container samples 
of completed product from each serial shall be tested as follows:
    (1) Hydrogen ion concentration. The hydrogen ion concentration shall 
be determined with a pH meter which has been standardized with a pH 7.0 
buffer just prior to use. The pH of the product shall be 7.0 0.3.
    (2) Total nitrogen determination. The nitrogen content shall be 
determined by the Kjeldahl method on duplicate 15

[[Page 812]]

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.
    (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

[[Page 813]]

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 1,000 x g 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 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

[[Page 814]]

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.
    (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.

[[Page 815]]

    (7) Determination of specificity index. The specificity index of a 
PPD tuberculin is determined by subtracting the average response 
obtained on M. avium sensitized guinea pigs from the average response 
obtained on M. bovis sensitized guinea pigs.
    (8) Validity of bioassay. The bioassay test results obtained on 
serials tested concurrently in a single test series are valid if the 
specificity index of the reference PPD tuberculin is at least 400 square 
millimeters. If the results are not valid, the bioassay test series must 
be repeated with a different set of sensitized guinea pigs.
    (9) Reactions in unsensitized guinea pigs. If a positive reaction 
(erythema) is observed in one or more of the 3 unsensitized guinea pigs, 
the serial is unsatisfactory.
    (10) Interpretation of specificity index. When a bioassay is valid 
and reactions are not observed in unsensitized guinea pigs, the 
following interpretation of the specificity index will be used for 
classifying each serial of PPD tuberculin:

------------------------------------------------------------------------
             Specificity index                     Classification
------------------------------------------------------------------------
440 mm \2\ or greater.....................  Satisfactory.
Between 360 mm \2\ and 440 mm \2\.........  Inconclusive.
Less than 360 mm \2\......................  Unsatisfactory.
------------------------------------------------------------------------

    (11) Second stage test. If a serial is classified as inconclusive, 
it can be declared unsatisfactory or undergo a second stage test. The 
second stage shall be conducted in a manner identical to the first 
stage, except that unsensitized guinea pig controls are not necessary. 
The results are evaluated by combining the results obtained on all 
guinea pigs tested in stages one and two. Calculate the average response 
on the 20 M. bovis sensitized animals and on the 20 M. avium sensitized 
animals and determine the specificity index. An inconclusive serial is 
satisfactory after the second stage test, if its specificity index is 
400 square millimeters or more, and unsatisfactory if its specificity 
index is less than 400 square millimeters.
    (d) Special chemical tests and requirements. Final container samples 
of completed product from each serial shall be tested as follows:
    (1) Protein concentration. The final product shall contain a protein 
concentration of 1.0 0.1 mg/ml. The Microkjeldahl 
Test for Nitrogen shall be used.
    (2) Phenol content. Phenol content of the final product shall be 
0.50 percent plus or minus 0.04 percent. A direct titration with a 
standardized bromide-bromate solution shall be conducted.

[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.''

[[Page 816]]

    (2) Bacterium-specific products. The true name of a bacterium-
specific product shall: include the term ``antibody'' if the component 
antibodies are directed against a nontoxin antigen or the term 
``antitoxin'' if the component antibodies are directed against toxin, 
specify the organism against which the product is intended, and indicate 
the type of animal that supplied the component antibodies. If the 
antibodies are monoclonal, the term ``monoclonal'' shall be used. 
Example: ``Escherichia Coli Monoclonal Antibody, Murine Origin.''
    (3) Failure of passive transfer products. The true name of a product 
for treatment of failure of passive transfer shall include the term 
``IgG'' and indicate the type of animal that supplied the component IgG. 
Example: ``Bovine IgG.''
    (4) Combination products. The true name of a product for treatment 
of failure of passive transfer as well as for the prevention and/or 
alleviation of a specific viral or bacterial disease shall be named 
according to the nomenclature prescribed above for virus-specific or 
bacterium-specific products.
    (c) Animals. All animals used in the production of antibody products 
shall be healthy. Their health status shall be determined by physical 
examination by, or under the direct supervision of, a licensed 
veterinarian and by tests for infectious diseases. Such animals shall be 
maintained at licensed establishments: Provided, That cows maintained at 
Grade A dairies (or the equivalent) that are not injected with antigens 
for the purpose of stimulating the production of specific antibodies and 
that are used only for the purpose of supplying lacteal secretions are 
exempt from being maintained at a licensed establishment.
    (1) No animal shall be used while showing clinical signs of disease. 
The presence of minor localized injuries or lesions (contusions, 
lacerations, burns, etc.) without body temperature elevation and without 
significant pain and distress shall not be construed as clinical 
evidence of disease.
    (2) Before first use and on a regular basis, all animals used in the 
manufacture of antibody products shall be individually subjected to 
applicable tests for infectious diseases. Records of all test results 
shall be maintained. An animal which tests positive for an infectious 
disease shall not be used in the manufacture of antibody products. 
Retests shall be conducted as deemed necessary by the Administrator.
    (i) Before first use, horses shall be tested as follows for:
    (A) Equine infectious anemia (EIA) at a laboratory approved by 
APHIS.
    (B) Piroplasmosis, dourine, and glanders at the National Veterinary 
Services Laboratories.
    (C) Brucellosis at a laboratory approved by APHIS. Horses with 
standard agglutination titers of 1:50 or less can be used for 
production. Horses with standard agglutination titers equal to or 
greater than 1:100 may be tested by the Rivanol or card tests. Reactors 
to these supplemental tests shall not be used for production. 
Nonreactors to the supplemental tests shall be retested after 30 days. 
If the supplemental tests are negative and the agglutination titer has 
not increased, the animal may be used for production. Otherwise, the 
animal is unsatisfactory for this purpose.
    (ii) Horses shall be retested annually for EIA and, if housed or 
pastured with any other species, shall be retested annually for 
brucellosis.
    (iii) Before first use, cattle shall be tested as follows for:
    (A) Tuberculosis by an accredited veterinarian: Provided, That 
cattle at Grade A dairies supplying only lacteal secretions need only be 
tested for tuberculosis in accordance with applicable Milk Ordinances or 
similar laws or regulations.
    (B) Brucellosis at a laboratory approved by APHIS. Cattle with 
standard agglutination titers of 1:50 or less can be used for 
production. Cattle with standard agglutination titers equal to or 
greater than 1:100 may be tested by the Rivanol or card tests. Reactors 
to these supplemental tests shall not be used for production. 
Nonreactors to the supplemental tests shall be retested after 30 days. 
If the supplemental tests are negative and the agglutination titer has 
not increased, the animal may be used for production; otherwise, the 
animal is unsatisfactory for this

[[Page 817]]

purpose. Cattle at Grade A dairies supplying only lacteal secretions 
need not be tested individually for brucellosis if a portion of their 
secretions contribute to the herd milk pool tested as required by the 
brucellosis ring test. An animal of a herd testing positive by this test 
shall not be used in production.
    (iv) Cattle shall be retested annually for both tuberculosis and 
brucellosis. Cattle at Grade A dairies supplying only lacteal secretions 
need only be tested for tuberculosis in accordance with applicable Milk 
Ordinances or similar laws or regulations. Cattle at Grade A dairies 
supplying only lacteal secretions need not be tested individually for 
brucellosis if a portion of their secretions contribute to the herd milk 
pool tested as required by the brucellosis ring test. An animal of a 
herd testing positive by this test shall not be used in production.
    (v) For other species, appropriate tests and the frequency with 
which they are applied shall be specified in the filed Outline of 
Production for the product.
    (vi) If a positive result is obtained on any prescribed test, the 
positive animal(s) shall be removed from the herd and the remaining 
animals retested. Production shall not be renewed until a negative herd 
test is obtained not less than 28 days following removal of the positive 
animal(s).
    (vii) Negative animals shall be maintained separate and apart from 
untested or positive animals of any species. Production animals shall 
not be used for any other purpose, such as testing, work, or recreation.
    (d) Collection procedures. Blood, lacteal secretions, and egg 
material shall be collected as described in the filed Outline of 
Production for the product.
    (e) Ingredient handling and processing. Blood derivatives (serum, 
plasma, etc.), lacteal secretions, and egg material used in the 
production of antibody products shall be subjected to an appropriate 
procedure for the inactivation of potential contaminating 
microorganisms. The procedure shall be one of those described below and 
specified in the filed Outline of Production for the product: Provided, 
That another procedure may be substituted if demonstrated to be at least 
as effective by data acceptable to APHIS and specified in the filed 
Outline of Production for the product. These data are expected to come 
from a study comparing the effectiveness of the established and 
substitute procedures against a satisfactory battery of potential 
contaminating microorganisms.
    (1) Blood derivatives of equine origin shall be heated at 58.0-59.0 
[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

[[Page 818]]

    (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 100 x 15 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 a No Test and 
may be repeated. If characteristic growth is observed on any of the 10 
plates containing samples of the serial, one retest to rule out faulty 
technique may be conducted on samples from 20 final containers. If 
characteristic growth is observed on any of the retest plates, or if a 
retest is not initiated within 21 days of the completion of the original 
test, the serial or subserial is unsatisfactory.
    (ii) Salmonellae. One milliliter of each rehydrated sample shall be 
pipetted into a 100 x 15 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 a No Test and 
may be repeated. If characteristic growth is observed on any of the 10 
plates containing samples of the serial, one retest to rule out faulty 
technique may be conducted on samples from 20 final containers. If 
characteristic growth is observed on any of the retest plates, or if a 
retest is not initiated within 21 days of the completion of the original 
test, the serial or subserial is unsatisfactory.
    (iii) Fungi. One milliliter of each rehydrated sample shall be 
pipetted into a 100 x 15 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

[[Page 819]]

on the negative control plate, or no growth is observed on the positive 
control plate, the test shall be considered a No Test and may be 
repeated. If growth is observed on any of the 10 plates containing 
samples of the serial, one retest to rule out faulty technique may be 
conducted on samples from 20 final containers. If growth is observed on 
any of the retest plates, or if a retest is not initiated within 21 days 
of the completion of the original test, the serial or subserial is 
unsatisfactory.
    (iv) Total bacterial count. One milliliter of each rehydrated 
sample, undiluted or diluted as prescribed in the Outline of Production, 
shall be pipetted into a 100 x 15 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 a No Test and may 
be repeated. If the average number of bacterial colonies on the 10 
plates containing samples of the serial exceeds that specified in the 
filed Outline of Production for the product, one retest to rule out 
faulty technique may be conducted on samples from 20 final containers. 
If the average number of bacterial colonies on the retest plates exceeds 
that specified in the filed Outline of Production for the product, or if 
a retest is not initiated within 21 days of the completion of the 
original test, the serial or subserial is unsatisfactory.
    (i) Safety tests. Bulk or final container samples of each serial 
shall be tested as prescribed in 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 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

[[Page 820]]

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 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.

[[Page 821]]

    (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.
    (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

[[Page 822]]

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 a No Test and 
shall be repeated: Provided, That, if the test is not repeated, the 
serial shall be declared unsatisfactory.
    (ii) If less than 80 percent of the mice inoculated with the mixture 
of 10 International Units of Standard Antitoxin and 10 L+ 
doses of Standard Toxin die, the results of the test are a No Test and 
shall be repeated: Provided, That, if the test is not repeated, the 
serial shall be declared unsatisfactory.
    (iii) If any mice inoculated with the mixture of 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.
    (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

[[Page 823]]

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 a No Test and shall 
be repeated: Provided, That, if the test is not repeated, the serial 
shall be declared unsatisfactory.
    (ii) If less than 80 percent of the mice inoculated with mixture of 
1 International Unit of Standard Antitoxin and 10 L+ doses of 
Standard Toxin die, the results of the test are a No Test and shall be 
repeated: Provided, That, if the test is not repeated, the serial shall 
be declared unsatisfactory.
    (iii) If any mice inoculated with the mixture of 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 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

[[Page 824]]

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 for a serial.
114.13 Determination of the dating period of a product.
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 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

[[Page 825]]

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 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

[[Page 826]]

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 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

[[Page 827]]

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) One copy of the Outline of Production shall be retained by the 
Animal and Plant Health Inspection Service and one copy returned to the 
licensee or permittee.
    (d) Each licensee shall review each Outline of Production for 
accuracy and sufficiency not less frequently than once a year. Revisions 
necessary to bring an Outline of Production into compliance with the 
regulations shall be submitted to Animal and Plant Health Inspection 
Service.
    (e) When a list of licensed products to be continued in production 
at a licensed establishment is requested by the Administrator in 
accordance with 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 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; 75 FR 20773, Apr. 21, 2010]



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) All 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.

[[Page 828]]

They shall bear the date prepared and refer to the date on the pages 
being superseded. If one replacement page supersedes more than one page, 
the new page shall indicate same, but if several replacement pages are 
added to supersede one page, the page number followed by letters shall 
be used.
    (5) The last page of both copies of either a new or a completely 
rewritten Outline of Production and each page revised separately shall 
be signed in the lower left corner by the authorized representative of 
the licensee (or foreign producer). Stamped or facsimile signatures are 
not acceptable.
    (6) A summary of changes shall appear on an attached page and refer 
to each page, paragraph, or subparagraph being changed.
    (7) Transmittal forms shall be used for the original and subsequent 
revisions. Transmittal forms are available on the Internet at (http://
www.aphis.usda.gov/ animal_health/vet_biologics/ vb_forms.shtml).
    (b) Special outline. An outline describing the preparation of a 
component of a biological product or an operation performed in the 
preparation of a biological product may be required if such special 
outline could be referred to in Outlines of Production to eliminate 
repetition. Each special outline shall be identified by number and shall 
not be used until accepted and filed by Animal and Plant Health 
Inspection Service.
    (c) Outline of Production for anti-serum, antitoxin, and normal 
serum shall be written according to the following:

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 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.

[[Page 829]]

    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 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.

[[Page 830]]

    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.
    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.

[[Page 831]]

    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.
    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.

[[Page 832]]

    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; 75 FR 20773, Apr. 21, 
2010]



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 must be protected at 
all times against improper storage and handling. Completed product must 
be kept under refrigeration at 35 to 46 [deg]F (2 to 8 [deg]C), unless 
the inherent nature of the product makes storage at different 
temperatures advisable, in which case, the proper storage temperature 
must be specified in the filed Outline of Production. All biological 
products to be shipped or delivered must be securely packed.

[81 FR 59436, Aug. 30, 2016]



Sec.114.12  Expiration date required for a serial.

    Unless otherwise provided for in a Standard Requirement or filed 
Outline of Production, each serial or subserial of a biological product 
prepared in a licensed establishment shall be given an expiration date 
according to the dating period of the product when computed from a date 
no later than the date of the initiation of the first potency test of 
the serial or subserial. A licensed biological product shall be 
considered worthless under the Virus-Serum-Toxin Act after the 
expiration date appearing on the label.

[83 FR 11143, Mar. 14, 2018]



Sec.114.13  Determination of the dating period of a product.

    The following requirements do not apply to those biological products 
used for diagnostic purposes.
    (a) Stability criteria. Stability criteria include the 
specifications for potency

[[Page 833]]

at release, potency throughout the dating period, and the length of the 
dating period.
    (b) Stability study requirement. The dating period of each fraction 
of each product shall be confirmed by conducting a stability study.
    (c) Licensure prior to completion of a stability study. Prior to 
licensure, the licensee shall propose a dating period for the product 
based on preliminary information available about the stability of each 
of its fractions. If the preliminary stability information is 
acceptable, the product may be licensed with the provision that the 
proposed dating period must be confirmed by conducting a real-time 
stability study with a stability-indicating potency assay that can 
detect changes over time in the potency of the product.
    (d) Use of stability-indicating assay. Stability studies must be 
conducted with a stability-indicating assay, with the following 
exceptions:
    (1) If the potency test specified in the filed Outline of Production 
of a licensed product is the one stated in the regulations, that potency 
test may be used in place of a stability-indicating assay for that 
fraction.
    (2) If the initial confirmation of dating study of a product in 
development on April 13, 2018 has an approved potency assay, that assay 
may be used.
    (e) Number of serials. At least three production serials of the 
product shall be selected for testing in the stability study.
    (f) Testing sequences--(1) Initial test. The first test in the 
sequence shall be as close as practical to the day of filling into final 
containers or the date of final formulation if the potency of the 
product is tested in bulk form.
    (2) Subsequent testing for in vitro assays. (i) One test every 3 
months during the first year of storage;
    (ii) One test every 6 months during the second year of storage; and
    (iii) One test annually thereafter throughout the proposed dating 
period.
    (3) Subsequent testing for in vivo assays. One test at the end of 
the proposed dating period.
    (g) When to conduct a stability study. Stability studies must be 
conducted for the following:
    (1) Newly licensed products whose dating has not been confirmed;
    (2) Licensed products with confirmed dating but a major change to 
the product or to the potency test has occurred; and
    (3) Licensed products with confirmed dating in which a change in one 
or more of the stability criteria is requested.
    (h) Submitting data. At the completion of the real-time stability 
study to confirm or change the dating period, the data shall be 
submitted to Animal and Plant Health Inspection Service for approval for 
filing and the approved for filing date shall be specified in section VI 
of the filed Outline of Production at the next revision.
    (i) Monitoring stability of the product. For products licensed 
subsequent to April 13, 2018, the licensee or permittee shall submit a 
plan to monitor the stability of the product and the suitability of its 
dating period that includes regularly testing selected serials for 
potency during and at the end of dating.

[83 FR 11143, Mar. 14, 2018]



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

[[Page 834]]

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 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]

[[Page 835]]



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]



Sec.115.2  Inspections of biological products.

    (a) Any biological product, the container of which bears a United 
States veterinary license number or a United States veterinary permit 
number or other mark required by these regulations, may be inspected at 
any time or place. If, as a result of such inspection, it appears that 
any such product is worthless, contaminated, dangerous, or harmful, the 
Secretary shall give notice to stop distribution and sale to the 
manufacturer (licensee) or importer (permittee) and may proceed against 
such product pursuant to the provisions of part 118 of this subchapter.
    (b) When notified to stop distribution and sale of a serial or 
subserial of a veterinary biological product by the Secretary, 
veterinary biologics licensees or permittees shall:
    (1) Stop the preparation, distribution, sale, barter, exchange, 
shipment, or importation of the affected serial(s) or subserial(s) of 
any such veterinary biological product pending further instructions from 
APHIS.
    (2) Immediately, but no later than 2 days, send stop distribution 
and sale notifications to any jobbers, wholesalers, dealers, foreign 
consignees, or other persons known to have any such veterinary 
biological product in their possession, which instruct them to stop the 
preparation, distribution, sale, barter, exchange, shipment, or 
importation of any such veterinary biological product. All notifications 
shall be documented in writing by the licensee or permittee.
    (3) Account for the remaining quantity of each serial(s) or 
subserial(s) of any such veterinary biological product at each location 
in the distribution channel known to the manufacturer (licensee) or 
importer (permittee).
    (4) When required by the Administrator, submit complete and accurate 
reports of all notifications concerning stop distribution and sale 
actions to the Animal and Plant Health Inspection Service pursuant to 
Sec.116.5 of this subchapter.
    (c) Unless and until the Secretary shall otherwise direct, no 
persons so notified shall thereafter sell, barter, or exchange any such 
product in any place under the jurisdiction of the United States or ship 
or deliver for shipment any such product in or from any State, 
Territory, or the District of Columbia. However, failure to receive such 
notice shall not excuse any person from compliance with the Virus-Serum-
Toxin Act.

(Approved by the Office of Management and Budget under control number 
0579-0318)

[72 FR 17798, Apr. 10, 2007]



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.

[[Page 836]]

116.5 Reports.
116.6 Animal records.
116.7 Test records.
116.8 Completion and retention of records.
116.9 Recording and reporting adverse events.

    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 and adverse event 
records) required by this part must be completed by the licensee, 
permittee, or foreign manufacturer, as the case may be, before any 
portion of a serial of any product may be marketed in the United States 
or exported.
    (b) In the case of imported products, each permittee shall maintain 
at the permittee's place of business detailed and accurate records that 
are relevant to each imported product and that include, but are not 
limited to, importation documents, sampling records, test summaries, 
shipping records, and inventory and disposition records as required in 
Sec.116.2.
    (c) When authorized by the Administrator, the licensee, permittee, 
or foreign manufacturer may maintain and retain records required under 
this part at an alternative location. Such authorization shall be 
confirmed by the filing of an addendum to the plot plan legend. The 
addendum shall list the location of the records and the condition of 
their storage and shall permit the inspection of the records by APHIS 
inspectors, or foreign inspectors acting on behalf of APHIS.

(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; 83 FR 22836, May 17, 
2018]



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.

[[Page 837]]

    (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, 1920 Dayton Avenue, P.O. Box 844, 
Ames, IA 50010; by electronic mail to ([email protected]); by fax to 
(515) 337-6120; or by telephone to (515) 337-6100.

(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; 75 
FR 20773, Apr. 21, 2010]



Sec.116.6  Animal records.

    Complete records shall be kept for all animals at a licensed 
establishment. Results of tests performed, antigens or treatment 
administered, maintenance and production records, disposition records, 
necropsy records, if any, and all other pertinent records shall be 
included.

(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 and adverse event 
records) required by this part must be completed by the licensee, 
permittee, or foreign manufacturer before any portion of a serial of any 
product may be marketed in the United States or exported. All records 
must be retained at the licensed or foreign establishment or permittee's 
place of business for a period of 2 years after the expiration date of a

[[Page 838]]

product or longer as may be required by the Administrator.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[83 FR 22836, May 17, 2018]



Sec.116.9  Recording and reporting adverse events.

    (a) Licensees and permittees must maintain a detailed record for 
every adverse event report the licensee or permittee receives for any 
biological product it produces or distributes. These records shall be 
maintained for a period of 3 years after the date the adverse event 
report is received. The adverse event report form and guidance on how to 
complete it, including guidance specific to the various information 
blocks on the form, is available on the APHIS website at https://
www.aphis.usda.gov/ aphis/ourfocus/animalhealth/veterinary-biologics or 
by writing to APHIS Center for Veterinary Biologics, 1920 Dayton Avenue, 
P.O. Box 844, Ames, Iowa 50010.
    (b) A report of all adverse events reports received by a licensee or 
permittee must be compiled and submitted to the Animal and Plant Health 
Inspection Service. The frequency of report submission is as follows:
    (1) Immediate notification is required if at any time there are 
indications that raise questions regarding the purity, safety, potency, 
or efficacy of a product, or if it appears that there may be a problem 
regarding the preparation, testing, or distribution of a product.
    (2) Adverse event reports determined by the licensee or permittee to 
be product-related, serious, and unexpected must also be reported 
immediately.
    (3) All other adverse event reports must be reported within 90 
calendar days of the date the report was first received.

(Approved by the Office of Management and Budget under control number 
0579-0209)

[83 FR 22836, May 17, 2018]



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 839]]

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 840]]

    (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 841]]



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 SELECT AGENTS AND TOXINS--
Table of Contents



Sec.
121.1 Definitions.
121.2 Purpose and scope.
121.3 VS select agents and toxins.
121.4 Overlap select agents and toxins.
121.5 Exemptions for VS select agents and toxins.
121.6 Exemptions for overlap select agents and toxins.
121.7 Registration and related security risk assessments.
121.8 Denial, revocation, or suspension of registration.
121.9 Responsible official.
121.10 Restricting access to select agents and toxins; security risk 
          assessments.
121.11 Security.
121.12 Biosafety.
121.13 Restricted experiments.
121.14 Incident response.
121.15 Training.
121.16 Transfers.
121.17 Records.
121.18 Inspections.

[[Page 842]]

121.19 Notification of theft, loss, or release.
121.20 Administrative review.

    Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.

    Source: 70 FR 13284, Mar. 18, 2005, unless otherwise noted.



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 U.S. Department of Agriculture.
    Attorney General. The Attorney General of the United States or any 
person authorized to act for the Attorney General.
    Biological agent. Any microorganism (including, but not limited to, 
bacteria, viruses, fungi, or protozoa), or infectious substance, or any 
naturally occurring, bioengineered, or synthesized component of any such 
microorganism or infectious substance, capable of causing:
    (1) Death, disease, or other biological malfunction in a human, an 
animal, a plant, or another living organism;
    (2) Deterioration of food, water, equipment, supplies, or material 
of any kind; or
    (3) Deleterious alteration of the environment.
    Centers for Disease Control and Prevention (CDC). The Centers for 
Disease Control and Prevention of the U.S. Department of Health and 
Human Services.
    Diagnosis. The analysis of specimens for the purpose of identifying 
or confirming the presence or characteristics of a select agent or 
toxin, provided that such analysis is directly related to protecting the 
public health or safety, animal health or animal products, or plant 
health or plant products.
    Entity. Any government agency (Federal, State, or local), academic 
institution, corporation, company, partnership, society, association, 
firm, sole proprietorship, or other legal entity.
    HHS Secretary. The Secretary of the Department of Health and Human 
Services or his or her designee, unless otherwise specified.
    HHS select agent and/or toxin. A biological agent or toxin listed in 
42 CFR 73.3.
    Import. To move into, or the act of movement into, the territorial 
limits of the United States.
    Information security. Protecting information and information systems 
from unauthorized access, use, disclosure, disruption, modification, or 
destruction in order to provide:
    (1) Integrity, which means guarding against improper information 
modification or destruction, and includes ensuring information 
authenticity;
    (2) Confidentiality, which means preserving authorized restrictions 
on access and disclosure, including means for protecting personal 
privacy and proprietary information; and
    (3) Availability, which means ensuring timely and reliable access to 
and use of information.
    Interstate. From one State into or through any other State, or 
within the District of Columbia, Guam, the Virgin Islands of the United 
States, or any other territory or possession of the United States.
    Occupational exposure. Any reasonably anticipated skin, eye, mucous 
membrane, parenteral contact, or respiratory aerosol exposure to select 
agents or toxins that may result from the performance of an employee's 
duties.
    Overlap select agent and/or toxin. A biological agent or toxin that 
is listed in Sec.121.4 and 42 CFR 73.4.
    Permit. A written authorization by the Administrator to import or 
move interstate select agents or toxins, under conditions prescribed by 
the Administrator.
    Principal investigator. The one individual who is designated by the 
entity to direct a project or program and who is responsible to the 
entity for the scientific and technical direction of that project or 
program.
    Proficiency testing. The process of determining the competency of an 
individual or laboratory to perform a specified test or procedure.
    Recombinant nucleic acids. (1) Molecules that are constructed by 
joining nucleic acid molecules and that can replicate in a living cell; 
or

[[Page 843]]

    (2) Molecules that result from the replication of those described in 
paragraph (1) of this definition.
    Responsible official. The individual designated by an entity with 
the authority and control to ensure compliance with the regulations in 
this part.
    Security barrier. A physical structure that is designed to prevent 
entry by unauthorized persons.
    Select agent and/or toxin. Unless otherwise specified, all of the 
biological agents or toxins listed in Sec. Sec.121.3 and 121.4.
    Specimen. Samples of material from humans, animals, plants, or the 
environment, or isolates or cultures from such samples, for diagnosis, 
verification, or proficiency testing.
    State. Any of the several States of the United States, the 
Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto 
Rico, the District of Columbia, Guam, the Virgin Islands of the United 
States, or any other territory or possession of the United States.
    Synthetic nucleic acids. (1) Molecules that are chemically or by 
other means synthesized or amplified, including those that are 
chemically or otherwise modified but can base pair with naturally 
occurring nucleic acid molecules (i.e., synthetic nucleic acids); or
    (2) Molecules that result from the replication of those described in 
paragraph (1) of this definition.
    Toxin. The toxic material or product of plants, animals, 
microorganisms (including, but not limited to, bacteria, viruses, fungi, 
or protozoa), or infectious substances, or a recombinant or synthesized 
molecule, whatever their origin and method of production, and includes:
    (1) Any poisonous substance or biological product that may be 
engineered as a result of biotechnology produced by a living organism; 
or
    (2) Any poisonous isomer or biological product, homolog, or 
derivative of such a substance.
    United States. All of the States.
    USDA. The U.S. Department of Agriculture.
    Validated inactivation procedure. A procedure, whose efficacy is 
confirmed by data generated from a viability testing protocol, to render 
a select agent non-viable but allows the select agent to retain 
characteristics of interest for future use; or to render any nucleic 
acids that can produce infectious forms of any select agent virus non-
infectious for future use.
    Verification. The demonstration of obtaining established performance 
(e.g., accuracy, precision, and the analytical sensitivity and 
specificity) specifications for any procedure used for diagnosis.
    Viability testing protocol. A protocol to confirm the validated 
inactivation procedure by demonstrating the material is free of all 
viable select agent.
    VS. The Veterinary Services Programs of the Animal and Plant Health 
Inspection Service.
    VS select agent and/or toxin. A biological agent or toxin listed in 
Sec.121.3.

[70 FR 13284, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012; 82 
FR 6206, Jan. 19, 2017]



Sec.121.2  Purpose and scope.

    This part implements the provisions of the Agricultural Bioterrorism 
Protection Act of 2002 setting forth the requirements for possession, 
use, and transfer of select agents and toxins. The biological agents and 
toxins listed in this part have the potential to pose a severe threat to 
public health and safety, to animal health, or to animal products. 
Overlap select agents and toxins are subject to regulation by both APHIS 
and CDC.



Sec.121.3  VS select agents and toxins.

    (a) Except as provided in paragraphs (d) and (e) of this section, 
the Administrator has determined that the biological agents and toxins 
listed in this section have the potential to pose a severe threat to 
animal health or to animal products. The select agents and toxins marked 
with an asterisk (*) are designated as Tier 1 select agents and toxins 
and are subject to additional requirements as listed in this part.
    (b) VS select agents and toxins: African horse sickness virus; 
African swine fever virus; Avian influenza virus; Classical swine fever 
virus; *Foot-and-mouth disease virus; Goat pox virus; Lumpy skin disease 
virus; Mycoplasma

[[Page 844]]

capricolum; Mycoplasma mycoides; Newcastle disease virus; \1\ Peste des 
petits ruminants virus; *Rinderpest virus; Sheep pox virus; Swine 
vesicular disease virus.
---------------------------------------------------------------------------

    \1\ A virulent Newcastle disease virus (avian paramyxovirus serotype 
1) has an intracerebral pathogenicity index in day-old chicks (Gallus 
gallus) of 0.7 or greater or has an amino acid sequence at the fusion 
(F) protein cleavage site that is consistent with virulent strains of 
Newcastle disease virus. A failure to detect a cleavage site that is 
consistent with virulent strains does not confirm the absence of a 
virulent virus.
---------------------------------------------------------------------------

    (c) Genetic elements, recombinant and/or synthetic nucleic acids, 
and recombinant and/or synthetic organisms:
    (1) Nucleic acids that can produce infectious forms of any of the 
select agent viruses listed in paragraph (b) of this section. \2\
---------------------------------------------------------------------------

    \2\ The importation and interstate movement of VS select agents or 
toxins listed in paragraphs (c)(1) through (c)(3) of this section may be 
subject to the permit requirements under part 122 of this subchapter.
---------------------------------------------------------------------------

    (2) Recombinant and/or synthetic nucleic acids that encode for the 
functional forms of any toxin listed in paragraph (b) of this section if 
the nucleic acids:
    (i) Can be expressed in vivo or in vitro; or
    (ii) Are in a vector or recombinant host genome and can be expressed 
in vivo or in vitro.
    (3) VS select agents and toxins listed in paragraph (b) of this 
section that have been genetically modified.
    (d) VS select agents or toxins that meet any of the following 
criteria are excluded from the requirements of this part:
    (1) Any VS select agent or toxin that is in its naturally occurring 
environment, provided that the agent or toxin has not been intentionally 
introduced, cultivated, collected, or otherwise extracted from its 
natural source.
    (2) Nonviable VS select agents or nontoxic VS toxins.\3\
---------------------------------------------------------------------------

    \3\ However, the importation and interstate movement of these 
nonviable select agents may be subject to the permit requirements under 
part 122 of this subchapter.
---------------------------------------------------------------------------

    (3) A select agent or toxin that has been subjected to 
decontamination or a destruction procedure when intended for waste 
disposal.
    (4) A select agent or regulated nucleic acids that can produce 
infectious forms of any select agent virus that has been subjected to a 
validated inactivation procedure that is confirmed through a viability 
testing protocol. Surrogate strains that are known to possess equivalent 
properties with respect to inactivation can be used to validate an 
inactivation procedure; however, if there are known strain-to-strain 
variations in the resistance of a select agent to an inactivation 
procedure, then an inactivation procedure validated on a lesser 
resistant strain must also be validated on the more resistant strains.
    (5) Material containing a select agent that is subjected to a 
procedure that removes all viable select agent cells, spores, or virus 
particles if the material is subjected to a viability testing protocol 
to ensure that the removal method has rendered the material free of all 
viable select agent.
    (6) A select agent or regulated nucleic acids that can produce 
infectious forms of any select agent virus not subjected to a validated 
inactivation procedure or material containing a select agent not 
subjected to a procedure that removes all viable select agent cells, 
spores, or virus particles if the material is determined by the 
Administrator to be effectively inactivated or effectively removed. To 
apply for a determination an individual or entity must submit a written 
request and supporting scientific information to APHIS. A written 
decision granting or denying the request will be issued.
    (7) A VS select toxin identified in an original food sample or 
clinical sample.
    (8) Waste generated during the delivery of patient care by health 
care professionals from a patient diagnosed with an illness or condition 
associated with a select agent, where that waste is decontaminated or 
transferred for destruction by complying with State and Federal 
regulations within 7 calendar days of the conclusion of patient care.
    (9) Any low pathogenic strains of avian influenza virus, avian 
paramyxovirus serotype-1 (APMV-1) viruses which do not meet the criteria

[[Page 845]]

for Newcastle disease virus,\4\ including those identified as pigeon 
paramyxovirus-1 \5\ isolated from a non-poultry species, all subspecies 
Mycoplasma capricolum except subspecies capripneumoniae (contagious 
caprine pleuropneumonia), and all subspecies Mycoplasma mycoides except 
subspecies mycoides small colony (Mmm SC) (contagious bovine 
pleuropneumonia), provided that the individual or entity can identify 
that the agent is within the exclusion category.
---------------------------------------------------------------------------

    \4\ An APMV-1 virus isolated from poultry which has an intracerebral 
pathogenicity index in day-old chicks (Gallus gallus) of 0.7 or greater 
or has an amino acid sequence at the fusion (F) protein cleavage site 
that is consistent with virulent strains of Newcastle disease virus. A 
failure to detect a cleavage site that is consistent with virulent 
strains does not confirm the absence of a virulent virus.
    \5\ Pigeon paramyxovirus (PPMV-1) is a species-adapted APMV-1 virus 
which is endemic in pigeons and doves in the United States and can be 
identified through monoclonal antibody testing and demonstration of 
their characteristic amino acid signature at the fusion gene cleavage 
site.
---------------------------------------------------------------------------

    (e) An attenuated strain of a select agent or a select toxin 
modified to be less potent or toxic may be excluded from the 
requirements of this part based upon a determination by the 
Administrator that the attenuated strain or modified toxin does not pose 
a severe threat to animal health or animal products.
    (1) To apply for exclusion, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued. An exclusion 
will be effective upon notification to the applicant. Exclusions will be 
listed on the National Select Agent Registry Web site at http://
www.selectagents.gov/.
    (2) If an excluded attenuated strain or modified toxin is subjected 
to any manipulation that restores or enhances its virulence or toxic 
activity, the resulting select agent or toxin will be subject to the 
requirements of this part.
    (3) An individual or entity may make a written request to the 
Administrator for reconsideration of a decision denying an application 
for the exclusion of an attenuated strain of a select agent or a select 
toxin modified to be less potent or toxic. The written request for 
reconsideration must state the facts and reasoning upon which the 
individual or entity relies to show the decision was incorrect. The 
Administrator will grant or deny the request for reconsideration as 
promptly as circumstances allow and will state, in writing, the reasons 
for the decision.
    (f) Any VS select agent or toxin seized by a Federal law enforcement 
agency will be excluded from the requirements of this part during the 
period between seizure of the agent or toxin and the transfer or 
destruction of such agent or toxin provided that:
    (1) As soon as practicable, the Federal law enforcement agency 
transfers the seized agent or toxin to an entity eligible to receive 
such agent or toxin or destroys the agent or toxin by a recognized 
sterilization or inactivation process.
    (2) The Federal law enforcement agency safeguards and secures the 
seized agent or toxin against theft, loss, or release, and reports any 
theft, loss, or release of such agent or toxin.
    (3) The Federal law enforcement agency reports the seizure of the 
select agent or toxin to APHIS or CDC.
    (i) The seizure of any of the following VS select agents and toxins 
must be reported within 24 hours by telephone, facsimile, or e-mail: 
African horse sickness virus, African swine fever virus, avian influenza 
virus (highly pathogenic), classical swine fever virus, foot-and-mouth 
disease virus, virulent Newcastle disease virus, rinderpest virus, and 
swine vesicular disease virus. This report must be followed by 
submission of APHIS/CDC Form 4 within 7 calendar days after seizure of 
the select agent or toxin.
    (ii) For all other VS select agents or toxins, APHIS/CDC Form 4 must 
be submitted within 7 calendar days after seizure of the agent or toxin.
    (iii) A copy of APHIS/CDC Form 4 must be maintained for 3 years.
    (4) The Federal law enforcement agency reports the final disposition 
of the select agent or toxin by submission of APHIS/CDC Form 4. A copy 
of the

[[Page 846]]

completed form must be maintained for 3 years.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 
77 FR 61077, Oct. 5, 2012; 79 FR 26830, May 12, 2014; 82 FR 6207, Jan. 
19, 2017; 83 FR 48202, Sept. 24, 2018]



Sec.121.4  Overlap select agents and toxins.

    (a) Except as provided in paragraphs (d) and (e) of this section, 
the Administrator has determined that the biological agents and toxins 
listed in this section have the potential to pose a severe threat to 
public health and safety, to animal health, or to animal products. The 
select agents and toxins marked with an asterisk (*) are designated as 
Tier 1 select agents and toxins and are subject to additional 
requirements as listed in this part.
    (b) Overlap select agents and toxins: *Bacillus anthracis; Bacillus 
anthracis (Pasteur strain); Brucella abortus; Brucella melitensis; 
Brucella suis; *Burkholderia mallei; *Burkholderia pseudomallei; Hendra 
virus; Nipah virus; Rift Valley fever virus; Venezuelan equine 
encephalitis virus.
    (c) Genetic elements, recombinant and/or synthetic nucleic acids, 
and recombinant and/or synthetic organisms:
    (1) Nucleic acids that can produce infectious forms of any of the 
overlap select agent viruses listed in paragraph (b) of this section. 
\6\
---------------------------------------------------------------------------

    \6\ The importation and interstate movement of overlap select agents 
or toxins listed in paragraphs (c)(1) through (c)(3) of this section may 
be subject to the permit requirements under part 122 of this subchapter.
---------------------------------------------------------------------------

    (2) Recombinant and/or synthetic nucleic acids that encode for the 
toxic forms of any overlap toxin listed in paragraph (b) of this section 
if the nucleic acids:
    (i) Can be expressed in vivo or in vitro; or
    (ii) Are in a vector or recombinant host genome and can be expressed 
in vivo or in vitro.
    (3) Overlap select agents and toxins listed in paragraph (b) of this 
section that have been genetically modified.
    (d) Overlap select agents or toxins that meet any of the following 
criteria are excluded from the requirements of this part:
    (1) Any overlap select agent or toxin that is in its naturally 
occurring environment, provided that the agent or toxin has not been 
intentionally introduced, cultivated, collected, or otherwise extracted 
from its natural source.
    (2) Nonviable overlap select agents or nontoxic overlap toxins.\7\
---------------------------------------------------------------------------

    \7\ However, the importation and interstate movement of these 
nonviable overlap select agents may be subject to the permit 
requirements under part 122 of this subchapter.
---------------------------------------------------------------------------

    (3) A select agent or toxin that has been subjected to 
decontamination or a destruction procedure when intended for waste 
disposal.
    (4) A select agent or regulated nucleic acids that can produce 
infectious forms of any select agent virus that has been subjected to a 
validated inactivation procedure that is confirmed through a viability 
testing protocol. Surrogate strains that are known to possess equivalent 
properties with respect to inactivation can be used to validate an 
inactivation procedure; however, if there are known strain-to-strain 
variations in the resistance of a select agent to an inactivation 
procedure, then an inactivation procedure validated on a lesser 
resistant strain must also be validated on the more resistant strains.
    (5) Material containing a select agent that is subjected to a 
procedure that removes all viable select agent cells, spores, or virus 
particles if the material is subjected to a viability testing protocol 
to ensure that the removal method has rendered the material free of all 
viable select agent.
    (6) A select agent or regulated nucleic acids that can produce 
infectious forms of any select agent virus not subjected to a validated 
inactivation procedure or material containing a select agent not 
subjected to a procedure that removes all viable select agent cells, 
spores, or virus particles if the material is determined by the 
Administrator or HHS Secretary to be effectively inactivated or 
effectively removed. To apply for a determination an individual or 
entity must submit a written request and supporting scientific 
information to APHIS or CDC. A written decision granting or denying the 
request will be issued.

[[Page 847]]

    (7) An overlap select toxin identified in an original food sample or 
clinical sample.
    (8) Waste generated during the delivery of patient care by health 
care professionals from a patient diagnosed with an illness or condition 
associated with a select agent, where that waste is decontaminated or 
transferred for destruction by complying with State and Federal 
regulations within 7 calendar days of the conclusion of patient care.
    (9) Any subtypes of Venezuelan equine encephalitis virus except for 
Subtypes IAB or IC, provided that the individual or entity can identify 
that the agent is within the exclusion category.
    (e) An attenuated strain of a select agent or a select toxin 
modified to be less potent or toxic may be excluded from the 
requirements of this part based upon a determination by the 
Administrator that the attenuated strain or modified toxin does not pose 
a severe threat to public health and safety, animal health, or animal 
products.
    (1) To apply for exclusion, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued. An exclusion 
will be effective upon notification to the applicant. Exclusions will be 
listed on the National Select Agent Registry Web site at http://
www.selectagents.gov/.
    (2) If an excluded attenuated strain or modified toxin is subjected 
to any manipulation that restores or enhances its virulence or toxic 
activity, the resulting select agent or toxin will be subject to the 
requirements of this part.
    (3) An individual or entity may make a written request to the 
Administrator or HHS Secretary for reconsideration of a decision denying 
an application for the exclusion of an attenuated strain of a select 
agent or a select toxin modified to be less potent or toxic. The written 
request for reconsideration must state the facts and reasoning upon 
which the individual or entity relies to show the decision was 
incorrect. The Administrator or HHS Secretary will grant or deny the 
request for reconsideration as promptly as circumstances allow and will 
state, in writing, the reasons for the decision.
    (f) Any overlap select agent or toxin seized by a Federal law 
enforcement agency will be excluded from the requirements of this part 
during the period between seizure of the agent or toxin and the transfer 
or destruction of such agent or toxin provided that:
    (1) As soon as practicable, the Federal law enforcement agency 
transfers the seized agent or toxin to an entity eligible to receive 
such agent or toxin or destroys the agent or toxin by a recognized 
sterilization or inactivation process.
    (2) The Federal law enforcement agency safeguards and secures the 
seized agent or toxin against theft, loss, or release, and reports any 
theft, loss, or release of such agent or toxin.
    (3) The Federal law enforcement agency reports the seizure of the 
overlap select agent or toxin to APHIS or CDC.
    (i) The seizure of any of the following overlap select agents and 
toxins must be reported within 24 hours by telephone, facsimile, or e-
mail: Bacillus anthracis, Burkholderia mallei, or Burkholderia 
pseudomallei. This report must be followed by submission of APHIS/CDC 
Form 4 within 7 calendar days after seizure of the overlap select agent 
or toxin.
    (ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 
must be submitted within 7 calendar days after seizure of the agent or 
toxin.
    (iii) A copy of APHIS/CDC Form 4 must be maintained for 3 years.
    (4) The Federal law enforcement agency reports the final disposition 
of the overlap select agent or toxin by submission of APHIS/CDC Form 4. 
A copy of the completed form must be maintained for 3 years.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 
77 FR 61078, Oct. 5, 2012; 79 FR 26830, May 12, 2014; 82 FR 6207, Jan. 
19, 2017]



Sec.121.5  Exemptions for VS select agents and toxins.

    (a) Diagnostic laboratories and other entities that possess, use, or 
transfer a VS select agent or toxin that is contained in a specimen 
presented for diagnosis or verification will be exempt

[[Page 848]]

from the requirements of this part for such agent or toxin contained in 
the specimen, provided that:
    (1) Unless directed otherwise by the Administrator, within 7 
calendar days after identification of the select agent or toxin, the 
select agent or toxin is transferred in accordance with Sec.121.16 or 
destroyed on-site by a recognized sterilization or inactivation process;
    (2) The agent or toxin is secured against theft, loss, or release 
during the period between identification of the agent or toxin and 
transfer or destruction of such agent or toxin, and any theft, loss, or 
release of such agent or toxin is reported;
    (3) Unless otherwise directed by the Administrator, the clinical or 
diagnostic specimens collected from a patient infected with a select 
agent are transferred in accordance with Sec.121.16 or destroyed on-
site by a recognized sterilization or inactivation process within 7 
calendar days after delivery of patient care by heath care professionals 
has concluded; and
    (4) The identification of the agent or toxin is reported to APHIS or 
CDC, the specimen provider, and to other appropriate authorities when 
required by Federal, State, or local law by telephone, facsimile, or 
email. This report must be followed by submission of APHIS/CDC Form 4 to 
APHIS or CDC within 7 calendar days after identification.
    (b) Diagnostic laboratories and other entities that possess, use, or 
transfer a VS select agent or toxin that is contained in a specimen 
presented for proficiency testing will be exempt from the requirements 
of this part for such agent or toxin contained in the specimen, provided 
that:
    (1) Unless directed otherwise by the Administrator, within 90 
calendar days of receipt, the agent or toxin is transferred in 
accordance with Sec.121.16 or destroyed on-site by a recognized 
sterilization or inactivation process;
    (2) The agent or toxin is secured against theft, loss, or release 
during the period between identification of the agent or toxin and 
transfer or destruction of such agent or toxin, and any theft, loss, or 
release of such agent or toxin is reported; and
    (3) The identification of the agent or toxin, and its derivative, is 
reported to APHIS or CDC. To report the identification of a select agent 
or toxin, APHIS/CDC Form 4 must be submitted within 90 days of receipt 
of the agent or toxin. A copy of the completed form must be maintained 
for 3 years.
    (c) Diagnostic reagents and vaccines that are, bear, or contain VS 
select agents or toxins that are produced at USDA diagnostic facilities 
will be exempt from the requirements of this part.
    (d) Unless the Administrator by order determines that additional 
regulation is necessary to protect animal health or animal products, 
products that are, bear, or contain VS select agents or toxins will be 
exempt from the requirements of this part if the products have been 
cleared, approved, licensed, or registered pursuant to:
    (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.);
    (2) Section 351 of Public Health Service Act (42 U.S.C. 262);
    (3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
    (4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 131 et seq.).
    (e) The Administrator may exempt from the requirements of this part 
an experimental product that is, bears, or contains a VS select agent or 
toxin if such product is being used in an investigation authorized by 
any Federal law and the Administrator determines that additional 
regulation under this part is not necessary to protect animal health or 
animal products. To apply for an exemption, an individual or entity must 
submit APHIS/CDC Form 5. A written decision granting or denying the 
exemption will be issued. The applicant must notify APHIS when an 
authorization for an investigation no longer exists. This exemption 
automatically terminates when such authorization is no longer in effect.
    (f) In addition to the exemptions provided in paragraphs (a) through 
(e) of this section, the Administrator may grant a specific exemption 
upon a showing of good cause and upon his or her determination that such 
exemption is consistent with protecting animal

[[Page 849]]

health or animal products. An individual or entity may request in 
writing an exemption from the requirements of this part. If granted, 
such exemptions are valid for a maximum of 3 years; thereafter, an 
individual or entity must request a new exemption. If a request for 
exemption is denied, an individual or entity may request reconsideration 
in writing to the Administrator. The request for reconsideration must 
state all of the facts and reasons upon which the individual or entity 
relies to show that the exemption was wrongfully denied. The 
Administrator will grant or deny the request for reconsideration as 
promptly as circumstances allow and will state, in writing, the reasons 
for the decision.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 
77 FR 61078, Oct. 5, 2012; 79 FR 26831, May 12, 2014; 82 FR 6208, Jan. 
19, 2017]



Sec.121.6  Exemptions for overlap select agents and toxins.

    (a) Clinical or diagnostic laboratories and other entities that 
possess, use, or transfer an overlap select agent or toxin that is 
contained in a specimen presented for diagnosis or verification will be 
exempt from the requirements of this part for such agent or toxin 
contained in the specimen, provided that:
    (1) Unless directed otherwise by the Administrator, within 7 
calendar days after identification of the select agent or toxin, the 
select agent or toxin is transferred in accordance with Sec.121.16 or 
destroyed on-site by a recognized sterilization or inactivation process;
    (2) The agent or toxin is secured against theft, loss, or release 
during the period between identification of the agent or toxin and 
transfer or destruction of such agent or toxin, and any theft, loss, or 
release of such agent or toxin is reported;
    (3) Unless otherwise directed by the Administrator or HHS Secretary, 
the clinical or diagnostic specimens collected from a patient infected 
with a select agent are transferred in accordance with Sec.121.16 or 
destroyed on-site by a recognized sterilization or inactivation process 
within 7 calendar days after delivery of patient care by heath care 
professionals has concluded; and
    (4) The identification of the agent or toxin is reported to APHIS or 
CDC, the specimen provider, and to other appropriate authorities when 
required by Federal, State, or local law by telephone, facsimile, or 
email. This report must be followed by submission of APHIS/CDC Form 4 to 
APHIS or CDC within 7 calendar days after identification.
    (b) Clinical or diagnostic laboratories and other entities that 
possess, use, or transfer an overlap select agent or toxin that is 
contained in a specimen presented for proficiency testing will be exempt 
from the requirements of this part for such agent or toxin contained in 
the specimen, provided that:
    (1) Unless directed otherwise by the Administrator or the HHS 
Secretary, within 90 days of receipt, the agent or toxin is transferred 
in accordance with Sec.121.16 or 42 CFR 73.16 or destroyed on-site by 
a recognized sterilization or inactivation process;
    (2) The agent or toxin is secured against theft, loss, or release 
during the period between identification of the agent or toxin and 
transfer or destruction of such agent or toxin, and any theft, loss, or 
release of such agent or toxin is reported; and
    (3) The identification of the agent or toxin, and its derivative, is 
reported to APHIS or CDC. To report the identification of an overlap 
select agent or toxin, APHIS/CDC Form 4 must be submitted within 90 
calendar days of receipt of the agent or toxin. A copy of the completed 
form must be maintained for 3 years.
    (c) Unless the Administrator by order determines that additional 
regulation of a specific product is necessary to protect animal health 
or animal products, products that are, bear, or contain overlap select 
agents or toxins will be exempt from the requirements of this part if 
the products have been cleared, approved, licensed, or registered 
pursuant to:
    (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.);
    (2) Section 351 of Public Health Service Act (42 U.S.C. 262);
    (3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or

[[Page 850]]

    (4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 131 et seq.).
    (d) After consultation with the HHS Secretary, the Administrator may 
exempt from the requirements of this part an investigational product 
that is, bears, or contains an overlap select agent or toxin if such 
product is being used in an investigation authorized by any Federal law 
and the Administrator determines that additional regulation under this 
part is not necessary to protect animal health or animal products.
    (1) To apply for an exemption, an individual or entity must submit 
APHIS/CDC Form 5.
    (2) The Administrator will make a determination regarding an 
exemption within 14 calendar days after receipt of the application and 
notification that the investigation has been authorized under a Federal 
law. A written decision granting or denying the exemption will be 
issued.
    (3) The applicant must notify APHIS or CDC when an authorization for 
an investigation no longer exists. This exemption automatically 
terminates when such authorization is no longer in effect.
    (e) If it is necessary to respond to a domestic or foreign 
agricultural emergency involving an overlap select agent or toxin, the 
Administrator may exempt an individual or entity from the requirements, 
in whole or in part, of this part for up to 30 calendar days. The 
Administrator may extend the exemption once for an additional 30 days.
    (f) Upon request of the Secretary of Health and Human Services, the 
Administrator may exempt an individual or entity from the requirements, 
in whole or in part, of this part for up to 30 calendar days if the 
Secretary of Health and Human Services has granted an exemption for a 
public health emergency involving an overlap select agent or toxin. The 
Administrator may extend the exemption once for an additional 30 days.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 
77 FR 61078, Oct. 5, 2012; 79 FR 26831, May 12, 2014; 82 FR 6208, Jan. 
19, 2017]



Sec.121.7  Registration and related security risk assessments.

    (a) Unless exempted under Sec.121.5, an individual or entity shall 
not possess, use, or transfer any VS select agent or toxin without a 
certificate of registration issued by the Administrator. Unless exempted 
under Sec.121.6 or 42 CFR 73.6, an individual or entity shall not 
possess, use, or transfer any overlap select agent or toxin without a 
certificate of registration issued by the Administrator and the HHS 
Secretary.
    (b) As a condition of registration, each entity is required to be in 
compliance with the requirements of this part for select agents and 
toxins listed on the registration regardless of whether the entity is in 
actual possession of the select agent or toxin. With regard to toxins, 
the entity registered for possession, use, or transfer of a toxin must 
be in compliance with the requirements of this part regardless of the 
amount of toxins currently in its possession.
    (c) As a condition of registration, each entity must designate an 
individual to be its responsible official. While most registrants are 
likely to be entities, in the event that an individual applies for and 
is granted a certificate of registration, the individual will be 
considered the responsible official.
    (d)(1) As a condition of registration, the following must be 
approved by the Administrator or the HHS Secretary based on a security 
risk assessment by the Attorney General:
    (i) The individual or entity;
    (ii) The responsible official; and
    (iii) Unless otherwise exempted under this section, any individual 
who owns or controls the entity.
    (2) Federal, State, or local governmental agencies, including public 
accredited academic institutions, are exempt from the security risk 
assessments for the entity and the individual who owns or controls such 
entity.
    (3) An individual will be deemed to own or control an entity under 
the following conditions: \8\
---------------------------------------------------------------------------

    \8\ These conditions may apply to more than one individual.
---------------------------------------------------------------------------

    (i) For a private institution of higher education, an individual 
will be deemed

[[Page 851]]

to own or control the entity if the individual is in a managerial or 
executive capacity with regard to the entity's select agents or toxins 
or with regard to the individuals with access to the select agents or 
toxins possessed, used, or transferred by the entity.
    (ii) For entities other than institutions of higher education, an 
individual will be deemed to own or control the entity if the 
individual:
    (A) Owns 50 percent or more of the entity, or is a holder or owner 
of 50 percent or more of its voting stock; or
    (B) Is in a managerial or executive capacity with regard to the 
entity's select agents or toxins or with regard to the individuals with 
access to the select agents or toxins possessed, used, or transferred by 
the entity.
    (4) An entity will be considered to be an institution of higher 
education if it is an institution of higher education as defined in 
section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), 
or is an organization described in 501(c)(3) of the Internal Revenue 
Code of 1986, as amended (26 U.S.C. 501(c)(3)).
    (5) To obtain a security risk assessment, an individual or entity 
must submit the information necessary to conduct a security risk 
assessment to the Attorney General.
    (e) To apply for a certificate of registration for only VS select 
agents or toxins, or for VS and PPQ select agents or toxins, an 
individual or entity must submit the information requested in the 
registration application package (APHIS/CDC Form 1) to APHIS. To apply 
for a certificate of registration for overlap select agents or toxins, 
overlap select agents or toxins and any combination of PPQ or VS select 
agents or toxins, or HHS select agents or toxins and any combination of 
PPQ or VS select agents or toxins, an individual or entity must submit 
the information requested in the registration application package 
(APHIS/CDC Form 1) to APHIS or CDC, but not both.
    (f) Prior to the issuance of a certificate of registration, the 
responsible official must promptly provide notification of any changes 
to the application for registration by submitting the relevant page(s) 
of the registration application.
    (g) The issuance of a certificate of registration may be contingent 
upon inspection or submission of additional information, such as the 
security plan, biosafety plan, incident response plan, or any other 
documents required to be prepared under this part.
    (h) A certificate of registration will be valid for one physical 
location (a room, a building, or a group of buildings) where the 
responsible official will be able to perform the responsibilities 
required in this part, for specific select agents or toxins, and for 
specific activities.
    (i) A certificate of registration may be amended to reflect changes 
in circumstances (e.g., replacement of the responsible official or other 
personnel changes, changes in ownership or control of the entity, 
changes in the activities involving any select agents or toxins, or the 
addition or removal of select agents or toxins).
    (1) Prior to any change, the responsible official must apply for an 
amendment to a certificate of registration by submitting the relevant 
page(s) of the registration application. \9\
---------------------------------------------------------------------------

    \9\ Depending on the change, a security risk assessment by the 
Attorney General may also be required (e.g., replacement of the 
responsible official, changes in ownership or control of the entity, new 
researchers or graduate students, etc.)
---------------------------------------------------------------------------

    (2) The responsible official will be notified in writing if an 
application to amend a certificate of registration has been approved. 
Approval of an amendment may be contingent upon an inspection or 
submission of additional information, such as the security plan, 
biosafety plan, incident response plan, or any other documents required 
to be prepared under this part.
    (3) No change may be made without such approval.
    (j) An entity must immediately notify APHIS or CDC if it loses the 
services of its responsible official. In the event that an entity loses 
the services of its responsible official, an entity may continue to 
possess or use select agents or toxins only if it appoints as the 
responsible official another individual who has been approved by the 
Administrator or the HHS Secretary following a security risk assessment 
by

[[Page 852]]

the Attorney General and who meets the requirements of this part.
    (k) A certificate of registration will be terminated upon the 
written request of the entity if the entity no longer possesses or uses 
any select agents or toxins and no longer wishes to be registered.
    (l) A certificate of registration will be valid for a maximum of 3 
years.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 
82 FR 6208, Jan. 19, 2017]



Sec.121.8  Denial, revocation, or suspension of registration.

    (a) An application may be denied or a certificate of registration 
revoked or suspended if:
    (1) The individual or entity, the responsible official, or an 
individual who owns or controls the entity is within any of the 
categories described in 18 U.S.C. 175b;
    (2) The individual or entity, the responsible official, or an 
individual who owns or controls the entity is reasonably suspected by 
any Federal law enforcement or intelligence agency of:
    (i) Committing a crime set forth in 18 U.S.C. 2332b(g)(5); or
    (ii) Knowing involvement with an organization that engages in 
domestic or international terrorism (as defined in 18 U.S.C. 2331) or 
with any other organization that engages in intentional crimes of 
violence; or
    (iii) Being an agent of a foreign power as defined in 50 U.S.C. 
1801;
    (3) The individual or entity does not meet the requirements of this 
part; \10\ or
---------------------------------------------------------------------------

    \10\ If registration is denied for this reason, we may provide 
technical assistance and guidance.
---------------------------------------------------------------------------

    (4) It is determined that such action is necessary to protect animal 
health or animal products.
    (b) Upon revocation or suspension of a certificate of registration, 
the individual or entity must:
    (1) Immediately stop all use of each select agent or toxin covered 
by the revocation or suspension order;
    (2) Immediately safeguard and secure each select agent or toxin 
covered by the revocation or suspension order from theft, loss, or 
release; and
    (3) Comply with all disposition instructions issued by the 
Administrator for each select agent or toxin covered by the revocation 
or suspension.
    (c) Denial of an application for registration and revocation of 
registration may be appealed under Sec.121.20. However, any denial of 
an application for registration or revocation of a certificate of 
registration will remain in effect until a final agency decision has 
been rendered.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 
82 FR 6208, Jan. 19, 2017]



Sec.121.9  Responsible official.

    (a) An individual or entity required to register under this part 
must designate an individual to be the responsible official. The 
responsible official must.
    (1) Be approved by the Administrator or the HHS Secretary following 
a security risk assessment by the Attorney General.
    (2) Be familiar with the requirements of this part.
    (3) Have authority and responsibility to act on behalf of the 
entity.
    (4) Ensure compliance with the requirements of this part.
    (5) Have a physical (and not merely a telephonic or audio/visual) 
presence at the registered entity to ensure that the entity is in 
compliance with the select agent regulations and be able to respond in a 
timely manner to onsite incidents involving select agents and toxins in 
accordance with the entity's incident response plan.
    (6) Ensure that annual inspections are conducted for each registered 
space where select agents or toxins are stored or used in order to 
determine compliance with the requirements of this part. The results of 
each inspection must be documented, and any deficiencies identified 
during an inspection must be corrected and the corrections documented.
    (7) Ensure that individuals are provided the contact information for 
the USDA Office of Inspector General Hotline and the HHS Office of 
Inspector General Hotline so that they may anonymously report any 
biosafety/biocontainment or security concerns related to select agents 
and toxins.

[[Page 853]]

    (8) Investigate to determine the reason for any failure of a 
validated inactivation procedure or any failure to remove viable select 
agent from material. If the responsible official is unable to determine 
the cause of a deviation from a validated inactivation procedure or a 
viable select agent removal method; or receives any report of any 
inactivation failure after the movement of material to another location, 
the responsible official must report immediately by telephone or email 
the inactivation or viable agent removal method failure to APHIS or CDC.
    (9) Review, and revise as necessary, each of the entity's validated 
inactivation procedures or viable select agent removal methods. The 
review must be conducted annually or after any change in principal 
investigator, change in the validated inactivation procedure or viable 
select agent removal method, or failure of the validated inactivation 
procedure or viable select agent removal method. The review must be 
documented and training must be conducted if there are any changes to 
the validated inactivation procedure, viable select agent removal 
method, or viability testing protocol.
    (b) An entity may designate one or more individuals to serve as an 
alternate responsible official who acts for the responsible official in 
his/her absence. These individuals must have the authority and control 
to ensure compliance with the regulations when acting as the responsible 
official.
    (c) The responsible official must report the identification and 
final disposition of any select agent or toxin contained in a specimen 
presented for diagnosis or verification.
    (1) The identification of any of the following select agents or 
toxins must be immediately reported by telephone, facsimile, or email: 
African horse sickness virus, African swine fever virus, avian influenza 
virus (highly pathogenic), Bacillus anthracis, Burkholderia mallei, 
Burkholderia pseudomallei, classical swine fever virus, foot-and-mouth 
disease virus, virulent Newcastle disease virus, rinderpest virus, or 
swine vesicular disease virus. The final disposition of the agent or 
toxin must be reported by submission of APHIS/CDC Form 4 within 7 
calendar days after identification. A copy of the completed form must be 
maintained for 3 years.
    (2) To report the identification and final disposition of any other 
select agent or toxin, APHIS/CDC Form 4 must be submitted within 7 
calendar days after identification. A copy of the completed form must be 
maintained for 3 years.
    (3) Less stringent reporting may be required during agricultural 
emergencies or outbreaks, or in endemic areas.
    (d) The responsible official must report the identification and 
final disposition of any select agent or toxin contained in a specimen 
presented for proficiency testing. To report the identification and 
final disposition of a select agent or toxin, APHIS/CDC Form 4 must be 
submitted within 90 calendar days of receipt of the agent or toxin. A 
copy of the completed form must be maintained for 3 years.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61332, Oct. 16, 2008; 
77 FR 61078, Oct. 5, 2012; 79 FR 26831, May 12, 2014; 82 FR 6208, Jan. 
19, 2017]



Sec.121.10  Restricting access to select agents and toxins; security 
risk assessments.

    (a) An individual or entity required to register under this part may 
not provide an individual access to a select agent or toxin, and an 
individual may not access a select agent or toxin, unless the individual 
is approved by the Administrator or the HHS Secretary following a 
security risk assessment by the Attorney General.
    (b) An individual will be deemed to have access at any point in time 
if the individual has possession of a select agent or toxin (e.g., 
carries, uses, or manipulates) or the ability to gain possession of a 
select agent or toxin.
    (c) Each individual with access to select agents or toxins must have 
the appropriate education, training, and/or experience to handle or use 
such agents or toxins.
    (d) To apply for access approval, each individual must submit the 
information necessary to conduct a security risk assessment to the 
Attorney General.
    (e) A person with valid approval from the HHS Secretary or 
Administrator to

[[Page 854]]

have access to select agents or toxins may request, through his or her 
Responsible Official, that the HHS Secretary or Administrator provide 
their approved access status to another registered individual or entity 
for a specified period of time. A responsible official must immediately 
notify the responsible official of the visited entity if the person's 
access to select agents and toxins has been terminated.
    (f) An individual's security risk assessment may be expedited upon 
written request by the responsible official and a showing of good cause 
(e.g., public health or agricultural emergencies, national security, or 
a short-term visit by a prominent researcher). A written decision 
granting or denying the request will be issued.
    (g) An individual's access approval for VS select agents or toxins 
may be denied, limited, or revoked if:
    (1) The individual is within any of the categories described in 18 
U.S.C. 175b;
    (2) The individual is reasonably suspected by any Federal law 
enforcement or intelligence agency of committing a crime set forth in 18 
U.S.C. 2332b(g)(5); knowing involvement with an organization that 
engages in domestic or international terrorism (as defined in 18 U.S.C. 
2331) or with any other organization that engages in intentional crimes 
of violence; or being an agent of a foreign power as defined in 50 
U.S.C. 1801; or
    (3) It is determined that such action is necessary to protect animal 
health or animal products.
    (h) For overlap select agents or toxins, an individual's access 
approval will be denied or revoked if the individual is within any of 
the categories described in 18 U.S.C. 175b. An individual's access 
approval may be denied, limited, or revoked for the reasons set forth in 
paragraphs (f)(2) through (f)(3) of this section.
    (i) An individual may appeal the Administrator's decision to deny, 
limit, or revoke access approval under Sec.121.20.
    (j) Access approval is valid for a maximum of 3 years.
    (k) The responsible official must immediately notify APHIS or CDC 
when an individual's access to select agents or toxins is terminated by 
the entity and the reasons therefore.

[70 FR 13284, Mar. 18, 2005, as amended at 77 FR 61079, Oct. 5, 2012; 82 
FR 6209, Jan. 19, 2017]



Sec.121.11  Security.

    (a) An individual or entity required to register under this part 
must develop and implement a written security plan. The security plan 
must be sufficient to safeguard the select agent or toxin against 
unauthorized access, theft, loss, or release.
    (b) The security plan must be designed according to a site-specific 
risk assessment and must provide graded protection in accordance with 
the risk of the select agent or toxin, given its intended use. A current 
security plan must be submitted for initial registration, renewal of 
registration, or when requested.
    (c) The security plan must:
    (1) Describe procedures for physical security, inventory control, 
and information systems control;
    (2) Contain provisions for the control of access to select agents 
and toxins, including the safeguarding of animals (including arthropods) 
or plants intentionally or accidentally exposed to or infected with a 
select agent, against unauthorized access, theft, loss or release.
    (3) Contain provisions for routine cleaning, maintenance, and 
repairs;
    (4) Establish procedures for removing unauthorized or suspicious 
persons;
    (5) Describe procedures for addressing loss or compromise of keys, 
keycards, passwords, combinations, etc. and protocols for changing 
access permissions or locks following staff changes;
    (6) Contain procedures for reporting unauthorized or suspicious 
persons or activities, loss or theft of select agents or toxins, release 
of select agents or toxins, or alteration of inventory records;
    (7) Contain provisions for ensuring that all individuals with access 
approval from the Administrator or the HHS Secretary understand and 
comply with the security procedures.
    (8) Describe procedures for how the responsible official will be 
informed of suspicious activity that may be criminal in nature and 
related to the entity,

[[Page 855]]

its personnel, or its select agents or toxins; and describe procedures 
for how the entity will notify the appropriate Federal, State, or local 
law enforcement agencies of such activity.
    (9) Contain provisions for information security that:
    (i) Ensure that all external connections to systems which manage 
security for the registered space are isolated or have controls that 
permit only authorized and authenticated users;
    (ii) Ensure that authorized and authenticated users are only granted 
access to select agent and toxin related information, files, equipment 
(e.g., servers or mass storage devices), and applications as necessary 
to fulfill their roles and responsibilities, and that access is modified 
when the user's roles and responsibilities change or when their access 
to select agents and toxins is suspended or revoked;
    (iii) Ensure that controls are in place that are designed to prevent 
malicious code (such as, but not limited to, computer viruses, worms, 
spyware) from compromising the confidentiality, integrity, or 
availability of information systems which manage access to spaces 
registered under this part or records as specified in Sec.121.17;
    (iv) Establish a robust configuration management practice for 
information systems to include regular patching and updates made to 
operating systems and individual applications; and
    (v) Establish procedures that provide backup security measures in 
the event that access control systems, surveillance devices, and/or 
systems that manage the requirements of Sec.121.17 are rendered 
inoperable.
    (10) Contain provisions and policies for shipping, receiving, and 
storage of select agents and toxins, including documented procedures for 
receiving, monitoring, and shipping of all select agents and toxins. 
These provisions must provide that an entity will properly secure 
containers on site and have a written contingency plan for unexpected 
shipments.
    (d) An individual or entity must adhere to the following security 
requirements or implement measures to achieve an equivalent or greater 
level of security:
    (1) Allow access only to individuals with access approval from the 
Administrator or the HHS Secretary;
    (2) Allow individuals not approved for access by the Administrator 
or the HHS Secretary to conduct routine cleaning, maintenance, repairs, 
and other activities not related to select agents or toxins only when 
continuously escorted by an approved individual if the potential to 
access to select agents or toxins exists;
    (3) Provide for the control of select agents and toxins by requiring 
freezers, refrigerators, cabinets, and other containers where select 
agents or toxins are stored to be secured against unauthorized access 
(e.g., card access system, lock boxes);
    (4) Inspect all suspicious packages before they are brought into or 
removed from an area where select agents or toxins are used or stored;
    (5) Establish a protocol for intra-entity transfers under the 
supervision of an individual with access approval from the Administrator 
or the HHS Secretary, including chain-of-custody documents and 
provisions for safeguarding against theft, loss, or release; and
    (6) Require that individuals with access approval from the 
Administrator or the HHS Secretary refrain from sharing with any other 
person their unique means of accessing a select agent or toxin (e.g., 
keycards or passwords);
    (7) Require that individuals with access approval from the 
Administrator or the HHS Secretary immediately report any of the 
following to the responsible official:
    (i) Any loss or compromise of keys, passwords, combinations, etc.;
    (ii) Any suspicious persons or activities;
    (iii) Any loss or theft of select agents or toxins;
    (iv) Any release of a select agent or toxin;
    (v) Any sign that inventory or use records for select agents or 
toxins have been altered or otherwise compromised; and
    (vi) Any loss of computer, hard drive or other data storage device 
containing information that could be used to gain access to select 
agents or toxins; and

[[Page 856]]

    (8) Separate areas where select agents and toxins are stored or used 
from the public areas of the building.
    (e) Entities must conduct complete inventory audits of all affected 
select agents and toxins in long-term storage when any of the following 
occur:
    (1) Upon the physical relocation of a collection or inventory of 
select agents or toxins for those select agents or toxins in the 
collection or inventory;
    (2) Upon the departure or arrival of a principal investigator for 
those select agents and toxins under the control of that principal 
investigator; or
    (3) In the event of a theft or loss of a select agent or toxin, all 
select agents and toxins under the control of that principal 
investigator.
    (f) In addition to the requirements contained in paragraphs (c) and 
(d) of this section, the security plan for an individual or entity 
possessing a Tier 1 select agent or toxin must also:
    (1) Describe procedures for conducting a pre-access suitability 
assessment of persons who will have access to a Tier 1 select agent or 
toxin;
    (2) Describe procedures for how an entity's responsible official 
will coordinate their efforts with the entity's safety and security 
professionals to ensure security of Tier 1 select agents and toxins and 
share, as appropriate, relevant information; and
    (3) Describe procedures for the ongoing assessment of the 
suitability of personnel with access to a Tier 1 select agent or toxin. 
The procedures must include:
    (i) Self- and peer-reporting of incidents or conditions that could 
affect an individual's ability to safely have access to or work with 
select agents and toxins, or to safeguard select agents and toxins from 
theft, loss, or release;
    (ii) The training of employees with access to Tier 1 select agents 
and toxins on entity policies and procedures for reporting, evaluation, 
and corrective actions concerning the assessment of personnel 
suitability; and
    (iii) The ongoing suitability monitoring of individuals with access 
to Tier 1 select agents and toxins.
    (4) Entities with Tier 1 select agents and toxins must prescribe the 
following security enhancements:
    (i) Procedures that will limit access to a Tier 1 select agent or 
toxin to only those individuals who are approved by the HHS Secretary or 
Administrator following a security risk assessment by the Attorney 
General, have had an entity-conducted pre-access suitability assessment, 
and are subject to the entity's procedures for ongoing suitability 
assessment;
    (ii) Procedures that limit access to laboratory and storage 
facilities outside of normal business hours to only those specifically 
approved by the responsible official or designee;
    (iii) Procedures for allowing visitors, their property, and vehicles 
at the entry and exit points to the registered space, or at other 
designated points of entry to the building, facility, or compound that 
are based on the entity's site-specific risk assessment;
    (iv) A minimum of three security barriers where each security 
barrier adds to the delay in reaching secured areas where select agents 
and toxins are used or stored. One of the security barriers must be 
monitored in such a way as to detect intentional and unintentional 
circumventing of established access control measures under all 
conditions (day/night, severe weather, etc.) The final barrier must 
limit access to the select agent or toxin to personnel approved by the 
HHS Secretary or Administrator, following a security risk assessment by 
the Attorney General.
    (v) All registered space or areas that reasonably afford access to 
the registered space must be protected by an intrusion detection system 
(IDS) unless physically occupied;
    (vi) Personnel monitoring the IDS must be capable of evaluating and 
interpreting the alarm and alerting the designated security response 
force or law enforcement;
    (vii) For powered access control systems, describe procedures to 
ensure that security is maintained in the event of the failure of access 
control systems due to power disruption affecting registered space;
    (viii) The entity must:
    (A) Determine that the response time for security forces or local 
police will not exceed 15 minutes where the response time is measured 
from the time

[[Page 857]]

of an intrusion alarm, or report of a security incident, to the arrival 
of the responders at the first security barrier or;
    (B) Provide security barriers that are sufficient to delay 
unauthorized access until the response force arrives in order to 
safeguard the select agents and toxins from theft, intentional release, 
or unauthorized access. The response time is measured from the time of 
an intrusion alarm, or report of a security incident, to the arrival of 
the responders at the first security barrier.
    (5) Entities that possess foot-and-mouth disease virus and 
rinderpest virus must have the following additional security 
requirements:
    (i) A minimum of four barriers, one of which must be a perimeter 
security fence or equivalent which is monitored 24 hours a day, 7 days a 
week (24/7) to detect the presence of unauthorized persons, vehicles, 
materials, or unauthorized activities;
    (ii) Onsite 24/7 armed security response force with roving patrol. 
Response time must not exceed 5 minutes from the time of an intrusion 
alarm or report of a security incident;
    (iii) CCTV surveillance with 24/7 monitoring and recording; and
    (iv) Transport vehicle with GPS tracking designed to serve as a 
containment vehicle.
    (g) In developing a security plan, an individual or entity should 
consider the document entitled, ``Security Plan Guidance.'' This 
document is available on the National Select Agent Registry at http://
www.selectagents.gov/.
    (h) The plan must be reviewed annually and revised as necessary. 
Drills or exercises must be conducted at least annually to test and 
evaluate the effectiveness of the plan. The plan must be reviewed and 
revised, as necessary, after any drill or exercise and after any 
incident. Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personal participants.

[70 FR 13284, Mar. 18, 2005, as amended at 77 FR 61079, Oct. 5, 2012; 79 
FR 26831, May 12, 2014; 82 FR 6209, Jan. 19, 2017; 83 FR 48202, Sept. 
24, 2018]



Sec.121.12  Biosafety.

    (a) An individual or entity required to register under this part 
must develop and implement a written biosafety plan that is commensurate 
with the risk of the select agent or toxin, given its intended use.\11\ 
The biosafety plan must contain sufficient information and documentation 
to describe the biosafety and containment procedures for the select 
agent or toxin, including any animals (including arthropods) or plants 
intentionally or accidentally exposed to or infected with a select 
agent. The current biosafety plan must be submitted for initial 
registration, renewal of registration, or when requested. The biosafety 
plan must include the following provisions:
---------------------------------------------------------------------------

    \11\ Technical assistance and guidance may be obtained by contacting 
APHIS.
---------------------------------------------------------------------------

    (1) The hazardous characteristics of each agent or toxin listed on 
the entity's registration and the biosafety risk associated with 
laboratory procedures related to the select agent or toxin;
    (2) Safeguards in place with associated work practices to protect 
entity personnel, the public, and the environment from exposure to the 
select agent or toxin including, but not limited to: Personal protective 
equipment and other safety equipment; containment equipment including, 
but not limited to, biological safety cabinets, animal caging systems, 
and centrifuge safety containers; and engineering controls and other 
facility safeguards;
    (3) Written procedures for each validated method used for 
disinfection, decontamination, or destruction, as appropriate, of all 
contaminated or presumptively contaminated materials including, but not 
limited to: Cultures and other materials related to the propagation of 
select agents or toxins, items related to the analysis of select agents 
and toxins, personal protective equipment, animal caging systems and 
bedding (if applicable), animal carcasses or extracted tissues and 
fluids (if applicable), laboratory surfaces and equipment, and effluent 
material; and
    (4) Procedures for the handling of select agents and toxins in the 
same spaces with non-select agents and toxins to prevent unintentional 
contamination.

[[Page 858]]

    (b) The biosafety and containment procedures must be sufficient to 
contain the select agent or toxin (e.g., physical structure and features 
of the entity, and operational and procedural safeguards).
    (c) In developing a biosafety plan, an individual or entity should 
consider the following:
    (1) The CDC/NIH publication, ``Biosafety in Microbiological and 
Biomedical Laboratories.'' This document is available on the National 
Select Agent Registry at http://www.selectagents.gov/.
    (2) The ``NIH Guidelines for Research Involving Recombinant or 
Synthetic Nucleic Acid Molecules.'' This document is available on the 
Internet at http://www.selectagents.gov/.
    (d) The biosafety plan must include an occupational health program 
for individuals with access to Tier 1 select agents and toxins, and 
those individuals must be enrolled in the occupational health program.
    (e) The plan must be reviewed annually and revised as necessary. 
Drills or exercises must be conducted at least annually to test and 
evaluate the effectiveness of the plan. The plan must be reviewed and 
revised, as necessary, after any drill or exercise and after any 
incident. Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personnel participants.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 
77 FR 61080, Oct. 5, 2012; 82 FR 6209, Jan. 19, 2017]



Sec.121.13  Restricted experiments.

    (a) An individual or entity may not conduct, or possess products 
resulting from, the following experiments unless approved by and 
conducted in accordance with the conditions prescribed by the 
Administrator:
    (1) Experiments that involve the deliberate transfer of, or 
selection for, a drug resistance trait to select agents that are not 
known to acquire the trait naturally, if such acquisition could 
compromise the control of disease agents in humans, veterinary medicine, 
or agriculture.
    (2) Experiments involving the deliberate formation of synthetic or 
recombinant DNA containing genes for the biosynthesis of select toxins 
lethal for vertebrates at an LD[50] <100 ng/kg body weight.
    (b) The Administrator may revoke approval to conduct any of the 
experiments in paragraph (a) of this section, or revoke or suspend a 
certificate of registration, if the individual or entity fails to comply 
with the requirements of this part.
    (c) To apply for approval to conduct any of the experiments in 
paragraph (a) of this section, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 
77 FR 61080, Oct. 5, 2012; 79 FR 26831, May 12, 2014]



Sec.121.14  Incident response. \12\
---------------------------------------------------------------------------

    \12\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or regulations.
---------------------------------------------------------------------------

    (a) An individual or entity required to register under this part 
must develop and implement a written incident response plan \13\ based 
upon a site specific risk assessment. The incident response plan must be 
coordinated with any entity-wide plans, kept in the workplace, and 
available to employees for review. The current incident response plan 
must be submitted for initial registration, renewal of registration, or 
when requested.
---------------------------------------------------------------------------

    \13\ Technical assistance and guidance may be obtained by contacting 
APHIS.
---------------------------------------------------------------------------

    (b) The incident response plan must fully describe the entity's 
response procedures for the theft, loss, or release of a select agent or 
toxin; inventory discrepancies; security breaches (including information 
systems); severe weather and other natural disasters; workplace 
violence; bomb threats and suspicious packages; and emergencies such as 
fire, gas leak, explosion, power outage, and other natural and man-made 
events.
    (c) The response procedures must account for hazards associated with 
the select agent or toxin and appropriate

[[Page 859]]

actions to contain such select agent or toxin, including any animals 
(including arthropods) or plants intentionally or accidentally exposed 
to or infected with a select agent.
    (d) The incident response plan must also contain the following 
information:
    (1) The name and contact information (e.g., home and work) for the 
individual or entity (e.g., responsible official, alternate responsible 
official(s), biosafety officer, etc.);
    (2) The name and contact information for the building owner and/or 
manager, where applicable;
    (3) The name and contact information for tenant offices, where 
applicable;
    (4) The name and contact information for the physical security 
official for the building, where applicable;
    (5) Personnel roles and lines of authority and communication;
    (6) Planning and coordination with local emergency responders;
    (7) Procedures to be followed by employees performing rescue or 
medical duties;
    (8) Emergency medical treatment and first aid;
    (9) A list of personal protective and emergency equipment, and their 
locations;
    (10) Site security and control;
    (11) Procedures for emergency evacuation, including type of 
evacuation, exit route assignments, safe distances, and places of 
refuge; and
    (12) Decontamination procedures.
    (e) Entities with Tier 1 select agents and toxins must have the 
following additional incident response policies or procedures:
    (1) The incident response plan must fully describe the entity's 
response procedures for failure of intrusion detection or alarm system; 
and
    (2) The incident response plan must describe procedures for how the 
entity will notify the appropriate Federal, State, or local law 
enforcement agencies of suspicious activity that may be criminal in 
nature and related to the entity, its personnel, or its select agents or 
toxins.
    (f) The plan must be reviewed annually and revised as necessary. 
Drills or exercises must be conducted at least annually to test and 
evaluate the effectiveness of the plan. The plan must be reviewed and 
revised, as necessary, after any drill or exercise and after any 
incident. Drills or exercises must be documented to include how the 
drill or exercise tested and evaluated the plan, any problems that were 
identified and corrective action(s) taken, and the names of registered 
entity personnel participants.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 
77 FR 61080, Oct. 5, 2012; 82 FR 6209, Jan. 19, 2017]



Sec.121.15  Training.

    (a) An individual or entity required to register under this part 
must provide information and training on biocontainment, biosafety, 
security (including security awareness), and incident response to:
    (1) Each individual with access approval from the Administrator or 
HHS Secretary. The training must address the particular needs of the 
individual, the work they will do, and the risks posed by the select 
agents or toxins. The training must be accomplished prior to the 
individual's entry into an area where a select agent is handled or 
stored, or within 12 months of the date the individual was approved by 
the Administrator or the HHS Secretary for access, whichever is earlier.
    (2) Each individual not approved for access to select agents and 
toxins by the Administrator or HHS Secretary before that individual 
enters areas under escort where select agents or toxins are handled or 
stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, 
storage areas, shipping/receiving areas, production facilities, etc.). 
Training for escorted personnel must be based on the risk associated 
with accessing areas where select agents and toxins are used and/or 
stored. The training must be accomplished prior to the individual's 
entry into where select agents or toxins are handled or stored (e.g., 
laboratories, growth chambers, animal rooms, greenhouses, storage areas, 
shipping/receiving areas, production facilities, etc.).
    (b) Entities with Tier 1 select agents and toxins must conduct 
annual insider threat awareness briefings on how to identify and report 
suspicious behaviors.

[[Page 860]]

    (c) Refresher training must be provided annually for individuals 
with access approval from the HHS Secretary or Administrator or at such 
time as the registered individual or entity significantly amends its 
security, incident response, or biosafety plans.
    (d) The responsible official must ensure a record of the training 
provided to each individual with access to select agents and toxins and 
each escorted individual (e.g., laboratory workers, visitors, etc.) is 
maintained. The record must include the name of the individual, the date 
of the training, a description of the training provided, and the means 
used to verify that the employee understood the training.
    (e) The responsible official must ensure and document that 
individuals are provided the contact information of the USDA Office of 
Inspector General Hotline and the HHS Office of Inspector General 
Hotline so that they may anonymously report any safety or security 
concerns related to select agents and toxins.

[77 FR 61081, Oct. 5, 2012, as amended at 82 FR 6209, Jan. 19, 2017]



Sec.121.16  Transfers.

    (a) Except as provided in paragraphs (c) and (d) of this section, a 
select agent or toxin may only be transferred to individuals or entities 
registered to possess, use, or transfer that agent or toxin. A select 
agent or toxin may only be transferred under the conditions of this 
section and must be authorized by APHIS or CDC prior to the transfer. 
\14\
---------------------------------------------------------------------------

    \14\ The requirements of this section do not apply to transfers 
within a registered entity (i.e., the sender and the recipient are 
covered by the same certificate of registration).
---------------------------------------------------------------------------

    (b) A transfer may be authorized if:
    (1) The sender:
    (i) Has at the time of transfer a certificate of registration that 
covers the particular select agent or toxin to be transferred and meets 
all the requirements of this part;
    (ii) Meets the exemption requirements for the particular select 
agent or toxin to be transferred; or
    (iii) Is transferring the select agent or toxin from outside of the 
United States and meets all import requirements.
    (2) At the time of transfer, the recipient has a certificate of 
registration that includes the particular select agent or toxin to be 
transferred and meets all of the requirements of this part.
    (c) A select agent or toxin that is contained in a specimen for 
proficiency testing may be transferred without prior authorization from 
APHIS or CDC provided that, at least 7 calendar days prior to the 
transfer, the sender reports to APHIS or CDC the select agent or toxin 
to be transferred and the name and address of the recipient.
    (d) On a case-by-case basis, the Administrator may authorize a 
transfer of a select agent or toxin not otherwise eligible for transfer 
under this part under conditions prescribed by the Administrator.
    (e) To obtain authorization for a transfer, APHIS/CDC Form 2 must be 
submitted.
    (f) After authorization is provided by APHIS or CDC, the packaging 
of the select agent(s) and toxin(s) is performed by an individual 
approved by the HHS Secretary or Administrator to have access to select 
agents and toxins and is in compliance with all applicable laws 
concerning packaging.
    (g) The sender must comply with all applicable laws governing 
shipping.
    (h) Transportation in commerce starts when the select agent(s) or 
toxin(s) are packaged for shipment and ready for receipt by a courier 
transporting select agent(s) or toxin(s) and ends when the package is 
received by the intended recipient who is an individual approved by the 
HHS Secretary or Administrator to have access to select agents and 
toxins, following a security risk assessment by the Attorney General.
    (i) The recipient must submit a completed APHIS/CDC Form 2 within 2 
business days of receipt of a select agent or toxin.
    (j) The recipient must immediately notify APHIS or CDC if the select 
agent or toxin has not been received within 48 hours after the expected 
delivery time or if the package containing the select agent or toxin has 
been damaged to the extent that a release of the select agent or toxin 
may have occurred.

[[Page 861]]

    (k) An authorization for a transfer shall be valid only for 30 
calendar days after issuance, except that such an authorization becomes 
immediately null and void if any facts supporting the authorization 
change (e.g., change in the certificate of registration for the sender 
or recipient, change in the application for transfer).
    (l) Transfer the amounts only after the transferor uses due 
diligence and documents that the recipient has a legitimate need (e.g., 
prophylactic, protective, bona fide research, or other peaceful purpose) 
to handle or use such toxins. Information to be documented includes, but 
is not limited, to the recipient information, toxin and amount 
transferred, and declaration that the recipient has legitimate purpose 
to store and use such toxins.

[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 
77 FR 61081, Oct. 5, 2012; 82 FR 6210, Jan. 19, 2017]



Sec.121.17  Records.

    (a) An individual or entity required to register under this part 
must maintain complete records relating to the activities covered by 
this part. Such records must include:
    (1) An accurate, current inventory for each select agent (including 
viral genetic elements, recombinant and/or synthetic nucleic acids, and 
organisms containing recombinant and/or synthetic nucleic acids) held in 
long-term storage (placement in a system designed to ensure viability 
for future use, such as in a freezer or lyophilized materials), 
including:
    (i) The name and characteristics (e.g., strain designation, GenBank 
Accession number, etc.);
    (ii) The quantity acquired from another individual or entity (e.g., 
containers, vials, tubes, etc.), date of acquisition, and the source;
    (iii) Where stored (e.g., building, room, and freezer or other 
storage container);
    (iv) When moved from storage and by whom and when returned to 
storage and by whom;
    (v) The select agent used, purpose of use, and, when applicable, 
final disposition;
    (vi) Records created under Sec.121.16 or 42 CFR 73.16 (Transfers);
    (vii) For intra-entity transfers (sender and the recipient are 
covered by the same certificate of registration), the select agent, the 
quantity transferred, the date of transfer, the sender, and the 
recipient; and
    (viii) Records created under Sec.121.19 or 42 CFR 73.19 
(Notification of theft, loss, or release);
    (2) An accurate, current accounting of any animals or plants 
intentionally or accidentally exposed to or infected with a select agent 
(including number and species, location, and appropriate disposition);
    (3) An accurate, current inventory for each toxin held, including:
    (i) The name and characteristics;
    (ii) The quantity acquired from another individual or entity (e.g., 
containers, vials, tubes, etc.), date of acquisition, and the source;
    (iii) The initial and current quantity amount (e.g., milligrams, 
milliliters, grams, etc.);
    (iv) The toxin used and purpose of use, quantity, date(s) of the use 
and by whom;
    (v) Where stored (e.g., building, room, and freezer or other storage 
container);
    (vi) When moved from storage and by whom and when returned to 
storage and by whom, including quantity amount;
    (vii) Records created under Sec.121.16 or 42 CFR 73.16 
(Transfers);
    (viii) For intra-entity transfers (sender and the recipient are 
covered by the same certificate of registration), the toxin, the 
quantity transferred, the date of transfer, the sender, and the 
recipient;
    (ix) Records created under Sec.121.19 or 42 CFR 73.19 
(Notification of theft, loss, or release);
    (x) If destroyed, the quantity of toxin destroyed, the date of such 
action, and by whom.
    (4) A current list of all individuals that have been granted access 
approval by the Administrator or the HHS Secretary;
    (5) Information about all entries into areas containing select 
agents or toxins, including the name of the individual, name of the 
escort (if applicable), and the date and time of entry;
    (6) Accurate, current records created under Sec.121.9 or 42 CFR 
73.9 (Responsible

[[Page 862]]

official), Sec.121.11 or 42 CFR 73.11 (Security), Sec.121.12 or 42 
CFR 73.12 (Biosafety), Sec.121.14 or 42 CFR 73.14 (Incident response), 
and Sec.121.15 or 42 CFR 73.15 (Training);
    (7) A written explanation of any discrepancies; and
    (8) For select agents or material containing select agents or 
regulated nucleic acids that can produce infectious forms of any select 
agent virus that have been subjected to a validated inactivation 
procedure or a procedure for removal of viable select agent:
    (i) A written description of the validated inactivation procedure or 
viable select agent removal method used, including validation data;
    (ii) A written description of the viability testing protocol used;
    (iii) A written description of the investigation conducted by the 
entity responsible official involving an inactivation or viable select 
agent removal failure and the corrective actions taken;
    (iv) The name of each individual performing the validated 
inactivation or viable select agent removal method;
    (v) The date(s) the validated inactivation or viable select agent 
removal method was completed;
    (vi) The location where the validated inactivation or viable select 
agent removal method was performed; and
    (vii) A certificate, signed by the principal investigator, that 
includes the date of inactivation or viable select agent removal, the 
validated inactivation or viable select agent removal method used, and 
the name of the principal investigator. A copy of the certificate must 
accompany any transfer of inactivated or select agent removed material.
    (b) The individual or entity must implement a system to ensure that 
all records and databases created under this part are accurate and 
legible, have controlled access, and that their authenticity may be 
verified.
    (c) The individual or entity must promptly produce upon request any 
information that is related to the requirements of this part but is not 
otherwise contained in a record required to be kept by this section. The 
location of such information may include, but is not limited to, 
biocontainment certifications, laboratory notebooks, institutional 
biosafety and/or animal use committee minutes and approved protocols, 
and records associated with occupational health and suitability 
programs. All records created under this part must be maintained for 3 
years.

[70 FR 13284, Mar. 18, 2005, as amended at 77 FR 61081, Oct. 5, 2012; 82 
FR 6210, Jan. 19, 2017]



Sec.121.18  Inspections.

    (a) Without prior notification, APHIS must be allowed to inspect any 
site at which activities regulated under this part are conducted and 
must be allowed to inspect and copy any records relating to the 
activities covered by this part.
    (b) Prior to issuing a certificate of registration to an individual 
or entity, APHIS may inspect and evaluate the premises and records to 
ensure compliance with this part.



Sec.121.19  Notification of theft, loss, or release.

    (a) An individual or entity must immediately notify APHIS or CDC 
upon discovery of the theft or loss of a select agent or toxin. Thefts 
or losses must be reported even if the select agent or toxin is 
subsequently recovered or the responsible parties are identified.
    (1) The theft or loss of a select agent or toxin must be reported by 
telephone, facsimile, or e-mail. The following information must be 
provided:
    (i) The name of the select agent or toxin and any identifying 
information (e.g., strain or other characterization information);
    (ii) An estimate of the quantity stolen or lost;
    (iii) An estimate of the time during which the theft or loss 
occurred;
    (iv) The location (building, room) from which the theft or loss 
occurred; and
    (v) The list of Federal, State, or local law enforcement agencies to 
which the individual or entity reported, or intends to report, the theft 
or loss.
    (2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar 
days.
    (b) An individual or entity must immediately notify APHIS or CDC 
upon discovery of a release of a select agent

[[Page 863]]

or toxin causing occupational exposure or a release of a select agent or 
toxin outside of the primary barriers of the biocontainment area.
    (1) The release of a select agent or toxin must be reported by 
telephone, facsimile, or e-mail. The following information must be 
provided:
    (i) The name of the select agent or toxin and any identifying 
information (e.g., strain or other characterization information);
    (ii) An estimate of the quantity released;
    (iii) The time and duration of the release;
    (iv) The environment into which the release occurred (e.g., in 
building or outside of building, waste system);
    (v) The location (building, room) from which the release occurred; 
and
    (vi) The number of individuals potentially exposed at the entity;
    (vii) Actions taken to respond to the release; and
    (viii) Hazards posed by the release.
    (2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar 
days.



Sec.121.20  Administrative review.

    (a) An individual or entity may appeal a denial, revocation, or 
suspension of registration under this part. The appeal must be in 
writing, state the factual basis for the appeal, and be submitted to the 
Administrator within 30 calendar days of the decision.
    (b) An individual may appeal a denial, limitation, or revocation of 
access approval under this part. The appeal must be in writing, state 
the factual basis for the appeal, and be submitted to the Administrator 
within 180 calendar days of the decision.
    (c) The Administrator's decision constitutes final agency action.

[77 FR 61081, Oct. 5, 2012]



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:
    (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

[[Page 864]]

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 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.

[[Page 865]]

                    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).
    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

[[Page 866]]

    (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 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, Policy, Evaluation, and 
Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010. 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

[[Page 867]]

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; 75 FR 20773, Apr. 21, 2010]



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.
    (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

[[Page 868]]

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, 
Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, 
Ames, IA 50010.
    (4) Contain a full statement of facts upon which the request for 
hearing is based;
    (5) Contain the name, the address, and the principal place of 
business of the person requesting the hearing; and
    (6) Contain a certification that the person requesting the hearing 
has served a true and complete copy of the request upon the petitioner 
of the due diligence determination and the applicant for patent term 
extension by certified or registered mail (return receipt requested) or 
by personal service.
    (c) The request must state whether the requesting party seeks a 
hearing not later than 30 days after the date APHIS receives the 
request, or, at the request of the person making the request, not later 
than 60 days after such date.

[58 FR 11369, Feb. 25, 1993, as amended at 59 FR 67617, Dec. 30, 1994; 
64 FR 43045, Aug. 9, 1999; 75 FR 20773, Apr. 21, 2010]



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.

[[Page 869]]

    (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 870]]



                         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 
          the APHIS-owned or -operated quarantine facilities, including 
          APHIS Animal Import Centers.
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.
130.23-130.29 [Reserved]
130.30 Hourly rate and minimum user fees.
130.31-130.48 [Reserved]
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 871]]

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.
    Import compliance assistance. Import compliance assistance includes 
services provided to an importer whose shipment arrives at a port of 
entry without the necessary paperwork or with incomplete paperwork and 
who requires assistance to meet the requirements for entry into the 
United States. Fees for import compliance assistance are charged in 
addition to the flat rate user fees.
    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.

[[Page 872]]

    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.
    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; 74 FR 14001, Mar. 30, 2009]



Sec.130.2  User fees for individual animals and certain birds quarantined in the APHIS-owned or -operated quarantine facilities, including APHIS Animal Import 
          Centers.

    (a) Standard requirements. User fees for any service rendered by an 
APHIS representative 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                  Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                                             2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                              30, 2009        2010          2011          2012      Oct. 1, 2012
----------------------------------------------------------------------------------------------------------------
Birds (excluding ratites and pet birds
 imported in accordance with part 93 of
 this subchapter):
    0-250 grams...........................         $2.50         $2.75         $2.75         $2.75         $3.00
    251-1,000 grams.......................          8.25          8.50          8.75          9.00          9.25
    Over 1,000 grams......................         18.00         19.00         19.00         20.00         21.00
Domestic or zoo animals (except equines,
 birds, and poultry):
    Bison, bulls, camels, cattle, or zoo          144.00        149.00        153.00        158.00        162.00
     animals..............................
    All others, including, but not limited         38.00         39.00         40.00         42.00         43.00
     to, alpacas, llamas, goats, sheep,
     and swine............................
Equines (including zoo equines, but
 excluding miniature horses):
1st through 3rd day (fee per day).........        382.00        393.00        405.00        417.00        429.00
    4th through 7th day (fee per day).....        276.00        284.00        292.00        301.00        310.00
    8th and subsequent days (fee per day).        235.00        242.00        249.00        256.00        264.00
    Miniature horses......................         86.00         89.00         91.00         94.00         97.00
Poultry (including zoo poultry):
    Doves, pigeons, quail.................          5.00          5.25          5.50          5.50          5.75
    Chickens, ducks, grouse, guinea fowl,           9.00          9.25          9.50          9.75         10.00
     partridge, pea fowl, pheasants.......

[[Page 873]]

 
    Large poultry and large waterfowl,             21.00         22.00         22.00         23.00         24.00
     including, but not limited to,
     gamecocks, geese, swans, and turkeys.
Ratites:
    Chicks (less than 3 months old).......         13.00         13.00         14.00         14.00         15.00
    Juveniles (3 months through 10 months          20.00         20.00         21.00         22.00         22.00
     old).................................
    Adults (11 months old or older).......         38.00         39.00         40.00         42.00         43.00
----------------------------------------------------------------------------------------------------------------

    (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.

----------------------------------------------------------------------------------------------------------------
                                                                       Daily user fee
                                           ---------------------------------------------------------------------
   Bird or poultry (nonstandard housing,      Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
            care, or handling)               2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                              30, 2009        2010          2011          2012      Oct. 1, 2012
----------------------------------------------------------------------------------------------------------------
Birds 0-250 grams and doves, pigeons and           $8.25         $8.50         $8.75         $9.00         $9.25
 quail....................................
Birds 251-1,000 grams and poultry such as          18.00         19.00         19.00         20.00         21.00
 chickens, ducks, grouse, guinea fowl,
 partridge, pea fowl, and pheasants.......
Birds over 1,000 grams and large poultry           35.00         36.00         37.00         39.00         40.00
 and large waterfowl, including, but not
 limited to gamecocks, 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.

(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; 72 FR 70765, Dec. 
13, 2007; 74 FR 14001, Mar. 30, 2009]



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               Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-   Beginning
                                             2009- Sept.    Sept. 30,     Sept. 30,     Sept. 30,    October 1,
                                              30, 2009        2010          2011          2012          2012
----------------------------------------------------------------------------------------------------------------
Newburgh, NY:

[[Page 874]]

 
    Space A...............................    $83,756.00    $86,268.00    $88,856.00   $91, 513.00    $94,249.00
    5,396 sq. ft..........................
    (503.1 sq. m.)........................
    Space B...............................    138,190.00    142,335.00    146,605.00    150,989.00    155,504.00
    8,903 sq. ft..........................
    (827.1 sq. m.)........................
    Space C...............................     14,047.00     14,469.00     14,903.00     15,348.00     15,807.00
    905 sq. ft............................
    (84.1 sq. m.).........................
----------------------------------------------------------------------------------------------------------------

    (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.
    (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 any service rendered by an APHIS representative 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; 72 FR 
70765, Dec. 13, 2007; 74 FR 14002, Mar. 30, 2009; 74 FR 18115, Apr. 21, 
2009]



Sec.130.4  User fees for processing import permit applications.

    User fees for any service rendered by an APHIS representative 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. These 
fees are nonrefundable. The table follows:

[[Page 875]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  User fee
                                                                                   ---------------------------------------------------------------------
                    Service                                     Unit                  Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                                                                                     2009- Sept.    Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                                                                      30, 2009        2010          2011          2012      Oct. 1, 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
Import compliance assistance:
    Simple (4 hours or less)...................  Per shipment.....................        $99.00       $102.00       $105.00       $108.00       $111.00
    Complicated (more than 4 hours)............  Per shipment.....................        514.00        514.00        531.00        548.00        565.00
Processing an application for a permit to
 import live animals, animal products or by
 products, organisms, vectors, or germ plasm
 (embryos or semen) or to transport organisms
 or vectors \1\
    Initial permit.............................  Per application..................        133.00        137.00        141.00        145.00        150.00
    Amended permit.............................  Per amended application..........         66.00         68.00         70.00         73.00         75.00
    Renewed permit \2\.........................  Per application..................         86.00         89.00         91.00         94.00         97.00
Processing an application for a permit to        Per application..................        455.00        469.00        483.00        497.00        512.00
 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; 72 
FR 70766, Dec. 13, 2007; 74 FR 14002, Mar. 30, 2009]



Sec.130.5  User fees for services at privately owned permanent and
temporary import quarantine facilities.

    (a) User fees for any service rendered by an APHIS representative 
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, as amended at 72 FR 70766, Dec. 13, 2007]



Sec.130.6  User fees for inspection of live animals at land border
ports along the United States-Mexico border.

    (a) User fees for any service rendered by an APHIS representative 
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 
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               April 29,   Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                                             2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                              30, 2009        2010          2011          2012      Oct. 1, 2012
----------------------------------------------------------------------------------------------------------------
Any ruminants (including breeder                  $13.00        $13.00        $14.00        $14.00        $14.00
 ruminants) not covered below.............
Feeder....................................          3.75          3.75          4.00          4.00          4.00
Horses, other than slaughter..............         62.00         64.00         66.00         68.00         70.00
In-bond or in-transit.....................          8.25          8.50          8.75          9.00          9.25

[[Page 876]]

 
Slaughter.................................          5.50          5.50          5.75          6.00          6.00
----------------------------------------------------------------------------------------------------------------

    (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; 
72 FR 70766, Dec. 13, 2007; 74 FR 14003, Mar. 30, 2009]



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 any service rendered by an APHIS representative 
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                  Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                                                                                     2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                                                                      30, 2009        2010          2011          2012      Oct. 1, 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
Animals being imported into the United States:
 Breeding animals (Grade animals, except
 horses):
    Sheep and goats............................  Per head.........................         $0.75         $0.75         $0.75         $1.00         $1.00
    Swine......................................  Per head.........................          1.25          1.25          1.25          1.25          1.25
All others.....................................  Per head.........................          4.75          4.75          5.00          5.25          5.25
Feeder animals:
    Cattle (not including calves)..............  Per head.........................          2.25          2.25          2.50          2.50          2.50
    Sheep and calves...........................  Per head.........................          0.75          0.75          1.00          1.00          1.00
    Swine......................................  Per head.........................          0.50          0.50          0.50          0.50          0.50
    Horses (including registered horses) other   Per head.........................         41.00         42.00         43.00         45.00         46.00
     than slaughter and in-transit.
    Poultry (including eggs), imported for any   Per load.........................         71.00         73.00         75.00         77.00         80.00
     purpose.
    Registered animals, all types (except        Per head.........................          8.50          8.75          9.25          9.50          9.75
     horses).
    Slaughter animals, all types (except         Per load.........................         35.00         36.00         37.00         39.00         40.00
     poultry).
Animals transiting \1\ the United States:
    Cattle.....................................  Per head.........................          2.25          2.25          2.50          2.50          2.50
    Sheep and goats............................  Per head.........................          0.50          0.50          0.50          0.50          0.50
    Swine......................................  Per head.........................          0.50          0.50          0.50          0.50          0.50
    Horses and all other animals...............  Per head.........................          9.75         10.00         10.00         10.00         11.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 in Sec. 130.30 will apply.

    (b) 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,

[[Page 877]]

in addition to the user fee listed in this section.

(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; 72 FR 70766, Dec. 13, 2007; 74 FR 14003, 
Mar. 30, 2009]



Sec.130.8  User fees for other services.

    (a) User fees for any service rendered by an APHIS representative 
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                  Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                                                                                     2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                                                                      30, 2009        2010          2011          2012      Oct. 1, 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
Germ plasm being exported: \1\
    Embryo:
    Up to 5 donor pairs........................  Per certificate..................       $117.00       $121.00       $124.00       $128.00       $132.00
    Each additional group of donor pairs, up to  Per group of donor pairs.........         52.00         54.00         55.00         57.00         59.00
     5 pairs per group on the same certificate.
    Semen......................................  Per certificate..................         72.00         74.00         76.00         79.00         81.00
Release from export agricultural hold:
    Simple (2 hours or less)...................  Per release......................         99.00        102.00        105.00        108.00        111.00
    Complicated (more than 2 hours)............  Per release......................        254.00        262.00        270.00        278.00        286.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. 130.3 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; 72 FR 70766, Dec. 13, 2007; 74 FR 14004, Mar. 
30, 2009]



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:

----------------------------------------------------------------------------------------------------------------
                                                                      Per lot user fee
                                           ---------------------------------------------------------------------
                  Service                     Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                                             2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                              30, 2009        2010          2011          2012      Oct. 1, 2012
----------------------------------------------------------------------------------------------------------------
(1) Which have been out of the United            $153.00       $157.00       $162.00       $167.00       $172.00
 States 60 days or less...................
(2) Which have been out of the United             363.00        374.00        385.00        397.00        409.00
 States 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.

[[Page 878]]



----------------------------------------------------------------------------------------------------------------
                                                                       Daily user fee
                                           ---------------------------------------------------------------------
        Number of birds in isolette           Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                                             2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                              30, 2009        2010          2011          2012      Oct. 1, 2012
----------------------------------------------------------------------------------------------------------------
1.........................................        $13.00        $13.00        $14.00        $14.00        $15.00
2.........................................         16.00         16.00         17.00         17.00         18.00
3.........................................         18.00         19.00         19.00         20.00         21.00
4.........................................         21.00         22.00         22.00         23.00         24.00
5 or more.................................         25.00         26.00         27.00         28.00         29.00
----------------------------------------------------------------------------------------------------------------

    (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; 74 FR 
14004, Mar. 30, 2009]



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. These user fees do not 
apply to inspection activities covered in Sec.130.30(a)(2).

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  User fee
                                                                                   ---------------------------------------------------------------------
                    Service                                     Unit                  Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                                                                                     2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                                                                      30, 2009        2010          2011          2012      Oct. 1, 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
Embryo collection center inspection and          Per year.........................       $537.00       $553.00       $570.00       $587.00       $604.00
 approval (all inspections required during the
 year for facility approval).
Inspection for approval of biosecurity level     Per inspection...................      1,381.00      1,422.00      1,465.00      1,509.00      1,554.00
 three labs (all inspections related to
 approving the laboratory for handling one
 defined set of organisms or vectors) \1\.
Inspection for approval of slaughter
 establishment:
    Initial approval (all inspections).........  Per year.........................        527.00        543.00        559.00        576.00        593.00
    Renewal (all inspections)..................  Per year.........................        457.00        470.00        484.00        499.00        514.00
Inspection of approved establishments,
 warehouses, and facilities under 9 CFR parts
 94 through 96:
    Approval (compliance agreement) (all         Per year.........................        563.00        579.00        597.00        615.00        633.00
     inspections for first year of 3-year
     approval).
    Renewal (all inspections for second and      Per year.........................        325.00        335.00        345.00        355.00        366.00
     third years of 3-year approval).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The hourly user fee rate in Sec. 130.30(2) applies to biosecurity level two laboratories.


[[Page 879]]

    (b) [Reserved]

[65 FR 52008, Aug. 28, 2000, as amended at 68 FR 51885, Aug. 29, 2003; 
68 FR 64507, Nov. 14, 2003; 72 FR 70766, Dec. 13, 2007; 74 FR 14004, 
Mar. 30, 2009]



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.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                 ---------------------------------------------------------------
            Reagent                   Unit         June 7, 2004-   Oct. 1, 2004-   Oct. 1, 2005-
                                                  Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                      1, 2006
----------------------------------------------------------------------------------------------------------------
Bovine antiserum, any agent...  1 mL............         $150.00         $155.00         $160.00         $165.00
Caprine antiserum, any agent..  1 mL............          184.00          189.00          195.00          202.00
Cell culture antigen/           1 mL............          103.00          106.00          109.00          111.00
 microorganism.
Equine antiserum, any agent...  1 mL............          186.00          192.00          198.00          204.00
Fluorescent antibody conjugate  1 mL............          169.00          172.00          176.00          179.00
Guinea pig antiserum, any       1 mL............          184.00          189.00          194.00          200.00
 agent.
Monoclonal antibody...........  1 mL............          222.00          229.00          235.00          243.00
Ovine antiserum, any agent....  1 mL............          176.00          181.00          187.00          193.00
Porcine antiserum, any agent..  1 mL............          152.00          157.00          162.00          167.00
Rabbit antiserum, any agent...  1 mL............          179.00          185.00          190.00          196.00
----------------------------------------------------------------------------------------------------------------

    (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.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                 ---------------------------------------------------------------
             Test                     Unit         June 7, 2004-   Oct. 1, 2004-   Oct. 1, 2005-
                                                  Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                      1, 2006
----------------------------------------------------------------------------------------------------------------
Agar gel immunodiffusion......  Test............          $30.00          $31.00          $32.00          $33.00
Card..........................  Test............           17.00           17.00           18.00           18.00
Complement fixation...........  Test............           36.00           37.00           38.00           40.00
Direct immunofluorescent        Test............           22.00           23.00           24.00           25.00
 antibody.
Enzyme linked immunosorbent     Test............           26.00           27.00           28.00           29.00
 assay.
Fluorescent antibody            Test............          194.00          201.00          208.00          215.00
 neutralization (classical
 swine fever).
Hemagglutination inhibition...  Test............           57.00           59.00           61.00           63.00
Immunoperoxidase..............  Test............           29.00           30.00           31.00           32.00
Indirect fluorescent antibody.  Test............           35.00           36.00           37.00           39.00
In-vitro safety...............  Test............          570.00          589.00          609.00          630.00
In-vivo safety................  Test............        5,329.00        5,387.00        5,447.00        5,509.00
Latex agglutination...........  Test............           23.00           24.00           25.00           26.00
Tube agglutination............  Test............           28.00           28.00           29.00           30.00
Virus isolation (oesophageal/   Test............          180.00          186.00          192.00          199.00
 pharyngeal).
Virus isolation in embryonated  Test............          346.00          358.00          370.00          383.00
 eggs.
Virus isolation, other........  Test............          155.00          160.00          166.00          171.00
Virus neutralization..........  Test............           52.00           54.00           56.00           58.00
----------------------------------------------------------------------------------------------------------------


[[Page 880]]

    (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.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                 ---------------------------------------------------------------
 Veterinary diagnostic service        Unit         June 7, 2004-   Oct. 1, 2004-   Oct. 1, 2005-
                                                  Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                      1, 2006
----------------------------------------------------------------------------------------------------------------
Bacterial isolation...........  Test............         $112.00         $115.00         $119.00         $123.00
Hourly user fee services \1\..  Hour............          445.00          460.00          476.00          492.00
Hourly user fee services--      Quarter hour....          111.00          115.00          119.00          123.00
 Quarter hour.
Infected cells on chamber       Slide...........           49.00           50.00           51.00           53.00
 slides or plates.
Reference animal tissues for    Set.............          171.00          177.00          182.00          187.00
 immunohistochemistry.
Sterilization by gamma          Can.............        1,740.00        1,799.00        1,860.00        1,923.00
 radiation.
Training (school or technical   Per person per            910.00          941.00          973.00        1,006.00
 assistance).                    day.
Virus titration...............  Test............          112.00          115.00          119.00         123.00
----------------------------------------------------------------------------------------------------------------
\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; 69 FR 25307, May 6, 2004]



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.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                ----------------------------------------------------------------
             Test                    Unit          Jan. 18,     Oct. 1,      Oct. 1,      Oct. 1,     Beginning
                                                  2008-Sept.   2008-Sept.   2009-Sept.   2010-Sept.    Oct. 1,
                                                   30, 2008     30, 2009     30, 2010     30, 2011       2011
----------------------------------------------------------------------------------------------------------------
Bacterial identification,      Isolate.........       $53.00       $54.00       $55.00       $57.00       $58.00
 automated.
Bacterial identification, non- Isolate.........        90.00        92.00        94.00        96.00        98.00
 automated.
Bacterial isolation..........  Sample..........        36.00        37.00        38.00        39.00        40.00
Bacterial serotyping, all      Isolate.........        55.00        56.00        56.00        57.00        58.00
 other.
Bacterial serotyping,          Isolate.........        18.00        19.00        19.00        19.00        20.00
 Pasteurella multocida.
Bacterial serotyping,          Isolate.........        36.00        37.00        38.00        39.00        40.00
 Salmonella.
Bacterial toxin typing.......  Isolate.........       120.00       123.00       126.00       128.00       131.00
Bacteriology requiring         Test............        92.00        94.00        96.00        98.00       101.00
 special characterization.
DNA fingerprinting...........  Test............        59.00        61.00        62.00        63.00        64.00
DNA probe....................  Test............        83.00        85.00        86.00        88.00        89.00
Fluorescent antibody.........  Test............        19.00        19.00        20.00        20.00        20.00
Mycobacterium identification   Isolate.........       115.00       117.00       120.00       122.00       125.00
 (biochemical).
Mycobacterium identification   Procedure.......        96.00        99.00       101.00       103.00       105.00
 (gas chromatography).
Mycobacterium isolation,       Submission......       844.00       852.00       868.00       884.00       900.00
 animal inoculations.
Mycobacterium isolation, all   Submission......       151.00       154.00       158.00       161.00       165.00
 other.
Mycobacterium                  Submission......        72.00        74.00        75.00        77.00        79.00
 paratuberculosis isolation.
Phage typing, all other......  Isolate.........        42.00        43.00        44.00        45.00        46.00

[[Page 881]]

 
Phage typing, Salmonella       Isolate.........        24.00        24.00        25.00        25.00        26.00
 enteritidis.
----------------------------------------------------------------------------------------------------------------

    (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.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                ----------------------------------------------------------------
             Test                    Unit          Jan. 18,     Oct. 1,      Oct. 1,      Oct. 1,     Beginning
                                                  2008-Sept.   2008-Sept.   2009-Sept.   2010-Sept.    Oct. 1,
                                                   30, 2008     30, 2009     30, 2010     30, 2011       2011
----------------------------------------------------------------------------------------------------------------
Fluorescent antibody tissue    Test............       $29.00       $30.00       $30.00       $31.00       $31.00
 section.
Virus isolation..............  Test............        48.00        49.00        50.00        51.00        52.00
----------------------------------------------------------------------------------------------------------------


(Approved by the Office of Management and Budget under control numbers 
0579-0055 and 0579-0094)

[63 FR 53792, Oct. 7, 1998, as amended at 69 FR 25308, May 6, 2004; 72 
FR 71746, Dec. 19, 2007]



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.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                ----------------------------------------------------------------
             Test                    Unit          Jan. 18,     Oct. 1,      Oct. 1,      Oct. 1,     Beginning
                                                  2008-Sept.   2008-Sept.   2009-Sept.   2010-Sept.    Oct. 1,
                                                   30, 2008     30, 2009     30, 2010     30, 2011       2011
----------------------------------------------------------------------------------------------------------------
Brucella ring (BRT)..........  Test............       $36.00       $37.00       $38.00       $39.00       $40.00
Brucella ring, heat            Test............        36.00        37.00        38.00        39.00        40.00
 inactivated (HIRT).
Brucella ring, serial (Serial  Test............        54.00        56.00        57.00        58.00        59.00
 BRT).
Buffered acidified plate       Test............         7.00         7.25         7.50         7.50         8.00
 antigen presumptive.
Card.........................  Test............         4.00         4.00         4.25         4.25         4.50
Complement fixation..........  Test............        16.00        17.00        17.00        18.00        18.00
Enzyme linked immunosorbent    Test............        16.00        17.00        17.00        18.00        18.00
 assay.
Indirect fluorescent antibody  Test............        14.00        15.00        15.00        15.00        16.00
Microscopic agglutination--    Sample..........        24.00        24.00        25.00        25.00        26.00
 includes up to 5 serovars.
Microscopic agglutination--    Sample..........         4.25         4.50         4.50         4.50         4.75
 each serovar in excess of 5
 serovars.
Particle concentration         Test............        36.00        37.00        38.00        38.00        39.00
 fluorescent immunoassay
 (PCFIA).
Plate........................  Test............         7.00         7.25         7.50         7.50         7.75
Rapid automated presumptive..  Test............         7.00         7.00         7.25         7.25         7.25
Rivanol......................  Test............         7.00         7.25         7.50         7.50         7.75
Tube agglutination...........  Test............         7.00         7.25         7.50         7.50         7.75
----------------------------------------------------------------------------------------------------------------


[[Page 882]]

    (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 user fees in accordance with Sec. Sec.130.50 and 
130.51.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                ----------------------------------------------------------------
             Test                    Unit          Jan. 18,     Oct. 1,      Oct. 1,      Oct. 1,     Beginning
                                                  2008-Sept.   2008-Sept.   2009-Sept.   2010-Sept.    Oct. 1,
                                                   30, 2008     30, 2009     30, 2010     30, 2011       2011
----------------------------------------------------------------------------------------------------------------
Agar gel immunodiffusion.....  Test............       $16.00       $17.00       $17.00       $17.00       $18.00
Complement fixation..........  Test............        16.00        17.00        17.00        18.00        18.00
Enzyme linked immunosorbent    Test............        16.00        17.00        17.00        18.00        18.00
 assay.
Hemagglutination inhibition..  Test............        14.00        15.00        15.00        15.00        16.00
Indirect fluorescent antibody  Test............        14.00        15.00        15.00        15.00        16.00
Latex agglutination..........  Test............        16.00        17.00        17.00        17.00        18.00
Peroxidase linked antibody...  Test............        15.00        16.00        16.00        16.00        17.00
Plaque reduction               Test............        18.00        18.00        19.00        19.00        19.00
 neutralization.
Rabies fluorescent antibody    Test............        45.00        46.00        47.00        49.00        50.00
 neutralization.
Virus neutralization.........  Test............        13.00        13.00        14.00        14.00        14.00
----------------------------------------------------------------------------------------------------------------


(Approved by the Office of Management and Budget under control numbers 
0579-0055 and 0579-0094)

[63 FR 53793, Oct. 7, 1998, as amended at 69 FR 25309, May 6, 2004; 72 
FR 71746, Dec. 19, 2007]



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.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                ----------------------------------------------------------------
             Test                    Unit          Jan. 18,     Oct. 1,      Oct. 1,      Oct. 1,     Beginning
                                                  2008-Sept.   2008-Sept.   2009-Sept.   2010-Sept.    Oct. 1,
                                                   30, 2008     30, 2009     30, 2010     30, 2011       2011
----------------------------------------------------------------------------------------------------------------
Aflatoxin quantitation.......  Test............       $30.00       $31.00       $32.00       $32.00       $33.00
Aflatoxin screen.............  Test............        29.00        29.00        30.00        30.00        31.00
Agar gel immunodiffusion spp.  Test............        13.00        13.00        13.00        14.00        14.00
 identification.
Antibiotic (bioautography)     Test............        66.00        67.00        68.00        70.00        72.00
 quantitation.
Antibiotic (bioautography)     Test............       119.00       122.00       125.00       128.00       130.00
 screen.
Antibiotic inhibition........  Test............        66.00        67.00        68.00        70.00        72.00
Arsenic......................  Test............        17.00        18.00        18.00        19.00        19.00
Ergot alkaloid screen........  Test............        66.00        67.00        68.00        70.00        72.00
Ergot alkaloid confirmation..  Test............        86.00        88.00        89.00        91.00        94.00
Feed microscopy..............  Test............        66.00        67.00        68.00        70.00        72.00
Fumonisin only...............  Test............        37.00        38.00        39.00        40.00        40.00
Gossypol.....................  Test............        98.00       100.00       103.00       105.00       107.00
Mercury......................  Test............       145.00       148.00       151.00       155.00       158.00
Metals screen................  Test............        44.00        45.00        46.00        47.00        48.00
Metals single element          Test............        13.00        13.00        13.00        14.00        14.00
 confirmation.
Mycotoxin: aflatoxin-liver...  Test............       119.00       122.00       125.00       128.00       130.00
Mycotoxin screen.............  Test............        48.00        49.00        50.00        51.00        52.00
Nitrate/nitrite..............  Test............        66.00        67.00        68.00        70.00        72.00
Organic compound confirmation  Test............        88.00        90.00        92.00        94.00        96.00
Organic compound screen......  Test............       151.00       155.00       158.00       161.00       165.00
Parasitology.................  Test............        29.00        29.00        30.00        30.00        31.00
Pesticide quantitation.......  Test............       132.00       135.00       138.00       141.00       144.00
Pesticide screen.............  Test............        60.00        62.00        63.00        64.00        66.00
pH...........................  Test............        26.00        27.00        28.00        28.00        29.00
Plate cylinder...............  Test............        98.00       100.00       103.00       105.00       107.00

[[Page 883]]

 
Selenium.....................  Test............        44.00        45.00        46.00        47.00        48.00
Silicate/carbonate             Test............        66.00        67.00        68.00        70.00        72.00
 disinfectant.
Temperature disks............  Test............       130.00       133.00       136.00       139.00       142.00
Toxicant quantitation, other.  Test............       110.00       112.00       115.00       117.00       120.00
Toxicant screen, other.......  Test............        33.00        33.00        34.00        35.00        36.00
Vomitoxin only...............  Test............        53.00        54.00        55.00        56.00        58.00
Water activity...............  Test............        33.00        33.00        34.00        35.00        36.00
Zearaleone quantitation......  Test............        53.00        54.00        55.00        56.00        58.00
Zearaleone screen............  Test............        29.00        29.00        30.00        30.00        31.00
----------------------------------------------------------------------------------------------------------------

    (b) [Reserved]

(Approved by the Office of Management and Budget under control numbers 
0579-0055 and 0579-0094)

[63 FR 53793, Oct. 7, 1998, as amended at 69 FR 25309, May 6, 2004; 72 
FR 71747, Dec. 19, 2007]



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.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                ----------------------------------------------------------------
           Reagent                   Unit          Jan. 18,     Oct. 1,      Oct. 1,      Oct. 1,     Beginning
                                                  2008-Sept.   2008-Sept.   2009-Sept.   2010-Sept.    Oct. 1,
                                                   30, 2008     30, 2009     30, 2010     30, 2011       2011
----------------------------------------------------------------------------------------------------------------
Anaplasma card test antigen..  2 mL............       $95.00       $97.00       $99.00      $101.00      $103.00
Anaplasma card test kit        Kit.............       127.00       130.00       133.00       136.00       139.00
 without antigen.
Anaplasma CF antigen.........  2 mL............        46.00        46.00        46.00        47.00        47.00
Anaplasma stabilate..........  4.5 mL..........       175.00       178.00       181.00       185.00       188.00
Avian origin bacterial         1 mL............        48.00        49.00        50.00        51.00        52.00
 antiserums.
Bacterial agglutinating        5 mL............        54.00        55.00        57.00        58.00        59.00
 antigens other than brucella
 and salmonella pullorum.
Bacterial conjugates.........  1 mL............        96.00        99.00       101.00       103.00       105.00
Bacterial disease CF           1 mL............        29.00        30.00        30.00        31.00        32.00
 antigens, all other.
Bacterial ELISA antigens.....  1 mL............        29.00        30.00        31.00        31.00        32.00
Bacterial or protozoal         1 mL............        60.00        61.00        63.00        64.00        66.00
 antiserums, all other.
Bacterial reagent culture \1\  Culture.........        73.00        74.00        76.00        78.00        79.00
Bacterial reference culture    Culture.........       228.00       233.00       239.00       244.00       249.00
 \2\.
Bacteriophage reference        Culture.........       172.00       176.00       180.00       183.00       188.00
 culture.
Bovine serum factor..........  1 mL............        18.00        18.00        19.00        19.00        19.00
Brucella abortus CF antigen..  60 mL...........       151.00       154.00       158.00       161.00       165.00
Brucella agglutination         60 mL...........       151.00       154.00       158.00       161.00       165.00
 antigens, all other.
Brucella buffered plate        60 mL...........       172.00       176.00       180.00       183.00       188.00
 antigen.
Brucella canis tube antigen..  25 mL...........       114.00       116.00       119.00       121.00       124.00
Brucella card test antigen     Package.........        90.00        92.00        94.00        96.00        98.00
 (packaged).
Brucella card test kit         Kit.............       113.00       114.00       116.00       117.00       119.00
 without antigen.
Brucella cells...............  Gram............        19.00        19.00        19.00        20.00        20.00
Brucella cells, dried........  Pellet..........         6.00         6.00         6.25         6.25         6.25
Brucella ring test antigen...  60 mL...........       241.00       246.00       252.00       257.00       263.00
Brucella rivanol solution....  60 mL...........        29.00        30.00        31.00        31.00        32.00
Dourine CF antigen...........  1 mL............        89.00        91.00        93.00        95.00        97.00
Dourine stabilate............  4.5 mL..........       109.00       111.00       112.00       114.00       116.00

[[Page 884]]

 
Equine and bovine origin       1 mL............       127.00       130.00       133.00       136.00       139.00
 babesia species antiserums.
Equine negative control CF     1 mL............       282.00       283.00       286.00       290.00       293.00
 antigen.
Flazo-orange.................  3 mL............        13.00        13.00        13.00        13.00        14.00
Glanders CF antigen..........  1 mL............        77.00        79.00        81.00        82.00        84.00
Hemoparasitic disease CF       1 mL............       541.00       553.00       565.00       577.00       590.00
 antigens, all other.
Leptospira transport medium..  10 mL...........         4.25         4.50         4.50         4.50         4.75
Monoclonal antibody..........  1 mL............        95.00        97.00        99.00       101.00       103.00
Mycobacterium spp. old         1 mL............        24.00        24.00        25.00        25.00        26.00
 tuberculin.
Mycobacterium spp. PPD.......  1 mL............        18.00        19.00        19.00        19.00        20.00
Mycoplasma hemagglutination    5 mL............       180.00       184.00       188.00       192.00       197.00
 antigens.
Negative control serums......  1 mL............        18.00        19.00        19.00        19.00        20.00
Rabbit origin bacterial        1 mL............        52.00        53.00        54.00        55.00        56.00
 antiserum.
Salmonella pullorum            5 mL............        15.00        16.00        16.00        16.00        17.00
 microagglutination antigen.
Stabilates, all other........  4.5 mL..........       684.00       690.00       703.00       716.00       730.00
----------------------------------------------------------------------------------------------------------------
\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
  agglutination 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.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                ----------------------------------------------------------------
           Reagent                   Unit          Jan. 18,     Oct. 1,      Oct. 1,      Oct. 1,     Beginning
                                                  2008-Sept.   2008-Sept.   2009-Sept.   2010-Sept.    Oct. 1,
                                                   30, 2008     30, 2009     30, 2010     30, 2011       2011
----------------------------------------------------------------------------------------------------------------
Antigen, except avian          2 mL............       $61.00       $62.00       $64.00       $65.00       $67.00
 influenza and chlamydia
 psittaci antigens, any.
Avian antiserum except avian   2 mL............        48.00        49.00        51.00        52.00        53.00
 influenza antiserum, any.
Avian influenza antigen, any.  2 mL............        33.00        34.00        35.00        36.00        36.00
Avian influenza antiserum,     6 mL............       103.00       105.00       108.00       110.00       113.00
 any.
Bovine or ovine serum, any...  2 mL............       127.00       130.00       133.00       136.00       139.00
Cell culture.................  Flask...........       151.00       154.00       158.00       161.00       165.00
Chlamydia psittaci spp. of     Panel...........        95.00        96.00        98.00        99.00       101.00
 origin monoclonal antibody
 panel.
Conjugate, any...............  1 mL............        73.00        75.00        76.00        78.00        80.00
Diluted positive control       2 mL............        24.00        25.00        25.00        26.00        27.00
 serum, any.
Equine antiserum, any........  2 mL............        45.00        46.00        47.00        48.00        49.00
Monoclonal antibody..........  1 mL............       102.00       104.00       106.00       108.00       110.00
Other spp. antiserum, any....  1 mL............        52.00        52.00        52.00        53.00        53.00
Porcine antiserum, any.......  2 mL............       105.00       108.00       110.00       113.00       115.00
Porcine tissue sets..........  Tissue set......       157.00       157.00       158.00       159.00       161.00
Positive control tissues, all  2 cm \2\ section        60.00        62.00        63.00        65.00        66.00
Rabbit origin antiserum......  1 mL............        52.00        53.00        54.00        55.00        56.00
Reference virus, any.........  0.6 mL..........       180.00       184.00       188.00       193.00       197.00
Viruses (except reference      0.6 mL..........        30.00        31.00        32.00        32.00        33.00
 viruses), chlamydia psittaci
 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; 69 
FR 25310, May 6, 2004; 72 FR 71748, Dec. 19, 2007]

[[Page 885]]



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.

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                ----------------------------------------------------------------
           Service                   Unit          Jan. 18,     Oct. 1,      Oct. 1,      Oct. 1,     Beginning
                                                  2008-Sept.   2008-Sept.   2009-Sept.   2010-Sept.    Oct. 1,
                                                   30, 2008     30, 2009     30, 2010     30, 2011       2011
----------------------------------------------------------------------------------------------------------------
Antimicrobial susceptibility   Isolate.........      $105.00      $107.00      $109.00      $112.00      $114.00
 test.
Avian safety test............  Test............     4,082.00     4,090.00     4,099.00     4,109.00     4,180.00
Check tests, culture.........  Kit \1\.........       176.00       179.00       182.00       185.00       189.00
Check tests, serology........  Kit \1\.........       361.00       369.00       377.00       385.00       394.00
Fetal bovine serum safety      Verification....     1,119.00     1,122.00     1,134.00     1,147.00     1,160.00
 test.
Hourly user fees: \2\
    Hour.....................  Hour............       104.00       104.00       108.00       112.00       112.00
    Quarter hour.............  Quarter Hour....        26.00        26.00        27.00        28.00        28.00
    Minimum..................  30.00...........        31.00        32.00        33.00        33.00
    Manual, brucellosis        1 copy..........       115.00       117.00       120.00       122.00       125.00
     culture.
    Manual, tuberculosis       1 copy..........       172.00       176.00       180.00       183.00       188.00
     Culture (English or
     Spanish).
    Manual, Veterinary         1 copy..........       172.00       176.00       180.00       183.00       188.00
     mycology.
    Manuals or standard        1 copy..........        34.00        35.00        36.00        37.00        37.00
     operating procedure
     (SOP), all other.
    Manuals or SOP, per page.  1 page..........         2.25         2.50         2.50         2.75         2.75
    Training (school or        Per person per         332.00       339.00       346.00       354.00       362.00
     technical assistance).     day.
----------------------------------------------------------------------------------------------------------------
\1\ Any reagents required for the check test will be charged separately.
\2\ For veterinary diagnostic services for which there is no flat 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, as amended at 69 FR 25311, May 6, 2004; 72 
FR 71749, Dec. 19, 2007]



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 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              Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                                             2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                              30, 2009        2010          2011          2012      Oct. 1, 2012
----------------------------------------------------------------------------------------------------------------
Animal and nonanimal products.............        $45.00        $47.00        $48.00        $49.00        $51.00
Hatching eggs.............................         42.00         44.00         45.00         46.00         48.00
Poultry, including slaughter poultry......         42.00         44.00         45.00         46.00         48.00

[[Page 886]]

 
Ruminants, except slaughter ruminants              47.00         48.00         49.00         51.00         52.00
 moving to Canada or Mexico...............
Slaughter animals (except poultry but              49.00         51.00         52.00         54.00         56.00
 including ruminants) moving to Canada or
 Mexico...................................
Other endorsements or certifications......         34.00         35.00         36.00         37.00         38.00
----------------------------------------------------------------------------------------------------------------

    (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 \1\ of tests or vaccinations and  ---------------------------------------------------------------------
     number of animals or birds on the        Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                certificate                  2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                              30, 2009        2010          2011          2012      Oct. 1, 2012
----------------------------------------------------------------------------------------------------------------
1-2 tests or vaccinations
Nonslaughter horses to Canada:
    First horse...........................        $54.00        $55.00        $57.00        $59.00        $60.00
    Each additional horse.................          6.25          6.25          6.50          6.75          7.00
Other animals or birds:
    First animal..........................        107.00        111.00        114.00        117.00        121.00
    Each additional animal................          6.25          6.25          6.50          6.75          7.00
3-6 tests or vaccinations
    First animal..........................        133.00        137.00        141.00        145.00        150.00
    Each additional animal................         10.00         11.00         11.00         11.00         12.00
7 or more tests or vaccinations
    First animal..........................        154.00        159.00        163.00        168.00        173.00
    Each additional animal................         12.00         12.00         13.00         13.00         14.00
----------------------------------------------------------------------------------------------------------------
\1\ Rabies vaccinations are not included in this number.

    (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 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,

[[Page 887]]

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. Redesignated at 58 FR 67655, Dec. 22, 1993]

    Editorial Note: For Federal Register citations affecting Sec.
130.20, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



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)(18) 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.

----------------------------------------------------------------------------------------------------------------
                                                                          User fee
                                           ---------------------------------------------------------------------
                                              Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
                                             2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                              30, 2009        2010          2011          2012      Oct. 1, 2012
----------------------------------------------------------------------------------------------------------------
Hourly rate:
    Per hour..............................       $120.00       $120.00       $124.00       $128.00       $132.00

[[Page 888]]

 
    Per quarter hour......................         30.00         30.00         31.00         32.00         33.00
    Per service minimum fee...............         35.00         36.00         37.00         39.00         40.00
----------------------------------------------------------------------------------------------------------------

    (1) Providing services to live animals for import or entry at 
airports, ocean ports, and rail ports.
    (2) Conducting inspections, including inspections of laboratories 
and facilities (such as biosecurity level two facilities), required 
either to obtain import permits for animal products, aquaculture 
products, or organisms or vectors, or to maintain compliance with import 
permits. This hourly rate does not apply to inspection activities 
covered in Sec.130.11.
    (3) Obtaining samples required to be tested, either to obtain import 
permits or to ensure compliance with import permits.
    (4) Providing services for imported birds or ratites that are not 
subject to quarantine, such as monitoring birds--including but not 
limited to pet birds--between flights.
    (5) Supervising the opening of in-bond shipments.
    (6) Providing services for in-bond or in-transit animals to exit the 
United States.
    (7) Inspecting an export isolation facility and the animals in it.
    (8) Supervising animal or bird rest periods prior to export.
    (9) Supervising loading and unloading of animals or birds for export 
shipment.
    (10) Inspecting means of conveyance used to export animals or birds.
    (11) Conducting inspections under part 156 of this chapter.
    (12) Inspecting and approving an artificial insemination center or a 
semen collection center or the animals in it.
    (13) Import or entry services for feeder animals including, but not 
limited to, feeder goats and feeder bison not covered by a flat rate 
user fee in Sec.130.7.
    (14) Export-related bird banding for identification.
    (15) Export-related inspection and approval of pet food facilities, 
including laboratories that perform pet food testing.
    (16) Export-related services provided at animal auctions.
    (17) Various export-related facility inspections, including, but not 
limited to, fertilizer plants that utilize poultry waste, rendering 
plants, and potential embarkation facilities.
    (18) Providing other import-or export-related veterinary services 
for which 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 fee
                                           ---------------------------------------------------------------------
  Overtime rates (outside the employee's      Apr. 29,    Oct. 1, 2009- Oct. 1, 2010- Oct. 1, 2011-
           normal tour of duty)              2009-Sept.     Sept. 30,     Sept. 30,     Sept. 30,     Beginning
                                              30, 2009        2010          2011          2012      Oct. 1, 2012
----------------------------------------------------------------------------------------------------------------
Premium hourly rate Monday through
 Saturday and holidays:
    Per hour..............................       $140.00       $144.00       $148.00       $152.00       $156.00
    Per quarter hour......................         35.00         36.00         37.00         38.00         39.00
Premium hourly rate for Sundays:
    Per hour..............................        160.00        164.00        168.00        172.00       $176.00
    Per quarter hour......................         40.00         41.00         42.00         43.00         44.00
----------------------------------------------------------------------------------------------------------------


[[Page 889]]


(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; 
72 FR 70766, Dec. 13, 2007; 74 FR 14006, Mar. 30, 2009]



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, 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), (ii), or (iii) 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     Nov. 2, 2015-      Oct. 1, 2016-
                                       tour of duty        Sept. 30, 2016     Sept. 30, 2017    Beginning  Oct.
                                                                                                    1, 2017
----------------------------------------------------------------------------------------------------------------
Rate for inspection, testing,      Monday-Saturday and                 $75                $75                $75
 certification or quarantine of     holidays.                           99                 99                100
 animals, animal products or       Sundays.............
 other commodities \3\.
Rate for commercial airline        Monday-Saturday and                  64                 65                 65
 inspection services \4\.           holidays.                           85                 86                 86
                                   Sundays.............
----------------------------------------------------------------------------------------------------------------
\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

[[Page 890]]

rate listed in Sec.130.30(b) for each employee needed to get the work 
done.
    (iii) For information on rules pertaining to the charges associated 
with employees of U.S. Customs and Border Protection performing 
agricultural inspection services, please see 7 CFR 354.1 and 9 CFR 97.1.
    (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 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.
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    (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; 80 FR 59567, Oct. 2, 2015]



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

[[Page 891]]

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.
    (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

[[Page 892]]

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 893]]



                   SUBCHAPTER G_LIVESTOCK IMPROVEMENT





PART 145_NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY--
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 Testing.
145.15 Diagnostic surveillance program for low pathogenic avian 
          influenza.

 Subpart B_Special Provisions for Multiplier 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 Multiplier 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.
145.45 Terminology and classification; compartments.

 Subpart E_Special Provisions for Hobbyist and Exhibition Poultry, and 
        Raised-for-Release Waterfowl 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.

   Subpart G_Special Provisions for Primary Egg-Type Chicken Breeding 
                           Flocks and Products

145.71 Definitions.
145.72 Participation.
145.73 Terminology and classification; flocks and products.
145.74 Terminology and classification; compartments.

  Subpart H_Special Provisions for Primary Meat-Type Chicken Breeding 
                           Flocks and Products

145.81 Definitions.
145.82 Participation.
145.83 Terminology and classification; flocks and products.
145.84 Terminology and classification; compartments.

Subpart I_Special Provisions for Meat-Type Waterfowl Breeding Flocks and 
                                Products

145.91 Definitions.
145.92 Participation.
145.93 Terminology and classification; flocks and products.
145.94 Terminology and classification; States.

Subpart J_Special Provisions for Egg/Meat-Type Game Bird and Raised-for-
             Release Game Bird Breeding Flocks and Products

145.101 Definitions.

[[Page 894]]

145.102 Participation.
145.103 Terminology and classification; flocks and products.
145.104 Terminology and classification; States.

    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 
collect official samples for submission to an authorized laboratory in 
accordance with part 147 of this subchapter.
    Authorized laboratory. An authorized laboratory is a laboratory that 
meets the requirements of Sec.147.52 and is thus qualified to perform 
assays in accordance with part 147 of this subchapter.
    Authorized testing agent. Any person designated under Sec.
145.11(a) to collect official samples for submission to an authorized 
laboratory in accordance with part 147 of this subchapter and to perform 
the stained antigen, rapid whole blood test for pullorum typhoid.
    Avian influenza. Avian influenza is defined as an infection of 
poultry caused by any influenza A virus of the H5 or H7 subtypes or by 
any influenza A virus with an intravenous pathogenicity index (IVPI) 
greater than 1.2 (or as an alternative at least 75 percent mortality).
    Baby poultry. Newly hatched poultry (chicks, poults, ducklings, 
goslings, keets, etc.).
    Colon bacilli. For the purpose of this chapter, those organisms 
which are gram negative, non spore-forming bacilli, which ferment 
lactose with gas formation, and serve as an index of fecal 
contamination.
    Dealer. An individual or business that deals in commerce in hatching 
eggs, newly-hatched poultry, and started poultry obtained from breeding 
flocks and hatcheries. This does not include an individual or business 
that deals in commerce in buying and selling poultry for slaughter only.
    Department. The U.S. Department of Agriculture.
    Domesticated. Propagated and maintained under the control of a 
person.
    Equivalent or equivalent requirements. Requirements which are equal 
to or exceed the program, conditions, criteria, or classifications with 
which they are compared, as determined by the Official State Agency and 
with the concurrence of the Service.
    Exposed (Exposure). Contact with birds, equipment, personnel, 
supplies, or any article infected with, or contaminated by, communicable 
poultry disease organisms.
    Flock--(1) As applied to breeding. All poultry of one kind of mating 
(breed and variety or combination of stocks) and of one classification 
on one farm;
    (2) As applied to disease control. All of the poultry on one farm 
except that, at the discretion of the Official State Agency, any group 
of poultry which is segregated from another group and has been so 
segregated for a period of at least 21 days may be considered as a 
separate flock.
    Fluff sample. Feathers, shell membrane, and other debris resulting 
from the hatching of poultry.
    Fowl typhoid or typhoid. A disease of poultry caused by Salmonella 
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

[[Page 895]]

breeder to produce and sell products under the breeder's strain or trade 
name.
    H5/H7 low pathogenic avian influenza (LPAI). An infection of poultry 
caused by an influenza A virus of H5 or H7 subtype that has an 
intravenous pathogenicity index in 6-week-old chickens less than or 
equal to 1.2 or causes less than 75 percent mortality in 4- to 8-week-
old chickens infected intravenously, or an infection with influenza A 
viruses of H5 or H7 subtype with a cleavage site that is not consistent 
with a previously identified highly pathogenic avian influenza virus.
    Hatchery. Hatchery equipment on one premises operated or controlled 
by any person for the production of baby poultry.
    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.
    Newcastle disease. Newcastle disease (ND) is defined as an infection 
of poultry caused by Newcastle disease virus (NDV), which is an avian 
paramyxovirus serotype 1 (APMV-1) that meets one of the following 
criteria for virulence:
    (1) The virus has an intracerebral pathogenicity index (ICPI) in 
day-old chicks (Gallusgallus) of 0.7 or greater; or
    (2) Multiple basic amino acids have been demonstrated in the virus 
(either directly or by deduction) at the C-terminus of the F2 protein 
and phenylalanine at residue 117, which is the N-terminus of the F1 
protein. The term 'multiple basic amino acids' refers to at least three 
arginine or lysine residues between residues 113 and 116. Failure to 
demonstrate the characteristic pattern of amino acid residues as 
described in the preceding sentences would require characterization of 
the isolated virus by an ICPI test.
    NPIP Program Standards. A document that contains tests and 
sanitation procedures approved by the Administrator in accordance with 
Sec.147.53 of this subchapter for use under this subchapter. This 
document may be obtained from the National Poultry Improvement Plan 
(NPIP) website at http://www.poultryimprovement.org/ or by writing to 
the Service at National Poultry Improvement Plan, APHIS, USDA, 1506 
Klondike Road, Suite 101, Conyers, GA 30094.
    NPIP Technical Committee. A committee made up of technical experts 
on poultry health, biosecurity, surveillance, and diagnostics. The 
committee consists of representatives from the poultry and egg 
industries, universities, and State and Federal governments and is 
appointed by the Senior Coordinator and approved by the General 
Conference Committee. The NPIP Technical Committee is divided into three 
subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP 
Technical Committee Members may serve on one, two, or all three 
subcommittees. The committee will evaluate proposed changes to the 
Provisions and Program Standards of the Plan which include, but are not 
limited to, tests and sanitation procedures, and provide recommendations 
to the Delegates of the National Plan Conference as to whether they are 
scientifically or technically sound.
    Official State Agency. The State authority recognized by the 
Department to cooperate in the administration of the Plan.
    Official supervision--(1) As applied to Plan programs. The 
direction, inspection, and critical evaluation by the Official State 
Agency of compliance with the provisions of the Plan;
    (2) As applied to non-Plan but equivalent State poultry improvement 
programs. The direction, inspection, and critical evaluation by an 
officer or agency of a State government, of compliance with a publicly 
announced State poultry improvement program.

[[Page 896]]

    Person. A natural person, firm, or corporation.
    Plan. The provisions of the National Poultry Improvement Plan 
contained in this part.
    Poultry. Domesticated fowl, including chickens, turkeys, ostriches, 
emus, rheas, cassowaries, waterfowl, and game birds, except doves and 
pigeons, which are bred for the primary purpose of producing eggs or 
meat.
    Primary breeding flock. A flock composed of one or more generations 
that is maintained for the purpose of establishing, continuing, or 
improving parent lines.
    Products. Poultry breeding stock and hatching eggs, baby poultry, 
and started poultry.
    Program. Management, sanitation, testing, and monitoring procedures 
which, if complied with, will qualify, and maintain qualification for, 
designation of a flock, products produced from the flock, or a state by 
an official Plan classification and illustrative design, as described in 
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 this part or in accordance with part 147 of this 
subchapter, for any poultry disease for which a program has been 
established under the Plan.
    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.
    Senior Coordinator. An employee of the Service whose duties may 
include, but will not necessarily be limited to:
    (1) Serving as executive secretary of the General Conference 
Committee;
    (2) Serving as chairperson of the Plan Conference described in Sec.
147.47;
    (3) Planning, organizing, and conducting the Plan Conference;
    (4) Reviewing NPIP authorized laboratories as described in Sec.
147.52;
    (5) Coordinating the State administration of the NPIP through 
periodic reviews of the administrative procedures of the Official State 
Agencies, according to the applicable provisions of the Plan and the 
Memorandum of Understanding;
    (6) Coordinating rulemaking to incorporate the proposed changes of 
the provisions approved at the Plan conference into the regulations in 
parts 145, 146, and 147 of this subchapter;
    (7) Directing the production of official NPIP publications;
    (8) Proposing an annual budget for plan activities and the General 
Conference Committee; and
    (9) Providing overall administration of the NPIP.
    Service. The Animal and Plant Health Inspection Service, Veterinary 
Services, of the Department.
    Serial. The total quantity of completed product which has been 
thoroughly mixed in a single container and identified by a serial 
number.
    Sexual maturity. The average age at which a species of poultry is 
biologically capable of reproduction.
    Started poultry. Young poultry (chicks, pullets, cockerels, capons, 
poults, ducklings, goslings, keets, etc.) that have been fed and watered 
and are less than 6 months of age.
    State. Any State, the District of Columbia, or Puerto Rico.
    State Inspector. Any person employed or authorized under 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.

[[Page 897]]

    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. Redesignated at 44 FR 61586, Oct. 26, 1979]

    Editorial Note: For Federal Register citations affecting Sec.
145.1, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.145.2  Administration.

    (a) The Department cooperates through a Memorandum of Understanding 
with Official State Agencies in the administration of the Plan. In the 
Memorandum of Understanding, the Official State Agency must designate a 
contact representative to serve as a liaison between the Service and the 
Official State Agency.
    (b) The administrative procedures and decisions of the Official 
State Agency are subject to review by the Service. The Official State 
Agency shall carry out the administration of the Plan within the State 
according to the applicable provisions of the Plan and the Memorandum of 
Understanding.
    (c) An Official State Agency may accept for participation an 
affiliated flock located in another State under a mutual understanding 
and agreement, in writing, between the two Official State Agencies 
regarding conditions of participation and supervision.
    (d) The Official State Agency of any State may, except as limited by 
Sec.145.3(e), adopt regulations applicable to the administration of 
the Plan in such State further defining the provisions of the Plan or 
establishing higher standards compatible with the Plan.
    (e) An authorized laboratory of the National Poultry Improvement 
Plan will conduct tests in accordance with part 147 of this subchapter 
when determining the status of a participating flock with respect to an 
official Plan classification.

(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; 74 
FR 14714, Apr. 1, 2009; 79 FR 38754, July 9, 2014; 81 FR 53249, Aug. 12, 
2016]



Sec.145.3  Participation.

    (a) The National Poultry Improvement Plan is a cooperative Federal-
State-Industry program through which new or existing diagnostic 
technology can be effectively applied to improve poultry and poultry 
products by controlling or eliminating specific poultry diseases. The 
Plan consists of programs that identify States, flocks, hatcheries, 
dealers, and slaughter plants that meet specific disease control 
standards specified in the Plan. Participants shall maintain records to 
demonstrate that they adhere to the disease control programs in which 
they participate.
    (b) Any person producing or dealing in products may participate in 
the Plan when he has demonstrated, to the satisfaction of the Official 
State Agency, that his facilities, personnel, and practices are adequate 
for carrying out the applicable provisions of the Plan, and has signed 
an agreement with the Official State Agency to comply with the general 
and the applicable specific provisions of the Plan and any regulations 
of the Official State Agency under Sec.145.2. Affiliated flockowners 
may participate without signing an agreement with the Official State 
Agency.
    (c) Each participant shall comply with the Plan throughout the 
operating year of the Official State Agency, or until released by such 
Agency.
    (d) A participant in any State shall participate with all of his 
poultry hatching egg supply flocks and hatchery operations within such 
State. The participant shall report to the Official State Agency on VS 
Form 9-2 (formerly NPIP Form 3B) or through other appropriate means each 
breeding flock before the birds reach 24 weeks of age or, in the case of 
ostriches, emus, rheas, and cassowaries, before the birds reach 20 
months of age. This report will include:

[[Page 898]]

    (1) Name and address of flockowner;
    (2) Flock location and designation;
    (3) Type: Primary or Multiplier;
    (4) Breed, variety, strain, or trade name of stock;
    (5) Source of males;
    (6) Source of females;
    (7) Number of birds in the flock; and
    (8) Intended classification of flock.
    (e) To ensure that Plan diseases are not spread, flocks must be 
qualified for their intended Plan classifications before being moved 
into breeder production facilities.
    (f) No person shall be compelled by the Official State Agency to 
qualify products for any of the other classifications described in Sec.
145.10 as a condition of qualification for the U.S. Pullorum-Typhoid 
Clean classification.
    (g) Participation in the Plan shall entitle the participant to use 
the Plan emblem reproduced below:
[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; 79 FR 38754, July 9, 2014; 81 FR 53249, Aug. 12, 
2016]



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 regulations of the Official State Agency and the Federal Trade 
Commission. A participant advertising products as being of any official 
classification may include in his advertising reference to associated or 
franchised hatcheries only when such hatcheries produce the same kind of 
products of the same classification.
    (d) Except as provided by this paragraph, participants in the Plan 
may not buy or receive products for any purpose from nonparticipants 
unless they are part of an equivalent program, as determined by the 
Official State Agency. Participants in the Plan may buy or receive 
products from flocks that are neither participants nor part of an 
equivalent program, for use in breeding flocks or for experimental 
purposes, under the following conditions only:
    (1) With the permission of the Official State Agency and the 
concurrence of the Service; and
    (2) By segregation of all birds before introduction into the 
breeding flock. Upon reaching sexual maturity, the segregated birds must 
be tested and found negative for pullorum-typhoid and any other disease 
for which the flock into which the birds are being introduced holds a 
disease classification. The Official State Agency may require a second 
test at its discretion.
    (e) Each participant shall be assigned a permanent approval number 
by the Service. This number, prefaced by the numerical code of the 
State, will be the official approval number of the participant and may 
be used on each certificate, invoice, shipping label, or other document 
used by the participant in the sale of his products. Each Official State 
Agency which requires an approval or permit number for out-of-

[[Page 899]]

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; 83 FR 28352, June 19, 2018]



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 in 
accordance with part 147 of this subchapter. The participating flock, 
its eggs, and all equipment used in connection with the flock shall be 
separated from nonparticipating flocks, in a manner acceptable to the 
Official State Agency.
    (b) All flocks shall consist of healthy, normal individuals 
characteristic of the breed, variety, cross, or other combination which 
they are stated to represent.
    (c) A flock shall be deemed to be a participating flock at any time 
only if it has qualified for the U.S. Pullorum-Typhoid Clean 
classification, as prescribed in Subparts B, C, D, E, F, G, H, or I 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; 79 FR 38754, July 9, 2014]



Sec.145.6  Specific provisions for participating hatcheries.

    (a) Hatcheries must be kept in sanitary condition, acceptable to the 
Official State Agency. The sanitary procedures outlined in the NPIP 
Program Standards, or other procedures approved by the Administrator in 
accordance with Sec.147.53(d), will be considered as a guide in 
determining compliance with this provision. The minimum requirements 
with respect to sanitation include the following:
    (1) Egg room walls, ceilings, floors, air filters, drains, and 
humidifiers should be cleaned and disinfected at least two times per 
week. Cleaning and disinfection procedures should be in accordance with 
part 147 of this subchapter.
    (2) Incubator room walls, ceilings, floors, doors, fan grills, 
vents, and ducts should be cleaned and disinfected after each set or 
transfer. Incubator rooms should not be used for storage. Plenums should 
be cleaned at least weekly. Egg trays and buggies should be cleaned and 
disinfected after each transfer. Cleaning and disinfection procedures 
should be in accordance with part 147 of this subchapter.
    (3) Hatcher walls, ceilings, floors, doors, fans, vents, and ducts 
should be cleaned and disinfected after each hatch. Hatcher rooms should 
be cleaned and disinfected after each hatch and should not be used for 
storage. Plenums should be cleaned after each hatch. Cleaning and 
disinfection procedures should be in accordance with part 147 of this 
subchapter.
    (4) Chick/poult processing equipment and rooms should be thoroughly 
cleaned and disinfected after each hatch. Chick/poult boxes should be 
cleaned and disinfected before being reused. Vaccination equipment 
should be cleaned and disinfected after each use. Cleaning and 
disinfection procedures should be in accordance with part 147 of this 
subchapter.
    (5) Hatchery residue, such as chick/poult down, eggshells, infertile 
eggs, and dead germs, should be disposed of promptly and in a manner 
satisfactory to the Official State Agency.
    (6) The entire hatchery should be kept in a neat, orderly condition 
and cleaned and disinfected after each hatch.
    (7) Effective insect and rodent control programs should be 
implemented.
    (b) A hatchery that keeps started poultry must keep such poultry 
separated from the incubator room in a manner satisfactory to the 
Official State Agency.
    (c) All baby and started poultry offered for sale under Plan 
terminology should be normal and typical of the

[[Page 900]]

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; 79 FR 38754, July 9, 2014]



Sec.145.7  Specific provisions for participating dealers.

    Dealers in hatching eggs, newly hatched poultry, or started poultry 
shall comply with the provisions in this part (within the NPIP Program 
Standards document, Program Standard C applies to hatcheries; 
alternatives to the program standards may also be approved by the 
Administrator under Sec.147.53 of this subchapter).

[85 FR 62564, Oct. 5, 2020]



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 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 that 
have met the requirements of a classification in this part may be 
designated by the corresponding illustrative design in this section.
    (a) [Reserved]
    (b) U.S. Pullorum-Typhoid Clean. (See Sec.145.23(b), Sec.
145.33(b), Sec.145.43(b), Sec. Sec.145.53(b), 145.63(a), 145.73(b), 
145.83(b), and 145.93(b).)
[GRAPHIC] [TIFF OMITTED] TC10SE91.002

    (c) U.S. M. Gallisepticum Clean. (See Sec. Sec.145.23(c), 
145.23(f), 145.33(c), 145.33(f), 145.43(c), 145.53(c), 145.73(c), and 
145.83(c).)

[[Page 901]]

[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. Sec.145.24(a), 
145.34(a), 145.44(a), 145.54(a), and 145.94(a).)
[GRAPHIC] [TIFF OMITTED] TR21MR96.000

    (h) U.S. Pullorum-Typhoid Clean State, Turkeys. (See Sec.
145.44(b).)

[[Page 902]]

[GRAPHIC] [TIFF OMITTED] TR21MR96.001

    (i) U.S.M. Gallisepticum Clean State, Turkeys. (See Sec.
145.44(c).)
[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).)

[[Page 903]]

[GRAPHIC] [TIFF OMITTED] TC10SE91.011

                                Figure 12
    (l) [Reserved]
    (m) U.S. S. Enteritidis Clean. (See Sec. Sec.145.23(d), 145.73(d), 
and 145.83(e).)
[GRAPHIC] [TIFF OMITTED] TR21MR96.002

    (n) U.S. M. Synoviae Clean State, Turkeys. (See Sec.145.44(d).)
    [GRAPHIC] [TIFF OMITTED] TR21MR96.003
    
    (o) U.S. Salmonella Monitored. (See Sec. Sec.145.53(f), 145.73(g), 
145.83(f), and 145.93(d).)
[GRAPHIC] [TIFF OMITTED] TR19AU97.000

    (p) U.S. M. Gallisepticum Monitored. (See Sec.145.33(j).)

[[Page 904]]

[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), 145.63(b), 145.73(f), and 145.83(g).)
[GRAPHIC] [TIFF OMITTED] TR17FE00.013

    (s) U.S. M. Meleagridis Clean State, Turkeys. (See Sec.145.44(e).)

[[Page 905]]

[GRAPHIC] [TIFF OMITTED] TR17FE00.008


[[Page 906]]


    (t) U.S. H5/H7 Avian Influenza Clean. (See Sec. Sec.145.43(g), 
145.53(e), and 145.93(c).)
[GRAPHIC] [TIFF OMITTED] TR14NO03.000


[38 FR 13706, May 24, 1973. Redesignated at 44 FR 61586, Oct. 26, 1979]

    Editorial Note: For Federal Register citations affecting Sec.
145.10, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec.145.11  Supervision.

    (a) The Official State Agency may designate qualified persons as 
Authorized Agents to do the sample collecting provided for in Sec.
145.14 and may designate qualified persons as Authorized Testing Agents 
to do the sample collecting and blood testing provided for in Sec.
145.14.
    (b) The Official State Agency shall employ or authorize qualified 
persons as State Inspectors to perform the qualification testing of 
participating flocks, and to perform the official inspections necessary 
to verify compliance with the requirements of the Plan.
    (c) Authorities issued under the provisions of this section shall be 
subject to cancellation by the official State agency on the grounds of 
incompetence or failure to comply with the provisions of the Plan or 
regulations of the official State agency. Such actions shall not be 
taken until a thorough investigation has been made by the official State 
agency and the authorized person has been given notice of the proposed 
action and the basis therefor and an opportunity to present his views.

[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 72 FR 1418, Jan. 12, 2007]



Sec.145.12  Inspections.

    (a) Each participating hatchery shall be audited at least one time 
annually or a sufficient number of times each year to satisfy the 
Official State Agency that the operations of the hatchery are in 
compliance with the provisions of the Plan.
    (b) The records of all flocks maintained primarily for production of 
hatching eggs shall be made available to and examined annually by a 
State Inspector. Records shall include VS Form 9-2, ``Flock Selecting 
and Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs, 
Chicks, and Poults''; set and hatch records; egg receipts; and egg/chick 
orders or invoices. Records shall be maintained for 3 years. On-site 
inspections of flocks and premises will be conducted if the State 
Inspector determines that a breach of sanitation, blood testing, or 
other provisions has occurred for Plan programs for which the flocks 
have or are being qualified.

[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; 72 FR 1418, Jan. 12, 2007; 81 
FR 53249, Aug. 12, 2016]



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

[[Page 907]]

notice of the bases for the debarment and opportunity to present his 
views with respect to the debarment in accordance with procedures 
adopted by the Official State Agency. The Official State Agency shall 
thereupon decide whether the debarment order shall continue in effect. 
Such decision shall be final unless the debarred participant, within 30 
days after the issuance of the debarment order, requests the 
Administrator to determine the eligibility of the debarred participant 
for participation in the Plan. In such event the Administrator shall 
determine the matter de novo in accordance with the rules of practice in 
7 CFR part 50, which are hereby made applicable to proceedings before 
the Administrator under this section. The definitions in 7 CFR 50.10 and 
the following definitions shall apply with respect to terms used in such 
rules of practice:
    (a) Administrator means the Administrator, Animal and Plant Health 
Inspection Service of the U.S. Department of Agriculture or any officer 
or employee to whom authority has heretofore been delegated or to whom 
authority may hereafter be delegated to act in his stead.

[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  Testing.

    Poultry must be more than 4 months of age when tested for an 
official classification: Provided, That turkey candidates under subpart 
D of this part may be tested at more than 12 weeks of age; game bird 
candidates under subpart E of this part may be tested when more than 4 
months of age or upon reaching sexual maturity, whichever comes first; 
and ostrich, emu, rhea, and cassowary candidates under subpart F of this 
part may be tested when more than 12 months of age. Samples for official 
tests shall be collected by an Authorized Agent, Authorized Testing 
Agent, or State Inspector and tested by an authorized laboratory, except 
that the stained antigen, rapid whole-blood test for pullorum-typhoid 
may be conducted by an Authorized Testing Agent or State Inspector. For 
Plan programs in which a representative sample may be tested in lieu of 
an entire flock, except the ostrich, emu, rhea, and cassowary program in 
Sec.145.63(a), the minimum number tested shall be 30 birds per house, 
unless otherwise specified within the Plan program, 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 other than ostriches, emus, rheas, and cassowaries, 
all birds in the house must be tested, unless otherwise specified within 
the Plan program.
    (a) For Pullorum-Typhoid. (1) The official blood tests for pullorum-
typhoid shall be the standard tube agglutination test, the 
microagglutination test, the enzyme-linked immunosorbent assay test 
(ELISA), or the rapid serum test for all poultry; and the stained 
antigen, rapid whole-blood test for all poultry except turkeys. Official 
blood tests must be conducted in accordance with part 147 of this 
subchapter or according to literature provided by the producer. Only 
antigens approved by the Department and of the polyvalent type shall be 
used for the rapid whole-blood and tube agglutination tests. Each serial 
of tube antigen shall be submitted by the antigen producer to the 
Department for approval upon manufacture and once a year thereafter as 
long as antigen from that serial continues to be made available for use. 
All microtest antigens and enzyme-linked immunosorbent assay reagents 
shall also be approved by the Department. \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

[[Page 908]]

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, 
145.63, 145.73, 145.83, and 145.93) the testing of a portion or sample 
of the birds may be used in lieu of testing each bird.
    (6) Poultry from flocks undergoing qualification testing for 
participation in the Plan that have a positive reaction to an official 
blood test named in paragraph (a)(1) of this section shall be evaluated 
for pullorum-typhoid as follows:
    (i) Serum samples that react on rapid serum test or enzyme-labeled 
immunosorbent assay test (ELISA), or blood from birds that react on the 
stained antigen, rapid whole-blood test for all birds except turkeys, 
shall be tested with either the standard tube agglutination test or the 
microagglutination test.
    (ii) Reactors to the standard tube agglutination test (in dilutions 
of 1:50 or greater) or the microagglutination test (in dilutions of 1:40 
or greater) shall be submitted to an authorized laboratory for 
bacteriological examination. If there are more than four reactors in a 
flock, a minimum of four reactors shall be submitted to the authorized 
laboratory; if the flock has four or fewer reactors, all of the reactors 
must be submitted. Bacteriological examination must be conducted in 
accordance with part 147 of this subchapter. 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

[[Page 909]]

    (iii) The testing of blood samples at an authorized laboratory using 
an official blood test named in paragraph (a)(1) of this section.
    (8) All domesticated fowl, except waterfowl, on the farm of the 
participant shall either be properly tested to meet the same standards 
as the participating flock or these birds and their eggs shall be 
separated from the participating flock and its eggs.
    (9) All tests for pullorum-typhoid in flocks participating in or 
candidates for participation in the Plan shall be reported to the 
Official State Agency within 10 days following the completion of such 
tests. All reactors shall be considered in determining the 
classification of the flock.
    (10) Any drug, for which there is scientific evidence of masking the 
test reaction or hindering the bacteriological recovery of Salmonella 
organisms, shall not be fed or administered to poultry within 3 weeks 
prior to a test or bacteriological examination upon which a Salmonella 
classification is based.
    (11) When suitable evidence, as determined by the Official State 
Agency or the State Animal Disease Control Official, indicates that baby 
or started poultry produced by participating hatcheries are infected 
with organisms for which the parent flock received an official control 
classification and this evidence indicates that the infection was 
transmitted from the parent flock, the Official State Agency may, at its 
discretion, require additional testing of the flock involved. If 
infection is found in the parent flock, its classification shall be 
suspended until the flock is requalified under the requirements for the 
classification. Furthermore, the Official State Agency may require that 
the hatching eggs from such flocks be removed from the incubator and 
destroyed prior to hatching. When Salmonella organisms are isolated from 
a specimen which originated in a participating hatchery, the Official 
State Agency shall attempt to locate the source of the infection. The 
results of the investigation and the action taken to eliminate the 
infection shall be reported by the Official State Agency to the Service.
    (b) For Mycoplasma gallisepticum, M. meleagridis, and M. synoviae. 
(1) The official tests for M. gallisepticum, M. meleagridis, and M. 
synoviae shall be the serum plate agglutination test, the 
hemagglutination inhibition (HI) test, the enzyme-linked immunosorbent 
assay (ELISA) test,\3\ or a molecular based test. The HI test or 
molecular based test shall be used to confirm the positive results of 
other serological screening tests. HI titers of 1:40 or more may be 
interpreted as suspicious, and final judgment must be based on further 
samplings and/or culture of reactors. Tests must be conducted in 
accordance with this paragraph (b) and in accordance with part 147 of 
this subchapter.
---------------------------------------------------------------------------

    \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 serological tests shall be conducted using M. gallisepticum, 
M. meleagridis, or M. synoviae antigens approved by the Department or 
the Official State Agency and shall be performed in accordance with the 
recommendations of the producer of the antigen.
    (3) When reactors to the test for which the flock was tested are 
submitted to a laboratory as prescribed by the Official State Agency, 
the final status of the flock will be determined in accordance with part 
147 of this subchapter.
    (4) Any drug, for which there is scientific evidence of masking the 
test reaction or hindering the bacteriological recovery of mycoplasma 
organisms, shall not be fed or administered to poultry within three 
weeks prior to a

[[Page 910]]

test or bacteriological examination upon which a Mycoplasma 
classification is based.
    (5) The official molecular examination procedures for M. 
gallisepticum are the PCR test described in Sec.147.30 of this 
subchapter and the real-time PCR test described in Sec.147.31 of this 
subchapter. The official molecular examination procedure for M. synoviae 
is the PCR test described in Sec.147.30 of this subchapter.
    (c) [Reserved]
    (d) For avian influenza. The official tests for avian influenza are 
described in paragraphs (d)(1) and (d)(2) of this section.
    (1) Antibody detection tests--(i) Enzyme-linked immunosorbent assay 
(ELISA) test. (A) The ELISA test must be conducted using test kits 
approved by the Department and the Official State Agency and must be 
conducted in accordance with the recommendations of the producer or 
manufacturer.
    (B) When positive ELISA samples are identified, an AGID test must be 
conducted within 48 hours.
    (ii) Agar gel immunodiffusion (AGID) test. (A) The AGID test must be 
conducted using reagents approved by the Department and the Official 
State Agency.
    (B) The AGID test for avian influenza must be conducted in 
accordance with this section (within the NPIP Program Standards 
document, Program Standard A applies to blood and yolk testing 
procedures; alternatives to the program standards may also be approved 
by the Administrator under Sec.147.53 of this subchapter) for the 
avian influenza agar gel immunodiffusion (AGID) test. The test can be 
conducted on egg yolk or blood samples. The AGID test is not recommended 
for use in waterfowl.
    (C) Positive tests for the AGID must be further tested by Federal 
Reference Laboratories using appropriate tests for confirmation. Final 
judgment may be based upon further sampling and appropriate tests for 
confirmation.
    (2) Agent detection tests. Agent detection tests may be used to 
detect influenza A virus but not to determine hemagglutinin or 
neuraminidase subtypes. Samples for agent detection testing should be 
collected from naturally occurring flock mortality or clinically ill 
birds.
    (i) The real time reverse transcriptase/polymerase chain reaction 
(RRT-PCR) assay. (A) The RRT-PCR tests must be conducted using reagents 
approved by the Department and the Official State Agency. The RRT-PCR 
must be conducted using the National Veterinary Services Laboratories 
(NVSL) official protocol for RRT-PCR or a test kit licensed by the 
Department and approved by the Official State Agency and the State 
Animal Health Official, and must be conducted by personnel who have 
passed an NVSL proficiency test. For non-National Animal Health 
Laboratory Network (NAHLN) authorized laboratories:
    (1) RRT-PCR testing may be used by primary breeder company 
authorized laboratories.
    (2) RRT-PCR testing can only be performed on their own breeding 
flocks and only used for routine surveillance.
    (3) The authorized laboratory must have a quality system that is 
accredited as ISO/IEC 17025 or equivalent to perform the avian influenza 
RRT-PCR assay.
    (4) The use of the RRT-PCR test by the authorized laboratory must be 
approved in the memorandum of understanding (MOU) between the authorized 
laboratory, the Official State Agency, and the State Animal Health 
Official(s) of both the location of the authorized laboratory and the 
location where the breeding flocks reside.
    (5) Split samples for testing must occur between the authorized 
laboratory and a NAHLN laboratory at a frequency designated in the MOU.
    (B) Positive results from the RRT-PCR must be further tested by 
Federal Reference Laboratories using appropriate tests for confirmation. 
Final judgment may be based upon further sampling and appropriate tests 
for confirmation.
    (ii) USDA-licensed type A influenza antigen capture immunoassay 
(ACIA). (A) The USDA-licensed type A influenza ACIA must be conducted 
using test kits approved by the Department and the Official State Agency 
and must be conducted in accordance with the recommendations of the 
producer or manufacturer.

[[Page 911]]

    (B) Chicken and turkey flocks that test positive on the ACIA must be 
further tested using the RRT-PCR or virus isolation. Positive results 
from the RRT-PCR or virus isolation must be further tested by Federal 
Reference Laboratories using appropriate tests for confirmation. Final 
judgment may be based upon further sampling and appropriate tests for 
confirmation.
    (3) The official determination of a flock as positive for the H5 or 
H7 subtypes of avian influenza may be made only by NVSL.
    (e) For Newcastle Disease (ND). The official tests for ND are 
serological tests for antibody detection or molecular-based tests for 
antigen detection.

(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 at www.govinfo.gov.



Sec.145.15  Diagnostic surveillance program for low pathogenic avian
influenza.

    (a) The Official State Agency must develop a diagnostic surveillance 
program for H5/H7 low pathogenic avian influenza for all poultry in the 
State. The exact provisions of the program are at the discretion of the 
States. The Service will use the standards in paragraph (b) of this 
section in assessing individual State plans for adequacy, including the 
specific provisions that the State developed. The standards should be 
used by States in developing those plans.
    (b) Avian influenza must be a disease reportable to the responsible 
State authority (State veterinarian, etc.) by all licensed 
veterinarians. To accomplish this, all laboratories (private, State, and 
university laboratories) that perform diagnostic procedures on poultry 
must examine all submitted cases of unexplained respiratory disease, egg 
production drops, and mortality for avian influenza by both an approved 
serological test and an approved antigen detection test. Memoranda of 
understanding or other means must be used to establish testing and 
reporting criteria (including criteria that provide for reporting H5 and 
H7 low pathogenic avian influenza directly to the Service) and approved 
testing methods. In addition, States should conduct outreach to poultry 
producers, especially owners of smaller flocks, regarding the importance 
of prompt reporting of clinical symptoms consistent with avian 
influenza.

[74 FR 14715, Apr. 1, 2009]



 Subpart B_Special Provisions for Multiplier 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 multiplier egg type chickens, and the eggs 
and chicks produced from them, shall comply with the applicable general 
provisions of subpart A of this part and the special provisions of this 
subpart B.
    (a) Started chickens shall lose their identity under Plan 
terminology when not maintained by Plan participants under the 
conditions prescribed in Sec.145.5(a).
    (b) Hatching eggs produced by multiplier breeding flocks should be 
nest clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
    (c) Any nutritive material provided to chicks must be free of the 
avian

[[Page 912]]

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; 72 FR 1419, Jan. 12, 2007; 79 FR 38755, July 9, 
2014]



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 (4) 
of this section: Provided, That a flock qualifying by means of a blood 
test shall be tested within the past 12 months, except that the 
retesting of a participating flock which is retained for more than 12 
months shall be conducted a minimum of 4 weeks after the induction of 
molt. (See Sec.145.14 relating to the official blood test where 
applicable.)
    (1) It has been officially blood tested with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. pullorum 
or S. gallinarum.
    (2) It is a multiplier breeding flock and meets the following 
specifications as determined by the Official State Agency and the 
Service:
    (i) The flock is located in a State where all persons performing 
poultry disease diagnostic services within the State are required to 
report to the Official State Agency within 48 hours the source of all 
poultry specimens from which S. pullorum or S. gallinarum is isolated;
    (ii) The flock is composed entirely of birds that originated from 
U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met 
equivalent requirements under official supervision; and
    (iii) The flock is located on a premises where a flock not 
classified as U.S. Pullorum-Typhoid Clean was located the previous year; 
Provided, That an Authorized Testing Agent must blood test up to 300 
birds per flock, as described in 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

[[Page 913]]

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 (b)(3) of this section, and in which pullorum disease or fowl typhoid 
is not known to exist nor to have existed in hatchery supply flocks 
within the State during the preceding 12 months.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management and in which freedom from M. 
gallisepticum has been demonstrated under the criteria specified in 
paragraph (c)(1)(i) or (ii) of this section.
    (i) [Reserved]
    (ii) It is a multiplier breeding flock which originated as U.S. M. 
Gallisepticum Clean chicks from primary breeding flocks and from which a 
sample comprised of a minimum of 150 birds per flock has been tested for 
M. gallisepticum as provided in 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 part 147 of this subchapter.
    (2) A participant handling U.S. M. Gallisepticum Clean products 
shall keep these products separate from other products in a manner 
satisfactory to the Official State Agency.
    (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes 
and delivered in trucks that have been cleaned and disinfected in 
accordance with part 147 of this subchapter.
    (d) U.S. S. Enteritidis Clean. This classification is intended for 
egg-type breeders wishing to assure their customers that the hatching 
eggs and chicks produced are certified free of Salmonella enteritidis.
    (1) A flock and the hatching eggs and chicks produced from it which 
have met the following requirements as determined by the Official State 
Agency:
    (i) The flock originated from a U.S. S. enteritidis Clean flock, or 
meconium

[[Page 914]]

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 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 accordance with part 147 of this 
subchapter with respect to flock sanitation, cleaning and disinfection, 
and Salmonella isolation, sanitation, and management. Rodents and other 
pests should be effectively controlled;
    (v) Environmental samples shall be collected from the flock by an 
Authorized Agent, in accordance with part 147 of this subchapter, when 
the flock is 2 to 4 weeks of age. The samples shall be examined 
bacteriologically for group D salmonella at an authorized laboratory. 
Cultures from positive samples shall be serotyped. The authorized agent 
shall also collect samples every 30 days after the first sample has been 
collected.
    (vi) Hatching eggs are collected as quickly as possible, and their 
sanitation is maintained in accordance with part 147 of this subchapter.
    (vii) Hatching eggs produced by the flock are incubated in a 
hatchery whose sanitation is maintained in accordance with part 147 of 
this subchapter and sanitized either by a procedure approved by the 
Official State Agency or in accordance with part 147 of this subchapter.
    (2) A flock shall not be eligible for this classification if 
Salmonella enteritidis 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, in accordance with part 147 of this subchapter, of a random 
sample of 60 live birds from a flock of 5,000 birds or more, or 30 live 
birds from a flock with fewer than 5,000 birds. If only one specimen is 
found positive for SE, the participant may request bacteriological 
examination of a second sample, equal in size to the first sample, from 
the flock. If no SE is recovered from any of the specimens in the second 
sample, the flock will be eligible for the classification.
    (3) In order for a hatchery to sell products of this classification, 
all products handled shall meet the requirements of the classification.
    (4) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures.
    (e) U.S.M. Synoviae Clean. (1) A flock maintained in accordance with 
part 147 of this subchapter with respect to Mycoplasma isolation, 
sanitation, and management and in which freedom from M. synoviae has 
been demonstrated under the criteria specified in paragraph (e)(1)(i) or 
(ii) of this section.
    (i) [Reserved]
    (ii) It is a multiplier breeding flock which originated as U.S. M. 
Synoviae Clean chicks from primary breeding flocks and from which a 
sample comprised of a minimum of 150 birds has been tested for M. 
synoviae as provided in 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 915]]

    (A) At intervals of not more than 90 days, 75 birds from the flock 
shall be tested: Provided, That fewer than 75 birds from the flock may 
be tested at any one time if all pens are equally represented and a 
total of at least 75 birds from the flock is tested within each 90-day 
period; or
    (B) At intervals of not more than 30 days, egg yolk testing shall be 
conducted in accordance with part 147 of this subchapter.
    (2) A participant handling U.S. M. Synoviae Clean products shall 
keep these products separate from other products in a manner 
satisfactory to the Official State Agency.
    (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and 
delivered in trucks that have been cleaned and disinfected in accordance 
with part 147 of this subchapter.
    (f) U.S. M. Gallisepticum Clean Started Poultry. (1) A flock which 
originated from U.S. M. Gallisepticum Clean breeding flocks and was 
hatched in a hatchery approved by the Official State Agency for the 
production of U.S. M. Gallisepticum Clean chicks.
    (2) All other poultry on the premises of the candidate flock must 
originate from U.S. M. Gallisepticum Clean sources.
    (3) The flock is maintained in accordance with part 147 of this 
subchapter with respect to Mycoplasma isolation, sanitation, and 
management.
    (4) The flock's freedom from M. Gallisepticum is demonstrated by a 
negative blood test, as provided in 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 in 
accordance with part 147 of this subchapter.
    (g) U.S. M. Synoviae Clean Started Poultry. (1) A flock which 
originated from U.S. M. Synoviae Clean breeding flocks and was hatched 
in a hatchery approved by the Official State Agency for production of 
U.S. M. Synoviae Clean chicks.
    (2) All other poultry on the premises of the candidate flock must 
originate from U.S. M. Synoviae Clean sources.
    (3) The flock is maintained in accordance with part 147 of this 
subchapter with respect to Mycoplasma isolation, sanitation, and 
management.
    (4) The 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 in 
accordance with part 147 of this subchapter.
    (h) U.S. Avian Influenza Clean. This program is intended to be the 
basis from which the breeding-hatchery industry may conduct a program 
for the prevention and control of avian influenza. It is intended to 
determine the presence of avian influenza in breeding chickens through 
routine surveillance of each participating breeding flock. A flock and 
the hatching eggs and chicks produced from it will qualify for this 
classification when the Official State Agency determines that they have 
met the following requirements:
    (1) It is a multiplier breeding flock in which a minimum of 30 birds 
have been tested and found negative to avian influenza when more than 4 
months of age. To retain this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period; or
    (iii) The flock is tested as provided in Sec.145.14(d) at 
intervals of 30 days or less and found to be negative, and a total of 30 
samples are collected and tested within each 90-day period; and
    (2) A sample of at least 11 birds must be tested and found negative 
to avian influenza within 21 days prior to slaughter.

(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

[[Page 916]]

Sections Affected, which appears in the Finding Aids section of the 
printed volume and at www.govinfo.gov.



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. Sec.145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 
145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 
145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 
145.103(b)(3)(i) through (ix).
    (ii) No pullorum disease or fowl typhoid is known to exist nor to 
have existed in hatchery supply flocks within the State during the 
preceding 12 months: Provided, That pullorum disease or fowl typhoid 
found within the preceding 24 months in waterfowl, exhibition poultry, 
and game bird breeding flocks will not prevent a State, which is 
otherwise eligible, from qualifying.
    (2) Discontinuation of any of the conditions described in paragraph 
(a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid 
occur in hatchery supply flocks described in paragraph (a)(1)(ii) of 
this section, or if an infection spreads from the originating premises, 
the Service shall have grounds to revoke its determination that the 
State is entitled to this classification. Such action shall not be taken 
until a thorough investigation has been made by the Service and the 
Official State Agency has been given an opportunity for a hearing in 
accordance with rules of practice adopted by the Administrator.
    (b) [Reserved]

[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; 72 
FR 1419, Jan. 12, 2007; 76 FR 15793, Mar. 22, 2011; 85 FR 62565, Oct. 5, 
2020]



 Subpart C_Special Provisions for Multiplier 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]



Sec.145.32  Participation.

    Participating flocks of multiplier meat type chickens, and the eggs 
and chicks produced from them, shall comply with the applicable general 
provisions of subpart A of this part and the special provisions of this 
subpart C.
    (a) Started chickens shall lose their identity under Plan 
terminology when not maintained by Plan participants under the 
conditions prescribed in Sec.145.5(a).
    (b) Hatching eggs produced by multiplier breeding flocks should be 
nest clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
    (c) Any nutritive material provided to chicks must be free of the 
avian pathogens that are officially represented in the Plan disease 
classifications listed in 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; 72 FR 1419, Jan. 12, 
2007; 79 FR 38756, July 9, 2014]

[[Page 917]]



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 (4) of this 
section: Provided, That a flock qualifying by means of a blood test 
shall be tested within the past 12 months, except that the retesting of 
a participating flock which is retained for more than 12 months shall be 
conducted a minimum of 4 weeks after the induction of molt. (See Sec.
145.14 relating to the official blood test where applicable.)
    (1) It has been officially blood tested with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. pullorum 
or S. gallinarum.
    (2) It is a multiplier breeding flock and meets the following 
specifications as determined by the Official State Agency and the 
Service:
    (i) The flock is located in a State where all persons performing 
poultry disease diagnostic services within the State are required to 
report to the Official State Agency within 48 hours the source of all 
poultry specimens from which S. pullorum or S. gallinarum is isolated;
    (ii) The flock is composed entirely of birds that originated from 
U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met 
equivalent requirements under official supervision; and
    (iii) The flock is located on a premises where a flock not 
classified as U.S. Pullorum-Typhoid Clean was located the previous year; 
Provided, That an Authorized Testing Agent must blood test up to 300 
birds per flock, as described in 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

[[Page 918]]

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.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management and in which freedom from M. 
gallisepticum has been demonstrated under the criteria specified in 
paragraph (c)(1)(i) or (ii) of this section.
    (i) [Reserved]
    (ii) It is a multiplier breeding flock which originated as U.S. M. 
Gallisepticum Clean chicks from primary breeding flocks and from which a 
sample comprised of a minimum of 150 birds per flock has been tested for 
M. gallisepticum as provided in 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 part 147 of this subchapter.
    (2) A participant handling U.S. M. Gallisepticum Clean products must 
keep these products separate from other products through the use of 
separate hatchers and incubators, separate hatch days, and proper 
hatchery sanitation and biosecurity in a manner satisfactory to the 
Official State Agency and in accordance with part 147 of this 
subchapter.
    (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes 
and delivered in trucks that have been cleaned and disinfected in 
accordance with part 147 of this subchapter.
    (4) Before male breeding birds may be added to a participating 
multiplier breeding flock, a sample of at least 30 birds to be added, 
with a minimum of 10 birds per pen, shall be tested for M. gallisepticum 
as provided in Sec.145.14(b), or by a polymerase chain reaction (PCR)-
based procedure in accordance with part 147 of this subchapter. If fewer 
than 30 male breeding birds are being added, all the birds shall be 
tested as described above. The male birds shall be tested no more than 
14 days prior to their intended introduction into the flock. If the 
serologic testing of the birds yields hemagglutination inhibition titers 
of 1:40 or higher as

[[Page 919]]

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 accordance with part 147 of this 
subchapter with respect to flock sanitation, cleaning and disinfection, 
and Salmonella isolation, sanitation, and management;
    (iii) If pelletized feed contains animal protein, the protein 
products shall be purchased from participants in the Animal Protein 
Products Industry (APPI) Salmonella Education/Reduction Program or the 
Fishmeal Inspection Program of the National Marine Fisheries Service. 
The protein products must have a minimum moisture content of 14.5 
percent and must have been heated throughout to a minimum temperature of 
190 [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 whose sanitation is 
maintained in accordance with part 147 of this subchapter and sanitized 
or fumigated in accordance with part 147 of this subchapter;
    (vii) An Authorized Agent shall take environmental samples, in 
accordance with part 147 of this subchapter, from each flock at 4 months 
of age and every 90 days thereafter. An authorized laboratory for 
Salmonella shall examine the environmental samples bacteriologically;
    (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 monitor the effectiveness of the 
sanitation practices in accordance with part 147 of this subchapter.
    (3) In order for a hatchery to sell products of this classification, 
all products handled shall meet the requirements of the classification.
    (4) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures.
    (e) U.S. M. Synoviae Clean. (1) A flock maintained in accordance 
with part 147 of this subchapter with respect to Mycoplasma isolation, 
sanitation, and management and in which freedom from M. synoviae has 
been demonstrated under the criteria specified in paragraph (e)(1)(i) or 
(ii) of this section.
    (i) [Reserved]
    (ii) It is a multiplier breeding flock which originated as U.S. M. 
Synoviae Clean chicks from primary breeding flocks and from which a 
sample comprised of a minimum of 150 birds has been tested for M. 
synoviae as provided in 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

[[Page 920]]

tested: Provided, That fewer than 75 birds from the flock may be tested 
at any one time if all pens are equally represented and a total of at 
least 75 birds from the flock is tested within each 90-day period; or
    (B) At intervals of not more than 30 days, egg yolk testing shall be 
conducted in accordance with part 147 of this subchapter.
    (2) A participant handling U.S. M. Synoviae Clean products shall 
keep these products separate from other products in a manner 
satisfactory to the official State Agency.
    (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and 
delivered in trucks that have been cleaned and disinfected in accordance 
with part 147 of this subchapter.
    (4) Before male breeding birds may be added to a participating 
multiplier breeding flock, a sample of at least 30 birds to be added, 
with a minimum of 10 birds per pen, shall be tested for M. synoviae as 
provided in Sec.145.14(b) or by a polymerase chain reaction (PCR)-
based procedure in accordance with part 147 of this subchapter. If fewer 
than 30 male breeding birds are being added, all the birds shall be 
tested as described above. The male birds shall be tested no more than 
14 days prior to their intended introduction into the flock. If the 
serologic testing of the birds yields hemagglutination inhibition titers 
of 1:40 or higher as provided in 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.
    (3) The flock is maintained in accordance with part 147 of this 
subchapter with respect to Mycoplasma isolation, sanitation, and 
management.
    (4) The flock's freedom from M. gallisepticum is demonstrated by a 
negative blood test, as provided in 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 in 
accordance with part 147 of this subchapter.
    (g) U.S. M. Synoviae Clean Started Poultry. (1) A flock which 
originated from U.S. M. Synoviae Clean breeding flocks and was hatched 
in a hatchery approved by the Official State Agency for the production 
of U.S. M. Synoviae Clean chicks.
    (2) All other poultry on the premises of the candidate flock must 
originate from U.S. M. Synoviae Clean sources.
    (3) The flock is maintained in accordance with part 147 of this 
subchapter with respect to Mycoplasma isolation, sanitation, and 
management.
    (4) The flock's freedom from M. synoviae is demonstrated by a 
negative blood test, as provided in 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 in 
accordance with part 147 of this subchapter.
    (h)-(i) [Reserved]
    (j) U.S. M. Gallisepticum Monitored. (1) A multiplier breeding flock 
in which all birds or a sample of at least 30 birds per house has been 
tested for M. gallisepticum as provided in 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:

[[Page 921]]

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 
Sec.145.83(c)(1)(i) are set.
    (3) U.S. M. Gallisepticum Monitored chicks shall be boxed in clean 
boxes and delivered in trucks that have been cleaned and disinfected in 
accordance with part 147 of this subchapter.
    (k) U.S. M. Synoviae Monitored. (1) A multiplier breeding flock in 
which all birds or a sample of at least 30 birds per house has been 
tested for M. synoviae as provided in 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 
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 Sec.145.83(d)(1)(i) are set.
    (3) U.S. M. Synoviae Monitored chicks shall be boxed in clean boxes 
and delivered in trucks that have been cleaned and disinfected in 
accordance with part 147 of this subchapter.
    (l) U.S. Avian Influenza Clean. This program is intended to be the 
basis from which the breeding-hatchery industry may conduct a program 
for the prevention and control of avian influenza. It is intended to 
determine the presence of avian influenza in multiplier breeding 
chickens through routine surveillance of each participating breeding 
flock. A flock and the hatching eggs and chicks produced from it will 
qualify for this classification when the Official State Agency 
determines that they have met the following requirements:
    (1) It is a multiplier breeding flock in which a minimum of 30 birds 
have been tested negative for antibodies to avian influenza using an 
approved test as described in Sec.145.14 when more than 4 months of 
age. To retain this classification:
    (i) A sample of at least 15 birds must be tested negative at 
intervals of 90 days; or
    (ii) A sample of fewer than 15 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 15 birds is tested within each 90-day period; or
    (iii) The flock is tested as provided in Sec.145.14(d) at 
intervals of 30 days or less and found to be negative, and a total of 15 
samples are collected and tested within each 90-day period; and
    (2) During each 90-day period, all multiplier spent fowl, up to a 
maximum of 30, must be tested and found negative for avian influenza 
within 21 days prior to movement to slaughter.
    (m) U.S. Salmonella Enteritidis Monitored. This classification is 
intended for multiplier meat-type breeders wishing to monitor their 
breeding flocks for Salmonella enteritidis.
    (1) A flock and the hatching eggs and chicks produced from it shall 
be eligible for this classification if they meet the following 
requirements, as determined by the Official State Agency:
    (i) The flock originated from a U.S. S. Enteritidis Clean primary 
meat-type breeding flock.
    (ii) The flock is maintained in accordance with part 147 of this 
subchapter with respect to Salmonella isolation, sanitation, and 
management.
    (iii) Environmental samples are collected from the flock in 
accordance with part 147 of this subchapter at 16-

[[Page 922]]

18 and 40-45 weeks of age. The samples shall be examined 
bacteriologically for group D Salmonella at an authorized laboratory, 
and cultures from group D positive samples shall be serotyped.
    (2) The following actions must be taken with respect to the test 
results that are generated from this S. enteritidis monitoring program:
    (i) If S. enteritidis is isolated from an environmental sample 
collected from the flock in accordance with paragraph (m)(1)(iii) of 
this section, a thorough evaluation of the practices and programs 
associated with the sampled flock shall be conducted with the goal of 
ascertaining the reason(s) for the positive finding.
    (ii) The test results and the results of any evaluations performed 
in accordance with paragraph (m)(2)(i) of this section will be reported 
on a quarterly basis to the Official State Agency and the NPIP Senior 
Coordinator.
    (iii) Participating broiler integrators shall combine their 
respective test results (and the results of any associated evaluations) 
to help guide their decisionmaking regarding programs and practices to 
implement or maintain to address S. enteritidis.
    (iv) Aggregate data regarding the prevalence of S. enteritidis in 
participating U.S. meat-type parent breeding flocks shall be made 
available to the U.S. Poultry and Egg Association and the National 
Chicken Council.
    (3) This classification may be revoked by the Official State Agency 
if the participant fails to comply with the requirements of this 
classification. The Official State Agency shall not revoke the 
participant's classification until the participant has been given an 
opportunity for a hearing in accordance with rules of practice adopted 
by the Official State Agency.

(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 at www.govinfo.gov.



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. Sec.145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 
145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 
145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 
145.103(b)(3)(i) through (ix).
    (ii) No pullorum disease or fowl typhoid is known to exist nor to 
have existed in hatchery supply flocks within the State during the 
preceding 12 months: Provided, That pullorum disease or fowl typhoid 
found within the preceding 24 months in waterfowl, exhibition poultry, 
and game bird breeding flocks will not prevent a State, which is 
otherwise eligible from qualifying.
    (2) Discontinuation of any of the conditions described in paragraph 
(a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid 
occur in hatchery supply flocks described in paragraph (a)(1)(ii) of 
this section, or if an infection spreads from the originating premises, 
the Service shall have grounds to revoke its determination that the 
State is entitled to this classification. Such action shall not be taken 
until a thorough investigation has been made by the Service and the 
Official State Agency has been given an opportunity for a hearing in 
accordance with rules of practice adopted by the Administrator.
    (b) U.S. M. Gallisepticum Clean State, Meat-Type Chickens. (1) A 
State will be declared a U.S. M. Gallisepticum Clean State, Meat-Type 
Chickens, when it has been determined by the Service that:
    (i) No M. gallisepticum is known to exist nor to have existed in 
meat-type chicken breeding flocks in production within the State during 
the preceding 12 months;
    (ii) All meat-type chicken breeding flocks in production are 
classified as U.S. M. Gallisepticum Clean in accordance with Sec. Sec.
145.33(c) and 145.83(c) or have met equivalent requirements for M. 
gallisepticum control under official supervision;

[[Page 923]]

    (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; 72 FR 1419, Jan. 12, 2007; 76 FR 15793, Mar. 22, 
2011; 85 FR 62565, Oct. 5, 2020]



  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 should be nest clean. They may be fumigated in 
accordance with part 147 of this subchapter or otherwise sanitized.
    (c) Any nutritive material provided to poults must be free of the 
avian pathogens that are officially represented in the Plan disease 
classifications listed in 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; 79 FR 38757, July 9, 
2014; 81 FR 53249, Aug. 12, 2016]



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 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

[[Page 924]]

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 either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. pullorum 
or S. gallinarum.
    (2) It is a multiplier breeding flock, or a breeding flock composed 
of progeny of a primary breeding flock which is intended solely for the 
production of multiplier breeding flocks, and meets the following 
specifications as determined by the Official State Agency and the 
Service:
    (i) The flock is located in a State where all persons performing 
poultry disease diagnostic services within the State are required to 
report to the Official State Agency within 48 hours the source of all 
poultry specimens from which S. pullorum or S. gallinarum is isolated;
    (ii) The flock is composed entirely of birds that originated from 
U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met 
equivalent requirements under official supervision; and
    (iii) The flock is located on a premises where a flock not 
classified as U.S. Pullorum-Typhoid Clean was located the previous year; 
Provided, That an Authorized Testing Agent must blood test up to 300 
birds per flock, as described in 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 for reacting flocks as contained in Sec.145.14(a)(5), and 
all birds fail to demonstrate pullorum or typhoid infection;
    (vii) [Reserved]

[[Page 925]]

    (viii) Discontinuation of any of the conditions or procedures 
described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), and (vi) of 
this section, or the occurrence of repeated outbreaks of pullorum or 
typhoid in turkey breeding flocks within or originating within the State 
shall be grounds for the Service to revoke its determination that such 
conditions and procedures have been met or complied with. Such action 
shall not be taken until a thorough investigation has been made by the 
Service and the Official State Agency has been given an opportunity to 
present its views.
    (4) It is a multiplier breeding flock located in a State which has 
been determined by the Service to be in compliance with the provisions 
of paragraph (b)(3) of this section and in which pullorum disease or 
fowl typhoid is not known to exist nor to have existed in turkey 
hatchery supply flocks within the State during the preceding 24 months.
    (5) It is a primary breeding flock located in a State determined to 
be in compliance with the provisions of paragraph (b)(4) of this section 
and in which a sample of 300 birds from flocks of more than 300, and 
each bird in flocks of 300 or less, has been officially tested for 
pullorum-typhoid with either no reactors or reactors that, upon further 
bacteriological examination conducted in accordance with part 147 of 
this subchapter, fail to isolate S. pullorum or S. gallinarum: Provided, 
That a bacteriological examination monitoring program acceptable to the 
Official State Agency and approved by APHIS may be used in lieu of blood 
testing.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management, and in which no 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 flock is being maintained in accordance with part 
147 of this subchapter with respect to Mycoplasma isolation, sanitation, 
and management. If a flock proves to be infected with M. gallisepticum, 
it shall lose this classification.
    (3) In order to sell hatching eggs or poults of this classification, 
all hatching eggs and poults handled by the participant must be of this 
classification.
    (d) U.S. M. Meleagridis Clean. (1) A flock in which freedom from M. 
meleagridis has been demonstrated under the following criteria:
    (i) A sample of 100 birds from each flock has been tested for M. 
meleagridis when more than 12 weeks of age: Provided, That to retain 
this classification, a minimum of 30 samples from male flocks and 60 
samples from female flocks shall be retested at 28-30 weeks of age and 
at 4-6 week intervals thereafter.
    (2)-(3) [Reserved]
    (4) When reactors to the official test are found and can be 
identified, 10 tracheal swabs and/or vaginal or phallus swabs and their 
corresponding blood samples shall be submitted to a laboratory for 
serological and cultural examination. If reactors cannot be identified, 
at least 30 tracheal swabs and/or vaginal or phallus swabs and their 
corresponding blood samples shall be submitted. In a flock with a low 
reactor rate (less than 5 reactors) the reactors may be submitted to the 
laboratory within 10 days for serology, necropsy, and thorough 
bacteriological examination.

[[Page 926]]

    (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. It is recommended that any birds 
that are showing clinical signs of M. synoviae infection be included in 
samples taken.
    (2) When reactors to the official test are found and can be 
identified, tracheal swabs and their corresponding blood samples from 10 
(all if fewer than 10) reacting birds shall be submitted to an 
authorized laboratory for serological and cultural examination. If 
reactors cannot be identified, at least 30 tracheal swabs and their 
corresponding blood samples shall be submitted. In a flock with a low 
reactor rate (less than five reactors) the reactors may be submitted to 
the laboratory within 10 days for serology, necropsy, and thorough 
bacteriological examination. When reactors to the official test are 
found, the procedures outlined in part 147 of this subchapter will be 
used to determine the status of the flock.
    (f) U.S. Sanitation Monitored, Turkeys. A flock or hatchery whose 
owner is controlling or reducing the level of salmonella through 
compliance with sanitation and management practices in accordance with 
part 147 of this subchapter, and where the following monitoring, 
testing, and management practices are conducted:
    (1) Hatchery debris (dead germ hatching eggs, fluff, and meconium 
collected by sexors), swabs collected from hatch debris in hatcher 
trays, a sample of all the poults that died within 10 days after 
hatching up to 10 poults, or a combination of 2 or all 3 of the above, 
from each hatch or a candidate breeding flock produced by a primary 
breeder, are examined bacteriologically at an authorized laboratory for 
Salmonella.
    (2) The poults for the candidate breeding flock are placed in a 
building that has been cleaned and disinfected. An Authorized Agent must 
collect environmental samples from the building and submit them to an 
authorized laboratory for a bacteriological examination for the presence 
of Salmonella, in accordance with part 147 of this subchapter.
    (3) Feed for turkeys in the candidate and breeding flock should meet 
the following requirements:
    (i) All feed manufactured in pellet form must have a maximum 
moisture content of 13.5 percent upon delivery to the farm. It should 
have been preconditioned to the minimum of one of the following 
parameters before pelleting:
    (A) Feed is to reach a minimum temperature of 185 [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
    (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.

[[Page 927]]

    (4) Environmental samples shall be taken by an Authorized Agent, in 
accordance with part 147 of this subchapter, from each flock at 12-20 
weeks of age and examined bacteriologically at an authorized laboratory 
for Salmonella.
    (5) Owners of flocks found infected with a paratyphoid Salmonella 
may vaccinate these flocks with an autogenous bacterin with a 
potentiating agent. \5\
---------------------------------------------------------------------------

    \5\ Preparation and use of this type of vaccine may be regulated by 
state statutes.
---------------------------------------------------------------------------

    (6) Environmental samples shall be taken by an Authorized Agent, in 
accordance with part 147 of this subchapter, from each flock at 35-50 
weeks of age and from each molted flock at midlay, and examined 
bacteriologically at an authorized laboratory for Salmonella.
    (7) Hatchery debris (dead germ hatching eggs, fluff, and meconium 
collected by sexors), swabs collected from hatch debris in hatcher 
trays, a sample of all the poults that died within 10 days after 
hatching up to 10 poults, or a combination of 2 or all 3 of the above, 
shall be cultured as a means of evaluating the effectiveness of the 
control procedures.
    (g) U.S. H5/H7 Avian Influenza Clean. This program is intended to be 
the basis from which the turkey breeding industry may conduct a program 
for the prevention and control of the H5/H7 subtypes of avian influenza. 
It is intended to determine the presence of the H5/H7 subtypes of avian 
influenza in breeding turkeys through routine surveillance of each 
participating breeding flock. A flock, and the hatching eggs and poults 
produced from it, will qualify for this classification when the Official 
State Agency determines that it has met one of the following 
requirements:
    (1) It is a primary breeding flock in which a minimum of 30 birds 
have been tested negative to the H5/H7 subtypes of avian influenza as 
provided in Sec.145.14(d) when more than 4 months of age and prior to 
the onset of egg production. To retain this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds are tested within each 90-day period.
    (2) It is a multiplier breeding flock in which a minimum of 30 birds 
have been tested negative for antibodies for avian influenza to the H5/
H7 subtypes of avian influenza as provided in Sec.145.14(d) when more 
than 4 months of age and prior to the onset of egg production. To retain 
this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds are tested within each 90-day period.
    (3) All spent fowl being marketed for meat from flocks that have 
been tested as required by this paragraph shall be tested at a rate of 6 
birds per flock within 21 days prior to movement to slaughter.
    (4) For both primary and multiplier breeding flocks, if a killed 
influenza vaccine against avian influenza subtypes other than H5 and H7 
is used, then the hemagglutinin and the neuraminidase subtypes of the 
vaccine must be reported to the Official State Agency for laboratory and 
reporting purposes.
    (h) U.S. Newcastle Disease Clean. The program in this paragraph (h) 
is intended to be the basis from which the breeding-hatchery industry 
may conduct a program for the prevention and control of Newcastle 
disease. It is intended to determine the presence of Newcastle disease 
in primary breeding turkeys through vaccination and/or monitoring of 
each participating breeding flock. A flock and the hatching eggs and 
poults produced from it will qualify for classification in this 
paragraph (h) when the Official State Agency determines that they have 
met the following requirements:
    (1) It is a primary breeding flock that is either:
    (i) Vaccinated for Newcastle disease using USDA-licensed vaccines 
and response to vaccination is serologically

[[Page 928]]

monitored using an approved test as described in Sec.145.14 when more 
than 4 months of age, and meets the criteria in paragraph (h)(2) of this 
section to retain classification; or
    (ii) Unvaccinated for Newcastle disease, in which a minimum of 30 
birds have tested negative to ND using an approved test as described in 
Sec.145.14 when more than 4 months of age and meets criteria in 
paragraph (h)(3) of this section to retain classification.
    (2) To retain the classification in this paragraph (h) for 
vaccinated flocks:
    (i) Vaccines for ND must be USDA-licensed vaccines administered 
during early stages of development through rearing, and inactivated 
vaccines as final vaccination prior to the onset of egg production; and
    (ii) The flock has been monitored for antibody response using 
approved serological tests as listed in Sec.145.14 and the results are 
compatible with immunological response against ND vaccination; and
    (iii) Testing must include a minimum of 30 birds with a serologic 
monitoring program when more than 4 months of age and prior to the onset 
of production and not longer than every 90 days thereafter.
    (3) To retain the classification in this paragraph (h) for 
unvaccinated flocks:
    (i) A minimum of 30 birds per flock must test negative using an 
approved test in Sec.145.14 at intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period; and
    (iii) During each 90-day period, all primary spent fowl, up to a 
maximum of 30, must test negative to ND within 21 days prior to movement 
to slaughter.
    (4) Newcastle disease must be a disease reportable to the 
responsible State authority (State veterinarian, etc.) by all licensed 
veterinarians. To accomplish this, all laboratories (private, State, and 
university laboratories) that perform diagnostic procedures on poultry 
must examine all submitted cases of unexplained respiratory disease, egg 
production drops, and mortality for ND.

(Approved by the Office of Management and Budget under control numbers 
0579-0007 and 0579-0474)

[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 at www.govinfo.gov.



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. Sec.145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 
145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 
145.73(b)(2)(i), Sec.145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), 
and 145.103(b)(3)(i) through (ix).
    (ii) No pullorum disease or fowl typhoid is known to exist nor to 
have existed in hatchery supply flocks within the State during the 
preceding 12 months: Provided, That pullorum disease or fowl typhoid 
found within the preceding 24 months in waterfowl, exhibition poultry, 
and game bird breeding flocks will not prevent a State, which is 
otherwise eligible, from qualifying.
    (2) Discontinuation of any of the conditions described in paragraph 
(a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid 
occur in hatchery supply flocks described in paragraph (a)(1)(ii) of 
this section, or if an infection spreads from the originating premises, 
the Service shall have grounds to revoke its determination that the 
State is entitled to this classification. Such action shall not be taken 
until a thorough investigation has been made by the Service and the 
Official State Agency has been given an opportunity for a hearing in 
accordance with rules of practice adopted by the Administrator.
    (b) U.S. Pullorum-Typhoid Clean State, Turkeys. (1) A State will be 
declared a U.S. Pullorum-Typhoid Clean State, Turkeys, when it has been 
determined by the Service that:

[[Page 929]]

    (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 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

[[Page 930]]

source of all turkey specimens that have been identified as being 
infected with M. synoviae;
    (vi) All reports of M. synoviae infection in turkeys are promptly 
followed by an investigation by the Official State Agency to determine 
the origin of the infection; and
    (vii) All turkey breeding flocks found to be infected with M. 
synoviae are quarantined until marketed under supervision of the 
Official State Agency.
    (2) The Service may revoke the State's classification as a U.S. M. 
Synoviae Clean State, Turkeys, if any of the conditions described in 
paragraph (d)(1) of this section are discontinued. The Service shall not 
revoke the State's classification as a U.S. M. Synoviae Clean State, 
Turkeys, until it has conducted an investigation and the Official State 
Agency has been given an opportunity for a hearing in accordance with 
rules of practice adopted by the Administrator of the Service.
    (e) U.S. M. Meleagridis Clean State, Turkeys. (1) A State will be 
declared a U.S. M. Meleagridis Clean State, Turkeys, if the Service 
determines that:
    (i) No Mycoplasma meleagridis is known to exist nor to have existed 
in turkey breeding flocks in production within the State during the 
preceding 12 months;
    (ii) All turkey breeding flocks in production are tested and 
classified as U.S. M. Meleagridis Clean or have met equivalent 
requirements for M. meleagridis control under official supervision;
    (iii) All turkey hatcheries within the State only handle products 
that are classified as U.S. M. Meleagridis Clean or have met equivalent 
requirements for M. meleagridis control under official supervision;
    (iv) All shipments of products from turkey breeding flocks other 
than those classified as U.S. M. Meleagridis Clean, or equivalent, into 
the State are prohibited;
    (v) All persons performing poultry disease diagnostic services 
within the State are required to report to the Official State Agency 
within 48 hours the source of all turkey specimens that have been 
identified as being infected with M. meleagridis;
    (vi) All reports of M. meleagridis infection in turkeys are promptly 
followed by an investigation by the Official State Agency to determine 
the origin of the infection; and
    (vii) All turkey breeding flocks found to be infected with M. 
meleagridis are quarantined until marketed under supervision of the 
Official State Agency.
    (2) The Service may revoke the State's classification as a U.S. M. 
Meleagridis Clean State, Turkeys, if any of the conditions described in 
paragraph (d)(1) of this section are discontinued. The Service will not 
revoke the State's classification as a U.S. M. Meleagridis Clean State, 
Turkeys, until it has conducted an investigation and the Official State 
Agency has been given an opportunity for a hearing in accordance with 
rules of practice adopted by the Administrator.

(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; 76 FR 
15793, Mar. 22, 2011; 85 FR 62565, Oct. 5, 2020]



Sec.145.45  Terminology and classification; compartments.

    (a) US H5/H7 AI and ND Clean Compartment. The program in this 
section is intended to be the basis from which the primary turkey 
breeding-hatchery industry may demonstrate the existence and 
implementation of a program that has been approved by the Official State 
Agency and APHIS to establish a compartment consisting of a primary 
breeding-hatchery company that is free of H5/H7 avian influenza (AI) and 
ND. This compartment has the purpose of protecting the defined 
subpopulation and avoiding the introduction and spread of H5/H7 AI and 
ND within that subpopulation by prohibiting contact with other 
commercial poultry operations, other domestic and wild birds, and other 
intensive animal operations. The program shall consist of the following:
    (1) Definition of the compartment. Based on the guidelines 
established by the World Organization for Animal Health (OIE) in the 
Terrestrial Animal

[[Page 931]]

Health Code and the guidelines in this paragraph (a), the primary 
breeder company will define the compartment with respect to H5/H7 AI and 
ND. Specifically, the company will use a comprehensive biosecurity 
program to define the compartment as a subpopulation of poultry with a 
health status for H5/H7 AI and ND that is separate from birds and 
poultry outside the compartment. The Official State Agency and the 
Service must approve all documentation submitted to substantiate the 
defined compartment as adequate to qualify for epidemiological 
separation from other potential sources of infection of H5/H7 AI and ND. 
Guidelines for the definition of the compartment include:
    (i) Definition and description of the subpopulation of birds and 
their health status. All birds included in the compartment must be U.S. 
H5/H7 Avian Influenza Clean in accordance with Sec.145.43(g) and ND 
Clean in accordance with Sec.145.43(h). The poultry must also be 
located in a State that has an initial State response and containment 
plan approved by APHIS under Sec.56.10 of this chapter and that 
participates in the diagnostic surveillance program for H5/H7 low 
pathogenicity AI as described in Sec.145.15. Within the compartment, 
all official tests for AI and ND, as described in Sec.145.14(d) and 
(e), must be conducted in State or Federal laboratories or in NPIP 
authorized laboratories that meet the minimum standards described in 
Sec.147.52 of this subchapter. In addition, the company must provide 
to the Service upon request any relevant historical and current H5/H7 AI 
and ND-related data for reference regarding surveillance for the disease 
within the compartment. Upon request, the Official State Agency may 
provide such data for other commercial poultry populations located in 
the State.
    (ii) Description of animal identification and traceability 
processes. The primary breeder company must also include a description 
of its animal identification and traceability records, including 
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries, 
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and 
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs, 
Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set 
and hatch records; egg receipts; and egg/chick invoices for the 
subpopulation. Documentation must also include breed identification 
(NPIP stock code). The Service should ensure that an effective flock 
identification system and traceability system are in place.
    (iii) Definition and description of the physical components or 
establishments of the defined compartment. The primary breeder company 
must provide documentation establishing that the defined compartment is 
epidemiologically separated from other poultry and bird populations. The 
documentation must be approved by the Official State Agency and the 
Service as indicating adequate epidemiological separation to maintain 
the compartment's separate health status with respect to H5/H7 AI and 
ND. The documentation should include descriptions of:
    (A) The physical and spatial factors that separate the compartment 
from surrounding bird populations and affect the biosecurity status of 
the compartment.
    (B) Relevant environmental factors that may affect exposure of the 
birds to AI and ND.
    (C) The functional boundary and fencing that are used to control 
access to the compartment.
    (D) Facilities and procedures to prevent access by wild birds and to 
provide separation from other relevant hosts.
    (E) The relevant infrastructural factors that may affect exposure to 
AI and ND, including the construction and design of buildings or 
physical components, cleaning and disinfection of buildings and physical 
components between production groups with quality assurance 
verification, cleaning and disinfection of equipment, and introduction 
of equipment or material into the compartment.
    (iv) Definition and description of the functional relationships 
between components of the defined compartment. Functional relationships 
between components of the compartment include traffic movement and flow 
at and among premises, personnel movement at and

[[Page 932]]

among premises, exposure to live bird populations, and any other factors 
that could affect biosecurity of the compartment. All physical 
components of the compartment must be maintained in compliance with 
hygiene and biosecurity procedures for poultry primary breeding flocks 
and hatcheries in accordance with part 147 of this subchapter. In 
addition, the company must provide a biosecurity plan for the 
compartment and all included components. The biosecurity plan should 
include:
    (A) Requirements that company employees and contract growers limit 
their contact with live birds outside the compartment.
    (B) An education and training program for company employees and 
contractors.
    (C) Standard operating procedures for company employees, 
contractors, and outside maintenance personnel.
    (D) Requirements for company employees and non-company personnel who 
visit any premises within the compartment.
    (E) Company veterinary infrastructure to ensure flock monitoring and 
disease diagnosis and control measures.
    (F) Policies for management of vehicles and equipment used within 
the compartment to connect the various premises.
    (G) Farm site requirements (location, layout, and construction).
    (H) Pest management program.
    (I) Cleaning and disinfection process.
    (J) Requirements for litter and dead bird removal and/or disposal.
    (v) Description of other factors important for maintaining the 
compartment. The company veterinary infrastructure will assess sanitary 
measures, environmental risk factors, and management and husbandry 
practices that relate to the separation of the compartment and the 
health status of the birds contained within the compartment that may 
affect risk of exposure to H5/H7 AI and ND. This assessment must include 
a description of internal monitoring and auditing systems (e.g., quality 
assurance and quality control programs) to demonstrate the effectiveness 
of the compartment. Upon request, the Service will provide the company 
with information on the epidemiology of H5/H7 AI and ND and the 
associated risk pathways in which the components of the compartment are 
located.
    (vi) Approval or denial. Based on this documentation provided under 
this paragraph (a)(1), as well as any other information the Service and 
the Official State Agency determine to be necessary, the Service and the 
Official State Agency will approve or deny the classification of the 
compartment as U.S. H5/H7 Avian Influenza and ND Clean.
    (2) Company activities for maintenance of the compartment. (i) The 
primary breeder company's management of biosecurity, surveillance, and 
disease control efforts must be uniform and equivalent among all 
components that are a part of the compartment. Oversight and inspection 
of these management practices must be conducted by the company's 
licensed, accredited veterinarians.
    (ii) Veterinary staff from the Official State Agency and NPIP staff 
will work in partnership with licensed, accredited veterinarians to 
train and certify auditors through Service-approved workshops. The 
trained auditors will conduct biosecurity and operational audits at 
least once every 2 years to ensure the integrity of the compartment. 
These audits will include evaluation of the critical control points and 
standard operating practices within the compartment, verification of the 
health status of the flock(s) contained within the compartment, and 
examination of the biosecurity and management system of the integrated 
components of the compartment.
    (iii) In addition, the company must demonstrate compliance with 
paragraph (a)(1) of this section for remaining in the U.S. H5/H7 Avian 
Influenza and ND Clean classifications, surveillance for H5/H7 AI and ND 
within the compartment, and conducting tests in State or Federal 
laboratories or in NPIP authorized laboratories. Accredited 
veterinarians are responsible for the enforcement of active and passive 
surveillance of H5/H7 AI and ND in primary breeder flocks. Baseline 
health status must be maintained for all flocks or subpopulations within 
the compartment, indicating the dates and negative results of all avian 
influenza

[[Page 933]]

and ND surveillance and monitoring testing, the dates and history of 
last disease occurrence (if any), the number of outbreaks, and the 
methods of disease control that were applied.
    (iv) Documentation will be maintained in the company's database and 
will be verified as required by the Service and/or the Official State 
Agency.
    (3) Service and Official State Agency activities for maintenance of 
the compartment. The Service will work in cooperation with the Official 
State Agencies to ensure the continued integrity of any recognized 
compartments. Activities will include:
    (i) Oversight of the establishment and management of compartments;
    (ii) Establishment of effective partnerships between the Service, 
the Plan, and the primary breeder industry;
    (iii) Approval or denial of classification of compartments as U.S. 
H5/H7 Avian Influenza and ND Clean Compartments under paragraph (a)(1) 
of this section;
    (iv) Official certification of the health status of the compartment, 
and commodities that may be traded from it through participation in the 
Plan for avian diseases, including the U.S. H5/H7 Avian Influenza Clean 
program as described in Sec.145.43(g) and ND Clean program as 
described in Sec.145.43(h) and diagnostic surveillance for H5/H7 low 
pathogenicity AI as described in Sec.145.15;
    (v) Conducting audits of compartments at least once every 2 years 
to:
    (A) Confirm that the primary breeding company's establishments are 
epidemiologically distinct and pathways for the introduction of disease 
into the compartment are closed through routine operational procedures; 
and
    (B) Evaluate and assess the management and husbandry practices 
relating to biosecurity to determine whether they are in compliance with 
hygiene and biosecurity procedures for poultry primary breeding flocks 
and hatcheries in accordance with part 147 of this subchapter;
    (vi) Providing, upon request, model plans for management and 
husbandry practices relating to biosecurity in accordance with part 147 
of this subchapter, risk evaluations in conjunction with the primary 
breeder industry (including disease surveillance such as VS Form 9-4, 
``Summary of Breeding Flock Participation''), and diagnostic capability 
summaries and systems for initial State response and containment plans 
in accordance with Sec.56.10 of this chapter; and
    (vii) Publicizing and sharing compartment information with 
international trading partners, upon request, to establish approval and 
recognition of the compartment, including timeliness and accuracy of 
disease reporting and surveillance measures as described in Sec. Sec.
145.15 and 145.43(g) and (h).
    (4) Emergency response and notification. In the case of a confirmed 
positive of H5/H7 AI and ND in the subpopulation of the compartment, the 
management of the compartment must notify the Service. The Service will 
immediately suspend the status of the compartment. A compartment will be 
eligible to resume trade with importing countries only after the 
compartment has adopted the necessary measures to reestablish the 
biosecurity level and confirm that H5/H7 AI and ND is not present in the 
compartment and the Service has reevaluated the management and 
biosecurity measures of the compartment and approved said compartment 
for trade.
    (b) [Reserved]

(Approved by the Office of Management and Budget under control number 
0579-0474)

[79 FR 38757, July 9, 2014, as amended at 83 FR 28352, June 19, 2018; 85 
FR 62566, Oct. 5, 2020]



 Subpart E_Special Provisions for Hobbyist and Exhibition Poultry, and 
        Raised-for-Release Waterfowl 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.

[[Page 934]]

    Hobbyist poultry. Domesticated fowl which are bred for the purpose 
of meat and/or egg production on a small scale as determined by the 
Official State Agency.
    Raised-for-release waterfowl. Domesticated fowl that normally swim, 
such as ducks and geese, grown under confinement for the primary purpose 
of producing eggs, chicks, started, or mature birds for release on game 
preserves or in the wild.

[36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 59 FR 12799, Mar. 18, 1994; 85 FR 62566, Oct. 5, 2020]



Sec.145.52  Participation.

    Participating flocks of hobbyist and exhibition poultry, raised-for-
release waterfowl, and the eggs, chicks, started, and mature poultry 
produced from them shall comply with the applicable general provisions 
of subpart A of this part and the special provisions of this subpart. 
The special provisions that apply to meat-type waterfowl flocks are 
found in subpart I of this part. The special provisions that apply to 
game bird flocks are found in subpart J of this part.
    (a) Started poultry shall lose their identity under Plan terminology 
when not maintained by Plan participants under the conditions prescribed 
in Sec.145.5(a).
    (b) Hatching eggs produced by primary breeding flocks shall be 
fumigated or otherwise sanitized in accordance with part 147 of this 
subchapter.
    (c) It is recommended that waterfowl flocks and gallinaceous flocks 
be kept separate.
    (d) Subject to the approval of the Service and the Official State 
Agencies in the importing and exporting States, participating flocks may 
report poultry sales to importing States by using either VS Form 9-3, 
``Report of Sales of Hatching Eggs, Chicks, and Poults,'' or by using a 
hatchery invoice form (9-3I) approved by the Official State Agency and 
the Service to identify poultry sales to clients. If the selling 
hatchery uses the 9-3I form, the following information must be included 
on the form:
    (1) The form number ``9-3I'', printed or stamped on the invoice;
    (2) The hatchery name and address;
    (3) The date of shipment;
    (4) The hatchery invoice number;
    (5) The purchaser name and address;
    (6) The quantity of products sold;
    (7) The NPIP hatchery approval number of the shipping hatchery;
    (8) Identification of the products by bird variety or by NPIP stock 
code as listed in the NPIP APHIS 91-55-078 appendix; and
    (9) The appropriate NPIP illustrative design in Sec.145.10. One of 
the designs in Sec.145.10(b) or (g) must be used. The following 
information must be provided in or near the NPIP design:
    (i) The NPIP State number and NPIP hatchery approval number; and
    (ii) The NPIP classification for which product is qualified (e.g., 
U.S. Pullorum-Typhoid Clean).
    (e) Any nutritive material provided to baby poultry must be free of 
the avian pathogens that are officially represented in the Plan disease 
classifications listed in Sec.145.10.
    (f) All participating raised-for-release waterfowl flocks, 
regardless of whether they are breeders or non-breeders, shall be 
enrolled under this subpart.

[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; 74 FR 14715, Apr. 1, 
2009; 76 FR 15793, Mar. 22, 2011; 79 FR 38759, July 9, 2014; 83 FR 
28353, June 19, 2018; 85 FR 62566, Oct. 5, 2020]



Sec.145.53  Terminology and classification; flocks and products.

    Participating flocks, and the eggs, chicks, started, and mature 
poultry produced from them, which have met the respective requirements 
specified in this section may be designated by the following terms and 
the corresponding designs illustrated in 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 either no reactors or reactors that, upon further bacteriological 
examination conducted in accordance with part 147 of

[[Page 935]]

this subchapter, fail to isolate S. pullorum or S. gallinarum.
    (2) It is a multiplier breeding flock, or a breeding flock composed 
of progeny of a primary breeding flock which is intended solely for the 
production of multiplier breeding flocks, and meets the following 
specifications as determined by the Official State Agency and the 
Service:
    (i) The flock is located in a State where all persons performing 
poultry disease diagnostic services within the State are required to 
report to the Official State Agency within 48 hours the source of all 
poultry specimens from which S. pullorum or S. gallinarum is isolated;
    (ii) The flock is composed entirely of birds that originated from 
U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met 
equivalent requirements under official supervision; and
    (iii) The flock is located on a premises where a flock not 
classified as U.S. Pullorum-Typhoid Clean was located the previous year; 
Provided, That an Authorized Testing Agent must blood test up to 300 
birds per flock, as described in 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),

[[Page 936]]

(vi), and (vii) of this section, or the occurrence of repeated outbreaks 
of pullorum or typhoid in poultry breeding flocks within or originating 
within the State shall be grounds for the Service to revoke its 
determination that such conditions and procedures have been met or 
complied with. Such action shall not be taken until a thorough 
investigation has been made by the Service and the Official State Agency 
has been given an opportunity to present its views.
    (4) It is a multiplier breeding flock located in a State which has 
been determined by the Service to be in compliance with the provisions 
of paragraph (b)(3) of this section, and in which pullorum disease or 
fowl typhoid is not known to exist nor to have existed in hatchery 
supply flocks within the State during the preceding 24 months.
    (5) It is a primary breeding flock located in a State determined to 
be in compliance with the provisions of paragraph (b)(4) of this 
section, and in which a sample of 300 birds from flocks of more than 
300, and each bird in flocks of 300 or less, has been officially tested 
for pullorum-typhoid within the past 12 months with either no reactors 
or reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. pullorum 
or S. gallinarum: Provided, That a bacteriological examination 
monitoring program or serological examination monitoring program for 
game birds acceptable to the Official State Agency and approved by the 
Service may be used in lieu of annual blood testing: And Provided 
further, That when a flock is a hobbyist or exhibition poultry primary 
breeding flock located in a State which has been deemed to be a U.S. 
Pullorum-Typhoid Clean State for the past 3 years, and during which time 
no isolation of pullorum or typhoid has been made that can be traced to 
a source in that State, a bacteriological examination monitoring program 
or a serological examination monitoring program acceptable to the 
Official State Agency and approved by the Service may be used in lieu of 
annual blood testing.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management and in which freedom from M. 
gallisepticum has been demonstrated under the criteria specified in 
paragraph (c)(1)(i) or (ii) of this section.
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. gallisepticum as provided in 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 or a targeted bird sample of the trachea or choanal 
cleft using appropriate swabs from all the birds in the flock if the 
flock size is less than 30, but at least 30 birds, shall be tested at 
intervals of not more than 90 days: And provided further, That a sample 
comprised of less than 30 birds may be tested at any one time, with the 
approval of the Official State Agency and the concurrence of the 
Service, provided that a total of at least 30 birds, or all birds in the 
flock if flock size is less than 30, is tested within each 90-day 
period; or
    (ii) It is a multiplier breeding flock which originated as U.S. M. 
Gallisepticum Clean baby poultry from primary breeding flocks and from 
which a random sample of birds has been tested for M. gallisepticum as 
provided in Sec.145.14(b) when more than 4 months of age or upon 
reaching sexual maturity. For flocks of more than 400 birds, 200 birds 
shall be tested. For flocks of 60 to 400 birds, 50 percent of the birds 
shall be tested. For flocks of fewer than 60 birds, all birds shall be 
tested up to a maximum of 30 birds: Provided, that to retain this 
classification, the flock shall be subjected to one of the following 
procedures:
    (A) At intervals of not more than 90 days, a random sample of serum 
or egg yolk or a targeted bird sample of the trachea or choanal cleft 
using appropriate swabs from all the birds in the flock if flock size is 
less than 30, but at least 30 birds, shall be tested; or
    (B) At intervals of not more than 30 days, a sample of 25 cull baby 
poultry

[[Page 937]]

produced from the flock shall be subjected to laboratory procedures 
acceptable to the Official State Agency and approved by the Service, for 
the detection and recovery of M. gallisepticum.
    (2) A participant handling U.S. M. Gallisepticum Clean products 
shall keep these products separate from other products in a manner 
satisfactory to the Official State Agency: Provided, That U.S. M. 
Gallisepticum Clean baby poultry from primary breeding flocks shall be 
produced in incubators and hatchers in which only eggs from flocks 
qualified under paragraph (c)(1)(i) of this section are set.
    (3) U.S. M. Gallisepticum Clean baby poultry shall be boxed in clean 
boxes and delivered in trucks that have been cleaned and disinfected in 
accordance with part 147 of this subchapter.
    (d) U.S. M. Synoviae Clean. (1) A flock maintained in accordance 
with part 147 of this subchapter with respect to Mycoplasma isolation, 
sanitation, and management and in which freedom from Mycoplasma synoviae 
has been demonstrated under the criteria specified in paragraph 
(d)(1)(i) or (d)(1)(ii) of this section.
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. synoviae as provided in 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 or a targeted bird sample of the trachea or choanal cleft 
using appropriate swabs (C.P. swabs) from all the birds in the flock if 
flock size is less than 30, but at least 30 birds, shall be tested at 
intervals of not more than 90 days: And provided further, That a sample 
comprised of less than 30 birds may be tested at any one time with the 
approval of the Official State Agency and the concurrence of the 
Service, provided that a total of at least 30 birds is tested within 
each 90-day period; or
    (ii) It is a multiplier breeding flock that originated as U.S. M. 
Synoviae Clean chicks from primary breeding flocks and from which a 
random sample of birds has been tested for M. synoviae as provided in 
Sec.145.14(b) when more than 4 months of age or upon reaching sexual 
maturity. For flocks of more than 400 birds, 200 birds shall be tested. 
For flocks of 60 to 400 birds, 50 percent of the birds shall be tested. 
For flocks of fewer than 60 birds, all birds shall be tested up to a 
maximum of 30 birds: Provided, that to retain this classification, the 
flock shall be subjected to one of the following procedures:
    (A) At intervals of not more than 90 days, a random sample of serum 
or egg yolk or a targeted bird sample of the trachea or choanal cleft 
using appropriate swabs from all the birds in the flock if the flock 
size is less than 30, but at least 30 birds shall be tested: Provided, 
That a sample of fewer than 30 birds may be tested at any one time with 
the approval of the Official State Agency and the concurrence of the 
Service, provided that a total of at least 30 birds, or the entire flock 
if flock size is less than 30, is tested each time and a total of at 
least 30 birds is tested within each 90-day period; or
    (B) At intervals of not more than 30 days, egg yolk testing shall be 
conducted in accordance with part 147 of this subchapter.
    (2) A participant handling U.S. M. Synoviae Clean products shall 
keep those products separate from other products in a manner 
satisfactory to the Official State Agency: Provided, That U.S. M. 
Synoviae Clean chicks from primary breeding flocks shall be produced in 
incubators and hatchers in which only eggs from flocks qualified under 
paragraph (d)(1)(i) or (d)(1)(ii) of this section are set.
    (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and 
delivered in trucks that have been cleaned and disinfected as described 
in in accordance with part 147 of this subchapter.
    (e) U.S. H5/H7 Avian Influenza Clean. This program is intended to be 
the basis from which the breeding-hatchery industry may conduct a 
program for the prevention and control of the H5 and H7 subtypes of 
avian influenza. It is intended to determine the presence of the H5 and 
H7 subtypes of avian influenza in hobbyist or exhibition waterfowl, 
exhibition poultry, and game bird breeding flocks through routine 
surveillance of each participating breeding flock. A flock, and the 
hatching eggs and chicks produced from it, will qualify for this 
classification when

[[Page 938]]

the Official State Agency determines that it has met one of the 
following requirements:
    (1) It is a primary breeding flock in which a minimum of 30 birds 
has been tested negative to the H5 and H7 subtypes of avian influenza as 
provided in Sec.145.14(d) when more than 4 months of age; Provided, 
that waterfowl flocks may test a minimum of 30 cloacal swabs for virus 
isolation. To retain this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 180 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds are tested within each 180-day period.
    (2) It is a multiplier breeding flock in which a minimum of 30 birds 
has been tested negative to the H5 and H7 subtypes of avian influenza as 
provided in Sec.145.14(d) when more than 4 months of age; Provided, 
that waterfowl flocks may test a minimum of 30 cloacal swabs for virus 
isolation. To retain this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 180 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds are tested within each 180-day period.
    (3) A sample of at least 30 birds must be tested and found negative 
to H5/H7 avian influenza within 21 days prior to movement to slaughter.
    (f) U.S. Salmonella Monitored. The program in this paragraph (f) is 
intended to be the basis from which the breeding-hatching industry may 
conduct a program for the prevention and control of salmonellosis. It is 
intended to reduce the incidence of Salmonella organisms in hatching 
eggs and day-old poultry through an effective and practical sanitation 
and testing program at the breeder farm and in the hatchery. This will 
afford other segments of the poultry industry an opportunity to reduce 
the incidence of Salmonella in their products. The following 
requirements must be met for a flock or hatchery to be eligible for the 
classification in this paragraph (f) as determined by the Official State 
Agency:
    (1) Hatcheries must be kept in a sanitary condition as applicable 
and as outlined in Sec.145.6 (within the NPIP Program Standards 
document, Program Standard C applies to hatcheries; alternatives to the 
program standards may also be approved by the Administrator under Sec.
147.53 of this subchapter).
    (2) An Authorized Agent shall collect and submit to an authorized 
laboratory:
    (i) A minimum of five samples from the hatchery at least every 30 
days while in operation. These samples may include: Hatchery debris, 
swabs from hatchers, setters, hatchery environment, hatchery equipment, 
sexing tables and belts, meconium, chick box papers, hatching trays, or 
chick transfer devices. Samples will be examined bacteriologically at an 
authorized laboratory for Salmonella; and
    (ii) Annual environmental samples from each pullet and breeder farm 
in accordance with this section (within the NPIP Program Standards 
document, Program Standard B applies to bacteriological examination 
procedures; alternatives to the program standards may also be approved 
by the Administrator under Sec.147.53 of this subchapter). Samples 
will be examined bacteriologically at an authorized laboratory for 
Salmonella.
    (3) If Salmonella is identified through this testing:
    (i) A qualified poultry health professional knowledgeable with the 
operation will be consulted and will:
    (A) Review test results to evaluate the Salmonella monitoring 
program.
    (B) Use the Salmonella monitoring program test results to develop 
appropriate and practical Salmonella intervention measures.
    (ii) [Reserved]
    (4) To claim products are of the classification in this paragraph 
(f), all products shall be derived from a farm or hatchery that meets 
the requirements of the classification.

(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]

[[Page 939]]


    Editorial Note: For Federal Register citations affecting Sec.
145.53, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



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 
Sec. Sec.145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 
145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 
145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 
145.103(b)(3)(i) through (ix).
    (ii) No pullorum disease or fowl typhoid is known to exist nor to 
have existed in hatchery supply flocks within the State during the 
preceding 12 months: Provided, That pullorum disease or fowl typhoid 
found within the preceding 24 months in waterfowl, exhibition poultry, 
and game bird breeding flocks will not prevent a State, which is 
otherwise eligible, from qualifying.
    (2) Discontinuation of any of the conditions described in paragraph 
(a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid 
occur in hatchery supply flocks described in paragraph (a)(1)(ii) of 
this section, or if an infection spreads from the originating premises, 
the Service shall have grounds to revoke its determination that the 
State is entitled to this classification. Such action shall not be taken 
until a thorough investigation has been made by the Service and the 
Official State Agency has been given an opportunity for a hearing in 
accordance with rules of practice adopted by the Administrator.

[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; 76 
FR 15794, Mar. 22, 2011; 85 FR 62567, Oct. 5, 2020]



   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 in accordance with part 147 of this 
subchapter.
    (c) Any nutritive material provided to chicks must be free of the 
avian pathogens that are officially represented in the Plan disease 
classifications listed in Sec.145.10.

[63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000; 79 
FR 38759, July 9, 2014]



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

[[Page 940]]

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 either no reactors or reactors that, upon further bacteriological 
examination conducted in accordance with part 147 of this subchapter, 
fail to isolate S. pullorum or S. gallinarum.
    (2) It is a breeding flock that meets one of the following criteria:
    (i)(A) It is a multiplier or primary breeding flock of fewer than 
300 birds in which a sample of 10 percent of the birds in a flock or at 
least 1 bird from each pen, whichever is more, has been officially 
tested for pullorum-typhoid within the past 12 months with either no 
reactors or reactors that, upon further bacteriological examination 
conducted in accordance with part 147 of this subchapter, fail to 
isolate S. pullorum or S. gallinarum; or
    (B) It is a multiplier or primary breeding flock of 300 birds or 
more in which a sample of a minimum of 30 birds has been officially 
tested for pullorum-typhoid within the past 12 months with either no 
reactors or reactors that, upon further bacteriological examination 
conducted in accordance with part 147 of this subchapter, fail to 
isolate S. pullorum or S. gallinarum.
    (ii) It is a flock that has already been designated U.S. Pullorum-
Typhoid Clean and uses a subsequent bacteriological examination 
monitoring program of hatcher debris or eggs for ostriches, emus, rheas, 
or cassowaries acceptable to the Official State Agency and approved by 
the Service in lieu of annual blood testing.
    (iii) It is a multiplier breeding flock located in a State that has 
been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 
years, and during which time no isolation of pullorum or typhoid has 
been made that can be traced to a source in that State, that uses a 
bacteriological examination monitoring program of hatcher debris or eggs 
or a serological examination monitoring program acceptable to the 
Official State Agency and approved by the Service in lieu of annual 
blood testing.
    (b) U.S. Avian Influenza Clean. This program is intended to be the 
basis from which the breeding-hatchery industry may conduct a program 
for the prevention and control of avian influenza. It is intended to 
determine the presence of avian influenza in all ostrich, emu, rhea, and 
cassowary breeding flocks through routine serological surveillance of 
each participating breeding flock. Acceptable tests include antigen and 
antibody detection tests, as approved by the Official State Agency. A 
flock, and the hatching eggs and chicks produced from it, will qualify 
for this classification when the Official State Agency determines that 
it has met one of the following requirements:
    (1) It is a primary breeding flock in which 10 percent of the flock, 
up to a maximum of 30 birds, has been tested negative for type A 
influenza virus with all pens represented equally and when the tested 
birds are more than 4 months of age. Positive samples shall be further 
tested by an authorized laboratory. To retain this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 180 days, or
    (ii) A sample of less than 10 percent of the birds, up to a maximum 
of 30 birds, may be tested and found to be negative at any one time if 
all pens are equally represented and a total of 30 birds are tested 
within each 180-day period.
    (2) It is a multiplier breeding flock in which a minimum of 30 birds 
has been tested negative to type A influenza virus with all pens 
represented equally and when the tested birds are more than 4 months of 
age. Positive samples shall be further tested by an authorized 
laboratory. To retain this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 180 days, or
    (ii) A sample of at least 10 percent of birds from each pen with all 
pens being represented must be tested negative at intervals of 180 days; 
or
    (iii) A sample of less than 10 percent of the birds may be tested, 
and found to be negative, at any one time if all

[[Page 941]]

pens are equally represented and a total of 10 percent of the birds are 
tested within each 180-day period.

[63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000; 72 
FR 1420, Jan. 12, 2007; 74 FR 14715, Apr. 1, 2009; 83 FR 28353, June 19, 
2018]



   Subpart G_Special Provisions for Primary Egg-Type Chicken Breeding 
                           Flocks and Products

    Source: 72 FR 1420, Jan. 12, 2007, unless otherwise noted.



Sec.145.71  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.
    Primary egg-type chicken breeding flocks. Foundation flocks that are 
composed of pedigree, great-grandparent, and grandparent stock that has 
been developed for egg production and are maintained for the principal 
purpose of producing multiplier breeding chicks used to produce table 
egg layers.
    Started chickens. Young chickens (chicks, pullets, cockerels, 
capons) which have been fed and watered and are less than 6 months of 
age.



Sec.145.72  Participation.

    Participating flocks of primary egg-type chickens, and the eggs and 
chicks produced from them, shall comply with the applicable general 
provisions of subpart A of this part and the special provisions of this 
subpart G.
    (a) Started chickens shall lose their identity under Plan 
terminology when not maintained by Plan participants under the 
conditions prescribed in Sec.145.5(a).
    (b) Hatching eggs produced by primary breeding flocks should be nest 
clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
    (c) Any nutritive material provided to chicks must be free of the 
avian pathogens that are officially represented in the Plan disease 
classifications listed in Sec.145.10.

[72 FR 1420, Jan. 12, 2007, as amended at 79 FR 38759, July 9, 2014]



Sec.145.73  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 paragraph (b)(1) or (b)(2) of this section: 
Provided, That a flock qualifying by means of a blood test shall be 
tested within the past 12 months, except that the retesting of a 
participating flock which is retained for more than 12 months shall be 
conducted a minimum of 4 weeks after the induction of molt. (See Sec.
145.14 relating to the official blood test where applicable.)
    (1) It has been officially blood tested with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. pullorum 
or S. gallinarum.
    (2) It is a primary breeding flock that meets the following 
criteria:
    (i) The primary breeding flock is located in a State in which 
pullorum disease or fowl typhoid is not known to exist nor to have 
existed in hatchery supply flocks during the preceding 12 months and in 
which it has been determined by the Service that:
    (A) All hatcheries within the State are qualified as ``National Plan 
Hatcheries'' or have met equivalent requirements for pullorum-typhoid 
control under official supervision;
    (B) All hatchery supply flocks within the State are qualified as 
U.S. Pullorum-Typhoid Clean or have met equivalent requirements for 
pullorum-typhoid control under official supervision: Provided, That if 
other domesticated fowl, except waterfowl, are maintained on the same 
premises as the participating flock, freedom from

[[Page 942]]

pullorum-typhoid infection shall be demonstrated by an official blood 
test of each of these fowl;
    (C) All shipments of products other than U.S. Pullorum-Typhoid 
Clean, or equivalent, into the State are prohibited;
    (D) All persons performing poultry disease diagnostic services 
within the State are required to report to the Official State Agency 
within 48 hours the source of all poultry specimens from which S. 
pullorum or S. gallinarum is isolated;
    (E) All reports of any disease outbreak involving a disease covered 
under the Plan are promptly followed by an investigation by the Official 
State Agency to determine the origin of the infection; Provided, That if 
the origin of the infection involves another State, or if there is 
exposure to poultry in another State from the infected flock, then 
officials administering the National Poultry Improvement Plan will 
conduct an investigation;
    (F) All flocks found to be infected with pullorum or typhoid are 
quarantined until marketed or destroyed under the supervision of the 
Official State Agency, or until subsequently blood tested following the 
procedure for reacting flocks as contained in Sec.145.14(a)(5), and 
all birds fail to demonstrate pullorum or typhoid infection;
    (G) All poultry, including exhibition, exotic, and game birds, but 
excluding waterfowl, going to public exhibition shall come from U.S. 
Pullorum-Typhoid Clean or equivalent flocks, or have had a negative 
pullorum-typhoid test within 90 days of going to public exhibition; and
    (H) Discontinuation of any of the conditions or procedures described 
in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the 
occurrence of repeated outbreaks of pullorum or typhoid in poultry 
breeding flocks within or originating within the State shall be grounds 
for the Service to revoke its determination that such conditions and 
procedures have been met or complied with. Such action shall not be 
taken until a thorough investigation has been made by the Service and 
the Official State Agency has been given an opportunity to present its 
views; and
    (ii) In the primary breeding flock, a sample of 300 birds from 
flocks of more than 300, and each bird in flocks of 300 or less, has 
been officially tested for pullorum-typhoid with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. pullorum 
or S. gallinarum: Provided, That a bacteriological examination 
monitoring program acceptable to the Official State Agency and approved 
by APHIS may be used in lieu of blood testing.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management and in which freedom from M. 
gallisepticum has been demonstrated under the criteria specified in 
paragraph (c)(1)(i) of this section.
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. gallisepticum as provided in 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 
fewer than 150 birds may be tested at any one time, if all pens are 
equally represented and a total of 150 birds is tested within each 90-
day period.
    (ii) [Reserved]
    (2) A participant handling U.S. M. Gallisepticum Clean products 
shall handle only products of equivalent status.
    (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes 
and delivered in trucks that have been cleaned and disinfected in 
accordance with part 147.
    (d) U.S. S. Enteritidis Clean. This classification is intended for 
primary egg-type breeders wishing to assure their customers that the 
hatching eggs and multiplier chicks produced are certified free of 
Salmonella enteritidis.
    (1) A flock and the hatching eggs and chicks produced from it which 
have met the following requirements as determined by the Official State 
Agency:
    (i) The flock originated from a U.S. S. Enteritidis Clean flock, or 
meconium from the chick boxes and a sample of chicks that died within 7 
days

[[Page 943]]

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 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 U.S. Food and Drug 
Administration.
    (iii) Feed shall be stored and transported in such a manner as to 
prevent possible contamination;
    (iv) The flock is maintained in accordance with part 147 of this 
subchapter with respect to flock sanitation, cleaning and disinfection, 
and Salmonella isolation, sanitation, and management. Rodents and other 
pests should be effectively controlled;
    (v) Environmental samples shall be collected from the flock by an 
Authorized Agent, in accordance with part 147 of this subchapter, when 
the flock is 2 to 4 weeks of age. The samples shall be examined 
bacteriologically for group D salmonella at an authorized laboratory. 
Cultures from positive samples shall be serotyped. The Authorized Agent 
shall also collect samples every 30 days after the first sample has been 
collected.
    (vi) Hatching eggs are collected as quickly as possible and are 
handled as described in Sec.147.22 of this subchapter and are 
sanitized or fumigated (see Sec.147.25 of this subchapter).
    (vii) Hatching eggs produced by the flock are incubated in a 
hatchery whose sanitation is maintained in accordance with part 147 of 
this subchapter and sanitized either by a procedure approved by the 
Official State Agency or in accordance with part 147 of this subchapter.
    (2) A flock shall not be eligible for this classification if 
Salmonella enteritidis serotype enteritidis (SE) is isolated from a 
specimen taken from a bird in the flock. Isolation of SE from an 
environmental or other specimen, as described in paragraph (d)(1)(v) of 
this section, will require bacteriological examination for SE in an 
authorized laboratory, in accordance with part 147 of this subchapter, 
of a random sample of 60 live birds from a flock of 5,000 birds or more, 
or 30 live birds from a flock with fewer than 5,000 birds. If only one 
specimen is found positive for SE, the participant may request 
bacteriological examination of a second sample, equal in size to the 
first sample, from the flock. If no SE is recovered from any of the 
specimens in the second sample, the flock will be eligible for the 
classification.
    (3) In order for a hatchery to sell products of this classification, 
all products handled shall meet the requirements of the classification.
    (4) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures. The 
Official State Agency shall not revoke the participant's classification 
until the participant has been given an opportunity for a hearing in 
accordance with rules of practice adopted by the Official State Agency.
    (e) U.S. M. Synoviae Clean. (1) A flock maintained in accordance 
with part 147 of this subchapter with respect to Mycoplasma isolation, 
sanitation, and management and in which freedom from M. synoviae has 
been demonstrated under the criteria specified in paragraph (e)(1)(i) of 
this section.
    (i) It is a flock in which a minimum of 300 birds has been tested 
for M. synoviae as provided in 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 fewer than 150 birds

[[Page 944]]

may be tested at any one time if all pens are equally represented and a 
total of 150 birds is tested within each 90-day period.
    (ii) [Reserved]
    (2) A participant handling U.S. M. Synoviae Clean products shall 
handle only products of equivalent status.
    (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and 
delivered in trucks that have been cleaned and disinfected in accordance 
with part 147 of this subchapter.
    (f) U.S. Avian Influenza Clean. This program is intended to be the 
basis from which the breeding-hatchery industry may conduct a program 
for the prevention and control of avian influenza. It is intended to 
determine the presence of avian influenza in primary breeding chickens 
through routine surveillance of each participating breeding flock. A 
flock and the hatching eggs and chicks produced from it will qualify for 
this classification when the Official State Agency determines that they 
have met the following requirements:
    (1) It is a primary breeding flock in which a minimum of 30 birds 
have been tested and found negative for avian influenza when more than 4 
months of age. To retain this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period; or
    (iii) The flock is tested as provided in Sec.145.14(d) at 
intervals of 30 days or less and found to be negative, and a total of 30 
samples are collected and tested within each 90-day period; and
    (2) A sample of at least 11 birds must be tested and found negative 
for avian influenza within 21 days prior to movement to slaughter.
    (g) U.S. Salmonella Monitored. This program is intended to be the 
basis from which the primary egg-type breeder industry may conduct a 
program for the prevention and control of salmonellosis. It is intended 
to reduce the incidence of Salmonella organisms in hatching eggs and 
chicks through an effective and practical sanitation program at the 
breeder farm and in the hatchery. This will afford other segments of the 
poultry industry an opportunity to reduce the incidence of Salmonella in 
their products.
    (1) A flock and the hatching eggs and chicks produced from it that 
have met the following requirements, as determined by the Official State 
Agency:
    (i) The flock is maintained in accordance with part 147 of this 
subchapter with respect to flock sanitation, cleaning and disinfection, 
and Salmonella isolation, sanitation, and management.
    (ii) Measures shall be implemented to control Salmonella challenge 
through feed, feed storage, and feed transport.
    (iii) Chicks shall be hatched in a hatchery whose sanitation is 
maintained in accordance with part 147 of this subchapter and sanitized 
or fumigated in accordance with part 147 of this subchapter.
    (iv) An Authorized Agent shall take environmental samples from the 
hatchery every 30 days; i.e., meconium or chick papers. An authorized 
laboratory for Salmonella shall examine the samples bacteriologically.
    (v) An Authorized Agent shall take environmental samples in 
accordance with part 147 of this subchapter from each flock at 4 months 
of age and every 30 days thereafter. An authorized laboratory for 
Salmonella shall examine the environmental samples bacteriologically. 
All Salmonella isolates from a flock shall be serogrouped and shall be 
reported to the Official State Agency on a monthly basis.
    (vi) Owners of flocks may vaccinate with a paratyphoid vaccine: 
Provided, That a sample of 350 birds, which will be banded for 
identification, shall remain unvaccinated until the flock reaches at 
least 4 months of age to allow for the serological testing required 
under paragraph (g)(1)(iv) of this section.
    (vii) Any flock entering the production period that is in compliance 
with all the requirements of this paragraph (g) with no history of 
Salmonella isolations shall be considered ``Salmonella negative'' and 
may retain this definition as long as no environmental or bird 
Salmonella isolations are identified and confirmed from the flock or

[[Page 945]]

flock environment by sampling on four separate collection dates over a 
minimum of a 2-week period. Sampling and testing must be performed as 
described in paragraph (g)(1)(vi) of this section. An unconfirmed 
environmental Salmonella isolation shall not change this Salmonella 
negative status.
    (2) The Official State Agency may monitor the effectiveness of the 
sanitation practices in accordance with part 147 of this subchapter.
    (3) In order for a hatchery to sell products of paragraphs (g)(1)(i) 
through (vii) of this section, all products handled shall meet the 
requirements of the classification.
    (4) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures.
    (h) U.S. Newcastle Disease Clean. The program in this paragraph (h) 
is intended to be the basis from which the breeding-hatchery industry 
may conduct a program for the prevention and control of Newcastle 
disease. It is intended to determine the presence of Newcastle disease 
in primary breeding chickens through vaccination and/or monitoring of 
each participating breeding flock. A flock and the hatching eggs and 
chicks produced from it will qualify for the classification in this 
paragraph (h) when the Official State Agency determines that they have 
met the following requirements:
    (1) It is a primary breeding flock that is either:
    (i) Vaccinated for Newcastle disease using USDA-licensed vaccines 
and response to vaccination is serologically monitored using an approved 
test as described in Sec.145.14 when more than 4 months of age and 
meets the criteria in paragraph (h)(2) of this section to retain 
classification; or
    (ii) Unvaccinated for Newcastle disease, in which a minimum of 30 
birds have tested negative to ND using an approved test as described in 
Sec.145.14 when more than 4 months of age and meets criteria in 
paragraph (h)(3) of this section to retain classification.
    (2) To retain the classification in this paragraph (h) for 
vaccinated flocks:
    (i) Vaccines for ND must be USDA-licensed vaccines administered 
during early stages of development through rearing, and inactivated 
vaccines as final vaccination prior to the onset of egg production; and
    (ii) The flock has been monitored for antibody response using 
approved serological tests as listed in Sec.145.14 and the results are 
compatible with immunological response against ND vaccination; and
    (iii) Testing must include a minimum of 30 birds with a serologic 
monitoring program when more than 4 months of age and prior to the onset 
of production and not longer than every 90 days thereafter.
    (3) To retain the classification in this paragraph (h) for 
unvaccinated flocks:
    (i) A minimum of 30 birds per flock must test negative using an 
approved test as described in Sec.145.14 at intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period; and
    (iii) During each 90-day period, all primary spent fowl, up to a 
maximum of 30, must test negative to ND within 21 days prior to movement 
to slaughter.
    (4) Newcastle disease must be a disease reportable to the 
responsible State authority (State veterinarian, etc.) by all licensed 
veterinarians. To accomplish this, all laboratories (private, State, and 
university laboratories) that perform diagnostic procedures on poultry 
must examine all submitted cases of unexplained respiratory disease, egg 
production drops, and mortality for ND.

(Approved by the Office of Management and Budget under control number 
0579-0474)

[72 FR 1420, Jan. 12, 2007, as amended at 76 FR 15794, Mar. 22, 2011; 79 
FR 38759, July 9, 2014; 83 FR 28353, June 19, 2018; 85 FR 62567, Oct. 5, 
2020]



Sec.145.74  Terminology and classification; compartments.

    (a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. 
This program is intended to be the basis from which the primary egg-type 
chicken breeding-hatchery industry may demonstrate the existence and 
implementation of a program that has been approved by the Official State 
Agency

[[Page 946]]

and the Service to establish a compartment consisting of a primary 
breeding-hatchery company that is free of H5/H7 avian influenza (AI) and 
Newcastle disease (ND). This compartment has the purpose of protecting 
the defined subpopulation and avoiding the introduction and spread of 
H5/H7 AI and ND within that subpopulation by prohibiting contact with 
other commercial poultry operations, other domestic and wild birds, and 
other intensive animal operations. The program shall consist of the 
following:
    (1) Definition of the compartment. Based on the guidelines 
established by the World Organization for Animal Health (OIE) in the 
Terrestrial Animal Health Code and the guidelines in this paragraph (a), 
the primary breeder company will define the compartment with respect to 
H5/H7 AI and ND. Specifically, the company will use a comprehensive 
biosecurity program to define the compartment as a subpopulation of 
poultry with a health status for H5/H7 AI and ND that is separate from 
birds and poultry outside the compartment. The Official State Agency and 
the Service must first approve all documentation submitted by the 
company to substantiate the defined compartment as adequate to qualify 
for epidemiological separation from other potential sources of infection 
of H5/H7 AI and ND. Guidelines for the definition of the compartment 
include:
    (i) Definition and description of the subpopulation of birds and 
their health status. All birds included in the compartment must be U.S. 
Avian Influenza Clean in accordance with Sec.145.73(f) and ND Clean in 
accordance with Sec.145.73(h). The poultry must also be located in a 
State that has an initial State response and containment plan approved 
by APHIS under Sec.56.10 of this chapter and that participates in the 
diagnostic surveillance program for H5/H7 low pathogenicity AI as 
described in Sec.145.15. Within the compartment, all official tests 
for AI and ND, as described in Sec.145.14(d) and (e), must be 
conducted in State or Federal laboratories or in NPIP authorized 
laboratories that meet the minimum standards described in Sec.147.52 
of this subchapter. In addition, the company must provide to the Service 
upon request any relevant historical and current H5/H7 AI and ND-related 
data for reference regarding surveillance for the disease within the 
compartment. Upon request, the Official State Agency may provide such 
data for other commercial poultry populations located in the State.
    (ii) Description of animal identification and traceability 
processes. The primary breeder company must also include a description 
of its animal identification and traceability records, including 
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries, 
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and 
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs, 
Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set 
and hatch records; egg receipts; and egg/chick invoices for the 
subpopulation. Documentation must also include breed identification 
(NPIP stock code). The Service should ensure that an effective flock 
identification system and traceability system are in place.
    (iii) Definition and description of the physical components or 
establishments of the defined compartment. The primary breeder company 
must provide documentation establishing that the defined compartment is 
epidemiologically separated from other poultry and bird populations. The 
documentation must be approved by the Official State Agency and the 
Service as indicating adequate epidemiological separation to maintain 
the compartment's separate health status with respect to H5/H7 AI and 
ND. The documentation should include descriptions of:
    (A) The physical and spatial factors that separate the compartment 
from surrounding bird populations and affect the biosecurity status of 
the compartment.
    (B) Relevant environmental factors that may affect exposure of the 
birds to AI and ND.
    (C) The functional boundary and fencing that are used to control 
access to the compartment.
    (D) Facilities and procedures to prevent access by wild birds and to 
provide separation from other relevant hosts.

[[Page 947]]

    (E) The relevant infrastructural factors that may affect exposure to 
AI and ND, including the construction and design of buildings or 
physical components, cleaning and disinfection of buildings and physical 
components between production groups with quality assurance 
verification, cleaning and disinfection of equipment, and introduction 
of equipment or material into the compartment.
    (iv) Definition and description of the functional relationships 
between components of the defined compartment. Functional relationships 
between components of the compartment include traffic movement and flow 
at and among premises, personnel movement at and among premises, 
exposure to live bird populations, and any other factors that could 
affect biosecurity of the compartment. All physical components of the 
compartment must be maintained in compliance with hygiene and 
biosecurity procedures for poultry primary breeding flocks and 
hatcheries in accordance with part 147 of this subchapter. In addition, 
the company must provide a biosecurity plan for the compartment and all 
included components. The biosecurity plan should include but not be 
limited to:
    (A) Requirements that company employees and contract growers limit 
their contact with live birds outside the compartment.
    (B) An education and training program for company employees and 
contractors.
    (C) Standard operating procedures for company employees, 
contractors, and outside maintenance personnel.
    (D) Requirements for company employees and non-company personnel who 
visit any premises within the compartment.
    (E) Company veterinary infrastructure to ensure flock monitoring and 
disease diagnosis and control measures.
    (F) Policies for management of vehicles and equipment used within 
the compartment to connect the various premises.
    (G) Farm site requirements (location, layout, and construction).
    (H) Pest management program.
    (I) Cleaning and disinfection process.
    (J) Requirements for litter and dead bird removal and/or disposal.
    (v) Description of other factors important for maintaining the 
compartment. The company veterinary infrastructure will assess sanitary 
measures, environmental risk factors, and management and husbandry 
practices that relate to the separation of the compartment and the 
health status of the birds contained within the compartment that may 
affect risk of exposure to H5/H7 AI and ND. This assessment must include 
a description of internal monitoring and auditing systems (e.g., quality 
assurance and quality control programs) to demonstrate the effectiveness 
of the compartment. Upon request, the Service will provide the company 
with information on the epidemiology of H5/H7 AI and ND and the 
associated risk pathways in which the components of the compartment are 
located.
    (vi) Approval or denial. Based on the documentation provided under 
this paragraph (a)(1), as well as any other information the Service and 
the Official State Agency determine to be necessary, the Service and the 
Official State Agency will approve or deny the classification of the 
compartment as U.S. Avian Influenza and ND Clean.
    (2) Company activities for maintenance of the compartment. (i) The 
primary breeder company's management of biosecurity, surveillance, and 
disease control efforts must be uniform and equivalent among all 
components that are a part of the compartment. Oversight and inspection 
of these management practices must be conducted by the company's 
licensed, accredited veterinarians.
    (ii) Veterinary staff from the Official State Agency and NPIP staff 
will work in partnership with licensed, accredited veterinarians to 
train and certify auditors through Service-approved workshops. The 
trained auditors will conduct biosecurity and operational audits at 
least once every 2 years to ensure the integrity of the compartment. 
These audits will include evaluation of the critical control points and 
standard operating practices within the compartment, verification of the 
health status of the flock(s) contained within the compartment, and 
examination of the biosecurity and management system of the integrated 
components of the compartment.

[[Page 948]]

    (iii) In addition, the company must demonstrate compliance with 
paragraph (a)(1) of this section for remaining in the U.S. Avian 
Influenza and ND Clean classifications, surveillance for H5/H7 AI and ND 
within the compartment, and conducting tests in State or Federal 
laboratories or in NPIP authorized laboratories. Accredited 
veterinarians are responsible for the enforcement of active and passive 
surveillance of H5/H7 AI and ND in primary breeder flocks. Baseline 
health status must be maintained for all flocks or subpopulations within 
the compartment, indicating the dates and negative results of all avian 
influenza and ND surveillance and monitoring testing, the dates and 
history of last disease occurrence (if any), the number of outbreaks, 
and the methods of disease control that were applied.
    (iv) Documentation will be maintained in the company's database and 
will be verified as required by the Service and/or the Official State 
Agency.
    (3) Service and Official State Agency activities for maintenance of 
the compartment. The Service will work in cooperation with the Official 
State Agencies to ensure the continued integrity of any recognized 
compartments. Activities include:
    (i) Oversight of the establishment and management of compartments;
    (ii) Establishment of effective partnerships between the Service, 
the Plan, and the primary breeder industry;
    (iii) Approval or denial of classification of compartments as U.S. 
Avian Influenza and ND Clean Compartments under paragraph (a)(1) of this 
section;
    (iv) Official certification of the health status of the compartment, 
and commodities that may be traded from it through participation in the 
Plan for avian diseases, including the U.S. Avian Influenza Clean 
program as described in Sec.145.73(f) and ND Clean program as 
described in Sec.145.73(h) and diagnostic surveillance for H5/H7 low 
pathogenicity AI as described in Sec.145.15;
    (v) Conducting audits of compartments at least once every 2 years 
to:
    (A) Confirm that the primary breeding company's establishments are 
epidemiologically distinct and pathways for the introduction of disease 
into the compartment are closed through routine operational procedures; 
and
    (B) Evaluate and assess the management and husbandry practices 
relating to biosecurity to determine whether they are in compliance with 
hygiene and biosecurity procedures for poultry primary breeding flocks 
and hatcheries in accordance with part 147 of this subchapter;
    (vi) Providing, upon request, model plans for management and 
husbandry practices relating to biosecurity in accordance with part 147 
of this subchapter, risk evaluations in conjunction with the primary 
breeder industry (including disease surveillance such as VS Form 9-4, 
``Summary of Breeding Flock Participation''), and diagnostic capability 
summaries and systems for initial State response and containment plans 
in accordance with Sec.56.10 of this chapter; and
    (vii) Publicizing and sharing compartment information with 
international trading partners, upon request, to establish approval and 
recognition of the compartment, including timeliness and accuracy of 
disease reporting and surveillance measures as described in Sec. Sec.
145.15, 145.73(f), and 145.73(h).
    (4) Emergency response and notification. In the case of a confirmed 
positive of H5/H7 AI and/or ND in the subpopulation of the compartment, 
the management of the compartment must notify the Service. The Service 
will immediately suspend the status of the compartment. A compartment 
will be eligible to resume trade with importing countries only after the 
compartment has adopted the necessary measures to reestablish the 
biosecurity level and confirm that H5/H7 AI and/or ND is not present in 
the compartment and the Service has reevaluated the management and 
biosecurity measures of the compartment and approved said compartment 
for trade.
    (b) [Reserved]

(Approved by the Office of Management and Budget under control number 
0579-0474)

[79 FR 38760, July 9, 2014, as amended at 83 FR 28354, June 19, 2018; 85 
FR 62567, Oct. 5, 2020]

[[Page 949]]



  Subpart H_Special Provisions for Primary Meat-Type Chicken Breeding 
                           Flocks and Products

    Source: 72 FR 1422, Jan. 12, 2007, unless otherwise noted.



Sec.145.81  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.
    Primary meat-type chicken breeding flocks. Foundation flocks that 
are composed of pedigree, great-grandparent, and grandparent stock that 
has been developed for meat production and are maintained for the 
principal purpose of producing multiplier breeding chicks used to 
produce commercial broilers.
    Started chickens. Young chickens (chicks, pullets, cockerels, 
capons) which have been fed and watered and are less than 6 months of 
age.



Sec.145.82  Participation.

    Participating flocks of primary meat-type chickens, and the eggs and 
chicks produced from them, shall comply with the applicable general 
provisions of subpart A of this part and the special provisions of this 
subpart H.
    (a) Started chickens shall lose their identity under Plan 
terminology when not maintained by Plan participants under the 
conditions prescribed in Sec.145.5(a).
    (b) Hatching eggs produced by primary breeding flocks should be nest 
clean. They may be fumigated in accordance with part 147 of this 
subchapter or otherwise sanitized.
    (c) Any nutritive material provided to chicks must be free of the 
avian pathogens that are officially represented in the Plan disease 
classifications listed in Sec.145.10.
    (d) Poultry must be protected from vectors known to be in the wild 
and thus must be housed in enclosed structures during brooding, rearing, 
grow-out, or laying periods with no intentional access to the outdoors, 
creatures found in the wild, or raised on open range or pasture, or be 
provided with untreated open source water such as that directly from a 
pond, stream, or spring that wild birds or vermin have access to for 
usage for drinking water, as a cooling agent, or during a wash down/
clean out process.

[72 FR 1422, Jan. 12, 2007, as amended at 79 FR 38762, July 9, 2014; 83 
FR 28354, June 19, 2018]



Sec.145.83  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 paragraph (b)(1) or (b)(2) of this section: 
Provided, That a flock qualifying by means of a blood test shall be 
tested within the past 12 months, except that the retesting of a 
participating flock which is retained for more than 12 months shall be 
conducted a minimum of 4 weeks after the induction of molt. (See Sec.
145.14 relating to the official blood test where applicable.)
    (1) It has been officially blood tested with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. pullorum 
or S. gallinarum.
    (2) It is a primary breeding flock that meets the following 
criteria:
    (i) The primary breeding flock is located in a State in which 
pullorum disease or fowl typhoid is not known to exist nor to have 
existed in hatchery supply flocks within the State during the preceding 
12 months and in which it has been determined by the Service that:
    (A) All hatcheries within the State are qualified as ``National Plan 
Hatcheries'' or have met equivalent requirements for pullorum-typhoid 
control under official supervision;
    (B) All hatchery supply flocks within the State are qualified as 
U.S. Pullorum-Typhoid Clean or have met equivalent requirements for 
pullorum-

[[Page 950]]

typhoid control under official supervision: Provided, That if other 
domesticated fowl, except waterfowl, are maintained on the same premises 
as the participating flock, freedom from pullorum-typhoid infection 
shall be demonstrated by an official blood test of each of these fowl;
    (C) All shipments of products other than U.S. Pullorum-Typhoid 
Clean, or equivalent, into the State are prohibited;
    (D) All persons performing poultry disease diagnostic services 
within the State are required to report to the Official State Agency 
within 48 hours the source of all poultry specimens from which S. 
pullorum or S. gallinarum is isolated;
    (E) All reports of any disease outbreak involving a disease covered 
under the Plan are promptly followed by an investigation by the Official 
State Agency to determine the origin of the infection; Provided, That if 
the origin of the infection involves another State, or if there is 
exposure to poultry in another State from the infected flock, then 
officials administering the National Poultry Improvement Plan will 
conduct an investigation;
    (F) All flocks found to be infected with pullorum or typhoid are 
quarantined until marketed or destroyed under the supervision of the 
Official State Agency, or until subsequently blood tested following the 
procedure for reacting flocks as contained in Sec.145.14(a)(5) of this 
subchapter, and all birds fail to demonstrate pullorum or typhoid 
infection;
    (G) All poultry, including exhibition, exotic, and game birds, but 
excluding waterfowl, going to public exhibition shall come from U.S. 
Pullorum-Typhoid Clean or equivalent flocks, or have had a negative 
pullorum-typhoid test within 90 days of going to public exhibition; and
    (H) Discontinuation of any of the conditions or procedures described 
in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the 
occurrence of repeated outbreaks of pullorum or typhoid in poultry 
breeding flocks within or originating within the State shall be grounds 
for the Service to revoke its determination that such conditions and 
procedures have been met or complied with. Such action shall not be 
taken until a thorough investigation has been made by the Service and 
the Official State Agency has been given an opportunity to present its 
views; and
    (ii) In the primary breeding flock, a sample of 300 birds from 
flocks of more than 300, and each bird in flocks of 300 or less, has 
been officially tested for pullorum-typhoid with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. pullorum 
or S. gallinarum: Provided, That a bacteriological examination 
monitoring program acceptable to the Official State Agency and approved 
by APHIS may be used in lieu of blood testing.
    (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in 
accordance with part 147 of this subchapter with respect to Mycoplasma 
isolation, sanitation, and management and in which freedom from M. 
gallisepticum has been demonstrated under the criteria specified in 
paragraph (c)(1)(i) of this section.
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. gallisepticum as provided in Sec.
145.14(b) of this subchapter when more than 4 months of age: Provided, 
That to retain this classification, a minimum of 40 birds shall be 
tested at intervals of not more than 28 days, and a total of at least 
150 birds shall be tested within each 90-day period.
    (ii) [Reserved]
    (2) A participant handling U.S. M. Gallisepticum Clean products must 
handle only products of equivalent status.
    (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes 
and delivered in trucks that have been cleaned and disinfected in 
accordance with part 147 of this subchapter.
    (d) U.S. M. Synoviae Clean. (1) A flock maintained in accordance 
with part 147 of this subchapter with respect to Mycoplasma isolation, 
sanitation, and management and in which freedom from M. synoviae has 
been demonstrated under the criteria specified in paragraph (d)(1)(i) of 
this section.
    (i) It is a flock in which all birds or a sample of at least 300 
birds has been tested for M. synoviae as provided in

[[Page 951]]

Sec.145.14(b) of this subchapter when more than 4 months of age: 
Provided, That to retain this classification, a sample of at least 40 
birds shall be tested at intervals of not more than 28 days, and a total 
of at least 150 birds shall be tested within each 90-day period.
    (ii) [Reserved]
    (2) A participant handling U.S. M. Synoviae Clean products shall 
handle only products of equivalent status.
    (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and 
delivered in trucks that have been cleaned and disinfected in accordance 
with part 147 of this subchapter.
    (e) U.S. S. Enteritidis Clean. This classification is intended for 
primary meat-type breeders wishing to assure their customers that the 
chicks produced are certified free of Salmonella enteritidis.
    (1) A flock and the hatching eggs and chicks produced from it shall 
be eligible for this classification if they meet the following 
requirements, as determined by the Official State Agency:
    (i) The flock originated from a U.S. S. Enteritidis Clean flock, or 
one of the following samples has been examined bacteriologically for S. 
enteritidis at an authorized laboratory in accordance with part 147 of 
this subchapter and any group D Salmonella samples have been serotyped:
    (A) A sample of chick papers, hatcher tray swabs, or fluff collected 
and cultured in accordance with part 147 of this subchapter; and
    (B) Samples of intestinal and liver or spleen tissues from a minimum 
of 30 chicks that died within 7 days after hatching and have been 
preserved daily by freezing prior to shipment to an authorized 
laboratory.
    (ii) The flock is maintained in compliance with isolation, 
sanitation, and management procedures for Salmonella in accordance with 
part 147 of this subchapter.
    (iii) Environmental samples are collected from the flock by or under 
the supervision of an Authorized Agent, in accordance with part 147 of 
this subchapter, when the flock reaches 4 months of age and every 30 
days thereafter. Once the flock is in egg production and chicks are 
hatching from it, the samples must include at least 4 individual test 
assay results every 30 days in flocks of more than 500 birds or 2 
individual assays per month in flocks of 500 birds or fewer. One of 
these results must come from samples collected from hatched chicks at a 
participating hatchery derived from said flock. These individual test 
assays may be derived from pooled samples from the farm or hatchery in 
accordance with part 147 of this subchapter, but must be run as separate 
test assays in the laboratory. The environmental samples shall be 
examined bacteriologically for group D Salmonella at an authorized 
laboratory, and cultures from group D positive samples shall be 
serotyped.
    (iv) Hatching eggs produced by the flock are collected as quickly as 
possible and their sanitation is maintained in accordance with part 147 
of this subchapter.
    (v) Hatching eggs produced by the flock are incubated in a hatchery 
whose sanitation is maintained in accordance with part 147 of this 
subchapter, and the hatchery must have been sanitized either by a 
procedure approved by the Official State Agency or by fumigation in 
accordance with part 147 of this subchapter.
    (2) If Salmonella enteritidis serotype enteritidis (SE) is isolated 
from a specimen taken from a bird in the flock, except as provided in 
paragraph (e)(3) of this section, the flock shall not be eligible for 
this classification.
    (3) If SE is isolated from an environmental sample collected from 
the flock in accordance with paragraph (e)(1)(iii) of this section, an 
additional environmental sampling and 25 live cull birds or fresh dead 
birds (if present), or other randomly selected live birds if fewer than 
25 culls can be found in the flock, must be bacteriologically examined 
for SE in accordance with part 147 of this subchapter. If only 1 bird 
from the 25-bird sample is found positive for SE., the participant may 
request bacteriological examination of a second 25-bird sample from the 
flock. In addition, if the flock with the SE isolation is in egg 
production and eggs are under incubation, the next four consecutive 
hatches shall be examined bacteriologically in accordance with part 147 
of

[[Page 952]]

this subchapter. Samples shall be collected from all of the hatching 
unit's chick trays and basket trays of hatching eggs, or from all chick 
box papers from the flock, and tested, pooling the samples into a 
minimum of 10 separate assays. Any followup hatchery-positive SE 
isolations shall result in discontinuation of subsequent hatches until 
the flock status is determined by bird culture. The flock will be 
disqualified for the U.S. S. Enteritidis Clean classification if a bird 
or subsequent flock environmental assay results in isolation of SE.
    (4) In order for a hatchery to sell products of this classification, 
all products handled by the hatchery must meet the requirements of this 
paragraph.
    (5) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures. The 
Official State Agency shall not revoke the participant's classification 
until the participant has been given an opportunity for a hearing in 
accordance with rules of practice adopted by the Official State Agency.
    (6) A pedigree, experimental, great-grandparent, or grandparent 
flock that is removed from the U.S. S. Enteritidis Clean program may be 
reinstated whenever the following conditions are met:
    (i) The owner attests that corrective measures have been 
implemented, which may include one or more of the following:
    (A) Test and slaughter infected birds based on blood tests of every 
bird in the flock, with either pullorum antigen or by a federally 
licensed Salmonella enteritidis enzyme-linked immunosorbent assay 
(ELISA) test when the flock is more than 4 months of age.
    (B) Perform other corrective actions including, but not limited to, 
vaccination, medication, cleaning and disinfection of houses, rodent 
control, and movement of uninfected birds to premises that have been 
determined to be environmentally negative for S. enteritidis in 
accordance with par 147 of this subchapter.
    (C) One hundred percent of blood samples from the birds moved to the 
clean premises are tested negative for Salmonella pullorum and group D 
Salmonella. All birds with positive or inconclusive reactions, up to a 
maximum of 25 birds, shall be submitted to an authorized laboratory and 
examined for the presence of group D Salmonella, in accordance with part 
147 of this subchapter. Cultures from positive samples shall be 
serotyped.
    (D) Two consecutive environmental drag swabs taken at the clean 
premises collected in accordance with part 147 of this subchapter 4 
weeks apart are negative for 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 
(e)(1)(v) of this section every 30 days and no positive samples are 
found and the flock meets the requirements set forth in Sec.145.83(e).
    (f) U.S. Salmonella Monitored. This program is intended to be the 
basis from which the breeding-hatching industry may conduct a program 
for the prevention and control of salmonellosis. It is intended to 
reduce the incidence of Salmonella organisms in hatching eggs and chicks 
through an effective and practical sanitation program at the breeder 
farm and in the hatchery. This will afford other segments of the poultry 
industry an opportunity to reduce the incidence of Salmonella in their 
products.
    (1) A flock and the hatching eggs and chicks produced from it that 
have met the following requirements, as determined by the Official State 
Agency.
    (i) Measures shall be implemented to control Salmonella challenge 
through feed, feed storage, and feed transport.
    (ii) Chicks shall be hatched in a hatchery whose sanitation is 
maintained in accordance with part 147 of this subchapter and sanitized 
or fumigated in accordance with part 147 of this subchapter.
    (iii) An Authorized Agent shall take environmental samples from the 
hatchery every 30 days; i.e., meconium or chick papers. An authorized 
laboratory for Salmonella shall examine the samples bacteriologically;
    (iv) An Authorized Agent shall take environmental samples in 
accordance

[[Page 953]]

with part 147 of this subchapter from each flock at 4 months of age and 
every 30 days thereafter. An authorized laboratory for Salmonella shall 
examine the environmental samples bacteriologically. All Salmonella 
isolates from a flock shall be serogrouped and shall be reported to the 
Official State Agency on a monthly basis;
    (v) Owners of flocks may vaccinate with a paratyphoid vaccine: 
Provided, That a sample of 350 birds, which will be banded for 
identification, shall remain unvaccinated until the flock reaches at 
least 4 months of age to allow for the serological testing required 
under paragraph (f)(1)(iv) of this section.
    (vi) Any flock entering the production period that is in compliance 
with all the requirements of Sec.145.83(f) with no history of 
Salmonella isolations shall be considered ``Salmonella negative'' and 
may retain this definition as long as no environmental or bird 
Salmonella isolations are identified and confirmed from the flock or 
flock environment by sampling on 4 separate collection dates over a 
minimum of a 2-week period. Sampling and testing must be performed as 
described in paragraph (f)(1)(iv) of this section. An unconfirmed 
environmental Salmonella isolation shall not change this Salmonella 
negative status.
    (2) The Official State Agency may monitor the effectiveness of the 
sanitation practices in accordance with part 147 of this subchapter.
    (3) In order for a hatchery to sell products of paragraphs (f)(1)(i) 
through (f)(1)(vi) of this section, all products handled shall meet the 
requirements of the classification.
    (4) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures.
    (g) U.S. Avian Influenza Clean. This program is intended to be the 
basis from which the breeding-hatchery industry may conduct a program 
for the prevention and control of avian influenza. It is intended to 
determine the presence of avian influenza in primary breeding chickens 
through routine surveillance of each participating breeding flock. A 
flock and the hatching eggs and chicks produced from it will qualify for 
this classification when the Official State Agency determines that they 
have met the following requirements:
    (1) It is a primary breeding flock in which a minimum of 30 birds 
have been tested negative for antibodies to avian influenza using an 
approved test as described in Sec.145.14 when more than 4 months of 
age. To retain this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period; or
    (iii) The flock is tested as provided in Sec.145.14(d) at 
intervals of 30 days or less and found to be negative, and a total of 30 
samples are collected and tested within each 90-day period; and
    (2) During each 90-day period, all primary spent fowl, up to a 
maximum of 30, must be tested serologically and found negative for 
antibodies for avian influenza within 21 days prior to movement to 
slaughter.
    (h) U.S. Newcastle Disease (ND) Clean. The program in this paragraph 
(h) is intended to be the basis from which the breeding-hatchery 
industry may conduct a program for the prevention and control of 
Newcastle disease. It is intended to determine the presence of Newcastle 
disease in primary breeding chickens through vaccination and/or 
monitoring of each participating breeding flock. A flock and the 
hatching eggs and chicks produced from it will qualify for the 
classification in this paragraph (h) when the Official State Agency 
determines that they have met the following requirements:
    (1) It is a primary breeding flock that is either:
    (i) Vaccinated for Newcastle disease using USDA-licensed vaccines 
and response to vaccination is serologically monitored using an approved 
test as described in Sec.145.14 when more than 4 months of age and 
meets the criteria in paragraph (h)(2) of this section to retain 
classification; or
    (ii) Unvaccinated for Newcastle disease, in which a minimum of 30 
birds

[[Page 954]]

have tested negative to ND using an approved test as described in Sec.
145.14 when more than 4 months of age and meets criteria in paragraph 
(h)(3) of this section to retain classification.
    (2) To retain the classification in this paragraph (h) for 
vaccinated flocks:
    (i) Vaccines for ND must be USDA-licensed vaccines administered 
during early stages of development through rearing, and inactivated 
vaccines as final vaccination prior to the onset of egg production; and
    (ii) The flock has been monitored for antibody response using 
approved serological tests as described in Sec.145.14 and the results 
are compatible with immunological response against ND vaccination; and
    (iii) Testing must include a minimum of 30 birds with a serologic 
monitoring program when more than 4 months of age and prior to the onset 
of production, and not longer than every 90 days thereafter.
    (3) To retain the classification in this paragraph (h) for 
unvaccinated flocks:
    (i) A minimum of 30 birds per flock must test negative using an 
approved test as described in Sec.145.14 at intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period; and
    (iii) During each 90-day period, all primary spent fowl, up to a 
maximum of 30, must test negative to ND within 21 days prior to movement 
to slaughter.
    (4) Newcastle disease must be a disease reportable to the 
responsible State authority (State veterinarian, etc.) by all licensed 
veterinarians. To accomplish this, all laboratories (private, State, and 
university laboratories) that perform diagnostic procedures on poultry 
must examine all submitted cases of unexplained respiratory disease, egg 
production drops, and mortality for ND.

(Approved by the Office of Management and Budget under control number 
0579-0474)

[72 FR 1422, Jan. 12, 2007, as amended at 76 FR 15794, Mar. 22, 2011; 79 
FR 38762, July 9, 2014; 79 FR 71624, Dec. 3, 2014; 81 FR 53250, Aug. 12, 
2016; 83 FR 28354, June 19, 2018; 85 FR 62568, Oct. 5, 2020]



Sec.145.84  Terminology and classification; compartments.

    (a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. 
This program is intended to be the basis from which the primary meat-
type chicken breeding-hatchery industry may demonstrate the existence 
and implementation of a program that has been approved by the Official 
State Agency and the Service to establish a compartment consisting of a 
primary breeding-hatchery company that is free of H5/H7 avian influenza 
(AI) and Newcastle disease (ND). This compartment has the purpose of 
protecting the defined subpopulation and avoiding the introduction and 
spread of H5/H7 AI and ND within that subpopulation by prohibiting 
contact with other commercial poultry operations, other domestic and 
wild birds, and other intensive animal operations. The program shall 
consist of the following:
    (1) Definition of the compartment. Based on the guidelines 
established by the World Organization for Animal Health (OIE) in the 
Terrestrial Animal Health Code and the guidelines in this paragraph (a), 
the primary breeder company will define the compartment with respect to 
H5/H7 AI and ND. Specifically, the company will use a comprehensive 
biosecurity program to define the compartment as a subpopulation of 
poultry with a health status for H5/H7 AI and ND that is separate from 
birds and poultry outside the compartment. The Official State Agency and 
the Service must first approve all documentation submitted by the 
company to substantiate the defined compartment as adequate to qualify 
for epidemiological separation from other potential sources of infection 
of H5/H7 AI and ND. Guidelines for the definition of the compartment 
include:
    (i) Definition and description of the subpopulation of birds and 
their health status. All birds included in the compartment must be U.S. 
Avian Influenza Clean in accordance with Sec.145.83(g) and ND Clean in 
accordance with Sec.145.83(h). The poultry must also be located in a 
State that has an initial State response and containment plan approved 
by APHIS under Sec.56.10 of this chapter and that participates in the 
diagnostic surveillance program for H5/H7 low

[[Page 955]]

pathogenicity AI as described in Sec.145.15. Within the compartment, 
all official tests for AI and ND, as described in Sec.145.14(d) and 
(e), must be conducted in State or Federal laboratories or in NPIP 
authorized laboratories that meet the minimum standards described in 
Sec.147.52 of this subchapter. In addition, the company must provide 
to the Service upon request any relevant historical and current H5/H7 AI 
and ND-related data for reference regarding surveillance for the disease 
and the health status of the compartment. Upon request, the Official 
State Agency may provide such data for other commercial poultry 
populations located in the State.
    (ii) Description of animal identification and traceability 
processes. The primary breeder company must also include a description 
of its animal identification and traceability records, including 
examples of Veterinary Services (VS) Form 9-5, ``Report of Hatcheries, 
Dealers and Independent Flocks''; VS Form 9-2, ``Flock Selection and 
Testing Report''; VS Form 9-3, ``Report of Sales of Hatching Eggs, 
Chicks and Poults''; VS Form 9-9, '' Hatchery Inspection Report''; set 
and hatch records; egg receipts; and egg/chick invoices for the 
subpopulation. Documentation must also include breed identification 
(NPIP stock code). The Service should ensure that an effective flock 
identification system and traceability system are in place.
    (iii) Definition and description of the physical components or 
establishments of the defined compartment. The primary breeder company 
must provide documentation establishing that the defined compartment is 
epidemiologically separated from other poultry and bird populations. The 
documentation must be approved by the Official State Agency and the 
Service as indicating adequate epidemiological separation to maintain 
the compartment's separate health status with respect to H5/H7 AI and 
ND. The documentation should include descriptions of:
    (A) The physical and spatial factors that separate the compartment 
from surrounding bird populations and affect the biosecurity status of 
the compartment.
    (B) Relevant environmental factors that may affect exposure of the 
birds to AI and ND.
    (C) The functional boundary and fencing that are used to control 
access to the compartment.
    (D) Facilities and procedures to prevent access by wild birds and to 
provide separation from other relevant hosts.
    (E) The relevant infrastructural factors that may affect exposure to 
AI and ND, including the construction and design of buildings or 
physical components, cleaning and disinfection of buildings and physical 
components between production groups with quality assurance 
verification, cleaning and disinfection of equipment, and introduction 
of equipment or material into the compartment.
    (iv) Definition and description of the functional relationships 
between components of the defined compartment. Functional relationships 
between components of the compartment include traffic movement and flow 
at and among premises, personnel movement at and among premises, 
exposure to live bird populations, and any other factors that could 
affect biosecurity of the compartment. All physical components of the 
compartment must be maintained in compliance with hygiene and 
biosecurity procedures for poultry primary breeding flocks and 
hatcheries in accordance with part 147 of this subchapter. In addition, 
the company must provide a biosecurity plan for the compartment and all 
included components. The biosecurity plan should include but not be 
limited to:
    (A) Requirements that company employees and contract growers limit 
their contact with live birds outside the compartment.
    (B) An education and training program for company employees and 
contractors.
    (C) Standard operating procedures for company employees, 
contractors, and outside maintenance personnel.
    (D) Requirements for company employees and non-company personnel who 
visit any premises within the compartment.
    (E) Company veterinary infrastructure to ensure flock monitoring and 
disease diagnosis and control measures.

[[Page 956]]

    (F) Policies for management of vehicles and equipment used within 
the compartment to connect the various premises.
    (G) Farm site requirements (location, layout, and construction).
    (H) Pest management program.
    (I) Cleaning and disinfection process.
    (J) Requirements for litter and dead bird removal and/or disposal.
    (v) Description of other factors important for maintaining the 
compartment. The company veterinary infrastructure will assess sanitary 
measures, environmental risk factors, and management and husbandry 
practices that relate to the separation of the compartment and the 
health status of the birds contained within the compartment that may 
affect risk of exposure to H5/H7 AI and ND. This assessment must include 
a description of internal monitoring and auditing systems (e.g., quality 
assurance and quality control programs) to demonstrate the effectiveness 
of the compartment. Upon request, the Service will provide the company 
with information on the epidemiology of H5/H7 AI and ND and the 
associated risk pathways in which the components of the compartment are 
located.
    (vi) Approval or denial. Based on the documentation provided under 
this paragraph (a)(1), as well as any other information the Service and 
the Official State Agency determine to be necessary, the Service and the 
Official State Agency will approve or deny the classification of the 
compartment as U.S. Avian Influenza and ND Clean.
    (2) Company activities for maintenance of the compartment. (i) The 
primary breeder company's management of biosecurity, surveillance, and 
disease control efforts must be uniform and equivalent among all 
components that are a part of the compartment. Oversight and inspection 
of these management practices must be conducted by the company's 
licensed, accredited veterinarians.
    (ii) Veterinary staff from the Official State Agency and NPIP staff 
will work in partnership with licensed, accredited veterinarians to 
train and certify auditors through Service-approved workshops. The 
trained auditors will conduct biosecurity and operational audits at 
least once every 2 years to ensure the integrity of the compartment. 
These audits will include evaluation of the critical control points and 
standard operating practices within the compartment, verification of the 
health status of the flock(s) contained within the compartment, and 
examination of the biosecurity and management system of the integrated 
components of the compartment.
    (iii) In addition, the company must demonstrate compliance with 
paragraph (a)(1) of this section for remaining in the U.S. Avian 
Influenza and ND Clean classifications, surveillance for H5/H7 AI and ND 
within the compartment, and conducting tests in State or Federal 
laboratories or in NPIP authorized laboratories. Accredited 
veterinarians are responsible for the enforcement of active and passive 
surveillance of H5/H7 AI and ND in primary breeder flocks. Baseline 
health status must be maintained for all flocks or subpopulations within 
the compartment, indicating the dates and negative results of all avian 
influenza and ND surveillance and monitoring testing, the dates and 
history of last disease occurrence (if any), the number of outbreaks, 
and the methods of disease control that were applied.
    (iv) Documentation will be maintained in the company's database and 
will be verified as required by the Service and/or the Official State 
Agency.
    (3) Service and Official State Agency activities for maintenance of 
the compartment. The Service will work in cooperation with the Official 
State Agencies to ensure the continued integrity of any recognized 
compartments. Activities include:
    (i) Oversight of the establishment and management of compartments;
    (ii) Establishment of effective partnerships between the Service, 
the Plan, and the primary breeder industry;
    (iii) Approval or denial of classification of compartments as U.S. 
Avian Influenza Clean Compartments under paragraph (a)(1) of this 
section;
    (iv) Official certification of the health status of the compartment, 
and commodities that may be traded from it through participation in the 
Plan for avian diseases, including the U.S.

[[Page 957]]

Avian Influenza Clean program as described in Sec.145.83(g) and ND 
Clean program as described in Sec.145.83(h) and diagnostic 
surveillance for H5/H7 low pathogenicity AI as described in Sec.
145.15;
    (v) Conducting audits of compartments at least once every 2 years 
to:
    (A) Confirm that the primary breeding company's establishments are 
epidemiologically distinct and pathways for the introduction of disease 
into the compartment are closed through routine operational procedures; 
and
    (B) Evaluate and assess the management and husbandry practices 
relating to biosecurity to determine whether they are in compliance with 
hygiene and biosecurity procedures for poultry primary breeding flocks 
and hatcheries in accordance with part 147 of this subchapter;
    (vi) Providing, upon request, model plans for management and 
husbandry practices relating to biosecurity in accordance with part 147 
of this subchapter, risk evaluations in conjunction with the primary 
breeder industry (including disease surveillance such as VS Form 9-4, 
``Summary of Breeding Flock Participation''), and diagnostic capability 
summaries and systems for initial State response and containment plans 
in accordance with Sec.56.10 of this chapter; and
    (vii) Publicizing and sharing compartment information with 
international trading partners, upon request, to establish approval and 
recognition of the compartment, including timeliness and accuracy of 
disease reporting and surveillance measures as described in Sec. Sec.
145.15 and 145.83(g) and (h).
    (4) Emergency response and notification. In the case of a confirmed 
positive of H5/H7 AI in the subpopulation of the compartment, the 
management of the compartment must notify the Service. The Service will 
immediately suspend the status of the compartment. A compartment would 
be eligible to resume trade with importing countries only after the 
compartment has adopted the necessary measures to reestablish the 
biosecurity level and confirm that H5/H7 AI is not present in the 
compartment and the Service has reevaluated the management and 
biosecurity measures of the compartment and approved said compartment 
for trade.
    (b) [Reserved]

(Approved by the Office of Management and Budget under control number 
0579-0474)

[79 FR 38763, July 9, 2014, as amended at 83 FR 28354, June 19, 2018; 85 
FR 62568, Oct. 5, 2020]



Subpart I_Special Provisions for Meat-Type Waterfowl Breeding Flocks and 
                                Products

    Source: 76 FR 15794, Mar. 22, 2011, unless otherwise noted.



Sec.145.91  Definitions.

    Except where the context otherwise requires, for the purposes of 
this subpart the following term shall be construed to mean:
    Meat-type waterfowl breeding flocks. Flocks of domesticated duck or 
goose that are composed of stock that has been developed and is 
maintained for the primary purpose of producing baby poultry that will 
be raised under confinement for the primary purpose of producing meat 
for human consumption.



Sec.145.92  Participation.

    Participating flocks of meat-type waterfowl and the eggs and baby 
poultry produced from them shall comply with the applicable general 
provisions of subpart A of this part and the special provisions of this 
subpart I.
    (a) Started poultry shall lose their identity under Plan terminology 
when not maintained by Plan participants under the conditions prescribed 
in Sec.145.5(a).
    (b) Hatching eggs produced by primary and multiplier breeding flocks 
should be nest clean. They may be fumigated in accordance with part 147 
of this subchapter or otherwise sanitized.
    (c) Any nutritive material provided to baby poultry must be free of 
the avian pathogens that are officially represented in the Plan disease 
classifications listed in Sec.145.10.

[76 FR 15794, Mar. 22, 2011, as amended at 79 FR 38764, July 9, 2014; 81 
FR 53250, Aug. 12, 2016]

[[Page 958]]



Sec.145.93  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 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 
(b)(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 either no reactors or reactors that, upon further bacteriological 
examination conducted in accordance with part 147 of this subchapter, 
fail to isolate S. pullorum or S. gallinarum.
    (2) It is a multiplier breeding flock, or a breeding flock composed 
of progeny of a primary breeding flock which is intended solely for the 
production of multiplier breeding flocks, and meets the following 
specifications as determined by the Official State Agency and the 
Service:
    (i) The flock is located in a State where all persons performing 
poultry disease diagnostic services within the State are required to 
report to the Official State Agency within 48 hours the source of all 
poultry specimens from which S. pullorum or S. gallinarum is isolated;
    (ii) The flock is composed entirely of birds that originated from 
U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met 
equivalent requirements under official supervision; and
    (iii) The flock is located on a premises where a flock not 
classified as U.S. Pullorum-Typhoid Clean was located the previous year; 
Provided, that an Authorized Testing Agent must blood test up to 300 
birds per flock, as described in 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 infected 
wild birds, contaminated feed or waste, or birds, equipment, supplies, 
or personnel from flocks infected with pullorum-typhoid.
    (3) It is a multiplier breeding flock that originated from U.S. 
Pullorum-Typhoid Clean breeding flocks or from flocks that met 
equivalent requirements under official supervision, and is located in a 
State in which it has been determined by the Service that:
    (i) All hatcheries within the State are qualified as ``National Plan 
Hatcheries'' or have met equivalent requirements for pullorum-typhoid 
control under official supervision;
    (ii) All hatchery supply flocks within the State are qualified as 
U.S. Pullorum-Typhoid Clean or have met equivalent requirements for 
pullorum-typhoid control under official supervision: Provided, That if 
other domesticated fowl are maintained on the same premises as the 
participating flock, freedom from pullorum-typhoid infection shall be 
demonstrated by an official blood test of each of these fowl;
    (iii) All shipments of products other than U.S. Pullorum-Typhoid 
Clean, or equivalent, into the State are prohibited;
    (iv) All persons performing poultry disease diagnostic services 
within the State are required to report to the Official State Agency 
within 48 hours the source of all poultry specimens from which 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;

[[Page 959]]

    (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 24 months.
    (5) It is a primary breeding flock located in a State determined to 
be in compliance with provisions of paragraph (b)(3) of this section, 
and in which a sample of 300 birds from flocks of more than 300, and 
each bird in flocks of 300 or less, has been officially tested for 
pullorum-typhoid within the past 12 months with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. pullorum 
or S. gallinarum: Provided, That when a flock is a primary breeding 
flock located in a State which has been deemed to be a U.S. Pullorum-
Typhoid Clean State for the past 3 years, and during which time no 
isolation of pullorum or typhoid has been made that can be traced to a 
source in that State, a bacteriological examination monitoring program 
or a serological examination monitoring program acceptable to the 
Official State Agency and approved by the Service may be used in lieu of 
annual blood testing.
    (c) U.S. H5/H7 Avian Influenza Clean. This program is intended to be 
the basis from which the breeding-hatchery industry may conduct a 
program for the prevention and control of the H5/H7 subtypes of avian 
influenza. It is intended to determine the presence of the H5/H7 
subtypes of avian influenza in meat-type waterfowl breeding flocks 
through routine surveillance of each participating breeding flock. A 
flock, and the hatching eggs and baby poultry produced from it, will 
qualify for this classification when the Official State Agency 
determines that it has met one of the following requirements:
    (1) It is a primary breeding flock in which a minimum of 30 birds 
have been tested negative to the H5/H7 subtypes of avian influenza as 
provided in Sec.145.14(d) when more than 4 months of age. To retain 
this classification:
    (i) A sample of at least 30 birds must be tested and found to be 
negative at intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds are tested within each 90-day period.
    (2) It is a multiplier breeding flock in which a minimum of 30 birds 
have been tested negative to the H5/H7 subtypes of avian influenza as 
provided in Sec.145.14(d) when more than 4 months of age. To retain 
this classification:
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 180 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds are tested within each 180-day period.
    (3) A sample of at least 11 birds must be tested and found negative 
to H5/H7

[[Page 960]]

avian influenza within 21 days prior to movement to slaughter.
    (d) U.S. Salmonella Monitored. This program is intended to be the 
basis from which the breeding-hatching industry may conduct a program 
for the prevention and control of salmonellosis. It is intended to 
reduce the incidence of Salmonella organisms in hatching eggs and day-
old waterfowl through an effective and practical sanitation program at 
the breeder farm and in the hatchery. This will afford other segments of 
the poultry industry an opportunity to reduce the incidence of 
Salmonella in their products.
    (1) A flock and the hatching eggs and day-old waterfowl produced 
from it must meet the following requirements, as determined by the 
Official State Agency, to be eligible for this classification:
    (i) The flock is maintained in compliance with isolation, 
sanitation, and management procedures for Salmonella in accordance with 
part 147 of this subchapter.
    (ii) If feed contains animal protein, the protein products must have 
been heated throughout to a minimum temperature of 190 [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.
    (iii) Feed shall be stored and transported in a manner that prevents 
contamination.
    (iv) Waterfowl shall be hatched in a hatchery whose sanitation is 
maintained in accordance with part 147 of this subchapter and sanitized 
or fumigated in accordance with part 147 of this subchapter.
    (v) An Authorized Agent shall take environmental samples from the 
hatchery every 30 days, i.e., meconium or box liner paper. An authorized 
laboratory for Salmonella shall examine the samples bacteriologically.
    (vi) An Authorized Agent shall take environmental samples in 
accordance with part 147 of this subchapter from each flock at 4 months 
of age and every 30 days thereafter. An authorized laboratory for 
Salmonella shall examine the environmental samples bacteriologically.
    (vii) Flocks may be vaccinated with a paratyphoid vaccine: Provided, 
that a sample of at least 100 birds will be segregated and shall remain 
unvaccinated until the flock reaches at least 4 months of age.
    (2) The Official State Agency may monitor the effectiveness of the 
egg sanitation practices in accordance with part 147 of this subchapter.
    (3) To claim products are of this classification, all products shall 
be derived from a hatchery and flock that meet the requirements of the 
classification.
    (4) This classification may be revoked by the Official State Agency 
if the participant fails to follow recommended corrective measures.

[76 FR 15794, Mar. 22, 2011, as amended at 79 FR 38764, July 9, 2014; 81 
FR 53250, Aug. 12, 2016; 83 FR 28355, June 19, 2018]



Sec.145.94  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. Sec.145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 
145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 
145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 
145.103(b)(3)(i) through (ix).
    (ii) No pullorum disease or fowl typhoid is known to exist nor to 
have existed in hatchery supply flocks within the State during the 
preceding 12 months: Provided, That pullorum disease or fowl typhoid 
found within the preceding 24 months in waterfowl, exhibition poultry, 
and game bird breeding flocks will not prevent a State that is otherwise 
eligible from qualifying.
    (2) Discontinuation of any of the conditions described in paragraph 
(a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid 
occur in hatchery supply flocks described in paragraph (a)(1)(ii) of 
this section, or if an infection spreads from the originating premises, 
the Service shall have grounds to revoke its determination that the 
State is entitled to this classification. Such action shall not be taken 
until a thorough investigation has been made by the Service and the

[[Page 961]]

Official State Agency has been given an opportunity for a hearing in 
accordance with rules of practice adopted by the Administrator.
    (b) [Reserved]

[76 FR 15794, Mar. 22, 2011, as amended at 85 FR 62568, Oct. 5, 2020]



Subpart J_Special Provisions for Egg/Meat-Type Game Bird and Raised-for-
             Release Game Bird Breeding Flocks and Products

    Source: 85 FR 62568, Oct. 5, 2020, unless otherwise noted.



Sec.145.101  Definitions.

    Except where the context otherwise requires, for the purposes of 
this subpart the following terms shall be construed, respectively, to 
mean:
    Egg/meat-type bird. Birds grown under confinement for the primary 
purpose of producing eggs and/or meat for human consumption.
    Game birds. Domesticated fowl such as pheasants, partridge, quail, 
grouse, and guineas, but not doves and pigeons.
    Raised-for-release bird. Birds grown under confinement for the 
primary purpose of producing eggs, chicks, started, or mature birds for 
release on game preserves or in the wild.



Sec.145.102  Participation.

    Participating flocks of egg/meat-type game birds, raised-for-release 
game birds, and the products produced from them shall comply with the 
applicable general provisions of subpart A of this part and the special 
provisions of this subpart. Participation is broken into the following 
categories of operation and products:
    (a) The categories for operation are:
    (1) Breeder. An individual or business that maintains a breeding 
flock for the purpose of producing eggs, chicks, started, or mature 
birds. A breeder that is also a hatchery and/or grower shall be 
categorized as a breeder.
    (2) Hatchery. A category of operations in which an individual or 
business does not have a breeding flock, but hatches eggs for the 
purpose of producing chicks, started, or mature birds. A hatchery that 
is also a grower shall be categorized as a hatchery.
    (3) Grower. A category of operations in which an individual or 
business does not have a breeding flock or hatchery, but raises birds 
for the purpose of selling started or mature birds.
    (4) Dealer. An individual or business that resells eggs, chicks, 
started, or mature birds. Products a dealer handles are typically resold 
within 30 days or less.
    (b) The categories for products are:
    (1) Egg. An egg laid by a female bird for the purpose of hatching a 
chick.
    (2) Chick. A bird that is newly hatched from an egg.
    (3) Started bird. A bird that is between the age of a newly hatched 
chick and a mature bird.
    (4) Mature bird. A bird that is fully colored and has reached the 
average maximum size specific to each species.
    (c) Products shall lose their identity under Plan terminology when 
not maintained by Plan participants under the conditions prescribed in 
Sec.145.5(a).
    (d) Hatching eggs produced by breeding flocks shall be nest clean, 
fumigated, or otherwise sanitized in accordance with part 147 of this 
subchapter.
    (e) It is recommended that gallinaceous flocks and waterfowl flocks 
be kept separate.
    (f) Any nutritive material provided to baby poultry must be free of 
the avian pathogens that are officially represented in the Plan disease 
classifications listed in Sec.145.10.
    (g) A flock of game birds that are not breeders, but are located on 
the same premise as game bird breeders, shall be covered under the same 
NPIP hatchery approval number as long as the appropriate testing 
requirements have been met.
    (h) All participating raised-for-release game bird flocks, 
regardless of whether they are breeders or non-breeders, shall be 
enrolled under this subpart.
    (i) A breeder, hatchery, or grower may also be a dealer without 
being categorized as a dealer. To resell products under the assigned 
NPIP number and avoid losing NPIP flock classifications, products must 
be purchased from an NPIP participant with equal or greater 
classifications or from a flock with

[[Page 962]]

equivalent or greater testing requirements under official supervision.
    (j) Subject to the approval of the Service and the Official State 
Agencies in the importing and exporting States, participating flocks may 
report poultry sales to importing States by using either VS Form 9-3, 
``Report of Sales of Hatching Eggs, Chicks, and Poults,'' or by using an 
invoice form (9-3I) approved by the Official State Agency and the 
Service to identify poultry sales to clients. If the 9-3I form is used, 
the following information must be included on the form:
    (1) The form number ``9-3I'', printed or stamped on the invoice;
    (2) The seller name and address;
    (3) The date of shipment;
    (4) The invoice number;
    (5) The purchaser name and address;
    (6) The quantity of products sold;
    (7) Identification of the products by bird variety or by NPIP stock 
code as listed in the NPIP APHIS 91-55-078 appendix; and
    (8) The appropriate NPIP illustrative design in Sec.145.10. One of 
the designs in Sec.145.10(b) or (g) must be used. The following 
information must be provided in or near the NPIP design:
    (i) The NPIP State number and NPIP approval number; and
    (ii) The NPIP classification for which product is qualified (e.g., 
U.S. Pullorum-Typhoid Clean).



Sec.145.103  Terminology and classification; flocks and products.

    Participating flocks, and the eggs, chicks, started, and mature 
birds produced from them, which have met the respective requirements 
specified in this section may be designated by the following terms and 
the corresponding designs illustrated in 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 paragraph (b)(1), (2), or (3) 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 either no reactors or reactors that, upon further bacteriological 
examination conducted in accordance with part 147 of this subchapter, 
fail to isolate S. pullorum or S. gallinarum.
    (2) It is a started or mature bird flock that meets the following 
specifications as determined by the Official State Agency and the 
Service:
    (i) The flock is located in a State where all persons performing 
poultry disease diagnostic services within the State are required to 
report to the Official State Agency within 48 hours the source of all 
poultry specimens from which S. pullorum or S. gallinarum is isolated;
    (ii) The flock is composed entirely of birds that originated from 
U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met 
equivalent requirements under official supervision; and
    (iii) The flock is located on a premises where a flock not 
classified as U.S. Pullorum-Typhoid Clean was located the previous year; 
Provided, That an Authorized Testing Agent must blood test up to 300 
birds per flock, as described in 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 infected 
wild birds, contact between the flock for which qualification is being 
sought and contaminated feed or waste, or contact between the flock for 
which qualification is being sought and birds, equipment, supplies, or 
personnel from flocks infected with pullorum-typhoid.
    (3) It is a breeding flock that originated from U.S. Pullorum-
Typhoid Clean breeding flocks or from flocks that met equivalent 
requirements under official supervision, and in which a sample of 300 
birds from flocks of more than 300, and each bird in flocks of 300 or 
less, has been officially tested for pullorum-typhoid with no reactors 
or reactors that upon bacteriologic examination fail to reveal Pullorum-

[[Page 963]]

Typhid: Provided, That a bacteriological examination monitoring program 
or serological examination monitoring program for game birds acceptable 
to the Official State Agency and approved by the Service may be used in 
lieu of annual blood testing: And provided further, That it is located 
in a State in which it has been determined by the Service that:
    (i) All hatcheries within the State are qualified as ``National Plan 
Hatcheries'' or have met equivalent requirements for pullorum-typhoid 
control under official supervision;
    (ii) All hatchery supply flocks within the State are qualified as 
U.S. Pullorum-Typhoid Clean or have met equivalent requirements for 
pullorum-typhoid control under official supervision: Provided, That if 
other domesticated fowl, except waterfowl, are maintained on the same 
premises as the participating flock, freedom from pullorum-typhoid 
infection shall be demonstrated by an official blood test of each of 
these fowl;
    (iii) All shipments of products other than U.S. Pullorum-Typhoid 
Clean, or equivalent, into the State are prohibited;
    (iv) All persons performing poultry disease diagnostic services 
within the State are required to report to the Official State Agency 
within 48 hours the source of all poultry specimens from which 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; and
    (viii) The flock is located in a State in which pullorum disease or 
fowl typhoid is not known to exist nor to have existed in hatchery 
supply flocks within the State during the preceding 24 months.
    (ix) Discontinuation of any of the conditions or procedures 
described in paragraphs (b)(3)(i) through (viii) of this section, or the 
occurrence of repeated outbreaks of pullorum or typhoid in poultry 
breeding flocks within or originating within the State shall be grounds 
for the Service to revoke its determination that such conditions and 
procedures have been met or complied with. Such action shall not be 
taken until a thorough investigation has been made by the Service and 
the Official State Agency has been given an opportunity to present its 
views.
    (c) U.S. H5/H7 Avian Influenza Clean. The program in this paragraph 
(c) is intended to be the basis from which the game bird industry may 
conduct a program for the prevention and control of the H5 and H7 
subtypes of avian influenza. It is intended to determine the presence of 
the H5 and H7 subtypes of avian influenza in game bird flocks through 
routine surveillance of each participating flock. A flock or premises, 
and the hatching eggs, chicks, started, and mature birds produced from 
it, will qualify for the classification in this paragraph (c) when the 
Official State Agency determines that it has met the following 
requirements:
    (1) It is a flock in which a minimum of 30 birds has been tested 
negative to the H5 and H7 subtypes of avian influenza as provided in 
Sec.145.14(d) when more than 4 months of age. To retain the 
classification in this paragraph (c):
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30

[[Page 964]]

birds are tested within each 90-day period.
    (2) For participants with non-breeding flocks retained for raised-
for-release or other purposes on the same premises as a breeding flock, 
a representative sample of at least 30 birds from the participating 
premises must be tested negative to the H5 and H7 subtypes of avian 
influenza as provided in Sec.145.14(d) when more than 4 months of age, 
every 90 days.
    (d) U.S. Salmonella Monitored. The program in this paragraph (d) is 
intended to be the basis from which the game bird industry may conduct a 
program for the prevention and control of salmonellosis. It is intended 
to reduce the incidence of Salmonella organisms in day-old poultry 
through an effective and practical sanitation program in the hatchery. 
This will afford other segments of the poultry industry an opportunity 
to reduce the incidence of Salmonella in their products. The following 
requirements must be met for a flock to be of this classification in 
this paragraph (d):
    (1) An Authorized Agent shall collect a minimum of five 
environmental samples, e.g., chick papers, hatching trays, and chick 
transfer devices, from the hatchery at least every 30 days. Testing must 
be performed at an authorized laboratory.
    (2) To claim products are of the classification in this paragraph 
(d), all products shall be derived from a hatchery that meets the 
requirements of the classification.
    (3) The classification in this paragraph (d) may be revoked by the 
Official State Agency if the participant fails to follow recommended 
corrective measures.



Sec.145.104  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. Sec.145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 
145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 
145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 
145.103(b)(3)(i) through (ix).
    (ii) No pullorum disease or fowl typhoid is known to exist nor to 
have existed in hatchery supply flocks within the State during the 
preceding 12 months: Provided, That pullorum disease or fowl typhoid 
found within the preceding 24 months in waterfowl, exhibition poultry, 
and game bird breeding flocks will not prevent a State, which is 
otherwise eligible, from qualifying.
    (2) If there is discontinuation of any of the conditions described 
in paragraph (a)(1)(i) of this section, or repeated outbreaks of 
pullorum or typhoid occur in hatchery supply flocks described in 
paragraph (a)(1)(ii) of this section, or if an infection spreads from 
the originating premises, the Service shall have grounds to revoke its 
determination that the State is entitled to this classification in this 
paragraph (a). Such action shall not be taken until a thorough 
investigation has been made by the Service and the Official State Agency 
has been given an opportunity for a hearing in accordance with rules of 
practice adopted by the Administrator.
    (b) [Reserved]



PART 146_NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY--
Table of Contents



                      Subpart A_General Provisions

Sec.
146.1 Definitions.
146.2 Administration.
146.3 Participation.
146.4 General provisions for all participating flocks and slaughter 
          plants.
146.5 Specific provisions for all participating flocks.
146.6 Specific provisions for participating slaughter plants.
146.7 Terminology and classification; general.
146.8 Terminology and classification; slaughter plants.
146.9 Terminology and classification; flocks, products, and States.
146.10 Supervision.
146.11 Inspections.
146.12 Debarment from participation.
146.13 Testing.
146.14 Diagnostic surveillance program for H5/H7 low pathogenic avian 
          influenza.

[[Page 965]]

   Subpart B_Special Provisions for Commercial Table-Egg Layer Flocks

146.21 Definitions.
146.22 Participation.
146.23 Terminology and classification; flocks and products.
146.24 Terminology and classification; States.

   Subpart C_Special Provisions for Meat-Type Chicken Slaughter Plants

146.31 Definitions.
146.32 Participation.
146.33 Terminology and classification; meat-type chicken slaughter 
          plants.

   Subpart D_Special Provisions for Meat-Type Turkey Slaughter Plants

146.41 Definitions.
146.42 Participation.
146.43 Terminology and classification; meat-type turkey slaughter 
          plants.
146.44 Terminology and classification; States.

     Subpart E_Special Provisions for Commercial Upland Game Birds, 
 Commercial Waterfowl, Raised-for-Release Upland Game Birds, and Raised-
                          for-Release Waterfowl

146.51 Definitions.
146.52 Participation.
146.53 Terminology and classification; slaughter plants and premises.

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

    Source: 71 FR 56328, Sept. 26, 2006, unless otherwise noted.



                      Subpart A_General Provisions



Sec.146.1  Definitions.

    Except where the context otherwise requires, for the purposes of 
this subpart the following terms shall be construed, respectively, to 
mean:
    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Affiliated flock. A meat-type flock that is owned by or has an 
agreement to participate in the Plan with a slaughter plant and that 
participates in the Plan through that slaughter plant.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the U.S. Department of Agriculture.
    Authorized Agent. Any person designated under Sec.146.10(a) to 
perform functions under this part.
    Authorized laboratory. An authorized laboratory is a laboratory that 
meets the requirements of Sec.147.52 and is thus qualified to perform 
the assays in accordance with part 147 of this subchapter.
    Classification. A designation earned by participation in a Plan 
program.
    Commercial meat-type flock. All of the meat-type chickens, spent 
fowl, meat-type turkeys, commercial upland game birds, or commercial 
waterfowl on one farm. However, at the discretion of the Official State 
Agency, any group of poultry which is segregated from another group in a 
manner sufficient to prevent the transmission of H5/H7 LPAI and has been 
so segregated for a period of at least 21 days may be considered as a 
separate flock.
    Commercial table-egg layer flock. All table-egg layers of common age 
or pullet source on one premises.
    Commercial table-egg layer premises. A farm containing contiguous 
flocks of commercial table-egg layers under common ownership.
    Commercial table-egg layer pullet flock. A table-egg layer flock 
prior to the onset of egg production.
    Cooperating State Agency. Any State authority recognized by the 
Department to cooperate in the administration of the provisions of part 
56 of this chapter. This may include the State animal health authority 
or the Official State Agency.
    Department. The U.S. Department of Agriculture.
    Domesticated. Propagated and maintained under the control of a 
person.
    Equivalent. Requirements which are equal to or exceed the program, 
conditions, criteria, or classifications with which they are compared, 
as determined by the Official State Agency and with the concurrence of 
the Service.
    H5/H7 low pathogenic avian influenza (LPAI). An infection of poultry 
caused by an influenza A virus of H5 or H7 subtype that has an 
intravenous pathogenicity index in 6-week-old chickens less than or 
equal to 1.2 or causes less than 75 percent mortality in 4- to 8-

[[Page 966]]

week-old chickens infected intravenously, or an infection with influenza 
A viruses of H5 or H7 subtype with a cleavage site that is not 
consistent with a previously identified highly pathogenic avian 
influenza virus.
    H5/H7 LPAI virus infection (infected). (1) Poultry will be 
considered to be infected with H5/H7 LPAI for the purposes of this part 
if:
    (i) H5/H7 LPAI virus has been isolated and identified as such from 
poultry; or
    (ii) Viral antigen or viral RNA specific to the H5 or H7 subtype of 
AI virus has been detected in poultry; or
    (iii) Antibodies to the H5 or H7 subtype of the AI virus that are 
not a consequence of vaccination have been detected in poultry. If 
vaccine is used, methods should be used to distinguish vaccinated birds 
from birds that are both vaccinated and infected. In the case of 
isolated serological positive results, H5/H7 LPAI infection may be ruled 
out on the basis of a thorough epidemiological investigation that does 
not demonstrate further evidence of H5/H7 LPAI infection, as determined 
by the Cooperating State Agency, the Official State Agency, and APHIS.
    (2) The official determination that H5/H7 LPAI virus has been 
isolated and identified, viral antigen or viral RNA specific to the H5 
or H7 subtype of AI virus has been detected, or antibodies to the H5 or 
H7 subtype of AI virus have been detected may only be made by the 
National Veterinary Services Laboratories.
    NPIP Technical Committee. A committee made up of technical experts 
on poultry health, biosecurity, surveillance, and diagnostics. The 
committee consists of representatives from the poultry and egg 
industries, universities, and State and Federal governments and is 
appointed by the Senior Coordinator and approved by the General 
Conference Committee. The NPIP Technical Committee is divided into three 
subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP 
Technical Committee Members may serve on one, two, or all three 
subcommittees. The committee will evaluate proposed changes to the 
Provisions and Program Standards of the Plan which include, but are not 
limited to, tests and sanitation procedures, and provide recommendations 
to the Delegates of the National Plan Conference as to whether they are 
scientifically or technically sound.
    Official State Agency. The State authority recognized by the 
Department to cooperate in the administration of the Plan.
    Person. A natural person, firm, or corporation.
    Plan. The provisions of the National Poultry Improvement Plan 
contained in this part.
    Poultry. Domesticated fowl, including chickens, turkeys, waterfowl, 
and game birds, except doves and pigeons, that are bred for the primary 
purpose of producing eggs or meat.
    Program. Management, sanitation, testing, and monitoring procedures 
which, if complied with, will qualify, and maintain qualification for, 
designation of a flock, a slaughter plant, or a State by an official 
Plan classification and illustrative design, as described in Sec.146.9 
of this part.
    Service. The Animal and Plant Health Inspection Service of the U.S. 
Department of Agriculture.
    State. Any of the States, the District of Columbia, the Commonwealth 
of Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, 
the Virgin Islands of the United States, or any territory or possession 
of the United States.
    State Inspector. Any person employed or authorized under Sec.
146.10(b) to perform functions under this part.
    United States. All of the States.

[71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14715, Apr. 1, 2009; 
75 FR 10658, Mar. 9, 2010; 76 FR 15796, Mar. 22, 2011; 79 FR 38765, July 
9, 2014; 81 FR 53250, Aug. 12, 2016; 83 FR 28355, June 19, 2018]



Sec.146.2  Administration.

    (a) The Department cooperates through a Memorandum of Understanding 
with the Official State Agency in the administration of the Plan. In the 
Memorandum of Understanding, the Official State Agency must designate a 
contact representative to serve as a liaison between the Service and the 
Official State Agency.
    (b) The administrative procedures and decisions of the Official 
State

[[Page 967]]

Agency are subject to review by the Service. The Official State Agency 
shall carry out the administration of the Plan within the State 
according to the applicable provisions of the Plan and the Memorandum of 
Understanding.
    (c)(1) An Official State Agency may accept for participation a 
commercial table-egg layer pullet flock, commercial table-egg layer 
flock, or a commercial meat-type flock (including an affiliated flock) 
located in another participating State under a mutual understanding and 
agreement, in writing, between the two Official State Agencies regarding 
conditions of participation and supervision.
    (2) An Official State Agency may accept for participation a 
commercial table-egg layer pullet flock, commercial table-egg layer 
flock, or a commercial meat-type flock (including an affiliated flock) 
located in a State that does not participate in the Plan under a mutual 
understanding and agreement, in writing, between the owner of the flock 
and the Official State Agency regarding conditions of participation and 
supervision.
    (d) The Official State Agency of any State may adopt regulations 
applicable to the administration of the Plan in such State further 
defining the provisions of the Plan or establishing higher standards, 
compatible with the Plan.
    (e) An authorized laboratory will conduct tests in accordance with 
part 147 of this subchapter when determining the status of a 
participating flock with respect to an official Plan classification.
    (f) Cooperating State Agencies will be responsible for making the 
determination to request Federal assistance under part 56 of this 
chapter in the event of an outbreak of H5/H7 LPAI.

[71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 
75 FR 10658, Mar. 9, 2010; 79 FR 38765, July 9, 2014; 81 FR 53250, Aug. 
12, 2016]



Sec.146.3  Participation.

    (a) Any commercial table-egg layer pullet flock, table-egg producer, 
raised-for-release upland game bird premises, and raised-for-release 
waterfowl premises and any commercial upland game bird, commercial 
waterfowl, meat-type chicken or meat-type turkey slaughter plant, 
including its affiliated flocks, may participate in the Plan when the 
producer or plant has demonstrated, to the satisfaction of the Official 
State Agency, that its facilities, personnel, and practices are adequate 
for carrying out the relevant special provisions of this part and has 
signed an agreement with the Official State Agency to comply with the 
relevant special provisions of this part.
    (b) Each participant shall comply with the Plan throughout the 
operating year, or until released by the Official State Agency.
    (c) A participating slaughter plant shall participate with all of 
the commercial upland game bird, commercial waterfowl, meat-type 
chicken, spent fowl, and/or meat-type turkey flocks that are processed 
at the facility, including affiliated flocks. Affiliated flocks must 
participate through a written agreement with a participating slaughter 
plant that is approved by the Official State Agency.
    (d) Participation in the Plan shall entitle the participant to use 
the Plan emblem reproduced as follows:
[GRAPHIC] [TIFF OMITTED] TR26SE06.000


[71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 
79 FR 38765, July 9, 2014; 81 FR 53250, Aug. 12, 2016]

[[Page 968]]



Sec.146.4  General provisions for all participating flocks and 
slaughter plants.

    (a) Records that establish the identity of products handled shall be 
maintained in a manner satisfactory to the Official State Agency.
    (b) Material that is used to advertise products shall be subject to 
inspection by the Official State Agency at any time.
    (c) Advertising must be in accordance with the Plan, and applicable 
rules and regulations of the Official State Agency and the Federal Trade 
Commission. A participant advertising products as being of any official 
classification may include in their advertising reference to associated 
or franchised slaughter or production facilities only when such 
facilities produce products of the same classification.
    (d) Each participant shall be assigned a permanent approval number 
by the Service. This number, prefaced by the numerical code of the 
State, will be the official approval number of the participant and may 
be used on each certificate, invoice, shipping label, or other document 
used by the participant in the sale of the participant's products. Each 
Official State Agency which requires an approval number for out-of-State 
participants to ship into its State shall honor this number.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[71 FR 56328, Sept. 26, 2006, as amended at 75 FR 10658, Mar. 9, 2010]



Sec.146.5  Specific provisions for all participating flocks.

    (a) Participating flocks, and all equipment used in connection with 
the flocks, shall be separated from non-participating flocks in a manner 
acceptable to the Official State Agency.
    (b) Poultry equipment, and poultry houses and the land in the 
immediate vicinity thereof, shall be kept in sanitary condition in 
accordance with part 147 of this subchapter.

[71 FR 56328, Sept. 26, 2006, as amended at 79 FR 38765, July 9, 2014]



Sec.146.6  Specific provisions for participating slaughter plants.

    (a) Only commercial upland game bird, commercial waterfowl, meat-
type chicken, and meat-type turkey slaughter plants that are under 
continuous inspection by the Food Safety and Inspection Service of the 
Department or under State inspection that the Food Safety and Inspection 
Service has recognized as equivalent to Federal inspection may 
participate in the Plan.
    (b) To participate in the Plan, meat-type chicken, meat-type turkey, 
and commercial upland game bird and commercial waterfowl slaughter 
plants must follow the relevant special provisions in Sec. Sec.
146.33(a), 146.43(a), and 146.53(a), respectively, for sample collection 
and flock monitoring, unless they are exempted from the special 
provisions under Sec. Sec.146.32(b), 146.42(b), or 146.52(b), 
respectively.

[74 FR 14716, Apr. 1, 2009]



Sec.146.7  Terminology and classification; general.

    The official classification terms defined in Sec. Sec.146.8 and 
146.9 and the various designs illustrative of the official 
classifications reproduced in Sec.146.9 may be used only by 
participants and to describe products that have met all of the specific 
requirements of such classifications.



Sec.146.8  Terminology and classification; slaughter plants.

    Participating slaughter plants shall be designated as ``U.S. H5/H7 
Avian Influenza Monitored.'' All Official State Agencies shall be 
notified by the Service of additions, withdrawals, and changes in 
classification.



Sec.146.9  Terminology and classification; flocks, products, and States.

    Participating flocks, products produced from them, and States that 
have met the requirements of a classification in this part may be 
designated by the corresponding illustrative design in this section.
    (a) U.S. H5/H7 Avian Influenza Monitored. (See Sec. Sec.146.23(a), 
146.33(a), 146.43(a), and 146.53(a) and (b).)

[[Page 969]]

[GRAPHIC] [TIFF OMITTED] TR26SE06.001

    (b) U.S. H5/H7 Avian Influenza Monitored State, Layers. (See Sec.
146.24.)
[GRAPHIC] [TIFF OMITTED] TR26SE06.002

    (c) U.S. H5/H7 Avian Influenza Monitored State, Turkeys. (See Sec.
146.44.)
[GRAPHIC] [TIFF OMITTED] TR26SE06.003


[71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 
76 FR 15796, Mar. 22, 2011]



Sec.146.10  Supervision.

    (a) The Official State Agency may designate qualified persons as 
Authorized Agents to do the sample collecting provided for in Sec.
146.13 of this part.
    (b) The Official State Agency shall employ or authorize qualified 
persons as State Inspectors to perform the selecting and testing of 
participating flocks and to perform the official inspections necessary 
to verify compliance with the requirements of the Plan.
    (c) Authorities issued to Authorized Agents or State Inspectors 
under the provisions of this section shall be subject to cancellation by 
the Official State Agency on the grounds of incompetence or failure to 
comply with the provisions of the Plan or regulations of the Official 
State Agency. Such actions shall not be taken until thorough 
investigation has been made by the Official State Agency and the 
authorized person has been given notice of the proposed action and the 
basis thereof and an opportunity to present his or her views.



Sec.146.11  Inspections.

    (a) Each participating slaughter plant shall be audited at least 
once annually or a sufficient number of times each year to satisfy the 
Official State

[[Page 970]]

Agency that the participating slaughter plant is in compliance with the 
provisions of this part. The yearly audit will consist of an evaluation 
of 2 weeks' worth of records, selected at random, of the following data:
    (1) The actual flock slaughter date for each flock. This information 
must come from a verifiable source. Verifiable sources include 
electronic record systems that have oversight from the Department's 
Grain Inspectors, Packers and Stockyards Administration or Food Safety 
and Inspection Service (FSIS) documents such as FSIS Form 9061-2.
    (2) Laboratory test results for each flock slaughtered with the 
sample collection date and test result. The test must be NPIP-approved 
and performed in an authorized laboratory of the NPIP.
    (b) A flock will be considered to be conforming to protocol if it 
meets the requirements as described in Sec.146.33(a), Sec.146.43(a), 
or Sec.146.53(a).
    (c) Two or more flocks that are found to be not conforming to 
protocol in the yearly audit for a slaughter plant shall be cause for a 
deficiency rating for that plant. However, if the root cause for the 
deficiency was identified, corrected, and documented, the plant will be 
eligible for an immediate reevaluation of 2 additional weeks' worth of 
records, again selected at random. If no more than one missed flock is 
identified in this reevaluation, the plant will be considered in 
compliance and no further action will be required. Plants found to be 
deficient must provide a written corrective action plan to the auditor 
within 2 weeks of receipt of the deficiency rating. A followup audit on 
the information in paragraphs (a)(1) and (a)(2) of this section will 
occur within 90 days from the receipt of the corrective action plan. 
Slaughter plants will retain their classification and may continue to 
use the Plan emblem in Sec.146.9(a) during this process. A failure on 
the followup audit may result in disbarment from participation according 
to the procedures in Sec.146.12.
    (d) On-site inspections of any participating flocks and premises 
will be conducted if a State Inspector determines that a breach of 
testing has occurred for the Plan programs for which the flocks are 
certified.
    (e) The official H5/H7 LPAI testing records of all participating 
flocks and slaughter plants shall be examined annually by a State 
Inspector. Official H5/H7 LPAI testing records shall be maintained for 3 
years.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 
75 FR 10658, Mar. 9, 2010; 81 FR 53250, Aug. 12, 2016]



Sec.146.12  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 Official State Agency may deem appropriate. The debarred participant 
shall be afforded notice of the bases for the debarment and opportunity 
to present his or her views with respect to the debarment in accordance 
with procedures adopted by the Official State Agency. The Official State 
Agency shall thereupon decide whether the debarment order shall continue 
in effect. Such decision shall be final unless the debarred participant, 
within 30 days after the issuance of the debarment order, requests the 
Administrator to determine the eligibility of the debarred participant 
for participation in the Plan. In such an event, the Administrator shall 
determine the matter de novo in accordance with the rules of practice in 
7 CFR part 50, which are hereby made applicable to proceedings before 
the Administrator under this section. The definitions in 7 CFR 50.10 and 
the following definitions shall apply with respect to terms used in such 
rules of practice:

[[Page 971]]

    (a) Administrator means the Administrator, Animal and Plant Health 
Inspection Service of the U.S. Department of Agriculture, or any officer 
or employee to whom authority has heretofore been delegated or to who 
authority may hereafter be delegated to act in his or her stead.
    (b) [Reserved]



Sec.146.13  Testing.

    (a) Samples. Either egg or blood samples may be used for testing. 
Samples must be collected in accordance with the following requirements:
    (1) Egg samples. Egg samples must be collected and prepared in 
accordance with part 147 of this subchapter.
    (2) Blood samples. Blood samples obtained in the slaughter plant 
should be collected after the kill cut with birds remaining on the kill 
line. Hold an open 1.5 mL snap cap micro-centrifuge tube under the neck 
of the bird directly after the kill cut and collect drips of blood until 
the tube is half full. Keep the blood tubes at room temperature for the 
clot to form, which should require a minimum of 4 hours and a maximum of 
12 hours. Refrigerate the tube after the clot has formed. Put tubes in a 
container and label it with plant name, date, shift (A.M. or Day, P.M. 
or Night), and flock number. After the clot is formed, the clot should 
be removed by the Authorized Agent in order to ensure good-quality sera. 
Prepare a laboratory submission form and ship samples with submission 
forms to the laboratory in a polystyrene foam cooler with frozen ice 
packs. Submission forms and the manner of submission must be approved by 
the Official State Agency and the authorized laboratory to ensure that 
there is sufficient information to identify the samples and that the 
samples are received in an acceptable condition for further tests to be 
reliably performed. Blood samples should be shipped routinely to the 
laboratory. Special arrangements should be developed for samples held 
over the weekend to ensure that the samples can be reliably tested. 
Blood samples for official tests shall be drawn by an Authorized Agent 
or State Inspector.
    (b) Avian influenza. The official tests for avian influenza are 
described in paragraphs (b)(1) and (b)(2) of this section:
    (1) Antibody detection tests--(i) Enzyme-linked immunosorbent assay 
(ELISA) test. (A) The ELISA test must be conducted using test kits 
approved by the Department and the Official State Agency and must be 
conducted in accordance with the recommendations of the producer or 
manufacturer.
    (B) When positive ELISA samples are identified, an AGID test must be 
conducted within 48 hours.
    (ii) Agar gel immunodiffusion (AGID) test. (A) The AGID test must be 
conducted using reagents approved by the Department and the Official 
State Agency.
    (B) The AGID test for avian influenza must be conducted in 
accordance with this section (within the NPIP Program Standards, Program 
Standard A applies to blood and yolk testing procedures; alternatives to 
the program standards may also be approved by the Administrator under 
Sec.147.53 of this subchapter) for the avian influenza AGID test. The 
test can be conducted on egg yolk or blood samples. The AGID test is not 
recommended for use in waterfowl.
    (C) Positive tests for the AGID must be further tested by Federal 
Reference Laboratories using appropriate tests for confirmation. Final 
judgment may be based upon further sampling and appropriate tests for 
confirmation.
    (2) Agent detection tests. Agent detection tests may be used to 
detect influenza A virus but not to determine hemagglutinin or 
neuraminidase subtypes. Samples for this testing should be collected 
from naturally occurring flock mortality or clinically ill birds.
    (i) The real time reverse transcriptase/polymerase chain reaction 
(RRT-PCR) assay. (A) The RRT-PCR tests must be conducted using reagents 
approved by the Department and the Official State Agency. The RRT-PCR 
must be conducted using the National Veterinary Services Laboratories 
(NVSL) official protocol for RRT-PCR and must be conducted by personnel 
who have passed an NVSL proficiency test.
    (B) Positive results from the RRT-PCR must be further tested by 
Federal

[[Page 972]]

Reference Laboratories using appropriate tests for confirmation. Final 
judgment may be based upon further sampling and appropriate tests for 
confirmation.
    (ii) USDA-licensed type A influenza antigen capture immunoassay 
(ACIA). (A) The USDA-licensed type A influenza ACIA must be conducted 
using test kits approved by the Department and the Official State Agency 
and must be conducted in accordance with the recommendations of the 
producer or manufacturer.
    (B) Chicken and turkey flocks that test positive on the ACIA must be 
retested using the RRT-PCR or virus isolation. Positive results from the 
RRT-PCR or virus isolation must be further tested by Federal Reference 
Laboratories using appropriate tests for confirmation. Final judgment 
may be based upon further sampling and appropriate tests for 
confirmation.
    (3) The official determination of a flock as positive for the H5 or 
H7 subtypes avian influenza may be made only by NVSL.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 
75 FR 10658, Mar. 9, 2010; 79 FR 38765, July 9, 2014; 85 FR 62571, Oct. 
5, 2020]



Sec.146.14  Diagnostic surveillance program for H5/H7 low pathogenic
avian influenza.

    (a) The Official State Agency must develop a diagnostic surveillance 
program for H5/H7 low pathogenic avian influenza for all poultry in the 
State. The exact provisions of the program are at the discretion of the 
States. The Service will use the standards in paragraph (b) of this 
section in assessing individual State plans for adequacy, including the 
specific provisions that the State developed. The standards should be 
used by States in developing those plans.
    (b) Avian influenza must be a disease reportable to the responsible 
State authority (State veterinarian, etc.) by all licensed 
veterinarians. To accomplish this, all laboratories (private, State, and 
university laboratories) that perform diagnostic procedures on poultry 
must examine all submitted cases of unexplained respiratory disease, egg 
production drops, and mortality for avian influenza by both an approved 
serological test and an approved antigen detection test. Memoranda of 
understanding or other means must be used to establish testing and 
reporting criteria (including criteria that provide for reporting H5 and 
H7 low pathogenic avian influenza directly to the Service) and approved 
testing methods. In addition, States should conduct outreach to poultry 
producers, especially owners of smaller flocks, regarding the importance 
of prompt reporting of clinical symptoms consistent with avian 
influenza.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[71 FR 56328, Sept. 26, 2006, as amended at 75 FR 10658, Mar. 9, 2010]



   Subpart B_Special Provisions for Commercial Table-Egg Layer Flocks



Sec.146.21  Definitions.

    Table-egg layer. A domesticated chicken grown for the primary 
purpose of producing eggs for human consumption.
    Table-egg layer pullet. A sexually immature domesticated chicken 
grown for the primary purpose of producing eggs for human consumption.

[71 FR 56328, Sept. 26, 2006, as amended at 76 FR 15796, Mar. 22, 2011]



Sec.146.22  Participation.

    (a) Participating commercial table-egg layer flocks shall comply 
with the applicable general provisions of subpart A of this part and the 
special provisions of subpart B of this part.
    (b) Commercial table-egg laying premises with fewer than 75,000 
birds are exempt from the special provisions of subpart B of this part.



Sec.146.23  Terminology and classification; flocks and products.

    Participating flocks which have met the respective requirements 
specified in this section may be designated by the following terms and 
the corresponding designs illustrated in Sec.146.9 of this part:

[[Page 973]]

    (a) U.S. H5/H7 Avian Influenza Monitored--(1) Table-egg layer pullet 
flocks. This program is intended to be the basis from which the table-
egg layer industry may conduct a program to monitor for the H5/H7 
subtypes of avian influenza. It is intended to determine the presence of 
the H5/H7 subtypes of avian influenza in table-egg layer pullets through 
routine surveillance of each participating commercial table-egg layer 
pullet flock. A flock will qualify for this classification when the 
Official State Agency determines that it has met one of the following 
requirements:
    (i) It is a commercial table-egg layer pullet flock in which a 
minimum of 11 birds have been tested negative to the H5/H7 subtypes of 
avian influenza as provided in Sec.146.13(b) within 21 days prior to 
movement; or
    (ii) It is a commercial table-egg layer pullet flock that has an 
ongoing active and diagnostic surveillance program for the H5/H7 
subtypes of avian influenza in which the number of birds tested is 
equivalent to the number required in paragraph (a)(1)(i) of this section 
and that is approved by the Official State Agency and the Service.
    (2) Table-egg layer flocks. This program is intended to be the basis 
from which the table-egg layer industry may conduct a program to monitor 
for the H5/H7 subtypes of avian influenza. It is intended to determine 
the presence of the H5/H7 subtypes of avian influenza in table-egg layer 
through routine surveillance of each participating commercial table-egg 
layer flock. A flock will qualify for this classification when the 
Official State Agency determines that it has met the following 
requirements:
    (i) It is a commercial table-egg layer flock in which a minimum of 
11 birds have been tested negative to the H5/H7 subtypes of avian 
influenza as provided in Sec.146.13(b) within 21 days prior to 
disposal; and either
    (ii) It is a commercial table-egg layer flock in which a minimum of 
11 birds have been tested negative for the H5/H7 subtypes of avian 
influenza as provided in Sec.146.13(b) within a 12-month period; or
    (iii) It is a commercial table-egg layer flock that has an ongoing 
active and diagnostic surveillance program for the H5/H7 subtypes of 
avian influenza in which the number of birds tested is equivalent to the 
number required in paragraph (a)(2)(i) or paragraph (a)(2)(ii) of this 
section and that is approved by the Official State Agency and the 
Service.
    (b) [Reserved]

[71 FR 56328, Sept. 26, 2006, as amended at 76 FR 15796, Mar. 22, 2011; 
79 FR 38765, July 9, 2014; 79 FR 71624, Dec. 3, 2014; 83 FR 28355, June 
19, 2018]



Sec.146.24  Terminology and classification; States.

    (a) U.S. H5/H7 Avian Influenza Monitored State, Layers. (1) A State 
will be declared a U.S. H5/H7 Avian Influenza Monitored State, Layers 
when it has been determined by the Service that:
    (i) All commercial table-egg layer flocks and all commercial table-
egg layer pullet flocks that supply those flocks in production within 
the State that are not exempt from the special provisions of this 
subpart B under Sec.146.22 are classified as U.S. H5/H7 Avian 
Influenza Monitored under Sec.146.23(a) of this part;
    (ii) All egg-type chicken breeding flocks in production within the 
State are classified as U.S. Avian Influenza Clean under Sec.145.23(h) 
of this subchapter;
    (iii) All persons performing poultry disease diagnostic services 
within the State are required to report to the Official State Agency, 
within 24 hours, the source of all table-egg layer and table-egg layer 
pullet specimens that were deemed positive on an official test for avian 
influenza, as designated in Sec.146.13(a) of this chapter;
    (iv) All table-egg layer and table-egg layer pullet specimens that 
were deemed positive on an official test for avian influenza, as 
designated in Sec.146.13(a) of this chapter, are sent to an authorized 
laboratory for subtyping; and
    (v) All table-egg layer and table-egg layer pullet flocks within the 
State that are found to be infected with the H5/H7 subtypes of avian 
influenza are quarantined, in accordance with an initial State response 
and containment plan as described in part 56 of this

[[Page 974]]

chapter and under the supervision of the Official State Agency.
    (2) If there is a discontinuation of any of the conditions described 
in paragraph (a)(1) of this section, or if repeated outbreaks of the H5/
H7 subtypes of avian influenza occur in commercial table-egg layer 
flocks as described in paragraph (a)(1)(i) of this section, or if an 
infection spreads from the originating premises, the Service shall have 
grounds to revoke its determination that the State is entitled to this 
classification. Such action shall not be taken until a thorough 
investigation has been made by the Service and the Official State Agency 
has been given an opportunity for a hearing in accordance with rules of 
practice adopted by the Administrator.
    (b) [Reserved]

(Approved by the Office of Management and Budget under control number 
0579-0007)

[71 FR 56328, Sept. 26, 2006, as amended at 75 FR 10658, Mar. 9, 2010; 
76 FR 15797, Mar. 22, 2011]



   Subpart C_Special Provisions for Meat-Type Chicken Slaughter Plants



Sec.146.31  Definitions.

    Meat-type chicken. A domesticated chicken grown for the primary 
purpose of producing meat, including but not limited to broilers, 
roasters, fryers, and cornish.
    Meat-type chicken slaughter plant. A meat-type chicken slaughter 
plant that is federally inspected or under State inspection that the 
Food Safety Inspection Service has recognized as equivalent to federal 
inspection.
    Shift. The working period of a group of employees who are on duty at 
the same time.
    Spent fowl. Domesticated poultry that were in production of hatching 
eggs or commercial table eggs and have been removed from such 
production.

[71 FR 56328, Sept. 26, 2006, as amended at 79 FR 38766, July 9, 2014]



Sec.146.32  Participation.

    (a) Participating meat-type chicken slaughter plants shall comply 
with applicable general provisions of subpart A of this part and the 
special provisions of this subpart C.
    (b) Meat-type chicken slaughter plants that slaughter fewer than 
200,000 meat-type chickens in an operating week are exempt from the 
special provisions of this subpart C.
    (c) If spent fowl are slaughtered at meat-type chicken slaughter 
plants that participate in the Plan, they may participate in the Plan 
through the provisions of this subpart C.

[71 FR 56328, Sept. 26, 2006, as amended at 79 FR 38766, July 9, 2014]



Sec.146.33  Terminology and classification; meat-type chicken 
slaughter plants.

    Participating meat-type chicken slaughter plants that have met the 
respective requirements specified in this section may be designated by 
the following terms and the corresponding designs illustrated in Sec.
146.9 of this part:
    (a) U.S. H5/H7 Avian Influenza Monitored. This program is intended 
to be the basis from which the meat-type chicken industry may conduct a 
program to monitor for the H5/H7 subtypes of avian influenza. It is 
intended to determine the presence of the H5/H7 subtypes of avian 
influenza in meat-type chickens through routine surveillance of each 
participating meat-type chicken slaughter plant. A meat-type chicken 
slaughter plant will qualify for this classification when the Official 
State Agency determines that it has met one of the following 
requirements:
    (1) It is a meat-type chicken slaughter plant where a minimum of 11 
birds per shift are tested negative for the H5/H7 subtypes of avian 
influenza, as provided in Sec.146.13(b), at slaughter; Provided, that 
with the approval of the Official State Agency, fewer than 11 birds per 
shift may be tested on any given shift if the total number of birds 
tested during the operating month is equivalent to testing 11 birds per 
shift; or
    (2) It is a meat-type chicken slaughter plant which accepts only 
meat-type chickens from flocks where a minimum of 11 birds have been 
tested negative for antibodies to the H5/H7 subtypes of avian influenza, 
as provided in Sec.146.13(b), no more than 21 days prior to slaughter; 
or

[[Page 975]]

    (3) It is a meat-type chicken slaughter plant that has an ongoing 
active and diagnostic surveillance program for the H5/H7 subtypes of 
avian influenza in which the number of birds tested is equivalent to the 
number required in paragraph (a)(1) or (a)(2) and that is approved by 
the Official State Agency and the Service.
    (b) [Reserved]

[71 FR 56328, Sept. 26, 2006, as amended at 76 FR 15797, Mar. 22, 2011; 
79 FR 38766, July 9, 2014]



   Subpart D_Special Provisions for Meat-Type Turkey Slaughter Plants



Sec.146.41  Definitions.

    Meat-type turkey. A domesticated turkey grown for the primary 
purpose of producing meat.
    Meat-type turkey slaughter plant. A meat-type turkey slaughter plant 
that is federally inspected or under State inspection that the Food 
Safety Inspection Service has recognized as equivalent to federal 
inspection.



Sec.146.42  Participation.

    (a) Participating meat-type turkey slaughter plants shall comply 
with applicable general provisions of subpart A of this part and the 
special provisions of this subpart D.
    (b) Meat-type turkey slaughter plants that slaughter fewer than 2 
million meat-type turkeys in a 12-month period are exempt from the 
special provisions of this subpart D.



Sec.146.43  Terminology and classification; meat-type turkey slaughter plants.

    Participating meat-type turkey slaughter plants which have met the 
respective requirements specified in this section may be designated by 
the following terms and the corresponding designs illustrated in Sec.
146.9 of this part:
    (a) U.S. H5/H7 Avian Influenza Monitored. This program is intended 
to be the basis from which the meat-type turkey industry may conduct a 
program to monitor for the H5/H7 subtypes of avian influenza. It is 
intended to determine the presence of avian influenza in meat-type 
turkeys through routine surveillance of each participating meat-type 
turkey slaughter plant. A participating meat-type turkey slaughter plant 
will qualify for this classification when the Official State Agency 
determines that it has met one of the following requirements:
    (1) It is a meat-type turkey slaughter plant that accepts only meat-
type turkeys from flocks where a minimum of 6 samples per flock have 
been collected no more than 21 days prior to movement to slaughter and 
tested negative with an approved test for type A avian influenza, as 
provided in Sec.146.13(b). It is recommended that samples be collected 
from flocks over 10 weeks of age with respiratory signs such as 
coughing, sneezing, snicking, sinusitis, or rales; depression; or 
decreases in food or water intake.
    (2) It is a meat-type turkey slaughter plant that has an ongoing 
active and diagnostic surveillance program for the H5/H7 subtypes of 
avian influenza in which the number of birds tested is equivalent to the 
number required in paragraph (a)(1) and that is approved by the Official 
State Agency and the Service.
    (b) [Reserved]

[71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14717, Apr. 1, 2009; 
76 FR 15797, Mar. 22, 2011; 79 FR 38766, July 9, 2014]



Sec.146.44  Terminology and classification; States.

    (a) U.S. H5/H7 Avian Influenza Monitored State, Turkeys. (1) A State 
will be declared a U.S. H5/H7 Avian Influenza Monitored State, Turkeys 
when it has been determined by the Service that:
    (i) All meat-type turkey slaughter plants within the State that are 
not exempt from the special provisions of this subpart D under Sec.
146.42 are classified as U.S. H5/H7 Avian Influenza Monitored under 
Sec.146.43(a) of this part;
    (ii) All turkey breeding flocks in production within the State are 
classified as U.S. H5/H7 Avian Influenza Clean under Sec.145.43(g) of 
this subchapter;
    (iii) All persons performing poultry disease diagnostic services 
within the State are required to report to the Official State Agency, 
within 24 hours, the source of all meat-type turkey specimens that were 
deemed positive on an official test for avian influenza, as designated 
in Sec.146.13(a) of this chapter;

[[Page 976]]

    (iv) All meat-type turkey specimens that were deemed positive on an 
official test for avian influenza, as designated in Sec.146.13(a) of 
this chapter, are sent to an authorized laboratory for subtyping; and
    (v) All meat-type turkey flocks within the State that are found to 
be infected with the H5/H7 subtypes of avian influenza are quarantined, 
in accordance with an initial State response and containment plan as 
described in part 56 of this chapter, and under the supervision of the 
Official State Agency.
    (2) If there is a discontinuation of any of the conditions described 
in paragraph (a)(1) of this section, or if repeated outbreaks of the H5/
H7 subtypes of avian influenza occur in meat-type turkey flocks as 
described in paragraph (a)(1)(i) of this section, or if an infection 
spreads from the originating premises, the Service shall have grounds to 
revoke its determination that the State is entitled to this 
classification. Such action shall not be taken until a thorough 
investigation has been made by the Service and the Official State Agency 
has been given an opportunity for a hearing in accordance with rules of 
practice adopted by the Administrator.

(Approved by the Office of Management and Budget under control number 
0579-0007)

[71 FR 56328, Sept. 26, 2006, as amended at 75 FR 10658, Mar. 9, 2010]



     Subpart E_Special Provisions for Commercial Upland Game Birds, 
 Commercial Waterfowl, Raised-for-Release Upland Game Birds, and Raised-
                          for-Release Waterfowl

    Source: 74 FR 14717, Apr. 1, 2009, unless otherwise noted.



Sec.146.51  Definitions.

    Except where the context otherwise requires, for the purposes of 
this subpart the following terms shall be construed, respectively, to 
mean:
    Egg/meat-type game birds. Domesticated fowl such as pheasants, 
partridge, quail, grouse, and guineas, but not doves and pigeons grown 
under confinement for the primary purposes of producing eggs and/or meat 
for human consumption.
    Egg/meat-type waterfowl. Domesticated ducks or geese grown under 
confinement for the primary purposes of producing eggs and/or meat for 
human consumption.
    Meat-type game bird slaughter plant. A meat-type game bird slaughter 
plant that is federally inspected or under State inspection that the 
U.S. Department of Agriculture's Food Safety and Inspection Service has 
recognized as equivalent to Federal inspection.
    Meat-type waterfowl slaughter plant. A meat-type waterfowl slaughter 
plant that is federally inspected or under State inspection that the 
U.S. Department of Agriculture's Food Safety and Inspection Service has 
recognized as equivalent to Federal inspection.
    Shift. The working period of a group of employees who are on duty at 
the same time.

[85 FR 62571, Oct. 5, 2020]



Sec.146.52  Participation.

    (a) Participating meat-type game bird slaughter plants, meat-type 
waterfowl slaughter plants, and egg-type game bird and egg-type 
waterfowl premises producing eggs for human consumption shall comply 
with the applicable general provisions of subpart A of this part and the 
special provisions of this subpart.
    (b) Meat-type game bird slaughter plants and meat-type waterfowl 
slaughter plants that slaughter fewer than 50,000 birds annually are 
exempt from the special provisions of this subpart.
    (c) Egg-type game bird and egg-type waterfowl premises with fewer 
than 25,000 birds are exempt from the special provisions of this 
subpart.

[85 FR 62571, Oct. 5, 2020]



Sec.146.53  Terminology and classification; slaughter plants
and premises.

    Participating slaughter plants and flocks which have met the 
respective requirements specified in this section may be designated by 
the following terms and the corresponding designs illustrated in Sec.
146.9:
    (a) U.S. H5/H7 Avian Influenza Monitored. The program in this 
paragraph

[[Page 977]]

(a) is intended to be the basis from which the egg/meat-type game bird 
and egg/meat-type waterfowl industry may conduct a program to monitor 
for the H5/H7 subtypes of avian influenza. It is intended to determine 
the presence of the H5/H7 subtypes of avian influenza in egg/meat-type 
game birds and egg/meat-type waterfowl through routine surveillance of 
each participating slaughter plant or, in the case of egg-producing 
flocks, the regular surveillance of these flocks. A slaughter plant or 
flock will qualify for the classification in this paragraph (a) when the 
Official State Agency determines that it has met one of the following 
requirements:
    (1) It is a meat-type game bird slaughter plant or meat-type 
waterfowl slaughter plant where a minimum of 11 birds per shift are 
tested negative for the H5/H7 subtypes of avian influenza, as provided 
in Sec.146.13(b), at slaughter;
    (2) It is a meat-type game bird slaughter plant or meat-type 
waterfowl slaughter plant that only accepts egg/meat-type game birds or 
egg/meat-type waterfowl from flocks where a minimum of 11 birds per 
flock have been tested negative for the H5/H7 subtypes of avian 
influenza, as provided in Sec.146.13(b), no more than 21 days prior to 
slaughter;
    (3) It is a meat-type game bird slaughter plant or meat-type 
waterfowl slaughter plant that has an ongoing active and passive 
surveillance program for H5/H7 subtypes of avian influenza that is 
approved by the Official State Agency and the Service.
    (4) It is an egg-type game bird or egg-type waterfowl flock that 
produces eggs for human consumption where a minimum of 11 birds per 
flock have been tested negative to the H5/H7 subtypes of avian influenza 
as provided in Sec.146.13(b) within 30 days of disposal or within a 12 
month period.
    (5) It is an egg-type game bird or egg-type waterfowl flock that has 
an on-going active and passive surveillance program for H5/H7 subtypes 
of avian influenza that is approved by the Official State Agency and the 
Service.
    (b) [Reserved]

[74 FR 14717, Apr. 1, 2009, as amended at 76 FR 15797, Mar. 22, 2011; 81 
FR 53250, Aug. 12, 2016; 85 FR 62571, Oct. 5, 2020]



PART 147_AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN--
Table of Contents



                   Subpart A_Blood Testing Procedures

Sec.
147.1 Blood testing procedures.
147.2-147.9 [Reserved]

             Subpart B_Bacteriological Examination Procedure

147.10 Bacteriological examination procedures.
147.11-147.17 [Reserved]

                     Subpart C_Sanitation Procedures

147.21 Sanitation procedures.
147.22-147.27 [Reserved]

               Subpart D_Molecular Examination Procedures

147.30 Molecular examination procedures.
147.31 [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.

  Subpart F_Authorized Laboratories and Approved Tests and Sanitation 
                               Procedures

147.51 Definitions.
147.52 Authorized laboratories.
147.53 Approved tests and sanitation procedures.
147.54 Approval of diagnostic test kits not licensed by the Service.

    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.

[[Page 978]]



                   Subpart A_Blood Testing Procedures



Sec.147.1  Blood testing procedures.

    Blood testing must be conducted in a manner approved by the 
Administrator. Approved blood testing procedures are listed in the NPIP 
Program Standards, as defined in Sec.147.51. Blood testing procedures 
may also be approved by the Administrator in accordance with Sec.
147.53(d)(1).

(Approved by the Office of Management and Budget under control number 
0579-0007)

[79 FR 38766, July 9, 2014]



Sec. Sec.147.2-147.9  [Reserved]



             Subpart B_Bacteriological Examination Procedure



Sec.147.10  Bacteriological examination procedures.

    Bacteriological examination must be conducted in a manner approved 
by the Administrator. Approved bacteriological examination procedures 
are listed in the NPIP Program Standards, as defined in Sec.147.51. 
Bacteriological examination procedures may also be approved by the 
Administrator in accordance with Sec.147.53(d)(1).

[79 FR 38766, July 9, 2014]



Sec. Sec.147.11-147.17  [Reserved]



                     Subpart C_Sanitation Procedures



Sec.147.21  Sanitation procedures.

    Sanitation must be maintained in a manner approved by the 
Administrator. Approved procedures for maintaining sanitation are listed 
in the NPIP Program Standards, as defined in Sec.147.51. Sanitation 
procedures may also be approved by the Administrator in accordance with 
Sec.147.53(d)(2).

(Approved by the Office of Management and Budget under control number 
0579-0007)

[79 FR 38766, July 9, 2014; 79 FR 44263, July 31, 2014]



Sec. Sec.147.22-147.27  [Reserved]



               Subpart D_Molecular Examination Procedures

    Source: 72 FR 1425, Jan. 12, 2007, unless otherwise noted.



Sec.147.30  Molecular examination procedures.

    Molecular examination must be conducted in a manner approved by the 
Administrator. Approved molecular examination procedures are listed in 
the NPIP Program Standards, as defined in Sec.147.51. Molecular 
examination procedures may also be approved by the Administrator in 
accordance with Sec.147.53(d)(1).

[79 FR 38766, July 9, 2014]



Sec.147.31  [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.
    Egg type chickens. Chickens bred for the primary purpose of 
producing eggs for human consumption.
    Exhibition Poultry. Domesticated fowl which are bred for the 
combined purposes of meat or egg production and competitive showing.
    Game birds. Domesticated fowl, such as pheasants, partridge, quail, 
grouse, and guineas, but not doves and pigeons.
    Meat type chickens. Chickens bred for the primary purpose of 
producing meat.
    NPIP Technical Committee. A committee made up of technical experts 
on poultry health, biosecurity, surveillance, and diagnostics. The 
committee consists of representatives from the poultry and egg 
industries, universities, and State and Federal governments and is 
appointed by the Senior Coordinator and approved by the General 
Conference Committee. The NPIP Technical Committee is divided into

[[Page 979]]

three subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP 
Technical Committee Members may serve on one, two, or all three 
subcommittees. The committee will evaluate proposed changes to the 
Provisions and Program Standards of the Plan which include, but are not 
limited to, tests and sanitation procedures, and provide recommendations 
to the Delegates of the National Plan Conference as to whether they are 
scientifically or technically sound.
    Plan Conference. A meeting convened for the purpose of recommending 
changes in the provisions of the Plan.
    Plan or NPIP. The National Poultry Improvement Plan.
    Service. The Animal and Plant Health Inspection Service, Veterinary 
Services, of the Department.
    State. Any State, the District of Columbia, or Puerto Rico.
    Waterfowl. Domesticated fowl that normally swim, such as ducks and 
geese.

[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, 
as amended at 79 FR 38766, July 9, 2014; 83 FR 28355, June 19, 2018]



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. The ballots for electing 
regional committee members and their alternates will be printed in such 
a way as to allow the specific selection of one nominee for member, and 
one nominee for alternate from the remaining nominees. At least one 
nominee from each region must be from an underrepresented group 
(minorities, women, or persons with disabilities). The process for 
soliciting nominations for regional committee members will include, but 
not be limited to: Advertisements in at least two industry journals, 
such as the newsletters of the American Association of Avian 
Pathologists, the National Chicken Council, the United Egg Producers, 
and the National Turkey Federation; a 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

[[Page 980]]

the Committee by the Secretary of Agriculture, and may not succeed 
themselves: Provided, That an alternate member who assumed a Committee 
member vacancy following mid-term would be eligible for re-election to a 
full term. When there is a vacancy for the member-at-large position, the 
General Conference Committee shall make an interim appointment and the 
appointee shall serve until the next Plan Conference at which time an 
election will be held. If a vacancy occurs due to both a regional member 
and alternate being unable to serve, the vacant position will be filled 
by an election at the earliest regularly scheduled national or regional 
Plan Conference, where members of the affected region have assembled.
    (d) The duties and functions of the General Conference Committee 
shall be as follows:
    (1) Advise and make recommendations to the Department on the 
relative importance of maintaining, at all times, adequate departmental 
funding for the NPIP to enable the Senior Coordinator and staff to fully 
administer the provisions of the Plan.
    (2) Advise and make yearly recommendations to the Department with 
respect to the NPIP budget well in advance of the start of the budgetary 
process.
    (3) Assist the Department in planning, organizing, and conducting 
the biennial National Poultry Improvement Plan Conference.
    (4) Consider each proposal submitted as provided in Sec.147.44 and 
make recommendations to subpart Committees and the Conference. Meet 
jointly with the NPIP Technical Committee and consider the technical 
aspects and accuracy of each proposal. Recommend whether new proposals 
(i.e., proposals that have not been submitted as provided in 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 an official advisory committee for the study of 
problems relating to poultry health and as the need arises, to make 
specific recommendations to the Secretary of Agriculture concerning ways 
in which the Department may assist the industry in solving these 
problems.
    (7) Serve as a direct liaison between the NPIP and the United States 
Animal Health Association.
    (8) Advise and make recommendations to the Department regarding NPIP 
involvement or representation at poultry industry functions and 
activities as deemed necessary or advisable for the purposes of the 
NPIP.

[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; 74 FR 14718, Apr. 1, 2009; 83 FR 
28355, June 19, 2018]



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)(4), proposed changes shall 
be submitted in writing so as to reach the Service not later than 150 
days prior to the opening date of the Plan Conference, and participants 
in the Plan shall submit their proposed changes through their Official 
State Agency.
    (c) The name of the proponent shall be indicated on each proposed 
change when submitted. Each proposal should

[[Page 981]]

be accompanied by a brief supporting statement.
    (d) The Service will notify all persons on the NPIP mailing lists 
concerning the dates and general procedure of the conference. Hatchery 
and dealer participants will be reminded of their privilege to submit 
proposed changes and to request copies of all the published proposed 
changes.
    (e) The proposed changes, together with the names of the proponents 
and supporting statements, will be compiled by the Service and issued in 
processed form. When two or more similar changes are submitted, the 
Service will endeavor to unify them into one proposal acceptable to each 
proponent. Copies will be distributed to officials of the Official State 
Agencies cooperating in the NPIP. Additional copies will be made 
available for meeting individual requests.

[36 FR 23121, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, 
and amended at 49 FR 19807, May 10, 1984; 79 FR 38766, July 9, 2014]



Sec.147.45  Official delegates.

    Each cooperating State shall be entitled to one official delegate 
for each of the programs prescribed in parts 145 and 146 of this 
subchapter in which it has one or more participants at the time of the 
Conference. The official delegates shall be elected by a representative 
group of participating industry members and be certified by the Official 
State Agency. It is recommended but not required that the official 
delegates be Plan participants. Individuals may be allowed to be an 
official delegate or alternate delegate for up to three States in which 
that delegate has flocks or is a plan participant with acknowledgement 
and approval of the Official State Agencies. Each official delegate 
shall endeavor to obtain, prior to the Conference, the recommendations 
of industry members of their State with respect to each proposed change.

[85 FR 62572, Oct. 5, 2020]



Sec.147.46  Committee consideration of proposed changes.

    (a) The following committees shall be established to give 
preliminary consideration to the proposed changes falling in their 
respective fields:
    (1) Egg-type breeding chickens.
    (2) Meat-type breeding chickens.
    (3) Breeding turkeys.
    (4) Breeding waterfowl, exhibition poultry, and game birds.
    (5) Breeding ostriches, emus, rheas, and cassowaries.
    (6) Egg-type commercial chickens.
    (7) Meat-type commercial chickens.
    (8) Meat-type commercial turkeys.
    (9) Commercial upland game birds and waterfowl and raised-for-
release upland game birds and waterfowl.
    (b) Each official delegate shall be appointed a voting member in one 
of the committees specified in paragraph (a) of this section.
    (c) Since several of the proposals may be interrelated, the 
committees shall consider them as they may relate to others, and feel 
free to discuss related proposals with other committees.
    (d) The committees shall make recommendations to the conference as a 
whole concerning each proposal. The committee report shall show any 
proposed change in wording and the record of the vote on each proposal, 
and suggest an effective date for each proposal recommended for 
adoption. The individual committee reports shall be submitted to the 
chairman of the conference, who will combine them into one report 
showing, in numerical sequence, the committee recommendations on each 
proposal. Once completed, the combined committee report will be 
distributed electronically to the Official State Agencies prior to the 
delegates voting on the final day of the biennial conference.
    (e) The committee meetings shall be open to any interested person. 
Advocates for or against any proposal should feel free to appear before 
the appropriate committee and present their views.

[36 FR 23121, Dec. 3, 1971, as amended at 41 FR 48727, Nov. 5, 1976. 
Redesignated at 44 FR 61586, Oct. 26, 1979, as amended at 65 FR 8023, 
Feb. 17, 2000; 71 FR 56333, Sept. 26, 2006; 74 FR 14718, Apr. 1, 2009; 
83 FR 28355, June 19, 2018]

[[Page 982]]



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 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 National 
Poultry Improvement Plan (NPIP) in parts 56, 145, and 146 of this 
chapter and this subpart. The Department reserves the right to approve 
or disapprove the recommendations of the conference as an integral part 
of its sponsorship of the National Poultry Improvement Plan. The 
Department will publish the recommendations in the Federal Register 
within 14 months following the NPIP Biennial Conference.

[85 FR 62572, Oct. 5, 2020]



  Subpart F_Authorized Laboratories and Approved Tests and Sanitation 
                               Procedures

    Source: 79 FR 38766, July 9, 2014, unless otherwise noted.

[[Page 983]]



Sec.147.51  Definitions.

    The following definitions apply in this subpart:
    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any other employee of the Animal and Plant Health Inspection 
Service delegated to act in the Administrator's stead.
    Animal and Plant Health Inspection Service (APHIS, the Service). The 
Animal and Plant Health Inspection Service of the U.S. Department of 
Agriculture.
    NPIP or Plan. The National Poultry Improvement Plan.
    NPIP Program Standards. A document that contains tests and 
sanitation procedures approved by the Administrator under Sec.147.53 
for use under this subchapter. This document may be obtained from the 
NPIP Web site at http://www.poultryimprovement.org/ or by writing to the 
Service at National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike 
Road, Suite 101, Conyers, GA 30094.
    NPIP Technical Committee. A committee made up of technical experts 
on poultry health, biosecurity, surveillance, and diagnostics. The 
committee consists of representatives from the poultry and egg 
industries, universities, and State and Federal governments and is 
appointed by the Senior Coordinator and approved by the General 
Conference Committee. The NPIP Technical Committee is divided into three 
subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP 
Technical Committee Members may serve on one, two, or all three 
subcommittees. The committee will evaluate proposed changes to the 
Provisions and Program Standards of the Plan which include, but are not 
limited to, tests and sanitation procedures, and provide recommendations 
to the Delegates of the National Plan Conference as to whether they are 
scientifically or technically sound.

[79 FR 38766, July 9, 2014, as amended at 83 FR 28355, June 19, 2018]



Sec.147.52  Authorized laboratories.

    These minimum requirements are intended to be the basis on which an 
authorized laboratory of the Plan can be evaluated to ensure that 
official Plan assays are performed in accordance with the NPIP Program 
Standards or other procedures approved by the Administrator in 
accordance with Sec.147.53(d)(1) and reported as described in 
paragraph (f) of this section. A satisfactory evaluation will result in 
the laboratory being recognized by the NPIP office of the Service as an 
authorized laboratory qualified to perform the assays provided for in 
this part.
    (a) Check-test proficiency. The NPIP will serve as the lead agency 
for the coordination of available check tests from the National 
Veterinary Services Laboratories. Further, the NPIP may approve and 
authorize additional laboratories to produce and distribute a check test 
as needed. The authorized laboratory must use the next available check 
test for each assay that it performs.
    (b) Trained technicians. Testing procedures at all authorized 
laboratories must be run or overseen by a laboratory technician who 
every 4 years has attended, and satisfactorily completed, Service-
approved laboratory workshops for Plan-specific diseases.
    (c) Laboratory protocol. Official Plan assays must be performed and 
reported as described in the NPIP Program Standards or in accordance 
with other procedures approved by the Administrator in accordance with 
Sec.147.53(d)(1). Assays must be performed using control reagents 
approved by the Plan or the reagent manufacturer.
    (d) State site visit. The Official State Agency will conduct a site 
visit and recordkeeping audit at least once every 2 years. This will 
include, but may not be limited to, review of technician training 
records, check test proficiency, and test results. The information from 
the site visit and recordkeeping audit will be made available to the 
NPIP upon request.
    (e) Service review. Authorized laboratories will be reviewed by the 
Service (NPIP staff) every 3 years. The Service's review may include, 
but will not necessarily be limited to, checking records, laboratory 
protocol, check-test proficiency, technician training, and peer review.
    (f) Reporting. (1) A memorandum of understanding or other means 
shall be

[[Page 984]]

used to establish testing and reporting criteria to the Official State 
Agency, including criteria that provide for reporting H5 and H7 low 
pathogenic avian influenza directly to the Service.
    (2) Salmonella pullorum and Mycoplasma Plan disease reactors must be 
reported to the Official State Agency within 48 hours.
    (g) Verification. Random samples may also be required to be 
submitted for verification as specified by the Official State Agency.

[79 FR 38766, July 9, 2014, as amended at 81 FR 53251, Aug. 12, 2016; 83 
FR 28355, June 19, 2018; 85 FR 62572, Oct. 5, 2020]



Sec.147.53  Approved tests and sanitation procedures.

    (a)(1) All tests that are used to qualify flocks for NPIP 
classifications must be approved by the Administrator as effective and 
accurate at determining whether a disease is present in a poultry flock 
or in the environment.
    (2) All sanitation procedures performed as part of qualifying for an 
NPIP classification must be approved by the Administrator as effective 
at reducing the risk of incidence of disease in a poultry flock or 
hatchery.
    (b) Tests and sanitation procedures that have been approved by the 
Administrator may be found in the NPIP Program Standards. In addition, 
all tests that use veterinary biologics (e.g., antiserum and other 
products of biological origin) that are licensed or produced by the 
Service and used as described in the NPIP Program Standards are approved 
for use in the NPIP.
    (c) New tests and sanitation procedures, or changes to existing 
tests and sanitation procedures, that have been approved by the NPIP in 
accordance with the process described in subpart E of this part are 
subject to approval by the Administrator. NPIP participants may submit 
new tests and sanitation procedures, or changes to current tests and 
sanitation procedures, through that process.
    (d)(1) Persons who wish to have a test approved by the Administrator 
as effective and accurate at determining whether a disease is present in 
a flock or in the environment may apply for approval by submitting the 
test, along with any supporting information and data, to the National 
Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, 
Conyers, GA 30094. Upon receipt of such an application, the NPIP 
Technical Committee will review the test and any supporting information 
and data supplied with the application. If the NPIP Technical Committee 
determines the test to be of potential general use, the test will be 
submitted for consideration by the General Conference Committee of the 
NPIP in accordance with subpart E of this part, and the Administrator 
will respond with approval or denial of the test.
    (2) Persons who wish to have a sanitation procedure approved by the 
Administrator as effective at reducing the risk of incidence of disease 
in a poultry flock or hatchery may apply for approval by submitting the 
sanitation procedure, along with any supporting information and data, to 
the National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, 
Suite 101, Conyers, GA 30094. Upon receipt of such an application, the 
NPIP Technical Committee will review the sanitation procedure and any 
supporting information and data supplied with the application. If the 
NPIP Technical Committee determines the sanitation procedure to be of 
potential general use, the sanitation procedure will be submitted for 
consideration by the General Conference Committee of the NPIP in 
accordance with subpart E of this part, and the Administrator will 
respond with approval or denial of the test.
    (e)(1) When the Administrator approves a new test or sanitation 
procedure or a change to an existing test or sanitation procedure, APHIS 
will publish a notice in the Federal Register making available the test 
or sanitation procedure. The notice will also provide for a public 
comment period.
    (2)(i) After the close of the public comment period, APHIS will 
publish a notice in the Federal Register indicating that the test or 
sanitation procedure will be added to the NPIP Program Standards, or 
that the NPIP Program Standards will be updated to reflect changes to an 
existing test or sanitation procedure, if:

[[Page 985]]

    (A) No comments were received on the notice;
    (B) The comments on the notice supported the action described in the 
notice; or
    (C) The comments on the notice were evaluated but did not change the 
Administrator's determination that approval of the test or sanitation 
procedure is appropriate based on the standards in paragraph (a) of this 
section.
    (ii) If comments indicate that changes should be made to the test or 
sanitation procedure as it was made available in the initial notice, 
APHIS will publish a notice in the Federal Register indicating that 
changes were made to the initial test or sanitation procedure.
    (iii) Whenever APHIS adds or makes changes to tests or sanitation 
procedures, APHIS will make available a new version of the NPIP Program 
Standards that reflects the additions or changes.
    (iv) If comments present information that causes the Administrator 
to determine that approval of the test or sanitation procedure would not 
be appropriate, APHIS will publish a notice informing the public of this 
determination after the close of the comment period.



Sec.147.54  Approval of diagnostic test kits not licensed by the 
Service.

    (a) Diagnostic test kits that are not licensed by the Service (e.g., 
bacteriological culturing kits) may be approved through the following 
procedure:
    (1) The sensitivity of the kit will be evaluated in at least three 
NPIP authorized laboratories by testing known positive samples, as 
determined by the official NPIP procedures found in the NPIP Program 
Standards or through other procedures approved by the Administrator. 
Field samples, for which the presence or absence of the target organism 
or analyte has been determined by the current NPIP test, are the 
preferred samples and should be used when possible. Samples from a 
variety of field cases representing a range of low, medium, and high 
analyte concentrations should be used. In some cases it may be necessary 
to utilize samples from experimentally infected animals. Spiked samples 
(clinical sample matrix with a known amount of pure culture added) 
should only be used in the event that no other sample types are 
available. When the use of spiked samples may be necessary, prior 
approval from the NPIP Technical Committee is required. Pure cultures 
should never be used. Additionally, laboratories should be selected for 
their experience with testing for the target organism or analyte with 
the current NPIP approved test. (e.g., a Salmonella test should be 
evaluated by NPIP authorized laboratories that test for Salmonella 
routinely). If certain conditions or interfering substances are known to 
affect the performance of the kit, appropriate samples will be included 
so that the magnitude and significance of the effect(s) can be 
evaluated.
    (2) The specificity of the kit will be evaluated in at least three 
NPIP authorized laboratories by testing known negative samples, as 
determined by tests conducted in accordance with the NPIP Program 
Standards or other procedures approved by the Administrator in 
accordance with Sec.147.53(d)(1). If certain conditions or interfering 
substances are known to affect the performance of the kit, appropriate 
samples will be included so that the magnitude and significance of the 
effect(s) can be evaluated.
    (3) The kit will be provided to the cooperating laboratories in its 
final form and include the instructions for use. The cooperating 
laboratories must perform the assay exactly as stated in the supplied 
instructions. Each laboratory must test a panel of at least 25 known 
positive samples. In addition, each laboratory must test at least 50 
known negative samples obtained from several sources, to provide a 
representative sampling of the general population. The cooperating 
laboratories must perform a current NPIP procedure or NPIP approved test 
on the samples alongside the test kit for comparison and must provide an 
outline of the method on the worksheet for diagnostic test evaluation. 
Reproducibility and robustness data should also be included.
    (4) Cooperating laboratories will submit to the kit manufacturer all 
compiled output data regarding the assay

[[Page 986]]

response. Each sample tested will be reported as positive or negative, 
and the official NPIP procedure used to classify the sample must be 
submitted in addition to the assay response value. A completed worksheet 
for diagnostic test evaluation is required to be submitted with the 
compiled output data and may be obtained by contacting the NPIP Senior 
Coordinator. Data and the completed worksheet for diagnostic test 
evaluation must be submitted to the NPIP Senior Coordinator 4 months 
prior to the next scheduled General Conference Committee meeting, which 
is when approval will be sought.
    (5) The findings of the cooperating laboratories will be evaluated 
by the NPIP Technical Committee, and the Technical Committee will make a 
majority recommendation whether to approve the test kit to the General 
Conference Committee at the next scheduled General Conference Committee 
meeting. If the Technical Committee recommends approval, the final 
approval will be granted in accordance with the procedures described in 
Sec. Sec.147.46, 147.47, and 147.48.
    (6) Diagnostic test kits that are not licensed by the Service (e.g., 
bacteriological culturing kits) and that have been approved for use in 
the NPIP in accordance with this section are listed in the NPIP Program 
Standards.
    (b) Approved tests modification and removal. (1) The specific data 
required for modifications of previously approved tests will be taken on 
a case-by-case basis by the technical committee.
    (2) If the Technical Committee determines that only additional field 
data is needed at the time of submission for a modification of a 
previously approved test, allow for a conditional approval for 60 days 
for data collection side-by-side with a current test. The submitting 
party must provide complete protocol and study design, including 
criteria for pass/fail to the Technical Committee. The Technical 
Committee must review the data prior to final approval. This would only 
apply to the specific situation where a modified test needs additional 
field data with poultry to be approved.
    (3) Approved diagnostic tests may be removed from the Plan by 
submission of a proposed change from a participant, Official State 
Agency, the Department, or other interested person or industry 
organization. The data in support of removing an approved test will be 
compiled and evaluated by the NPIP Technical Committee, and the 
Technical Committee will make a majority recommendation whether to 
remove the test kit to the General Conference Committee at the next 
scheduled General Conference Committee meeting. If the Technical 
Committee recommends removal, the final decision to remove the test will 
be granted in accordance with the procedures described in Sec. Sec.
147.46, 147.47, and 147.48.

[81 FR 53251, Aug. 12, 2016, as amended at 83 FR 28356, June 19, 2018]



PART 149_VOLUNTARY TRICHINAE CERTIFICATION PROGRAM--Table of Contents



Sec.
149.0 Purpose and scope.
149.1 Definitions.
149.2 Program participation.
149.3 Site audit.
149.4 Spot audit.
149.5 Offsite identification and segregation of certified swine.
149.6 Slaughter facilities.
149.7 Recordkeeping at site.
149.8 Program fees and charges.
149.9 Pilot program sites.

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136a; 7 CFR 2.22, 
2.80, and 371.4.

    Source: 73 FR 60479, Oct. 10, 2008, unless otherwise noted.



Sec.149.0  Purpose and scope.

    The Trichinae Certification Program described in this part is 
intended to enhance the ability of swine producers, as well as slaughter 
facilities and other persons that handle or process swine from pork 
production sites that have been certified under the program, to export 
fresh pork and pork products to foreign markets.



Sec.149.1  Definitions.

    Accredited veterinarian. A veterinarian approved by the APHIS 
Administrator in accordance with part 161 of this chapter to perform 
functions specified in subchapters B, C, D, and G of this chapter.
    Agricultural Marketing Service (AMS). The Agricultural Marketing 
Service of

[[Page 987]]

the United States Department of Agriculture.
    AMS Administrator. The Administrator, Agricultural Marketing 
Service, or any person authorized to act for the AMS Administrator.
    AMS representative. Any individual employed by or acting as an agent 
on behalf of the Agricultural Marketing Service who is authorized by the 
AMS Administrator to perform services required by this part.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Animal disposal plan. A written document that describes methods for 
the removal and disposal of dead swine or swine remains from a pork 
production site.
    Animal movement record. A written record of the movement of swine 
into or from a pork production site.
    APHIS Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the APHIS 
Administrator.
    APHIS representative. Any individual employed by or acting as an 
agent on behalf of the Animal and Plant Health Inspection Service who is 
authorized by the APHIS Administrator to perform the services required 
by this part.
    Approved laboratory. A non-Federal laboratory approved by the 
Agricultural Marketing Service and recognized by the APHIS Administrator 
or FSIS Administrator for performing validated tests to determine the 
presence of trichinae infection in reference to the Trichinae 
Certification Program.
    Audit. An inspection process, as provided in this part, that 
generates a written record documenting a pork production site's 
adherence to the required good production practices.
    Auditor. A qualified accredited veterinarian (QAV) or a qualified 
veterinary medical officer (QVMO) who is trained and authorized by APHIS 
to perform auditing activities under the Trichinae Certification 
Program.
    Certification (certified). A designation given by the APHIS 
Administrator to a pork production site for compliance with good 
production practices and other program requirements of the Trichinae 
Certification Program as provided in this part.
    Certified pork. Pork products originating from certified swine from 
a certified production site with identity of such animals or carcasses 
maintained throughout receiving, handling, and processing. \1\
---------------------------------------------------------------------------

    \1\ The labeling of all certified pork or pork products leaving a 
slaughter or processing facility must comply with 9 CFR 317.4 and all 
other applicable FSIS labeling regulations.
---------------------------------------------------------------------------

    Certified production site. A pork production site that has attained 
a program status of Stage II or higher, based on adherence to good 
production practices and other program requirements as provided in this 
part.
    Certified swine. Swine produced under the Trichinae Certification 
Program on a certified production site.
    Confinement unit. A structure on a pork production site in which 
swine are housed and fed that is totally roofed and that is constructed 
in such a manner as to prevent swine from being exposed to free-flying 
birds and other wildlife, and from coming into contact with the carrion 
of free-flying birds or other wildlife.
    Decertification (decertified). Removal of the certified status of a 
production site by the APHIS Administrator when it has been determined 
that the criteria of the Trichinae Certification Program are not being 
met or maintained.
    Enzyme-linked immunosorbent assay (ELISA). A method of testing swine 
for the presence of trichinae infection by looking for antibodies to 
Trichinella spp. in the sera, plasma, whole blood, tissue fluid, or meat 
juice of swine.
    EPA. The United States Environmental Protection Agency.
    Feed mill quality assurance affidavit. A written statement signed by 
the feed mill representative and the producer that documents the quality 
and safety of feed or feed ingredients delivered from the feed mill to 
the pork production site.
    Food Safety and Inspection Service (FSIS). The Food Safety and 
Inspection Service of the United States Department of Agriculture.
    FSIS Administrator. The Administrator, Food Safety and Inspection

[[Page 988]]

Service, or any person authorized to act for the Administrator.
    FSIS program employee. Any individual employed by or acting as an 
agent on behalf of the Food Safety and Inspection Service who is 
authorized by the FSIS Administrator to perform the services required by 
this part.
    Good manufacturing practices. Feed manufacturing practices that 
reduce, eliminate, or avoid the risk of exposure of swine to Trichinella 
spp.
    Good production practices. Pork production management practices that 
reduce, eliminate, or avoid the risk of exposure of swine to Trichinella 
spp.
    Harborage. Any object, debris, clutter, or area that could serve as 
shelter or refuge for rodents or wildlife.
    Laboratory approval audit. An audit performed by AMS representatives 
to determine if a laboratory meets minimum requirements for approval, as 
established by AMS, for performing validated tests under this part.
    National Trichinae Certified Herd. All swine raised on certified 
production sites in the United States.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, joint stock company, or other legal entity.
    Pest control operator. A person trained and State-licensed in the 
control of pests and vermin (particularly rodents).
    Pooled sample digestion method (digestion method). A method of 
testing swine for trichinae infection by identifying the presence of 
Trichinella spp. from a sample of the animal's muscle tissue.
    Pork production site (site). A geographically definable area that 
includes pork production facilities and ancillary structures under 
common ownership or management systems and the surrounding space within 
a 100-foot perimeter of the confinement unit.
    Positive test result. Outcome of a validated test indicating the 
presence of Trichinella spp.
    Premises Identification Number (PIN). A number assigned to a pork 
production site by the APHIS Administrator.
    Process-verification testing. Testing of a statistically valid 
sample of swine belonging to the National Trichinae Certified Herd at 
the time of slaughter using a validated test to verify that the 
adherence to good manufacturing practices and good production practices 
is resulting in the absence of Trichinella spp. infection in swine from 
that herd.
    Producer. An individual or entity that owns or controls the 
production or management of swine.
    Qualified accredited veterinarian (QAV). An accredited veterinarian 
who has been granted a program certification by the APHIS Administrator 
pursuant to Sec.161.5 of this chapter based on completion of an APHIS-
approved training program in good production practices in swine 
management, and who is authorized by the APHIS Administrator to perform 
site audits and other specified program services required by this part. 
\2\
---------------------------------------------------------------------------

    \2\ Accredited veterinarians interested in obtaining program 
certification related to the Trichinae Certification Program should 
contact APHIS' National Trichinae Coordinator at (515) 284-4122 or write 
to: USDA, APHIS, Veterinary Services, Trichinae Certification Program, 
210 Walnut St., Room 891, Des Moines, IA 50309.
---------------------------------------------------------------------------

    Qualified veterinary medical officer (QVMO). A VMO of the State or 
Federal Government who is trained in good production practices and is 
authorized by the APHIS Administrator to perform site audits, spot 
audits, and other specified program services required by this part.
    Rodent control logbook. A written record that documents a rodent 
control program for a pork production site.
    Site audit. An audit, performed by a QAV or a QVMO, to determine the 
trichinae risk factor status of a pork production site based on the 
site's adherence to all of the required good production practices that 
reduce, eliminate, or avoid the risk of exposure of swine to Trichinella 
spp.
    Slaughter facility. A slaughtering establishment operating under the 
Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or a State meat 
inspection act that receives certified swine under the Trichinae 
Certification Program.
    Slaughter facility representative. Any individual employed by, or 
acting as an agent on behalf of, a slaughter facility who is authorized 
by the slaughter facility to perform the specified program services 
required by this part.

[[Page 989]]

    Spot audit. An audit of a certified pork production site performed 
by a QVMO to ensure program integrity and consistency.
    Stage I enrolled. Preliminary program status of a pork production 
site attained when the APHIS Administrator approves the outcome of an 
initial site audit.
    Stage II certified. Program status attained upon APHIS approval of a 
site audit of a Stage I enrolled site.
    Stage III certified. Program status attained upon APHIS approval of 
a site audit of a Stage II certified site and maintained upon APHIS 
approval of subsequent site audits for renewal of Stage III certified 
status.
    Sterile zone. An open area immediately adjacent to and surrounding 
the confinement unit that serves as both a buffer and detection zone for 
rodent and wildlife activity.
    Temporary withdrawal. The voluntary withdrawal of a certified 
production site from the Trichinae Certification Program at the request 
of the producer for a period not to exceed 180 days.
    Trichinae. A generic term that refers to Trichinella spp.
    Trichinae Certification Program (program). A voluntary pre-harvest 
pork safety program in which APHIS certifies pork production sites that 
follow all of the required good production practices that reduce, 
eliminate, or avoid the risk of exposure of swine from their sites to 
Trichinella spp.
    Trichinella spp. Parasitic nematodes (roundworms) capable of 
infecting many warm-blooded carnivores and omnivores, including swine.
    USDA. The United States Department of Agriculture.
    Validated test. An analytical method licensed by APHIS or accepted 
by AMS for the diagnosis of Trichinella spp. in swine.
    Veterinary medical officer (VMO). A veterinarian employed by the 
State or Federal Government who is authorized to perform official animal 
health activities on their behalf.

[73 FR 60479, Oct. 10, 2008, as amended at 74 FR 65010, Dec. 9, 2009]



Sec.149.2  Program participation.

    A producer's initial enrollment and continued participation in the 
Trichinae Certification Program requires that the producer adhere to all 
of the good production practices, as confirmed by periodic site audits, 
and comply with other recordkeeping and program requirements provided in 
this part. Pork production sites accepted into the program by APHIS will 
participate under one of the following three program stages:
    (a) Stage I enrolled status. (1) Stage I enrolled status signifies 
that the site has met good production practices and other recordkeeping 
and program requirements provided in this part.
    (2) Swine from a Stage I enrolled site cannot be identified as 
products from a certified production site.
    (3) A Stage I enrolled site must complete a site audit for Stage II 
certified status in accordance with Sec.149.3(d). Under Sec.
149.3(d), the site audit must be performed no sooner than 150 days from 
the date the site was awarded Stage I enrolled status, and must be 
completed, with the audit form and payment submitted to APHIS, no later 
than 210 days from the date the site was awarded Stage I enrolled 
status.
    (4) A Stage I enrolled site that is found not to be adhering to one 
or more good production practices as a result of a site audit or spot 
audit, or that fails to follow the prescribed timetable for completing a 
site audit and submitting the completed audit form and payment for 
consideration as a Stage II certified site, will be subject to a review 
by APHIS to consider the nature of the infraction(s), and may lose its 
status as a Stage I enrolled site.
    (b) Stage II certified status. (1) Stage II certified status 
signifies that the site is adhering to all of the required good 
production practices and other recordkeeping and program requirements 
provided in this part.
    (2) An APHIS-issued certificate or letter indicating the site's 
status as a Stage II certified site must be filed at the site and be 
readily available for inspection.
    (3) Swine from a Stage II certified site may be identified as 
certified products from a certified production site.
    (4) A Stage II certified site must complete a site audit for Stage 
III certified status in accordance with

[[Page 990]]

Sec.149.3(e). Under Sec.149.3(e), the site audit must be performed 
no sooner than 240 days from the date the site was awarded Stage II 
certified status, and must be completed, with the audit form and payment 
submitted to APHIS, no later than 300 days from the date the site was 
awarded Stage II certified status.
    (5) A Stage II certified site that is found not to be adhering to 
one or more good production practices as a result of a site audit or 
spot audit, or that fails to meet the Stage III site audit requirements 
of Sec.149.3(e) within the prescribed timetable, will be subject to a 
review by APHIS to consider the nature of the infraction(s) and 
determine whether to decertify the site, as provided in paragraph (e)(1) 
of this section. During the time a site is decertified, swine from that 
site cannot be identified as certified products from a certified 
production site.
    (c) Stage III certified status. (1) Stage III certified status 
signifies that the site is adhering to all of the required good 
production practices and other recordkeeping and program requirements 
provided in this part.
    (2) An APHIS-issued certificate or letter indicating the site's 
status as a Stage III certified site must be filed at the site and be 
readily available for inspection.
    (3) Swine from a Stage III certified site may be identified as 
certified products from a certified production site.
    (4) In order to maintain Stage III certified status, sites must 
arrange for site audits to renew such status according to the timetable 
set forth in Sec.149.3(f). Under Sec.149.3(f), the site audit must 
be performed no sooner than 14 months from the date the site was awarded 
Stage III certified status or the date that status was last renewed, and 
must be completed, with the audit form and payment submitted to APHIS, 
no later than 16 months from either the date the site was awarded Stage 
III certified status or the date that status was last renewed.
    (5) A Stage III certified site that is found not to be adhering to 
one or more good production practices as a result of a site audit or 
spot audit, or that fails to follow the prescribed timetable for 
completing a site audit and submitting the completed audit form and 
payment to determine its continued participation as a Stage III 
certified site, will be subject to a review by APHIS to consider the 
nature of the infraction(s) and determine whether to decertify the site, 
as provided in paragraph (e)(1) of this section. During the time a site 
is decertified, swine from that site cannot be identified as certified 
products from a certified production site.
    (d) Change of ownership--(1) Stage I enrolled site. If there is a 
change in ownership in a Stage I enrolled site, and the new ownership 
wishes to remain in the program, then the Stage I enrolled site will 
remain on the same timetable as under the previous ownership for 
purposes of completing a site audit for Stage II certified status. No 
additional site audit is necessary as a result of the change of 
ownership of the site.
    (2) Stage II or Stage III certified sites. When a change of 
ownership occurs at a Stage II or Stage III certified site, the previous 
owner of the site must notify APHIS of this change as soon as the 
transaction is finalized. Within 60 days of this notification, a site 
audit must be performed in order for the site to maintain its certified 
status. It is the new ownership's responsibility that a site audit be 
performed within 60 days of this notification, otherwise the site may be 
subject to decertification, in accordance with paragraph (e)(1) of this 
section. If the site audit is satisfactory, then the Stage II or Stage 
III certified site will continue in the program, initially as a Stage II 
certified site. However, a new program anniversary date for that site 
will be established based on the date the site was audited to continue 
in the program as a Stage II certified site, and the producer of the 
site must arrange for a site audit to gain (or regain) Stage III 
certified status based on that new anniversary date and according to the 
timetable prescribed in Sec.149.3(e). If the results of the site audit 
do not meet program requirements, the Stage II or Stage III site will be 
subject to a review by APHIS to consider the nature of the infraction(s) 
and determine whether to decertify the site, as provided in paragraph 
(e)(1) of this section. Once a site is decertified by

[[Page 991]]

APHIS, either because the new ownership fails to arrange for a site 
audit to be performed within the allotted 60-day time period, or because 
the site is found not to meet program requirements, a producer wishing 
to participate in the program again must follow the procedures for 
requesting an initial audit for Stage I enrolled status. If a 
decertified site is reenrolled after a successful Stage I site audit, a 
new program anniversary date for that site will be established based on 
the date of reenrollment.
    (e) Site decertification and program withdrawal--(1) Decertification 
by APHIS. (i) A Stage II or Stage III certified site that is found not 
to be adhering to one or more of the good production practices as a 
result of a site audit, or that fails to follow the prescribed timetable 
for completing a site audit and submitting the completed audit form and 
payment to continue participation in the program, will be subject to a 
review by APHIS to consider the nature of the infraction(s) and to 
determine whether the site should be decertified. Decertification will 
result from infraction(s) that APHIS determines to be substantive, 
prolonged, and/or repeated as a result of this review.
    (ii) During the time a site is decertified, swine from such sites 
cannot be identified as certified products from a certified production 
site.
    (iii) Once a site is decertified by APHIS, a producer wishing to 
participate in the program again must follow the procedures for 
requesting a site audit for Stage I enrolled status. If a decertified 
site is reenrolled after a successful Stage I site audit, a new program 
anniversary date for that site will be established based on the date of 
recertification. If a decertified site is recertified after a successful 
Stage II site audit, a new program anniversary date for that site will 
be established based on the date of recertification.
    (2) Temporary withdrawal by producer. (i) A producer may request 
that one or more certified production sites be temporarily withdrawn. A 
producer's request must be made in writing and is subject to the APHIS 
Administrator's approval.
    (ii) Each certified production site can be temporarily withdrawn no 
more than once every 2 years for a period not to exceed 180 days.
    (iii) During the time a site is temporarily withdrawn:
    (A) Swine from such sites cannot be identified as certified products 
from a certified production site; and
    (B) The producer must continue to adhere to all good production 
practices and other recordkeeping and program requirements provided in 
this part, including documentation in the animal movement record of the 
arrival and departure of all swine from this site, as well as whether 
the swine arriving at the site are from certified or noncertified 
sources, unless a program requirement is specifically waived by the 
Administrator.
    (iv) If granted a waiver by the Administrator, a producer may 
receive swine 5 weeks of age or older originating from a noncertified 
source during the period of withdrawal.
    (v) Before being reinstated as a certified production site, the 
temporarily withdrawn site must pass a site audit to indicate that it is 
now adhering to all good production practices (including any practices 
waived by the Administrator at the beginning of the period of 
withdrawal) as follows:
    (A) The site audit must be performed while the site is still under 
temporary withdrawal status. If swine 5 weeks of age or older 
originating from a noncertified source have been received at the site 
during the time of withdrawal, then the site audit for reinstatement 
must be performed within 30 days of the date the last swine from a 
noncertified source was removed from the site, but no later than 180 
days from the date the site was granted temporary withdrawal status.
    (B) If the results of the site audit are satisfactory and it is 
determined that the site is now adhering to good production practices 
and other program requirements provided in this part, then the withdrawn 
site will be reinstated as a Stage II certified site. The timetable for 
performing future site audits for attaining and renewing Stage III 
certified status will be based on the date the site was reinstated as a 
Stage II certified site.

[[Page 992]]

    (C) If the results of the site audit are not satisfactory, or, if 
the period of temporary withdrawal has exceeded 180 days, then the site 
will be subject to a review by APHIS to consider the nature of the 
infraction(s) and to determine whether to decertify the site, as 
provided in paragraph (e)(1) of this section. Once the site is 
decertified by APHIS, the producer must follow the procedures for 
requesting an initial site audit for Stage I enrolled status in order 
for the site to be reenrolled in the program. If a site is decertified 
by APHIS and then reenrolled after a successful Stage I site audit, a 
new program anniversary date for that site will be established based on 
the date of enrollment.
    (3) Program withdrawal. (i) If a producer decides to withdraw one or 
more of pork production sites from the program, then it is the 
producer's responsibility to notify the APHIS Administrator in writing 
of this intent. When this is done, the site will be removed from the 
program.
    (ii) If at a later date the producer requests that a site be 
reinstated in the program, then the producer must follow the procedures 
for requesting an initial audit for Stage I enrolled status. If a 
withdrawn site is reenrolled after a successful Stage I site audit, then 
a new program anniversary date for that site will be established based 
on the date of reenrollment.
    (f) Request for review. If there is a conflict as to any material 
fact relating to the results of a site audit, spot audit, or other 
determination affecting a producer's program status or ability to 
participate in the program, the producer may submit a written request 
for review to the Administrator. The producer must include in the 
request the reasons, including any supporting documentation, why the 
audit result or other determination should be different than the result 
or determination made by the Administrator. The initial audit result or 
other determination will remain in force pending the completion of the 
Administrator's review. The decision by the Administrator upon reviewing 
the producer's written request will be final.



Sec.149.3  Site audit.

    (a) General. (1) The producer must contact a QAV or QVMO to request 
a site audit. A list of available QAVs may be obtained by accessing the 
Trichinae Certification Program Web site on the Internet at http://
www.aphis.usda.gov/vs/trichinae. If a QAV is not available to perform a 
site audit, the producer must then contact the APHIS area office to 
request that a QVMO perform the site audit. The site audit is to be 
arranged at a mutually agreed-upon time.
    (2) The producer or the producer's designated representative will 
accompany the auditor during the site audit.
    (3) During the site audit, the auditor will record whether the 
producer is adhering to all of the required good production practices at 
the site, as provided in paragraph (b) of this section, in order to 
reduce, eliminate, or avoid the risk of exposure of swine to Trichinella 
spp.
    (4) The auditor will use APHIS-approved audit forms in performing 
the site audit. After the auditor has completed all sections of the 
audit form, the producer or the producer's designated representative 
must sign the audit form attesting to the accuracy of the information 
obtained during the site audit and to evidence his or her intent to 
continue adhering to the good production practices and other program 
requirements, as provided in this part. The auditor also must sign the 
audit form at this time.
    (5) If a QVMO performs the site audit, then the producer will pay 
the QVMO at the time the site audit is performed in accordance with the 
rate and other conditions set by the QVMO's governmental employer. If an 
APHIS-employed QVMO performs the site audit, then the producer will pay 
APHIS by certified check or U.S. money order for this service at a rate 
determined in accordance with Sec.149.8.
    (6) In addition to the possible cost of the site audit, the producer 
is also responsible for paying a separate program fee in an amount 
specified in Sec.149.8 to cover APHIS' administrative costs in 
processing the audit and operating the program. This program fee, 
payable to APHIS by certified check or U.S. money order, must be 
remitted to

[[Page 993]]

the auditor at the time each site audit is performed.
    (7) The auditor will submit the completed audit form, program fee, 
and payment for the services of an APHIS-employed QVMO, if applicable, 
to the nearest APHIS area office. If a QAV performs the site audit, the 
producer will be responsible for ensuring that the QAV submits the 
completed audit form and program fee to APHIS in a timely manner.
    (8) Upon receipt of the completed audit form and payment, APHIS will 
determine the initial enrollment or certification status for the site 
based on an evaluation of the site audit. APHIS will provide the 
producer with written notification of the audit results. Pork production 
sites that meet all good production practices as provided in paragraph 
(b) of this section, as well as other program requirements provided in 
this part, will be issued program status at the appropriate program 
stage.
    (9) If the site audit shows that the site does not substantively 
meet all good production practices or other program requirements, APHIS 
will provide the producer with written notification that includes 
documentation of the deficiencies that prevented the site from being 
conferred program status.
    (b) Good production practices. In a site audit, the auditor will 
determine whether all of the required good production practices are 
being carried out at the site to reduce, eliminate, or avoid the risk of 
exposure of swine to Trichinella spp. as follows:
    (1) The movement of all non-breeding swine 5 weeks of age or older 
into or from the pork production site must be documented in an animal 
movement record, as provided in Sec.149.7, that ensures that all such 
swine moved into or from the site can be subsequently traced back to 
that site, or to any previous site (if applicable).
    (2) All non-breeding swine entering a site must have originated from 
another certified production site, except that non-breeding swine less 
than 5 weeks of age may have originated from either a certified or 
noncertified production site. The animal movement record must include 
the PIN of the certified production site from which the swine 
originated. If the swine are less than 5 weeks of age and come from a 
noncertified site, then the animal movement record must provide the name 
and full address of the noncertified site where the swine originated.
    (3) Feed or feed ingredients from offsite sources that are used at 
the site must meet good manufacturing practices or other quality 
assurance standards recognized by the feed industry. The adherence to 
good manufacturing practices or other quality assurance standards must 
be documented in a feed mill quality assurance affidavit, as provided in 
Sec.149.7.
    (4) Swine at the site must be housed and fed in a confinement unit. 
The confinement unit, feed preparation and storage areas, and office 
areas and connecting hallways at the site must be inspected regularly 
and found free of signs of rodent and wildlife activity (evidence of 
rodent activity consists of fresh rodent droppings, fresh gnawing marks, 
new structural damage, rodent urine, rodent blood, rodent smear marks 
(body oil), rodent tracks, or recent burrowing or burrow use. Evidence 
of wildlife activity consists of wildlife feces, footprints, fur, or 
hair observed in or near the stored feed or feed ingredients, dead or 
live wildlife observed in or near the stored feed or feed ingredients, 
or wildlife burrows or nests observed in or near the stored feed or feed 
ingredients). Any movable harborage (exterior or interior) on the site 
that is not necessary to the day-to-day operation of the site must be 
removed. Harborage that cannot be removed or is movable but necessary to 
the day-to-day operation of the site (e.g., equipment) must be checked 
for signs of rodent or wildlife activity. In addition, domesticated 
animals, including pets such as dogs and cats, must be excluded from the 
confinement unit and feed preparation and storage areas at the site. 
Exterior rodent bait stations and/or traps must be placed around the 
perimeter of the confinement unit. Exterior rodent bait stations and/or 
traps also must be placed around areas of potential rodent entry into 
the confinement unit (i.e., doorways, vent openings, loading chutes, 
cool cells, etc.). Interior rodent bait stations and/or traps must be 
placed

[[Page 994]]

near high-risk rodent zones such as entryways, hallways, office areas, 
swine load-out areas, vents, cool cells, storage areas, utility rooms, 
cabinets, locker rooms, bathrooms, and break rooms, and systematically 
maintained. Interior rodent bait stations and/or traps must be placed so 
that swine will not come in contact with the bait or trap. Rodent bait 
stations and/or traps also must be placed near exterior or interior 
harborage on the site that cannot be removed or that is movable but 
necessary to the day-to-day operation of the site. In all instances, 
rodent bait stations must be intact, systematically maintained, and 
contain fresh bait that consists of an EPA-registered rodenticide 
formulation that is applied according to its label. In addition, a 
sterile zone must be maintained around the perimeter of the confinement 
unit. The sterile zone must be devoid of any harborage or feed or water 
sources that could attract rodents or wildlife, but must contain rodent 
bait stations and/or rodent traps. The sterile zone also must be devoid 
of any vegetation unless it is decorative vegetation that is well 
maintained (i.e., residential height grass, flowers, shrubs, or trees). 
A sterile zone with decorative vegetation will require increased rodent 
control measures. The producer must provide documentation of rodent 
control practices by maintaining at the site an up-to-date rodent 
control logbook with a site diagram and other recordkeeping evidencing 
implementation of rodent control measures, which can include documents 
provided by a pest control operator, as provided in Sec.149.7.
    (5) Feed or feed ingredients stored at the site must be prepared, 
maintained, and handled in a manner that protects the feed or feed 
ingredients from possible exposure to or contamination by rodents or 
wildlife. Any movable harborage in the immediate vicinity of feed 
production and feed storage areas that is not necessary to the day-to-
day operation of the site must be removed. Harborage that cannot be 
removed or harborage that is movable but necessary to the day-to-day 
operation of the site (e.g., equipment, etc.) must be checked for signs 
of rodent or wildlife activity. Rodent bait stations and/or traps must 
be placed around (and in, if applicable) all feed preparation and 
storage areas, as well as near any harborage in the vicinity that cannot 
be removed or that is movable but necessary to the day-to-day operation 
of the site. Rodent bait stations must be intact, systematically 
maintained, and contain fresh bait that consists of an EPA-registered 
rodenticide formulation that is applied according to its label. In 
addition, feed or feed ingredients that are stored in paper bags must be 
elevated off the floor and be a sufficient distance away from the walls 
to allow for inspection, baiting, and/or trapping. The rodent control 
logbook, as provided in Sec.149.7, must document that adequate rodent 
control procedures have been implemented in the feed production and feed 
storage areas.
    (6) Swine must not have access to dead or live wildlife at the site. 
Dead or live wildlife must not be intentionally fed to swine.
    (7) Swine at the site must not be fed waste that contains meat.
    (8) Procedures must be in place and carried out for the prompt 
removal and proper disposal of dead swine or swine remains found in pens 
in order to eliminate the opportunity for cannibalism, as well as to 
prevent the attraction of rodents or wildlife. Such procedures must be 
documented in the animal disposal plan, as provided in Sec.149.7.
    (9) General hygiene and sanitation of the site must be maintained at 
all times to prevent the attraction of rodents and wildlife. Solid non-
fecal waste (facility refuse) must be placed in covered receptacles and 
be regularly removed from the site. Spilled feed also must be regularly 
removed and properly disposed of.
    (10) All records required under Sec.149.7 must be kept up to date 
and readily available for inspection at the site.
    (c) Initial site audit for Stage I enrolled status. (1) Producers 
interested in participating in the program should request and review a 
pre-audit information packet prepared by APHIS that discusses the 
program, as well as the steps in preparing for and requesting

[[Page 995]]

an initial site audit. \3\ When the producer and the producer's herd 
health personnel believe that a site meets program standards, the 
producer must arrange for an initial site audit, as provided in 
paragraph (a) of this section.
---------------------------------------------------------------------------

    \3\ The pre-audit information packet may be obtained from a 
qualified accredited veterinarian (QAV), State or Federal animal health 
offices, or the National Pork Board, or by writing to: USDA, APHIS, 
Veterinary Services, Trichinae Certification Program, 210 Walnut St., 
Room 891, Des Moines, IA 50309. A pre-audit packet also may be requested 
electronically through the program Web site on the Internet at http://
www.aphis.usda.gov/vs/trichinae.
---------------------------------------------------------------------------

    (2) Upon completion of the initial site audit and submission of the 
completed audit form and payment, APHIS will review the completed audit 
form and make a determination within 30 days as to enrollment of the 
site in the program. A pork production site that is found to meet all 
good production practices and other program requirements in this part 
will be awarded Stage I enrolled status.
    (d) Site audit for Stage II certified status. (1) A producer of a 
Stage I enrolled site must arrange for another site audit for Stage II 
certified status. The site audit must be performed no sooner than 150 
days (i.e., approximately 5 months) from the date the site was awarded 
Stage I enrolled status, and must be completed, with the audit form and 
payment submitted to APHIS, no later than 210 days (i.e., approximately 
7 months) from the date the site was awarded Stage I enrolled status.
    (2) APHIS will review the completed audit form and make a 
determination as to Stage II certified status within 7 days of receipt 
of the audit form and payment.
    (i) A Stage I enrolled site that is found to meet all good 
production practices and other program requirements in this part will be 
awarded Stage II certified status.
    (ii) A Stage I enrolled site that is found, during a site audit, not 
to be adhering to one or more good production practices, or that fails 
to follow the prescribed timetable for completing a site audit and 
submitting the completed audit form and payment, will be subject to a 
review by APHIS to consider the nature of the infraction(s), and may 
lose its status as a Stage I site.
    (e) Site audit for Stage III certified status. (1) A producer of a 
Stage II enrolled site must arrange for another site audit for Stage III 
certified status. The site audit must be performed no sooner than 240 
days (i.e., approximately 8 months) from the date the site was awarded 
Stage II certified status, and must be completed, with the audit form 
and payment submitted to APHIS, no later than 300 days (i.e., 
approximately 10 months) from the date the site was awarded Stage II 
certified status.
    (2) APHIS will review the completed audit form and make a 
determination as to Stage III certified status within 30 days of receipt 
of the audit form and payment.
    (i) A Stage II certified site that is found to meet all good 
production practices and other program requirements in this part will be 
awarded Stage III certified status.
    (ii) A Stage II certified site that is found, during a site audit, 
not to be adhering to one or more good production practices, or that 
fails to follow the prescribed timetable for completing a site audit and 
submitting the completed audit form and payment, will be subject to a 
review by APHIS to consider the nature of the infraction(s) and 
determine whether to decertify the site, as provided in Sec.
149.2(e)(1).
    (f) Site audit for renewal of Stage III certified status. (1) A 
producer seeking to renew a site's Stage III certified status must 
arrange for another site audit. The site audit must be performed no 
sooner than 14 months from the date the site was awarded Stage III 
certified status or the date that status was last renewed, and must be 
completed, with the audit form and payment submitted to APHIS, no later 
than 16 months from either the date the site was awarded Stage III 
certified status or the date the that status was last renewed.
    (2) APHIS will review the completed audit form and make a 
determination as to renewing the site's Stage III certified status 
within 30 days of receipt of the audit form and payment.

[[Page 996]]

    (i) A Stage III certified site that is found to meet all good 
production practices and other program requirements in this part will 
have its status as a Stage III certified site renewed.
    (ii) A Stage III certified site that is found, during a site audit, 
not to be adhering to one or more good production practices, or that 
fails to follow the prescribed timetable for completing a site audit and 
submitting the completed audit form and payment, will be subject to a 
review by APHIS to consider the nature of the infraction(s) and 
determine whether to decertify the site, as provided in Sec.
149.2(e)(1).

(Approved by the Office of Management and Budget under control number 
0579-0323)



Sec.149.4  Spot audit.

    (a) In addition to regularly scheduled site audits, certified 
production sites will be subject to spot audits.
    (1) Random spot audit. Certified production sites will be selected 
by the APHIS Administrator at random for a spot audit in order to:
    (i) Ensure the integrity of the audit process;
    (ii) Verify that the audit process is performed in a consistent 
manner across the program; and
    (iii) Verify that all required good production practices are being 
maintained between regularly scheduled site audits.
    (2) Spot audit for cause. A certified production site may be subject 
to a spot audit to trace back and investigate any positive test results 
as a result of testing of certified swine from that site at the 
slaughter facility.
    (b) All spot audits will be performed by a QVMO. The producer of the 
certified production site subject to spot audit will not be charged for 
the spot audit. APHIS will provide the producer with written 
notification of the results of the spot audit, including documentation 
of any deficiencies noted during the audit. If the site is found not to 
be adhering to one or more of the required good production practices, 
then the site will be subject to a review by APHIS to consider the 
nature of the infraction and to determine whether to decertify the site, 
as provided in Sec.149.2(e)(1). Unless a spot audit results in 
decertification, it does not otherwise affect the timetables for the 
completion of site audits set forth in paragraphs (e) and (f) of Sec.
149.3.



Sec.149.5  Offsite identification and segregation of certified swine.

    Certified swine moved from a certified production site to another 
location, whether to another certified production site, buying station, 
collection point, or slaughter facility, must remain segregated from 
noncertified swine at all times and otherwise maintain their identity as 
certified swine in such a way that they could be readily traced back to 
the certified production site from which they came. Information relating 
to the identification of the certified swine must be documented in the 
animal movement record maintained by the producer. Failure to properly 
segregate or maintain the identity of certified swine from noncertified 
swine after leaving the certified production site will result in the 
loss of certified status for that shipment of swine.



Sec.149.6  Slaughter facilities.

    Only slaughter facilities that are under continuous inspection by 
the Food Safety and Inspection Service or under State inspection that 
the Food Safety and Inspection Service has recognized as equivalent to 
Federal inspection may participate in the program. To participate in the 
program, slaughter facilities must follow the relevant provisions of 
this section relating to verification, segregation, testing, and 
recordkeeping. Participating slaughter facilities that fail to comply 
with any of the applicable requirements of this section will not be 
allowed to continue to participate in the Trichinae Certification 
Program and the pork or pork products prepared by the facility will not 
be eligible for a certificate of export that identifies the product as 
meeting the standards of the Trichinae Certification Program.
    (a) Verification of certification. A slaughter facility receiving 
certified swine must verify the current certification status of the pork 
production site from which the animals came. The current certification 
status may be

[[Page 997]]

verified by maintaining dated certification documentation on file or by 
accessing the Trichinae Certification Program Web site on the Internet 
at http://www.aphis.usda.gov/vs/trichinae. If the slaughter facility is 
unable to verify a site's certification status through documentation on 
file or through the program Web site, the slaughter facility then should 
contact the APHIS area office in the State where the site is located.
    (b) Maintaining identity and segregation of certified swine and pork 
products. For certified swine to be identified as certified pork, 
certified swine and edible pork products derived from certified swine 
must remain segregated from swine and edible pork products from 
noncertified sites throughout receiving, handling, and processing at the 
slaughter facility, as well as while awaiting shipment from the 
facility. The slaughter facility must maintain the identity of the 
certified swine or pork in a manner that allows the certified swine or 
pork to be traced back to the certified production site from which it 
came. A slaughter facility's failure to properly segregate or maintain 
the identity of certified swine and edible pork products derived from 
the certified swine will result in the loss of certified status for that 
shipment of swine, as well as the edible pork products derived from 
those animals.
    (c) Process-verification testing. A slaughter facility processing 
certified swine is responsible for performing process-verification 
testing to determine the Trichinella spp. infection status of certified 
swine under its control as follows:
    (1) Validated tests. Process-verification testing must be performed 
by using a validated test. When testing involves meat, the sample used 
for such testing must be at least 20 grams. \4\
---------------------------------------------------------------------------

    \4\ A copy of the testing methods and checklist for conducting 
validated tests may be obtained by contacting the AMS Trichinae Analyst 
and Laboratory Certification Program Manager, USDA, AMS, Science and 
Technology Programs, Technical Services Branch, 1400 Independence Ave., 
SW., Mail Stop 0272, Washington, DC 20250-0272. The manager may be 
contacted by phone at (202) 690-0621.
---------------------------------------------------------------------------

    (2) Laboratory approval. Process-verification testing must be 
performed in an approved laboratory that has been approved for trichinae 
testing by the Agricultural Marketing Service (AMS). \5\ The approved 
laboratory may be maintained and operated by the slaughter facility or 
by another business entity either on the premises of the slaughter 
facility or at another location. Laboratory staff performing process-
verification testing must be accredited by AMS to perform this program 
function. For purposes of quality assurance, all laboratory staff 
approved to perform process-verification testing will receive periodic 
proficiency test panels from AMS that must be analyzed correctly in 
order to maintain their approval status.
---------------------------------------------------------------------------

    \5\ A copy of the AMS Trichinae Accredited Laboratory Program 
Requirements may be obtained by contacting the AMS Trichinae Analyst and 
Laboratory Certification Program Manager (see footnote 4).
---------------------------------------------------------------------------

    (3) Testing sample size and frequency. Process-verification testing 
must meet the following minimum requirements relating to sample size and 
frequency:
    (i) Slaughter facility representatives shall determine the yearly 
processing capacity of the slaughter facility for the next 12 months. 
Officials may use the processing capacity over the previous 12 months if 
this period is representative of a typical processing year.
    (ii) Slaughter facility representatives shall estimate the 
percentage of swine processed that are likely to come from certified 
production sites considering all swine expected to be processed at the 
slaughter facility during the selected 12-month period. Swine that come 
from certified production sites are considered the eligible population 
to be sampled.
    (iii) Slaughter facility representatives shall use the Trichinae 
Certification Slaughter Facility Sample Size Determination Table on the 
Internet at http://www.aphis.usda.gov/vs/trichinae to find the number of 
samples to collect from the population of swine from certified 
production sites. \6\ If the eligible

[[Page 998]]

population is not listed in that table, the next largest number will be 
used to determine the number of samples to collect. Select the number of 
samples to collect from the column on that table that reflects a 99 
percent confidence level of detecting a positive carcass in a population 
with a prevalence rate of 0.013 percent. The number selected from the 
table will be the total number of samples that slaughter facility 
representatives must collect and test per year and per month during the 
selected 12-month period.
---------------------------------------------------------------------------

    \6\ More information regarding sampling sizes may be obtained by 
writing to USDA, APHIS, Veterinary Services, Trichinae Certification 
Program, 210 Walnut St., Room 891, Des Moines, IA 50309.
---------------------------------------------------------------------------

    (iv) For each sample collected, slaughter facility representatives 
must maintain the identity of the sample using the PIN of the certified 
production site that was the source of the swine from which the sample 
was taken.
    (v) FSIS program employees at the slaughter facility will review and 
verify that an adequate number of samples have been collected and that 
proper frequency of collection is maintained. FSIS will report this 
information to APHIS.
    (vi) AMS representatives will verify through a laboratory approval 
audit that the laboratory performing process-verification testing is 
correctly following written procedures relating to the receipt, 
handling, identification, and testing of samples. These written 
procedures must be maintained by the laboratory in a quality assurance 
manual, as provided in paragraph (c)(6) of this section. In addition, a 
laboratory that performs process-verification testing at a location 
other than the slaughter facility must include a declaration of 
methodology used to test samples when providing test results.
    (vii) The APHIS Administrator may, at APHIS' expense, periodically 
request that testing be performed on swine brought to the slaughter 
facility from specific certified production sites. Requests to test 
swine from specific certified production sites will count towards the 
slaughter facility's total monthly testing requirement.
    (4) Results of testing. (i) The results of all process-verification 
testing relating to certified swine handled at the slaughter facility 
must be retained in a separate file or notebook as written records at 
the slaughter facility and must be readily available for inspection by 
FSIS program employees.
    (ii) FSIS will report to APHIS the results of all process-
verification testing.
    (iii) In the event of a positive test result, the slaughter facility 
representative must notify the FSIS program employee designated by the 
FSIS Administrator immediately, who in turn will report the PIN of the 
certified production site that was the source of the swine from which 
the sample was taken and the test results of the affected sample to the 
respective APHIS area office. The following sequence of events must take 
place following a positive test result:
    (A) If a test sample yields a positive test result based on the 
digestion method, the certified production site that was the source of 
the swine from which the sample was taken will be decertified.
    (B) If a test sample yields a positive test result based on an ELISA 
method and is confirmed positive by further testing using the digestion 
method, the certified production site that was the source of the swine 
from which the sample was taken will be decertified.
    (C) If a test sample yields a positive test result based on an ELISA 
method, but is not confirmed positive by further testing using the 
digestion method, then the certified production site that was the source 
of the swine from which the sample was taken will be investigated by 
APHIS.
    (1) The investigation may include a spot audit of the affected site. 
Further testing of animals or carcasses from the affected site also may 
be performed as part of the investigation. This investigation would 
determine if the production facility has sufficient safeguards and is 
following good production practices.
    (2) While the affected site is under investigation, its program 
status as a certified production site will be suspended. While the site 
is under suspension, the producer must continue to adhere to all of the 
required good production practices and other recordkeeping and program 
requirements provided in

[[Page 999]]

this part. During this suspension, swine at the site may be sent to 
slaughter; however, swine from the suspended site cannot be identified 
as product from a certified production site. The Administrator will 
determine the program status of the affected site within 30 days of the 
initiation of the suspension.
    (3) A finding that risk factors are inadequately addressed in the 
site investigation or the finding of additional positive test results 
based on samples from animals or carcasses from the affected site will 
be grounds for APHIS decertification of the site.
    (5) Slaughter facility recordkeeping. (i) All slaughter facilities 
that receive certified swine must maintain records relating to such 
animals, including the number of certified swine processed, the source 
of the certified swine, including the PIN of the certified production 
site from which the swine came from, and all test results relating to 
process-verification testing. Records relating to certified swine must 
be retained at the slaughter facility for a period of at least 3 years 
following the processing of such animals.
    (ii) All slaughter facilities must have documented procedures on how 
certified swine under its control, and edible pork products derived from 
certified swine, will remain segregated from swine and edible pork 
products from noncertified sites throughout receiving, handling, and 
processing at the facility, as well as while awaiting shipment from the 
facility. The slaughter facility must also have documented procedures 
for maintaining the identity of the certified swine or pork with respect 
to the certified production site from which it came.
    (iii) All such records and other documentation required to be 
maintained by slaughter facilities under this part must be readily 
available for inspection by FSIS program employees.
    (6) Approved laboratory recordkeeping. Approved laboratories must 
have written procedures that specify standards for sample size, sample 
handling, sample identification, and sample test methods used in 
process-verification testing. All such written procedures must be 
maintained in a laboratory quality assurance manual specifically for 
this program, or as a separate section of an existing laboratory quality 
assurance manual, and must be retained at the approved laboratory 
throughout the time the approved laboratory is performing process-
verification testing under this program. All such written procedures 
relating to process-verification testing must be readily available for 
inspection by FSIS program employees or AMS representatives.
    (7) Slaughter facility overall responsibility for process-
verification testing. The slaughter facility is responsible for 
obtaining testable samples and for ensuring that the correct number of 
testable samples are sent to the testing laboratory. Once the 
slaughtering facility receives the test results, it is responsible for 
reporting those results in its facility trichinae testing record. 
Moreover, the slaughter facility is responsible for ensuring that 
process-verification testing is carried out in accordance with this 
part, including the reporting of test results, regardless of whether it 
is performed at the slaughter facility or another location, and 
regardless of whether the testing is performed by slaughter facility 
personnel or other persons.



Sec.149.7  Recordkeeping at site.

    (a) Stage I enrolled sites, Stage II or Stage III certified sites, 
and any site that has been suspended or voluntarily decertified must 
maintain the following program records: Animal disposal plan, animal 
movement record, feed mill quality assurance affidavit (if applicable), 
and rodent control logbook. All such records must be readily available 
for inspection at the pork production site at the time of an audit by a 
QAV or QVMO, or by other APHIS representatives during normal business 
hours.
    (1) Animal disposal plan. The animal disposal plan must meet the 
following minimum requirements:
    (i) It must provide for the removal of all dead swine or swine 
remains from swine pens immediately upon detection. Inspections for 
purposes of detecting dead animals must occur at least once every 24 
hours.
    (ii) It must specify how often and at what intervals the swine pens 
are observed each day.

[[Page 1000]]

    (iii) It must provide for the proper storage of dead swine or swine 
remains in accordance with local, State, and Federal laws and 
regulations. If the carcass storage facility or composting facility is 
located on the site, then the animal disposal plan must provide for a 
storage or composting facility that precludes rodent or wildlife contact 
with dead swine or swine remains being stored or composted.
    (iv) It must provide for the disposal of swine and other mammals by 
rendering, incineration, composting, burial, or other means, as allowed 
by and in accordance with local, State, and Federal laws and 
regulations. For sites that use rendering services, the animal disposal 
plan also must include the name, address, and phone number of the 
renderer.
    (v) It must be updated as animal disposal practices are changed at 
the site.
    (vi) It must be signed and dated by the producer, as well as the 
caretaker of the site (if the caretaker is a different person than the 
producer).
    (vii) It may be valid for a period no longer than 2 years after the 
date of signature by the producer and (if applicable) the site 
caretaker.
    (2) Animal movement record. The animal movement record must meet the 
following minimum requirements:
    (i) It must be filled out completely and properly, accounting for 
the movement of all non-breeding swine into and from the pork production 
site.
    (ii) In the case of non-breeding swine coming into the site, it must 
include the date and number of arriving animals, as well as the PIN of 
the certified production site where the animals originated, or 
alternatively, if the swine are less than 5 weeks of age and originated 
from a noncertified site, the name and full address of the noncertified 
site where the animals originated. The animal movement record must 
clearly document that all non-breeding swine 5 weeks of age or older 
arriving at the site originated from another certified production site.
    (iii) In the case of non-breeding swine leaving the site, it must 
include the date and number of departing animals, and their destination.
    (iv) It must document the number of dead non-breeding swine that are 
removed from the site, as well as the number of dead non-breeding swine 
that are buried or composted at the site, if swine burial or composting 
is permitted in that State or locality.
    (v) All entries to the animal movement record must be signed or 
initialed and dated by the producer or other site caretaker making the 
entry.
    (3) Rodent control logbook. The rodent control logbook, which may 
include records from a pest control operator, must meet the following 
minimum requirements:
    (i) It must include a rodent control diagram for the site indicating 
the location of all rodent bait stations and rodent traps at the site. 
The diagram must be updated whenever bait stations are added, moved, or 
removed.
    (ii) It must document the number of rodent traps set (if 
applicable), the number of new rodent bait stations set, and how often 
bait is refreshed.
    (iii) It must document the disposal method for all unused bait that 
is replaced.
    (iv) It must document the brand name and active ingredient of bait, 
which must be EPA-registered and applied according to its label, as well 
as the quantity of bait used (number of pounds).
    (v) If possible, it should document the number of rodents caught or 
killed and indicate how many were rats.
    (vi) If possible, it should document the number of rats sighted 
monthly.
    (vii) All entries to the rodent control logbook must be signed or 
initialed, as well as dated by the producer or other site caretaker 
making the entry. It must be updated at least monthly.
    (4) Feed mill quality assurance affidavit. The feed mill quality 
assurance affidavit, to be used in conjunction with feed or feed 
ingredients delivered to the pork production site, must meet the 
following minimum requirements:
    (i) It must include the name of the producer and the identity of the 
site, including the PIN if it has been issued, and the site address, as 
well as the name and address of the feed mill and the name and title of 
the feed mill representative.

[[Page 1001]]

    (ii) It must provide information that the feed mill is following 
good manufacturing practices, and further specify, as evidence of these 
good manufacturing practices, the following:
    (A) That the feed mill has a rodent control system that is 
maintained by the feed mill itself or by a pest control firm (include 
name and address of pest control firm).
    (B) The frequency with which such rodent control system is 
maintained (i.e., on a weekly basis, etc.); and
    (C) That the feed mill maintains records of pest management 
practices or has records generated by a pest control operator, which 
must be made available to the producer upon request.
    (iii) It must be signed by the feed mill representative and by the 
producer or the producer's designated representative, to remain in 
effect for a period of 2 years.
    (b) All such records and other documentation required under this 
section must be retained at the pork production site for a period of 2 
years.
    (c) All such records and other documentation required under this 
section must be readily available for inspection at the pork production 
site at the time of an audit by a QAV or QVMO, or by other APHIS 
representatives during normal business hours.

(Approved by the Office of Management and Budget under control number 
0579-0323)



Sec.149.8  Program fees and charges.

    (a) Site audit. If a QVMO performs the site audit, then the producer 
will pay the QVMO at the time the site audit is performed in accordance 
with the rate and other conditions set by the QVMO's governmental 
employer. Further, if the QVMO who performs the site audit is employed 
by APHIS, then the producer will pay APHIS for this service at the 
hourly rate listed in table 1 for each employee required to perform the 
service. If the APHIS-employed QVMO performs the site audit on a Sunday, 
on a holiday, or at any time outside the normal tour of duty of that 
employee, then the producer will pay APHIS for this service at the 
hourly rate listed in table 2 for each employee required to perform the 
service. Payment to APHIS for the services of an APHIS-employed QVMO, by 
certified check or U.S. money order, must be remitted to the QVMO at the 
time the site audit is performed.

                   Table 1--Rates for Services of QVMO
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Hourly rate:
    Per hour.................................................     $84.00
    Per quarter hour.........................................      21.00
Per service minimum fee......................................      25.00
------------------------------------------------------------------------


  Table 2--Overtime Rates for Services of QVMO (Outside the Employee's
                          Normal Tour of Duty)
------------------------------------------------------------------------
 
------------------------------------------------------------------------
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
------------------------------------------------------------------------

    (b) Program fee. The producer must pay APHIS a program fee at the 
time of each site audit in the amount of $51 to cover APHIS' 
administrative costs in processing the audit and operating the program. 
This program fee, payable to APHIS by certified check or U.S. money 
order, is due at the time of submitting the completed site audit form 
for APHIS evaluation.
    (c) A producer will not be charged for the cost of having a spot 
audit performed at the pork production site.



Sec.149.9  Pilot program sites.

    Pork production sites participating in an APHIS-approved trichinae 
pilot program at the time of implementation of the Trichinae 
Certification Program on November 10, 2008 will maintain their same 
program status as either a Stage I enrolled, Stage II certified, or 
Stage III certified site, as well as their same program anniversary date 
for purposes of completing a site audit and submitting the completed 
audit form and payment.

[[Page 1002]]



                       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.
    The Act. Item 100.01 in part 1, schedule 1, of title I of the Tariff 
Act of 1930, as amended (19 U.S.C. 1202, schedule 1, part 1, item 
100.01).
    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Agent. Custom broker or other person authorized to act as agent for 
the importer or owner of an animal.
    Animal. Any purebred animal imported specially for breeding purposes 
except a black, silver, or platinum fox, or any fox which is a mutation 
or type developed therefrom.
    Animal and Plant Health Inspection Service. The Animal and Plant 
Health Inspection Service of the United States Department of Agriculture 
(APHIS).
    Book of record. A printed book or an approved microfilm record 
sponsored by a registry association and containing breeding data 
relative to a large number of registered purebred animals used as a 
basis for the issuance of pedigree certificates.
    Certificates of pure breeding. A certificate issued by the 
Administrator, for Bureau of Customs use only, certifying that the 
animal to which the certificate refers is a purebred animal of a 
recognized breed and duly registered in a book of record recognized 
under the regulations in this part for that breed.
    Department. The United States Department of Agriculture.
    Inspector. An inspector of APHIS or of the Bureau of Customs of the 
United States Treasury Department authorized to perform functions under 
the regulations in this part.
    Pedigree certificate. A document issued by a registry association 
giving the pedigree of an animal and certifying that it is registered in 
the book of record of the association issuing the document, and 
containing all pertinent information relating to the registered animal, 
such as color and natural and artificial markings, a record of the name 
and address of the breeder, and the name and address of each subsequent 
owner of the animal.
    Port of entry. Any port designated under 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 1003]]

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 1004]]

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 1005]]



                                 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  ......do........  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 1006]]

 
  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  ......do........  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 1007]]

 
  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  ......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.
  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 1008]]

 
  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  ......do........  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 1009]]

 
  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 1010]]

 
  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 1011]]

 
                                  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 
Standardbred horses registered therein: Provided, That no Standard bred 
so registered shall be certified under the act as purebred unless a 
pedigree certificate showing three complete generations of known and 
recorded purebred Standardbred ancestry, issued by the Canadian Standard 
Bred Horse Society, is submitted for each such horse.
    (5) Charolais cattle in canada (Code 1112). The full French book of 
record of the Canadian Charolais Association, Calgary, Alberta, Canada, 
is recognized for the Charolais breed registered therein.
    (6) Maine-Anjou cattle in Canada (Code 1113). The full French book 
of record of the Canadian Maine-Anjou Association, which is maintained 
by the Canadian National Live Stock Records, is recognized for the 
Maine-Anjou breed registered in the Canadian Maine-Anjou Herd Book: 
Provided, That no Maine-Anjou cattle so registered shall be certified 
under the act as purebred unless a pedigree certificate showing at least 
three generations of known and recorded purebred ancestry of the breed 
involved, issued by the Canadian National Live Stock Records, is 
submitted for each such animal.
    (7) Simmental cattle in Canada (Code 1114). The Canadian Simmental 
Association, Calgary, Alberta, Canada, of which Mr. John Kish is 
Executive Secretary, is recognized for the Simmental breed registered in 
the Canadian Simmental Association Full Blood Herd Book: Provided, That 
no simmental cattle so registered shall be certified under the act as 
purebred unless a pedigree certificate showing at least three 
generations of known and recorded purebred ancestry of the breed 
involved, issued by the Canadian Simmental Association is submitted for 
each such animal.
    (8) Hereford cattle in Canada (Code 1110). The Canadian Hereford 
Herd Book of The Canadian Hereford Association, 5160 Skyline Way NE., 
Calgary, Alberta, Canada, of which Dr. Duncan J. Porteous is General-
Manager, is recognized for the Hereford breed registered therein.

[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 at www.govinfo.gov.



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 affecting the registration of animals in 
said book.

[24 FR 2644, Apr. 7, 1959, as amended at 54 FR 34970, Aug. 23, 1989]

[[Page 1012]]



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 1013]]



       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 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.
    Department. The United States Department of Agriculture.
    Inspector. Any officer or employee of the Department of cooperating 
agency authorized to perform any duties at any plant furnished service 
under this part.
    Inspector in charge. An inspector of the Department assigned by the 
Administrator to supervise, review, and perform official work pertaining 
to a plant furnished service under this part.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, joint stock company, or other form of 
organization.

[23 FR 10111, Dec. 23, 1958, as amended at 57 FR 30899, July 13, 1992; 
62 FR 19040, Apr. 18, 1997; 72 FR 70766, Dec. 13, 2007]



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 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 to receive service under this part may 
apply therefor to the Administrator, upon an

[[Page 1014]]

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; 72 FR 70766, Dec. 13, 2007]



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; the requirements of part 130 of this title are met; 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; 72 FR 70766, Dec. 13, 2007]



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  User fees under 9 CFR part 130.

    User fees under part 130 of this chapter for service (including 
travel and other expenses incurred in connection with the furnishing of 
service) under this part shall be paid by the applicant. If required by 
the Administrator, the user fees under part 130 of this chapter shall be 
paid in advance. Since the user fees under part 130 of this chapter are 
for the purpose of reimbursing the Department for all costs incurred in 
connection with the furnishing of service under this part, the 
appropriate user fees under part 130 of this chapter to cover any such 
costs shall be paid even if service is withheld pursuant to Sec.156.8.

[72 FR 70766, Dec. 13, 2007]



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 
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

[[Page 1015]]

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 1016]]



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:
    Accreditation. The action of the Administrator initially approving a 
veterinarian in accordance with the provisions of part 161 of this 
subchapter to perform functions specified in subchapters B, C, D, and G 
of this chapter, in one State.
    Accredited veterinarian. A veterinarian approved by the 
Administrator in accordance with the provisions of part 161 of this 
subchapter to perform functions specified in subchapters B, C, D, and G 
of this chapter.
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service or any individual authorized to act for the 
Administrator.
    Animal, animals. All animals except humans, including but not 
limited to cattle, sheep, goats, other ruminants, swine, horses, asses, 
mules, zebras, birds, and poultry.
    Animal and Plant Health Inspection Service. The Animal and Plant 
Health Inspection Service, United States Department of Agriculture.
    APHIS. The Animal and Plant Health Inspection Service.
    Approved digital signature. Digital signatures approved by the 
Administrator for electronic transmission, for example, via a computer. 
To be approved, a digital signature must be able to verify the identity 
of the accredited veterinarian signing the document and indicate if the 
integrity of the data in the signed document was compromised.
    Authorization. The action of the Administrator approving an 
accredited veterinarian in accordance with the provisions of part 161 of 
this subchapter to perform functions specified in subchapters B, C, D, 
and G of this chapter, in a State or States other than the State in 
which the veterinarian was initially accredited.
    Category I animals. All animals except: Food and fiber species, 
horses, birds, farm-raised aquatic animals, all other livestock species, 
and zoo animals that can transmit exotic animal diseases to livestock.
    Category II animals. All animals.
    Examine, examination. Physical study of an individual animal that 
enables an accredited veterinarian to determine if any abnormality in 
physical condition or bodily function is suggestive of clinical signs of 
communicable disease.
    Herd or flock health plan. A written herd or flock health management 
plan, which may include an agreement signed by the owner of a herd or 
flock, the accredited veterinarian, and a State or APHIS representative, 
in which each participant agrees to undertake actions specified in the 
agreement to maintain the health of the animals and detect signs of 
communicable disease.
    Inspect, inspection. Visual study of the physical appearance, 
physical condition, and behavior of animals (singly or in groups) that 
enables an accredited veterinarian to determine whether any abnormality 
in physical condition or bodily function is evident.
    Issue. The distribution, including electronic transmission, of an 
official animal health document that has been signed.
    Official certificate, document, seal, form, record, report, tag, 
band, or other identification. Any certificate, document, seal, form, 
record, report, tag, band, or other identification, prescribed by 
statute or regulations, or prescribed by a State form approved by the 
Administrator, for use by an accredited veterinarian performing official 
functions under this subchapter.
    Qualified accredited veterinarian (QAV). An accredited veterinarian 
who has been granted a program certification by the Administrator 
pursuant to Sec.161.5 of this subchapter based on completion of an 
APHIS-approved orientation or training program.

[[Page 1017]]

    Regular health maintenance program. An arrangement between an 
accredited veterinarian and a livestock producer whereby the 
veterinarian inspects every animal on the premises of the producer at 
least once every 30 days.
    Sign, (Signed). For an accredited veterinarian to put his or her 
signature in his or her own hand, or by means of an approved digital 
signature, on a certificate, form, record, or report. No certificate, 
form, record, or report is signed if:
    (1) Someone other than the accredited veterinarian has signed it on 
behalf of or in the name of the accredited veterinarian, regardless of 
the authority granted them by the accredited veterinarian; or
    (2) If any mechanical device, other than an approved digital 
signature, has been used to affix the signature.
    State. Any State, the District of Columbia, Puerto Rico, Guam, the 
Northern Mariana Islands, the Virgin Islands of the United States, and 
any other territory or possession of the United States.
    State Animal Health Official. The State animal health official who 
is responsible for the livestock and poultry disease control and 
eradication programs of a State.
    Veterinary Official. The APHIS veterinarian who is assigned by the 
Administrator to supervise and perform the official work of APHIS in a 
State or group of States.

[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; 73 FR 60488, Oct. 
10, 2008; 74 FR 65010, Dec. 9, 2009; 85 FR 10564, Feb. 25, 2020]



PART 161_REQUIREMENTS AND STANDARDS FOR ACCREDITED VETERINARIANS AND 
SUSPENSION OR REVOCATION OF SUCH ACCREDITATION--Table of Contents



Sec.
161.1 Statement of purpose; requirements and application procedures for 
          accreditation.
161.2 Performance of accredited duties in additional States.
161.3 Renewal of accreditation.
161.4 Standards for accredited veterinarian duties.
161.5 Program certifications.
161.6 Suspension or revocation of veterinary accreditation and 
          reaccreditation; criminal and civil penalties.
161.7 Activities performed by non-accredited veterinarians.

    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; requirements and application procedures 
for accreditation.

    (a) This subchapter concerns a program administered by APHIS to 
accredit veterinarians and thereby authorize them to perform, on behalf 
of APHIS, certain activities specified in this chapter. This program is 
intended to ensure that an adequate number of qualified veterinarians 
are available in the United States to perform such activities.
    (b) Categories of accreditation. A veterinarian may be accredited as 
a Category I veterinarian or a Category II veterinarian. A veterinarian 
who is accredited under Category I is only authorized to perform 
accredited duties on Category I animals, as defined in Sec.160.1. A 
veterinarian who is accredited under Category II is authorized to 
perform accredited duties on both Category I animals and Category II 
animals.
    (c) Application for initial accreditation. A veterinarian may apply 
for accreditation by completing an application for accreditation and 
submitting it to APHIS. In completing the application, the veterinarian 
will choose one of the accreditation activity categories, either 
Category I or Category II, as discussed in paragraph (b) of this 
section. Applications for Category I accreditation must include 
certification that the applicant is able to perform the tasks listed in 
paragraph (g)(1) of this section. Applications for Category II 
accreditation must include certification that the applicant is able to 
perform the tasks listed in paragraph (g)(2) of this section. An 
accredited veterinarian must not perform duties requiring a program 
certification unless he or she is accredited under Category II and 
qualified to perform such duties in accordance with Sec.161.5 of this 
part.

[[Page 1018]]

    (d) Review of application. Applications for accreditation received 
by APHIS shall be forwarded to the State Animal Health Official for the 
State in which the veterinarian wishes to perform accredited duties for 
approval. Within 14 days after receiving an application, a State Animal 
Health Official shall either endorse the application or send a written 
statement to the Administrator explaining why it was not endorsed; but 
if the State Animal Health Official fails to take one of these actions 
within 14 days, APHIS shall proceed to review the application. The 
Administrator will review the application and the written statement, if 
any, and determine whether the applicant meets the requirements for 
accreditation contained in this part.
    (e) Accreditation requirements. The Administrator is hereby 
authorized to accredit a veterinarian when he or she determines that:
    (1) The veterinarian is a graduate with a Doctorate of Veterinary 
Medicine or an equivalent degree (any degree that qualifies the holder 
to be licensed by a State to practice veterinary medicine) from a 
college of veterinary medicine;
    (2) The veterinarian is licensed to practice veterinary medicine in 
the State in which the veterinarian wishes to perform accredited duties. 
An unlicensed veterinarian is legally able to practice veterinary 
medicine in a State provided that the veterinarian is granted written 
authorization by that State's veterinary licensing authority or given 
legal authority through State statute to provide veterinary services for 
a veterinary employer (such as a cooperative, corporation, laboratory, 
or other institution recognized by the State authority but not involving 
contact with animals owned by the public, or a college or school of 
veterinary medicine). Such authorizations may limit accredited duties to 
specific geographical areas and/or activities within the State. APHIS 
will confirm the licensing or legal status of the applicant by 
contacting the State board of veterinary medical examiners or any 
similar State organization that maintains records of veterinarians 
licensed or otherwise legally able to practice in a State;
    (3) The veterinarian has completed initial accreditation training, 
using content provided by APHIS; and
    (4) The veterinarian has completed an orientation program approved 
by the Veterinary Official for the State in which the veterinarian 
wishes to perform accredited duties, and upon completion of the 
orientation, has signed a written statement listing the date and place 
of orientation, the subjects covered in the orientation, and any written 
materials provided to the veterinarian at the orientation. The 
Veterinary Official shall also give the State Animal Health Official an 
opportunity to review the contents of the orientation, and invite him or 
her to participate in developing orientation materials and conducting 
the orientation. The veterinarian applying for accreditation must have 
completed the orientation program within 3 years prior to submitting the 
application for accreditation. The orientation program shall include the 
following topics:
    (i) Federal animal health laws, regulations, and rules;
    (ii) Interstate movement requirements for animals;
    (iii) Import and export requirements for animals;
    (iv) USDA animal disease eradication and control programs;
    (v) Laboratory support in confirming disease diagnoses;
    (vi) Ethical and professional responsibilities of an accredited 
veterinarian;
    (vii) Foreign animal disease awareness;
    (viii) Animal health emergency management; and
    (ix) Animal health procedures, issues, and information resources 
relevant to the State in which the veterinarian wishes to perform 
accredited duties.
    (f) Change in accreditation category--(1) Category I to Category II. 
A veterinarian who is accredited under Category I may become accredited 
under Category II if the veterinarian applies for accreditation under 
Category II by completing an application for accreditation, including 
certification that the applicant is able to perform the tasks listed in 
paragraph (g)(2) of this section, and submitting it to APHIS. The 
veterinarian must also have fulfilled the training requirements in Sec.
161.3(b)

[[Page 1019]]

that are associated with renewal of accreditation under Category II.
    (2) Category II to Category I. A veterinarian who is accredited 
under Category II may become accredited under Category I if the 
veterinarian applies for accreditation under Category I by completing an 
application for accreditation, including certification that the 
applicant is able to perform the tasks listed in paragraph (g)(1) of 
this section, and submitting it to APHIS. The veterinarian must also 
have fulfilled the training requirements in Sec.161.3(b) that are 
associated with renewal of accreditation under Category I.
    (g) Tasks that applicants for accredited status must be able to 
perform. Applicants for accredited status must be able to:
    (1) Category I. (i) Perform physical examination of individual 
Category I animals to determine whether they are free from any clinical 
signs suggestive of communicable disease.
    (ii) Recognize the common breeds of Category I animals and 
accurately record breed information on official documents.
    (iii) Apply common animal identification for Category I animals.
    (iv) Properly complete certificates for domestic and international 
movement of Category I animals.
    (v) Perform necropsies on Category I animals.
    (vi) Recognize and report clinical signs and lesions of exotic 
animal diseases that occur in Category I animals.
    (vii) Vaccinate Category I animals and accurately complete the 
vaccination certificates.
    (viii) Properly collect and ship specimen samples to the appropriate 
laboratory for testing with complete and accurate paperwork.
    (ix) Develop appropriate biosecurity protocols, as well as cleaning 
and disinfection protocols, to control communicable disease spread in 
Category I animals.
    (2) Category II. (i) Perform physical examination of individual 
animals and visually inspect herds or flocks to determine whether the 
animals are free from any clinical signs suggestive of communicable 
disease.
    (ii) Recognize the common breeds of Category I and Category II 
animals, including the types of poultry as defined by the National 
Poultry Improvement Plan in subchapter G of this chapter and the common 
breeds of livestock, and be able to accurately record breed information 
on official documents.
    (iii) Recognize all USDA animal identification systems.
    (iv) Estimate the age of livestock using a dental formula.
    (v) Apply USDA-recognized identification (e.g., eartag, microchip, 
tattoo) for the USDA animal identification system.
    (vi) Certify the health status of an avian flock regarding diseases 
of domestic or international regulatory concern, and evaluate records 
pertaining to poultry flock testing and participation in Federal and 
State poultry health programs and classifications.
    (vii) Properly complete certificates for domestic and international 
movement of animals.
    (viii) Apply and remove official seals.
    (ix) Perform necropsies on animals.
    (x) Recognize and report clinical signs and lesions of exotic animal 
diseases.
    (xi) Develop a herd or flock health plan consistent with 
requirements in subchapters B, C, D, and G of this chapter.
    (xii) Vaccinate for USDA program diseases and accurately complete 
the vaccination certificate.
    (xiii) Properly collect and ship sample specimens to an appropriate 
laboratory for testing with complete and accurate paperwork.
    (xiv) Properly perform testing for tuberculosis (e.g., caudal fold 
test).
    (xv) Develop appropriate biosecurity protocols, as well as cleaning 
and disinfection protocols, to control communicable disease spread.
    (xvi) Explain basic principles for control of diseases for which 
APHIS or APHIS-State cooperative programs presently exist.
    (h) Authorization to perform duties. An accredited veterinarian may 
not perform accredited duties in a State until after receiving written 
authorization from APHIS. If a Category I accredited veterinarian 
completes the necessary training requirements and becomes a Category II 
accredited veterinarian,

[[Page 1020]]

the veterinarian may not perform Category II accredited duties in a 
State until after receiving written authorization from APHIS.

(Approved by the Office of Management and Budget under control number 
0579-0297)

[57 FR 54912, Nov. 23, 1992, as amended at 74 FR 65010, Dec. 9, 2009; 85 
FR 10564, Feb. 25, 2020; 85 FR 41905, July 13, 2020]



Sec.161.2  Performance of accredited duties in additional States.

    (a) If an accredited veterinarian wishes to perform accredited 
duties in a State other than the State in which the veterinarian was 
initially accredited in accordance with Sec.161.1(e), the accredited 
veterinarian must complete an application to request authorization to 
perform accredited duties in the additional State from the Veterinary 
Official of that State. The Veterinary Official of the additional State 
may require the accredited veterinarian to complete, prior to performing 
any accredited duties in the additional State, an orientation in animal 
health procedures and issues relevant to the additional State. The 
Veterinary Official shall review the content of each such orientation 
and shall approve its use after determining that it includes adequate 
information about animal health agencies, regulatory requirements, 
administrative procedures, and animal disease issues in the additional 
State, to prepare an accredited veterinarian from another State to 
perform accredited duties in the additional State. The Veterinary 
Official shall also give the State Animal Health Official of the 
additional State an opportunity to review the contents of the 
orientation, and invite him or her to participate in developing 
orientation materials and conducting the orientation.
    (b) An accredited veterinarian may not perform accredited duties in 
a State in which the accredited veterinarian is not licensed or 
otherwise permitted by the State's veterinary licensing authority to 
practice veterinary medicine in that State without a license.
    (c) An accredited veterinarian may not perform accredited duties in 
a State other than the one in which the veterinarian was initially 
accredited until the veterinarian receives written authorization from 
APHIS to perform accredited duties in the additional State.

(Approved by the Office of Management and Budget under control numbers 
0579-0032 and 0579-0297)

[74 FR 65011, Dec. 9, 2009, as amended at 85 FR 10564, Feb. 25, 2020]



Sec.161.3  Renewal of accreditation.

    (a) Accredited veterinarians who wish to continue participating in 
the National Veterinary Accreditation Program must renew their 
accreditation every 3 years by completing an application for 
accreditation renewal and submitting it to APHIS. Newly accredited 
veterinarians must renew their accreditation within 3 years of 
completing the orientation program described in Sec.161.1(e)(4) of 
this part, regardless of when their accreditation was granted. Other 
veterinarians must renew their accreditation within 3 years of the 
previous renewal.
    (b) Accredited veterinarians who wish to renew their accreditation 
under Category I must complete 3 supplemental training units approved by 
APHIS by the end of their 3-year tenure as an accredited veterinarian. 
Accredited veterinarians who wish to renew their accreditation under 
Category II must complete 6 supplemental training units approved by 
APHIS by the end of their 3-year tenure as an accredited veterinarian. 
Accredited veterinarians who wish to change the category in which they 
are accredited, rather than renew accreditation in their current 
accreditation category, should follow the procedure in Sec.161.1(f) of 
this part.
    (c) Accredited veterinarians who do not complete the required 
training within 3 years as specified in paragraph (a) of this section 
will have their accredited status expire. Veterinarians whose 
accreditation has expired will not be allowed to perform accredited 
duties until they receive notification of their reinstatement from 
APHIS. Veterinarians who perform duties that only accredited 
veterinarians are authorized to perform while their accredited status 
has expired will be subject to such criminal and civil penalties as are 
provided by the Animal Health Protection Act (7 U.S.C. 8301 et seq.) or

[[Page 1021]]

other applicable Federal statutes or regulations. To be reinstated, the 
veterinarian must complete the necessary supplemental training units for 
the appropriate category and submit an application for renewal of 
veterinary accreditation to APHIS. A veterinarian who allows his or her 
accredited status to expire must have completed the required number of 
supplemental training units within 3 years of his or her application for 
renewal in order to be approved for renewal. Supplemental training units 
completed since the veterinarian's last renewal but more than 3 years 
before the veterinarian's application for renewal will not count towards 
fulfilling his or her training requirement.
    (d) Veterinarians who are accredited as of February 1, 2010, may 
continue to perform accredited duties between February 1, 2010, and the 
date of their first renewal. APHIS will provide notice for 3 months to 
accredited veterinarians who are accredited as of February 1, 2010, to 
notify them that they must elect to participate in the NVAP as a 
Category I or Category II veterinarian. Veterinarians must elect to 
continue to participate by October 1, 2011, or their accredited status 
will expire. When APHIS receives notice from an accredited veterinarian 
that he or she elects to participate, APHIS will notify the accredited 
veterinarian of his or her date for first renewal. The accredited 
veterinarian must then complete all the training requirements for 
renewal, as described in this section, by his or her first renewal date.

(Approved by the Office of Management and Budget under control number 
0579-0297)

[74 FR 65011, Dec. 9, 2009, as amended at 76 FR 52549, Aug. 23, 2011]



Sec.161.4  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 Veterinary Official and in accordance with any 
regulations and instructions issued to the accredited veterinarian by 
the Veterinary Official, and shall observe the following specific 
standards:
    (a) An accredited veterinarian shall not issue a certificate, form, 
record or report which reflects the results of any inspection, test, 
vaccination or treatment performed by him or her with respect to any 
animal, other than those in regular health maintenance programs, unless 
he or she has personally inspected that animal within 10 days prior to 
issuance. Inspections under this paragraph must be conducted in a 
location that allows the accredited veterinarian sufficient space to 
observe the animal in such a manner as to detect abnormalities related 
to areas such as, but not limited to, locomotion, body excretion, 
respiration, and skin conditions. An accredited veterinarian shall 
examine such an animal showing abnormalities, in order to determine 
whether or not there is clinical evidence compatible with the presence 
or absence of a communicable disease.
    (1) Following the first two inspections of a herd or flock as part 
of a regular health maintenance program, an accredited veterinarian 
shall not issue a certificate, form, record or report which reflects the 
results of any inspection, test, vaccination or treatment performed by 
him or her with respect to any animal in that program, unless he or she 
has personally inspected that animal within 10 days prior to issuance.
    (2) Following the third and subsequent inspections of a herd or 
flock in a regular health maintenance program, an accredited 
veterinarian shall not issue a certificate, form, record or report which 
reflects the results of any inspection, test, vaccination or treatment 
performed by him or her with respect to any animal in that program, 
unless he or she has personally inspected that animal within 30 days 
prior to issuance.
    (b) An accredited veterinarian shall not issue, or allow to be used, 
any certificate, form, record or report, until, and unless, it has been 
accurately and fully completed, clearly identifying the

[[Page 1022]]

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 Veterinary 
Official.
    (c) An accredited veterinarian shall not issue any certificate, 
form, record, or report which reflects the results of any inspection, 
test, vaccination, or treatment performed by another accredited 
veterinarian, unless:
    (1) The signing accredited veterinarian has exercised reasonable 
care, that is, a standard of care that a reasonably prudent person would 
use under the circumstances in the course of performing professional 
duties, to determine that the certificate, form, or report is accurate;
    (2) The certificate, form, or report indicates that the inspection, 
test, vaccination, or treatment was performed by the other accredited 
veterinarian; identifies the other accredited veterinarian by name; and 
includes the date and the place where such inspection, test, or 
vaccination was performed; and,
    (3) For a certificate, form, or report indicating results of a 
laboratory test, the signing accredited veterinarian shall keep a copy 
of the certificate, form, or report and shall attach to it either a copy 
of the test results issued by the laboratory, or a written record 
(including date and participants' names) of a conversation between the 
signing accredited veterinarian and the laboratory confirming the test 
results.
    (d) An accredited veterinarian shall perform official tests, 
inspections, treatments, and vaccinations and shall submit specimens to 
designated laboratories in accordance with Federal and State regulations 
and instructions issued to the accredited veterinarian by the Veterinary 
Official.
    (e) An accredited veterinarian shall identify or be physically 
present to supervise the identification of reactor animals by tagging or 
such other method as may be prescribed in instructions issued to him or 
her by the Veterinary Official or by a State Animal Health Official 
through the Veterinary Official.
    (f) An accredited veterinarian shall immediately report to the 
Veterinary Official and the State Animal Health Official all diagnosed 
or suspected cases of a communicable animal disease for which a APHIS 
has a control or eradication program in 9 CFR chapter I, and all 
diagnosed or suspected cases of any animal disease not known to exist in 
the United States as provided by 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 Veterinary Official, or by a State official through 
the Veterinary Official, governing the movement of animals, and on 
procedures applicable to disease control and eradication programs, 
including emergency programs.
    (i) An accredited veterinarian shall not use or dispense in any 
manner, any pharmaceutical, chemical, vaccine or serum, or other 
biological product authorized for use under any Federal regulation or 
cooperative disease eradication program, in contravention of applicable 
Federal or State statutes, regulations, and policies.
    (j) An accredited veterinarian shall be responsible for the security 
and proper use of all official certificates, forms, records, and 
reports; tags, bands, or other identification devices; and approved 
digital signature capabilities used in his or her work as an accredited 
veterinarian and shall take reasonable care to prevent the misuse 
thereof. An accredited veterinarian

[[Page 1023]]

shall immediately report to the Veterinary Official the loss, theft, or 
deliberate or accidental misuse of any such certificate, form, record, 
or report; tag, band, or other identification device; or approved 
digital signature capability.
    (k) An accredited veterinarian may issue an origin health 
certificate for export use pursuant to part 91 of this chapter without 
including test results from a laboratory, if the Veterinary Official has 
determined that such action is necessary to save time in order to meet 
an exportation schedule and agrees to add the test results to the 
certificate at a later time. In such cases, the accredited veterinarian 
shall state on a removable attachment to the certificate that such test 
results are to be added by the Veterinary Official.

[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. Redesignated at 74 FR 65011, Dec. 9, 2009, as 
amended at 85 FR 10565, Feb. 25, 2020]



Sec.161.5  Program certifications.

    A program certification recognized by the Administrator may be 
granted to an accredited veterinarian in Category II upon completion of 
an additional orientation or training program approved by APHIS that 
focuses on the specific area for which the veterinarian is seeking 
program certification. Veterinarians accredited under Category I are not 
eligible to earn program certifications. Accredited veterinarians may 
elect to participate in a program certification on a voluntary basis. 
Participants in these program certifications will be qualified in a 
particular area or specialty. In addition to Category II training, 
qualification for a program certification will include additional 
specialized training, which may include periodic training updates. For 
certain program certifications, the cost of orientation or training may 
be borne by the accredited veterinarian. An accredited veterinarian 
granted a program certification will be referred to as a qualified 
accredited veterinarian or QAV. A QAV will be authorized to perform 
those accredited duties related to the program certification he or she 
has earned; accredited veterinarians not granted program certifications 
will not be permitted to perform accredited duties related to that 
particular program certification. If a QAV allows his or her Category II 
accreditation to expire, the QAV's program certification expires as 
well, and the QAV must be qualified for the program certification again 
in accordance with this section.

[74 FR 65012, Dec. 9, 2009]



Sec.161.6  Suspension or revocation of veterinary accreditation 
and reaccreditation; 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.
161.4 of this part or with any of the other regulations in this 
subchapter, or is otherwise found to be unfit to be accredited. 
Veterinarians who perform duties that only accredited veterinarians are 
authorized to perform while their accredited status is suspended or 
revoked will be subject to such criminal and civil penalties as are 
provided by the Animal Health Protection Act (7 U.S.C. 8301 et seq.) or 
other applicable Federal statutes or regulations. Performing accredited 
duties while accreditation status is suspended or revoked will be 
considered grounds for the Administrator to suspend accreditation, 
revoke accreditation, or deny application for reaccreditation, as 
circumstances warrant. A veterinarian whose accreditation has been 
suspended or revoked or whose application for reaccreditation has been 
denied may request a hearing under Sec.162.13 to challenge the 
Administrator's decision.
    (b) Reinstatement after suspension. A veterinarian whose 
accreditation has been suspended for less than 6 months (other than a 
summary suspension that is changed to a revocation as a result of an 
adjudicatory proceeding) will be automatically reinstated as an 
accredited veterinarian upon completion of the suspension. A 
veterinarian whose accreditation has been suspended for 6 months or more 
must complete a reaccreditation orientation program in

[[Page 1024]]

accordance with paragraph (c)(2)(ii) of this section before 
accreditation will be reinstated.
    (c) Reaccreditation after revocation. A veterinarian whose 
accreditation has been revoked may apply for reaccreditation by 
completing an application for reaccreditation and submitting it to the 
Veterinary Official of the State or area where he or she wishes to 
perform accredited work. The application may be submitted when the 
revocation has been in effect for not less than 2 years, unless the 
revocation order specifies that the veterinarian whose accreditation has 
been revoked may not submit an application for reaccreditation until the 
revocation has been in effect for a period of time longer than 2 years.
    (1) Completed applications for reaccreditation received by a 
Veterinary Official shall be reviewed by the State Animal Health 
Official for the State in which the veterinarian wishes to perform 
accredited duties. Within 14 days after receiving an application, the 
State Animal Health Official shall either endorse the application or 
send a written statement to the Administrator explaining why it was not 
endorsed; but if the State Animal Health Official fails to take one of 
these actions within 14 days, the Veterinary Official shall proceed to 
review the application. The Administrator will review the application 
and the written statement, if any, and determine whether the applicant 
meets the requirements for reaccreditation contained in this part.
    (2) Once a veterinarian whose accreditation has been revoked has 
correctly applied for reaccreditation in accordance with the 
requirements of paragraph (c) of this section, the Administrator will 
determine whether to reaccredit or to deny reaccreditation. This 
determination will be based on whether the veterinarian has fulfilled 
the following conditions:
    (i) The veterinarian is licensed or legally able to practice 
veterinary medicine in the State in which the veterinarian wishes to 
perform accredited duties;
    (ii) The veterinarian has completed a reaccreditation orientation 
program approved by the Veterinary Official for the State in which the 
veterinarian wishes to perform accredited work, and upon completion of 
the orientation, has signed a written statement listing the date and 
place of orientation, the subjects covered in the orientation, and any 
written materials provided to the veterinarian at the orientation. The 
Veterinary Official shall also give the State Animal Health Official an 
opportunity to review the contents of the reaccreditation orientation, 
and invite him or her to participate in developing orientation materials 
and conducting the orientation. The orientation program shall include 
topics addressing the subject areas which led to loss of accreditation 
for the applicant, and subject areas which have changed since the 
applicant lost accreditation; and
    (iii) The professional integrity and reputation of the applicant 
support a conclusion that the applicant will faithfully fulfill the 
duties of an accredited veterinarian in the future. In making this 
conclusion, the Administrator shall review all available information 
about the applicant, including recommendations of the State Animal 
Health Official, and shall consider:
    (A) Any criminal conviction records indicating that the applicant 
may lack the honesty, integrity, and reliability to appropriately and 
effectively perform accredited duties and to uphold the integrity of the 
National Veterinary Accreditation Program;
    (B) Official records of the applicant's actions participating in 
Federal, State, or local veterinary programs;
    (C) Judicial determinations in civil litigation adversely reflecting 
on the honesty, integrity, and reliability of the applicant; and
    (D) Any other evidence reflecting on the honesty, professional 
integrity, reliability and reputation of the applicant.
    (3)(i) If a veterinarian is reaccredited under paragraph (c)(2) of 
this section, the veterinarian may begin performing accredited duties 
again upon receipt of notification from the Administrator that he or she 
is eligible to do so.
    (ii) If an application for reaccreditation is denied under paragraph 
(c)(2) of this section, the veterinarian may apply for reaccreditation 
in accordance with this paragraph (c) not less than 2

[[Page 1025]]

years after the application was last denied, unless the decision 
specifies that the veterinarian may not reapply for reaccreditation 
until a period of time longer than 2 years has passed.
    (d) Accreditation shall be automatically terminated when an 
accredited veterinarian is not licensed or legally able to practice 
veterinary medicine in at least one State.
    (e) Accreditation shall be automatically revoked when an accredited 
veterinarian is convicted of a crime in either State or Federal court, 
if such conviction is based on the performance or nonperformance of any 
act required of the veterinarian in his or her capacity as an accredited 
veterinarian.
    (f) Any accredited veterinarian who knowingly issues or signs a 
false, incorrect, or mislabeled animal health or inspection certificate, 
blood sample, official brucellosis vaccination certificate, or official 
tuberculin test certificate in accordance with this chapter, shall be 
subject to such civil penalties and such criminal liabilities as are 
provided by 7 U.S.C. 8313, 18 U.S.C. 1001, or other applicable Federal 
statutes. Such action may be in addition to, or in lieu of, suspension 
or revocation of accredited veterinarian status in accordance with this 
section.
    (g) Notice of warning. In lieu of suspension or revocation, the 
Administrator is authorized to issue a written notice of warning to an 
accredited veterinarian when the Administrator determines a notice of 
warning will be adequate to attain compliance with the Standards for 
Accredited Veterinarian Duties in Sec.161.4 of this part.

[57 FR 54912, Nov. 23, 1992, as amended at 68 FR 6346, Feb. 7, 2003. 
Redesignated and amended at 74 FR 65011, 65012, Dec. 9, 2009; 85 FR 
10565, Feb. 25, 2020]



Sec.161.7  Activities performed by non-accredited veterinarians.

    (a) Full-time Federal (including military) and State employed 
veterinarians are authorized to perform functions specified in 
subchapters B, C, D, and G of this chapter, pursuant to delegation of 
authority by the Administrator or cooperative agreements, without 
specific accreditation under the provisions of this subchapter.
    (b) Except as provided by paragraph (a) of this section, anyone who 
performs accredited veterinarian duties that he or she is not authorized 
to perform will be subject to such criminal and civil penalties as are 
provided by the Animal Health Protection Act (7 U.S.C. 8301 et seq.) or 
other applicable Federal statutes or regulations. Performing accredited 
duties without having been accredited will be considered grounds for the 
Administrator to deny an application for accreditation.

[74 FR 65013, Dec. 9, 2009, as amended at 85 FR 10565, Feb. 25, 2020]



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 or revocation 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.

[[Page 1026]]



                Subpart B_Supplemental Rules of Practice



Sec.162.10  Summary suspension or revocation of accreditation 
of veterinarians.

    In any situation where the Administrator has reason to believe that 
any veterinarian accredited under the provisions of parts 160 and 161 of 
this subchapter has knowingly violated the Animal Health Protection Act 
(7 U.S.C. 8301 et seq.), the Administrator may summarily suspend the 
accreditation of such veterinarian pending final determination in either 
a suspension or revocation proceeding, effective upon oral or written 
notification, whichever is earlier. In the event of oral notification, a 
written confirmation thereof shall be given to such veterinarian as 
promptly as circumstances permit.

[74 FR 65013, Dec. 9, 2009]



Sec.162.11  Notification.

    The Veterinary Official shall notify an accredited veterinarian when 
there is reason to believe that the accredited veterinarian has not 
complied with the ``Standards for Accredited Veterinarian Duties'' as 
contained in Sec.161.4 of this subchapter. The notification shall be 
in writing, with a copy to the State Animal Health Official, and shall 
include a statement of the basis for the belief that the accredited 
veterinarian has failed to comply with the Standards and shall notify 
the accredited veterinarian if the Veterinary Official has arranged to 
hold an informal conference to discuss the matter.

[57 FR 54915, Nov. 23, 1992, as amended at 75 FR 57658, Sept. 22, 2010; 
85 FR 10565, Feb. 25, 2020]



Sec.162.12  Informal conference.

    (a) The Veterinary Official, in consultation with the State Animal 
Health Official and the accredited veterinarian, shall designate the 
time and place for the holding of an informal conference to review the 
matter, unless the Veterinary Official determines that an informal 
conference is inappropriate. An informal conference is inappropriate 
only if the Veterinary Official decides to dismiss the case based on 
available facts, or if civil or criminal charges based on the actions or 
inactions believed to be in violation of the ``Standards for Accredited 
Veterinarian Duties'' contained in Sec.161.4 of this subchapter are 
pending against the accredited veterinarian. An informal conference 
shall include the Veterinary Official or his or her representative, the 
accredited veterinarian, and any other persons the Veterinary Official 
requests to attend due to their involvement in or knowledge of the 
possible violation. The State Animal Health Official will be invited to 
attend each informal conference held regarding activities in his or her 
State.
    (b) If prior to, during, or after the informal conference, but prior 
to the issuance of a formal complaint, the accredited veterinarian is 
found not to have violated the regulations, the Veterinary Official will 
issue a letter dismissing the case, and provide a copy of the letter to 
the accredited veterinarian and to the State Animal Health Official. 
Prior to, during, or after the informal conference, the Veterinary 
Official may issue a letter identifying actions of the accredited 
veterinarian that were minor violations of the Standards, instructing 
the accredited veterinarian in proper procedures, and admonishing the 
accredited veterinarian to use greater care in performing these 
procedures in the future.
    (c) Prior to, during, or at the conclusion of the informal 
conference, the Veterinary Official may issue a written warning to the 
accredited veterinarian without further procedure after determining that 
a warning with appropriate instructions will be adequate to attain 
compliance with the Standards.
    (d) If prior to, during, or at the conclusion of, the informal 
conference, the accredited veterinarian consents, in writing, to the 
issuance of an order revoking or suspending his or her accreditation for 
a specified period of time, in lieu of further procedure, the Veterinary 
Official may issue such a consent order without further procedure.

[57 FR 54915, Nov. 23, 1992; 57 FR 60086, Dec. 18, 1992, as amended at 
74 FR 65013, Dec. 9, 2009; 75 FR 57659, Sept. 22, 2010; 85 FR 10565, 
Feb. 25, 2020]

[[Page 1027]]



Sec.162.13  Formal complaint.

    If a consent order has not been issued, or if, after an informal 
conference, the Veterinary Official has not issued a letter of dismissal 
or letter of warning to the accredited veterinarian, a formal complaint 
may be issued by the Administrator in accordance with Sec.1.135 of the 
Uniform Rules of Practice (7 CFR 1.135).

[57 FR 54915, Nov. 23, 1992, as amended at 85 FR 10565, Feb. 25, 2020]

[[Page 1028]]



                     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 1029]]



                  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 1030]]

    Processed product. Material derived in whole or in part from the 
meat of any animal (including fish and poultry) or other animal 
material, and other refuse of any character whatsoever that has been 
associated with any such material, that has undergone an industrial 
manufacturing procedure to prevent spoilage or add shelf stability, and 
that has, at a minimum, been cooked to a temperature of 167 [deg]F (75 
[deg]C) for at least 30 minutes or has been subjected to an industrial 
process demonstrated to provide an equivalent level of inactivation of 
disease organisms, as approved by the Administrator.
    Rendered product. Waste material derived in whole or in part from 
the meat of any animal (including fish and poultry) or other animal 
material, and other refuse of any character whatsoever that has been 
associated with any such material, resulting from the handling, 
preparation, cooking or consumption of food that has been ground and 
heated to a minimum temperature of 230 [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; 74 FR 15218, Apr. 3, 2009]



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: Processed products; rendered products; bakery waste; 
candy waste; eggs; domestic dairy products (including milk); fish from 
the Atlantic Ocean within 200 miles of the continental United States or 
Canada; or fish from inland waters of the United States or Canada which 
do not flow into the Pacific Ocean.
    (b) No person operating such a facility may be licensed to treat 
garbage unless he or she meets the requirements of this part designed to 
prevent the introduction or dissemination of any infectious or 
communicable disease of animals and unless the facility is so 
constructed that swine are unable to have access to untreated garbage or 
equipment and material coming in contact with untreated garbage.
    (c) The regulations of this part shall not be construed to repeal or 
supersede State laws that prohibit feeding of garbage to swine or to 
prohibit any State from enforcing requirements relating to the treatment 
of garbage that is to be fed to swine or the feeding thereof which are 
more stringent than the requirements contained in this part. In a State 
which prohibits the feeding of garbage to swine, a license under the Act 
will not be issued to any applicant.

[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; 74 FR 15218, Apr. 3, 
2009]



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

[[Page 1031]]

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 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

[[Page 1032]]

and fed to swine shall apply for a license on a form which will be 
furnished, upon request, by the Area Veterinarian in Charge or, in 
States with primary enforcement responsibility, by the State animal 
health official in the State in which the person operates or intends to 
operate. When a person operates more than one treatment facility, a 
separate application to be licensed shall be made for each facility. 
Exemptions to the requirements of this paragraph may be granted in 
States other than those with primary enforcement responsibility by the 
Administrator, if he finds that there would not be a risk to the swine 
industry in the United States. Any person operating or desiring to 
operate a facility to treat garbage to be fed to swine who would 
otherwise be required under this part to obtain a license to treat 
garbage only because it contains one or more of the items allowed to be 
fed to swine under 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

[[Page 1033]]

rules of practice which shall be adopted for the proceeding.
    (b) Summary suspension. If the Administrator has reason to believe 
that any licensee has not complied or is not complying with any 
provisions of the Act or regulations in this part and the Administrator 
deems such action necessary in order to protect the public health, 
interest, or safety, the Administrator may summarily suspend the license 
of such persons pending a final determination in formal proceedings and 
any judicial review thereof, effective upon verbal or written notice of 
such suspension and the reasons therefor. In the event of verbal 
notification, written confirmation shall follow as soon as circumstances 
permit. This summary suspension shall continue in effect pending the 
completion of the proceeding and any judicial review thereof, unless 
otherwise ordered by the Administrator.
    (c) The license of a person shall be automatically revoked, without 
action of the Administrator, upon the final effective date of the second 
criminal conviction of such person, as is stated in section 5(c) of the 
Act. The licensee will be notified in writing of such revocation by the 
Area Veterinarian in Charge or, in States having primary enforcement 
responsibility, by the State animal health official.
    (d) Any person whose license has been suspended or revoked for any 
reason shall not be licensed in such person's own name or in any other 
manner, nor shall any of such person's employees be licensed for the 
purpose of operating the facility owned or operated by said licensee 
while the order of suspension or revocation is in effect. Any person 
whose license has been revoked shall not be eligible to apply for a new 
license for a period of 1 year from the effective date of such 
revocation. Any person who desires the reinstatement of a license that 
has been revoked must follow the procedure for new licensees set forth 
in 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 referenced in 
Sec.166.15(a), the State animal health official shall cancel the 
license of a licensee when the Area Veterinarian in Charge or, in States 
referenced in Sec.166.15(a), the State animal health official finds 
that no garbage has been treated for a period of 4 consecutive months at 
the facility operated by the licensee. Before such action is taken, the 
licensee of the facility will be informed in writing of the reasons for 
the proposed action and be given an opportunity to respond in writing. 
In those instances where there is a conflict as to the facts, the 
licensee shall, upon request, be afforded a hearing in accordance with 
rules of practice which shall be adopted for the proceeding.
    (b) Any licensee may voluntarily have his or her license canceled by 
requesting such cancellation in writing and sending such request to the 
Area Veterinarian in Charge, \1\ or, in States referenced in Sec.
166.15(a), to the State animal health official. The Area Veterinarian in 
Charge or, in States referenced in Sec.166.15(a), the State animal 
health official shall cancel such license and shall notify the licensee 
of the cancellation in writing.
---------------------------------------------------------------------------

    \1\ To find the name and address of the Area Veterinarian in Charge, 
go to https://www.aphis.usda.gov/ animal_health/contacts/ field-
operations-districts.pdf.
---------------------------------------------------------------------------

    (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.

[52 FR 4891, Feb. 18, 1987, as amended at 56 FR 26899, June 12, 1991; 59 
FR 67618, Dec. 30, 1994; 84 FR 64415, Nov. 22, 2019]



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:

[[Page 1034]]

    (1) Inspect the facility, including cooker function;
    (2) Take samples of garbage;
    (3) Observe and physically inspect the health status of all species 
of animals on the premises;
    (4) Review records and make copies of such records; and
    (5) Take photographs. A copy of each photograph will be provided to 
the licensee within 14 days.
    (b) A licensee shall notify an inspector immediately upon detection 
of illness or death not normally associated with the licensee's 
operation in any animal species on the licensee's premises.
    (c) A licensee shall notify an inspector or the State animal health 
official or the Area Veterinarian in Charge, as appropriate, of any 
change in the name, address, management or substantial control or 
ownership of his business or operation within 30 days after making such 
change.
    (d) A licensee shall supply, upon request by an inspector, 
information concerning sources of garbage. Such information shall 
include the dates of supply and the names and addresses of the person 
and/or organization from which the garbage was received.

(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

[[Page 1035]]

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 Animal and Plant Health Inspection Service (APHIS) will 
maintain on its website \2\ the following lists of States:
    (1) States that prohibit the feeding of garbage to swine;
    (2) States that allow the feeding of treated garbage to swine;
    (3) States that have primary enforcement responsibility under the 
Act; and
    (4) States that issue licenses under cooperative agreements with 
APHIS, but do not have primary responsibility under the Act.
    (b) For information concerning the feeding of garbage to swine, the 
public may contact the APHIS Area Veterinarian in Charge, the State 
animal health official, or Veterinary Services, 4700 River Road, Unit 
37, Riverdale, MD 20737-1231. \2\
---------------------------------------------------------------------------

    \2\ https://www.aphis.usda.gov/ aphis/ourfocus/animalhealth/animal-
disease-information/ swine-disease-information.

84 FR 64415, Nov. 22, 2019]



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 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 1037]]



                              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.


  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 1039]]



                    Table of CFR Titles and Chapters




                     (Revised as of January 1, 2021)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 1040]]

     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)
      XXIX  Department of Labor (Parts 2900--2999)
       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
     XXXVI  Office of National Drug Control Policy, Executive 
                Office of the President (Parts 3600--3699)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)
       LIX  Gulf Coast Ecosystem Restoration Council (Parts 5900--
                5999)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)

                   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)
        IV  Office of Personnel Management and Office of the 
                Director of National Intelligence (Parts 1400--
                1499)
         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 (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600--3699)

[[Page 1041]]

    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  U.S. International Development Finance Corporation 
                (Parts 4300--4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
     XXXVI  Department of Homeland Security (Parts 4600--4699)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)

[[Page 1042]]

     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
    XCVIII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)
      XCIX  Military Compensation and Retirement Modernization 
                Commission (Parts 9900--9999)
         C  National Council on Disability (Parts 10000--10049)
        CI  National Mediation Board (Part 10101)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--199)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         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  Agricultural Marketing Service (Federal Grain 
                Inspection Service, Fair Trade Practices Program), 
                Department of Agriculture (Parts 800--899)

[[Page 1043]]

        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  [Reserved]
      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  [Reserved]
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      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 Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      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  National Institute of Food and 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)

[[Page 1044]]

         L  Rural Business-Cooperative Service, Rural Housing 
                Service, and Rural Utilities Service, Department 
                of Agriculture (Parts 5001--5099)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (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  Agricultural Marketing Service (Federal Grain 
                Inspection Service, Fair Trade Practices Program), 
                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)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      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  (Parts 500--599) [Reserved]
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  (Parts 900--999) [Reserved]

[[Page 1045]]

         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research (Parts 1600--1699)
      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 (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (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--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 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)

[[Page 1046]]

      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  National Technical Information Service, 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) [Reserved]

                    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)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. 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  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599) [Reserved]

[[Page 1047]]

                     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  Office of Workers' Compensation Programs, 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 Service, 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 (Parts 900--999)
         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)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       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)

[[Page 1048]]

                          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)
      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)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799) [Reserved]
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099) [Reserved]
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

[[Page 1049]]

                           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--899)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900--999)
        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 (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           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--799)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       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)

[[Page 1050]]

        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  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 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)

[[Page 1051]]

      VIII  Office of Investment Security, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      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  Department of Defense, Defense Logistics Agency (Parts 
                1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     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, Department 
                of Defense (Parts 200--399)
        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)

[[Page 1052]]

       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Career, Technical, and Adult Education, 
                Department of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599) 
                [Reserved]
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  (Parts 1100--1199) [Reserved]
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             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)
        VI  [Reserved]
       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 (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  U.S. Copyright Office, Library of Congress (Parts 
                200--299)
       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  National Institute of Standards and Technology, 
                Department of Commerce (Parts 400--599)

[[Page 1053]]

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory 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)
      VIII  Gulf Coast Ecosystem Restoration Council (Parts 1800--
                1899)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            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)
   62--100  [Reserved]
            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)
  103--104  (Parts 103-001--104-099) [Reserved]
       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)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]

[[Page 1054]]

            Subtitle E--Federal Information Resources Management 
                Regulations System [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 303-1--303-99)
       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)
   II--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   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 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             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
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)

[[Page 1055]]

       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)
        IX  Denali Commission (Parts 900--999)
         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  Administration for Children and Families, 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 of Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Parts 2300--2399)
      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)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)

[[Page 1056]]

        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)
         V  The First Responder Network Authority (Parts 500--599)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, 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  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)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199) [Reserved]
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]

[[Page 1057]]

        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        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  Pipeline and Hazardous Materials Safety 
                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 (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   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)
         V  Marine Mammal Commission (Parts 500--599)

[[Page 1058]]

        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 1059]]





           Alphabetical List of Agencies Appearing in the CFR




                     (Revised as of January 1, 2021)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, VIII, IX, X, XI; 9, 
                                                  II
Agricultural Research Service                     7, V
Agriculture, Department of                        2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, VIII, IX, X, XI; 9, 
                                                  II
  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
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 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
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  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 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 of                          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
Architectural and Transportation Barriers         36, XI
   Compliance Board
[[Page 1060]]

Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI; 38, II
Army, Department of                               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
Career, Technical, and Adult Education, Office    34, IV
     of
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazard Investigation Board    40, VI
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X, XIII
Civil Rights, Commission on                       5, LXVIII; 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 of                           2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  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; 37, IV
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Technical Information Service          15, XI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Secretary of Commerce, Office of                15, Subtitle A
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 Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I
Defense, Department of                            2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III; 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I

[[Page 1061]]

  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy, Department of                             32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 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
Denali Commission                                 45, IX
Disability, National Council on                   5, C; 34, XII
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical, and Adult Education, Office  34, IV
       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
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
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 Policy, National Commission for        1, IV
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 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                   2, XV; 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
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, II
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
       States
Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV

[[Page 1062]]

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                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
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 Agency                    5, LXXX; 12, XII
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
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
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
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 Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F

[[Page 1063]]

  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 Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Gulf Coast Ecosystem Restoration Council          2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 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, XIII
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 5, XXXVI; 6, I; 8, 
                                                  I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Housing and Urban Development, Department of      2, XXIV; 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
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Independent Counsel, Offices of                   28, VI
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
Industry and Security, Bureau of                  15, VII

[[Page 1064]]

Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior, Department of                           2, XIV
  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
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Safety and Enforcement Bureau, Bureau of        30, II
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  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 Development Finance Corporation,    5, XXXIII; 22, VII
     U.S.
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
Investment Security, Office of                    31, VIII
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 of                            2, XXVIII; 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
  Independent Counsel, Offices of                 28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor, Department of                              2, XXIX; 5, XLII
  Benefits Review Board                           20, VII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment Standards Administration             20, VI
  Employment and Training Administration          20, V
  Federal Acquisition Regulation                  48, 29
  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50

[[Page 1065]]

  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
  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, VI
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Libraries and Information Science, National       45, XVII
     Commission on
Library of Congress                               36, VII
  Copyright Royalty Board                         37, III
  U.S. Copyright Office                           37, II
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, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Military Compensation and Retirement              5, XCIX
     Modernization Commission
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
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
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 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   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV, VI
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           2, XXXVI; 21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Geospatial-Intelligence Agency           32, I
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II; 37, IV
National Intelligence, Office of Director of      5, IV; 32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          5, CI; 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                       2, XXV; 5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI; 47, II
National Security Council and Office of Science   47, II
   and Technology Policy
[[Page 1066]]

National Technical Information Service            15, XI
National Telecommunications and Information       15, XXIII; 47, III, IV, V
     Administration
National Transportation Safety Board              49, VIII
Natural Resource Revenue, Office of               30, XII
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy, Department of                               32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
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                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, IV, 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
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory 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
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Contracts, Department of Labor             41, 50
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Utilities Service                           7, XVII, XVIII, XLII
Safety and Environmental Enforcement, Bureau of   30, II
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                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI

[[Page 1067]]

Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State, Department of                              2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  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; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  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 of the                       2, X; 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                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
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
U.S. Copyright Office                             37, II
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs, Department of                   2, VIII; 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
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVIII

[[Page 1069]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2016 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, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.govinfo.gov. For changes to this volume of the 
CFR prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 
1964-1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. 
The ``List of CFR Sections Affected 1986-2000'' is available at 
www.govinfo.gov.

                                  2016

9 CFR
                                                                   81 FR
                                                                    Page
Chapter I
53.2 (b) revised; interim...........................................6750
53.3 Heading revised; (a) amended; (e) added; interim...............6750
53.4 Heading revised; (b) added; interim............................6750
53.9 Heading revised; amended; interim..............................6750
53.10 (c) and (d) amended; (g) added; interim.......................6750
53.11 Added; interim................................................6750
56.1 Amended.......................................................53249
77.7 (a) amended; interim..........................................52326
77.9 (a) amended; interim..........................................52326
91 Revised..........................................................2980
91.3 (a)(2) revised................................................74279
93.101 (d) introductory text footnote 4 and (f)(2)(iii)(B) 
        introductory text amended..................................40151
93.103 (a)(1) introductory text footnote 8 amended.................40151
93.206 (c) added...................................................40151
93.215 (a)(2) amended..............................................40151
93.305 (c) added...................................................40151
93.407 (c) added...................................................40151
93.421 (a)(2) amended..............................................40151
93.506 (c) added...................................................40151
93.519 (a)(2) amended..............................................40151
93.704 (b) revised.................................................40151
93.802 (b) revised.................................................40151
93.804 Introductory text amended...................................40151
93.905 (b) added...................................................40152
94.6 (d) amended...................................................40152
94.15 (b)(1) and (c)(1) amended....................................40152
94.24 (b)(2) revised...............................................40152
94.27 (b) introductory text amended................................40152
101.3 (q) added....................................................59433
103.3 (d) revised..................................................59433
112.2 (a)(1) through (5), (7), (10), (d)(3), (e) and (f) revised; 
        (a)(6) and (9)(iv) amended.................................59433
    (a)(12) added..................................................78500
112.3 (f)(2) revised...............................................59434
112.5 (a) correctly amended........................................47005
    (a) and (d)(2)(vi) amended; (d)(2)(ii), (v), (e)(1)(iii), 
(iv), (4) and (f)(1) revised; (d)(2)(vii) through (x) added; 
(f)(2) removed; (f)(3) redesignated as new (f)(2)..................59435
112.6 (a) revised..................................................59435
112.7 (e), (f), (i) and (l) revised; (n) added.....................59435
113.206 (d)(2) amended.............................................59436
114.11 Revised.....................................................59436
145.2 (d) amended..................................................53249
145.3 (a) through (f) redesignated as (b) through (g); new (a) 
        added......................................................53249
145.12 (b) amended.................................................53249
145.14 (a)(5) and (b)(1) revised...................................53249
145.42 (b) revised.................................................53249

[[Page 1070]]

145.53 (c)(1)(i), (ii) introductory text, (A), (d)(1)(i), (ii) 
        introductory text and (A) revised..........................53249
145.83 (f)(1)(i) and (3) revised; (f)(1)(ii) and (iii) removed; 
        (f)(1)(iv) through (viii) redesignated as new (f)(1)(ii) 
        through (vi); new (f)(1)(v) and (vi) amended...............53250
145.92 (b) revised.................................................53250
145.93 (c)(3) amended..............................................53250
146.1 Amended......................................................53250
146.2 (c) revised..................................................53250
146.3 (a) amended..................................................53250
146.11 (b) revised.................................................53250
146.51 Amended.....................................................53250
146.52 (a) and (c) revised.........................................53250
146.53 (a) introductory text amended; (a)(4) and (5) added.........53250
147.52 (d) revised.................................................53251
147.54 Revised.....................................................53251

                                  2017

9 CFR
                                                                   82 FR
                                                                    Page
Chapter I
94.29 (i) amended...................................................6212
    (g) revised; OMB numbers.......................................42732
121.1 Amended.......................................................6206
    Regulation at 82 FR 6206 eff. date delayed to 3-21-17..........10855
121.3 (d)(3) redesignated as (d)(4); new (d)(3), (5) through (9) 
        and (e)(3) added; (d)(2) and new (4) revised................6207
    Regulation at 82 FR 6207 eff. date delayed to 3-21-17..........10855
121.4 (c)(1) footnote 4 and (d)(3) redesignated as (c)(1) footnote 
        6 and (d)(9); (c)(2) introductory text amended; (d)(2) 
        revised; new (d)(3) through (8) and (e)(3) added............6207
    Regulation at 82 FR 6207 eff. date delayed to 3-21-17..........10855
121.5 (a) revised...................................................6208
    Regulation at 82 FR 6208 eff. date delayed to 3-21-17..........10855
121.6 (a)(2) amended; (a)(3) redesignated as (a)(4); new (a)(3) 
        added; (a)(1) and new (4) revised...........................6208
    Regulation at 82 FR 6208 eff. date delayed to 3-21-17..........10855
121.7 (b) through (k) redesignated as (c) through (l); new (b) 
        added; new (d)(3) introductory text footnote 6 and new 
        (i)(1) footnote 7 redesignated as footnote 8 and footnote 
        9...........................................................6208
    Regulation at 82 FR 6208 eff. date delayed to 3-21-17..........10855
121.8 Footnote 8 redesignated as footnote 10........................6208
    Regulation at 82 FR 6208 eff. date delayed to 3-21-17..........10855
121.9 (a)(1) through (6) amended; (a)(7), (8) and (9) added.........6208
    Regulation at 82 FR 6208 eff. date delayed to 3-21-17..........10855
121.10 (e) amended..................................................6209
    Regulation at 82 FR 6209 eff. date delayed to 3-21-17..........10855
121.11 (c)(5), (d)(7)(iv) and (h) amended; (d)(7)(vi) added.........6209
    Regulation at 82 FR 6209 eff. date delayed to 3-21-17..........10855
121.12 (a) revised; (c)(2) removed; (c)(3) redesignated as new 
        (c)(2); new (c)(2) and (e) amended..........................6209
    Regulation at 82 FR 6209 eff. date delayed to 3-21-17..........10855
121.14 Heading footnote 10 and (a) footnote 11 redesignated as 
        footnote 12 and footnote 13; (a) and (f) amended............6209
    Regulation at 82 FR 6209 eff. date delayed to 3-21-17..........10855
121.15 (a) revised; (e) added.......................................6209
    Regulation at 82 FR 6209 eff. date delayed to 3-21-17..........10855
121.16 (a) footnote 12 redesignated as footnote 14; (b) 
        introductory text revised; (l) added........................6210
    Regulation at 82 FR 6210 eff. date delayed to 3-21-17..........10855
121.17 (a)(1)(iii), (3)(v), (6) and (7) amended; (a)(1)(v), (b) 
        and (c) revised; (a)(8) added...............................6210
    Regulation at 82 FR 6210 eff. date delayed to 3-21-17..........10855

                                  2018

9 CFR
                                                                   83 FR
                                                                    Page
Chapter I
1.1 Amended........................................................25554
2.1 (a)(3)(iii), (vii), and (c)(2) revised.........................25555

[[Page 1071]]

3.6 (a)(2)(xii) revised; (b)(1)(i) and (ii) introductory text 
        removed; (b)(1)(ii)(A), (B), (C), (iii), and (iv) 
        redesignated as (b)(1)(i) through (v)......................25555
3.80 (b)(1) and (2) introductory text removed; (b)(2)(i) through 
        (iv) redesignated as (b)(1) through (4); new (b)(1) 
        footnote 4, new (2), new (4), and (c) amended..............25555
3.127 (d)(5) amended...............................................25555
53 Heading revised.................................................15492
53.1 Amended................................................15492, 40438
53.2 Regulation at 81 FR 6750 confirmed............................40433
53.3 Regulation at 81 FR 6750 confirmed............................40433
53.4 Regulation at 81 FR 6750 confirmed............................40433
53.9 Regulation at 81 FR 6750 confirmed............................40433
53.10 Regulation at 81 FR 6750 confirmed...........................40433
53.10 (g) introductory text removed; (g)(1) revised; OMB number....40438
53.11 Regulation at 81 FR 6750 confirmed...........................40433
53.11 (e) and (f) added; OMB number................................40438
71.3 (b) amended...................................................15492
91 Authority citation revised......................................15492
93.404 (a)(2), (c) heading, introductory text, and (4) amended.....15492
93.405 (a)(1) amended..............................................15492
93.427 (c)(1) and (e)(3)(i) revised; eff. 1-14-19..................64225
93.504 (a)(2), (c) heading, introductory text, and (4) amended.....15492
93.505 (a) amended.................................................15492
94 Authority citation revised......................................15493
94 Heading revised.................................................15493
94.1 Heading, (a) introductory text, and (2) revised; (a)(1) (b), 
        (c), and (d) introductory text amended.....................15493
94.2 Amended.......................................................15493
94.3 Amended.......................................................15493
94.4 Heading revised; section amended..............................15493
94.11 (a)(1) revised; (a)(3) and (c) amended.......................15493
94.16 (b) introductory text, (c) introductory text, and (d) 
        amended....................................................15493
94.17 Heading and (m)(1) revised; (b) and (c) amended..............15493
95.1 Amended.......................................................15493
95.3 Revised.......................................................15493
95.16 (a)(1) and (3)(ii) amended...................................15493
95.17 (c) amended..................................................15494
95.18 (a) and (c) amended..........................................15494
95.19 (c) amended..................................................15494
95.20 (a) amended; (c) revised.....................................15494
95.21 (c) amended..................................................15494
95.23 (c) amended..................................................15494
95.25 (a) amended..................................................15494
95.26 Amended......................................................15494
95.27 (c) amended..................................................15494
95.28 Amended......................................................15494
95.32 Amended......................................................15494
95.34 Introductory text and (c) amended............................15494
95.37 (c) introductory text and (d) amended........................15494
98.2--98.10a (Subpart A) Heading revised...........................15494
98.3 Introductory text amended.....................................15494
98.11--98.21 (Subpart B) Heading revised...........................15494
98.12 (a) amended..................................................15494
98.13 (a) amended..................................................15494
98.15 Introductory text, (a)(1)(i), (ii), (2)(i), (ii), (3), 
        (5)(ii)(A), (B), (7)(i)(A), (B), (8)(i)(A), and (B) 
        amended....................................................15494
98.16 Introductory text amended....................................15494
98.34 (a)(2), (c) heading, introductory text, (1)(ii), (iii), (v), 
        (5), (6), and (7) amended; (c)(1)(i) revised...............15494
101.2 Amended......................................................22835
101.5 (s) added....................................................11143
104.2 (b) revised..................................................15495
114.12 Revised.....................................................11143
114.13 Revised.....................................................11143
116.1 (a)(3) revised...............................................22836
116.8 Revised......................................................22836
116.9 Added........................................................22836
121.3 (d)(9) and (f)(3)(i) amended.................................48202
121.11 (g) amended.................................................48202
145.1 Amended......................................................28352
145.4 (d)(2) amended...............................................28352
145.10 (o) amended.................................................28352

[[Page 1072]]

145.14 Introductory text amended; (d)(2)(i)(A) revised.............28352
145.23 (b)(1) revised..............................................28352
145.33 (b)(1) revised..............................................28352
145.43 (b)(1) and (5) revised......................................28352
145.45 (a) introductory text revised; (a)(1) introductory text, 
        (i), (iii) introductory text, (v), (2)(iii), and (4) 
        amended....................................................28352
145.52 (d)(7) and (8) redesignated as (d)(8) and (9); new (d)(7) 
        added......................................................28353
145.53 (b)(1), (5), (c)(1)(ii) introductory text, and (d)(1)(ii) 
        introductory text revised; (c)(1)(i), (ii)(A), (d)(1)(i), 
        and (ii)(A) amended........................................28353
145.63 (a)(1) and (2)(i) revised...................................28353
145.73 (b)(1) and (2)(ii) revised; (g) added.......................28353
145.74 (a) introductory text, (1) introductory text, (i), (iii) 
        introductory text, (v), (2)(iii), and (4) amended..........28354
145.82 (d) added...................................................28354
145.83 (b)(1) and (2)(ii) revised..................................28354
145.84 (a) introductory text, (1) introductory text, (i), (iii) 
        introductory text, (v), (2)(iii), and (4) amended..........28354
145.93 (b)(1) and (5) revised; (b)(3)(viii) and (4) amended........28355
146.1 Amended......................................................28355
146.23 (a)(1)(i) and (2)(i) amended................................28355
147.41 Amended.....................................................28355
147.43 (b) amended.................................................28355
147.46 (d) amended.................................................28355
147.51 Amended.....................................................28355
147.52 (a) revised.................................................28355
147.54 (a)(1), (3), and (4) revised................................28356

                                  2019

9 CFR
                                                                   84 FR
                                                                    Page
Chapter I
Chapter I Notification.............................................47405
54.1 Amended.......................................................11179
54.2 Amended.......................................................11182
54.3 (b) revised; OMB number.......................................11182
54.4 (a)(5) revised; OMB number....................................11182
54.5 (d) amended; OMB number.......................................11183
54.6 Revised.......................................................11183
54.7 (a), (d), and (e)(2) introductory text revised; (e) 
        introductory text and (1) amended; (e)(2)(i) removed; 
        (e)(2)(ii) and (iii) redesignated as new (e)(2)(i) and 
        (ii); (e)(2)(iii) and (iv) added; OMB number...............11183
54.8 Revised.......................................................11183
54.10 Revised......................................................11185
54.11 Revised......................................................11185
54.20--54.22 (Subpart B) Heading revised...........................11186
54.21 Revised......................................................11186
79.1 Amended.......................................................11186
79.2 Revised.......................................................11189
79.2 Footnote 4 amended............................................28202
79.3 Revised.......................................................11193
79.4 Revised.......................................................11195
79.5 Revised.......................................................11195
79.6 (a) introductory text and (b) amended; (a)(10)(i) through 
        (vi) redesignated as (a)(12) through (17); (a)(10) 
        revised; (a)(11) and (c) added; OMB number.................11196
166.12 (c) amended; footnote 1 revised; nomenclature change........64415
166.15 Revised.....................................................64415

                                  2020

9 CFR
                                                                   85 FR
                                                                    Page
Chapter I
1.1 Amended........................................................28795
2.1 (d) removed; (e) redesignated as new (d); (a)(1), (2), (b), 
        (c), and new (d) revised...................................28795
2.2 Revised........................................................28796
2.3 Revised........................................................28796
2.5 Revised........................................................28796
2.6 Removed........................................................28796
2.7 Removed........................................................28796
2.8 Removed........................................................28796
2.9 Revised........................................................28796
2.10 Revised.......................................................28796
2.11 Revised.......................................................28797
2.12 Revised.......................................................28797
2.13 Added.........................................................28797
2.25 (a) amended...................................................28797
2.26 Amended.......................................................28797
2.27 Amended.......................................................28797
2.30 Amended.......................................................28797
2.35 Amended.......................................................28797
2.36 (a) amended...................................................28797
2.38 (c) revised; (g)(1) introductory text, (7) footnote 1, and 
        (i) introductory text amended..............................28797

[[Page 1073]]

2.52 Footnote 4 amended............................................28798
2.75 (a)(3) and (b)(2) amended.....................................28798
2.77 (b) amended...................................................28798
2.102 (a) and (b) introductory text amended........................28798
2.126 (c) amended..................................................28798
2.127 Revised......................................................28798
2.132 Amended......................................................28798
2.150 (a), (c)(8), and section amended.............................28798
2.151 (a) introductory text, (b)(1), (2) introductory text, and 
        section amended............................................28798
2.152 Amended......................................................28798
2.153 Amended......................................................28798
3.6 (b)(5) and (c)(3) amended......................................28798
3.10 Revised.......................................................28798
3.13 Redesignated as 3.14; new section added.......................28798
3.14 Redesignated as 3.15; new section redesignated from 3.13......28798
3.14 New (c) introductory text, new (d), and new (e) introductory 
        text amended...............................................28799
3.15 Redesignated as 3.16; new section redesignated from 3.14......28798
3.15 New (h) amended...............................................28799
3.16 Redesignated as 3.17; new section redesignated from 3.15......28798
3.17 Redesignated as 3.18; new section redesignated from 3.16......28798
3.17 New (a) amended...............................................28799
3.18 Redesignated as 3.19; new section redesignated from 3.17......28798
3.18 New (a), new (b), and new (d) amended.........................28799
3.19 Redesignated as 3.20; new section redesignated from 3.18......28798
3.19 New (f) amended...............................................28799
3.20 New section redesignated from 3.19............................28798
3.20 New (a)(1) and new (3) amended................................28799
3.61 (b) and (f) amended...........................................28799
3.78 Heading revised...............................................28799
3.110 (a) amended..................................................28799
3.111 Footnote 14 amended..........................................28799
56.1 Amended.......................................................62562
56.3 Heading, (a) introductory text, (b), and (c) revised..........62562
56.4 Revised.......................................................62563
56.5 Heading, (c)(2), and (d) revised; (c)(1) introductory text 
        amended....................................................62563
56.6 Heading and (b) revised; (a) and (c) amended..................62564
56.8 (a) introductory text amended; (b) revised....................62564
56.9 (a) and (b) amended...........................................62564
56.10 (a) introductory text amended; OMB number....................62564
71.1 Amended........................................................4194
71.20 Footnote 7 redesignated as footnote 1.........................4194
71.21 Footnotes 8 and 9 redesignated as footnotes 2 and 3...........4194
71.22 Added.........................................................4194
75.4 Heading revised; (a) amended; (c) and (d) removed..............4195
80.1 Amended........................................................4195
92 Heading revised.................................................11835
92.1 Amended.......................................................11835
92.2 Revised.......................................................11835
92.4 Revised.......................................................11836
93.301 (e)(2)(iii) and (5)(i) amended; (i) removed..................4195
93.303 Footnote 12 redesignated as footnote 10......................4195
93.308 Footnotes 13 through 15 redesignated as footnotes 11 
        through 13..................................................4195
93.400 Amended.....................................................57951
93.401 (d) added...................................................57952
93.406 (a), (c), and (d) removed...................................57952
93.408 Amended.....................................................57952
93.417--93.421 Undesignated center heading footnote 8 redesignated 
        as footnote 9..............................................57952
93.418 (b) and (c) removed; (d) heading added; (d) introductory 
        text amended...............................................57952
93.422--93.423 Undesignated center heading footnote 9 redesignated 
        as footnote 10.............................................57952
93.423 (a) amended.................................................57952
93.424--93.429 Undesignated center heading footnote 10 
        redesignated as footnote 11................................57952
93.424 (b) revised.................................................57952
93.427 (a) and (c) revised; (d) removed; (e) introductory text 
        amended....................................................57952
93.432 Removed.....................................................57953
93.437 Added.......................................................57953
93.438 Added.......................................................57953
93.439 Added.......................................................57954
93.440 Added.......................................................57955
93.441 Added.......................................................57955
93.442 Added.......................................................57956
145.1 Amended......................................................62564
145.7 Revised......................................................62564

[[Page 1074]]

145.14 (d)(1) and (2) introductory text revised; (e) added.........62564
145.23 (d)(1)(vi) and (vii), (3) removed; (d)(1)(viii) and (ix) 
        and redesignated as new (d)(1)(vi) and new (vii); (d)(4) 
        and (5) redesignated as new (d)(3) and (4).................62565
145.24 (a)(1)(i) amended...........................................62565
145.33 (l)(1)(ii) amended; (l)(2) revised..........................62565
145.34 (a)(1)(i) amended...........................................62565
145.43 (h) revised; OMB number.....................................62565
145.44 (a)(1)(i) amended...........................................62565
145.45 (a) introductory text revised; (a)(1) introductory text, 
        (i), (iii) introductory text, (B), (E), (v), (vi), 
        (2)(iii), (3)(iii), (iv), (vii), and (4) amended; OMB 
        number.....................................................62566
145.51--146.54 (Subpart E) Heading revised.........................62566
145.51 Amended.....................................................62566
145.52 Introductory text revised; (c) amended; (f) added...........62566
145.53 Introductory text and (b)(5) amended; (f) revised...........62566
145.54 (a)(1)(i) amended...........................................62567
145.73 (d)(1)(vi), (vii), and (3) removed; (d)(1)(viii), (ix), 
        (4), and (5) redesignated as new (d)(1)(vi), new (vii), 
        new (3), and (4); (h) added; OMB number....................62567
145.74 (a) introductory text, (1) introductory text, (i), (iii) 
        introductory text, (B), (E), (v), (vi), (2)(iii), 
        (3)(iii), and (iv) amended.................................62567
145.83 (e)(1)(iv) removed; (e)(1)(v) and (vi) redesignated as new 
        (e)(1)(iv) and (v); (h) added; OMB number..................62568
145.84 (a) introductory text, (1) introductory text, (iii) 
        introductory text, (B), (E), (v), (vi), (2)(iii), (3)(iv), 
        and (vii) amended; (a)(1)(i) revised; OMB number...........62568
145.94 (a)(1)(i) amended...........................................62568
145.101--145.104 (Subpart J) Added.................................62568
146.13 (b)(1) revised; (b)(2) introductory text amended............62571
146.51 Revised.....................................................62571
146.52 Revised.....................................................62571
146.53 Introductory text, (a)(1) and (3) through (5) amended; (a) 
        introductory text and (2) revised; (b) removed.............62571
147.45 Revised.....................................................62572
147.48 Revised.....................................................62572
147.52 (b) revised.................................................62572
160.1 Amended......................................................10564
161.1 (e)(2) revised; (e)(4) introductory text and (g)(2)(xi) 
        amended....................................................10564
161.1 Correction: (e)(4) introductory text amended.................41905
161.2 Heading and (b) revised; (a) and (c) amended.................10564
161.4 Amended......................................................10565
161.6 Amended......................................................10565
161.7 (a) amended..................................................10565
162.11 Amended.....................................................10565
162.12 Amended.....................................................10565
162.13 Amended.....................................................10565


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