TITLE 9 CODE OF FEDERAL REGULATIONS
CHAPTER 1
9 CFR Ch. I (1994 Edition)
Animal and Plant Health Inspection Service, USDA
SUBCHAPTER A - ANIMAL WELFARE
PART 1 - DEFINITION OF TERMS
Authority: 7 U.S.C. 2131-2157; 7 CFR 2.17, 2.51, and 371.2(g).
§ 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 means the Administrator of the Animal and Plant Health Inspection
Service, U.S. Department of Agriculture, or any other official of the Animal
and Plant Health Inspection Service to whom authority has been delegated
to act in his stead. Ambient temperature means the air temperature surrounding
the animal.
Animal means any live or dead dog, cat, nonhuman primate, guinea pig, hamster,
rabbit, or any other warmblooded animal, which is being used, or is intended
for use for research, teaching, testing, experimentation, or exhibition
purposes, or as a pet. This term excludes: Birds, rats of the genus Rattus
and mice of the genus Mus bred for use in research, and horses not
used for research purposes and other farm animals, such as, but not limited
to livestock or poultry, used or intended for use as food or fiber, or livestock
or poultry used or intended for use for improving animal nutrition, breeding,
management, or production efficiency, or for improving the quality of food
or fiber. With respect to a dog, the term means all dogs, including those
used for hunting, security, or breeding purposes.
Animal act means any performance of animals where such animals are
trained to perform some behavior or action or are part of a show, performance,
or exhibition.
APHIS means the Animal and Plant Health Inspection Service, United
States Department of Agriculture.
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.
APHIS, REAC Sector Supervisor means a veterinarian or his designee,
employed by APHIS, who is assigned by the Administrator to supervise and
perform the official work of APHIS in a given State or States. As used in
part 2 of this subchapter, the APHIS, REAC Sector Supervisor shall be deemed
to be the person in charge of the official work of APHIS in the State in
which the dealer, exhibitor, research facility, intermediate handler, carrier,
or operator of an auction sale has his principal place of business.
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.
Business hours means a reasonable number of hours between 7 a.m.
and 7 p.m., Monday through Friday, except for legal Federal holidays, each
week of the year, during which inspections by APHIS may be made.
Business year means the 12-month period during which business is
conducted, and may be either on a calendar or fiscal-year basis.
Carrier means the operator of any airline, railroad, motor carrier,
shipping line, or other enterprise which is engaged in the business of transporting
any animals for hire.
Cat means any live or dead cat (Felis catus) or any cat-hybrid cross.
Class ``A'' licensee (breeder) means a person subject to the licensing
requirements under part 2 and meeting the definition of a ``dealer'' (§
1.1), and whose business involving animals consists only of animals that
are bred and raised on the premises in a closed or stable colony and those
animals acquired for the sole purpose of maintaining or enhancing the breeding
colony.
Class ``B'' licensee means a person subject to the licensing requirements
under part 2 and meeting the definition of a ``dealer'' (§ 1.1), and
whose business includes the purchase and/or resale of any animal. This term
includes brokers, and operators of an auction sale, as such individuals
negotiate or arrange for the purchase, sale, or transport of animals in
commerce. Such individuals do not usually take actual physical possession
or control of the animals, and do not usually hold animals in any facilities.
A class ``B'' licensee may also exhibit animals as a minor part of the business.
Class ``C'' licensee (exhibitor) means a person subject to the licensing
requirements under part 2 and meeting the definition of an ``exhibitor''
(§ 1.1), and whose business involves the showing or displaying of animals
to the public. A class ``C'' licensee may buy and sell animals as a minor
part of the business in order to maintain or add to his animal collection.
Commerce means trade, traffic, transportation, or other commerce:
(1) Between a place in a State and any place outside of such State, including
any foreign country, or between points within the same State but through
any place outside thereof, or within any territory, possession, or the District
of Columbia; or
(2) Which affects the commerce described in this part. Committee means the
Institutional Animal Care and Use Committee (IACUC) established under section
13(b) of the Act. It shall consist of at least three (3) members, one of
whom is the attending veterinarian of the research facility and one of whom
is not affiliated in any way with the facility other than as a member of
the committee, however, if the research facility has more than one Doctor
of Veterinary Medicine (DVM), another DVM with delegated program responsibility
may serve. The research facility shall establish the Committee for the purpose
of evaluating the care, treatment, housing, and use of animals, and for
certifying compliance with the Act by the research facility.
Dealer means any person who, in commerce, for compensation or profit,
delivers for transportation, or transports, except as a carrier, buys, or
sells, or negotiates the purchase or sale of: Any dog or other animal whether
alive or dead (including unborn animals, organs, limbs, blood, serum, or
other parts) for research, teaching, testing, experimentation, exhibition,
or for use as a pet; or any dog for hunting, security, or breeding purposes.
This term does not include: A retail pet store, as defined in this section,
unless such store sells any animals to a research facility, an exhibitor,
or a dealer (wholesale); or any person who does not sell, or negotiate the
purchase or sale of any wild or exotic animal, dog, or cat and who derives
no more than $500 gross income from the sale of animals other than wild
or exotic animals, dogs, or cats, during any calendar year.
Department means the U.S. Department of Agriculture.
Deputy Administrator means the Deputy Administrator for Regulatory
Enforcement and Animal Care (REAC) or any other official of REAC to whom
authority has been delegated to act in his stead.
Dog means any live or dead dog (Canis familiaris) or any dog-hybrid
cross.
Dwarf hamster means any species of hamster such as the Chinese and
Armenian species whose adult body size is substantially less than that attained
by the Syrian or Golden species of hamsters.
Endangered species means those species defined in the Endangered
Species Act (16 U.S.C. 1531 et seq.) and as it may be subsequently
amended.
Euthanasia means the humane destruction of an animal accomplished
by a method that produces rapid unconsciousness and subsequent death without
evidence of pain or distress, or a method that utilizes anesthesia produced
by an agent that causes painless loss of consciousness and subsequent death.
Exhibitor means any person (public or private) exhibiting any animals,
which were purchased in commerce or the intended distribution of which affects
commerce, or will affect commerce, to the public for compensation, as determined
by the Secretary. This term includes carnivals, circuses, animal acts, zoos,
and educational exhibits, exhibiting such animals whether operated for profit
or not. This term excludes retail pet stores, horse and dog races, organizations
sponsoring and all persons participating in State and county fairs, livestock
shows, rodeos, field trials, coursing events, purebred dog and cat shows
and any other fairs or exhibitions intended to advance agricultural arts
and sciences as may be determined by the Secretary.
Exotic animal means any animal not identified in the definition of
``animal'' provided in this part that is native to a foreign country or
of foreign origin or character, is not native to the United States, or was
introduced from abroad. This term specifically includes animals such as,
but not limited to, lions, tigers, leopards, elephants, camels, antelope,
anteaters, kangaroos, and water buffalo, and species of foreign domestic
cattle, such as Ankole, Gayal, and Yak.
Farm animal means any domestic species of cattle, sheep, swine, goats,
llamas, or horses, which are normally and have historically, been kept and
raised on farms in the United States, and used or intended for use as food
or fiber, or for improving animal nutrition, breeding, management, or production
efficiency, or for improving the quality of food or fiber. This term also
includes animals such as rabbits, mink, and chinchilla, when they are used
solely for purposes of meat or fur, and animals such as horses and llamas
when used solely as work and pack animals.
Federal agency means an Executive agency as such term is defined
in section 105 of title 5, United States Code, and with respect to any research
facility means the agency from which the research facility receives a Federal
award for the conduct of research, experimentation, or testing involving
the use of animals.
Federal award means any mechanism (including a grant, award, loan,
contract, or cooperative agreement) under which Federal funds are used to
support the conduct of research, experimentation, or testing, involving
the use of animals. The permit system established under the authorities
of the Endangered Species Act, the Marine Mammal Protection Act, and the
Migratory Bird Treaty Act, are not considered to be Federal awards under
the Animal Welfare Act.
Federal research facility means each department, agency, or instrumentality
of the United States which uses live animals for research or experimentation.
Field study means any study conducted on free-living wild animals
in their natural habitat, which does not involve an invasive procedure,
and which does not harm or materially alter the behavior of the animals
under study.
Handling means petting, feeding, watering, cleaning, manipulating,
loading, crating, shifting, transferring, immobilizing, restraining, treating,
training, working and moving, or any similar activity with respect to any
animal.
Housing facility means any land, premises, shed, barn, building,
trailer, or other structure or area housing or intended to house animals.
Hybrid cross means an animal resulting from the crossbreeding between
two different species or types of animals. Crosses between wild animal species,
such as lions and tigers, are considered to be wild animals. Crosses between
wild animal species and domestic animals, such as dogs and wolves or buffalo
and domestic cattle, are considered to be domestic animals.
Impervious surface means a surface that does not permit the absorption
of fluids. Such surfaces are those that can be thoroughly and repeatedly
cleaned and disinfected, will not retain odors, and from which fluids bead
up and run off or can be removed without their being absorbed into the surface
material.
Indoor housing facility means any structure or building with environmental
controls housing or intended to house animals and meeting the following
three requirements:
(1) It must be capable of controlling the temperature within the building
or structure within the limits set forth for that species of animal, of
maintaining humidity levels of 30 to 70 percent and of rapidly eliminating
odors from within the building; and
(2) It must be an enclosure created by the continuous connection of a roof,
floor, and walls (a shed or barn set on top of the ground does not have
a continuous connection between the walls and the ground unless a foundation
and floor are provided); and
(3) It must have at least one door for entry and exit that can be opened
and closed (any windows or openings which provide natural light must be
covered with a transparent material such as glass or hard plastic).
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,
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, hutch, or tether. In the case of animals restrained
by a tether (e.g., dogs on chains), it includes the shelter and the area
within reach of the tether.
Principal investigator means an employee of a research facility,
or other person associated with a research facility, responsible for a proposal
to conduct research and for the design and implementation of research involving
animals.
Quorum means a majority of the Committee members.
Random source means dogs and cats obtained from animal pounds or
shelters, auction sales, or from any person who did not breed and raise
them on his or her premises.
Registrant means any research facility, carrier, intermediate handler,
or exhibitor not required to be licensed under section 3 of the Act, registered
pursuant to the provisions of the Act and the regulations in part 2 of this
subchapter.
Research facility means any school (except an elementary or secondary
school), institution, organization, or person that uses or intends to use
live animals in research, tests, or experiments, and that (1) purchases
or transports live animals in commerce, or (2) receives funds under a grant,
award, loan, or contract from a department, agency, or instrumentality of
the United States for the purpose of carrying out research, tests, or experiments:
Provided, That the Administrator may exempt, by regulation, any such
school, institution, organization, or person that does not use or intend
to use live dogs or cats, except those schools, institutions, organizations,
or persons, which use substantial numbers (as determined by the Administrator)
of live animals the principal function of which schools, institutions, organizations,
or persons, is biomedical research or testing, when in the judgment of the
Administrator, any such exemption does not vitiate the purpose of the Act.
Retail pet store means any outlet where only the following animals
are sold or offered for sale, at retail, for use as pets: Dogs, cats, rabbits,
guinea pigs, hamsters, gerbils, rats, mice, gophers, chinchilla, domestic
ferrets, domestic farm animals, birds, and coldblooded species. Such definition
excludes--
(1) Establishments or persons who deal in dogs used for hunting, security,
or breeding purposes;
(2) Establishments or persons exhibiting, selling, or offering to exhibit
or sell any wild or exotic or other nonpet species of warmblooded animals
(except birds), such as skunks, raccoons, nonhuman primates, squirrels,
ocelots, foxes, coyotes, etc.;
(3) Any establishment or person selling warmblooded animals (except birds,
and laboratory rats and mice) for research or exhibition purposes; and
(4) Any establishment wholesaling any animals (except birds, rats and mice).
(5) Any establishment exhibiting pet animals in a room that is separate
from or adjacent to the retail pet store, or in an outside area, or anywhere
off the retail pet store premises.
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.
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]
PART 2 - REGULATIONS
Subpart A - Licensing
Sec.
2.1 Requirements and application.
2.2 Acknowledgement of regulations and standards.
2.3 Demonstration of compliance with regulations and standards.
2.4 Non-interference with APHIS officials.
2.5 Duration of license and termination of license.
2.6 Annual license fees.
2.7 Annual report by licensees.
2.8 Notification of change of name, address, control, or ownership of business.
2.9 Officers, agents, and employees of licensees whose licenses have been
suspended or revoked.
2.10 Licensees whose licenses have been suspended or revoked.
2.11 Denial of initial license application.
Subpart B - Registration
2.25 Requirements and procedures.
2.26 Acknowledgement of regulations and standards.
2.27 Notification of change of operation.
Subpart C - Research Facilities
2.30 Registration.
2.31 Institutional Animal Care and Use Committee (IACUC).
2.32 Personnel qualifications.
2.33 Attending veterinarian and adequate veterinary care.
2.34 [Reserved]
2.35 Recordkeeping requirements.
2.36 Annual report.
2.37 Federal research facilities.
2.38 Miscellaneous.
Subpart D - Attending Veterinarian and Adequate Veterinary Care
2.40 Attending veterinarian and adequate veterinary care (dealers and exhibitors).
Subpart E - Identification of Animals
2.50 Time and method of identification.
2.51 Form of official tag.
2.52 How to obtain tags.
2.53 Use of tags.
2.54 Lost tags.
2.55 Removal and disposal of tags.
Subpart F - Stolen Animals
2.60 Prohibition on the purchase, sale, use, or transportation of stolen animals.
Subpart G - Records
2.75 Records: Dealers and exhibitors.
2.76 Records: Operators of auction sales and brokers.
2.77 Records: Carriers, and intermediate handlers.
2.78 Health certification and identification.
2.79 C.O.D. shipments.
2.80 Records, disposition.
Subpart H - Compliance With Standards and Holding Period
2.100 Compliance with standards.
2.101 Holding period.
2.102 Holding facility.
Subpart I - Miscellaneous
2.125 Information as to business; furnishing of same by dealers, exhibitors,
operators of auction sales, intermediate handlers, and carriers.
2.126 Access and inspection of records and property.
2.127 Publication of names of persons subject to the provisions of this
part.
2.128 Inspection for missing animals.
2.129 Confiscation and destruction of animals.
2.130 Minimum age requirements.
2.131 Handling of animals.
2.132 Procurement of random source dogs and cats, dealers.
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.17, 2.51, and 371.2(g).
Source: 54 FR 36147, Aug. 31, 1989, unless otherwise noted.
Subpart A - Licensing
§ 2.1 Requirements and application.
(a)(1) Any person operating or desiring to operate as a dealer, exhibitor,
or operator of an auction sale, except persons who are exempted from the
licensing requirements under paragraph (a)(3) of this section, must have
a valid license. A person must be 18 years of age or older to obtain a license.
A person seeking a license shall apply on a form which will be furnished
by the APHIS, REAC Sector Supervisor in the State in which that person operates
or intends to operate. The applicant shall provide the information requested
on the application form, including a valid mailing address through which
the licensee or applicant can be reached at all times, and a valid premises
address where animals, animal facilities, equipment, and records may be
inspected for compliance. The applicant shall file the completed application
form with the APHIS, REAC Sector Supervisor.
(2) If an applicant for a license or license renewal operates in more than
one State, he or she shall apply in the State in which he or she has his
or her principal place of business. All premises, facilities, or sites where
such person operates or keeps animals shall be indicated on the application
form or on a separate sheet attached to it. The completed application form,
along with the application fee indicated in paragraph (d) of this section,
and the annual license fee indicated in table 1 or 2 of § 2.6 shall
be filed with the APHIS, REAC Sector Supervisor.
(3) The following persons are exempt from the licensing requirements under
section 2 or section 3 of the Act:
(i) Retail pet stores which sell nondangerous, pet-type animals, such as
dogs, cats, birds, rabbits, hamsters, guinea pigs, gophers, domestic ferrets,
chinchilla, rats, and mice, for pets, at retail only: Provided, That, Anyone
wholesaling any animals, selling any animals for research or exhibition,
or selling any wild, exotic, or nonpet animals retail, must have a license;
(ii) Any person who sells or negotiates the sale or purchase of any animal
except wild or exotic animals, dogs, or cats, and who derives no more than
$500 gross income from the sale of such animals to a research facility,
an exhibitor, a dealer, or a pet store during any calendar year and is not
otherwise required to obtain a license;
(iii) Any person who maintains a total of three (3) or fewer breeding female
dogs and/or cats and who sells only the offspring of these dogs or cats,
which were born and raised on his or her premises, for pets or exhibition,
and is not otherwise required to obtain a license;
(iv) Any person who sells fewer than 25 dogs and/or cats per year which
were born and raised on his or her premises, for research, teaching, or
testing purposes or to any research facility and is not otherwise required
to obtain a license. The sale of any dog or cat not born and raised on the
premises for research purposes requires a license;
(v) Any person who arranges for transportation or transports animals solely
for the purpose of breeding, exhibiting in purebred shows, boarding (not
in association with commercial transportation), grooming, or medical treatment,
and is not otherwise required to obtain a license;
(vi) Any person who buys, sells, transports, or negotiates the sale, purchase,
or transportation of any animals used only for the purposes of food or fiber
(including fur);
(vii) Any person who breeds and raises domestic pet animals for direct retail
sales to another person for the buyer's own use and who buys no animals
for resale and who sells no animals to a research facility, an exhibitor,
a dealer, or a pet store (e.g., a purebred dog or cat fancier) and is not
otherwise required to obtain a license;
(viii) Any person who buys animals solely for his or her own use or enjoyment
and does not sell or exhibit animals, or is not otherwise required to obtain
a license;
(b) Any person who sells fewer than 25 dogs or cats per year for research
or teaching purposes and who is not otherwise required to obtain a license
may obtain a voluntary license, provided the animals were born and raised
on his or her premises. A voluntary licensee shall comply with the requirements
for dealers set forth in this part and the Specifications for the Humane
Handling, Care, Treatment, and Transportation of Dogs and Cats set forth
in part 3 of this subchapter and shall agree in writing on a form furnished
by APHIS to comply with all the requirements of the Act and this subchapter.
Voluntary licenses will not be issued to any other persons. To obtain a
voluntary license the applicant shall submit to the APHIS, REAC Sector Supervisor
the application fee of $10 plus an annual license fee. The class of license
issued and the fee for a voluntary license shall be that of a Class ``A''
licensee (breeder). Voluntary licenses will not be issued to any other persons
or for any other class of license.
(c) No person shall have more than one license.
(d) A license will be issued to any applicant, except as provided in §
§ 2.10 and 2.11, when the applicant:
(1) Has met the requirements of this section and of § § 2.2 and
2.3; and
(2) Has paid the application fee of $10 and the annual license fee indicated
in § 2.6 to the APHIS, REAC Sector Supervisor and the payment has cleared
normal banking procedures. (e)(1) On or before the expiration date of the
license, a licensee who wishes a renewal shall submit to the APHIS, REAC
Sector Supervisor a completed application form and the application fee of
$10, plus the annual license fee indicated in § 2.6 by certified check,
cashier's check, personal check, or money order. A voluntary licensee who
wishes a renewal shall also submit the $10 application fee plus an annual
license fee. An applicant whose check is returned by the bank will be charged
a fee of $15 for each returned check. One returned check will be deemed
nonpayment of fees and will result in denial of license. Payment of fees
must then be made by certified check, cashier's check, or money order. An
applicant will not be licensed until his or her payment has cleared normal
banking procedures.
(2) The $10 application fee must also be paid if an applicant is applying
for a changed class of license. The applicant may pay such fees by certified
check, cashier's check, personal check, or money order. An applicant whose
check is returned by a bank will be charged a fee of $15 for each returned
check and will be required to pay all subsequent fees by certified check,
money order, or cashier's check. A license will not be issued until payment
has cleared normal banking procedures.
(f) The failure of any person to comply with any provision of the Act, or
any of the provisions of the regulations or standards in this subchapter,
shall constitute grounds for denial of a license; or for its suspension
or revocation by the Secretary, as provided in the Act.
§ 2.2 Acknowledgment of regulations and standards.
APHIS will supply a copy of the applicable regulations and standards to
the applicant with each request for a license application or renewal. The
applicant shall acknowledge receipt of the regulations and standards and
agree to comply with them by signing the application form before a license
will be issued or renewed.
§ 2.3 Demonstration of compliance with standards
and regulations.
(a) Each applicant must demonstrate that his or her premises and any animals,
facilities, vehicles, equipment, or other premises used or intended for
use in the business comply with the regulations and standards set forth
in parts 2 and 3 of this subchapter. Each applicant for an initial license
or license renewal must make his or her animals, premises, facilities, vehicles,
equipment, other premises, and records available for inspection during business
hours and at other times mutually agreeable to the applicant and APHIS,
to ascertain the applicant's compliance with the standards and regulations.
(b) In the case of an application for an initial license, the applicant
must demonstrate compliance with the regulations and standards, as required
in paragraph (a) of this section, before APHIS will issue a license. If
the applicant's animals, premises, facilities, vehicles, equipment, other
premises, or records do not meet the requirements of this subchapter, APHIS
will advise the applicant of existing deficiencies and the corrective measures
that must be completed to come into compliance with the regulations and
standards. The applicant will have two more chances to demonstrate his or
her compliance with the regulations and standards through re-inspection
by APHIS. If the applicant fails the third inspection he or she will forfeit
the application fee and cannot re-apply for a license for a period of 6
months following the third inspection. Issuance of the license will be denied
until the applicant demonstrates upon inspection that the animals, premises,
facilities, vehicles, equipment, other premises and records are in compliance
with all regulations and standards in this subchapter.
§ 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.
§ 2.5 Duration of license and termination of license.
(a) A license issued under this part shall be valid and effective unless:
(1) The license has been revoked or suspended pursuant to section 19 of
the Act.
(2) The license is voluntarily terminated upon request of the licensee,
in writing, to the APHIS, REAC Sector Supervisor.
(3) The license has expired or been terminated under this part.
(4) The applicant has failed to pay the application fee and the annual license
fee as required in § § 2.1 and 2.6.
There will be no refund of fees if a license is terminated prior to its
expiration date.
(b) Any person who is licensed must file an application for a license renewal
and an annual report form (VS Form 18-3) as required by § 2.7, and
pay the required fees, on or before the expiration date of the present license
or the license shall expire and automatically terminate on its anniversary
date. The licensee will be notified by certified mail at least 60 days prior
to the expiration date of the license. Failure to comply with the annual
reporting requirements, or to pay the required license fees prior to the
expiration date of the license, shall result in automatic termination of
such license on the anniversary date of the license.
(c) Licensees must accept delivery of registered mail or certified mail
notice and provide the APHIS, REAC Sector Supervisor notice of their address
in conformity with the requirements in § 2.1.
(d) Any person who seeks the reinstatement of a license that has been automatically
terminated must follow the procedure applicable to new applicants for a
license set forth in § 2.1.
(e) Licenses are issued to specific persons for specific premises and do
not transfer upon change of ownership, nor are they valid at a different
location.
(f) A license which is invalid under this part shall be surrendered to the
APHIS, REAC Sector Supervisor. If the license cannot be found, the licensee
shall provide a written statement so stating to the APHIS, REAC Sector Supervisor.
§ 2.6 Annual license fees.
(a) In addition to the application fee of $10 required to be paid upon the
application for a license, license renewal, or changed class of license
under § 2.1, each licensee shall submit to the APHIS, REAC Sector Supervisor
the annual license fee prescribed in this section. Paragraph (b) of this
section indicates the method used to calculate the appropriate fee. The
amount of the fee is determined from Table 1 or 2 in paragraph (c) of this
section.
(b)(1) Class ``A'' license. The annual license renewal fee for a Class ``A''
dealer shall be based on 50 percent of the total gross amount, expressed
in dollars, derived from the sale of animals to research facilities, dealers,
exhibitors, retail pet stores, and persons for use as pets, directly or
through an auction sale, by the dealer or applicant during his or her preceding
business year (calendar or fiscal) in the case of a person who operated
during such a year. If animals are leased, the lessor shall pay a fee based
on 50 percent of any compensation received from the leased animals and the
lessee shall pay a fee based upon the net compensation received from the
leased animals, as indicated for dealers in Table 1 in paragraph (c) of
this section.
(2) Class ``B'' license. The annual license renewal fee for a Class ``B''
dealer shall be established by calculating the total amount received from
the sale of animals to research facilities, dealers, exhibitors, retail
pet stores, and persons for use as pets, directly or through an auction
sale, during the preceding business year (calendar or fiscal) less the amount
paid for the animals by the dealer or applicant. This net difference, exclusive
of other costs, shall be the figure used to determine the license fee of
a Class ``B'' dealer. If animals are leased, the lessor and lessee shall
each pay a fee based on the net compensation received from the leased animals
calculated from Table 1 in paragraph (c) of this section.
(3) The annual license renewal fee for a broker or operator of an auction
sale shall be that of a class ``B'' dealer and shall be based on the total
gross amount, expressed in dollars, derived from commissions or fees charged
for the sale of animals, or for negotiating the sale of animals, by brokers
or by the operator of an auction sale, to research facilities, dealers,
exhibitors, retail pet stores, and persons for use as pets, during the preceding
business year (calendar or fiscal).
(4) In the case of a new applicant for a license as a dealer, broker or
operator of an auction sale who did not operate during a preceding business
year, the annual license fee will be based on the anticipated yearly dollar
amount of business, as provided in paragraphs (b)(1), (2), and (3) of this
section, derived from the sale of animals to research facilities, dealers,
exhibitors, retail pet stores, and persons for use as pets, directly or
through an auction sale.
(5) The amount of the annual fee to be paid upon application for a class
``C'' license as an exhibitor under this section shall be based on the number
of animals which the exhibitor owned, held, or exhibited at the time the
application is signed and dated or during the previous year, whichever is
greater, and will be the amount listed in Table 2 in paragraph (c) of this
section. Animals which are leased shall be included in the number of animals
being held by both the lessor and the lessee when calculating the annual
fee. An exhibitor shall pay his or her annual license fee on or before the
expiration date of the license and the fee shall be based on the number
of animals which the exhibitor is holding or has held during the year (both
owned and leased).
(c) The license fee shall be computed in accordance with the following tables:
Table 1-Dealers, Brokers and Operators of an Auction Sale Class ``A'' and
``B'' License
$0 ........... $500 .......... $30
500 ......... 2,000 .......... 60
2,000 .......10,000 .......... 120
10,000 ......25,000 .......... 225
25,000 ......50,000 .......... 350
50,000 .....100,000 .......... 475
100,000 ...................... 750
Table 2-Exhibitors-Class ``C''
1 to 5 ....................... $30
6 to 25 ...................... 75
26 to 50 ..................... 175
51 to 500 .................... 225
501 and up ................... 300
(d) If a person meets the licensing requirements for more than one class
of license, he shall be required to obtain a license and pay the fee for
the type business which is predominant for his operation, as determined
by the Secretary.
(e) In any situation in which a licensee shall have demonstrated in writing
to the satisfaction of the Secretary that he or she has good reason to believe
that the dollar amount of his or her business for the forthcoming business
year will be less than the previous business year, then his or her estimated
dollar amount of business shall be used for computing the license fee for
the forthcoming business year: Provided, however, That if the dollar
amount upon which the license fee is based for that year does in fact exceed
the amount estimated, the difference in amount of the fee paid and that
which was due under paragraphs (b) and (c) of this section based upon the
actual dollar business upon which the license fee is based, shall be payable
in addition to the required annual license fee for the next subsequent year,
on the anniversary date of his or her license as prescribed in this section.
§ 2.7 Annual report by licensees.
(a) Each year, within 30 days prior to the expiration date of his or her
license, a licensee shall file with the APHIS, REAC Sector Supervisor an
application for license renewal and annual report upon a form which the
APHIS, REAC Sector Supervisor will furnish to him or her upon request.
(b) A person licensed as a dealer shall set forth in his or her license
renewal application and annual report the dollar amount of business, from
the sale of animals, upon which the license fee is based, directly or through
an auction sale, to research facilities, dealers, exhibitors, retail pet
stores, and persons for use as pets, by the licensee during the preceding
business year (calendar or fiscal), and any other information as may be
required thereon.
(c) A licensed dealer who operates as a broker or an operator of an auction
sale shall set forth in his or her license renewal application and annual
report the total gross amount, expressed in dollars, derived from commissions
or fees charged for the sale of animals by the licensee to research facilities,
dealers, exhibitors, retail pet stores, and persons for use as pets, during
the preceding business year (calendar or fiscal), and any other information
as may be required thereon.
(d) A person licensed as an exhibitor shall set forth in his or her license
renewal application and annual report the number of animals owned, held,
or exhibited by him or her, including those which are leased, during the
previous year or at the time he signs and dates the report, whichever is
greater.
§ 2.8 Notification of change of name, address, control, or ownership
of business.
A licensee shall promptly notify the APHIS, REAC Sector Supervisor by certified
mail of any change in the name, address, management, or substantial control
or ownership of his business or operation, or of any additional sites, within
10 days of any change
§ 2.9 Officers, agents, and employees of licensees whose licenses
have been suspended or revoked.
Any person who has been or is an officer, agent, or employee of a licensee
whose license has been suspended or revoked and who was responsible for
or participated in the violation upon which the order of suspension or revocation
was based will not be licensed within the period during which the order
of suspension or revocation is in effect.
§ 2.10 Licensees whose licenses have been suspended or revoked.
(a) Any person whose license has been suspended for any reason shall
not be licensed in his or her own name or in any other manner within the
period during which the order of suspension is in effect. No partnership,
firm, corporation, or other legal entity in which any such person has a
substantial interest, financial or otherwise, will be licensed during that
period. Any person whose license has been suspended for any reason may apply
to the APHIS, REAC Sector Supervisor, in writing, for reinstatement of his
or her license.
(b) Any person whose license has been revoked shall not be licensed in his
or her own name or in any other manner; nor will any partnership, firm,
corporation, or other legal entity in which any such person has a substantial
interest, financial or otherwise, be licensed.
(c) Any person whose license has been suspended or revoked shall not buy,
sell, transport, exhibit, or deliver for transportation, any animal during
the period of suspension or revocation.
§ 2.11 Denial of initial license application.
(a) A license will not be issued to any applicant who:
(1) Has not complied with the raquirements of § § 2.1, 2.2, 2.3,
and 2.4 and has not paid the fees indicated in § 2.6;
(2) Is not in compliance with any of the regulations or standards in this
subchapter;
(3) Has had a license revoked or whose license is suspended, as set forth
in § 2.10;
(4) Has been fined, sentenced to jail, or pled nolo contendere (no contest)
under State or local cruelty to animal laws within l year of application,
except that if no penalty is imposed as a result of the plea of nolo contendere
the applicant may reapply immediately; or
(5) Has made any false or fraudulent statements, or provided any false or
fraudulent records to the Department.
(b) An applicant whose license application has been denied may request a
hearing in accordance with the applicable rules of practice for the purpose
of showing why the application for license should not be denied. The license
denial shall remain in effect until the final legal decision has been rendered.
Should the license denial be upheld, the applicant may again apply for a
license l year from the date of the final order denying the application.
(c) No partnership, firm, corporation, or other legal entity in which a
person whose license application has been denied has a substantial interest,
financial or otherwise, will be licensed within 1 year of the license denial.
Subpart B - Registration
§ 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 APHIS, REAC Sector Supervisor.
The registration form shall be filed with the APHIS, REAC Sector Supervisor
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 APHIS, REAC Sector
Supervisor.
(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.
§ 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 APHIS,
REAC Sector Supervisor.
§ 2.27 Notification of change of operation.
(a) A registrant shall notify the APHIS, REAC Sector Supervisor 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 APHIS, REAC Sector Supervisor A registrant
shall notify the APHIS, REAC Sector Supervisor 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 APHIS, REAC Sector Supervisor. 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.
Subpart C - Research Facilities
§ 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 APHIS, REAC Sector Supervisor. The registration form shall be filed
with the APHIS, REAC Sector Supervisor 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 APHIS, REAC Sector Supervisor. Except as provided in
paragraph (a)(2) of this section, where a school or department of a university
or college uses or intends to use live animals for research, tests, experiments,
or teaching, the university or college rather than the school or department
will be considered the research facility and will be required to register
with the Secretary. An official who has the legal authority to bind the
parent organization shall sign the registration form.
(2) In any situation in which a school or department of a university or
college demonstrates to the Secretary that it is a separate legal entity
and its operations and administration are independent of those of the university
or college, the school or department will be registered rather than the
university or college.
(3) A subsidiary of a business corporation, rather than the parent corporation,
will be registered as a research facility unless the subsidiary is under
such direct control of the parent corporation that the Secretary determines
that it is necessary that the parent corporation be registered to effectuate
the purposes of the Act.
(b) Acknowledgment of regulations and standards. APHIS will supply a copy
of the regulations and standards in this subchapter with each registration
form. The research facility shall acknowledge receipt of and shall agree
to comply with the regulations and standards by signing a form provided
for this purpose by APHIS, and by filing it with the APHIS, REAC Sector
Supervisor.
(c) Notification of change of operation. (1) A research facility shall notify
the APHIS, REAC Sector Supervisor 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 APHIS, REAC Sector Supervisor. A research
facility shall file an annual report of its status (active or inactive).
A research facility shall notify the APHIS, REAC Sector Supervisor 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 APHIS, REAC
Sector Supervisor. 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.
§ 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:
(1) Review, at least once every six months, the research facility's program
for humane care and use of animals, using title 9, chapter I, subchapter
A-Animal Welfare, as a basis for evaluation;
(2) Inspect, at least once every six months, all of the research facility's
animal facilities, including animal study areas, using title 9, chapter
I, subchapter A - Animal Welfare, as a basis for evaluation; Provided, however,
That animal areas containing free-living wild animals in their natural habitat
need not be included in such inspection;
(3) Prepare reports of its evaluations conducted as required by paragraphs
(c) (1) and (2) of this section, and submit the reports to the Institutional
Official of the research facility; Provided, however, That the IACUC may
determine the best means of conducting evaluations of the research facility's
programs and facilities; and Provided, further, That no Committee member
wishing to participate in any evaluation conducted under this subpart may
be excluded. The IACUC may use subcommittees composed of at least two Committee
members and may invite ad hoc consultants to assist in conducting the evaluations,
however, the IACUC remains responsible for the evaluations and reports as
required by the Act and regulations. The reports shall be reviewed and signed
by a majority of the IACUC members and must include any minority views.
The reports shall be updated at least once every six months upon completion
of the required semiannual evaluations and shall be maintained by the research
facility and made available to APHIS and to officials of funding Federal
agencies for inspection and copying upon request. The reports must contain
a description of the nature and extent of the research facility's adherence
to this subchapter, must identify specifically any departures from the provisions
of title 9, chapter I, subchapter A-Animal Welfare, and must state the reasons
for each departure. The reports must distinguish significant deficiencies
from minor deficiencies. A significant deficiency is one which, with reference
to Subchapter A, and, in the judgment of the IACUC and the Institutional
Official, is or may be a threat to the health or safety of the animals.
If program or facility deficiencies are noted, the reports must contain
a reasonable and specific plan and schedule with dates for correcting each
deficiency. Any failure to adhere to the plan and schedule that results
in a significant deficiency remaining uncorrected shall be reported in writing
within 15 business days by the IACUC, through the Institutional Official,
to APHIS and any Federal agency funding that activity;
(4) Review, and, if warranted, investigate concerns involving the care and
use of animals at the research facility resulting from public complaints
received and from reports of noncompliance received from laboratory or research
facility personnel or employees;
(5) Make recommendations to the Institutional Official regarding any aspect
of the research facility's animal program, facilities, or personnel training;
(6) Review and approve, require modifications in (to secure approval), or
withhold approval of those components of proposed activities related to
the care and use of animals, as specified in paragraph (d) of this section;
(7) Review and approve, require modifications in (to secure approval), or
withhold approval of proposed significant changes regarding the care and
use of animals in ongoing activities; and
(8) Be authorized to suspend an activity involving animals in accordance
with the specifications set forth in paragraph (d)(6) of this section.
(d) IACUC review of activities involving animals. (1) In order to approve
proposed activities or proposed significant changes in ongoing activities,
the IACUC shall conduct a review of those components of the activities related
to the care and use of animals and determine that the proposed activities
are in accordance with this subchapter unless acceptable justification for
a departure is presented in writing; Provided, however, That field studies
as defined in part 1 of this subchapter are exempt from this requirement.
Further, the IACUC shall determine that the proposed activities or significant
changes in ongoing activities meet the following requirements:
(i) Procedures involving animals will avoid or minimize discomfort, distress,
and pain to the animals;
(ii) The principal investigator has considered alternatives to procedures
that may cause more than momentary or slight pain or distress to the animals,
and has provided a written narrative description of the methods and sources,
e g., the Animal Welfare Information Center, used to determine that alternatives
were not available;
(iii) The principal investigator has provided written assurance that the
activities do not unnecessarily duplicate previous experiments;
(iv) Procedures that may cause more than momentary or slight pain or distress
to the animals will:
(A) Be performed with appropriate sedatives, analgesics or anesthetics,
unless withholding such agents is justified for scientific reasons, in writing,
by the principal investigator and will continue for only the necessary period
of time;
(B) Involve, in their planning, consultation with the attending veterinarian
or his or her designee;
(C) Not include the use of paralytics without anesthesia;
(v) Animals that would otherwise experience severe or chronic pain or distress
that cannot be relieved will be painlessly euthanized at the end of the
procedure or, if appropriate, during the procedure;
(vi) The animals' living conditions will be appropriate for their species
in accordance with part 3 of this subchapter, and contribute to their health
and comfort. The housing, feeding, and nonmedical care of the animals will
be directed by the attending veterinarian or other scientist trained and
experienced in the proper care, handling, and use of the species being maintained
or studied;
(vii) Medical care for animals will be available and provided as necessary
by a qualified veterinarian;
(viii) Personnel conducting procedures on the species being maintained or
studied will be appropriately qualified and trained in those procedures;
(ix) Activities that involve surgery include appropriate provision for pre-operative
and post-operative care of the animals in accordance with established veterinary
medical and nursing practices. All survival surgery will be performed using
aseptic procedures, including surgical gloves, masks, sterile instruments,
and aseptic techniques. Major operative procedures on 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 Administrator, APHIS, USDA, 6505 Belcrest Road, Room 268, Hyattsville,
MD 20782;
(xi) Methods of euthanasia used must be in accordance with the definition
of the term set forth in 9 CFR part 1, § 1.1 of this subchapter, unless
a deviation is justified for scientific reasons, in writing, by the investigator.
(2) Prior to IACUC review, each member of the Committee shall be provided
with a list of proposed activities to be reviewed. Written descriptions
of all proposed activities that involve the care and use of animals shall
be available to all IACUC members, and any member of the IACUC may obtain,
upon request, full Committee review of those activities. If full Committee
review is not requested, at least one member of the IACUC, designated by
the chairman and qualified to conduct the review, shall review those activities,
and shall have the authority to approve, require modifications in (to secure
approval), or request full Committee review of any of those activities.
If full Committee review is requested for a proposed activity, approval
of that activity may be granted only after review, at a convened meeting
of a quorum of the IACUC, and with the approval vote of a majority of the
quorum present. No member may participate in the IACUC review or approval
of an activity in which that member has a conflicting interest (e.g., is
personally involved in the activity), except to provide information requested
by the IACUC, nor may a member who has a conflicting interest contribute
to the constitution of a quorum;
(3) The IACUC may invite consultants to assist in the review of complex
issues arising out of its review of proposed activities. Consultants may
not approve or withhold approval of an activity, and may not vote with the
IACUC unless they are also members of the IACUC;
(4) The IACUC shall notify principal investigators and the research facility
in writing of its decision to approve or withhold approval of those activities
related to the care and use of animals, or of modifications required to
secure IACUC approval. If the IACUC decides to withhold approval of an activity,
it shall include in its written notification a statement of the reasons
for its decision and give the principal investigator an opportunity to respond
in person or in writing. The IACUC may reconsider its decision, with documentation
in Committee minutes, in light of the information provided by the principal
investigator;
(5) The IACUC shall conduct 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.
§ 2.32 Personnel qualifications.
(a) It shall be the responsibility of the research facility to ensure that
all scientists, research technicians, animal technicians, and other personnel
involved in animal care, treatment, and use are qualified to perform their
duties. This responsibility shall be fulfilled in part through the provision
of training and instruction to those personnel.
(b) Training and instruction shall be made available, and the qualifications
of personnel reviewed, with sufficient frequency to fulfill the research
facility's responsibilities under this section and § 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.
§ 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
(5) Adequate pre-procedural and post-procedural care in accordance with
current established veterinary medical and nursing procedures.
§ 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 § 2.31(c)(3)
of this subpart, and forwarded to the Institutional Official.
(b) Every research facility shall make, keep, and maintain records or forms
which fully and correctly disclose the following information concerning
each live dog or cat purchased or otherwise acquired, owned, held, or otherwise
in their possession or under their control, transported, euthanized, sold,
or otherwise disposed of by the research facility. The records shall include
any offspring born of any animal while in the research facility's possession
or under its control:
(1) The name and address of the person from whom a dog or cat was purchased
or otherwise acquired, whether or not the person is required to be licensed
or registered under the Act;
(2) The USDA license or registration number of the person if he or she is
licensed or registered under the Act;
(3) The vehicle license number and state, and the driver's license number
and state of the person, if he or she is not licensed or registered under
the Act;
(4) The date of acquisition of each dog or cat;
(5) The official USDA tag number or tattoo assigned to each dog or cat under
§ 2.38(g) of this subpart;
(6) A description of each dog or cat which shall include:
(i) The species and breed or type of animal;
(ii) The sex;
(iii) The date of birth or approximate age; and
(iv) The color and any distinctive markings;
(7) Any identification number or mark assigned to each dog or cat by the
research facility.
(c) In addition to the information required to be kept and maintained by
every research facility concerning each live dog or cat under paragraph
(a) of this section, every research facility transporting, selling, or otherwise
disposing of any live dog or cat to another person, shall make and maintain
records or forms which fully and correctly disclose the following information:
(1) The name and address of the person to whom a live dog or cat is transported,
sold, or otherwise disposed of;
(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 (VS Form 18-1) and Record of Dogs and Cats on Hand (VS
Form 18-5) are forms which may be used by research facilities to keep and
maintain the information required by paragraph (b) of this section.
(2) The USDA Interstate and International Certificate of Health Examination
for Small Animals (VS Form 18-1) and Record of Disposition of Dogs and Cats
(VS Form 18-6) are forms which may be used by research facilities to keep
and maintain the information required by paragraph (c) of this section.
(e) One copy of the record containing the information required by paragraphs
(b) and (c) of this section shall accompany each shipment of any live dog
or cat sold or otherwise disposed of by a research facility Provided, however,
That, except as provided by in section 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.
§ 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
APHIS, REAC Sector Supervisor 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 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.
§ 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 § 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.
§ 2.38 Miscellaneous.
(a) Information as to business: furnishing of same by research facilities.
Each research facility shall furnish to any APHIS official any information
concerning the business of the research facility which the APHIS official
may request in connection with the enforcement of the provisions of the
Act, the regulations, and the standards in this subchapter. The information
shall be furnished within a reasonable time and as may be specified in the
request for information.
(b) Access and inspection of records and property. (1) Each research
facility shall, during business hours, allow APHIS officials:
(i) To enter its place of business;
(ii) To examine records required to be kept by the Act and the regulations
in this part;
(iii) To make copies of the records;
(iv) To inspect the facilities, property, and animals, as the APHIS officials
consider necessary to enforce the provisions of the Act, the regulations,
and the standards in this subchapter; and
(v) To document, by the taking of photographs and other means, conditions
and areas of noncompliance.
(2) The use of a room, table or other facilities necessary for the proper
examination of the records and for inspection of the property or animals
shall be extended to APHIS officials by the research facility.
(c) Publication of names of research facilities subject to the provisions
of this part. APHIS will publish lists of research facilities registered
in accordance with the provisions of this subpart in the Federal Register.
The lists may be obtained upon request from the APHIS, REAC Sector Supervisor.
(d) Inspection for missing animals. Each research facility shall
allow, upon request and during business hours, police or officers of other
law enforcement agencies with general law enforcement authority (not those
agencies whose duties are limited to enforcement of local animal regulations)
to enter its place of business to inspect animals and records for the purpose
of seeking animals that are missing, under the following conditions:
(1) The police or other law officer shall furnish to the research facility
a written description of the missing animal and the name and address of
its owner before making a search;
(2) The police or other law officer shall abide by all security measures
required by the research facility to prevent the spread of disease, including
the use of sterile clothing, footwear, and masks where required, or to prevent
the escape of an animal.
(e) Confiscation and destruction of animals. (1) If an animal being
held by a research facility is not being used to carry out research, testing,
or experimentation, and is found by an APHIS official to be suffering as
a result of the failure of the research facility to comply with any provision
of the regulations or the standards set forth in this subchapter, the APHIS
official shall make a reasonable effort to notify the research facility
of the condition of the animal(s) and request that the condition be corrected
and that adequate care be given to alleviate the animal's suffering or distress,
or that the animal(s) be destroyed by euthanasia. In the event that the
research facility refuses to comply with this request, the APHIS official
may confiscate the animal(s) for care, treatment, or disposal as indicated
in paragraph (e)(2) of this section, if, in the opinion of the Administrator,
the circumstances indicate the animal's health is in danger.
(2) In the event that the APHIS official is unable to locate or notify the
research facility as required in this section, the APHIS official shall
contact a local police or other law officer to accompany him or her to the
premises and shall provide for adequate care when necessary to alleviate
the animal's suffering. If, in the opinion of the Administrator, the condition
of the animal(s) cannot be corrected by this temporary care, the APHIS official
shall confiscate the animal(s).
(3) Confiscated animals may be placed, by sale or donation, with other registrants
or licensees that comply with the standards and regulations and can provide
proper care, or they may be euthanized. The research facility from which
the animals were confiscated shall bear all costs incurred in performing
the placement or euthanasia activities authorized by this section.
(f) Handling. (1) Handling of all animals shall be done as expeditiously
and carefully as possibls in a manner that does not cause trauma, overheating,
excessive cooling, behavioral stress, physical harm, or unnecessary discomfort.
(2)(i) Physical abuse shall not be used to train, work, or otherwise handle
animals.
(ii) Deprivation of food or water shall not be used to train, work, or otherwise
handle animals; Provided, however: That the short-term withholding
of food or water from animals, when specified in an IACUC-approved activity
that includes a description of monitoring procedures, is allowed by these
regulations.
(g) Identification of dogs and cats. (1) All live dogs or cats, including
those from any exempt source, delivered for transportation, transported,
purchased or otherwise acquired. sold, or disposed of by a research facility,
shall be identified at the time of such delivery for transportation, purchase,
sale, disposal, or acquisition in one of the following ways:
(i) By the official tag or tattoo which was affixed to the animal at the
time it was acquired by the research facility, as required by this section;
or
(ii) By a tag, tattoo, or collar, applied to the live dog or cat by the
research facility and which individually identifies the dog or cat by number.
(2) All official tag or tattoo numbers shall be correctly listed in the
records of purchase, acquisition, disposal, or sale which shall be maintained
in accordance with § 2.35.
(3) Unweaned puppies or kittens need not be individually identified while
they are maintained as a litter with their dam in the same primary enclosure,
provided the dam has been individually identified.
(4) The official tag shall be made of a durable alloy such as brass, bronze,
or steel, or of a durable plastic. Aluminum of a sufficient thickness to
assure the tag is durable and legible may also be used. The tag may be circular
in shape and not less than 1 1/4 inches in diameter, or oblong and flat
in shape and not less than 2 inches by 3/4 inch, and riveted to an acceptable
collar.
(5) Each tag shall have the following information embossed or stamped on
so that it is easily readable:
(i) The letters ``USDA'';
(ii) Numbers identifying the State and dealer, exhibitor, or research facility
(e.g., 39-AB); and
(iii) Numbers identifying the animal (e.g., 82488).
(6) Official tags shall be serially numbered and shall be applied to dogs
or cats in the manner set forth in this section in as close to consecutive
numerical order as possible. No tag number shall be used to identify more
than one animal or shall be reused within a 5-year period.
(7) Research facilities may obtain, at their own expense, official tags
from commercial tag manufacturers. At the time the research facility is
registered, the Department will assign identification letters and numbers
to be used on the official tags.
(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 vetarinarian 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 Administrator, APHIS, USDA, Room 268, Federal Building, 6505 Belcrest
Road, Hyattsville, MD 20782.
(3) The U.S. Interstate and International Certificate of Health Examination
for Small Animals (VS Form 18-1) may be used for health certification by
a licensed veterinarian as required by this section.
(i) Holding of animals. If any research facility obtains prior approval
of the APHIS, REAC Sector Supervisor, it may arrange to have another person
hold animals: Provided, That:
(1) The other person agrees, in writing, to comply with the regulations
in this part and the standards in part 3 of this subchapter, and to allow
inspection of the premises by an APHIS official during business hours;
(2) The animals remain under the total control and responsibility of the
research facility; and
(3) The Institutional Official agrees, in writing, that the other person
or premises is a recognized animal site under its research facility registration.
Veterinary Services Form 18-9 shall be used for approval.
(j) Holding period. Research facilities that obtain dogs and cats
from sources other than dealers, exhibitors, and exempt persons shall hold
the animals for 5 full days, not including the day of acquisition, after
acquiring the animal, excluding time in transit, before they may be used
by the facility. Research facilities shall comply with the identification
of animals requirements set forth in § 2.38(g) during this period.
(k) Compliance with standards and prohibitions. (1) Each research
facility shall comply in all respects with the regulations set forth in
subpart C of this part and the standards set forth in part 3 of this subchapter
for the humane handling, care, treatment, housing, and transportation of
animals; Provided, however, That exceptions to the standards in part
3 and the provisions of subpart C of this part may be made only when such
exceptions are specified and justified in the proposal to conduct the activity
and are approved by the IACUC.
(2) No person shall obtain live random source dogs or cats by use of false
pretenses, misrepresentation, or deception.
(3) No person shall acquire, buy, sell, exhibit, use for research, transport,
or offer for transportation, any stolen animal.
(4) Each research facility shall comply with the regulations set forth in
section 2.133 of subpart I of this part.
Subpart D - Attending Veterinarian and Adequate Veterinary Care
§ 2.40 Attending veterinarian and adequate veterinary care
(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
§ 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 § 2.51 affixed
to the animal's neck by means of a collar made of material generally considered
acceptable to pet owners as a means of identifying their pet dogs or cats,
or shall be identified by a distinctive and legible tattoo marking acceptable
to and approved by the Administrator.
(2) Live puppies or kittens, less than 16 weeks of age, shall be identified
by:
(i) An official tag as described in § 2.51;
(ii) A distinctive and legible tattoo marking approved by the Administrator;
or
(iii) A plastic-type collar acceptable to the Administrator which has legibly
placed thereon the information required for an official tag pursuant to
§ 2.51.
(b) A class ``B'' dealer shall identify all live dogs and cats under his
or her control or on his or her premises as follows:
(1) When live dogs or cats are held, purchased, or otherwise acquired, they
shall be immediately identified:
(i) By affixing to the animal's neck an official tag as set forth in §
2.51 by means of a collar made of material generally acceptable to pet owners
as a means of identifying their pet dogs or cats; or
(ii) By a distinctive and legible tattoo marking approved by the Administrator.
(2) If any live dog or cat is already identified by an official tag or tattoo
which has been applied by another dealer or exhibitor, the dealer or exhibitor
who purchases or otherwise acquires the animal may continue identifying
the dog or cat by the previous identification number, or may replace the
previous tag with his own official tag or approved tattoo. In either case,
the class B dealer or class C exhibitor shall correctly list all old and
new official tag numbers or tattoos in his or her records of purchase which
shall be maintained in accordance with § § 2.75 and 2.77. Any
new official tag or tattoo number shall be used on all records of any subsequent
sales by the dealer or exhibitor, of any dog or cat.
(3) Live puppies or kittens less than 16 weeks of age, shall be identified
by:
(i) An official tag as described in § 2.51;
(ii) A distinctive and legible tattoo marking approved by the Administrator;
or
(iii) A plastic-type collar acceptable to the Administrator which has legibly
placed thereon the information required for an official tag pursuant to
§ 2.51.
(4) When any dealer has made a reasonable effort to affix an official tag
to a cat, as set forth in paragraphs (a) and (b) of this section, and has
been unable to do so, or when the cat exhibits serious distress from the
attachment of a collar and tag, the dealer shall attach the collar and tag
to the door of the primary enclosure containing the cat and take measures
adequate to maintain the identity of the cat in relation to the tag. Each
primary enclosure shall contain no more than one weaned cat without an affixed
collar and official tag, unless the cats are identified by a distinctive
and legible tattoo or plastic-type collar approved by the Administrator.
(c) A class ``C'' exhibitor shall identify all live dogs and cats under
his or her control or on his or her premises, whether held, purchased, or
otherwise acquired:
(1) As set forth in paragraph (b)(1) or (b)(3) of this section, or
(2) By identifying each dog or cat with:
(i) An official USDA sequentially numbered tag that is kept on the door
of the animal's cage or run;
(ii) A record book containing each animal's tag number, a written description
of each animal, the data required by § 2.75(a), and a clear photograph
of each animal; and
(iii) A duplicate tag that accompanies each dog or cat whenever it leaves
the compound or premises.
(d) Unweaned puppies or kittens need not be individually identified as required
by paragraphs (a) and (b) of this section while they are maintained as a
litter with their dam in the same primary enclosure, provided the dam has
been individually identified.
(e)(1) All animals, except dogs and cats, delivered for transportation,
transported, purchased, sold, or otherwise acquired or disposed of by any
dealer or exhibitor shall be identified by the dealer or exhibitor at the
time of delivery for transportation, purchase, sale, acquisition or disposal,
as provided for in this paragraph and in records maintained as required
in § § 2.75 and 2.77.
(2) When one or more 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 § 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.
§ 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.
§ 2.52 How to obtain tags.
Dealers or exhibitors may obtain, at their own expense, official tags from commercial tag manufacturers. 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.
§ 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 § 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.
§ 2.54 Lost tags.
Each dealer or exhibitor shall be held accountable for all official tags acquired. In the event an official tag is lost from a dog or cat while in the possession of a dealer or exhibitor, the dealer or exhibitor shall make a diligent effort to locate and reapply the tag to the proper animal. If the lost tag is not located, the dealer or exhibitor shall affix another official tag to the animal in the manner prescribed in § 2.50, and record the tag number on the official records.
§ 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
§ 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
§ 2.75 Records: Dealers and exhibitors.
(a)(1) Each dealer, other than operators of auction sales and brokers
to whom animals are consigned, and each exhibitor shall make, keep, and
maintain records or forms which fully and correctly disclose the following
information concerning each dog or cat purchased or otherwise acquired,
owned, held, or otherwise in his or her possession or under his or her control,
or which is transported, euthanized, sold, or otherwise disposed of by that
dealer or exhibitor. The records shall include any offspring born of any
animal while in his or her possession or under his or her control.
(i) The name and address of the person from whom a dog or cat was purchased
or otherwise acquired whether or not the person is required to be licensed
or registered under the Act;
(ii) The USDA license or registration number of the person if he or she
is licensed or registered under the Act;
(iii) The vehicle license number and state, and the driver's license number
and state of the person, if he or she is not licensed or registered under
the Act;
(iv) The name and address of the person to whom a dog or cat was sold or
given and that person's license or registration number if he or she is licensed
or registered under the Act;
(v) The date a dog or cat was acquired or disposed of, including by euthanasia;
(vi) The official USDA tag number or tattoo assigned to a dog or cat under
§ § 2.50 and 2.54;
(vii) A description of each dog or cat which shall include:
(A) The species and breed or type;
(B) The sex;
(C) The date of birth or approximate age; and
(D) The color and any distinctive markings;
(viii) The method of transportation including the name of the initial carrier
or intermediate handler or, if a privately owned vehicle is used to transport
a dog or cat, the name of the owner of the privately owned vehicle;
(ix) The date and method of disposition of a dog or cat, e.g., sale, death,
euthanasia, or donation.
(2) Record of Dogs and Cats on Hand (VS Form 18-5) and Record of Disposition
of Dogs and Cats (VS Form 18-6) are forms which may be used by dealers and
exhibitors to make, keep, and maintain the information required by paragraph
(a)(1) of this section.
(3) The USDA Interstate and International Certificate of Health Examination
for Small Animals (VS Form 18-1) may be used by dealers and exhibitors to
make, keep, and maintain the information required by paragraph (a)(1) of
this section and § 2.79.
(4) One copy of the record containing the information required by paragraph
(a)(1) of this section shall accompany each shipment of any dog or cat purchased
or otherwise acquired by a dealer or exhibitor. One copy of the record containing
the information required by paragraph (a)(1) of this section shall accompany
each shipment of any dog or cat sold or otherwise disposed of by a dealer
or exhibitor: Provided, however, that, except as provided in section 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
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) (VS Form 18-19)
and Record of Acquisition, Disposition, or Transport of Animals (other than
dogs and cats) (VS Form 18-20) are forms which may be used by dealers and
exhibitors to keep and maintain the information required by paragraph (b)(1)
of this section concerning animals other than dogs and cats except as provided
in § 2.79.
(3) One copy of the record containing the information required by paragraph
(b)(1) of this section shall accompany each shipment of any animal(s) other
than a dog or cat purchased or otherwise acquired by a dealer or exhibitor.
One copy of the record containing the information required by paragraph
(b)(1) of this section shall accompany each shipment of any animal other
than a dog or cat sold or otherwise disposed of by a dealer or exhibitor;
Provided, however, That information which indicates the source and
date of acquisition of any animal other than a dog or cat need not appear
on the copy of the record accompanying the shipment. The dealer or exhibitor
shall retain one copy of the record containing the information required
by paragraph (b)(1) of this section.
§ 2.76 Records: Operators of auction sales and brokers.
(a) Every operator of an auction sale or broker shall make, keep, and
maintain records or forms which fully and correctly disclose the following
information concerning each animal consigned for auction or sold, whether
or not a fee or commission is charged:
(1) The name and address of the person who owned or consigned the animal(s)
for sale;
(2) The name and address of the buyer or consignee who received the animal;
(3) The USDA license or registration number of the person(s) selling, consigning,
buying, or receiving the animals if he or she is licensed or registered
under the Act;
(4) The vehicle license number and state, and the driver's license number
and state of the person, if he or she is not licensed or registered under
the Act;
(5) The date of the consignment;
(6) The official USDA tag number or tattoo assigned to the animal under
§ § 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.
§ 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 § 2.80, including, where necessary, both the return transportation
charges and an amount sufficient to reimburse the carrier for out-of-pocket
expenses incurred for the care, feeding, and storage of the animal. The
carrier or intermediate handler at destination shall also keep and maintain
a copy of the shipping document containing the time, date, and method of
each attempted notification and the final notification to the consignee
and the name of the person notifying the consignee, as provided in §
2.80.
(b) In connection with all live dogs, cats, or nonhuman primates delivered
for transportation, in commerce, to any carrier or intermediate handler,
by any dealer, research facility, exhibitor, operator of an auction sale,
broker, or department, agency or instrumentality of the United States or
of any state or local government, the accepting carrier or intermediate
handler shall keep and maintain a copy of the health certification completed
as required by § 2.79, tendered with each live dog, cat, or nonhuman
primate.
§ 2.78 Health certification and identification.
(a) No dealer, exhibitor, operator of an auction sale, broker, or department,
agency, or instrumentality of the United States or of any State or local
government shall deliver to any intermediate handler or carrier for transportation,
in commerce, or shall transport in commerce any dog, cat, or nonhuman primate
unless the dog, cat, or nonhuman primate is accompanied by a health certificate
executed and issued by a licensed veterinarian. The health certificate shall
state that:
(1) The licensed veterinarian inspected the dog, cat, or nonhuman primate
on a specified date which shall not be more than 10 days prior to the delivery
of the dog, cat, or nonhuman primate for transportation; and
(2) when so inspected, the dog, cat, or nonhuman primate appeared to the
licensed veterinarian to be free of any infectious disease or physical abnormality
which would endanger the animal(s) or other animals or endanger public health.
(b) The Secretary may provide exceptions to the health certification requirement
on an individual basis for animals shipped to a research facility for purposes
of research, testing, or experimentation when the research facility requires
animals not eligible for certification. Requests should be addressed to
the Administrator, APHIS, USDA, Room 206, Federal Building, 6505 Belcrest
Road, Hyattsville, MD 20782.
(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 (VS Form 18-1) may be used for health certification by
a licensed veterinarian as required by this section.
§ 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 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.
§ 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
§ 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.
§ 2.101 Holding period.
(a) Any live dog or cat acquired by a dealer 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:
(FOOTNOTE) \5\An operator of an auction sale is not considered to have acquired
a dog or cat which is sold through the auction sale.
(1) That any live dog or cat acquired by a dealer or exhibitor from any
private or contract animal pound or shelter shall be held by that dealer
or exhibitor under his or her supervision and control for a period of not
less than 10 full days, not including the day of acquisition, after acquiring
the animal, excluding time in transit;
(2) Live dogs or cats which have completed a 5-day holding period with another
dealer or exhibitor, or a 10-day holding period with another dealer or exhibitor
if obtained from a private or contract shelter or pound, may be sold or
otherwise disposed of by subsequent dealers or exhibitors after a minimum
holding period of 24 hours by each subsequent dealer or exhibitor excluding
time in transit;
(3) Any dog or cat suffering from disease, emaciation, or injury may be
destroyed by euthanasia prior to the completion of the holding period required
by this section; and
(4) Any live dog or cat, 120 days of age or less, that was obtained from
the person that bred and raised such dog or cat, may be exempted from the
5-day holding requirement and may be disposed of by dealers or exhibitors
after a minimum holding period of 24 hours, excluding time in transit. Each
subsequent dealer or exhibitor must also hold each such dog or cat for a
24-hour period excluding time in transit.
(b) During the period in which any dog or cat is being held as required
by this section, the dog or cat shall be unloaded from any means of conveyance
in which it was received, for food, water, and rest, and shall be handled,
cared for, and treated in accordance with the standards set forth in part
3, subpart A, of this subchapter and § 2.131.
§ 2.102 Holding facility.
(a) If any dealer or exhibitor obtains the prior approval of the APHIS,
REAC Sector Supervisor, he may arrange to have another person hold animals
for the required period provided for in paragraph (a) of § 2.101:
Provided, That:
(1) The other person agrees in writing to comply with the regulations in
part 2 and the standards in part 3 of this subchapter and to allow inspection
of his premises by an APHIS official during business hours; and
(2) The animals remain under the total control and responsibility of the
dealer or exhibitor.
(3) Approval will not be given for a dealer or exhibitor holding a license
as set forth in § 2.1 to have animals held for purposes of this section
by another licensed dealer or exhibitor. Veterinary Services Form 18-9 shall
be used for approval.
(b) If any intermediate handler obtains prior approval of the APHIS, REAC
Sector Supervisor, 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.
Subpart I - Miscellaneous
§ 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, exhib