The full-text of the Code of Federal Regulations, Title 9, Chapter 1,
Subchapter A - Animal Welfare is available at:
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 warm-blooded 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 a study conducted on free-living wild
animals in their natural habitat. However, this term excludes
any study that involves an invasive procedure, or which harms
or materially alters 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 warm-blooded animals (except birds), such as skunks, raccoons,
nonhuman primates, squirrels, ocelots, foxes, coyotes, etc.;
(3) Any establishment or person selling warm-blooded 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]
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§ 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, 4700 River
Road, Suite 6D02, Riverdale, Maryland 20737-1234;
(xi) Methods of euthanasia used must be in accordance with
the definition of the term set forth in 9 CFR part 1, § 1.1
of this subchapter, unless a deviation is justified for scientific
reasons, in writing, by the investigator.
(2) Prior to IACUC review, each member of the Committee
shall be provided with a list of proposed activities to be reviewed.
Written descriptions of all proposed activities that involve the
care and use of animals shall be available to all IACUC members,
and any member of the IACUC may obtain, upon request, full Committee
review of those activities. If full Committee review is not requested,
at least one member of the IACUC, designated by the chairman and
qualified to conduct the review, shall review those activities,
and shall have the authority to approve, require modifications
in (to secure approval), or request full Committee review of any
of those activities. If full Committee review is requested for
a proposed activity, approval of that activity may be granted
only after review, at a convened meeting of a quorum of the IACUC,
and with the approval vote of a majority of the quorum present.
No member may participate in the IACUC review or approval of an
activity in which that member has a conflicting interest (e.g.,
is personally involved in the activity), except to provide information
requested by the IACUC, nor may a member who has a conflicting
interest contribute to the constitution of a quorum;
(3) The IACUC may invite consultants to assist in the review
of complex issues arising out of its review of proposed activities.
Consultants may not approve or withhold approval of an activity,
and may not vote with the IACUC unless they are also members of
the IACUC;
(4) The IACUC shall notify principal investigators and
the research facility in writing of its decision to approve or
withhold approval of those activities related to the care and
use of animals, or of modifications required to secure IACUC approval.
If the IACUC decides to withhold approval of an activity, it shall
include in its written notification a statement of the reasons
for its decision and give the principal investigator an opportunity
to respond in person or in writing. The IACUC may reconsider its
decision, with documentation in Committee minutes, in light of
the information provided by the principal investigator;
(5) The IACUC shall conduct 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 possible in a manner that does not cause trauma,
overheating, excessive cooling, behavioral stress, physical harm,
or unnecessary discomfort.
(2)(i) Physical abuse shall not be used to train, work,
or otherwise handle animals.
(ii) Deprivation of food or water shall not be used to
train, work, or otherwise handle animals; Provided, however:
That the short-term withholding of food or water from animals,
when specified in an IACUC-approved activity that includes a description
of monitoring procedures, is allowed by these regulations.
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Updated August 20, 2003