Animal
Welfare Act
The
Animal Welfare Act (AWA) was passed in 1966 and amended in
1970, 1976, and 1985. It regulates
the transportation, care and treatment
of animals used in research or exhibition,
and for sale as pets. Animals covered
by the AWA regulations are “any live or
dead dog, cat, nonhuman primate, guinea
pig, hamster, rabbit, or any other
warmblooded animal which is domesticated
or raised in captivity or which normally
can be found in the wild state, and
is being used or is intended for use
for research, testing, experimentation
or exhibition purposes, or as a pet.”
Currently excluded from consideration
are “birds, rats and mice, and
horses and other farm animals such
as livestock used or intended for
use as food or fiber, or used for
improving nutrition, breeding, management,
or production efficiency, or for improving
the quality of food or fiber.”
The
U.S. Department of Agriculture (USDA)
is responsible for promulgation of
rules and regulations that meet the
mandates of the AWA and for their
enforcement.
Regulations
promulgated under the AWA deal with matters such as record-keeping,
animal identification, holding periods,
license fees, confiscation of animals,
and miscellaneous administrative procedures
and rules. Included are requirements
that an institution engaged in research
using animals must be registered with
the USDA.
They also must permit unannounced
inspections of their animal facilities
and laboratories by USDA inspectors (usually veterinarians)
to determine institutional compliance.
The institution must have an attending
veterinarian who establishes and maintains
programs of disease control and prevention,
euthanasia, and veterinary care. An
annual report must be filed, signed
by a facility official and the attending
veterinarian, showing that animals
are treated and cared for in accordance
with professionally acceptable standards.
The
regulations also set forth the legal
minimum standards for the humane care,
handling, treatment and transportation
of animals. The standards are divided
into three general categories: Facilities
and Operating Standards, Animal Health
and Husbandry Standards, and Transportation
Requirements.
Facilities
and Operating Standards cover requirements for general, indoor
and outdoor facilities and primary
enclosures (cages and pens). General
facility standards are for structural
strength, availability of water and
electric power, storage facilities
for food and bedding, waste disposal,
and provisions for washrooms and sinks
to maintain cleanliness. Standards
for indoor facilities include requirements
for heating, ventilation, lighting,
interior surfaces which are sanitizable
and impervious to moisture, and suitable
drainage. Outdoor facilities standards
include requirements for shelter from
sunlight, rain or snow, cold weather,
and provisions for drainage. Standards
for primary enclosures include consideration
of structural soundness and safety,
as well as general and detailed size
requirements for each regulated species. Animal Health
and Husbandry Standards include
requirements for feeding and watering,
sanitation methods and intervals,
number of employees, classification
and separation of certain animals,
and veterinary care. Included in the
standards for veterinary care are
requirements for:
- Programs of disease control and prevention,
euthanasia, and adequate
veterinary care established and maintained
under the supervision and assistance
of
a veterinarian;
- Veterinary treatment of sick or injured
animals or their humane disposal;
- Use of anesthetic, analgesic, and
tranquilizing drugs when such use
is appropriate in the opinion of the
attending veterinarian and
- Providing guidelines and consultation
to research personnel with respect
to the type and amOunt of tranquilizers,
anesthetics, or analgesics appropriate
for each species of animal used.
Transportation
Requirements cover commercial carriers and intermediate
handlers, and deal with standards
for temperature limits, crate construction,
size of primary enclosures used to
transport animals, primary conveyances
(motor vehicle, rail, air, and boat),
food and water in transit, etc.
Regulations
implementing the 1985 amendment to
the AWA reflect the following statutory requirements
of the amendment:
- Animal care, treatment, and practices
in experimental procedures must ensure
that animal pain and distress are
minimized, and adequate veterinary
care with the appropriate use of anesthetics,
analgesics, tranquilizing drugs, and
euthanasia are provided. (Animals
actually under experimentation were
previously excluded.);
- Exercise of dogs, and a physical environment
adequate to promote the psychological
well-being of primates must be provided;
- Alternatives to painful procedures
in experimentation must be considered;
- A doctor of veterinary medicine must
be consulted in any practice which
could cause pain to animals;
- No animal may be used in more than
one major operative experiment from
which it is allowed to recover except
in cases of scientific necessity or
other special circumstances determined
by the Secretary, USDA;
- Exceptions to the standards in the
regulations may be made only when
specified by research protocol and
any such exception shall be detailed
and explained in a report filed
with the Institutional Animal Care
and Use Committee;
- Research facilities are required to
show on inspection and report annually
that provisions of the Act are being
followed and that professionally acceptable
standards governing the care, treatment
and use of animals are being followed
during actual research and experimentation;
- Research facilities are required to
have at least one institutional animal
care and use committee which includes
a member not affiliated with the facility,
“intended to provide representation
for general community interests in
the proper care and treatment of animals.”
Committee responsibilities include
semi-annual review of programs and
inspections of facilities for animals;
with review of the condition of animals
and of practices involving animal
pain. The committee must file a report
with in the institution and the request
must be made available to the USDA
inspector. If a research facility
is notified by the committee of a
major deficiency and fails to correct
it, the Committee shall report it
to USDA and any federal funding agency;
- Institutions must provide training
for scientists, technicians and other
personnel involved with animals. Required
areas include: humane practices in
maintenance and experimentation; methods
to minimize or eliminate animal use
or limit pain and distress; utilization
of the information service at the
National Agriculture Library; and
deficiency reporting methods,
The
amendment directs the Secretary, USDA,
in cooperation with the National Library
of Medicine, to establish an information
service at the National Agriculture
Library providing information on employee
training, prevention of unintended
duplication of research, and improved
methods of reducing or replacing animal
use and minimizing pain.
Good
Laboratory Practice Regulations
Good
Laboratory Practice regulations (GLP’s) of
the Food and Drug Administration and
The Environmental Protection Agency,
are specifically applicable to nonclinical
and safety testing. Although the principles
upon which the GLP’s are based
are valuable, the GLP’s do not
technically apply to studies such
as basic research and clinical testing.
Rather, they address many areas of
laboratory operations, including requirements
for a Quality Assurance Unit to conduct
internal inspections, and Standard
Operating Procedures (SOP’s)
to guide all aspects of each study.
Both agencies’ GLP’s require SOP’s
for animal housing, feeding, handling
and care, with additional standards
on separation, disease control and
treatment, identification, sanitation,
feed and water inspection, bedding
and pest control.
The
documents referred to in this section
are available from OAR,1720 E Campus Loop, 882-3111.
Chapter
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2 | Chapter
3 | Chapter
4 | Chapter
5 | Chapter
6 | Chapter
7 | Chapter
8
Chapter 9 | Chapter 10 | Chapter 11 | Chapter 12 |
