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Regulating Mice, Rats and
Birds
The Animal Welfare Act
(AWA) (7USC 2131) provides for warm-blooded animals, including purpose-bred laboratory rats, mice and birds, to
be regulated. When the U. S. Department of
Agriculture (USDA) issued the first set of regulations, laboratory-bred rats, mice and
birds were excluded by administrative rule. The
inclusion of these warm-blooded animals has not been considered with the additional
changes in the USDA regulations (9 CFR: parts 1, 2 & 3). Congress did not specifically exclude
laboratory-bred rats, mice and birds from the AWA.
The Secretary of Agriculture excluded them from the regulations. Therefore, all that is needed to include
laboratory-bred rats, mice and birds under the law would be for the USDA to make
appropriate changes in the regulations. This
process includes publishing proposed regulations in the Federal Register, public hearings
and comments from interested parties, and then a final regulation (ruling) issued by the
Secretary of Agriculture. No further
Congressional action is required to modify the regulations that pertain to the AWA.
The National Institutes
of Health (NIH) forecast a rise in the use of mice and rats in biomedical research in
fields like molecular biology, transgenics and gene mapping. The fact that laboratory-bred rats, mice and birds
are not covered by USDA regulations sends the wrong message to scientists entering these
rapidly developing fields of science, as well as to the public. The Scientists Center for
Animal Welfare (SCAW )strongly feels that the USDA should act promptly to change
laboratory-bred rats, mice and birds from non-regulated species to regulated species.
The major concerns
associated with the inclusion of laboratory-bred
rats, mice and birds under the USDA regulations are the additional costs and the
administrative burdens that would be placed on both the regulated entities and the USDA. SCAW believes that some of these issues may be
alleviated through the adoption of performance based standards, the use of statistical
sampling methods for the inspection process, and new enforcement practices. An example of one of these initiatives is the USDA
proposed Partners for Animal Care Excellence (PACE)
program. SCAW is willing to provide
assistance to the USDA and USDA regulated institutions in order to seek a suitable format
to ensure the inclusion of laboratory-bred
rats, mice and birds.
It is important to
note that most registered research institutions already provide laboratory animal programs
that meet or exceed universally acceptable standards of care for all animals, including
laboratory rats, mice and birds. The Public
Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) applies to
all activities involving live vertebrate animals conducted or supported by the Public
Health Service. The National Research
Council, the National Institutes of Health, and the Food and Drug Administration comply
with the Guide for the Care and Use of Laboratory
Animals (Institute of Laboratory Animal Research, National Academy Press, revised
1996), a primary reference on laboratory animal (including rats, mice and birds) care and
use. Many biomedical institutions are
accredited by Association for Assessment and Accreditation of Laboratory Animal Care
International (AAALAC) which cites the Guide as
its core reference. For accreditation, AAALAC
requires that all animals be covered. The
vast majority of the laboratory-bred rats,
mice and birds in the USA are in facilities that already meet or exceed standards based on
the institutions accreditation by AAALAC or equivalent compliance with the Guide.
By far the greatest
number of the animals used in biomedical research studies in the USA are laboratory-bred
rats and mice. Their coverage under the AWA
and by USDA regulations is appropriate and proper.
The Scientists Center
for Animal Welfare promotes excellence in science coupled with excellence in animal
welfare. Therefore, we consider AWA coverage
of all animals appropriate. SCAW has always
included these warm-blooded animals in our educational programs. SCAW supports the principle that laboratory-bred
rats, mice and birds should be included under USDA regulations.
Revised
June 23, 1999
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