AAMC's Comment Letter to
USDA on the Definition of "Animal" in the Animal
Welfare Act Regulations
[On January 28, 1999, the Animal and Plant Health Inspection
Service issued a Federal Register notice (64 FR 4356)
seeking comments on a "Petition for Rulemaking"
regarding the definition of "animal" in the regulations
implementing Animal Welfare Act. The AAMC response is provided
below. AAMC sent a letter
to USDA Secretary Glickman on September 8, 2000 on this same
topic.]
May 28, 1999
Regulatory Analysis and Development Program
Planning and Development
Animal and Plant Health
Inspection Service (APHIS)
U.S. Department of Agriculture
Suite 3C03
4700 River Road, Unit 118
Riverdale, MD 20737-1238
RE: Docket No. 98-106-1
Dear Sir:
The Association of American Medical Colleges (AAMC) appreciates
having the opportunity to comment on the petition currently
before the Department requesting that the definition of "animal"
in the Animal Welfare Act (AWA) regulations be amended to
include rats and mice bred for research, as well as birds.
The AAMC represents the nation's 125 accredited medical schools,
nearly 400 major teaching hospitals, more than 87,000 faculty
in 87 professional and scientific societies, and the nation's
67,000 medical students and 102,000 residents. More than half
of the extramural research funding awarded by the National
Institutes of Health goes to medical schools and their affiliated
teaching hospitals. Much of this research involves the use
of rats and mice. As such, the Association has a long history
of involvement in legislative and regulatory issues concerning
the use of animals in research.
The Association has reviewed the comment letter of the National
Association for Biomedical Research (NABR) and heartily
endorses the NABR position. The AAMC and many of its constituent
institutions are members of NABR and contributed to its analysis
of the petition under consideration. We particularly urge
the Department to review NABR's discussion of the legislative
history behind the definition of "animal" in the
Animal Welfare Act as well as its analysis of the related
legal issues.
The AAMC has a strong commitment to the humane care and treatment
of laboratory animals. For ethical, scientific and financial
reasons, AAMC member institutions recognize their responsibility
to develop and maintain the highest standards of laboratory
animal care and treatment. Most AAMC member institutions are
accredited by the Association
for Assessment and Accreditation of Laboratory Animal Care
(AAALAC). Participation in the voluntary accreditation program
of AAALAC demonstrates that these research institutions are
not only meeting the minimums required by law, but are going
the extra step to achieve and showcase excellence in animal
care and use.
Questions Posed in APHIS' Notice of Petition and Request
for Comment
1. Should the definition of "animal" in 9 CFR
Part 1 be revised to include laboratory rats, laboratory mice,
and birds, or any of the three?
The Association has no philosophical objection to including
research rats, mice and birds in the AWA regulatory definition
of "animal." However, there are profound implementation
issues related to such an action that make us apprehensive
about the wisdom of such a decision. All of our institutions
are currently subject to the standards embodied in the U.S.
Public Health Service Policy on Humane Care and Use of Laboratory
Animals and the Institute for Laboratory Animal Research Guide.
Our institutions believe the humane care and use of research
animals is necessary for scientific as well as ethical reasons.
Reliable research results can only be obtained if researchers,
institutional officials and veterinarians are attentive to
laboratory animal well-being.
Should APHIS proceed to include rats, mice and birds under
the AWA regulatory regime, a number of implementation issues
must be carefully considered:
- The regulation of the species must be done in a manner
that is fully consistent with the standards embodied in
the U.S.
Public Health Service Policy on Humane Care and Use of Laboratory
Animals and the Institute
for Laboratory Animal Research Guide. Such regulations
should be based on performance standards and not engineering
standards.
- The regulatory and paperwork burden on institutions and
researchers must be minimized. Every dollar spent on needless
and inefficient recordkeeping is a dollar that cannot be
used for research on potentially life-saving research.
- APHIS must be given the financial and other resources
to perform properly the major additional responsibilities
that would necessarily derive from such a redefinition.
New obligations must not be permitted to compromise existing
animal welfare enforcement activities.
2. If the definition of "animal" in 9 CFR Part
1 is amended to include laboratory rats, laboratory mice,
and birds, should [the Office of] Animal Care regulate the
care provided to these species in all circumstances covered
by the AWA or in certain circumstances, such as use in research,
only?
Regulations must be based on a demonstrated need and not
based on expediency. Although initially regulating rats, mice
and birds at currently USDA-registered research facilities
may be the expedient approach, these institutions may be the
last ones that need additional oversight. Similarly, suggestions
that APHIS perform abbreviated or modified inspections of
rats, mice and birds are equally troubling. Inspection authority
is an important feature of the USDA's animal welfare responsibilities.
As NABR noted, "Since there are already federal and private
animal welfare standards for rats, mice and birds used in
research, if USDA does not intend to conduct inspections,
it is exceedingly difficult to understand why the Department
would choose to create redundant federal regulations."
Any new regulations must be consistent with existing enforcement
efforts and have a fair and logical rationale in terms of
the need to adopt them. A patchwork system of regulation makes
compliance difficult and enforcement nearly impossible.
3. The AWA requires that USDA inspect all research facilities
at least once a year. Because of current and anticipated resources
for AWA enforcement, any coverage of rats, mice and birds
would result in significantly reduced numbers of inspections
for other AWA-regulated entities, such as dog and cat dealers,
intermediate handlers and carriers, large and small zoos,
and circuses. Should AWA enforcement activities be equal for
all species covered by the AWA? If not, what should be the
relative priorities?
In our view, it is unacceptable to reduce further the number
of inspections conducted at currently registered or licensed
entities. All species and regulated entities covered by AWA
regulations should be treated equally. APHIS should be provided
with sufficient resources to accomplish this objective.
4. If the definition of "animal" in 9 CRR Part
1 is amended to include laboratory rats, laboratory mice,
and birds, how many additional facilities would come under
USDA regulation?
We do not possess any data that would assist in estimating
the number of new facilities that would be subject to USDA
regulation should rats, mice and birds be included in the
AWA regulations. However, countless high schools and community
colleges use rats and mice in non-invasive behavioral research
and hundreds of biotechnology firms use only transgenic mice
in their research activities. A broadened definition of "animal"
would subject these firms and institutions to USDA regulation
for the first time. We understand that NABR has gathered data
that may provide USDA with more quantitative information on
this issue. We appreciate the opportunity to comment on this
issue. Please feel free to contact the Association if we can
provide additional comments as you consider the petition.
Sincerely,
Jordan J. Cohen, M.D.
President, AAMC
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