AAMC's Letter to USDA Secretary
Daniel R. Glickman 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 responded
to this request. Subsequently, the AAMC sent the following
letter to USDA Secretary Glickman on this same topic.]
September 8, 2000
The Honorable Daniel R. Glickman
Secretary
U.S. Department of
Agriculture
Room 200-A 1400
Independence Avenue S.W.
Washington, DC 20250
Dear Secretary Glickman:
We have learned from various sources that the Department
of Agriculture is in the process of negotiating an out-of-court
settlement in a case seeking to increase the regulatory burden
on scientists and their institutions that use mice, rats,
and birds in vital biomedical research. We believe that efforts
to settle the ARDF vs. Glickman litigation without
the input of the research community and other currently regulated
parties are a serious mistake.
Such negotiations, outside of the open and orderly regulatory
process, may result in a settlement that is both unworkable
and burdensome, cost hundreds of millions of dollars to implement,
and exceed Congressional intent in drafting the Animal
Welfare Act. At the same time, such a settlement is likely
not to improve the welfare of research animals one iota, while
simultaneously further taxing the U.S.D.A's already understaffed
and underfunded animal
welfare enforcement program.
The Association of American Medical Colleges respectfully
urges you:
- To halt these misguided settlement negotiations;
- Energetically oppose the litigation filed by the ARDF;
- Actively encourage and facilitate the involvement, in
both the litigation and in any settlement discussions, both
officials from the Department of Health and Human Services
(as required by 7
USC 2145), the National Institutes of Health, and representatives
of the research community. We understand that the National
Association for Biomedical Research (NABR), of which
we are a member, has a petition before the court requesting
intervenor status in the ARDF vs. Glickman litigation. We
urge the Department to support NABR's petition, as well
as other petitions that may be filed by regulated parties,
such as medical schools;
- Consult with Congress on their intent with regards to
regulating the use of mice, rats, and birds in research;
and
- Commit the Department to support only those regulatory
approaches on this issue that do not add to the unfunded
regulatory burden faced by researchers and their institutions.
We outlined our concerns about extending the AWA
regulations to rats, mice and birds in the attached letter
submitted in May 1999 in response to the Department's request
for comment on a petition filed by various animal rights groups
and activists (64
FR 4356). We expressed our serious concerns about the
profound implementation issues related to including research
rats, mice and birds in the AWA regulatory definition of "animal."
Since this comment letter was filed, the Department's enthusiasm
for increasing the regulatory burden of reporting animal "pain
and distress" has only increased our apprehension about
the wisdom of expanding the AWA regulatory definition.
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. Thus any change
in the AWA regulations regarding mice, rats, and birds is
likely only to increase our institution's reporting requirements.
The costs could be enormous. A NABR analysis projects that
the inclusion of rats, mice and birds to the AWA regulations
potentially would make hundreds, if not thousands, of new
institutions and other parties subject to AWA regulation at
a cost that was conservatively estimated at $80 to $280 million
for the paperwork burden alone!
Should USDA change its "pain
and distress" reporting requirements, the costs would
soar even higher - again, with no likely effect on animal
welfare. It is critical that any cost analysis of a proposed
settlement of the ARDF vs. Glickman litigation consider
the additional costs that could be mandated by changes in
the U.S.D.A.'s "pain and distress" reporting requirements.
If the estimate includes revised "pain and distress"
reporting requirements, we believe the regulatory cost burden
will dwarf all previous cost estimates.
The AAMC represents the nation's 125 accredited medical schools,
nearly 400 major teaching hospitals, more than 87,000 faculty
in 91 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 and has a strong commitment
to the humane care and treatment of laboratory animals.
We would welcome the opportunity to bring a group of institutional
leaders in to meeting with you to discuss this matter. If
your schedule will allow such a meeting, please have your
staff contact my colleague Tony Mazzaschi [tmazzaschi@aamc.org]
at (202-828-0059).
Sincerely,
Jordan J. Cohen
President, AAMC
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