AAMC's Letter to USDA on
their Request for Comments Concerning the "Definitions
for and Reporting of Pain and Distress"
October 26, 2000
Regulatory Analysis and Development
PPD, APHIS
Suite 3C03
4700 River Road Unit 118
Riverdale, MD 20737-1238
Docket No. 00-005-1
Dear Sir/Madam:
The Association of American Medical Colleges (AAMC) appreciates
the opportunity to comment on the Agency's Request for Comments
[text
or PDF]
concerning the "Definitions for and Reporting of Pain
and Distress." We believe any modification of existing
AWA regulations
and the related reporting requirements on regulated parties
must benefit the welfare of research animals, promote research
progress, harmonize with other federal regulatory requirements,
and minimize unnecessary administrative costs and regulatory
burdens. We do not believe that the suggested changes in the
regulations regarding the reporting of pain and distress meet
these criteria.
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 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 research animals.
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 letters of the National
Association for Biomedical Research (NABR), the American
Physiological Society (APS) and the Federation
of American Societies for Experimental Biology (FASEB).
We heartily endorse their comments and commend them to your
attention. The AAMC and many of its constituent institutions
are members of NABR and contributed to its comment letter.
The APS is a member of the AAMC Council
of Academic Societies, as are many of the FASEB constituent
societies.
We do not believe that a definition of distress should be
included in the AWA regulations. While guidelines generated
by the scientific community for recognition of distress may
be helpful, a single, standardized definition could not adequately
convey the complexities and subtleties of this issue, and
therefore do little to enhance the ability of institutions
to recognize, minimize, or report animal distress across species
and situations. Instead, we share APS's view that the USDA
should direct local animal care committees to the peer-reviewed
scientific literature on this issue and endorse the NRC/ILAR
report, "Recognition
and Alleviation of Pain and Distress in Laboratory Animals
(1992)." As FASEB notes, "It is in the best interest
of both animal welfare and research progress for local Institutional
Animal Care and Use Committees (IACUCs) to take responsibility
in this area and to foster a partnership among scientists,
veterinarians, veterinary technicians, animal husbandry staff,
government and professional associations that will enhance
the stewardship of animals."
The draft definition of distress proffered by the USDA ("Distress
refers to a state in which an animal cannot escape from or
adapt to the internal or external stressors or conditions
it experiences, resulting in negative effects on its well-being")
is extraordinarily vague and almost mandates highly subjective
interpretations. Distress is a continuum that may be caused
by various physiological, psychological or environmental factors.
As was noted in the NRC/ILAR report, stress responses are
integral to life and in some cases may even help animals adapt,
and there are no simple criteria to mark the point where an
animal that experiences stress becomes distressed. Thus, we
are convinced that a static regulatory definition of distress
is ill-considered biologically and unhelpful operationally.
We share the views of our colleagues that the current reporting
system already goes beyond the intent of Congress as expressed
in the AWA in requiring that the numbers of animals in each
pain and distress classification category be reported annually
to the USDA. The USDA must establish a clear rationale for
any further elaboration of distress classification and reporting,
and the expansion of costs and burdens that would necessarily
result. The USDA also must be able to demonstrate that any
new regulations it proposes are scientifically valid and will
measurably improve the care of animals without imposing administrative
costs and paperwork burden that will interfere unduly with
research progress.
Sincerely,
Jordan J. Cohen, M.D.
President, AAMC
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