**Doris Day Animal League**

January 2, 2004

Connie Atwell, Ph.D. (via e-mail: atwellc@ninds.nih.gov)

Rodney Brown, Ph.D. (via e-mail: Rodney.J.Brown@usda.gov)

Co-Chairs, Research Business Models Subcommittee, Committee on Science

National Science and Technology Council (nstc_rbm@ostp.eop.gov)

Washington, D.C.

Dear Drs. Atwell and Brown:

During the public meeting of the Research Business Models Subcommittee,
held on December 8 and 9 as part of the subcommittee's review of federal
policies and practices for funding research, one of the themes that
emerged repeatedly was the need to minimize the "regulatory burden" in
order to maximize returns on scientific endeavors.

We caution the subcommittee against summarily labeling all regulations
"burdensome." We recognize that some federal policies and
recommendations result in more paperwork for the research community
rather than in any meaningful oversight. However, that is not
universally the case, and compliance is one means by which to ensure
public accountability and transparency, also raised as responsibilities
of those engaging in federally funded science. In fact, some regulations
help ensure the integrity of the scientific process itself.

The Research Business Models Subcommittee should under no circumstances
entertain any proposal for weakening federal rules pertaining to the use
of animals in research.

Specifically, it should reject the attempt by the Federation of American
Societies for Experimental Biology (FASEB) to classify as "impediments
to biomedical research" two fundamentally important regulations: first,
that principal investigators whose work will cause pain or distress in
laboratory animals perform a database search or use other means to
locate possible alternatives; and second, that facilities provide for
the psychological enrichment of primates.

FASEB wrongly claims that the "literature on alternatives is...not
sufficiently broad to address adequately the availability of
alternatives." It is evident that FASEB itself does

Suite 100 · 227 Massachusetts Ave, NE, Washington, D.C. 20002 ·
202-546-1761 Fax: 202-546-2193 E-mail: <nancy@ddal.org> · www.ddal.org

CONNIE ATWELL, PH.D.

RODNEY BROWN, PH.D.

January 2, 2004

Page 2

not stay current in this area, or they would know that existing
databases are more than sufficient to enable a researcher to ascertain
whether a suitable non-animal or less painful alternative to his/her
protocol exists.

How can scientists or their institutions credibly argue that they lack
the ability or the means to conduct a proper search for alternatives?
After all, these are, according to everyone who spoke at the meeting,
the world's premier facilities and most capable scientists. They can
travel back in time to search for "dark energy" (as in one proposed DoE
project), but they can't search for less painful procedures? No, the
problem is not with the resources available for conducting the search,
nor even the potential for finding a suitable alternative. The problem
is the lack of institutional commitment to developing a culture that
places a priority on minimizing and, if possible, eliminating pain in
the millions of animals used in research. If that commitment were
present, methods would be found to overcome the issues related to
identifying alternatives to painful procedures.

The same lack of commitment exists with respect to providing humane
living conditions for research animals. It is unfortunate that, thanks
to pressure from the scientific commun-ity, USDA has failed to implement
any regulations with respect to the psychological well-being of
primates.

FASEB also wants you to believe that there are layers upon layers of
conflicting rules with which researchers must comply. The truth is this:
Only the regulations established under the *Animal Welfare Act* and
enforced by the USDA, under which fall both the alternatives and the
primate enrichment requirements, have the force of law. These
requirements are the *minimum* safeguards research should be providing
and, as of last year, this law no longer covers 90 percent of the
animals used in research, i.e., birds, rats, and mice. The standards
established by the NIH under its PHS Policy on the Humane Care and Use
of Laboratory Animals are widely used, although oversight leaves much to
be desired and there is no legal recourse in the event of violations.
Other grant-making agencies may provide "policy guidelines" for animal
research, but they do not exceed either the *Animal Welfare Act* or the
PHS guidelines and do not have the force of law. Moreover, we know of no
case in which a grant recipient has been punished for failing to adhere
to any guideline, or, for that matter, for violating the *Animal Welfare
Act*.

These requirements for consideration of alternatives to animal
experimentation and the psychological well-being of nonhuman primates
are not merely regulations that can be changed through agency action;
**they are part of the law**. The language is quite specific in
requiring standards for "a physical environment adequate to promote the
psychological well-being of primates" and in requiring that principal
investigators consider "alternatives

CONNIE ATWELL, PH.D.

RODNEY BROWN, PH.D.

January 2, 2004

Page 3

to any procedure likely to produce pain or distress in an experimental
animal." \[*Animal Welfare Act* 7 USC §2143 (a)(2)(B) and (a)(3)(B)\]

These *legal requirements* not only respond to the public's demand that
research be con- ducted as humanely as possible, but they also
contribute to the integrity of the scientific process, as it is widely
known that pain, distress, and inhumane living conditions affect animals
in ways that impact research outcomes.

We understand that the subcommittee's next steps include assigning
priorities to recom-mendations and determining what can and should be
achieved. Two touchstones for these decisions outlined at the meeting
are to be the likelihood that a given change would have a "significant
impact on maximizing public investment in science," and the ease with
which the change can be accomplished. Allowing scientists to forgo a
search for non-animal/less painful alternatives, or endorsing any effort
to interfere with the issuance of a final rule governing primate
enrichment, would adversely affect the public investment in science by
encouraging research to stay mired in practices that, by causing pain
and suffering in animals, directly affect research results and increase
costs. Just as importantly, to aid and abet the research community's
failure to take seriously its responsibility to explore alternatives and
provide for primate enrichment makes a mockery of any "commitment" to
public accountability and transparency.

There are members of the research community who believe in the
importance of these rules and would be appalled at any recommendation to
weaken or eliminate them. We feel certain such a move would not gain the
consensus you seek, and it would also meet with stiff resistance from
the animal protection community. We hope you will not bring any such
proposals to your future discussions.

Sincerely,

Nancy Blaney Peter Theran, D.V.M.

Federal Policy Consultant Vice President, Animal Sciences

Doris Day Animal League Massachusetts Society for the Prevention of
Cruelty to Animals

Martin Stephens, Ph.D. Michelle Thew

Vice President, Animal Research Issues Chief Executive Officer

Humane Society of the United States Animal Protection Institute

CONNIE ATWELL, PH.D.

RODNEY BROWN, PH.D.

January 2, 2004

Page 4

Kathleen Conlee Sue Leary

Program Officer, Animal Research Issues President

Humane Society of the United States Alternatives Research and
Development Foundation

Tina Nelson Cathy Liss

Executive Director President

American AntiVivisection Society Animal Welfare Institute

John McArdle, Ph.D.

Executive Director

International Center for Alternatives Resources