Date: May 10, 1999

To: National Institutes of Health, regburd@od.nih.gov

From: Cathy Liss, Executive Director and Adam Roberts, Research
Associate

Animal Welfare Institute

Re: Comments on the Report on Regulatory Burden, VI. Animal Care and Use

On behalf of the Animal Welfare Institute I am writing to register our
strong opposition to the "Section VI. Animal Care and Use" of the Report
on Regulatory Burden and to express outrage at those who seek to
dismantle the current sound laws and regulations enforced by the U.S.
Department of Agriculture

The Animal Welfare Institute seeks to reduce the sum total of pain and
fear inflicted on animals by people. We are not an anti-vivisection
organization. We seek humane treatment of animals in the laboratory and
support the universally-accepted "3 R's" (replacement of experimental
animals by alternatives, refinement to reduce pain and suffering when
animals are still used, and reduction of numbers of animals used). We
produce a quarterly newsletter and books such as [Comfortable Quarters
for Laboratory Animals]{.underline} and [Environmental Enhancement for
Caged Rhesus Macaques]{.underline} which we make available free of
charge to research facilities.

The use of animals in research includes a weighty responsibility to
ensure the best possible care and treatment for these animals whose
lives will be sacrificed following experimentation. Animals who are
treated well will produce more sound research results with a lower
variance. ("The Benefits of Giving Experimental Animals the Best
Possible Environment" by Michael Chance and William Russell,
[Comfortable Quarters for Laboratory Animals]{.underline}, pages 12-14)
However, there is a segment of the research community who do not wish to
be regulated or who would like to reduce the regulatory requirements
imposed on them.

In 1995, following widespread public concern and extensive documentation
of the need for legislation and of the failure of institutions to
self-regulate, hearings in both the House of Representatives and the
Senate, and careful consideration and negotiation, Congress adopted the
Improved Standards for Laboratory Animals amendment to the Animal
Welfare Act. Many researchers and the lobbyists who represented them
fought against this law, as those before them fought against the
Laboratory Animal Welfare Act of 1966 (later re-named the Animal Welfare
Act). Having lost that battle, opponents fought against regulations for
enforcement of the law until weakened regulations were finally adopted
four years later. Now a new avenue is being pursued, to wipe out as much
of the Animal Welfare Act as possible under the guise of "regulatory
burden".

Following are my specific comments:

The Committee make-up and individuals interviewed should have included a
wider spectrum of people including the non-affiliated member of the
Institutional Animal Care and Use Committee (IACUC) and scientists who
are known for their advocacy of animal well-being, at least one
representative from the Animal Welfare Information Center at the
National Agricultural Library and members of the humane community. Any
future committees that may be established should have this broader
constitution.

I recently participated in an extremely well-attended, national
laboratory animal conference, the annual meeting of Public
Responsibility in Medicine and Research. I was shocked to hear an
administrator and researcher from a large institution announce from the
podium that most researchers do not know what the "3 R's" are. That this
should be said 10 years following implementation of a law that mandates
research investigators to consider alternatives reveals the need for
additional regulation or oversight, rather than weakening of the current
system.

Unfortunately, at far too many institutions, the directors of the
facilities and the chairs of the IACUCs do not place sufficient emphasis
on alternatives and fail to encourage consideration of alternatives by
the researchers at the institution. As a result, the literature search,
conducted as a last step in the process, is seen as a mandatory hurdle
to comply with the law and not as the valuable tool that it is. The
investigators are merely going through the motions.

Perhaps what is needed is more specific direction about the literature
search. For example, the search for alternatives should be conducted
early in the development of a research protocol, at a time when the
investigator is conducting other searches of the literature. In
addition, the search needs to look at all three "R's", not just
alternatives to the use of animals. Can the numbers of animals used be
reduced? And particularly, what refinements can be used to improve the
situation for the animals? Perhaps the refinement is as simple as
provision of better post-surgical bedding.

It is appropriate that researchers consider alternatives to procedures
which may cause more than momentary pain or distress to animals, even if
pain relief is given. There are a number of reasons for this including
the fact that a number of animals will experience different degrees of
"discomfort" despite provision of pain relief and it is important to
ensure that the best, most suitable method of pain relief is
provided\--and at the proper dose and intervals.

An OIG audit titled "Enforcement of the Animal Welfare Act", dated
January 5, 1995, identified the failure of IACUCs to meet their current
responsibilities under the law and the failure of researchers to provide
a complete protocol for review by the IACUC. At 12 of 26 facilities,
"the committees were not adequately fulfilling their responsibilities
under the Act." Further, when committee members were questioned about
the deficiencies, they "stated that they were not aware of the
provisions of the Act." "The deficiencies disclosed by our review show
the need for tighter controls over the activities of the committees."
Protocol review should continue to be mandated at least once per year,
and USDA's careful oversight of the IACUC is vital.

I have conducted tours of research facilities across the country.
Despite the fact that my visits are announced, I have always seen some
failure to comply with the minimum requirements of the Animal Welfare
Act. Site visits are extremely important. There is great usefulness in
the current system that mandates, at minimum, bi-annual inspections by
the IACUC (permitting some self-regulation), but augmenting this with
the UNANNOUNCED inspections by USDA veterinary inspectors. Review of
USDA inspection report forms provides powerful evidence of the utility
and great need for their work.

Accreditation inspections of hospitals should not be compared to
inspections of animal research facilities for two major reasons. At
research facilities, those entitled to protection under the law are
animals, unable to voice objections to conditions, and secondly,
hospitals are frequented by the general public, people who are able to
voice concerns without fear of reprisals.

Perhaps NIH can do away with their site visits since it is not an
activity which they undertake with regularity. In those instances where
a registered research facility is not in compliance with the law,
perhaps it is a USDA inspector who should be sent in to conduct an
unannounced inspection, rather than a team of individuals organized by
NIH who make a scheduled visit.

I do not know why the Association for Accreditation of Laboratory Animal
Care International (AAALAC) is mentioned in this report on regulatory
burden at all. An institution's decision to request accreditation by
AAALAC is voluntary, therefore, those institutions who do not wish to be
burdened with the additional responsibilities or cost of accreditation
can simply refrain from requesting accreditation. The majority of
research facilities in the United States are not accredited.

In this age of computerization, it is easy to prepare a program so
research facility personnel can enter data for use in generating two
separate annual reports, one for USDA and another for NIH.
Alternatively, the research institution is not prohibited from providing
additional information beyond what is mandated by the agency, so the
requirements of both USDA and NIH could be supplied in one document.
These agencies do not have the legal authority to mandate this, so it
must be left up to the research facility. I'm certain that the two
agencies could agree on one submission deadline for the annual report.

The requirement in the Animal Welfare Act for no animal to be subject to
more than one major operative procedure is sound. Exceptions are
permitted, but must be approved by the Deputy Administrator, Animal
Care, APHIS. There is no indication that the Deputy Administrator takes
an excessive amount of time in responding to requests for exceptions.
Such exceptions should rarely be necessary and submission of an
already-completed protocol to the Deputy Administrator for approval
cannot be viewed as overly burdensome.

It is appalling for the report to complain of USDA's rigid requirements
for cage sizes. USDA's requirements are MINIMUM standards, and
facilities should be providing at least the mandated amount of space.
Animals should not have to sacrifice space in order to get
companionship.

Regarding training of inspectors, why doesn't the report suggest the
need for additional funds for training? Such training should not include
"the philosophy underlying the use of animals in research" since this
has nothing to do with enforcement of the Animal Welfare Act, and would
not serve to enhance the quality of inspections conducted by USDA.

In the Section titled, "Complexity of regulations governing the
transportation of animals and biological materials from non-human
primates," the suggestion that the "rigid interpretation of these
regulations, have the unintended consequence of impeding research, and
can also be life-threatening" is both hyperbolic and anecdotal. The
regulations governing import and export of CITES listed specimens,
whether a live animal or the part or product from a live animal, are
based on an international Treaty, the tenets of which have been agreed
to and implemented by the 145 Parties to CITES, including the United
States.

The primary responsibility of the FWS is to ensure that trade in
CITES-listed species is done in accordance with the Convention and that
the precautionary principle is applied when examining each permit
application for a species in trade. The FWS is not charged with
facilitating "transportation of research materials." Furthermore,
although "non-human primates" is referred to specifically in the
background discussion, the recommendations under 7. contain no such
specificity. Hence, if changed, the regulations will be unacceptably
misleadingly, and vaguely weakened beyond any specific species
reference.

Although the notification claims that there are three categories of
species' population status and subsequent protection, these references
have no correspondence to legal language in the Endangered Species Act
or the CITES Treaty. The notice asserts: "The highest level of control
is on those animals threatened with extinction, where a permit is
required from both the importing and exporting country; those not
threatened with extinction, but likely to be so without trade
regulation, require an export certificate; and species for which any of
the 100 signatory nations has designated a restriction requires an
export permit, a re-export certificate, or a certificate of origin."
Nowhere in the Treaty's description of Appendix I or Appendix II
specimens are the phrases in recommendation 7.b. "immediately threatened
with extinction" or "not presently threatened with extinction" found.
Without strict adherence to the textual language of CITES, it is
impossible to address proposed alterations to regulatory controls
accurately. It is illogical and unacceptable to change regulatory
responsibility for the Fish and Wildlife Service, while using language
that does not have any regulatory reference in the domestic or
international law which the Service is charged with enforcing.

Both recommendations (7. a. and b.) concerning reform of regulations on
importation of threatened and endangered specimens reveal a fundamental
lack of knowledge of, and confidence in, the CITES Treaty. Specimens on
CITES Appendix I, by definition, "include all species threatened with
extinction which are or may be affected by trade. Trade in specimens of
these species must be subject to particularly strict regulation in order
not to endanger further their survival and must only be authorized in
exceptional circumstances." Hence, to weaken in any way the regulatory
structure for Appendix I specimens would be to bring the United States
government in violation of the Treaty it signed in Washington , DC in
1973. Appendix I species, by definition, require the greatest
international controls to prevent further population decline.

Further, according to the Treaty, specimens on CITES Appendix II "shall
include: all species which although not necessarily now threatened with
extinction may become so unless trade in such species is subject to
strict regulation in order to avoid utilization incompatible with their
survival." Again, the regulation of trade in threatened wildlife is
mandated by CITES and implemented by the United States - not the other
way around. By requiring proper permits and certificates, the US Fish
and Wildlife Service is meeting its international obligations under the
CITES Treaty.

The CITES Treaty was signed specifically to protect "certain species of
wild fauna and flora against over-exploitation through international
trade." But these trade controls do not prohibit access to or
importation of wild and captive-bred specimens; they merely provide a
standard process governing such trade.

The text of the CITES Treaty specifically defines "specimen" as "any
animal or plant, whether alive or dead" and, for species in Appendices I
and II, "any readily recognizable part or derivative thereof."

Appropriate CITES permit controls are fundamentally necessary, even in
the event of importation or exportation of blood, tissue, and other
bodily fluids or organs. Without such regulatory controls, threatened
and endangered wild populations may meet increased pressure for samples
of these specimens - which may result in increased mortality and
significant adverse impacts to animal well-being in the collection
process. This is precisely why the Treaty requires a non-detriment
finding before any export of Appendix II specimens is authorized.

The scenario used by the working group to justify the complaint that the
CITES permitting process is too cumbersome is fundamentally misapplied:
"A workgroup member described an incident involving an individual bitten
by a zoo animal (non-endangered) in Canada where a blood sample from the
animal could not be immediately shipped to the U.S. for tests to
ascertain the possibility of transmission of a deadly disease." In this
instance, the zoo animal is noted as being "(non-endangered)". Assuming
this is a reference to an Appendix II species, no import permit from the
US is required - all that is required is an export permit from Canada.
Any delays in transport of the blood sample in question is not
representative of any problem with the process from the United States
side of the equation.

Issuing blanket permits to research institutions is dangerous and
unnecessary. No blanket permit should be given to a research institution
for the importation of any species listed under the Endangered Species
Act or the Appendices to CITES. In general, each species importation
and/or exportation must be looked at individually to determine whether
there is a justifiable reason for such importation and to see the impact
of such import on the species' wild populations.

It is absolutely unacceptable and a potential violation of the Treaty to
propose eliminating "the extension of permit requirements for research
materials to those animals not categorized as being immediately
threatened with extinction." Again, as stated above, Appendix II species
(if that's what we are referring to), which are not yet threatened with
extinction, also require trade controls - but not importation permits.
Therefore, any concern over alleged delays in importing CITES Appendix
II species are concerns that cannot be addressed by the regulations of
the Fish and Wildlife Service since the Fish and Wildlife Service does
not issue Appendix II import permits. The delays come from the exporting
government, not the US.