Office of the Undersecretary for Marketing
and Regulatory Programs
U.S. Department of Agriculture
1400 Independence Avenue, S.W.
Washington, D.C. 20250
On November 1, 2001, the Department of Agriculture (USDA) submitted the
Animal and Plant Health Inspection Service (APHIS) draft policy titled
"Policy on Environment Enhancement for Nonhuman Primates" to the Office
of Management and Budget (OMB) for review under Executive Order No. 12866.
The intent of this policy is to clarify the factors that APHIS believes
must be considered and included in environment enhancement plans in order
for dealers, exhibitors, and research facilities to adequately promote
the psychological well-being of nonhuman primates.
As part of its review, the Office of Information and Regulatory Affairs
(OIRA) shared this draft with the Interagency Research Animal Committee
(IRAC), which represents agencies that have an interest in the area, including
the National Institutes of Health and the Food and Drug Administration
within the Department of Health and Human Services, and the Department
of Defense. After reviewing USDA's draft, IRAC raised serious concerns
with the APHIS policy (See Enclosure). IRAC and APHIS have discussed the
draft policy and it is our understanding that IRAC and APHIS will be working
together to address the concerns that have been raised.
We also raised questions and several concerns about the policy in addition
to those raised by IRAC. In particular, since there are likely significant
economic impacts to this policy, APHIS should evaluate these impacts as
required by Executive Order 12866. Also, if the agency is to expand documentation
and recordkeeping requirements as described in the current document, APHIS
must comply with the Paperwork Reduction Act. OMB's current approval for
the information collection associated with the environmental enhancement
plan does not include the expanded requirements.
Since the resolution of these concerns will take some additional time,
I am returning the policy to the Department for your reconsideration.
My staff is available for further discussion with you on the concerns
that have been raised. We look forward to working with you.
John D. Graham
Office of Information and Regulatory Affairs
OF HEALTH & HUMAN SERVICES
Public Health Service
National Institutes of Health
Bethesda, Maryland 20892
Office of Information and Regulatory Affairs
Office of Management and Budget
New Executive Office Building, Room 10202
725 17th Street N.W.
Washington, DC. 20503
28, 2001, the Interagency Research Animal Committee (IRAC) convened and,
per your request, reviewed the United States Department of Agriculture
(USDA) -Proposed Policy on Environmental Enhancement for Nonhuman Primates
which was recently submitted to your offices by the USDA.
member agencies oppose OMB approval of the proposed Policy as currently
of that review and recommendations resulting from those deliberations
are provided in the attachment.
in the recommendations, the IRAC agencies stand ready to provide advice
and assistance to the USDA on any future initiatives associated with this
or other subjects associated with the Animal Welfare Act and/or its implementing
regulations and policies.
James F. Taylor, D.V.M.
Chairman, Interagency Research
for the Office of Management and Budget (0MB) on:
Department of Agriculture (USDA) - Proposed Policy on Environmental Enhancement
for Nonhuman Primates - December 2001
Interagency Research Animal Committee (IRAC)
- The proposed
policy" is an "interpretive rule" and, as such, should not extend the
existing regulations without a formal rulemaking process. Contrary to
the assertions in the USDA analysis of public comments on the proposed
"policy," it appears to the committee that the proposed policy does
extend the language in the existing regulations in several important
- The proposed
"policy" would create a de facto requirement to pair or group house
animals because exceptions to pair/group housing would have to be scientifically
justified and subject to USDA review. The existing regulations do not
actually require pair/group housing. The costs of this change could
constitute a "major rule" and should be analyzed.
- For animals
in persistent psychological distress, the proposed "policy" would require
consultation with a primate behaviorist or veterinarian with specialized
training in primate behavior. This is a new requirement.
requirements for the "policy" exceed those of the regulations. Contrary
to the language in the USDA analysis of public comments, the documentation/record-keeping
requirements are significantly greater in the "policy" and were not
considered by 0MB in its review of paragraph 3.81 of the original regulations
(Federal Register Feb 15,1991, p 6426-6505). The original requirement
for documentation applied only to the creation of a written plan, not
the daily implementation of it. This is made clear in the 1991 Fed.Reg.
notice. The proposed "policy" extends documentation to include records
of daily implementation and assessment of its effectiveness.
members believe there is a potential problem with the proposed requirement
that "Primates should be given the option of placing their tail comfortably
within the enclosure, without having to rest any part of it in or on
waste or food pans." In the case of long-tailed macaques (cynomolgus
monkeys), tails can and do touch the cage bottom, but generally without
damage except for some hair loss from the tail tip in some monkeys.
If taller cages will be required to prevent tail-floor contact, there
will be a very significant cost associated with new caging systems and
a probable concomitant need to modify existing doorways. If, instead
of higher cages, existing stacked caging were to be made effectively
taller by eliminating the horizontal barrier between upper and lower
caging, the number of animals housed per caging unit and per animal
room would be greatly decreased. Either of these, or other, solutions
would have substantial cost without any proven benefit to animal health
should have taken advantage of the opportunity to adopt an existing
scientifically acceptable guideline "The Psychological Well-Being of
Nonhuman Primates 1998," produced by the Institute of Laboratory Animal
Research (ILAR), of the National Academy of Science (NAS), as recommended
earlier by the National Institutes of Health (NIH) and the majority
of the commenters from the biomedical research community. Contrary to
the statements in the USDA analysis, the ILAR publication (1998) was
available prior to the publication of the final USDA internal report
("Final Report on Environmental Enhancement to Promote the Psychological
Well-Being of Nonhuman Primates," 1999) on the subject.
- We understand
that one of the motivating factors behind the USDA initiative to develop
an interpretive rule was a lawsuit. Plaintiff alleged that the existing
regulations do not meet the intent of the statute (Animal Welfare Act
(AWA)) regarding a minimum standard for promoting the psychological
well-being of nonhuman primates. We believe that the court has subsequently
determined that the existing regulations do indeed satisfy the AWA.
the points raised above, the IRAC membership reached consensus on the
- USDA should
adopt the "Psychological Well-Being of Nonhuman Primates" and the "Guide
for the Care and Use of Laboratory Animals" guidelines developed by
the NAS/ILAR as the professional standards on which to base and evaluate
the required institutional primate enrichment plans.
- The USDA
proposed "policy" should not be issued as an "interpretive rule." If
issued at all, it should be modified to include examples of acceptable
enrichment plans and designated as a non-binding "best practice" resource
document. The NIH and other IRAC member agencies are prepared to cooperate
with USDA and the scientific community in the creation of such a resource.
- The IRAC
agencies welcome, and expect, the opportunity to review, and offer collaboration
with fellow agencies on. proposed policies or interpretive rules that
are acknowledged to have potential significant resource impact on agency
programs, whether intramural or via grant or contract.