January 29, 2002

The Honorable Bill Hawks
Office of the Undersecretary for Marketing
   and Regulatory Programs
U.S. Department of Agriculture
Room 228W
1400 Independence Avenue, S.W.
Washington, D.C. 20250

Dear Mr. Hawks:

     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

Public Health Service
National Institutes of Health
Bethesda, Maryland 20892

December 7, 2001

Ms. Margaret Malanoski
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

On November 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.

The IRAC member agencies oppose OMB approval of the proposed Policy as currently written.

A summary of that review and recommendations resulting from those deliberations are provided in the attachment.

As noted 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
Animal Committee


Comments for the Office of Management and Budget (0MB) on:

United States Department of Agriculture (USDA) - Proposed Policy on Environmental Enhancement for Nonhuman Primates - December 2001

From the Interagency Research Animal Committee (IRAC)

  1. 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 areas.

  2. 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.

  3. 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.

  4. "Documentation" 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.

  5. IRAC 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 and/or well-being.

  6. USDA 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.

  7. 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.

After considering the points raised above, the IRAC membership reached consensus on the following recommendations:

  1. 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.

  2. 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.

  3. 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.