January 29, 2002

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.