Office of the Undersecretary for Marketing
and Regulatory Programs
U.S. Department of Agriculture
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
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