80 FR 24840 - Petition To Develop Specific Ethologically Appropriate Standards for Nonhuman Primates in Research

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 84 (May 1, 2015)

We are notifying the public that the Animal and Plant Health Inspection Service has received a petition requesting that we amend the Animal Welfare Act regulations to specify ethologically appropriate standards that researchers must adhere to in order to promote the psychological well-being of nonhuman primates used in research. We are making this petition available to the public and soliciting comments regarding the petition and any issues raised by the petition that we should take into account as we consider this petition.

[Federal Register Volume 80, Number 84 (Friday, May 1, 2015)]
[Proposed Rules]
[Pages 24840-24841]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10195]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 3

[Docket No. APHIS-2014-0098]


Petition To Develop Specific Ethologically Appropriate Standards 
for Nonhuman Primates in Research

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of petition.

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SUMMARY: We are notifying the public that the Animal and Plant Health 
Inspection Service has received a petition requesting that we amend the 
Animal Welfare Act regulations to specify ethologically appropriate 
standards that researchers must adhere to in order to promote the 
psychological well-being of nonhuman primates used in research. We are 
making this petition available to the public and soliciting comments 
regarding the petition and any issues raised by the petition that we 
should take into account as we consider this petition.

DATES: We will consider all comments that we receive on or before June 
30, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0098.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0098, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-
0098 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Carol Clarke, Research Program 
Manager, USDA, APHIS, Animal Care, 4700 River Road Unit 84, Riverdale, 
MD 20737-1234; (301) 851-3751.

SUPPLEMENTARY INFORMATION: The Animal Welfare Act (AWA, 7 U.S.C. 2131 
et seq.), among other things, authorizes the Secretary of Agriculture 
(Secretary) to promulgate standards and other requirements governing 
research facilities. The Secretary has delegated the responsibility for 
enforcing the AWA to the Administrator of the Animal and Plant Health 
Inspection Service (APHIS). Within APHIS, the responsibility for 
administering the AWA has been delegated to the Deputy Administrator 
for Animal Care.
    Regulations and standards promulgated under the AWA are contained 
in Title 9 of the Code of Federal Regulations, parts 1, 2, and 3 
(referred to collectively below as the AWA regulations). Part 3 of the 
AWA regulations contains specific standards regarding the humane 
handling, care, treatment, and transportation of species of animals 
covered under the AWA.
    Within part 3 of the AWA regulations, subpart D (Sec. Sec.  3.75-
3.92) contains standards for the humane handling, care, treatment, and 
transportation of nonhuman primates.
    Section 3.81 of the AWA regulations requires research facilities 
that house nonhuman primates to develop, document, and follow an 
appropriate plan for environmental enhancement adequate to promote the 
psychological well-being of nonhuman primates. The section further 
specifies that the plan must be in accordance with currently accepted 
professional standards as cited in appropriate professional journals or 
reference guides, and as directed by the attending veterinarian for the 
facility. The plan must be available to APHIS upon request, and in the 
case of research facilities, it must also be available to the funding 
agency. The plan must address at a minimum: Social grouping, 
environmental enrichment, special considerations, and use of restraint 
devices. Exemptions to the plan can be made by the attending 
veterinarian for the facility because of a particular animal's health 
or condition, or in consideration of that animal's well-being. 
Additionally, the Institutional Animal Care and Use Committee (IACUC), 
a committee entrusted with ensuring the research facility's compliance 
with the AWA

[[Page 24841]]

regulations, may exempt individual nonhuman primates from the plan for 
scientific reasons, provided these reasons are set forth in a research 
proposal and reviewed by the IACUC.
    On May 7, 2014, APHIS received a petition submitted jointly by the 
New England Anti-Vivisection Society, the North American Primate 
Sanctuary Alliance, the Laboratory Primate Advocacy Group, and the 
Animal Legal Defense Fund requesting that we initiate rulemaking to 
amend the AWA regulations. Specifically, the petition asks that we 
amend Sec.  3.81 to require that research facilities construct and 
maintain an ethologically appropriate environment for nonhuman primates 
housed at the facilities, that is, an environment that is appropriate 
with respect to the patterns of behavior exhibited by the nonhuman 
primates in their natural state. The petition also asks that we amend 
Sec.  3.81 to specify minimum standards that must be met in order for 
an environment to be considered ethologically appropriate. The petition 
cites standards recently adopted by the National Institutes of Health 
(NIH) for chimpanzees used in NIH-funded research as a reference point 
for the development of such generally applicable minimum standards and 
as evidence of their feasibility.
    The petition agrees that the intent of Sec.  3.81 of the AWA 
regulations is to ensure that the environment provided to nonhuman 
primates housed at research facilities promotes the psychological well-
being of the primates. The petition suggests, however, that because of 
ambiguities in the current regulations, research facilities have broad 
discretion regarding the actual environment provided to nonhuman 
primates at their facilities, and can meet the requirements in Sec.  
3.81 without actually meeting their intent.
    The petition states that, by amending the AWA regulations in the 
manner that the petitioners suggest, we would remove these ambiguities 
and facilitate regulatory compliance.
    We are making this petition available to the public and soliciting 
comments to help determine what action, if any, to take in response to 
this request. The petition and any comments submitted are available for 
review as indicated under ADDRESSES above. We welcome all comments on 
the issues outlined in the petition. In particular, we invite responses 
to the following questions:
    1. Should APHIS amend Sec.  3.81 of the AWA regulations to require 
research facilities to construct and maintain an ethologically 
appropriate environment for nonhuman primates, and specify the minimum 
standards that must be met for an environment to be considered 
ethologically appropriate?
    2. What constitutes an ethologically appropriate environment for a 
nonhuman primate? Does this differ among species of nonhuman primates? 
If so, how does it differ?
    3. Are there any environmental conditions that make an environment 
ethologically inappropriate for a nonhuman primate? If so, what are 
they? Do they differ among species of nonhuman primates?
    4. Does an ethologically appropriate environment for nonhuman 
primates used in research differ from an ethologically appropriate 
environment for nonhuman primates that are sold or exhibited? If so, in 
what ways does it differ?
    5. Who should make the determination regarding the ethological 
appropriateness of the environment for nonhuman primates at a 
particular research facility: The attending veterinarian for the 
facility, APHIS, or both parties? If both parties should jointly make 
such a determination, which responsibilities should fall to the 
attending veterinarian and which to APHIS?
    We encourage the submission of scientific data, studies, or 
research to support your comments and position. We also invite data on 
the costs and benefits associated with any recommendations. We will 
consider all comments and recommendations received.

    Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.

    Done in Washington, DC, this 27th day of April 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-10195 Filed 4-30-15; 8:45 am]
 BILLING CODE 3410-34-P