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)
Animal and Plant Health Inspection Service
Federal Register Volume 80, Issue 84 (May 1, 2015)
| Page Range | 24840-24841 | |
| FR Document | 2015-10195 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![24840 Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Proposed Rules
to respond (such as through the use of ■ b. By removing paragraph (c). Monday through Friday, except
appropriate automated, electronic, ■ c. By redesignating paragraphs (d) holidays. To be sure someone is there to
mechanical, or other technological through (h) as paragraphs (c) through help you, please call (202) 799–7039
collection techniques or other forms of (g), respectively. before coming.
information technology; e.g., permitting Done in Washington, DC, this 27th day of FOR FURTHER INFORMATION CONTACT: Dr.
electronic submission of responses). April 2015. Carol Clarke, Research Program
Estimate of burden: Public reporting Kevin Shea, Manager, USDA, APHIS, Animal Care,
burden for this collection of information Administrator, Animal and Plant Health 4700 River Road Unit 84, Riverdale, MD
is estimated to average 2.6 hours per Inspection Service. 20737–1234; (301) 851–3751.
response. [FR Doc. 2015–10199 Filed 4–30–15; 8:45 am] SUPPLEMENTARY INFORMATION: The
Respondents: NPPO of Peru, Animal Welfare Act (AWA, 7 U.S.C.
BILLING CODE 3410–34–P
producers/growers, and importers. 2131 et seq.), among other things,
Estimated annual number of authorizes the Secretary of Agriculture
respondents: 67. DEPARTMENT OF AGRICULTURE (Secretary) to promulgate standards and
Estimated annual number of other requirements governing research
responses per respondent: 14. Animal and Plant Health Inspection facilities. The Secretary has delegated
Estimated annual number of Service the responsibility for enforcing the
responses: 912. AWA to the Administrator of the
Estimated total annual burden on 9 CFR Part 3 Animal and Plant Health Inspection
respondents: 2,334 hours. (Due to Service (APHIS). Within APHIS, the
[Docket No. APHIS–2014–0098]
averaging, the total annual burden hours responsibility for administering the
may not equal the product of the annual Petition To Develop Specific AWA has been delegated to the Deputy
number of responses multiplied by the Ethologically Appropriate Standards Administrator for Animal Care.
reporting burden per response.) for Nonhuman Primates in Research Regulations and standards
Copies of this information collection promulgated under the AWA are
can be obtained from Ms. Kimberly AGENCY: Animal and Plant Health contained in Title 9 of the Code of
Hardy, APHIS’ Information Collection Inspection Service, USDA. Federal Regulations, parts 1, 2, and 3
Coordinator, at (301) 851–2727. ACTION: Notice of petition. (referred to collectively below as the
E-Government Act Compliance AWA regulations). Part 3 of the AWA
SUMMARY: We are notifying the public
regulations contains specific standards
The Animal and Plant Health that the Animal and Plant Health
regarding the humane handling, care,
Inspection Service is committed to Inspection Service has received a
treatment, and transportation of species
compliance with the E-Government Act petition requesting that we amend the
of animals covered under the AWA.
to promote the use of the Internet and Animal Welfare Act regulations to
Within part 3 of the AWA regulations,
other information technologies, to specify ethologically appropriate
subpart D (§§ 3.75–3.92) contains
provide increased opportunities for standards that researchers must adhere
standards for the humane handling,
citizen access to Government to in order to promote the psychological
care, treatment, and transportation of
information and services, and for other well-being of nonhuman primates used
nonhuman primates.
purposes. For information pertinent to in research. We are making this petition Section 3.81 of the AWA regulations
E-Government Act compliance related available to the public and soliciting requires research facilities that house
to this proposed rule, please contact Ms. comments regarding the petition and nonhuman primates to develop,
Kimberly Hardy, APHIS’ Information any issues raised by the petition that we document, and follow an appropriate
Collection Coordinator, at (301) 851– should take into account as we consider plan for environmental enhancement
2727. this petition. adequate to promote the psychological
DATES: We will consider all comments well-being of nonhuman primates. The
List of Subjects in 7 CFR Part 319
that we receive on or before June 30, section further specifies that the plan
Coffee, Cotton, Fruits, Imports, Logs, 2015. must be in accordance with currently
Nursery stock, Plant diseases and pests,
ADDRESSES: You may submit comments accepted professional standards as cited
Quarantine, Reporting and
by either of the following methods: in appropriate professional journals or
recordkeeping requirements, Rice,
Vegetables. • Federal eRulemaking Portal: Go to reference guides, and as directed by the
http://www.regulations.gov/#!docket attending veterinarian for the facility.
Accordingly, we propose to amend 7
Detail;D=APHIS-2014-0098. The plan must be available to APHIS
CFR part 319 as follows:
• Postal Mail/Commercial Delivery: upon request, and in the case of
PART 319—FOREIGN QUARANTINE Send your comment to Docket No. research facilities, it must also be
NOTICES APHIS–2014–0098, Regulatory Analysis available to the funding agency. The
and Development, PPD, APHIS, Station plan must address at a minimum: Social
■ 1. The authority citation for part 319 3A–03.8, 4700 River Road Unit 118, grouping, environmental enrichment,
continues to read as follows: Riverdale, MD 20737–1238. special considerations, and use of
Authority: 7 U.S.C. 450, 7701–7772 and
Supporting documents and any restraint devices. Exemptions to the
comments we receive on this docket plan can be made by the attending
mstockstill on DSK4VPTVN1PROD with PROPOSALS
7781–7786; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.3. may be viewed at http:// veterinarian for the facility because of a
www.regulations.gov/ particular animal’s health or condition,
§ 319.56–41 [Amended] #!docketDetail;D=APHIS-2014-0098 or or in consideration of that animal’s
■ 2. Section 319.56–41 is amended as in our reading room, which is located in well-being. Additionally, the
follows: room 1141 of the USDA South Building, Institutional Animal Care and Use
■ a. In the introductory text, by adding 14th Street and Independence Avenue Committee (IACUC), a committee
the word ‘‘continental’’ between the SW., Washington, DC. Normal reading entrusted with ensuring the research
words ‘‘the’’ and ‘‘United States’’. room hours are 8 a.m. to 4:30 p.m., facility’s compliance with the AWA
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![Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Proposed Rules 24841
regulations, may exempt individual minimum standards that must be met SUMMARY: The U.S. Department of
nonhuman primates from the plan for for an environment to be considered Energy (DOE) has completed a
scientific reasons, provided these ethologically appropriate? provisional analysis of the potential
reasons are set forth in a research 2. What constitutes an ethologically economic impacts and energy savings
proposal and reviewed by the IACUC. appropriate environment for a that could result from promulgating an
On May 7, 2014, APHIS received a nonhuman primate? Does this differ energy conservation standard for
petition submitted jointly by the New among species of nonhuman primates? commercial and industrial fans and
England Anti-Vivisection Society, the If so, how does it differ? blowers. This analysis incorporates
North American Primate Sanctuary 3. Are there any environmental information and comments received
Alliance, the Laboratory Primate conditions that make an environment after the completion of an analysis
Advocacy Group, and the Animal Legal ethologically inappropriate for a presented in a notice of data availability
Defense Fund requesting that we initiate nonhuman primate? If so, what are (NODA) published in December 2014.
rulemaking to amend the AWA they? Do they differ among species of At this time, DOE is not proposing an
regulations. Specifically, the petition nonhuman primates? energy conservation standard for
asks that we amend § 3.81 to require 4. Does an ethologically appropriate commercial and industrial fans and
that research facilities construct and environment for nonhuman primates blowers. This analysis may be used in
maintain an ethologically appropriate used in research differ from an support of the Appliance Standards
environment for nonhuman primates ethologically appropriate environment Federal Rulemaking Advisory
housed at the facilities, that is, an for nonhuman primates that are sold or Committee (ASRAC) commercial and
environment that is appropriate with exhibited? If so, in what ways does it industrial fans working group
respect to the patterns of behavior differ? negotiations to develop a
exhibited by the nonhuman primates in 5. Who should make the recommendation for regulating
their natural state. The petition also asks determination regarding the ethological commercial and industrial fans. DOE
that we amend § 3.81 to specify appropriateness of the environment for encourages stakeholders to provide any
minimum standards that must be met in nonhuman primates at a particular additional data or information that may
order for an environment to be research facility: The attending improve the analysis and to present
considered ethologically appropriate. veterinarian for the facility, APHIS, or comments submitted to this NODA and
The petition cites standards recently both parties? If both parties should to the NODA published in December
adopted by the National Institutes of jointly make such a determination, 2014 to the working group.
Health (NIH) for chimpanzees used in which responsibilities should fall to the DATES: Information is available as of
NIH-funded research as a reference attending veterinarian and which to May 1, 2015.
point for the development of such APHIS?
generally applicable minimum ADDRESSES: The analysis for this NODA
We encourage the submission of is available at: http://www1.eere.energy.
standards and as evidence of their scientific data, studies, or research to
feasibility. gov/buildings/appliance_standards/
support your comments and position. rulemaking.aspx?ruleid=25.
The petition agrees that the intent of
We also invite data on the costs and Interested persons are encouraged to
§ 3.81 of the AWA regulations is to
benefits associated with any submit comments using the Federal
ensure that the environment provided to
recommendations. We will consider all eRulemaking Portal at: http://
nonhuman primates housed at research
comments and recommendations www.regulations.gov. Follow the
facilities promotes the psychological
received. instructions for submitting comments.
well-being of the primates. The petition
suggests, however, that because of Authority: 7 U.S.C. 2131–2159; 7 CFR 2.22, Alternatively, interested persons may
ambiguities in the current regulations, 2.80, and 371.7. submit comments, identified by Docket
research facilities have broad discretion Done in Washington, DC, this 27th day of number EERE–2013–BT–STD–0006, by
regarding the actual environment April 2015. any of the following methods:
provided to nonhuman primates at their Kevin Shea, (1) Email: to CIFB2013STD0006@
facilities, and can meet the requirements Administrator, Animal and Plant Health ee.doe.gov. Include EERE–2013–BT–
in § 3.81 without actually meeting their Inspection Service. STD–0006 in the subject line of the
intent. [FR Doc. 2015–10195 Filed 4–30–15; 8:45 am] message. Submit electronic comments
The petition states that, by amending BILLING CODE 3410–34–P
in WordPerfect, Microsoft Word, PDF,
the AWA regulations in the manner that or ASCII file format, and avoid the use
the petitioners suggest, we would of special characters or any form of
remove these ambiguities and facilitate encryption.
regulatory compliance. DEPARTMENT OF ENERGY (2) Mail: Ms. Brenda Edwards, U.S.
We are making this petition available Department of Energy, Building
10 CFR Part 431 Technologies Program, Mailstop EE–2J,
to the public and soliciting comments to
help determine what action, if any, to [Docket No. EERE–2013–BT–STD–0006] Revisions to Energy Efficiency
take in response to this request. The Enforcement Regulations, EERE–2013–
petition and any comments submitted RIN 1904–AC55 BT–STD–0006, 1000 Independence
are available for review as indicated Avenue SW., Washington, DC 20585–
under ADDRESSES above. We welcome Energy Conservation Standards for 0121. Phone: (202) 586–2945. If
mstockstill on DSK4VPTVN1PROD with PROPOSALS
all comments on the issues outlined in Commercial and Industrial Fans and possible, please submit all items on a
the petition. In particular, we invite Blowers: Availability of Provisional CD, in which case it is not necessary to
responses to the following questions: Analysis Tools include printed copies.
1. Should APHIS amend § 3.81 of the AGENCY: Office of Energy Efficiency and (3) Hand Delivery/Courier: Ms.
AWA regulations to require research Renewable Energy, Department of Brenda Edwards, U.S. Department of
facilities to construct and maintain an Energy. Energy, Building Technologies Program,
ethologically appropriate environment 6th Floor, 950 L’Enfant Plaza SW.,
ACTION: Notice of Data Availability.
for nonhuman primates, and specify the Washington, DC 20024. Phone: (202)
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Document Created: 2018-02-21 10:21:05
Document Modified: 2018-02-21 10:21:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notice of petition. | |
| Dates | We will consider all comments that we receive on or before June 30, 2015. | |
| Contact | Dr. Carol Clarke, Research Program Manager, USDA, APHIS, Animal Care, 4700 River Road Unit 84, Riverdale, MD 20737-1234; (301) 851-3751. | |
| FR Citation | 80 FR 24840 |
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