80 FR 16592 - Petition To Define Alternatives to Procedures That May Cause Pain or Distress and To Establish Standards Regarding Consideration of These Alternatives
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 80, Issue 60 (March 30, 2015)
Animal and Plant Health Inspection Service
Federal Register Volume 80, Issue 60 (March 30, 2015)
| Page Range | 16592-16593 | |
| FR Document | 2015-07221 |
[Federal Register Volume 80, Number 60 (Monday, March 30, 2015)] [Proposed Rules] [Pages 16592-16593] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07221] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 1 and 2 [Docket No. APHIS-2014-0050] Petition To Define Alternatives to Procedures That May Cause Pain or Distress and To Establish Standards Regarding Consideration of These Alternatives 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 (AWA) regulations to define the term alternatives, clarify the existing definition of painful procedure, and establish standards governing the consideration of such alternatives at research facilities that are registered under the AWA regulations. 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 May 29, 2015. ADDRESSES: You may submit comments by either of the following methods:Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0050. Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2014-0050, 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- 0050 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.) authorizes the Secretary of Agriculture 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 1 contains definitions of terms used within parts 2 and 3. Part 2 contains licensing and registration regulations, regulations specific to research facilities, and regulations governing veterinary care, [[Page 16593]] animal identification, recordkeeping, access for inspection, confiscation of animals, and handling, among other requirements. Within part 2, subpart C contains the regulations specific to research facilities. Among other requirements, research facilities, other than Federal research facilities, must register with APHIS and appoint an Institutional Animal Care and Use Committee (IACUC). The IACUC, which must be composed of a chairperson and at least two other members, is required to perform certain functions in order to ensure the facility's compliance with the AWA regulations. As one of these functions, the IACUC must review proposed activities involving animals that are performed at the facility, as well as significant changes in ongoing activities, in order to determine that the principle investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources used to determine that alternatives were not available. On October 30, 2013, APHIS received a petition from the Physicians Committee for Responsible Medicine (referred to below as PCRM) requesting that we initiate rulemaking to amend the AWA regulations. Specifically, PCRM asks that we amend part 1 to add a definition of the term alternatives in order to delineate what a primary investigator is required to consider in lieu of a procedure that may cause more than momentary or slight pain or distress to the animals. The petition also asks that we amend the existing definition of painful procedure in order to codify a long-standing APHIS policy that a procedure should be considered to be painful if it may cause more than momentary or slight pain of distress to the animals, even if this pain is subsequently relieved through anesthesia. Finally, the petition asks that we amend part 2 to specify what must occur as part of a consideration of alternatives. The petition states that the intent of the AWA is to authorize research facilities to undertake procedures likely to produce pain or distress in animals only if no alternatives exist to these procedures, and that the AWA regulations support this interpretation of the AWA itself. The petition suggests, however, that because of ambiguities in the AWA regulations, research facilities have sometimes construed them to mean that cursory deliberation regarding alternatives suffices to meet this regulatory and statutory requirement to consider alternatives. The petition states that, by amending the AWA regulations in the manner that PCRM suggests, 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 establish regulatory standards for consideration of alternatives to procedures that may cause more than momentary or slight pain or distress to animals? 2. What constitutes an alternative to a procedure that may cause more than momentary or slight pain or distress? If we amend the AWA regulations to define the term alternative, what definition should we use? 3. What constitutes a thorough consideration of alternatives? Does this differ depending on the nature of the research conducted? If so, how? 4. Who should make a determination regarding the thoroughness of a primary investigator's consideration of alternatives: The IACUC for a facility, APHIS, or both parties? 5. If the IACUC and APHIS should jointly make a determination, which responsibilities should fall to APHIS and which to the IACUC in terms of evaluating thoroughness? 6. What documentation should the primary investigator provide to demonstrate that he or she has done a thorough consideration of alternatives? 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 we receive. Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7. Done in Washington, DC, this 24th day of March 2015. Jere L. Dick, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2015-07221 Filed 3-27-15; 8:45 am] BILLING CODE 3410-34-P
![16592 Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules
handlers. While assessments impose 2015, and the marketing order requires procedure, and establish standards
some additional costs on handlers, the that the rate of assessment for each governing the consideration of such
costs are minimal and uniform on all fiscal year apply to all assessable olives alternatives at research facilities that are
handlers. Some of the additional costs handled during such fiscal year; (2) the registered under the AWA regulations.
may be passed on to producers. committee needs to have sufficient We are making this petition available to
However, these costs would be offset by funds to pay its expenses, which are the public and soliciting comments
the benefits derived from the operation incurred on a continuous basis; and (3) regarding the petition and any issues
of the marketing order. In addition, the both regulated handlers were present at raised by the petition that we should
committee’s meeting was widely the December 9, 2014, meeting, and are take into account as we consider this
publicized throughout the California’s aware of this action, which was petition.
olive industry and all interested persons unanimously recommended by the DATES: We will consider all comments
were invited to attend the meeting and committee at a public meeting, and is that we receive on or before May 29,
participate in committee deliberations similar to other assessment rate actions 2015.
on all issues. Like all committee issued in past years.
meetings, the December 9, 2014, ADDRESSES: You may submit comments
meeting was a public meeting and all List of Subjects in 7 CFR Part 932 by either of the following methods:
entities, both large and small, were Olives, Marketing agreements, • Federal eRulemaking Portal: Go to
encouraged to express views on this Reporting and recordkeeping http://www.regulations.gov/
issue. Finally, interested persons are requirements. #!docketDetail;D=APHIS-2014-0050.
invited to submit comments on this For the reasons set forth in the • Postal Mail/Commercial Delivery:
proposed rule including the regulatory preamble, 7 CFR part 932 is proposed to Send your comment to Docket No.
and informational impacts of this action be amended as follows: APHIS–2014–0050, Regulatory Analysis
on small businesses. and Development, PPD, APHIS, Station
In accordance with the Paperwork PART 932—OLIVES GROWN IN 3A–03.8, 4700 River Road Unit 118,
Reduction Act of 1995 (44 U.S.C. CALIFORNIA Riverdale, MD 20737–1238.
Chapter 35), the order’s information Supporting documents and any
collection requirements have been ■ 1. The authority citation for 7 CFR comments we receive on this docket
previously approved by the Office of part 932 continues to read as follows: may be viewed at http://
Management and Budget (OMB) and Authority: 7 U.S.C. 601–674. www.regulations.gov/
assigned OMB No. 0581–0178. No ■ 2. Section 932.230 is revised to read #!docketDetail;D=APHIS-2014-0050 or
changes in those requirements as a as follows: in our reading room, which is located in
result of this action are necessary. room 1141 of the USDA South Building,
§ 932.230 Assessment rate.
Should any changes become necessary, 14th Street and Independence Avenue
they would be submitted to OMB for On and after January 1, 2015, an SW., Washington, DC. Normal reading
approval. assessment rate of $26.00 per ton is room hours are 8 a.m. to 4:30 p.m.,
This proposed rule would impose no established for California olives. Monday through Friday, except
additional reporting or recordkeeping Dated: March 24, 2015. holidays. To be sure someone is there to
requirements on either small or large Rex A. Barnes, help you, please call (202) 799–7039
California olive handlers. As with all Associate Administrator, Agricultural before coming.
Federal marketing order programs, Marketing Service. FOR FURTHER INFORMATION CONTACT: Dr.
reports and forms are periodically [FR Doc. 2015–07116 Filed 3–27–15; 8:45 am] Carol Clarke, Research Program
reviewed to reduce information BILLING CODE 3410–02–P Manager, USDA, APHIS, Animal Care,
requirements and duplication by
4700 River Road Unit 84, Riverdale, MD
industry and public sector agencies.
AMS is committed to complying with 20737–1234; (301) 851–3751.
DEPARTMENT OF AGRICULTURE SUPPLEMENTARY INFORMATION: The
the E-Government Act to promote the
use of the internet and other Animal and Plant Health Inspection Animal Welfare Act (AWA, 7 U.S.C.
information technologies to provide Service 2131 et seq.) authorizes the Secretary of
increased opportunities for citizen Agriculture to promulgate standards and
access to Government information and 9 CFR Parts 1 and 2 other requirements governing research
services, and for other purposes. facilities. The Secretary has delegated
USDA has not identified any relevant [Docket No. APHIS–2014–0050] the responsibility for enforcing the
Federal rules that duplicate, overlap, or AWA to the Administrator of the
Petition To Define Alternatives to Animal and Plant Health Inspection
conflict with this action.
Procedures That May Cause Pain or Service (APHIS). Within APHIS, the
A small business guide on complying
Distress and To Establish Standards responsibility for administering the
with fruit, vegetable, and specialty crop
Regarding Consideration of These AWA has been delegated to the Deputy
marketing agreements and orders may
Alternatives Administrator for Animal Care.
be viewed at: http://www.ams.usda.gov/
MarketingOrdersSmallBusinessGuide. AGENCY: Animal and Plant Health Regulations and standards
Any questions about the compliance Inspection Service, USDA. promulgated under the AWA are
guide should be sent to Jeffrey Smutny ACTION: Notice of petition. contained in Title 9 of the Code of
tkelley on DSK3SPTVN1PROD with PROPOSALS
at the previously-mentioned address in Federal Regulations, parts 1, 2, and 3
the FOR FURTHER INFORMATION CONTACT SUMMARY: We are notifying the public (referred to collectively below as the
section. that the Animal and Plant Health AWA regulations). Part 1 contains
A 30-day comment period is provided Inspection Service has received a definitions of terms used within parts 2
to allow interested persons to respond petition requesting that we amend the and 3. Part 2 contains licensing and
to this proposed rule. Thirty days is Animal Welfare Act (AWA) regulations registration regulations, regulations
deemed appropriate because: (1) The to define the term alternatives, clarify specific to research facilities, and
2015 fiscal year began on January 1, the existing definition of painful regulations governing veterinary care,
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![Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules 16593
animal identification, recordkeeping, requirement to consider alternatives. DEPARTMENT OF AGRICULTURE
access for inspection, confiscation of The petition states that, by amending
animals, and handling, among other the AWA regulations in the manner that Animal and Plant Health Inspection
requirements. Within part 2, subpart C PCRM suggests, we would remove these Service
contains the regulations specific to ambiguities and facilitate regulatory
research facilities. compliance. 9 CFR Parts 51, 71, 75, 78, 85, and 86
Among other requirements, research
facilities, other than Federal research We are making this petition available [Docket No. APHIS–2014–0018]
facilities, must register with APHIS and to the public and soliciting comments to
RIN 0579–AE02
appoint an Institutional Animal Care help determine what action, if any, to
and Use Committee (IACUC). The take in response to this request. The Livestock Marketing Facilities
IACUC, which must be composed of a petition and any comments submitted
chairperson and at least two other are available for review as indicated AGENCY: Animal and Plant Health
members, is required to perform certain under ADDRESSES above. We welcome Inspection Service, USDA.
functions in order to ensure the all comments on the issues outlined in ACTION: Proposed rule; reopening of
facility’s compliance with the AWA the petition. In particular, we invite comment period.
regulations. responses to the following questions:
As one of these functions, the IACUC SUMMARY: We are reopening the
1. Should APHIS establish regulatory comment period for our proposed rule
must review proposed activities
involving animals that are performed at standards for consideration of that would amend the regulations
the facility, as well as significant alternatives to procedures that may governing approval of facilities that
changes in ongoing activities, in order to cause more than momentary or slight receive livestock moved in interstate
determine that the principle investigator pain or distress to animals? commerce, as well as the conditions
has considered alternatives to 2. What constitutes an alternative to a under which livestock may move to
procedures that may cause more than procedure that may cause more than such facilities without official
momentary or slight pain or distress to momentary or slight pain or distress? If identification or prior issuance of an
the animals, and has provided a written we amend the AWA regulations to interstate certificate of veterinary
narrative description of the methods define the term alternative, what inspection or alternative
and sources used to determine that documentation. This action will allow
definition should we use?
alternatives were not available. interested persons additional time to
On October 30, 2013, APHIS received 3. What constitutes a thorough prepare and submit comments.
a petition from the Physicians consideration of alternatives? Does this DATES: The comment period for the
Committee for Responsible Medicine differ depending on the nature of the proposed rule published on January 2,
(referred to below as PCRM) requesting research conducted? If so, how? 2015 (80 FR 6 through 13) is reopened.
that we initiate rulemaking to amend 4. Who should make a determination We will consider all comments that we
the AWA regulations. Specifically, regarding the thoroughness of a primary receive on or before April 15, 2015.
PCRM asks that we amend part 1 to add investigator’s consideration of ADDRESSES: You may submit comments
a definition of the term alternatives in alternatives: The IACUC for a facility, by either of the following methods:
order to delineate what a primary APHIS, or both parties? • Federal eRulemaking Portal: Go to
investigator is required to consider in http://www.regulations.gov/
lieu of a procedure that may cause more 5. If the IACUC and APHIS should
jointly make a determination, which #!docketDetail;D=APHIS-2014-0018.
than momentary or slight pain or • Postal Mail/Commercial Delivery:
distress to the animals. The petition also responsibilities should fall to APHIS
Send your comment to Docket No.
asks that we amend the existing and which to the IACUC in terms of
APHIS–2014–0018, Regulatory Analysis
definition of painful procedure in order evaluating thoroughness?
and Development, PPD, APHIS, Station
to codify a long-standing APHIS policy 6. What documentation should the 3A–03.8, 4700 River Road Unit 118,
that a procedure should be considered primary investigator provide to Riverdale, MD 20737–1238.
to be painful if it may cause more than demonstrate that he or she has done a Supporting documents and any
momentary or slight pain of distress to thorough consideration of alternatives? comments we receive on this docket
the animals, even if this pain is
We encourage the submission of may be viewed at http://
subsequently relieved through
scientific data, studies, or research to www.regulations.gov/
anesthesia. Finally, the petition asks
support your comments and position. #!docketDetail;D=APHIS-2014-0018 or
that we amend part 2 to specify what
We also invite data on the costs and in our reading room, which is located in
must occur as part of a consideration of
benefits associated with any Room 1141 of the USDA South
alternatives.
The petition states that the intent of Building, 14th Street and Independence
recommendations. We will consider all
the AWA is to authorize research Avenue SW., Washington, DC. Normal
comments and recommendations we
facilities to undertake procedures likely reading room hours are 8 a.m. to 4:30
receive.
to produce pain or distress in animals p.m., Monday through Friday, except
Authority: 7 U.S.C. 2131–2159; 7 CFR 2.22, holidays. To be sure someone is there to
only if no alternatives exist to these
2.80, and 371.7. help you, please call (202) 799–7039
procedures, and that the AWA
Done in Washington, DC, this 24th day of before coming.
tkelley on DSK3SPTVN1PROD with PROPOSALS
regulations support this interpretation
of the AWA itself. The petition suggests, March 2015. FOR FURTHER INFORMATION CONTACT: Mr.
however, that because of ambiguities in Jere L. Dick, Neil Hammerschmidt, Program
the AWA regulations, research facilities Acting Administrator, Animal and Plant
Manager, Animal Disease Traceability,
have sometimes construed them to Health Inspection Service. VS, APHIS, 4700 River Road Unit 200,
mean that cursory deliberation [FR Doc. 2015–07221 Filed 3–27–15; 8:45 am]
Riverdale, MD 20737–1236; (301) 851–
regarding alternatives suffices to meet 3539.
BILLING CODE 3410–34–P
this regulatory and statutory SUPPLEMENTARY INFORMATION:
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Document Created: 2015-12-18 11:32:56
Document Modified: 2015-12-18 11:32:56
| 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 May 29, 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 16592 | |
| CFR Citation | 9
CFR
1 9 CFR 2 |
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