Petition To Define Alternatives to Procedures That May Cause Pain or Distress and To Establish Standards Regarding Consideration of These Alternatives, 16592-16593 [2015-07221]

Download as PDF tkelley on DSK3SPTVN1PROD with PROPOSALS 16592 Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to producers. However, these costs would be offset by the benefits derived from the operation of the marketing order. In addition, the committee’s meeting was widely publicized throughout the California’s olive industry and all interested persons were invited to attend the meeting and participate in committee deliberations on all issues. Like all committee meetings, the December 9, 2014, meeting was a public meeting and all entities, both large and small, were encouraged to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule including the regulatory and informational impacts of this action on small businesses. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order’s information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581–0178. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval. This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large California olive handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this action. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/ MarketingOrdersSmallBusinessGuide. Any questions about the compliance guide should be sent to Jeffrey Smutny at the previously-mentioned address in the FOR FURTHER INFORMATION CONTACT section. A 30-day comment period is provided to allow interested persons to respond to this proposed rule. Thirty days is deemed appropriate because: (1) The 2015 fiscal year began on January 1, VerDate Sep<11>2014 18:31 Mar 27, 2015 Jkt 235001 2015, and the marketing order requires that the rate of assessment for each fiscal year apply to all assessable olives handled during such fiscal year; (2) the committee needs to have sufficient funds to pay its expenses, which are incurred on a continuous basis; and (3) both regulated handlers were present at the December 9, 2014, meeting, and are aware of this action, which was unanimously recommended by the committee at a public meeting, and is similar to other assessment rate actions issued in past years. List of Subjects in 7 CFR Part 932 Olives, Marketing agreements, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, 7 CFR part 932 is proposed to be amended as follows: PART 932—OLIVES GROWN IN CALIFORNIA 1. The authority citation for 7 CFR part 932 continues to read as follows: ■ Authority: 7 U.S.C. 601–674. 2. Section 932.230 is revised to read as follows: ■ § 932.230 Assessment rate. On and after January 1, 2015, an assessment rate of $26.00 per ton is established for California olives. Dated: March 24, 2015. Rex A. Barnes, Associate Administrator, Agricultural Marketing Service. [FR Doc. 2015–07116 Filed 3–27–15; 8:45 am] BILLING CODE 3410–02–P 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 Animal and Plant Health Inspection Service, USDA. ACTION: Notice of petition. AGENCY: 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 SUMMARY: PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 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. We will consider all comments that we receive on or before May 29, 2015. DATES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://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 https:// 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, ADDRESSES: E:\FR\FM\30MRP1.SGM 30MRP1 tkelley on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules 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 VerDate Sep<11>2014 17:11 Mar 27, 2015 Jkt 235001 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 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 16593 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 51, 71, 75, 78, 85, and 86 [Docket No. APHIS–2014–0018] RIN 0579–AE02 Livestock Marketing Facilities Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule; reopening of comment period. AGENCY: We are reopening the comment period for our proposed rule that would amend the regulations governing approval of facilities that receive livestock moved in interstate commerce, as well as the conditions under which livestock may move to such facilities without official identification or prior issuance of an interstate certificate of veterinary inspection or alternative documentation. This action will allow interested persons additional time to prepare and submit comments. DATES: The comment period for the proposed rule published on January 2, 2015 (80 FR 6 through 13) is reopened. We will consider all comments that we receive on or before April 15, 2015. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!docketDetail;D=APHIS-2014-0018. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2014–0018, 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 https:// www.regulations.gov/ #!docketDetail;D=APHIS-2014-0018 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: Mr. Neil Hammerschmidt, Program Manager, Animal Disease Traceability, VS, APHIS, 4700 River Road Unit 200, Riverdale, MD 20737–1236; (301) 851– 3539. SUPPLEMENTARY INFORMATION: SUMMARY: E:\FR\FM\30MRP1.SGM 30MRP1

Agencies

[Federal Register Volume 80, Number 60 (Monday, March 30, 2015)]
[Proposed Rules]
[Pages 16592-16593]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07221]


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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 https://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 https://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
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