[Federal Register Volume 80, Number 121 (Wednesday, June 24, 2015)]
[Proposed Rules]
[Pages 36251-36252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15499]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 80, No. 121 / Wednesday, June 24, 2015 / 
Proposed Rules  

[[Page 36251]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 2

[Docket No. APHIS-2015-0033]


Petition To Amend the Reporting Requirements for Research 
Facilities Under the Animal Welfare Act Regulations

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 (APHIS) has received a petition requesting that we 
amend the regulations to require that research facilities include 
information about the uses of animals in the annual report they submit 
to APHIS. We are making this petition available to the public and 
soliciting comments regarding any issues raised by the petition that we 
should consider.

DATES: We will consider all comments that we receive on or before 
August 24, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0033.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0033, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The petition and any comments we receive on this docket may be 
viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0033 
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) 851-3724.

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, 
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.
    The regulations in paragraph (a) of Sec.  2.36 require that the 
reporting facility be the segment of the research facility, or that 
department, agency, or instrumentality of the United States, that uses 
or intends to use live animals in research, tests, experiments, or for 
teaching. Each reporting facility is required to submit an annual 
report\1\ to the Animal Care Regional Director for the State where the 
facility is located on or before December 1 of each calendar year. The 
annual report has to be signed and certified by the chief executive 
officer or institutional official and cover the previous Federal fiscal 
year.
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    \1\ Annual reports for the years they were issued can be viewed 
at: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare/!ut/p/a1/04_Sj9CPykssy0xPLMnMz0vMAfGjzOK9_D2MDJ0MjDzd3V2dDDz93HwCzL29jAyCzYAKIvEo8DYlTr-zu6OHibmPgYGBiYWRgaeLk4eLuaWvgYGnGXH6DXAARwNC-sP1o_AqAfkArACfE8EK8LihIDc0NMIg0xMAwhVB1g!!/?1dmy&urile=wcm%3apath%3a%2FAPHIS_Content_Library%2FSA_Our_Focus%2FSA_Animal_Welfare%2FSA_Obtain_Research_Facility_Annual_Report%2F.
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    Under Sec.  2.36, the annual report is required to assure that 
professionally acceptable standards governing the care, treatment, and 
use of animals, including appropriate use of anesthetic, analgesic, and 
tranquilizing drugs, were used prior to, during, and following actual 
procedures, and that each principal investigator has considered 
alternatives to painful procedures. The annual report is also required 
to assure that the facility is adhering to the standards and 
regulations under the AWA. Exceptions to the standards and regulations 
are required to be attached to the annual report as a summary that 
includes a brief explanation as well as the species and number of 
animals affected.
    In addition, the regulations require the annual report to state the 
location of all facilities where animals were housed or used in actual 
research, testing, teaching, or experimentation, or held for these 
purposes.
    The regulations also require the annual report to include the 
common names and numbers of animals involved in procedures for which: 
(1) No pain, distress, or use of pain-relieving drugs was involved; (2) 
appropriate anesthetic, analgesic, or tranquilizing drugs were provided 
where there was accompanying pain or distress to the animals; or (3) 
pain and distress was involved and the use of appropriate anesthetic, 
analgesic, or tranquilizing drugs for relief would have adversely 
affected the procedures, results, or interpretation of the teaching, 
research, experiments, surgery, or tests. An explanation of the 
procedures producing pain or distress in these animals and the reasons 
such drugs were not used is required to be attached to the annual 
report.
    Lastly, the annual report is required under the regulations to 
include the common names and numbers of animals being bred, 
conditioned, or held for use in teaching, testing, research, 
experiments, or surgery, but not yet used for such purposes.
    APHIS received a petition from the National Anti-Vivisection 
Society (referred to below as NAVS) dated December 15, 2014. In the 
petition, NAVS stated that the online Animal

[[Page 36252]]

Care Information System \2\ and the APHIS annual report provide an 
insufficient level of detail about animals used for research. NAVS 
requested that we amend the AWA reporting regulations to require 
research facilities to provide us with information about how animals 
are being used for research and experimentation and that we publish 
this information in the annual report of research facilities. NAVS also 
requested that APHIS replace the current reporting form \3\ used by 
research facilities with a template \4\ comparable to that used by 
Member States of the European Union (EU), which provides an accounting 
of the numbers and types of animals, and for what specific research, 
testing, and educational purposes the animals are being used.
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    \2\ Animal Care Information System (ACIS), accessible at: 
https://acissearch.aphis.usda.gov/LPASearch/faces/Warning.jspx.
    \3\ Form 7023, Annual Report of Research Facility: http://www.aphis.usda.gov/library/forms/pdf/APHIS_7023.pdf.
    \4\ The EU reporting template cited by NAVS can be viewed at 
http://www.navs.org/file/APHIS-Modified-Template_121214.xls.
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    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 the regulations to require research 
facilities that use animals for teaching, testing, and experimentation 
to provide specific information about how regulated animals are used 
(for example, for safety testing, teaching purposes, or disease 
research)? Would reporting this information improve animal welfare? If 
so, how?
    2. If research facilities were required to report the purposes of 
their animal research activities, what types of information should be 
provided, and why?
    3. What might be the effects, if any, on research facilities if 
they are required to collect and report this additional information?
    4. Does the annual reporting form currently required to be used by 
research facilities capture sufficient information? If not, what 
information is missing?
    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 we receive.

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

    Done in Washington, DC, this 18th day of June 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-15499 Filed 6-23-15; 8:45 am]
 BILLING CODE 3410-34-P