[Federal Register Volume 65, Number 132 (Monday, July 10, 2000)]
[Proposed Rules]
[Pages 42304-42305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17280]


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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. 65, No. 132 / Monday, July 10, 2000 / 
Proposed Rules  

[[Page 42304]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 1 and 2

[Docket No. 00-005-1]


Animal Welfare; Definitions for and Reporting of Pain and 
Distress

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Request for comments.

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SUMMARY: We are considering several changes to the Animal Welfare 
regulations to promote the humane treatment of live animals used in 
research, testing, and teaching and to improve the quality of 
information we report to Congress concerning animal pain and distress. 
Specifically, we are considering adding a definition for the term 
``distress.'' Although this term is used throughout the Animal Welfare 
regulations, it is not defined. The addition of such a definition would 
clarify what we consider to be ``distress'' and could help assist 
research facilities to recognize and minimize distress in animals in 
accordance with the Animal Welfare Act (AWA).
    We are also considering replacing or modifying the system we use to 
classify animal pain and distress. Professional standards regarding the 
recognition and relief of animal pain and distress have changed 
significantly since we established our classification system. Some 
biomedical research professionals and animal welfare advocates believe 
our classification system is outdated and inadequate. A different 
categorization system could produce data that more accurately depict 
the nature of animal pain or distress and provide a better tool to 
measure efforts made to minimize animal pain and distress at research 
facilities.
    We are soliciting public comments on the changes we are 
considering. We are also interested in obtaining information on 
specific pain and distress classification systems other than the one we 
now use.

DATES: We invite you to comment on this docket. We will consider all 
comments that we receive by September 8, 2000.

ADDRESSES: Please send your comment and three copies to: Docket No. 00-
005-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 
4700 River Road, Unit 118, Riverdale, MD 20737-1238.
    Please state that your comment refers to Docket No. 00-005-1. You 
may read any comments that we receive on this docket in our reading 
room. The reading room 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) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Jodie Kulpa, Staff Veterinarian, 
AC, APHIS, 4700 River Road Unit 84, Riverdale, MD 20737-1234; (301) 
734-7833.

SUPPLEMENTARY INFORMATION:

Background

    Under the Animal Welfare Act (AWA) (7 U.S.C. 2131 et seq.), the 
Secretary of Agriculture is authorized to promulgate standards and 
other requirements regarding the humane handling, care, treatment, and 
transportation of certain animals by dealers, research facilities, 
exhibitors, carriers and intermediate handlers. The Secretary has 
delegated responsibility for administering the AWA to the Animal and 
Plant Health Inspection Service (APHIS) of the United States Department 
of Agriculture (USDA). Regulations established under the AWA are 
contained in the Code of Federal Regulations (CFR) in title 9, parts 1, 
2, and 3 (referred to below as the regulations). Part 1 contains 
definitions for terms used in parts 2 and 3. Part 2 contains general 
requirements for regulated parties. Part 3 contains specific 
requirements for the care and handling of certain animals.
    We are soliciting comments on an approach, discussed below, for 
amending the regulations by defining ``distress'' in part 1 and by 
modifying or replacing the animal pain and distress classification 
system in part 2.

Definition for Distress

    In the regulations, we define a ``painful procedure'' as any 
procedure that would reasonably be expected to cause more than slight 
or momentary pain or distress in a human being to which that procedure 
was applied. Although we use the term ``distress'' in this definition 
and elsewhere in the regulations, there is no definition for distress 
in the regulations. We are considering adding such a definition because 
of requests from the biomedical research community and animal advocacy 
groups. These parties have asked USDA to provide guidance on what is 
considered to be distress in a procedure involving research animals in 
order to improve recognition of animal distress, to classify and report 
it more accurately, and to create a heightened awareness of the 
regulations' requirement to minimize animal distress and pain.

Pain and Distress Classification System

    Section 13(a)(7)(B) of the AWA requires research facilities to 
annually provide ``information on procedures likely to produce pain or 
distress in any animal.'' In accordance with the AWA, the regulations 
at Sec. 2.36 require facilities that use or intend to use live animals 
for research, tests, experiments, or teaching to submit an annual 
report to the Animal Care Regional Director for the State where the 
facility is located. Among other things, the report must state the 
common names and the numbers of animals upon which teaching, 
experiments, research, surgery, or tests were conducted involving: (1) 
No pain, distress, or use of pain-relieving drugs; (2) accompanying 
pain or distress to the animals and for which appropriate anesthetic, 
analgesic, or tranquilizing drugs were used; and (3) accompanying pain 
or distress to the animals and for which the use of appropriate 
anesthetic, analgesic, or tranquilizing drugs would have adversely 
affected the procedures, results, or interpretation of the teaching, 
research, experiments, surgery, or tests.

[[Page 42305]]

    To provide these data, each research facility must assess the 
potential for animal pain or distress associated with the proposed 
procedures. This assessment is performed prospectively (i.e., before 
the procedure) and typically forms the basis for the pain and distress 
report provided by the facility to USDA. The assessment, therefore, is 
an estimate based on professional judgment, knowledge, and experience, 
and the resulting report may or may not accurately reflect the 
conditions the animals actually experience. The research facility can, 
as an option, retrospectively (i.e., during or after the procedure) 
assess the animal pain and distress observed and report these results. 
We do not know how often facilities perform retrospective reporting.
    There is no provision in the current classification system to 
address some areas identified by the research community and animal 
advocacy groups. For example, the current system does not include a 
means to report:
     An assessment of the relative intensity or duration of 
pain or distress either observed in the animal or anticipated to be 
experienced by the animal;
     An assessment of the anticipated or observed efficacy of 
the pain- or distress-relieving agent provided to animals undergoing a 
painful or distressful procedure;
     A distinction between procedures causing animal pain and 
procedures causing animal distress;
     Animals that were prevented from experiencing pain or 
distress by the appropriate and effective use of pain- or distress-
relieving methods or procedures (e.g., well-anesthetized animals that 
undergo terminal surgery);
     Animals that did not experience pain or distress due to 
the appropriate and effective use of pain- or distress-relieving 
methods or procedures other than anesthetic, analgesic, or 
tranquilizing agents;
     Animals that experience unrelieved pain or distress for a 
reason other than that the use of anesthetic, analgesic, or 
tranquilizing drugs would have adversely affected the procedures, 
results, experiments, surgery, or tests; or
     Animals that experience pain or distress without having 
been used in a procedure (e.g., illness in animals that have been 
genetically altered to develop disease).
    We are aware of several alternative pain and distress 
classification systems. For example, the system adopted by the Canadian 
Council on Animal Care, ``Categories of Invasiveness in Animal 
Experiments,'' may be viewed on the Internet at http://www.ccac.ca/english/categ.htm. The system proposed by the Humane Society of the 
United States may be viewed on the Internet at http://hsus.org/
programs/research/usda_proposed_scale.html.\1\ Other classification 
systems, varying greatly in complexity, are in use in other countries, 
such as Switzerland and Sweden.
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    \1\ If you do not have access to the Internet, you may obtain a 
copy of the system adopted by Canadian Council on Animal Care or the 
system proposed by the Humane Society of the United States by 
contacting the person listed under FOR FURTHER INFORMATION CONTACT 
at the beginning of this document.
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    Modifying the current USDA system, in lieu of replacing it, could 
also be an option. This could involve replacing or redefining the 
existing categories to:
     Separately report pain and distress;
     Quantify pain and distress intensity and duration;
     Separately classify anesthetized or otherwise treated 
animals undergoing potentially painful procedures but not experiencing 
pain or distress; or
     Modify the system in other ways.
    We invite your comments on adding a definition for distress to the 
regulations and replacing or modifying our animal pain and distress 
classification system. We are particularly interested in soliciting 
comments addressing the following questions:
    1. Would adding a definition for distress to the regulations help 
institutions using animals for research, testing, or teaching better 
recognize, minimize, and report animal distress?
    2. If a definition for distress is added to the regulations, what 
key elements should be included in that definition?
    3. What are the benefits and limitations of our pain and distress 
classification system?
    4. Should our animal pain and distress classification system be 
modified or replaced? If so, what specific modifications or alternate 
classification systems should we consider?
    5. Should animal pain and distress be prospectively or 
retrospectively reported?
    Written comments should be submitted within the 60-day comment 
period specified in this document (see DATES and ADDRESSES).

Executive Order 12866

    This action has been reviewed under Executive Order 12866. The 
action has been determined to be not significant for the purposes of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget.

    Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.2(g).

    Done in Washington, DC, this 3rd day of July 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-17280 Filed 7-7-00; 8:45 am]
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