The USDA is currently considering the problem of
"Definitions for and reporting of Pain and Distress" and new definitions
have been proposed. They were published in the Federal Register on 10
July 2000 (Volume 65, No. 132, pages 42304-42305). Public comments are
due by 8 September 2000. It is very important that people concerned with
the plight of experimental animals comment. I have seen reports to USDA
from primate centers and other facilities in which the claim is made
that, for the year of the report, no animal suffered unrelieved pain or
distress.
The information comes from:
http://www.aphis.usda.gov/ppd/rad/webrepor.html
Proposed Rules
Federal Register
[[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welfare advocates believe our classification system is outdated and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.
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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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).
Shirley McGreal, Chairwoman, International Primate
Protection League
POB 766 Summerville SC 29484 USA
Phone: 843-871-2280 Fax: 843-871-7988
E-mail spm@awod.com or ippl@awod.com
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