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 sub



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