Appendix A

APHIS/USDA Policy 11 and Policy 12

POLICY #11—PAINFUL/DISTRESSFUL PROCEDURES—APRIL 14, 1997

References: AWA Sections 13(a)(3), 13(a)(7), 13(e)(2, 3) and 9 CFR, Part 2, Sections 2.31(d)(1)(i,ii,iii,iv), 2.31(e)(4), 2.33(b)(4) and 9 CFR, Part 3, Section 3.6(b)(5,6,7)

History: Replaces letters dated May 8, 1992, November 7, 1991, November 9, 1990, and March 1, 1990.

Justification: Provides requested guidance. Procedures involving animals will avoid or minimize discomfort, distress and/or pain.

Policy:

A painful procedure is defined as any procedure that would reasonably be expected to cause more than slight or momentary pain and/or distress in a human being to which that procedure is applied. The Institutional Animal Care and Use Committee (IACUC) is responsible for ensuring that investigators have appropriately considered alternatives to any procedures that may cause more than slight or momentary pain or distress. A written narrative description of the methods and sources used to search for alternatives must be provided. Where specific testing procedures are required by Federal law, the CFR references or other legal guidelines requiring them should be noted.



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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 Appendix A APHIS/USDA Policy 11 and Policy 12 POLICY #11—PAINFUL/DISTRESSFUL PROCEDURES—APRIL 14, 1997 References: AWA Sections 13(a)(3), 13(a)(7), 13(e)(2, 3) and 9 CFR, Part 2, Sections 2.31(d)(1)(i,ii,iii,iv), 2.31(e)(4), 2.33(b)(4) and 9 CFR, Part 3, Section 3.6(b)(5,6,7) History: Replaces letters dated May 8, 1992, November 7, 1991, November 9, 1990, and March 1, 1990. Justification: Provides requested guidance. Procedures involving animals will avoid or minimize discomfort, distress and/or pain. Policy: A painful procedure is defined as any procedure that would reasonably be expected to cause more than slight or momentary pain and/or distress in a human being to which that procedure is applied. The Institutional Animal Care and Use Committee (IACUC) is responsible for ensuring that investigators have appropriately considered alternatives to any procedures that may cause more than slight or momentary pain or distress. A written narrative description of the methods and sources used to search for alternatives must be provided. Where specific testing procedures are required by Federal law, the CFR references or other legal guidelines requiring them should be noted.

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 Examples of procedures that can be expected to cause more than momentary or slight pain include, but are not limited to, the following: Terminal Surgery is considered a painful procedure which is alleviated by anesthesia. Freund's Complete Adjuvant used for antibody production may cause results ranging from momentary or slight pain to severe pain depending on the product, procedure, and species. Ocular and Skin Irritancy Testing. The dosing procedure itself is generally not painful but the reaction caused by the product being tested may cause pain. Examples of procedures that may cause more than momentary or slight distress include, but are not limited to, the following: Food or water deprivation beyond that necessary for normal presurgical preparation. Noxious electrical shock that is not immediately escapable. Paralysis or immobility in a conscious animal. Many procedures, including any of those in the lists above, may cause both pain and distress. An example of a procedure that can be expected to cause more than momentary or slight pain as well as distress would be a study involving extensive irradiation. Animals exhibiting signs of pain, discomfort, or distress such as decreased appetite/activity level, adverse reactions to touching inoculated areas, open sores/ necrotic skin lesions, abscesses, lameness, conjunctivitis, corneal edema, and photophobia are expected to receive appropriate relief unless written scientific justification is provided in the animal activity proposal and approved by the IACUC. Research facilities must have a mechanism in place for ensuring that animals are reported in the appropriate pain category on the annual report (APHIS Form 7023). Individual animals that do not experience pain/distress from testing procedures should be reported in column C. Individual animals experiencing pain/ distress which is alleviated with anesthetics, analgesics, sedatives and/or tranquilizers should be reported in column D. This category includes terminal surgery under anesthesia. Individual animals in which needed anesthetics, analgesics, sedatives, and/or tranquilizers are withheld should be reported in column E. For all column E animals, a written justification, approved by the IACUC, must be provided, including CFR references or other guidelines if appropriate.

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 POLICY #12 — CONSIDERATION OF ALTERNATIVES TO PAINFUL/DISTRESSFUL PROCEDURES — JUNE 21, 2000 References: AWA Section 13(a)(3)(B), 9 CFR, Part 2, Section 2.31 (d)(1)(ii)and (e), 9 CFR, Part 2, Section 2.32 (c)(2) and (5)(ii), Animal Welfare Information Center History: Provides guidance on the requirement to provide a written narrative of the consideration of alternatives to painful and distressful procedures. Replaces Policy #12 dated April 14, 1997. Justification: The Animal Welfare Act (AWA) regulations require principal investigators to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals and provide a written narrative of the methods used and sources consulted to determine the availability of alternatives, including refinements, reductions, and replacements. Policy: Alternatives or alternative methods are generally regarded as those that incorporate some aspect of replacement, reduction, or refinement of animal use in pursuit of the minimization of animal pain and distress consistent with the goals of the research. These include methods that use non-animal systems or less sentient animal species to partially or fully replace animals (for example, the use of an in vitro or insect model to replace a mammalian model), methods that reduce the number of animals to the minimum required to obtain scientifically valid data, and methods that refine animal use by lessening or eliminating pain or distress and, thereby, enhancing animal well-being. Potential alternatives that do not allow the attainment of the goals of the research are not, by definition, alternatives. A fundamental goal of the AWA and the accompanying regulations is the minimization of animal pain and distress via the consideration of alternatives and alternative methods. Toward this end, the regulations state that any proposed animal activity, or significant changes to an ongoing animal activity, must include: a rationale for involving animals, the appropriateness of the species, and the number of animals to be used; a description of procedures or methods designed to assure that discomfort and pain to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; a written narrative description of the methods and sources used to consider

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 alternatives to procedures that may cause more than momentary or slight pain or distress to the animals; and the written assurance that the activities do not unnecessarily duplicate previous experiments. We believe that the performance of a database search remains the most effective and efficient method for demonstrating compliance with the requirement to consider alternatives to painful/distressful procedures. However, in some circumstances (as in highly specialized fields of study), conferences, colloquia, subject expert consultants, or other sources may provide relevant and up-to-date information regarding alternatives in lieu of, or in addition to, a database search. When other sources are the primary means of considering alternatives, the Institutional Animal Care and Use Committee (IACUC) and the inspecting Veterinary Medical Officer should closely scrutinize the results. Sufficient documentation, such as the consultant's name and qualifications and the date and content of the consult, should be provided to the IACUC to demonstrate the expert's knowledge of the availability of alternatives in the specific field of study. For example, an immunologist cited as a subject expert may or may not possess expertise concerning alternatives to in vivo antibody production. When a database search is the primary means of meeting this requirement, the narrative must, at a minimum, include: the names of the databases searched; the date the search was performed; the period covered by the search; and the key words and/or the search strategy used. The Animal Welfare Information Center (AWIC) is an information service of the National Agricultural Library specifically established to provide information about alternatives. AWIC offers expertise in formulation of the search strategy and selection of key words and databases, access to unique databases, on- and off-site training of institute personnel in conducting effective alternatives searches, and is able to perform no-cost or low-cost electronic database searches. AWIC can be contacted at (301) 504-6212, via E-mail at awic@nal.usda.gov, or via its Web site at http://www.nal.usda.gov/awic. Other excellent resources for assistance with alternative searches are available and may be equally acceptable. Regardless of the alternatives sources(s) used, the written narrative should include adequate information for the IACUC to assess that a reasonable and good faith effort was made to determine the availability of alternatives or alternative methods. If a database search or other source identifies a bona fide alternative

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 method (one that could be used to accomplish the goals of the animal use proposal), the written narrative should justify why this alternative was not used. The written narrative for federally mandated animal testing (for example, testing product safety/efficacy/potency) need only to include a citation of the appropriate government agency's regulation and guidance documents. Mandating agency guidelines should be consulted since they may provide alternatives (for example, refinements such as humane endpoints or replacements such as the Murine Local Lymph Node Assay) that are not included in the Code of Federal Regulations. If a mandating agency-accepted alternative is not used, the principal investigator should explain the reason in the written narrative. Alternatives should be considered in the planning phase of the animal use proposal. When a proposal is modified during its performance, significant changes are subject to prior review by the IACUC, including the review of the implications of those changes concerning the availability of alternatives. Although additional attempts to identify alternatives or alternative methods are not required by Animal Care at the time of each annual review of the animal protocol, Animal Care would normally expect the principal investigator to reconsider alternatives at least once every 3 years, consistent with the triennial review requirements of the Public Health Service Policy (IV,C,5).