. "Appendix A: APHIS/USDA Policy 11 and Policy 12." Definition of Pain and Distress and Reporting Requirements for Laboratory Animals: Proceedings of the Workshop Held June 22, 2000. Washington, DC: The National Academies Press, 2000.
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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.
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