IACUC – USDA Policy #12 Consideration of Alternative to Painful/Distressful Procedures

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 alternative to painful and distressful procedures. Replaces Policy #12 dated April 14, 1997

Justification: The Animal Welfare Act (AWA) regulations require principal investigators to consider alternative to procedures that may cause more than momentary or slight pain or distress to the animal 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 partial or fully replace animal (for example, the use of an in vitro insect model to replace a mammalian model), methods that reduce the number of animal 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 alternative that do no allow the attainment of the goals or the research are not, but 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 on 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 appropriated to minimize discomfort and pain to animals;
• a written narrative description of the methods and sources used to consider alternative to procedures that may cause more than momentary or slight pain or distress to the animals;
• 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 source 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 alternative, 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 qualification and the date and content of the consult, should be provided to the IACUC to demonstrate the expert's knowledge of the availability of alternative in the specific field of study. For example, an immunologist cited as a subject expert may or may not possess expertise concerning alternative 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
• the key words and/or the search

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 website. Other excellent resources for assistance with alternative searches are available and may be equally acceptable.

Regardless of the alternatives sources 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 identified a bona fide alternative method (one that could be used to accomplish the goals of the animal use proposal), the written narrative should justify why the alternative was not used.

The written narrative for federal-mandated animal testing (for example, testing product safety/efficacy/potency) needs 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 alternative (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 Regulation. If a mandating agency-accepted alternative is not used, the principal investigator should explain the reason in the written narrative.

Alternative should be consider 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 alternative 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 one every 3 years, consistent with the triennial review requirements of the Public Health Service Policy (IV, C, 5).