Institutional Animal Care and Use Committee (IACUC)

USDA Policies

USDA Policy Statements

Policy 12-Alternatives to Painful Procedures

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:

1. a rationale for involving animals, the appropriateness of the species, and the number of animals to be used;
2. 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;
3. a written narrative description of the methods and sources used to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals; and
4. 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-todate 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:

1. the names of the databases searched;
2. the date the search was performed;
3. the period covered by the search; and
4. 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 alternative 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 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) 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 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).

Policy 14-Major Survival Surgery

No animal assigned to a proposal is to be used in more than one major survival operative procedure unless the multiple procedures are included within one proposal, justified for scientific reasons by the Principal Investigator, and preapproved by the Institutional Animal Care and Use Committee (IACUC). However, an animal that has an emergency major operative procedure as part of proper veterinary care may still be used in a proposal that requires a major survival operative procedure.

A major survival operative procedure must not be performed a second time on an animal in a separate proposal. In order to comply with the intent of the Animal Welfare Act (AWA), animals surviving a major operative procedure must be identified (written documentation) to prevent their use in a second major survival operative procedure.

The AWA and its regulations allow an exemption to limiting animals from being used in only one proposal with a major survival operative procedure. The Institutional Official of the research facility should make the exemption request to the appropriate Animal Care Regional Director, who forwards it to the Animal Care Assistant Deputy Administrator for review and recommendation to the Deputy Administrator. The request for exemption should include the following information:

1. An outline of the research proposals for which the procedure is requested
2. The species and the approximate number of animals involved in the exemption request
3. The time frame for the proposed exempt procedure Animal Care Resource Guide Policies Major Survival Surgery
4. The number of major operative procedures to be performed on a given animal, the frequency of such procedures, and the period of time between each major operative procedure
5. Measures to be taken to ensure that pain/distress are minimized
6. A complete justification for the exemption in which cost is not normally a major criterion
7. An assurance that all other stipulated requirements of the AWA and regulations will be met in consideration of this exemption
8. An assurance that the facility’s IACUC has approved the exemption.

The Animal & Plant Health Inspection Service (APHIS) may respond to the formal request by approving the request as written, granting a portion of the request, imposing additional limitations, or denying the request. An annual IACUC evaluation of the exemption is required, which consists of an IACUC assessment of the animals and the effectiveness and soundness of the methods and procedures used. This information is to be included in the report of the IACUC functions. Considerations for the renewal or continuation of the exemption will be based on the IACUC’s recommendations following their review. The exemption must be included in the Annual Report (APHIS Form 7023).

Policy 15-IACUC Membership

For Animal Welfare Act (AWA) enforcement purposes, the nonaffiliated member of the Insitutional Animal Care and Use Committee (IACUC) is to "provide representation for general community interests." The outside nonaffiliated member cannot be a laboratory animal user at any research facility. Compensation of the nonaffiliated member is permissable only when it does not jeopardize the member’s status as a nonaffiliated member. Compensation varies but is normally limited to payment for travel and related expenses, such as parking and meals, to modest monetary payments for participation. The dollar amount of compensation, if any, should not be so substantial as to be considered an important source of income or to influence voting on the IACUC.

The regulations provide for four specific roles within the Animal Care and Use Program:

1. Institutional Official
2. IACUC Chairperson
3. Attending Veterinarian
4. Nonaffiliated Member

These positions are meant to provide a system of checks and balances which is not normally achieved if any one person fills more than one of these roles. While the regulations do not specifically prohibit one person from filling more than one role, the Animal and Plant Health Inspection Service (APHIS) strongly discourages such assignments because of the potential for conflicts of interest and/or undue influence by one person over the facility’s program. However, a veterinarian who is not the attending veterinarian may assume any one of the other program positions. No IACUC member can review his/her own proposal.