USDA - APHIS - Animal Welfare

| Download PDF Format |

Policy #14: Major Survival Surgery Dealers Selling Surgically-Altered Animals to Research
Issue Date: March 25, 2011

References:
AWA Section 2143(a)(3)(A,B,C,D,E)
9 CFR, Part 2, Section 2.31 (d)(1)(i,ii,iv,viii,ix,x)

History:
Combines previous policies 14 and 16. Replaces letters dated June 5, 1990, and April 21, 1992, and policies dated April 14, 1997.

Justification:
No animal is to be used in more than one major survival operative procedure except in cases of scientific necessity, veterinary care or other special circumstances as determined by APHIS. The Institutional Animal Care and Use Committee (IACUC) must ensure that survival surgery will avoid or minimize pain and is aseptically performed by qualified personnel.

Policy:
No animal assigned to a proposal is to be used in more than one major survival operative procedure unless the multiple procedures are required to meet the objective of a single animal study activity, justified for scientific reasons by the Principal Investigator, and approved by the Institutional Animal Care and Use Committee (IACUC). A dealer performing surgery on animals as a necessary part of a proposed animal activity at a research facility must also register as a research facility or be a site of the research facility requesting the altered animals.

However, an animal that has a major operative procedure as part of a facility’s veterinary care program (unrelated to research), or as an emergency surgery, may still be used in a research proposal that requires a major survival operative procedure. An approved research proposal is not required for routine veterinary care or animal husbandry that involves surgery.

A 2nd major survival operative procedure must not be performed on an animal in a separate animal study activity. In order to comply with the intent of the Animal Welfare Act (AWA), animals surviving major operative procedures in one animal study activity must be identified in a manner that effectively precludes their use in additional animal study activities involving major survival operative procedures.

Under special circumstances, the AWA allows for exemptions to the limitation that only one major operative procedure be performed on an animal. The Institutional Official of the research facility should make the exemption request to the appropriate Animal Care Regional Director, who will forward it to the Animal Care Deputy Administrator. The request for exemption should include the following information:

An outline of the research proposal for which the procedure(s) is requested;

A means by which to uniquely identify the research proposal;

The species and the approximate number of animals involved in the exemption request;

A method of permanently identifying the individual animals involved;

The time frame for the proposed exempt procedure;

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;

Measures to be taken to ensure that pain/distress are minimized;

A complete scientific justification for the exemption. Cost is not an acceptable justification.

An assurance that all other stipulated requirements of the AWA and regulations will be met in consideration of this exemption; and

An assurance that the facility’s IACUC has approved the exemption.

The Animal and Plant Health Inspection Service (APHIS) may respond to the formal request by approving the request as written, requesting further information, 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 submitted to the Institutional Official. 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).