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FDA DEVELOPMENT OF ANIMAL TESTING ALTERNATIVES WOULD BE REQUIRED

Executive Summary

FDA DEVELOPMENT OF ANIMAL TESTING ALTERNATIVES WOULD BE REQUIRED under an option proposed by the congressional Office of Technology Assessment. In a Feb. 1 report, OTA identifies seven policy issues related to the use of alternative testing procedures and sets forth a number of policy options for consideration by Congress. Among them, OTA points out that "because testing is so closely tied to regulation, funding could be directed to FDA, [the Environmental Protection Agency], the Consumer Protection Safety Commission and the National Institute for Occupational Safety and Health." If Congress were to fund such activity, OTA recommends that regulatory agencies be required to develop alternatives to specified tests or to earmark funds for their development. However, OTA acknowledges that the "most likely" agencies to produce alternatives in toxicological testing would be the National Institutes of Health, specifically, the National Cancer Institute. Senate Labor and Human Resources Committee Chairman Orrin Hatch (R-Utah) requested the report in March 1983. Although there is no identifiable, targeted U.S. government funding of testing and research into alternatives, some federal dollars already support work in that area, the report said. For example, FDA is developing alternatives such as rat embryo cultures to detect agents that cause developmental toxicity. Among the alternatives currently in use at the agency is an in vitro test for percutaneous absorption of cosmetic ingredients. Other options in the report, entitled "Alternatives to Animal Use in Research, Testing and Education," include: the implementation of alternative methods; the promotion of R&D into more and better alternatives; the dissemination of information about animal experimentation; restriction of animal use; assessment of the number of animals actually used; and changing the implementation of, or amending, the Animal Welfare Act. The act reguates housing, feeding and other aspects of animal care, but bars the U.S. Department of Agriculture from control over the design or performance of actual testing. Based on rough estimates by the USDA and the Animal and Plant Health Inspection Service, OTA said that at least 17-22 mil. animals were used in U.S. research and testing in 1983. Of that number, approximately 75% were rats and mice. The report includes a section on private funding of research into alternatives. Among the privately supported institutions listed is the Johns Hopkins Center for Alternatives to Animal Testing. The 18-member OTA advisory panel that assisted in preparing the report was chaired by Arthur Caplan, from The Hastings Center. Panel members included Earl Brauer (Revlon Research Center), Alan Goldberg (Johns Hopkins School of Public Health) and D.C. attorney Peter Hutt (Covington & Burling). The 441-page document covers the scientific, regulatory, economic, legal and ethical considerations involved in animal testing. Copies may be obtained for $16 from the Superintendent of Documents, U.S. government Printing Office, Washington, D.C. 20402. Request OTA-BA-273.

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