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Executive Summary

HHS OPPOSING LEGISLATION REQUIRING JUSTIFICATION OF ANIMAL TESTING; Health and Human Services Department Assistant Secretary for Health James Mason told a Nov. 8 Senate subcommittee that the department opposed the two main provisions of a bill, S 891, introduced last May by Sen. Reid (D-Nev.), to restrictanimal testing of consumer products. Speaking before the Senate Commerce/Consumer Subcommittee, Mason objected to the bill's prohibition against federal agencies accepting LD[50] data and its requirement that agencies must justify the acceptance of any animal toxicity tests. According to Mason, although the bill "purports to provide for the modernization of testing of consumer products," the result would be that "biomedical research and drug development programs would be severely impeded by restrictions on the choice of scientific method and the administrative burden of justifying the use of animals for each type of toxicity testing." The bill is called the "Consumer Product Safety Testing Act." Mason added, "In point of fact, [the bill] makes state of the art animal studies the exception and elevates non-animal methods to the norm." The legislation calls for limiting the use of acute toxicity test data by federal agencies "when determining product safety, labeling, or transportation requirements for federal regulation." The bill is identical to House legislation introduced in April by Rep. Boxer (D-Calif.). The measure also would require federal agencies to periodically review regulations which call for the use of animal toxicity tests and to promulgate "regulations which specify that non-animal toxicity tests be used," rather than animal tests. Should an agency find that a specific, non-animal test is less valid than an animal toxicity test, that agency would be required to publish an explanation and justification of continued animal model use in the Federal Register. With regard to the Draize rabbit eye irritation test, Mason said that while FDA is actively considering alternatives to the Draize, "it is more likely that these efforts will result in reduction or refinement as opposed to replacement." Mason added that he does "not foresee a day when alternatives will replace whole animal models" in toxicity testing.

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