Toxicity testing guidelines and standards: Their role in retrospective safety reviews
Harris, Jane E. | Morgenroth, Victor H. III.
The FDA recommends retrospective review of older food additive safety judgments, in light of changing product use patterns and advancements in toxicological knowledge. A priority substance review system should be based on relative toxicity and extent of human exposure. FDA plans to publish guidelines for designing, conducting, and reporting tests on oral and chronic toxicity, carcinogenicity, teratogenicity, reproduction, and pharmacokinesis. Standards will be applied to assess the adequacy of toxicological data used in evaluating food safety; current standards include: number of surviving animals; number of doses; and number and type of tissues examined histopathologically. Data that do not meet current standards may still be used as a basis for further research requests or interim safety determinations, but these must meet a set of care standards developed from previous customs and current scientific opinion. (cj)
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