Safety assessment of animal drugs

Abstract

The Food and Drug Administration has published a proposal ( Chemical Compounds in Food-Producing Animals: Criteria and Procedures for Evaluating Assays for Carcinogenic Residues, Federal Register 44, 17070–17114 March 20 1979 ) to establish procedures and minimum criteria to ensure the absence of cancer-causing residues in edible products of food-producing animals to which drugs, food additives, or color additives have been administered. Section III of the proposed rule (termed the Sensitivity of the Method Document or SOM) would require that metabolism and comparative metabolism studies be conducted in target (food-producing) and test (laboratory) animals, respectively. As a practical matter, current agency policy prescribes that information from such studies would be required whether the compound was considered to be a suspect carcinogen or a noncarcinogen. Metabolism studies to determine what drug-derived residues may be present in the tissues of food-producing animals at a particular withdrawal time as well as comparative metabolism studies to determine the appropriateness of the laboratory animal as a test species, and the relationship of the two studies to each other, are discussed in terms of the procedures used for the human safety assessment of animal drugs.