Issue Date: September 15, 2011
Issued by: Center for Veterinary Medicine
Topic(s): Human Food Safety, VICH
Status: Final
CVM GFI #206 (VICH GL47) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals
The human food safety evaluation of veterinary drug residues helps ensure that food derived from treated food-producing animals is safe for human consumption. As part of the data collection process, studies should be conducted to characterize the metabolites to which laboratory animals are auto-exposed during the toxicological testing of the veterinary drug. The purpose of these studies is to determine whether the metabolites that people will consume from tissues of target food-producing animals are also produced by metabolism in the laboratory animals used for the safety testing. It is understood that, if the laboratory animals produce substantially similar metabolites as those produced by the food-producing animal, the laboratory animals will have been auto-exposed to the metabolites that humans will consume from tissues of treated food-producing animals. Auto-exposure of metabolites will ordinarily be taken as evidence that the safety of metabolites has been adequately assessed in the toxicology studies. The objective of this guidance is to provide recommendations for internationally harmonized procedures to identify the metabolites of veterinary drugs produced by laboratory animals.
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