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Guidance Issuing OfficeCenter for Veterinary Medicine
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-D-8229.