Issue Date: July 27, 2006
Issued by: Center for Veterinary Medicine
Topic(s): Human Food Safety, VICH
Status: Final
CVM GFI #141 (VICH GL28) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing
In order to establish the safety of veterinary drug residues in human food, a number of toxicological evaluations are recommended including the assessment of potential to induce neoplasia. The objective of this guidance is to ensure that the assessment of carcinogenic potential is appropriate for human exposure to veterinary drug residues in human food. The assessment of carcinogenic potential has been identified as one of the key areas to be considered in the evaluation of the safety of veterinary drug residues in human food. Exposure to residues of veterinary drugs will usually occur at extremely low levels, but potentially for long periods, possibly over a lifetime. To ensure that substances that could pose carcinogenic potential at relevant exposure levels are adequately assessed, a number of issues should be considered, including genotoxicity, metabolic fate, species differences, and cellular changes. This guidance sets out a recommended data-driven decision pathway to determine whether carcinogenicity studies should be conducted. It also provides guidance on the conduct of carcinogenicity studies.
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