Issue Date: September 30, 2024
Issued by: Center for Veterinary Medicine
Topic(s): Human Food Safety, VICH
Status: Draft
CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)
In order to establish the safety of veterinary drug residues in human food, a number of toxicological evaluations are recommended, including investigation of possible hazards from genotoxic activity. Many carcinogens and/or genotoxicants have a genotoxic mode of action, and it is prudent to regard genotoxicants as potential carcinogens unless there is convincing evidence that this is not the case. The results of genotoxicity tests will normally not affect the numerical value of an acceptable daily intake (ADI), but they may influence the decision on whether carcinogenicity tests are needed and whether an ADI can be established. The objective of this guidance is to ensure international harmonization of genotoxicity testing of veterinary drug residues.
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