Issue Date: September 2, 2026
Issued by: Center for Veterinary Medicine
Topic(s): Human Food Safety, VICH
Status: Final
CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)
FDA is announcing the availability of a final guidance for industry (GFI) #116 (VICH GL23(R2)) titled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2).” This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to ensure international harmonization of genotoxicity testing of veterinary drug residues.
Download the Guidance Document
