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 for industry (GFI) is to ensure international harmonization of genotoxicity testing of veterinary drug residues.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Download the Final Guidance Document

https://www.fda.gov/media/70134/download

Read the Federal Register Notice

https://www.federalregister.gov/public-inspection/2026-17928/guidance-international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of