CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2) September 2026

GUIDANCE DOCUMENT

• Docket Number: FDA-2000-D-0598
• Issued by: Center for Veterinary Medicine

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.

---

Submit Comments

Submit Comments Online

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:

Dockets Management
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-2000-D-0598.

Questions?