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

CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2) September 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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

Docket Number:
FDA-2000-D-0598
Issued by:
Guidance Issuing Office
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 is to ensure international harmonization of genotoxicity testing of veterinary drug residues.

Questions?

Contact Point
Li You
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
Li.You@fda.hhs.gov
240-402-0828
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