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GUIDANCE DOCUMENT

CVM GFI #116 (VICH GL23) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing May 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
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 foods, a number of toxicological evaluations are recommended, including investigation of possible hazard from genotoxic activity. Many carcinogens and/or mutagens 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. Additionally, substances causing reproductive and/or developmental toxicity may have a mode of action that involves genotoxic mechanisms. The results of genotoxicity tests will not normally affect the numerical value of an acceptable daily intake (ADI), but they may influence the decision about whether an ADI can be established.

The objective of this guidance is to ensure international harmonization of genotoxicity testing.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2000-D-0598.

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