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Guidance Issuing OfficeCenter for Veterinary Medicine
In order to establish the safety of veterinary drug residues in human food, a number of toxicological evaluations are recommended including the assessment of potential to induce neoplasia. The objective of this guidance is to ensure that the assessment of carcinogenic potential is appropriate for human exposure to veterinary drug residues in human food.
The assessment of carcinogenic potential has been identified as one of the key areas to be considered in the evaluation of the safety of veterinary drug residues in human food. Exposure to residues of veterinary drugs will usually occur at extremely low levels, but potentially for long periods, possibly over a lifetime. To ensure that substances that could pose carcinogenic potential at relevant exposure levels are adequately assessed, a number of issues should be considered, including genotoxicity, metabolic fate, species differences, and cellular changes.
This guidance sets out a recommended data-driven decision pathway to determine whether carcinogenicity studies should be conducted. It also provides guidance on the conduct of carcinogenicity studies.
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:
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-2001-D-0101.