CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Toxicity Testing (Revision 1) May 2024

GUIDANCE DOCUMENT

Submit Comments by 07/22/2024

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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-0784

---

• Docket Number: FDA-2000-D-0784
• 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 the assessment of any effects on reproduction. The objective of this guidance is to ensure international harmonization of reproduction toxicity testing, which is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures, such as may be encountered from the presence of veterinary drug residues in food.

The current guidance is one of a series of guidances developed to facilitate the mutual acceptance of safety data necessary for the determination of Acceptable Daily Intakes (ADIs) for veterinary drug residues in human food by the relevant regulatory authorities. This guidance should be read in conjunction with the guidance on the overall strategy for the safety evaluation of veterinary residues in human food (see VICH GL-33).

This document provides guidance on the core recommendation for a multigeneration study for those veterinary medicinal products that leave residues in human food.  However, it does not seek to limit the studies that may be performed to establish the safety of residues in human food with respect to reproductive function. Neither does it preclude the possibility of alternative approaches that may offer an equivalent assurance of safety, including scientifically-based reasons as to why such data may not need to be provided. This guidance is not intended to cover the information that may be recommended to establish the safety of a veterinary product with respect to reproduction in the target species.

Questions?