July 10, 2019
On July 10, 2019, the U.S. Food and Drug Administration’s Center for Veterinary Medicine issued a final rule, “New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.” This final rule standardizes and clarifies the standards for determining, codifying, and updating tolerances, and also provides a definition section of key terms that the FDA uses in the determination of tolerances. This final rule will enhance understanding of tolerance determination and improve the overall readability of the relevant regulations. The rule does not establish new tolerances. The FDA first proposed the rule in 2012 and requested public comment. The agency issued a supplemental proposed rule for a second public comment period in 2016, and the FDA took these comments into consideration while developing the final rule. The final rule will become effective 60 days from the date of publication in the Federal Register.
October 27, 2016 CVM Update - FDA Seeks Public Comments on Updating Tolerances for Residues of New Animal Drugs in Food
The U.S. Food and Drug Administration issued a proposal today to amend its 2012 proposed rule for New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.
The 2012 proposed rule included revisions to the animal drug regulations regarding tolerances for residues of approved and conditionally-approved new animal drugs in food. In addition to proposing to standardize, simplify, and clarify the standards of determination and codification style for tolerances, FDA proposed a new definition section. In direct response to comments received, the document issued today revises or removes some of the previously proposed definitions.
The FDA is also proposing to add definitions for key terms, in order to more clearly explain the current thinking about certain provisions of the proposed rule based on comments from stakeholders. The FDA is reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule.
The FDA is accepting public comments beginning on October 28, 2016. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2012-N-1067 in the search box.
To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2012-N-1067 on each page of your written comments.
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
- 2019 Final Rule; New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
- 2016 Proposed Rule; New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
- 2012 Proposed Rule; New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
- Regulations.gov - Please note that the public comment period opens on October 28, 2016.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.