This month, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine issued a final rule on tolerances for animal drugs in food. The regulations apply only to foods intended for human consumption.
The rule, “New Animal Drugs: Updating Tolerances for Residues of New Animal Drugs in Food,” standardizes and clarifies the standards for determining, codifying, and updating tolerances. The final rule also provides a definition section of key terms that 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 this rule in 2012 and requested public comment. The agency issued a supplemental proposed rule for a second public comment period in 2016, and 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, which will be September 9, 2019.
See the final rule as it appears in the Federal Register here.