Background

The Food and Drug Administration has issued a final rule that codifies procedures and food safety criteria by which tolerances for residues of unapproved new animal drugs in any edible portion of any animal imported into the U.S. may be established, amended, or revoked. This rule will take effect Jan. 19, 2022.

A 1996 law authorized the establishment of import tolerances that would provide a basis for the legal marketing of imported animal-derived food containing residues of new animal drugs neither approved nor conditionally approved in the U.S. Without an import tolerance, any amount of such residue would cause the food to be adulterated because the drug would be deemed unsafe, and such food could be denied entry. It remains unlawful to import animal-derived food containing a residue of an unapproved new animal drug unless an import tolerance has been established for that drug and any residue of that drug in the imported food does not exceed that import tolerance.

The FDA’s new rule covers who may initiate proceedings to establish an import tolerance; the contents of import tolerance requests; sources of data and information supporting the safety of a proposed import tolerance; FDA procedures for establishing, amending, or revoking an import tolerance; public disclosure of import tolerance-related actions; and environmental impact assessments of import tolerance-related actions.

For more information on this rule and its impact, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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