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New Import Tolerance Procedures for Residues of Unapproved Animal Drugs in Food Under Consideration

The Food and Drug Administration has unveiled a proposal that would establish procedures by which a person may request that the agency establish or amend tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs. Such import tolerances provide a basis for legally marketing food of animal origin that is imported into the U.S. and contains residues of unapproved new animal drugs. Comments on this proposal may be submitted by 24 April.

Under the Federal Food, Drug, and Cosmetic Act, any amount of residue in imported, animal-derived food from a new animal drug not approved or conditionally approved in the U.S. and for which no import tolerance exists, even a level of residue considered safe by a country where the new animal drug is lawfully used, would cause the imported, animal-derived food to be adulterated because the drug would be deemed unsafe. Such food could be denied entry into the U.S. under section 801(a)(3) of the FD&C Act. The FDA is now proposing to adopt procedures for requesting the establishment or amendment of import tolerances for new animal drugs not approved or conditionally approved in the U.S. and revoke existing import tolerances. The FDA notes that this regulation would not preclude it from establishing or amending an import tolerance on its own initiative.

Any proposals to establish or amend an import tolerance would have to include (1) the established name and all pertinent information concerning the new animal drug, including chemical identity and composition of the new animal drug and its physical, chemical and biological properties; (2) the conditions of use for the new animal drug, including the route of administration and dosage, together with all labelling, directions and recommendations regarding the uses in countries in which the new animal drug is lawfully used; (3) the proposed import tolerance(s) for the new animal drug; (4) human food safety information to support the proposed import tolerance(s); and (5) a complete description of a practicable validated method for measuring the residue level in imported edible portions of any animal treated with the new animal drug. The contents of the request would have to include data sufficient to demonstrate that a proposed tolerance is safe based on similar human food safety criteria used by the FDA to establish tolerances for applications for new animal drugs filed under section 512(b)(1) of the FD&C Act. This may include data submitted by the drug manufacturer, including data submitted to appropriate regulatory authorities in any country where the new animal drug is lawfully used, or data available from a relevant international organisation such as the Codex Alimentarius Commission to the extent such data are not inconsistent with the criteria used by the FDA to establish a tolerance for applications for new animal drugs.

The FDA also indicates that it intends to harmonise its import tolerances with the maximum residue limits established by the Codex Alimentarius Commission of the Joint Food and Agriculture Organisation/World Health Organisation Food Standards Program (Codex MRL), provided that the Codex Alimentarius Commission has established a permanent Codex MRL and that the FDA has sufficient information to make a determination that the permanent Codex MRL will protect the U.S. public health and will meet the standards of the FD&C Act.

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