FDA Proposes Rule on Drug Residue Import Tolerances for Animal-Derived Food

(The Animal Drug Availability Act of 1996 (ADAA) amended the Federal Food, Drug, and Cosmetic (FD&C) Act to allow the Secretary to establish import tolerances for applications for new animal drugs. If an import tolerance is established and any edible portion of any animal imported into the U.S. does not contain residues¹ exceeding such tolerance, a use or intended use of a new animal drug will not be deemed unsafe. This proposed rule, if finalized, would be FDA's last action to fully implement the ADAA.)

Certain Animal-Derived Food w/ Unapproved Drug Residues Can be Denied Entry

It is unlawful to import animal-derived food that bears or contains residues of a new animal drug that is not approved or conditionally approved in the U.S., unless a tolerance has been established for the residues of that new animal drug and the residue of the new animal drug in such imported food does not exceed the import tolerance.

Thus, 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 under the FD&C Act and deemed unsafe. Such food could be denied entry into the U.S.

Proposed Rule Would Establish Steps to Create, Amend, Revoke Tolerances

This proposed rule establishes procedures by which a person could request that the FDA establish, amend, or revoke an import tolerance for residues of a new animal drug not approved or conditionally approved for use in the U.S. but lawfully used in other countries and present in imported, animal-derived food and food products, as well as procedures to reconsider or stay actions regarding an import tolerance.

With this proposed rule, FDA also intends to harmonize its import tolerances with the Maximum Residue Limits (MRLs) established by the Codex Alimentarius Commission of the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Food Standards Program (Codex MRL).

Proposed Procedures to Establish New and Amend Import Tolerances

This proposed rule would create section 510.201 to 21 CFR to provide the following procedures by which a person may request the establishment or amendment of an import license (see proposed rule for full details):

Anyone could request new/amended tolerance. Any person would be able to request that the FDA Commissioner establish or amend an import tolerance. The Commissioner would also be able to initiate a proceeding to establish or amend an import tolerance on his/her own initiative.

Requests would have to contain certain info, etc. Among other things, requests would have to contain information on (i) the established name and all pertinent information concerning the new animal drug, including its chemical identity and composition, and its physical, chemical and biological properties; (ii) the conditions of use for the new animal drug, including the route of administration and dosage, together with labeling, directions, and recommendations regarding the uses in countries in which the new animal drug is lawfully used; (iii) proposed import tolerance(s) for the new animal drug; (iv) human food safety information to support the proposed import tolerance(s) (may be provided in two forms, depending on whether a Codex MRL has or has not been established); (v) other human food safety information deemed necessary by the Commissioner; and (vi) a description of practicable methods for determining the quantity, if any, of the new animal drug in or on food, and any substance formed in or on food because of its use.

Review & public disclosure of request. The Commissioner will review the information submitted in the request and when determined to be complete for FDA's consideration, will provide public notification of the request and a summary of the basis for decision.

New/amended tolerance to be issued in public notice. If a request is granted, the Commissioner will provide public notification establishing or amending an import tolerance, which will be effective from the date of publication. A tolerance established in an approved new animal drug application or a conditionally approved application will supersede an existing import tolerance.

Proposed Procedure to Revoke an Already Established Import Tolerance

Proposed section 510.207 to 21 CFR specifies the procedures by which an established tolerance for residues of an unapproved new animal drug in food products of animal origin imported into the U.S. could be revoked. The Commissioner, on his or her own initiative or on the petition of an interested party would be able to revoke an import tolerance based on (1) scientific evidence showing an import tolerance to be unsafe; or (2) information demonstrating that the use of a new animal drug results in food being imported into the U.S. with residues exceeding the import tolerance.

Also Proposes Process for Reconsideration or Stay of Commissioner Decisions

The proposed rule also specifies the processes for an interested person to petition that the Commissioner (i) reconsider a decision to establish, amend, or revoke an import tolerance and (ii) stay or extend the effective date of such a decision. The proposed rule would also make various conforming changes to the regulations. See proposed rule for full details.

¹A residue is any compound present in edible tissues that results from the use of a drug and includes the drug, its metabolites, and any other substance formed in or on food because of the drug's use.

FDA Contact -- Scott Melton (240) 276-8666, scott.melton@fda.hhs.gov

(DN FDA-2001-N-0075, FR Pub 01/25/12)