Today, January 25, 2012, FDA published its long-awaited proposal (in the form of a Proposed Rule) to establish procedures for requesting new animal drug import tolerances for food animals (e.g., cattle, swine, poultry and fish). This initiative has been closely followed by members of the food industry, who are expected to work with FDA to finalize the proposal in the coming months. According to FDA, the establishment of an import tolerance will require the submission of data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria normally used by FDA to establish tolerances for applications for new animal drugs filed under the FD&C Act. FDA will also consider and may rely on data that was previously submitted to a foreign regulatory authority in countries where the new animal drug is lawfully used. Further, FDA will review any pertinent information it has in its files on the subject animal drug. Requests to establish an import tolerance should include, among others things, pertinent information on the new animal drug and its physical, chemical, and biological properties; the conditions of use for the new animal drug; human food safety information; and, the proposed import tolerance for the new animal drug. Information included in a request that is not deemed trade secret/confidential will be made available to the public. FDA will publish new/amended import tolerances when granted, and the new tolerance will become effective on the date of publication. FDA is accepting comments on the Proposed Rule until April 24, 2012.

For more information, please contact Georgia C. Ravitz or Jim Hartten at Arent Fox. A copy of the Proposed Rule can be found here.