FDA Proposes Import Tolerances for Unapproved New Animal Drugs
Kelley Drye Client Advisory
February 1, 2012

 The FDA published a proposed rule to establish procedures by which a person may request that the agency establish, amend or revoke tolerances for unapproved new animal drugs in edible portions of animals imported into the United States as part of its implementation of the Animal Drug Availability Act of 1996 (“ADAA”).

The ADAA was designed to speed up the new animal drug and medicated feed approval process, thus increasing the number of animal drugs available to the industry. The portion of ADAA addressing import tolerances was designed to improve international harmonization of regulatory standards concerning the use of animal drugs in food animals, including livestock animals and fish/aquaculture.  Under the new proposed procedures, once an import tolerance is established, companies would be permitted to import animal food products that were produced using drugs that are not approved for use in the United States, provided that the unapproved drugs were used legally in another country and the amount of the drug contained in the product falls below the established import tolerance amount.

Requests to establish or amend an import tolerance must be in the form specified in the proposed rule. Such a request would have to include:

  1. the established name and all pertinent information about the new animal drug, including the drug’s chemical identity and composition, and its physical, chemical and biological properties;

  2. conditions of use for the new animal drug, including route of administration, dosage, as well as all labeling, directions and recommendations regarding uses in countries in which the drug is lawfully used;

  3. the proposed import tolerances;

  4. human food safety information to support the proposed import tolerances, in the form of either monographs and reports from the Joint Expert Committee on Food Additives and/or the Joint Meeting on Pesticide Residues of the Food and Agriculture Organization and the World Health Organization of the United Nations that supported the development of a permanent Codex Maximum Residue Limit (“MRL”) for the drug or, if no permanent Codex MRL has been established, full reports of investigations made with respect to the human food safety of the drug;

  5. a complete description of a practical validated method for measuring the residue levels in imported edible portions of any animal treated with the drug;

  6. either a statement that all reports of investigations of human food safety have been submitted or an explanation of why such reports were not submitted;

  7. for each non clinical study submitted, either a statement that the study was conducted in compliance with the good laboratory practices of 21 C.F.R. part 58, or a brief statement of the reason for the noncompliance and an explanation of how the noncompliance may have impacted the study;

  8. any other information that could be deemed necessary by the Commissioner to address particular human food safety concerns that may be associated with certain new animal drugs or classes of new animal drugs; and

  9. an environmental assessment, as described in 21 C.F.R. 25.40, to facilitate the FDA’s assessment of potential environmental impacts.

A petition to revoke an import tolerance must be submitted in the form of a Citizen’s Petition, specified at 21 C.F.R. 10.30.  An import tolerance may be revoked based on scientific evidence showing an import tolerance to be unsafe, or information demonstrating that the use of a new animal drug results in food being imported into theUnited Stateswith residues exceeding the import tolerance. Persons who so choose will have 30 days to file a petition to reconsider an import tolerance or a request for stay of action.

FDA is accepting comments on the proposed rule untilApril 24, 2012.

Kelley Drye & Warren LLP

Kelley Drye's team of Food and Drug lawyers strives to integrate our clients' business strategies with FDA compliance and to help resolve regulatory enforcement matters when they arise. Working side-by-side with business development and marketing professionals, we provide comprehensive regulatory counseling and assist in developing products, labels, and promotional materials that achieve our clients' goals without running afoul of regulatory requirements. With close knowledge of FDA's enforcement priorities and deep experience with the FTC's regulation of advertising, our team can provide comprehensive legal advice with an eye towards giving clients a competitive edge.

For more information about this Client Advisory, please contact:

Sarah Roller
(202) 342-8582
sroller@kelleydrye.com