EPA and the American Chemistry Council (ACC) have reached a settlement regarding the ACC’s petition concerning data requirements for antimicrobial pesticides. This settlement addresses a Final Rule published by EPA on May 8, 2013, “Data Requirements for Antimicrobial Pesticides,” for which the ACC, the chemical industry trade group, sought judicial review in the U.S. Court of Appeals for the D.C. Circuit.
Under the settlement, EPA will within the next four months release for public comment a proposed guidance document, “Antimicrobial Pesticide Use Site Index.” This guidance will include “a compilation of existing antimicrobial pesticide use sites and identify how each use site fits within the 12 use patterns established in the regulation.” The Use Site Index will include the following descriptions, as set forth in the settlement:
- Direct Food Use: a use is generally considered to be a direct food use if an antimicrobial pesticide is intended to be directly applied to food (defined for purposes of the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 321(f)) or applied to a material or article for the purpose of treating food.
- Indirect Food Use: a use is generally considered to be an indirect food use if the use involves application of the antimicrobial pesticide in or on a material or article that comes into contact with food and may result in residues in or on food, but the use is not intended for pesticidal treatment of food.
- Nonfood Use: a use is generally considered to be a nonfood use when there is a reasonable certainty of no residues in or on food, for example because the antimicrobial pesticide is not expected to come into contact (directly or indirectly) with food as a result of its intended use.
In addition to the Site Index proposed guidance, the settlement agreement provides that EPA shall propose an interim guidance document and then a “correction to the Final Rule” regarding the 200 ppb level for antimicrobial residues in or on a food item, as established at 40 C.F.R. § 158.2230(d). Under the Final Rule, additional toxicology tests are required for indirect food uses with antimicrobial residue levels greater than 200 ppb. Within 60 days, EPA must issue an interim guidance document “explaining EPA’s interpretation of the 200 ppb level established in the Final Rule.” Within two and a half years, EPA must propose a “correction” to make “clear that the 200 ppb level established in the Final Rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity.”