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EPA published a proposed rule correction pertaining to the "200 ppb level" described in 40 CFR section158.2230(d) to clarify that the 200 ppb level is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food. This change is intended to enhance understanding of the data required to support an antimicrobial pesticide registration and does not alter the burden or costs associated with these previously-promulgated requirements. EPA is not proposing any new data requirements or any other revisions (substantive or otherwise) to existing requirements. This correction specifically addresses a commitment in a settlement agreement reached with the American Chemistry Council that became effective on March 2, 2015. This settlement agreement is available in www.regulations.gov using the document ID number EPA-HQ-OPP-2008-0110-0139. The proposed rule (82 FR 39399) published August 18, 2017.

Overall Description of Deadline: Under the settlement agreement with ACC, EPA agreed to propose by 9/2/2017 a correction to the current language at 40 CFR 158.2230(d) referring to the 200 ppb level as "the concentration of the antimicrobial residues in or on the food item" in order to make the language consistent with the U.S. Food and Drug Administration's policy set forth in "Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. Final Guidance. April 2002."