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EPA/OCSPP RIN: 2070-AK41 Publication ID: Fall 2018 
Title: Pesticides; Technical Amendment to Data Requirements for Antimicrobial Pesticides 

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 using the document ID number EPA-HQ-OPP-2008-0110-0139. The proposed rule (82 FR 39399) published August 18, 2017.

Agency: Environmental Protection Agency(EPA)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Not subject to, not significant 
CFR Citation: 40 CFR 158   
Legal Authority: 7 U.S.C. 136 to 136y, Federal Insecticide Fungicide and Rodenticide Act   
Legal Deadline:
Action Source Description Date
NPRM  Judicial  Settlement agreement  09/02/2017 

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."

Action Date FR Cite
NPRM  08/18/2017  82 FR 39399   
Final Rule  10/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Sectors Affected: 325320 Pesticide and Other Agricultural Chemical Manufacturing 
RIN Data Printed in the FR: No 
Agency Contact:
Cameo Smoot
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
1200 Pennsylvania Avenue NW, Mail Code 7506P,
Washington, DC 20460
Phone:703 305-5454

Ryne Yarger
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
1200 Pennsylvania Avenue NW,
Washington, DC 20460
Phone:703 605-1193