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EPA Announces Interim Guidance on Antimicrobial Data Requirements

May 7, 2015

EPA issued interim guidance to clarify the Agency's toxicology data requirements for antimicrobial pesticides used on food-contact surfaces. The interim guidance explains that if pesticide residues in food resulting from use on food-contact surfaces are 200 parts per billion (ppb) or less, EPA requires certain toxicology data. If residues are greater than 200 ppb, additional data may be required. The 200 ppb trigger is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food, which is consistent with the U.S. Food and Drug Administration's (FDA) policy.

The interim guidance was issued as part of a March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC) that resulted from a legal challenge by ACC to several EPA amendments to the data requirements for antimicrobial pesticides (specifically, subpart 158W of Title 40 of the Code of Federal Regulations) in the U.S. Court of Appeals in the District of Columbia.

In addition, the EPA is issuing a letter to antimicrobial registrants with information about how the Agency has been implementing Part 158W with respect to existing registered antimicrobial pesticides as well as new and pending antimicrobial pesticide applications. The settlement agreement and additional documents are available at www.regulations.gov in docket EPA-HQ-OPP-2008-0110. For more information on how EPA and FDA regulate antimicrobials in food-contact materials, see the PackagingLaw.com article, The Regulation of Antimicrobial in Food Packaging.