EPA Issues Interim Guidance on Antimicrobial Data Requirements
1 May 2015 EPA issued interim guidance that clarifies its toxicology data requirements for antimicrobial pesticides used on food contact surfaces.
In general, 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, depending on other conditions such as test results. The interim guidance clarifies that 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. This interpretation is consistent with the U.S. Food and Drug Administration’s (FDA) policy.
The interim guidance clarifies EPA’s 2013 amendments to data requirements for antimicrobial pesticides, which were designed to make the registration process for these pesticides more efficient and transparent. The interim guidance satisfies a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC), which followed ACC’s July 2013 initiation of a legal challenge to the data requirements regulation (subpart 158W of Title 40 of the Code of Federal Regulations) in the U.S. Court of Appeals in the District of Columbia. Under that settlement agreement, EPA will also propose by September 2, 2017, a correction to 40 CFR § 158.2230(d) to make the rule’s language as it pertains to the 200 ppb level more clearly consistent with the FDA’s use of that same level.
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. Both the interim guidance and the implementation letter are available online: www2.epa.gov/pesticide-registration/epa-data-requirements-registration-antimicrobial-pesticides-part-158w The settlement agreement and additional documents are available at www.regulations.gov in docket EPA-HQ-OPP-2008-0110. For more information on antimicrobial policies and guidance visit http://www.epa.gov/oppad001/regpolicy.htm
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