Final Rule Clarifying Toxicology Data Requirements for Antimicrobial Pesticides Used on Food Contact Surfaces

For Release: May 3, 2019

EPA issued a final rule clarifying data requirements for antimicrobial pesticides in 40 CFR Part 158 Subpart W (158W), making the registration process for these pesticides more efficient and transparent. View the final rule at www.regulations.gov, docket ID # EPA-HQ-OPP-2018-0668-0004.

The final rule states, in general, if pesticide residues found on food resulting from the use of antimicrobial pesticides on food contact surfaces are 200 ppb or less, EPA requires a certain set of toxicology data to be submitted. If residues are greater than 200 ppb, additional data may be required, depending on other conditions such as test results. The final rule also clarifies that the referenced 200 ppb level is based on total estimated daily dietary intake rather than on the amount of residue present on a single commodity. This interpretation is consistent with the U.S. Food and Drug Administration’s policy.

In 2017, EPA published the proposed rule and held a public comment period. The proposed rule satisfied a condition of the March 2, 2015 settlement agreement between EPA and the American Chemistry Council (ACC). Under the settlement agreement, EPA agreed to propose a change to the rule’s language as it pertains to the 200 ppb level established in 40 C.F.R. § 158.2230(d) to make it consistent with the U.S. Food and Drug Administration’s use of that same level. For more information, see the Settlement Agreement available www.regulations.gov in docket ID #EPA-HQ-OPP-2008-0110-0139.

This change offers the regulated community clearer, more understandable, and transparent information about the data required to support pesticide product registration decisions and does not impose any new burdens or costs.