EPA Releases Draft Guidance for Pesticide Submissions for New Outdoor Uses that Require Endangered Species Act Reviews

Released on September 21, 2023

The U.S. Environmental Protection Agency (EPA) is seeking public comment on draft guidance to improve the efficiency of EPA’s Endangered Species Act (ESA) analyses for of existing conventional and biopesticide pesticide active ingredients. This guidance, when finalized, fulfills requirements outlined in the Pesticide Registration Improvement Act of 2022 (PRIA 5) and furthers goals outlined in EPA’s 2022 ESA Workplan to protect listed species from exposure to pesticides.

Among other requirements, PRIA 5 mandates that EPA develop and issue guidance to registrants regarding analyses necessary to support the evaluation of potential adverse effects from new outdoor uses of pesticide products on listed species and designated critical habitat. PRIA 5 specifies that the draft guidance be available for public comment and be finalized within twelve months of PRIA 5 issuance.

The draft guidance applies to new uses of existing conventional pesticides and biopesticides that are intended for outdoor uses.

PRIA 5 also required that the EPA develop ESA guidance to applicants for new active ingredients or registration review decisions of products with one or more outdoor uses for conventional pesticides and biopesticides that have outdoor exposures. While under PRIA 5, a new active ingredient application and a new outdoor use are different actions, the underlying ESA analyses for evaluating listed species are fundamentally similar. Therefore, the information contained in this guidance is largely the same as that contained in the PRIA 5 guidance for new active ingredients and registration review.

Although this document does not create new requirements for applicants, the recommendations in the guidance will help applicants address potential effects to listed species for new outdoor uses of existing pesticide active ingredients actions in their applications to EPA In particular, the recommendations focus on actions that applicants can voluntarily pursue to inform their proposed mitigation measures for listed species. These actions include identifying where a pesticide will be used, how species may be exposed to the pesticide, and how to select mitigation to reduce the exposure. If followed, these recommendations should expedite the FIFRA action and improve the efficiency of the overall ESA-FIFRA process.

• New uses for active ingredients where EPA has already met its ESA obligations (i.e., have completed consultation for one or more registered uses);
• New uses for active ingredients registered since the EPA’s new active ingredient policy;
• The first outdoor use of a registered active ingredient; and
• New uses for which EPA can meet is ESA obligations because there is ‘no effect’ on listed species or their critical habitat

For all other new uses, EPA will still consider them on a case-by-case basis as consistent with the EPA ESA workplan.

The draft guidance, which incorporates lessons EPA has learned over the past several years as it has worked to implement EPA’s ESA workplan, is available for public comment in docket EPA-HQ-OPP-2023-0281 at www.regulations.gov for 15 days.