EPA Releases Final Guidance for New Pesticide Applications and Registration Review Activities That Require Endangered Species Act Reviews

On September 14, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of final guidance to improve the efficiency of EPA’s Endangered Species Act (ESA) analyses for new pesticide active ingredient applications and active ingredients undergoing registration review. EPA states this guidance 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.

PRIA 5 mandates that EPA develop and issue guidance to registrants on analyses EPA needs to evaluate the potential adverse effects from 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 PRIA 5 specifies that the draft guidance be available for public comment and be issued in final within nine months of PRIA 5 enactment.  

EPA held a comment period on the draft guidance from May 16 to June 16, 2023, and received 20 comments from stakeholders, including pesticide registrants, commodity groups, and environmental organizations.

The guidance applies to:

• New conventional pesticides and biopesticides that are intended for outdoor use; and

• Existing conventional pesticides and biopesticides that are intended for outdoor use that are being reevaluated under registration review.

EPA states that although this document does not create new requirements, the recommendations in the guidance are intended to help applicants address potential effects to listed species for new active ingredients and registration review actions. The guidance is intended to provide applicants with some steps that could be taken prior to the submission of a new outdoor use package for conventional pesticides and biopesticides. These steps should lead to a more efficient process for conducting an ESA analysis. One of the recommendations focuses on activities that applicants can voluntarily pursue to inform potential mitigation measures that address impacts to listed species. These actions include identifying where a pesticide will be used, how species may be exposed to the pesticide, and how to recommend potential mitigation measures to reduce the exposure(s). If followed, EPA states it expects that these recommendations will help expedite EPA’s consideration of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) action and improve the efficiency of the overall ESA-FIFRA process.

EPA indicates that it expects to make guidance on new uses of existing active ingredients available at a later date.

The guidance and additional information is available in docket EPA-HQ-OPP-2023-0281 and on EPA’s website.

Commentary

In the past 18 months, EPA has issued a variety of documents reflecting a renewed effort to address the problems that have beset the effort to integrate the requirements of ESA into the pesticide registration process. First was a report refreshingly candid in noting problems that characterized efforts up to now. In April 2022, EPA released its ESA Workplan that states the problem of how the current efforts are effectively impossible to succeed in any reasonable time.

The 2022 ESA Workplan outlines ideas to fashion programmatic reforms and policies to implement ESA-compliant pesticide label requirements using broad policies to ensure species protection (beyond that already imposed by EPA to meet long-standing FIFRA requirements to prevent “unreasonable risks to man and the environment”). The 2022 ESA Workplan was followed by an “ESA Workplan Update” issued in November 2022 (ESA Workplan Update), which includes more options for specific mitigation measures to protect species.

In June 2023, EPA released its “Vulnerable Listed (Endangered and Threatened) Species Pilot Project: Proposed Mitigations, Implementation Plan, and Possible Expansion” (Vulnerable Species Pilot). That was followed in July 2023 by the “Herbicide Strategy,” where EPA announced its plans for ESA restrictions on herbicides as a class. 

The newly announced outline discusses how new active ingredient reviews will incorporate ESA review in one of the many steps that have been developed as part of the Biden Administration’s latest efforts to address integrating the requirements of both statutes. These efforts reflect significant progress in outlining programmatic reforms at EPA that might offer a path forward to what has been a seemingly intractable effort over the past many years.

What remains uncertain is whether these new programmatic efforts will delay new active ingredient review schedules or result in what some stakeholders fear will be “impossible” mitigation options affecting the availability of pest control tools newly developed or those which have been used in the past.