On January 11, 2022, the U.S. Environmental Protection Agency (EPA) announced that, effective immediately, the Agency’s review of applications for new pesticide active ingredients (AI) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) will uniformly incorporate analysis under the Endangered Species Act (ESA) with the intention of prioritizing protection for listed species as much as possible. The new policy applies to AI applications already submitted for consideration as well as incoming applications, and it does not immediately implicate any pending litigation regarding established AIs. Under the new policy, before registering any new conventional AI, the agency will evaluate the potential effects of the AI on federally listed threatened or endangered species and their designated critical habitats, and initiate ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Services (the Services) as appropriate.

Prior to this policy change, EPA has not uniformly required ESA analysis for all applications for new AIs, which often resulted in litigation against EPA. EPA expects the new policy to reduce litigation in general and improve the overall legal defensibility of new AI registrations.

Under the new policy, EPA will seek to more uniformly meet the set requirements of the ESA which state that the agency must ensure its actions are not likely to result in “jeopardy or adverse modification” of a designated critical habitat for species federally listed as endangered or threatened. To determine whether the action “may affect” these listed species or designated critical habitat, EPA makes species-specific effects determinations. There are three types of effects determinations:

  • No Effect (NE)
  • Not Likely to Adversely Affect (NLAA)
  • Likely to Adversely Affect (LAA)

If EPA makes a NLAA determination, it will seek concurrence on that determination from the Services, adopt any mitigations necessary, and, assuming the Services concur, move toward registration for the new AI.  An LAA determination, on the other hand, will initiate a formal consultation with the Services before granting a new AI registration and also determine if, and to what extent, measures to further reduce exposure are warranted. As part of the analysis, EPA will consider the likelihood that the registration of the AI would jeopardize the continued existence of the listed species or adversely modify their habitat and provide those findings to the Services. Throughout this process, EPA will be responsible for using appropriate ecological effects determinations and the Services’ biological opinions to predict outcomes and determine any appropriate mitigation strategies.

EPA expects that, under the new policy, applicants for new AI applications will often need to incorporate some type of ESA mitigation prior to EPA issuing a new registration decision. Mitigation measures may even be required if EPA makes an NLAA or LAA determination.

EPA has explained that it intends to provide several mitigation options to allow the greatest flexibility for pesticide users while still ensuring protections for listed species. Mitigation efforts often include measures intended to avoid or minimize exposure routes between where pesticides are used and where the species live, restrict the geographic or temporal scope of pesticide applications, and reduce the number of pesticide applications allowed on a treated site.

Although the policy is effective immediately, EPA anticipates it may issue some AI registrations prior to completing any necessary formal consultations with the Services in order to provide regulatory predictability to registrants, growers, and other pesticide users. Under ESA Section 7(d), EPA may issue registrations before completing formal consultations as long as issue the registration will not result in “irretrievable or irreversible commitment of resources” that would foreclose the Services’ development and EPA’s implementation of any ESA reasonable and prudent alternatives. And to facilitate this approach, EPA will likely require applicants to adopt early mitigation efforts to avoid possible jeopardy or adverse modification. EPA stated that as consultations become more efficient and as agency resources allow, EPA expects to complete formal consultations, where necessary, prior to issuing registration decisions for new AIs.

Whenever EPA requires registrants to adopt mitigations, whether as a result of formal consultations with the Services or as a result of allowing AIs to be registered prior to completing any necessary consultation, EPA states that it may instruct registrants to include mitigation measures on their registration and product labeling to minimize the effects of incidental take to listed species that could result from pesticide use. Further, EPA stated that it also may find it necessary for registrants to incorporate a link to Bulletins Live! Two (an online system that describes use limitations for EPA-registered pesticides by geographic area) into the labeling as well.