On January 11, 2022, the US Environmental Protection Agency (EPA) announced a new policy on the evaluation and registration of new traditional pesticide active ingredients (AI) to further comply with the Endangered Species Act (ESA). Announced that it will be implemented (ESA policy). The EPA has also issued a Q & A document on the ESA policy. The EPA will come into force immediately and the potential for new traditional AI for endangered or listed endangered species (listed species) and their designated critical habitats by the federal government. The US Department of Fish and Wildlife and the US Department of Marine Fisheries (Services), if necessary, before the EPA registers a new traditional AI. The new ESA policy applies to all new traditional AI applications, including applications that have already been submitted to the EPA but have not yet been completed.
Under the ESA, the EPA must ensure that its behavior is unlikely to result in dangerous or unfavorable changes in the designated significant habitat or listed species. To determine if behavior could affect the listed species and their designated significant habitat, the EPA has no impact (NE) and is unlikely to adversely affect (NLAA). , Or make one of three species-specific impact determinations (LAA). ). Historically, the EPA has stated that “when registering a new AI, we have not consistently assessed the potential impact of traditional pesticides on the listed species.” It states that the EPA has “insufficient protection from new AI for listed species and resources for the EPA to register new AI before assessing its potential impact on listed species. It caused a lawsuit that consumes a lot. ” The EPA believes that its new ESA policy should help reduce these types of proceedings against EPA and improve the legal defenses of the new AI.
Under the new ESA policy, the EPA states that if the EPA makes a LAA decision through an analysis of the new traditional pesticide AI, the EPA will initiate formal consultations with the service before granting a new AI registration. .. As part of the analysis and under existing authorities, the EPA considers that registration measures could jeopardize the survival of listed species or adversely alter designated important habitats, resulting in To the service. To determine or predict the potential impact of pesticides on these species and habitats, the EPA used appropriate ecological assessment principles and learned from past impact determinations and biological views of services. Apply that. The EPA states that it is determining whether the new information will help assess the potential impact of the new AI on listed species, and to discuss whether the EPA’s ESA needs additional information. Specifically contact the registrant with the new Al application currently under consideration. Evaluation of new conventional AI.
If EPA determines that a designated significant habitat or listed species may undergo dangerous or unfavorable changes, it is likely that EPA will prevent such dangerous or unfavorable changes. Only after requesting the registrant to implement the mitigation measures determined to be, will the new traditional AI registration decision be made. Registrants are minimal, even if the EPA determines that the new AI is likely to adversely affect the listed species or their critical habitat, but is unlikely to cause dangerous or unfavorable changes. Mitigation measures should be included as part of the registration and product label to keep it in check. Potential effects of accidental ingestion on the listed species that may result from the use of pesticides. In either situation, the EPA states that the service must make the final risky or unfavorable change decision, so formal consultation with the service is still required. Regarding the time frame, the EPA stated in a Q & A that it would “strive to complete new AI applications within the PRIA timeline,” but if the EPA considers that additional time is needed under the ESA policy, it will have an impact. “Re-negotiate” the PRIA deadline in cooperation with the registration you receive.
The EPA says it prioritizes traditional pesticide AI, but continues to consider applying these new ESA approaches to new biopesticide AI and new antibacterial AI. The EPA is also developing a comprehensive strategy for dealing with pesticide ESAs at all stages of the registration process. The EPA is now working to promote ESA compliance, including more efficient protection of high-risk species, more flexible mitigation measures for producers, and steps to increase stakeholder involvement. We have a detailed work plan outlining additional improvements.
Commentary
This announcement is made by the Pesticide Program Authority (OPP) to comply with ESA requirements in a more legally defensive way while continuing to review and approve new pesticide AI, as the ESA policy points out. It represents the next attempt. In recent years, the EPA has attempted a variety of almost useless discussions to convince the court that past attempts to comply with the ESA are sufficient.
This ESA policy suggests both significant changes in EPA’s past rhetoric regarding compliance and possible changes in the way ESA assessments were conducted in the past. On record, the EPA maintains ESA compliance when registering new products. The court ruled that the allegation was not upheld and, in most cases, agreed with the group that challenged the allegation. With a few exceptions, the EPA has not fully resolved ESA concerns, but has considered ESA issues more “in advance.” However, such early attention to resolving ESA concerns can significantly increase the time and data requirements spent assessing and addressing ESA issues.
The relatively successful cases of the past few years have been renewed by the Biden administration’s ESA policy, which seeks to solve the long-standing problem of establishing a registration process that better addresses ESA issues, especially by improving coordination between EPAs. Complements explicit commitments. Service procedure and review process (and conclusions). Past administrations have expressed similar rhetoric, but so far many have tried and all have failed.
In various forums, the EPA patiently describes this effort as follows: More importantly, and perhaps a new addition to this mix, the EPA has been specifically tasked with leading efforts on the ESA-FIFRA integration process as a senior political appointee (as a deputy administrator of the OCSPP). Jake Lee) is there.
For new traditional AI applicants and registrants, these revised efforts may introduce some delay in the current expected time frame for “solving” ESA concerns early in the process. there is. And importantly, the EPA’s ESA policy explains how new approvals can include more “preliminary” mitigations designed to protect endangered species well, or at least to a better extent. I am. This seems to be a significant change designed to reduce proceedings. Risks that have hindered new registration decisions in recent years.