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By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On March 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the publication of its Revised Method for National Level Listed Species Biological Evaluations of Conventional Pesticides (Revised Method), a method for conducting Biological Evaluations under the Endangered Species Act (ESA). 

The Revised Method will be used by EPA to evaluate potential risks from pesticides to federally listed endangered and threatened species and to make effects determinations during initial registration and as part of periodic registration review.  The Revised Method allows EPA to include historical usage data that reflects where and how certain pesticides have been applied to make predictions about the future.

The Revised Method includes a three-step process to identify and evaluate the potential risk to endangered species by the assessed pesticide:

Topic Step 1 Step 2 Step 3
Assessment Biological Evaluation Biological Evaluation Biological Opinion
Scale Individual and Field Individual and Field/Landscape/Watershed1 Population and Landscape/Watershed
Determination No Effect/May Affect Not Likely to Adversely Affect/Likely to Adversely Affect No Jeopardy/Jeopardy2

1 Although Step 2 is conducted at an individual level, consideration is given to the likelihood that an exposure and effect will occur. This step considers the proportion exposed across the landscape/watershed and the distribution of exposure among individuals.

2 This is the determination for listed species. The determination for designated critical habitats is “No Adverse Modification/Adverse Modification.”

EPA Administrator Andrew Wheeler stated: “EPA’s improved methodology will better protect and promote the recovery of endangered species while ensuring pesticide registration review decisions are conducted in a timely, transparent manner and are based on the best available science.”

EPA has also released for public comment draft Biological Evaluations for carbaryl and methomyl, which were conducted using the final Revised Method.  If EPA determines a pesticide may affect a listed species or its critical habitat, it must consult with the Fish and Wildlife Service and the National Marine Fisheries Service (the Services).  The Services will then issue a Biological Opinion to determine if the population of a species would be adversely impacted and, if so, propose ways to reduce risks.

Comments on the draft Biological Evaluations are due on or before May 18, 2020.  The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2020-0090

Commentary

Critics of the new method for doing Biological Evaluations have alleged that the purpose of the changes in this method, and of other recent revisions in ESA procedures, is to reduce the number of formal consultations that must be conducted with the Services.  Such allegations must be evaluated in the context of the severe bottlenecks in the current consultation process created by the limited resources and personnel that are available at the Services to conduct any required consultations and to prepare formal Biological Opinions.  The EPA method for doing Biological Evaluations has always been intended to use worst case assumptions to quickly remove from consideration those pesticides that are unlikely to pose any potential risk to endangered and threatened species, so that the limited resources available for the more extensive assessment triggered by consultation are used efficiently to address the most significant potential hazards.  Worst case assumptions, however, exaggerate the “reasonable worst case” and other more realistic scenarios.  Given the reality of limited review resources, focus on more uncertain risks draws resources away from attention on more certain risks to species.  Eventually the assessment system is expected to include other techniques (example: use of probabilistic models) to refine the analyses to concentrate further regulatory options on the most effective ways to protect species.

The draft BE for carbaryl and methomyl are available here and here.  More information on ESA issues is available on our blog.


 

By James V. Aidala

On January 31, 2018, Scott Pruitt, the Administrator of the U.S. Environmental Protection Agency (EPA), announced the establishment of an Interagency Working Group to Coordinate Endangered Species Act (ESA) Consultations for Pesticide Registrations and Registration Review.  EPA, the U.S. Fish and Wildlife Service, and the National Marine Fisheries Service (NMFS) (the Services) signed a Memorandum of Agreement (MOA) on the establishment of the working group.  The stated purpose of the working group is that it “will provide recommendations to EPA, FWS, and NMFS leadership on improving the [ESA] consultation process for pesticide registration and registration review (‘pesticide consultation process’) and will ensure that the new process is recorded and formalized as appropriate.”  The working group’s action plan includes the following:

  1. Analyze relevant statutes, regulations, and case law.  The Working Group will review the statutory requirements under ESA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the case law that has developed on the intersection of ESA and FIFRA; and existing regulations for the pesticide consultation process. 
  2. Review past ESA pesticide consultation practices to learn lessons from recent experience and review current and previous pesticide consultation practices to identify problems and areas for improvement, as well as best practices that should be used in future pesticide consultations.
  3. Prepare recommendations to improve scientific and policy approaches to ESA pesticide consultations.  For example, the Working Group will develop a streamlined process for identifying which actions require no consultation, informal consultation, or formal consultation.  The Working Group will also help provide clarity as to what constitutes the “best scientific and commercial data available” in the fields of pesticide use and ecological risk assessment, which EPA and the Services are required to use under ESA section 7(a)(2).
  4. To the extent that current authorities and practices do not allow for the timely and accurate review of pesticides consistent with governing authorities, the Working Group may memorialize its recommendations for a revised regulatory framework, including addressing agency responsibilities, recommended technical approaches, and recommendations for new regulations, a memorandum of understanding, or other appropriate documentation. 

Commentary

Like others before them, the Trump Administration is embarking on a journey to address the problem of how to integrate ESA assessment and consultation requirements with the FIFRA registration process.  This directive will help organize a senior level effort to coordinate activities of EPA and the Services and, like past efforts, at the senior management level there will likely be at least a recognition that something needs to be done to fashion a more efficient and predictable process.  Currently ESA reviews add months and years to the registration review process and, to date, that process is followed by seemingly inevitable litigation challenging the EPA decision as not sufficient to meet ESA requirements.

The result has been an exhaustive, time and resource intensive initial set of “pilot” biological opinions, and a very long list of promised consultations resulting from past litigation cases.  Currently, the workload already committed will be virtually unattainable for a number of years, and as EPA plans to have ESA assessments as part of the registration review process for older pesticides (as well as for future new product applications), the budget and staffing implications are staggering.  Meantime, agricultural stakeholders, including pesticide manufacturers and grower groups who use pesticides, fear that the current process might result in the loss or delay in the introduction of needed pest control products.

This is the context for the current attempt to devise an integrated, more efficient process to have any realistic chance to fashion a process which meets the requirements of both statutes.  We wish any and all participants good luck and constant senior political level involvement -- they will likely need much of it.

More information on ESA issues is available on our blog.