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Waterborne Helps to Advance the Quality and Effectiveness of Endangered Species Risk Assessments

Posted by Michael Scott on December 13, 2016


There has been significant activity in the area of risk assessments for federally-listed threatened and endangered species since our 2015 update. Endangered Species risk Assessment (ESA) is a focus area where Waterborne continues to partner with and support our clients to provide solution-focused assessment tools and regulatory support. We have had opportunities to review the approaches of the federal agencies (United States Environmental Protection Agency (USEPA), United States Fish and Wildlife Service (USFWS), National Marine Fisheries Service (NMFS), United States Department of Agriculture (USDA)) in conducting ESAs, while also providing comments and suggested improvements to the process. We have evaluated and used the information presented by regulators at public meetings and formal releases to update the methodologies we use and identified areas for refinement or alternative, species-focused methodologies. While the full national scale assessment has been the emphasis of USEPA and Services (USFWS and NMFS), we continue to identify areas where the focused use of reliable and relevant best-available data (compound specific environmental fate, surrogate ecotoxicity, species biology and actual use patterns and methods) can lead to refinement opportunities to simplify and improve a species-focused risk assessment. Additional clarity from the regulatory world has emerged in the past year and the need for an informed screening-level risk assessment (Image 1) and a species-focused national-level risk assessment (Image 2) has continued to be apparent.

IMAGE 1: Waterborne Endangered Species National Risk Assessment Framework

Our update last fall provided details on Waterborne’s pragmatic approach to ESA. In the past year, these important events have occurred:

  • The draft methodology portions of the biological opinions for the three organophosphate (OP) compounds were released in December 2015 and provides more detail regarding the use of exposure models, ecotoxicological data and determination of thresholds.
  • The complete draft Biological Evaluations (BEs) were released in April 2016 and included the risk characterization chapter which identified “No Effect/May Affect” and “Likely/Not Likely to Adverse Affect” determinations. These versions also included some updates to the December 2015 documents. Unfortunately, the approaches taken by the federal agencies did not provide practical or probablistic risk characterization of species. As it currently stands, the absence of a tiered risk assessment methodology resulted in most species requiring a Biological Opinions (for the determination of Jeopardy/No Jeopardy). A review of the draft BEs highlight areas that could have led to more reasonable conclusions based on better use of data, a greater focus on species-relevant information and more refined exposure or habitat designation. Much of Waterborne’s current focus has been looking at options for making best use of available species data (both from an effect or exposure standpoint) to identify areas where a determination of “Not Likely to Adverse Affect” or negligible risk could be made.
  • Waterborne joined CropLife America partners to compile public comments to the draft BEs and can be found here: https://www.regulations.gov/document?D=EPA-HQ-OPP-2008-0850-0907
  • Waterborne participated in a public workshop with the federal agencies and other stakeholders in June 2016. The workshop was a very productive interaction of stakeholders with the goal of making short and long-term improvements to the ESA process based on the pilot documents for the three OPs (workshop details below).

An ESA stakeholder workshop was held June 2016 at United States Fish and Wildlife Service (USFWS) headquarters in Arlington, VA. Waterborne joined federal staff, non-government organizations, registrants, academia and consultants in a two-day workshop focused on making suggestions for improvements based on a set of charge questions. There were six breakout sessions with final work products generated:

  • AQUATIC 1: “Improving Aquatic Modeling: Changes to conceptual and mathematical approaches incorporated into Bins 3 and 4 (flowing waters)”: Modifications to EPA’s current modeling approach and parameterization to flowing bins as well as the use of other watershed models (e.g., SWAT, WARP).
  • AQUATIC 2: “Improving Aquatic Modeling: Evaluating watershed model results”: Use of multiple lines-of-evidence to evaluate watershed model results as well as the role of metadata requirements for use of monitoring data in evaluating IMAGE watershed results.
  • REFINEMENTS 1: “Refinements to Steps 1 and 2: Spatial analysis”: Methods to better identify pesticide use sites, methods to better understand the distribution of individuals within a listed species range, and improvements to the overlap analyses between species range and potential pesticide use.
  • REFINEMENTS 2: “Refinements to Steps 1 and 2: Non-spatial analysis”: Identification of use patterns (e.g., those resulting in minimal exposures) and/or listed species (e.g., those found on uninhabited islands) that may not need to be fully evaluated, methods to utilize thresholds that are more probabilistic, and methods to incorporate exposure durations into the analysis of potential effects.
  • WOE 1 (ANIMALS): “Weight of Evidence for Listed Animals”: Included improvements to the evaluation of information and criteria used to draw risk conclusions as well as incorporation of additional information into the weight of evidence approach.
  • WOE 2 (PLANTS): “Weight of Evidence for Listed Plants”: Included improvements to the evaluation of information and criteria used to draw risk conclusions as well as incorporation of additional information into the weight of evidence approach.

IMAGE 2: Informed Screening Diagram

With the scheduled release of the final organophosphate BEs in late 2016 or early 2017 (and draft BEs for two carbamate products), we will gain further insight into how the recommendations from the workshop and public comments were incorporated.Waterborne scientists will continue to track the changing endangered species risk assessment process for crop protection product registration in the US and develop pragmatic, species-focused approaches to the assessment. We are fully engaged in the regulatory process and supporting our clients’ business and environmental goals.

Questions about our ESA capabilities? Contact Matt Kern, kernm@waterborne-env.com.