On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was seeking comment on its Draft Revised Method for National Level Endangered Species Risk Assessment Process for Biological Evaluations of Pesticides (Draft Revised Method). 84 Fed. Reg. 22120. It also announced that it would host a public meeting on June 10, 2019, in which it will present the Draft Revised Method and provide an additional opportunity for the public to provide feedback.
The Draft Revised Method states it is intended to be “used in the evaluation of potential risks from pesticides to listed species” and that it will be “used by EPA for making effects determinations under registration review, which will also be used to inform biological opinions from the Fish and Wildlife Service and the National Marine Fisheries Service [(the Services)].”
EPA states that the Draft Revised Method document “describes proposed revisions to the interim methods used to conduct effects determinations as documented in EPA’s [biological evaluations (BE)] for federally threatened and endangered species for pesticides.” EPA states the revisions are based on: (1) “refinements” following the method used in the first three national-level BEs for chlorpyrifos, diazinon, and malathion; (2) consideration of public comments provided through stakeholder meetings and submitted to the docket for the pilot draft BEs; (3) consideration of National Research Council (NRC) recommendations; and (4) “lessons learned during the development of the first three BEs.”
EPA states that the following are major aspects of its proposed revisions on which it is seeking comments:
• To more accurately represent where and to what extent a pesticide is likely to be applied, EPA is proposing an approach for incorporating pesticide-specific usage data into Steps 1 and 2 of the BEs. While the pilot BEs relied on use assumptions from pesticide product labels to represent where the pilot chemicals were likely to be applied (e.g., applied to all labeled crops at maximum application rates simultaneously), the Draft Revised Method proposes to incorporate usage data (e.g., survey data, including actual application rates) in the determination.
• Based on the accuracy of the spatial data utilized and the conservative assumptions related to the action area and potential drift, EPA’s notice states that it is proposing to interpret “a <1% overlap of listed species’ ranges with potential use sites as unreliable and not representative of real exposure potential.”
• EPA is proposing an approach for introducing components of probabilistic analysis into the BE, as the “goal of the probabilistic analysis is to more fully capture and characterize the variability in the range of potential exposures and toxicological effects to listed species to better inform the biological opinion.”
• EPA is proposing a weight-of-evidence framework “to distinguish those listed species that are likely to be adversely affected (LAA) from those that are not likely to be adversely affected (NLAA), based on criteria (e.g., dietary preferences, migration patterns, extent of range potentially exposed) associated with the likelihood that an individual will be exposed and affected.”