termination, many of which seem to result from different assumptions, technical approaches (data and models used), and risk-calculation methods. What is needed is a common, scientifically credible approach that is acceptable to EPA and the Services. The committee concludes that the risk-assessment paradigm that traces its origins to the seminal NRC report Risk Assessment in the Federal Government: Managing the Process1 and more recently to the NRC report Science and Decisions: Advancing Risk Assessment2 provides such an approach. After 30 years of use and refinement, this risk-assessment paradigm has become scientifically credible, transparent, and consistent; can be reliably anticipated by all parties involved in decisions regarding pesticide use; and clearly articulates where scientific judgment is required and the bounds within which such judgment can be applied. The process is used for human-health and ecological risk assessments and is used broadly throughout the federal government. Thus, the committee concludes that the risk-assessment paradigm reflected in the ecological risk assessment (ERA) process is singularly appropriate for evaluating risks posed to ecological receptors, such as listed species, by chemical stressors, such as pesticides.
Figure S-1 shows the three major steps in the ESA process in connection with the ERA framework. As illustrated in the figure, the framework is the same at each step, but the contents of each element (problem formulation, exposure and effects analysis, and risk characterization) are expected to change as the focus shifts from assessing whether a pesticide “may affect” a listed species (Step 1) to whether it is “likely to adversely affect” a listed species (Step 2) to whether it is likely to jeopardize the continued existence of a listed species (Step 3). That is, the assessment becomes more focused and specific to the chemicals, species, and habitats of concern as it moves from Step 1 to Step 3. If the Services can build on the EPA assessment conducted for Steps 1 and 2 rather than conducting a completely new analysis for Step 3, the ERA will likely be more effective and scientifically credible. Although the committee does not expect the basic risk-assessment framework to change, it recognizes that risk-assessment approaches and methods for determining, for example, what is hazardous, what concentration or quantity is hazardous, what end points constitute an adverse effect, and when, where, and how much exposure is occurring will continue to evolve.
Given the changing scope of the ERA process from Step 1 to Step 3, EPA and the Services need to coordinate to ensure that their own technical needs are met. One approach is to use problem formulation, conducted as part of the ERA process, as an effective means for agencies to coordinate and reach agreement
1NRC (National Research Council). 1983. Risk Assessment in the Federal Government: Managing the Process. Washington, DC: National Academy Press.
2NRC (National Research Council). 2009. Science and Decisions: Advancing Risk Assessment. Washington, DC: National Academies Press.