Assessing Risks to Endangered and Threatened Species from Pesticides (2013) / Chapter Skim
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2 A Common Approach and Other Overarching Issues
2 A Common Approach and Other Overarching Issues
Pages 28-48
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From page 28... ...
A COMMON APPROACH To comply with or administer the ESA during the pesticide registration process, EPA and the Services need to determine the probability of adverse effects on listed species or their habitats due to expected pesticide use that is consistent with label requirements. The committee understands that EPA and the Services are responding to different federal regulations and legal requirements 28
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From page 29... ...
Scientific obstacles to reaching agreement between EPA and the Services during consultation have emerged apparently because of the agencies' differences in implementation of the ERA process, including differences in underlying assumptions, technical approaches, data use, exposure models, and risk-calculation methods. Agreement has also been impeded because of a lack of communication and coordination throughout the process.
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From page 30... ...
NO Formal Consultation Exposure Effects Analysis Analysis Jeopardy? REGISTRATION OR REREGISTRATION NO Risk OF PESTICIDE Characterization YES EPA DECIDES WHETHER AND UNDER WHAT CONDITIONS TO REGISTER PESTICIDE FIGURE 2-1 Relationship between the Endangered Species Act (ESA)
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From page 31... ...
Consequently, the committee has concluded that the risk-assessment paradigm reflected in the ERA process is singularly appropriate for evaluating risks to ecological receptors, such as listed species, posed by chemical stressors, such as pesticides. TABLE 2-1 Steps in the ESA Process as Related to Elements in the ERA Process for Pesticidesa Element of the ERA Process Effect (Exposure- Risk Step in ESA Process Exposure Analysis Response)
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From page 32... ...
The possible differences in risk assessments between Steps 2 and 3 in the ESA process can be seen by considering that the imaginary pesticide X -- designated PX for this discussion -- will be applied to wheat in Illinois in summer. In this hypothetical example, EPA decides that because PX is used in a region where there are listed sturgeon species, some PX could get into streams and possibly affect the fish.
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From page 33... ...
, incorporate effects thresholds from the same studies, and review the same studies on sublethal effects. EPA uses reasonable worst-case assumptions of effects of PX on individual fish to reach a "likely to adversely affect" conclusion, whereas FWS uses site-specific data, incorporates spatial variability, and bases its decision on changes in population growth rates to reach a finding of "no jeopardy." The committee concludes that using a common approach would eliminate many problems in assessing risks to listed species that are being encountered by EPA and the Services.
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From page 34... ...
The committee emphasizes that given the changing scope of the ERA process from Steps 1-3, EPA and the Services need to coordinate to ensure that their own technical needs are met. First, before a risk assessment is even initiated, the agencies need to connect the decision that must be made with the risk assessment that will inform it.
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From page 35... ...
The periodicity of such discussions would necessarily be at the discretion of the agencies, but the committee recommends a frequency of at least once every 2 years to capture updates in risk-assessment and population-biology methods, newly listed species, new pesticide classes, and changing agricultural practices. The committee concludes further that coordination during problem formulation regarding the ESA and ERA processes would be enhanced if a common outline, such as the one shown in Box 2-1, were adopted.
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From page 36... ...
Designated Critical Habitats 1.2. Action Area (based on use and natural history)
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From page 37... ...
Although the committee is aware of the administrative and other nonscientific hurdles that will need to be overcome to implement such an approach, it nonetheless has concluded that moving the uncertainty analysis from a narrative addendum to an integral part of the assessment is both possible and necessary to provide realistic, objective estimates of risk. Because a core dataset is required for all pesticide registration decisions, there should be sufficient information to conduct a quantitative assessment, which can include a quantification of the associated uncertainty.
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From page 38... ...
; TIM version 2.0 includes Monte Carlo simulations for calculating pesticide concentrations in a simulated farm pond and estimating activity patterns of potentially exposed wildlife. The committee recognizes that the use of frequentist statistics and Monte Carlo simulations, although widespread, is only one approach to quantifying and propagating uncertainty through an ERA.
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From page 39... ...
. Data used by EPA in pesticide risk assessments are typically derived from detailed reports of standardized studies required for pesticide registration under FIFRA; studies in peer-reviewed journals or other publications, such as reference books; and government reports and surveys.
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From page 40... ...
EPA has a formal set of data relevance and quality criteria that are applied in selecting information for use in regulatory assessment. The EPA Science Policy Council published a set of five assessment factors for evaluating scientific and technical information on the basis of EPA practices, input from the public, and results from a workshop hosted by the National Academy of Sciences (EPA 2003)
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From page 41... ...
that follow closely the government-wide OMB guidelines. Similar basic principles for achieving a scientifically credible assessment are prescribed in the IQGs from the agencies; the agencies are committed to ensuring the quality of evaluations and the transparency of information from external sources used in their disseminated assessments and actions (EPA 2003; NMFS 2005)
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From page 42... ...
The detailed reporting allows EPA scientists to evaluate study quality independently and to conduct data analysis beyond what is possible with studies published in the open literature.1 EPA's evaluation is documented in a data evaluation record (DER) , which contains information on study methods, results, and discussions.
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From page 43... ...
, the committee emphasizes the value of external peer review to enhance the quality, transparency, and credibility of a risk assessment. CONCLUSIONS AND RECOMMENDATIONS A Common Approach and Coordination among the Agencies Lack of a common approach has created scientific obstacles to reaching agreement between EPA and the Services during consultation.
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From page 44... ...
Given the changing scope of the ERA process from Step 1 to Step 3, EPA and the Services should coordinate to ensure that their own technical needs are met. Problem formulation, conducted as part of the ERA process, could be an effective way for the agencies to coordinate and reach agreement on many of the key technical issues involved in assessing risks posed by pesticide exposure.
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From page 45... ...
1997. EFED's Summary of the SAP Review of Ecological Risk Assessment Meth odologies.
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From page 46... ...
2011. Procedures for Screening, Review ing, and Using Published Open Literature Toxicity Data in Ecological Risk As sessments.
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From page 47... ...
U.S. Fish and Wildlife Service and National Marine Fisheries Service, Washington, DC [online]
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From page 48... ...
Fish and Wildlife Service, and William Hogarth, Assistant Administrator, National Marine Fisheries Service. January 24, 2004 [online]
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