visory Panel for FIFRA in 1996 (Bailey et al. 1997) and was explicitly addressed in a workshop held in 2009 (Warren-Hicks and Hart 2010). EPA has since developed and begun to implement the Terrestrial Investigation Model (TIM; Odenkirchen 2003); 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. Bayesian approaches to environmental assessments, some of which also use Monte Carlo simulations, have become more widely understood and more feasible over the last few decades as computational power and capability have improved (Ellison 1996; McCarthy 2007; Link and Barker 2010). For example, Borsuk and Lee (2009) describe the application of Bayesian approaches to increase environmental realism in population modeling, and Reckhow (1999) applies similar approaches to water-quality predictions. Their applicability to analyses of data on chemicals and to other environmental risk assessments (Clark 2005), including those for endangered species, has been recognized in the federal government (FDA 2010; Conn and Silber 2013), although they have not yet been widely adopted for chemical risk assessment. Bayesian methods reliably estimate modeled variables, and Bayesian models can readily propagate uncertainties in data (such as measurement errors) and uncertainties in model structure (such as selection of covariates and relationships among them). The models can incorporate data from multiple sources, expert knowledge, and empirical evidence about relationships among variables and about the shape of the data distributions; however, these are not required to use or run the models. Bayesian approaches are most useful during Step 3 of ESA pesticide analyses when an in-depth analysis is needed, such as when alternative pesticide-use scenarios or proposed mitigation actions might have large spatial or economic consequences.

EPA has noted that “the explicit treatment of uncertainty during problem formulation is particularly important because it will have repercussions throughout the remainder of the assessment” (EPA 1998, p. 26). For ESA Section 7 consultations on pesticide risk to listed species, it is likely that the amount of data available for producing a risk estimate will vary by species and by chemical. The risk assessor will therefore need to ascertain during problem formulation how much confidence in the risk estimate the decision-maker requires to support a decision, given the decision context. Does the decision-maker need a risk estimate with low uncertainty or is, for example, ± 25% acceptable? Decisions regarding uncertainty need to be balanced with a discussion about availability of time and resources and need to consider the extent to which uncertainties are unavoidable given likely data gaps. A quantitative analysis of expected value of information could be conducted to answer the question of whether the reduction in uncertainty warrants obtaining more information (Yokota and Thompson 2004; Runge et al. 2011; Moore and Runge 2012). However, the committee recognizes that time limitations might preclude such an analysis (Yo-



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