Risk assessment, in the framework of Figure 8-1, would typically be asked to examine risks associated with the “no intervention” option in addition to examining risk reductions (and possible increases) associated with each of the proposed interventions. Questions arising from consideration of options need to be well formulated (including a sufficient precision and breadth of issues) to ensure that important risk issues are not inadvertently overlooked; this requires that the array of options not be unnecessarily restricted.

As emphasized in Chapter 3 and elsewhere, without early and careful consideration of the decision-context, risk assessors cannot identify the types of assessments and the required level of their scientific depth necessary to support decisions (or, indeed, whether risk assessment is even the appropriate decision support tool, as shown in Figure 3-1). Without such a well-defined context, assessments will often lack well-defined stopping points and may yield ancillary analyses (for example, highly detailed quantitative uncertainty analyses) that are not essential for the decision at hand, prolonging the decision process unnecessarily (Chapter 4). By focusing on early and careful problem formulation and on the options for managing the problem, implementation of the framework can do much to improve the utility of risk assessment. Indeed, without such a framework, risk assessments may be addressing the wrong questions and yielding results that fail to address the needs of risk managers.

The framework is based on a re-examination of one of the misinterpretations of the Red Book—that assessors should be shielded from the specific decision-making issues that their analyses are intended to support. Instead, it asserts that risk assessment is of little usefulness, and can even waste resources, if it is not oriented to help discriminate among risk-management options that have to be informed by risk (and often nonrisk) considerations. More important, the framework should ensure that decisions themselves will be improved if risk-assessment information is presented to demonstrate how it affects the worth of competing choices, not for how it sheds light on an isolated substance or “problem.” To be clear, the framework maintains the conceptual distinction between risk assessment and risk management articulated in the Red Book, and it remains intent on not allowing the manipulation of risk-assessment calculations to support predetermined policy choices. The conduct of risk assessments used to evaluate the risk-management options are in no way to be influenced by the preferences of risk managers.

The proposed decision-making framework resembles the well-known decision-analytic process that has been used in diverse fields for many decades (Raiffa 1968; Weinstein et al. 1980; Lave and Omenn 1986; Lave et al. 1988; Clemen 1991), in which the utility of various concrete policy options is evaluated according to the benefits that each provides. Similarly, the need to ensure that the full range of policy options is considered for the analysis has been emphasized by others including Finkel (2003); Hattis and Goble (2003); and Ashford and Caldart (2008). The committee also recognizes that numerous previous reports and guidance documents, and EPA practice in some settings, have anticipated this framework to some extent. For example, Science and Judgment in Risk Assessment (NRC 1994) emphasized that “risk assessment is a tool, not an end in itself,” and recommended that resources be focused on obtaining information that “helps risk managers to choose the best possible course of action among the available options.” The 1996 National Research Council report Understanding Risk: Informing Decisions in a Democratic Society (NRC 1996) emphasized that “risk characterization should be a decision driven activity, to inform choices in solving problems.” The latter report also called for attention to problem formulation, with an explicit options-selection step, and representation of interested and affected parties from the earliest stages of the process. The framework also builds on but goes beyond the recommendations of the 1997 Presidential/Congressional Commission on Risk Assessment and Risk Management report (PCCRARM 1997) that called for a six-stage risk-management frame-

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