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8 Improving the Utility of Risk Assessment
Pages 240-257

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From page 240...
... Risk assessment in EPA is not an end in itself but a means to develop policies that make the best use of resources to protect the health of the public and of ecosystems. In Chapter 3, the committee demonstrated the importance of increased attention to risk-assessment planning and to ensuring that the levels and complexity of risk assessment (their "design")
From page 241...
... That means, of course, that the questions posed to risk assessors must be both relevant to the problems and decisions faced and sufficiently comprehensive to ensure that the best available options for managing risks are given due consideration. This chapter provides guidance on the development and application of questions, methods, and decision processes to enhance the utility of risk assessment; although many elements of the guidance are applicable in the near term, our emphasis is on the longer-term future.
From page 242...
... The more complex and multifaceted the problem to be dealt with, the more important the need to operate in that fashion. As noted in the previous section, the Red Book framework was not oriented to identifying the optimal process for complex decision-making but rather to ensuring the conceptual separation of risk assessment and risk management.
From page 243...
... FORMAL PROVISIONS FOR INTERNAL AND EXTERNAL STAKEHOLDER INVOLVEMENT AT ALL STAGES • The involvement of decision-makers, technical specialists, and other stakeholders in all phases of the processes leading to decisions should in no way compromise the technical assessment of risk, which is carried out under its own standards and guidelines. FIGURE 8-1  A framework for risk-based decision-making that maximizes the utility of risk assessment.
From page 244...
... 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)
From page 245...
... As articulated in more detail below, the present committee views the framework as a step beyond previous proposals and current practice -- one that can possibly meet multiple objectives: • Systematically identify problems and options that risk assessors should evaluate at the earliest stages of decision-making. • Expand the range of effects assessed beyond individual end points (for example, cancer, respiratory problems, and individual species)
From page 246...
... As noted earlier, the framework is intended to provide guidance that was not provided by the Red Book. Elements of the Framework: A Process Map In this section, we outline the content of each of the elements of the framework.
From page 247...
... c. What types of risk assessments and other technical and cost assessments are necessary to evaluate existing conditions, and how do the various risk-management options alter the conditions?
From page 248...
... •  What do the technical analyses (Box 8-4) reveal about how existing conditions and resulting exposures/doses would be altered by each proposed risk-management option?
From page 249...
... . Other technical analyses are typically required to evaluate how specific interventions will alter existing conditions; the information developed through such technical analyses (see Box 8-4)
From page 250...
... Adequate stakeholder involvement and communication among those involved in the policy and technical evaluations are difficult to achieve, but they are necessary for success. It is time that formal processes be established to ensure implementation of effective stakeholder participation in all stages of risk assessment.
From page 251...
... In addition, the methodologic developments proposed in Chapter 5 and elsewhere are meant in part to provide greater insight for risk managers regarding the health-risk implications of specific management decisions, feeding directly into the proposed framework. A related trend involves the growth of life-cycle assessment, which includes many aspects of risk assessment but also evaluates a broader array of issues related to energy use, water consumption, and other characteristics of technologies, industrial processes, and products that determine their propensity to consume natural resources or to generate pollution.
From page 252...
... We believe that questions about the risks posed by industrial processes can often be answered better by considering risk-risk tradeoffs and evaluating risk-management options than by studying risks in isolation from the feasible means of control. Although the expanded scope may exceed the bounds of EPA decision-making (either in a practical sense, given current regulations, or in a theoretical sense, given the agency's jurisdiction)
From page 253...
... Although many regulatory, legislative, and logistical constraints complicate the simultaneous consideration of costs of control and benefits, the framework would, where applicable and feasible, encourage the use of similar methods between disciplines (such as the explicit incorporation of uncertainty and variability and the development of default assumptions and criteria for departure in economic analyses) and would spur collaboration between risk assessors and regulatory economists.
From page 254...
... The committee proposed earlier that the framework will help risk assessments to come to closure by focusing on the information needed to discriminate among risk-management options rather than focusing on the information needed to "get the number right." However, it could be argued that the need to quantify benefits among multiple potential risk-management options, including tradeoffs and multimedia considerations, will greatly expand the analytic requirements of a given assessment, especially given that the uncertainties in a simpler assessment may prove too large for discrimination among options. That is an important concern, but many of the more analytically complex components (for example, cumulative risk assessment and multimedia exposure)
From page 255...
... A risk manager who keeps analysts in the dark about the choices can still order them to "make the risk look smaller (bigger) ." Safeguards against any form of manipulation of the risk-assessment process, whether related to the framework or not, must be in place; it seems to the committee that a process that emphasizes evaluation of risk-management options will by definition involve broader participation, which implies more "sunshine" and less opportunity for the type of manipulation that the Red Book committee was justifiably concerned with.
From page 256...
... should have as its core elements a problem-formulation and scoping phase in which the available risk-management options are identified, a planning and assessment phase in which risk-assessment tools are used to determine risks under existing conditions and with proposed options, and a management phase in which risk and nonrisk information is integrated to inform choices among options. • EPA should develop multiple guidance documents relevant to the framework, including a more expansive development of the framework itself (with explicit steps to determine the appropriate scope of the risk assessment)
From page 257...
... 2002. Estimating the Public Health Benefits of Proposed Air Pollution Regula tions.


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