Science and Decisions Advancing Risk Assessment (2009) / Chapter Skim
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Pages 1-14
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From page 3... ...
Risk assessment, however, is at a crossroads, and its credibility is being challenged (Silbergeld 1993; Montague 2004; Michaels 2008) . Because it provides a primary scientific rationale for informing regulations that will have national and global impact, risk assessment is subject to considerable scientific, political, and public scrutiny.
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From page 4... ...
To address current challenges, EPA asked the National Research Council to perform an independent study on improving risk-analysis approaches, one of a number of studies by the National Research Council that have examined risk assessment in EPA. Specifically, the committee selected by the National Research Council was charged to identify practical improvements that EPA could make in the near term (2-5 years)
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From page 5... ...
The committee recommends an important extension of the Red Book model to meet today's challenges better -- that risk assessment should be viewed as a method for evaluating the relative merits of various options for managing risk rather than as an end in itself. Risk assessment should continue to capture and accurately describe what various research findings do and do not tell us about threats to human health and to the environment, but only after the risk-management questions that risk assessment should address have been clearly posed, through careful evaluation of the options available to manage the environmental problems at hand, similar to what is done in ecologic risk assessment.
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From page 6... ...
Variability in human susceptibility has not received sufficient or consistent attention in many EPA health risk assessments although there are encouraging exceptions, such as those for lead, ozone, and sulfur oxides. For example, although EPA's 2005 Guidelines for Carcinogen Risk Assessment acknowledges that susceptibility can depend on one's stage in life, PA (U.S.
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From page 7... ...
Selection and Use of Defaults Uncertainty is inherent in all stages of risk assessment, and EPA typically relies on assumptions when chemical-specific data are not available. The 1983 Red Book recommended the development of guidelines to justify and select from among the available inference options, the assumptions -- now called defaults -- to be used in agency risk assessments to ensure consistency and avoid manipulations in the risk-assessment process.
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From page 8... ...
Noncancer effects do not necessarily have a threshold, or low-dose nonlinearity, and the mode of action of carcinogens varies. Background exposures and underlying disease processes contribute to population background risk and can lead to linearity at the population doses of concern.
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From page 9... ...
Cumulative Risk Assessment EPA is increasingly asked to address broader public-health and environmental-health questions involving multiple exposures, complex mixtures, and vulnerability of exposed populations -- issues that stakeholder groups (such as communities affected by environmental exposures) often consider to be inadequately captured by current risk assessments.
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From page 10... ...
A recent National Research Council report on phthalates addresses issues related to the framework within which dose-response assessment can be conducted in the context of simultaneous exposures to multiple stressors. Recommendation: EPA should draw on other approaches, including those from ecologic risk assessment and social epidemiology, to incorporate interactions between chemical and nonchemical stressors in assessments; increase the role of biomonitoring, epide miologic, and surveillance data in cumulative risk assessments; and develop guidelines and methods for simpler analytical tools to support cumulative risk assessment and to provide for greater involvement of stakeholders.
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From page 11... ...
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 S-1 A framework for risk-based decision-making that maximizes the utility of risk assessment.
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From page 12... ...
Under this framework, the questions posed arise from early and careful planning of the types of assessments (including risks, costs, and technical feasibility) and the required level of scientific depth that are needed to evaluate the relative merits of the options being considered.11 Risk management involves choosing among the options after the appropriate assessments have been undertaken and evaluated.
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From page 13... ...
Although EPA has numerous programs and guidance documents related to stakeholder involvement, it is important that it adhere to its own guidance, particularly in the context of cumulative risk assessment, in which communities often have not been adequately involved. Recommendation: EPA should establish a formal process for stakeholder involvement in the framework for risk-based decision-making with time limits to ensure that deci sion-making schedules are met and with incentives to allow for balanced participation of stakeholders, including impacted communities and less advantaged stakeholders.
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From page 14... ...
CONCLUDING REMARKS Global impacts are combining with the high financial and political stakes of risk management to place unprecedented pressure on risk assessors in EPA. But risk assessment remains essential to the agency's mission to ensure protection of public health and the environment.
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