Science and Decisions Advancing Risk Assessment (2009) / Chapter Skim
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9 Toward Improved Risk-Based Decision-Making
9 Toward Improved Risk-Based Decision-Making
Pages 258-272
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From page 258... ...
The transition will require support, including guidance and resources, from the EPA leadership community, the executive and legislative branches of government, and key stakeholders. Those and related implementation recommendations signify the committee's recognition that assembling, evaluating, and interpreting information called for in the framework introduce major changes in EPA's various risk-assessment and decision-making processes.
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From page 259... ...
Institutional Processes The framework presents opportunities for EPA to review and realign some institutional processes to foster consistent approaches to using risk assessment and other analyses (in his T committee comment is prompted by recent congressional testimony on the impact of budget cuts on EPA's capacity to meet the demands of risk assessment as currently practiced (Renner 2007)
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From page 260... ...
Committee recommendations for expanding risk-assessment activities to give more emphasis to, for example, cumulative risk, quantitative uncertainty and variability analysis, and harmonizing analyses for cancer and noncancer end points call for state-of-the-science improvements that easily fall within the agency's existing authority: for more than 20 years, EPA has regularly incorporated state-of-the-science improvements of this kind to develop and amend general risk-assessment guidelines and conduct individual assessments. The committee's more far-reaching recommendations -- such as broad-based discussion of risk-management options early in the process, extensive stakeholder participation throughout the process, and consideration of life-cycle approaches in a broader array of agency programs -- can be viewed as common-sense extensions throughout the agency as a whole of practices that are now limited to selected programs or are unevenly and incompletely implemented.
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From page 261... ...
Such analyses demand a multidisciplinary and scientifically sophisticated workforce, experienced not only in the underlying disciplines but in special aspects of the risk-assessment process. Quantitative uncertainty analysis and cumulative risk assessment, for example, may well require expertise not now available in EPA or the larger scientific community in the numbers and experience levels needed to implement recommendations in this report.
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From page 262... ...
In summary, informed and, in some cases, ground-breaking governance are intended to improve EPA risk-assessment processes, focus the assessment on the relevant questions, discourage political interference or pre-determined policy biases, and promote senior-level oversight of the timeliness, relevance, and impact of decision-making. The present report presents a major opportunity for EPA to re-examine its decision-making processes, innovate reforms, and expedite change that takes account of 21st century scientific developments, the faster pace of the global marketplace, and the needs of contemporary policy-making.
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From page 263... ...
Design of Risk Assessment The process of planning risk assessment and ensuring that its level and complexity are consistent with the needs to inform decision-making can be thought of as the "design" of risk assessment. The committee encourages EPA to focus greater attention on design in the formative stages of risk assessment, specifically on planning and scoping and problem formulation, as articulated in EPA guidance for ecologic and cumulative risk assessment (EPA 1998, 2003)
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From page 264... ...
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. The committee acknowledges EPA's efforts to examine scientific data related to defaults (EPA 1992, 2004, 2005a)
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From page 265... ...
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 266... ...
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 267... ...
. 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 268... ...
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 9-1 A framework for risk-based decision-making that maximizes8-1.eps of risk assessment.
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From page 269... ...
The committee is mindful of concerns about political interference in the process, and the framework maintains the conceptual distinction between risk assessment and risk management articulated in the Red Book. It is imperative that risk assessments used to evaluate risk-management options not be inappropriately influenced by the preferences of risk managers.
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From page 270... ...
The committee's recommendations call for considerable modification of EPA risk-assessment efforts (for example, implementation of the risk-based decision-making framework, emphasis on problem formulation and scoping as a discrete stage in risk assessment, and greater stakeholder participation) and of technical aspects of risk assessment (for example, unification of cancer and noncancer dose-response assessments, attention to quantitative uncertainty analysis, and development of methods for cumulative risk assessment)
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From page 271... ...
Presentation at the Third Meeting of Improving Risk Analysis Approaches Used by EPA, February 26, 2007, Washington, DC. Callahan, M.A., and K
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