that determine the degree to which it meets the needs of the agency risk managers, how risk-management conclusions differ as a result of its application, and the effectiveness of measures to ensure that risk managers and policy-makers do not inappropriately influence the scientific conduct of risk assessments.

Recommendation: To make risk assessments most useful for risk-management decisions, the committee recommends that EPA adopt a framework for risk-based decision-making (see Figure S-1) that embeds the Red Book risk-assessment paradigm into a process with initial problem formulation and scoping, upfront identification of risk-management options, and use of risk assessment to discriminate among these options.

Stakeholder Involvement

Many stakeholders believe that the current process for developing and applying risk assessments lacks credibility and transparency. That may be partly because of failure to involve stakeholders adequately as active participants at appropriate points in the risk-assessment and decision-making process rather than as passive recipients of the results. Previous National Research Council and other risk-assessment reports (for example, NRC 1996; PCCRARM 1997)12 and comments received by the committee (Callahan 2007; Kyle 2007)13 echo such concerns.

The committee agrees that greater stakeholder involvement is necessary to ensure that the process is transparent and that risk-based decision-making proceeds effectively, efficiently, and credibly. Stakeholder involvement needs to be an integral part of the risk-based decision-making framework, beginning with problem formulation and scoping.

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 decision-making schedules are met and with incentives to allow for balanced participation of stakeholders, including impacted communities and less advantaged stakeholders.


Improving risk-assessment practice and implementing the framework for risk-based decision-making will require a long-term plan and commitment to build the requisite capacity of information, skills, training, and other resources necessary to improve public-health and environmental decision-making. 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


NRC (National Research Council). 1996. Understanding Risk: Informing Decisions in a Democratic Society. Washington, DC: National Academy Press; PCCRARM (Presidential/Congressional Commission on Risk Assessment and Risk Management). 1997. Framework for Environmental Health Risk Management - Final Report, Vol. 1.


Callahan, M.A. 2007. Improving Risk Assessment: A Regional Perspective. Presentation at the Third Meeting of Improving Risk Analysis Approaches Used by EPA, February 26, 2007, Washington, DC; Kyle, A. 2007. Community Needs for Assessment of Environmental Problems. Presentation at the Fourth Meeting of Improving Risk Analysis Approaches Used by EPA, April 17, 2007, Washington, DC.

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