BACKGROUND

Since the 1983 publication of the National Research Council’s report Risk Assessment in the Federal Government: Managing the Process (the so-called Red Book), EPA has made efforts to advance risk assessment with the generation of risk-assessment guidelines, the establishment of intra-agency and cross-agency science-policy panels, and improvements in peer-review standards for agency risk assessments. The Red Book committee demonstrated how risk assessment could fill the gap between results emerging from the research setting and their use in risk management. A framework for systematically carrying out the process of risk assessment was established, and the Red Book’s risk-assessment framework remains in place today. The Red Book also revealed how the development of what were called inference guidelines (see below) was necessary to ensure the scientific integrity of the process by which risk assessments were conducted and of the product of that process.

Various closely related forms of the risk-assessment framework have been widely used by international organizations and other federal agencies, including the Consumer Product Safety Commission, the Nuclear Regulatory Commission, the Food and Drug Administration, the Occupational Safety and Health Administration, the U.S. Department of Agriculture, the Department of Defense, and the Department of Energy. OSTP (50 Fed. Reg. 10371[1985]) adopted the Red Book framework for carcinogen analysis and provided agencies a basis for developing the guidelines recommended by NRC (1983).

Publication of the Red Book was followed by an intensification of risk-assessment activity in EPA. EPA endorsed the Red Book in the publication, Risk Assessment and Management: Framework for Decision Making (EPA 1984). The agency established in 1984 what is now called the Risk Assessment Forum and in 1993 added a Science Policy Council (see Appendix C for a timeline of selected risk-assessment activities)—evidence that the Red Book and EPA’s efforts to advance risk assessment fell on fertile ground (Goldman 2003). William Ruckelshaus, during his second tour as administrator of EPA (1983-1985), used the Red Book as the basis of a main theme of his tenure: strengthening risk assessment as a tool to inform decision-making. EPA initially focused on human health risk assessment with the Guidelines for Carcinogen Risk Assessment (EPA 1986) and the agency’s Unfinished Business: A Comparative Assessment of Environmental Problems (EPA 1987), which compared the magnitude of environmental risks with EPA’s resource allocations to programs that address them. The agency’s Science Advisory Board evaluated the latter document in another key report, Reducing Risk: Setting Priorities and Strategies for Environmental Protection (EPA SAB 1990), and EPA was involved in a 1992 conference that evaluated the risk-based model for setting national priorities against several alternatives that incorporated information about solutions, environmental justice, and other factors (Finkel and Golding 1994).

In the 1990s, the four-step approach outlined in the Red Book was adapted to ecologic risk assessment to address evaluations in which human health is not the primary focus (EPA 2004). Ecologic risk assessors pioneered new approaches to complex risk problems by delineating the need for “planning and problem formulation” to address technically challenging assessments of ecosystems, chemical mixtures, and cumulative risk. In the planning step, the risk managers—in consultation with risk assessors and other interested parties—frame management goals, management options, and the scope and necessary level of complexity for the risk assessment. Problem formulation is the phase in which the risk managers’ charge to the assessors is converted into an actionable plan for performing the assessment (EPA 1998; Suter 2007).

Several National Research Council and other expert panels expanded on the risk-assessment principles presented in the Red Book with the publication of reports that included



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