Public-opinion polls have consistently shown strong support throughout the United States for effective environmental stewardship and for identifying and addressing risks to the environment, public health, and worker health. At the same time, many citizens and local officials are demanding greater attention to priorities and costs. There is an emerging national vision of sustainable development for our environment, our economy, and our society, which this Commission shares. Regulatory agencies, businesses, environmental and public health advocates, and communities deserve credit for well-documented gains in air quality, water quality, habitat protection, product safety, waste disposal, recycling, and pollution prevention achieved over the last 25 years. The Commission values and seeks to sustain such gains. Our findings and recommendations reflect an increasing need to recognize and capitalize on lessons learned and our intent to stimulate even more efficient, more effective, risk-based means of protecting public health and the environment.

The Commission on Risk Assessment and Risk Management was mandated by Congress in the Clean Air Act Amendments of 1990 "to make a full investigation of the policy implications and appropriate uses of risk assessment and risk management in regulatory programs under various Federal laws to prevent cancer and other chronic human health effects which may result from exposure to hazardous substances." The Commission began meeting in May 1994 and held hearings across the country, obtaining information and insights that made important contributions to our deliberations and to our findings and recommendations. With this draft report, we introduce a framework for making risk-management decisions; we evaluate and make recommendations about the uses and limitations of risk assessment, economic analysis, risk management, and regulatory decision-making; and we address selected activities of specific regulatory agencies and programs. The Commission continues to seek comments as we refine our recommendations for the final report to Congress and the president of the United States.

The Commission has adopted a unique risk-management perspective to guide investments of precious public-sector and private-sector resources in risk-related research, risk assessment, risk characterization, and risk reduction. We recognize that it is time to modify the traditional approaches to assessing and reducing risks that have relied on a chemical-by-chemical, medium-by-medium, risk-by-risk strategy. While risk assessment has been growing more complex and sophisticated, the output of risk assessment for the regulatory process often seems too focused on refining assumption-laden mathematical estimates of small risks associated with exposure to individual chemicals rather than on the overall goal--risk reduction and improved health status. Scientists, federal agencies, the National Academy of Sciences/National Research Council, and many other organizations have issued many reports with recommendations for improving health risk assessment. Despite many years of managing risks, however, there have been few systematic attempts to examine the role of risk assessment itself in risk management and health and environmental protection. No generally accepted framework or principles for making risk-management decisions has emerged.

We propose a systematic, comprehensive framework that can address various contaminants, media, and sources of exposure, as well as public values, perceptions, and ethics, and that keeps the focus on the risk-management goal. The new risk-management framework comprises six stages (see figure):

The Commission's Risk Management Framework

The framework explicitly embraces collaborative involvement of stakeholders; the process can be refined and its conclusions can be changed as important new information is acquired.

The framework requires first that a potential or current problem be put into a broader context of public health or environmental health and that the interdependence of related multimedia problems be identified. For example, the risks associated with the hazardous air pollutants regulated at one industrial facility or category of facilities can be considered in context with the risks associated with other stationary and mobile sources that emit the same pollutants. The next layer of context would be provided by comparisons with risks associated with other important air pollutants, such as particles and carbon monoxide, emitted by the same sources. A multimedia context would lead to a comprehensive plan that includes risks associated with air, water, and solid waste in a particular geographic area.

The framework actively engages stakeholders, especially at the initial stage of formulating the problem; we want to go beyond worker and community right-to-know requirements and make stakeholders partners in risk assessment and risk management. In later stages of the framework, risk managers and stakeholders investigate the risks, including cumulative risks to human and environmental health; risk-reduction options are identified, and potential consequences evaluated, including the benefits, costs, and social, cultural, ethical, political, and legal dimensions of each option; and the responsible agency then makes a decision that reflects input from stakeholders, implements a risk-reduction action, and seeks credible evaluation of the outcome. As new information or new technology becomes available, the problem can be redefined, and the risk-management process repeated, if appropriate.

This framework can help to improve the cumbersome, fragmented risk-management approach often used by the federal regulatory agencies--an approach that resulted from the patchwork of Congressional statutes that have been passed over the last 25 years to address individual risks. Coordination within and among agencies and among Congressional committees and subcommittees can advance the more-comprehensive proposed framework without a new, overarching environmental statute. The framework is also applicable to risk-management activities carried out by public and private entities at the state, regional, and local levels. Despite potential obstacles, we believe that implementation of this framework will enable the country to manage risks more effectively and more efficiently and to make progress toward the goal of sustainable development.

The Commission considers risk assessment a useful analytic process that provides valuable contributions to risk-management, public-health, and environmental-policy decisions. Risk assessment was developed because Congress, regulators, and the public require scientists to go beyond scientific observations of the relationships between exposures to chemicals and pollutants and their effects on people, the environment, or test systems, and to rely on many scientific inferences and assumptions to answer social questions about what is unsafe. When basic judgments regarding a chemical's toxicity to humans are unresolved, however, sophisticated and complex risk assessments might not be immediately helpful to risk managers. We recommend that the performance of risk assessments be guided by an understanding of the issues that will be important to managers' decisions and to the public's understanding of what is needed to protect public health and the environment.

Use of Good Science in Toxicity Assessments: The Commission recognizes that important advances are being made in the scientific basis for risk assessment. Further developments will improve the recognition and estimation of risks to humans associated with chemical and other exposures in the environment and provide biologic markers for measuring exposure, early effects, and variation in susceptibility. We recommend the use of all relevant peer-reviewed information about a chemical's mode of action in evaluating the weight of the scientific evidence supporting its toxicity in humans. We support current agency efforts to distinguish more clearly between experimental findings in rodent or other bioassays that are predictive for humans and findings that are not. We recognize that risks from microbial and radiation exposures, not just chemical exposures, need to be addressed, and we recommend the evaluation of a common metric to assist comparative risk assessment, risk communication, and risk characterization related to both carcinogens and noncarcinogens.

Use of Realistic Scenarios in Exposure Assessments: The Commission supports basing risk-management decisions on exposure assessments derived from realistic scenarios. Agencies should continue to move away from using the hypothetical "maximally exposed individual" to evaluate whether a risk exists, toward more realistic assumptions based on available scientific data, as they have done in recent analyses. We recommend use of analytic methods that, when data permit, combine the many characteristics of probable exposure into an assessment of the overall population's exposures. Where possible, exposure assessments should include information about specific groups, such as infants, children, pregnant women, low-income groups, and minority-group communities with exposures tied to particular cultural or social practices. Stakeholders can provide information about patterns and sources of exposure that otherwise might be neglected.

Recognition of Risk Associated with Chemical Mixtures: We agree with testimony that we need data and risk estimates about chemical mixtures and combined chemical-microbial-radiation exposures, because people are exposed to multiple hazards. We recommend direct toxicity assays of environmental mixtures.

The Commission supports the use of economic analysis as a consideration, but not as an overriding determinant of risk-management decisions. Both human-health and ecological benefits should be accounted for when the consequences of actions to reduce emissions, exposures, and risks are being evaluated. We call for explicit descriptions of the assumptions, data sources, sources of uncertainty, and distributions of benefits and costs across society associated with economic analyses, in parallel with the descriptions associated with risk assessments.

Risk assessment and economic analysis provide only part of the information that risk managers use--with information about public values and statutory requirements--to make decisions about the need for and methods of risk reduction. The wide array of statutes and their implementing regulations have resulted in different definitions of negligible and unacceptable risk, and the use of risk assessment has differed in decision-making and regulatory programs.

Improvement of Risk Communication: In communicating to various audiences about risks, risk assessors must seek a two-way interaction, learning about patterns of exposure, gaining an understanding of the different perceptions people have of what is a negligible risk and what is an unacceptable risk, and describing risks and uncertainties openly and understandably. Relying on overprecise single estimates of risk is unwarranted.

We support the use of comparisons of specific risks related to a proposed action with emphasis on chemically related agents, different agents to which humans might be exposed in similar ways, different sources of exposure to the same agents, and different agents that produce similar effects. Such context can help all stakeholders, including risk assessors, to understand the potential benefit of reducing exposures to an agent. We recommend that such risks be expressed in terms of potential adverse effects per year in a given community or exposed population, as well as per hypothetical lifetime.

Bright Lines: Bright lines are specific exposure concentrations or levels of risk that are meant to provide a clear distinction between what is considered safe and what is not. Bright lines can be useful as guideposts or goals for decision-making but should not be applied inflexibly, because of uncertainty about risks and susceptibility. We support the use of sets of bright lines to protect both the general population and specific populations potentially at higher risk, such as children and pregnant women. We do not support efforts by Congress to legislate particular bright lines.

Peer Review: We support efficient use of peer review, with care to exclude conflicts of financial interest, for both risk assessment and economic analysis. Peer-review quality and effectiveness should be evaluated regularly. We urge Congress to match resources to its demands on agencies for research, risk assessment, and economic analysis and to allow the agencies considerable discretion in allocating resources to their peer-review efforts.

Standards of Judicial Review: We recommend that judicial review be limited, as now, to final agency action, and that the existing arbitrary-and-capricious standard be retained as is.

The Commission developed findings and recommendations about several federal agencies and programs, partly to illustrate our general recommendations, partly to address inconsistencies, and partly to try to assist Congress and the agencies on particular matters.

Environmental Protection Agency: In the 1990 amendments to the Clean Air Act, Congress mandated that this Commission review and make recommendations on the analysis and treatment of residual risks associated with section 112 hazardous air pollutants after the completion of the current technology-based risk-reduction program. We present a tiered approach to set priorities for this huge effort. We recommend that residual risks associated with hazardous air pollutants be considered in the context of risks associated with the same pollutants from other sources and in the context of other risks to health.

We recommend more frequent determinations of future land use at the start of Superfund-site risk assessments, and updating of the Toxic Substances Control Act to reflect advances in the understanding of chemical toxicology. We endorse a comprehensive watershed-management approach to managing risks under the Clean Water Act.

Food and Drug Administration: We propose a substantial modification of the "Delaney clause", international harmonization of risk assessment and clinical-trial protocols for pharmaceuticals, and restoration of FDA's authority to require scientific evidence supporting health claims for dietary supplements.

Department of Agriculture: We recommend that risk assessment and benefit-cost analysis be performed early in the rule-making process instead of at the decision stage.

Department of Energy and Department of Defense: We propose further development and evaluation of risk-based approaches to priority-setting and budget-making.

NOTE: The entire report is a draft. Four critical monthly meetings scheduled to take place from October 1995 through January 1996 were canceled because of the budget negotiations. The Commission is particularly eager to have substantial public comment by August 9 and to modify its report for public release in October 1996.