Executive Summary
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, worker health and safety, 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 effective, more efficient, 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. We issued a Draft Report for public review and comment in June 1996, and introduced a framework for making risk management decisions. Based on the 130 formal comments that we received, on comments made at public meetings and scientific meetings, and on numerous informal discussions with stakeholders, we refined our recommendations to produce this Final Report to Congress and the President of the United States. Part 1 of our two-volume Final Report focuses solely on our Risk Management Framework and its implementation. It is a reader-friendly document explaining the Framework, the process of putting problems in public health context, and the strategies that can be used to stimulate effective stakeholder involvement. It has many real-world examples.
Now in Volume 2, we have revised the entire Draft Report to update our findings. We 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.
A New Risk Management Framework
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):
• Formulate the problem in broad context.
• Analyze the risks.
• Define the options.
• Make sound decisions.
• Take actions to implement the decisions.
• Perform an evaluation of the effectiveness of the actions taken.
The Framework explicitly embraces collaborative and early involvement of stakeholders; the process can be refined and its conclusions can be changed as important new information is acquired. The Framework requires 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. The Framework focuses on cumulative risks to human and environmental health and on addressing the benefits, costs, and social, cultural, ethical, political, and legal dimensions of risk reduction options. Our Framework is described in great detail in Volume 1 and is summarized in Section 2 of this volume.
The Commission’s 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 enacted 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. When individual environmental statutes are reauthorized, they can be modified to reflect the comprehensive nature of the Framework. The Framework is also applicable to risk management activities carried out by public and private entities at the state, regional, and local levels and through federal/state performance partnerships. 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.
Risk Management and Regulatory Decision-Making
Risk managers use information from risk assessment and economic analysis, together 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.
Improvement of Risk Communication: In communicating with various audiences about risks, risk assessors and risk managers 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 overly precise single estimates of risk is unjustified.
We support the use of comparisons of specific risks related to a proposed action. Such comparisons are most understandable and helpful when they involve chemically related agents, different sources of exposure to the same agents, different agents to which humans might be exposed in similar ways, 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.
We also recommend the identification and evaluation of a common metric to assist comparative risk assessment and risk communication related to both carcinogens and noncarcinogens. We have moved this recommendation from the toxicity assessment section to the risk communication section.
Bright Lines: Bright lines are specific exposure concentrations 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 variation in 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 recommend that Congress not legislate particular bright lines. In response to comments, we have clarified the differences between bright lines for measurable emissions, exposures, and contaminant concentrations and attempts to use bright bright lines for estimated low levels of probabilistic risks, which cannot be measured.
Standards for 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.
Uses and Limitations of Risk Assessment
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 cannot substitute for basic ignorance about the chemical’s toxicity to humans. 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 Scientific Advances 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.
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 influenced by 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.
Uses and Limitations of Economic Analysis
The Commission supports the use of economic analysis as a consideration, but not as the 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.
The Role of Peer Review
We support efficient use of peer review, with care to exclude financial conflicts, for both risk assessment and economic analysis. Overall quality and effectiveness of peer review practices should be evaluated periodically by the agencies. 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 for peer review.
Recommendations for Agencies
The Commission developed findings and recommendations about several federal agencies and programs in order to illustrate our general recommendations, address inconsistencies, and assist Congress and the agencies on particular matters. As agencies begin to comply with the Government Performance and Results Act of 1993, these recommendations may be helpful in identifying performance indicators.
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 management 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 and emphasize the critical need for more and better emissions and exposure data before meaningful analyses are possible. 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, in the context of other air pollutants, and in the context of other risks to health. We have clarified the tiered scheme presented in the Draft Report.
We recommend more frequent determinations of future land use at the start of Superfund site risk assessments and we endorse a comprehensive watershed management approach to managing risks under the Clean Water Act. We are pleased that our recommendations were accommodated in the 1996 Safe Drinking Water Act.
Occupational Safety and Health Administration: We recommend establishing guidelines for agency risk assessments and a streamlined process for developing permissible exposure limits for air contaminants in the workplace. We also endorse greater cooperation between OSHA and the National Institute for Occupational Safety and Health.
Food and Drug Administration: We recommend a substantial modification of the "Delaney clause" to a standard of reasonable certainty of no harm for all population groups, as was enacted in the Food Quality Protection Act of 1996. We endorse 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 for both microbial and chemical hazards.
Department of Energy and Department of Defense: We support further development and evaluation of risk-based approaches to priority-setting and budget-making for cleanup of contaminated sites at federal facilities.
The Commission will remain active until June 1997 to assist the Congress, the Administration, and various other interested parties in considering these recommendations and finding common ground with relevant proposals from others. The Commission believes that our Risk Management Framework will prove to be far more useful and effective than traditional regulatory approaches to solving common multimedia risk problems and, along with the other recommendations in our Final Report, will help improve risk management decision-making as we tackle the problems of the 21st Century.