Chapter 1, Introduction of the Risk Commission Final Report, Vol. 2

This report authored by the Commission on Risk Assessment and Risk Management, proposes a major new era in environmental and health protection. Our Framework for Risk Management puts particular risks in both a public health and ecological context, involves stakeholders from the earliest stages, and moves beyond the one-chemical, one-risk, medium-by-medium approach of most current regulation.

The Commission on Risk Assessment and Risk Management was mandated by Congress in the 1990 amendments to the Clean Air Act to address the assessment and management of risks that are regulated under the many laws aimed at protecting both the environment and the health and safety of the American people from potentially dangerous exposures to chemicals and other hazardous substances in air, water, food, the workplace, and consumer products. Of the ten members of the Commission, three were appointed by the president, six by the majority and minority leaders of the House and Senate, and one by the president of the National Academy of Sciences. Biographies of the Commissioners appear in Appendix A1.

The Commission’s mandate (see Appendix A2) is summarized in the following phrases:

The Clinton Administration subsequently asked the Commission to comment on the conclusions of Science and Judgment in Risk Assessment (NRC 1994a) (see Appendix A3) and to make recommendations about peer review.

Congress decided to create the Commission when agreement could not be reached, during drafting of the 1990 Clean Air Act Amendments, on the best way for the U.S. Environmental Protection Agency (EPA) to determine whether any significant risks to human health will remain after the implementation of technology-based controls to reduce hazardous pollutant emissions from stationary sources and, if so, what to do about those residual risks. Disagreement persisted about the risk assessment techniques and assumptions that should be used to estimate such residual risks, about the benchmarks to distinguish between negligible and unacceptable risks, and about the risk management methods to mitigate unacceptable risks. The Commission’s mandate is not restricted to evaluating air pollution, the particulars of the Clean Air Act, or even the EPA. It is, however, limited to assessing "cancer and other chronic human health effects," so we have not addressed physical safety or acute-exposure health hazards nor such environmental problems as global climate change, ozone depletion in the stratosphere, and protection of wetlands and other habitats. In this report we do discuss the dependence of human health on a healthy environment, the applicability of the general approaches of health risk assessment to ecological risk assessment, and the need for benefit-cost analyses of proposed actions to assess benefits beyond those to human health.

Through our deliberations, the Commission developed a shared vision of a sustainable environment, economy, and society. Like the National Commission on the Environment (1992) and the President’s Council on Sustainable Development (1996), we seek a convergence of economic and environmental goals and actions. We also recognize the need to encompass the diverse socioeconomic conditions and cultural practices of the people of this nation. Finally, we propose a comprehensive, risk-based approach that puts specific actions in a public health and ecological context.

The public recognition of environmental problems has produced tremendous improvement during the last 25 years in air quality, water quality, safety at work, safety of consumer products (including drugs and foods), testing of new chemicals before they are introduced into commerce, cleanup and disposal of hazardous wastes, and scientific study of the health and ecological effects of chemicals, radiation, and microorganisms. Historically, improvements in the health of the public have come primarily from environmental interventions, such as proper waste disposal, industrial hygiene, quarantines, clean water, and vaccines. Although many federal environmental laws have an overarching goal of protecting the public’s health and the environment, most environmental statutes have been media-specific and have relied on regulatory rather than public health approaches.

Only continued action can sustain the progress of the last 25 years, especially as the economy and the population grow and new technologies emerge. We believe that the effort will be most effective if regulatory and public health agencies work together.

What Is Risk?

Risk is defined as the probability that a substance or situation will produce harm under specified conditions. Risk is a combination of two factors:

• The probability that an adverse event will occur (such as a specific disease or type of injury).

• The consequences of the adverse event.

Risk encompasses impacts on public health and on the environment, and arises from exposure and hazard. Risk does not exist if exposure to a harmful substance or situation does not or will not occur. Hazard is determined by whether a particular substance or situation has the potential to cause harmful effects.

What Is Risk Assessment?

Risk assessment is the systematic, scientific characterization of potential adverse effects of human or ecological exposures to hazardous agents or activities. Risk assessment is performed by considering the types of hazards, the extent of exposure to the hazards, and information about the relationship between exposures and responses, including variation in susceptibility. Adverse effects or responses could result from exposures to chemicals, microorganisms, radiation, or natural events.

What Is Risk Management?

Risk management is the process of identifying, evaluating, selecting, and implementing actions to reduce risk to human health and to ecosystems. The goal of risk management is scientifically sound, cost-effective, integrated actions that reduce or prevent risks while taking into account social, cultural, ethical, political, and legal considerations.

Risk is a combination of the probability of an adverse event and the nature and severity of the event. We deal with risks all the time in everyday life—risks to our health, our environment, our pocketbooks, our social relationships. Risk is time-related, ranging from immediate consequences of various actions or lack of action to consequences over a lifetime for an individual and much longer periods for the whole society or the planet. We make decisions to avoid risks, to reduce risks, to reduce the consequences of events, and to insure against the financial consequences of risks. We tend to downplay some risks; we find others frightening. Of course, people vary in their assessments of risk, and their actions or concerns tend to vary accordingly. Often, the people who face specific risks are different from the people who benefit from the products or activities that generate the risks, leading to conflict and litigation over proposed risk-reduction actions. Risk assessment itself has become controversial because of its important role in the protection of human health and the environment.

A generally accepted framework and nomenclature for health risk assessment was established in 1983 by a National Academy of Sciences committee report, Risk Assessment in the Federal Government: Managing the Process (NRC 1983). The now universally recognized four-step framework for characterizing the likelihood of adverse health effects from particular chemical exposures is described briefly below and shown in the context of scientific issues and regulatory impact in Figure 1.1.

Congress directed the Commission to focus on what it called "chronic health effects," meaning effects that do not occur immediately—unlike injuries from falling off a construction platform—but are the result of exposures that might take months, years, or decades to manifest as health problems. Risks from chronic exposures arise from activities associated with the use and production of food, energy, industrial and consumer goods, and from the wastes produced through daily living. We recognize that voluntary uses of specific consumer products are also major contributors to death and poor health. Cigarette smoking leads the list by a wide margin, accounting for an estimated 400,000 deaths every year; use of alcoholic beverages, for about 100,000 deaths; and motor vehicle collisions for about 25,000 deaths.

While individual sources of contaminants may contribute little to overall public health risks, the risk may be substantial when viewed collectively. As an example, 60,000 deaths per year have been attributed to occupational and environmental chemical exposures of all types (McGinnis and Foege 1993). A more recent estimate attributes up to 60,000 deaths per year to particulate air pollution (Shprentz et al. 1996). Aggregating and setting priorities among environmental problems would allow them to compete for attention and resources with other public health problems.

Although people most fear cancer as a cause of death, cancer is not the only health concern associated with environmental pollutants. Reproductive impairments, birth abnormalities, asthma and other respiratory diseases, and effects on all the organ systems of the body warrant serious attention from a risk management and disease prevention perspective. Even when those health effects have modest impacts on mortality, they may be important burdens on the quality of life.

Risk assessment goes beyond scientific observations of exposures and effects in people, animals, or test systems to investigating social questions about what is unsafe. There is a difference between what can be studied experimentally or be observed directly and what represents policy-driven extrapolation based on scientific inferences and many assumptions. The 1994 National Research Council report Science and Judgment in Risk Assessment captured this combination of science and values in its title. The usefulness, credibility, and validity of risk assessments would be greatly enhanced by generating more data and relying on fewer assumptions.

We face a huge challenge to manage comprehensively the health risks associated with the vast array of pollution-generating activities in this country. Actions that reduce hazardous substance emissions or exposures can reduce risks to health. Our regulatory agencies are expected to control potential cancer risks, for example, down to an extremely low level. A limit of less than one extra cancer death from a particular chemical per one million persons exposed over a 70-year lifetime is commonly used for screening purposes; when exceeded, such risk levels serve as a justification for seeking monitoring data to more accurately characterize exposures and risks or for taking actions to reduce exposures. In contrast, risk criteria used in regulating occupational exposure to specific chemicals often correspond to about one extra cancer death among a hypothetical 1,000 workers exposed over a working lifetime. For noncancer risks, regulatory agencies aim to reduce exposures below presumed threshold levels for adverse effects.

As directed by Congress and reinforced by the Clinton Administration, we have framed our analyses and recommendations from the perspective of risk management. What are the community, public health, and environmental contexts for formulating a particular problem, characterizing its risks, choosing a course of action, and evaluating the impact of such actions? How do we use the tools of risk assessment and of economic analysis and consider social and cultural information to make more efficient, more understandable, and less costly decisions about reducing risks that are judged to be too high? How do we make decisions when information about risks, benefits, and costs is incomplete or uncertain? How do we compare risks and risk-reduction actions of various kinds to determine which deserve higher priority? It is crucial to reach out to affected parties and communities to obtain knowledge about the nature of past and present exposures and to understand their concerns and perceptions about the risks under discussion and related risks. Communication about risks is a two-way process.

To address those questions, in June 1996 the Commission proposed a comprehensive Risk Management Framework for making decisions about reducing risks to public health and the environment. The process includes detailed consideration of risk and cost and provides a context for social and cultural considerations. One important feature of the Framework is its explicit involvement of stakeholders in decisions about how to reduce the risks that affect them, through consensus or despite disagreement, depending on the circumstances. Another feature is the integrated, multimedia approach the Framework takes to address multiple risks instead of individual risks. Public comments on the Draft Report showed strong support for the Framework and its key elements of context and stakeholder involvement, but emphasized the clear need for more and better data to support evaluations of risk.

This report is Volume 2 of the Commission’s Final Report. Volume 1 focuses exclusively on the characteristics and implementation of the Commission’s Framework for Risk Management, in response to public comments advising that the Framework be clarified and illustrated in a format broadly accessible to diverse stakeholders.

Both volumes are the product of the Commission’s hearings and deliberations since May 1994 and address concerns of those who provided testimony before the Commission (Appendix A4), concerns of those who provided comments on our June 1996 Draft Report (Appendices A5 and A6), and points raised in issue papers prepared for the Commission by several experts (Appendix A7).

Section 2 following this introduction describes the Framework and its application. Section 3 addresses ways to improve risk communication and risk management. Section 4 provides guidance on how to approach risk assessment. Section 5 provides guidance for analysis of the options and costs of potential risk reduction actions. Section 6 focuses on the role of peer review in risk assessment and risk management. Finally, Section 7 offers recommendations for specific federal regulatory agencies and programs. The Final Report, the reports abstracted in Appendix A7, and the June 1996 Draft Report are available from the Commission’s home page on the internet at http://www.riskworld.com.