Understanding Risk Informing Decisions in a Democratic Society (1996) / Chapter Skim
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1 THE IDEA OF RISK CHARACTERIZATION
1 THE IDEA OF RISK CHARACTERIZATION
Pages 11-36
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From page 11... ...
Risk characterization involves complex, valueladen judgments and a need for effective dialogue between technical experts and interested and affected citizens who may lack technical expertise, yet have essential information and often hold strong views and substantial power in our democratic society. See Glossary for the terms used in this volume.
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From page 12... ...
Many groups before us have studied aspects of risk decision-making processes in order to improve decisions. We undertook this study to evaluate and make recommendations about risk characterization, described in the committee's initial task statement as the part of the decision process at which "the information in a risk assessment is translated into a form usable by a risk manager, individual decision maker, or the public." Stating the committee's charge in this way highlights a central dilemma of risk decision making in a democracy: detailed scientific and technical information is essential for understanding risks and making wise decisions about them, yet the people responsible for making the decisions and the people affected by the decisions and who may therefore also take part in them are not themselves expert in the relevant science and technology.
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From page 13... ...
Third, we find that in order to improve risk characterization, one must consider other parts of the risk decision process, particularly the various analytic activities that provide the information used in characterizing risks. The purpose of risk characterization is to improve understanding of risk, and everything that goes into such understanding is necessary for effective risk characterization.
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From page 14... ...
Figure 1-1, taken from the Red Book, schematically represents the traditional view of risk characterization and its relations to the other elements of risk decision making. In this schema (National Research Council, 1983:28)
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From page 16... ...
reflect both analysis and deliberation, with appropriate input from the interested and affected parties, and (4) be appropriate to the decision.3 The rest of this section describes and illustrates these four facets of risk characterization and the risk decision process.
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From page 17... ...
Among the most likely present uses for such a risk characterization are to inform decisions concerning operating permits for municipal and industrial facilities, siting waste incinerators, making policy decisions about Vietnam veterans exposed to dioxin, and remediating Superfund sites. Yet in all of these contexts, dioxin is only one of many hazardous chemicals involved and cancer is only one of many outcomes of concern, so dioxin-induced cancer is at best only part of the problem and a dioxin risk characterization, though relevant, can only hope to provide some of the information needed for the decision.
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From page 18... ...
In the Yucca Mountain case, the government's risk characterizations seem to have relied too much on only one subset of scientific information, presuming that it was obvious which question needed to be answered. Opponents were concerned with a different set of issues, which were not addressed in the risk analyses, such as the fairness of placing nuclear waste in a region that does not have any nuclear power plants and is already host to the nation's nuclear testing facility (several such concerns are listed in National Research Council, 1995:21-23~.
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From page 19... ...
Recognizing All Significant Concerns The people who participate in risk decisions public officials, experts in risk analysis, and interested and affected parties may be concerned with a variety of possible harms or losses. Sometimes, risks to social, ethical, or ecological values are at least as important as risks to health and safety.
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From page 20... ...
Another was that delaying definitive risk analysis until test burns were performed might permit so much investment in construction and testing that government could not then refuse the incinerator, regardless of the results of the risk assessments. Because of this concern, some of the neighbors distrusted the entire risk assessment process.
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From page 21... ...
The composition of untreated water was important to some of the interested and affected parties because they wanted to consider rules allowing non-chlorine disinfectant technologies. To consider the feasibility and wisdom of using such technologies would require additional analysis, using new information.
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From page 22... ...
It is likely to be necessary to develop unique procedures for characterizing risk in these situations. Some examples of procedures involving repetitive risk decisions are those for reapproving existing permits for discharge of pollutants from industrial plants, for testing new drugs prior to approval decisions, for issuing Remanufacturing approval for the industrial production of new chemicals, and for deciding whether to exclude an individual from receiving a vaccine or giving blood.
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From page 23... ...
PARTICIPATION AND KNOWLEDGE IN RISK DECISIONS In the framework we have outlined, risk characterization cannot succeed as an activity added at the end of a risk analysis, but must result from a recursive process that includes problem formulation, analysis, and deliberation. Two essential aspects of that process are appropriately broad participation by the interested and affected parties and appropriate incorporation of science.
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From page 24... ...
In particular, risk analysis often needs the substantive and methodological expertise of the economic, social, and behavioral sciences: for instance, effects on property values, tourism, scenic value, human population migrations, fairness, and public trust in government may be important outcomes of risk decisions, and
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From page 25... ...
The assumption of the null hypothesis as used in risk analysis contains an implicit bias because it places a greater burden of proof on those who would restrict than those who would pursue a hazardous activity, presuming these activities are safe until proven otherwise. Evidence that science has been censored or distorted to favor particular interested parties has long been a source of conflict over risk characterizations (e.g., Rosner and Markowitz, 1985; Lilienfeld, 1991~.
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From page 26... ...
This point deserves special emphasis in the light of recent proposals for "risk-based" decision rules that could tie public risk decisions to standardized technical procedures of risk analysis. Risk decisions are, ultimately, public policy choices.
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From page 27... ...
The rest of this chapter specifies the role of risk characterization in this process; the rest of the book elaborates on the key elements in the figure and on ways to improve risk characterization. A New Definition and Its Implications We begin with a definition of risk characterization and then elaborate key parts of it: Risk characterization is a synthesis and summary of information about a potentially hazardous situation that addresses the needs and interests of decision makers and of interested and affected parties.
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From page 29... ...
In principle, the full range of potential harms and losses from a hazard is appropriate for treatment in a risk characterization. In addition to the biological and physical outcomes that are typically covered, decision makers and interested and affected parties often need to know about the significant economic costs and benefits of alternatives, the secondary effects of hazard events, or the efficacy of alternative regulatory mechanisms.
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From page 30... ...
Public officials and some scientists are usually included in the process that leads to risk characterization, but the interested and affected parties are sometimes overlooked. Their inclusion is critical to ensure that all relevant information is included, that it is synthesized in a way that addresses the parties' concerns, and that those who may be affected by a risk decision are sufficiently well informed and involved to participate meaningfully in the decision.
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From page 31... ...
In both conceptions, risk characterization involves synthesizing or summarizing information; the difference lies in who is involved in producing the characterization, what is synthesized, and how. In Figure 1-1, risk characterization is an activity conducted by experts in risk analysis that synthesizes or summarizes the results of analytical work by the same or similar experts.
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From page 32... ...
Before the 1970s, much of the deliberation that drove federal risk decisions occurred in Congress; by the time agency officials entered the process, legislation had already formulated the problems, defined the decision processes, and identified the adverse outcomes that would trigger regulatory action. Regulatory agen
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From page 33... ...
Over the past two decades, however, agencies have increasingly been called on to conduct risk analyses with less well-specified purposes-for example, to call to legislative attention new problems that may require regulation; to assess loosely formulated risk problems, such as those involving risks to ecosystems; and to address local issues, such as those of hazardous wastes, where legislation has not specified how agencies should arrive at decisions or which outcomes they should consider. A narrow concept of risk characterization and a linear view of the risk decision process may have been adequate when an organization was dealing with only a small part of the process; now, when public agencies are routinely responsible for much more of the process, a broader view is necessary.
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From page 34... ...
Our judgment partly reflects several developments since 1983. Risk characterizations have been needed for a much wider range of policy questions, including many in which the nature of the problem and the identity of the available choices is not at all obvious; articulate and scientifically informed public opposition to risk decisions has revealed gaps in many risk analyses; experiences with risk communication have demonstrated that official summaries of risk are often incomprehensible, confusing, or irrelevant to many of the affected parties; and public trust in many of the organizations that conduct risk assessments has declined.
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From page 35... ...
Methods of risk analysis can make only a limited contribution to improving such judgments. Progress can be made, however, by strengthening the processes, only some of which are analytical in nature, that are used for informing risk decisions.
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From page 36... ...
Chapter 7 presents a set of principles for implementing the process and approach to risk characterization that we advocate. Appendix A details some of the risk decision cases that are referred to briefly throughout the text, and Appendix B briefly discusses some common approaches to deliberation and public participation, noting the research literatures on them.
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