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Summary Coping with risk situations can be complex and controversial. Government and industry have devoted considerable resources to developing and applying techniques of risk analysis and risk characterization in order to make better informed and more trustworthy decisions about hazards to human health, welfare, and the environment, yet these methods often fail to meet expectations that they can improve decision making. One reason lies in inadequacies in the techniques available for analyzing risks. A second is the fundamental and continuing uncertainty in information about risks. Another, less well appreciated, reason for the failure lies in a basic misconception of risk characterization. Risk characterization is often conceived as a summary or translation of the results of technical analysis for the use of a decision maker. Seen in this light, a risk characterization may fail for two reasons: it may portray the scientific and technical information in a way that leads to an unwise decision, or it may provide scientific and technical information in a way that is not useful for the decision maker. Although such failures do occur, an often overlooked danger to risk decision making is a fundamental misconception about how risk characterization should relate to the over- all process of comprehending and dealing with risk. We propose that it is necessary to reconceive risk characterization in order to increase the likelihood of achieving sound and acceptable deci- sions. We envision a process in which the characterization of risk emerges 1

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2 UNDERSTANDING RISK: INFORMING DECISIONS INA DEMOC~TIC SOCIETY from a combination of analysis and deliberation. We offer seven prin- ciples for implementing the process. Risk characterization should be a decision-driven activity, directed toward informing choices and solving problems. The view of risk characterization as a translation or summary is seri- ously deficient. What is needed for successful characterization of risk must be considered at the very beginning of the process of developing decision-relevant understanding. Risk characterization should not be an activity added at the end of risk analysis; rather, its needs should largely determine the scope and nature of risk analysis. The aim of risk characterization, and therefore of the analytic-delib- erative process on which it is based, is to describe a potentially hazardous situation in as accurate, thorough, and decision-relevant a manner as pos- sible, addressing the significant concerns of the interested and affected parties, and to make this information understandable and accessible to public officials and to the parties. Although risk characterizations are often completed for the benefit only of an organization's decision maker, it is important to recognize that various other parties use them when they exercise their rights to partici- pate in the decision, either before or after the organization acts. These interested and affected parties include legislators, judges, industry groups, environmentalists, citizens' groups, and a variety of others. Acceptance of risk decisions by the broad spectrum of the interested and affected parties is usually critical to their implementation. Risk characterization processes and products should provide all the decision participants with the information they need to make informed choices, in the form in which they need it. A risk characterization that fails to address their questions is likely to be criticized as irrelevant or incompetent, regardless of how carefully it addresses the questions it selects for attention. The appropriate level of effort for a risk characterization is situation specific. Judgment is critical in determining the amount, content, and timing of effort that are appropriate for supporting a particular risk char- acterization. Two things are critical: careful diagnosis of the decision situation to arrive at preliminary judgments and openness to reconsider- ing those judgments as the process moves along. The procedures that govern risk characterization should leave enough flexibility to be ex- panded or simplified to suit the needs of the decision. Coping with a risk situation requires a broad understanding of the relevant losses, harms, or consequences to the interested and affected parties.

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SUMMARY 3 A risk characterization must address what the interested and affected parties believe to be at risk in the particular situation, and it must incorpo- rate their perspectives and specialized knowledge. It may need to con- sider alternative sets of assumptions that may lead to divergent estimates of risk; to address social, economic, ecological, and ethical outcomes as well as consequences for human health and safety; and to consider out- comes for particular populations in addition to risks to whole popula- tions, maximally exposed individuals, or other standard affected groups. Under certain conditions, such as when the stakes are high and trust in the responsible organization is low, the organization may need to make special efforts to ensure that the interested and affected parties accept key underlying assumptions about risk-generating processes and risk estima- tion methods as reasonable. Adequate risk analysis and characterization thus depend on incorpo- rating the perspectives and knowledge of the interested and affected par- ties from the earliest phases of the effort to understand the risks. The challenges of asking the right questions, making the appropriate assump- tions, and finding the right ways to summarize information can be met by designing processes that pay appropriate attention to each of these judg- ments, inform them with the best available knowledge and the perspec- tives of the spectrum of decision participants, and make the choices through a process that those parties trust. Risk characterization is the outcome of an analytic-deliberative process. Its success depends critically on systematic analysis that is appropriate to the problem, responds to the needs of the interested and affected parties, and treats uncertainties of im- portance to the decision problem in a comprehensible way. Success also depends on deliberations that formulate the deci- sion problem, guide analysis to improve decision participants' understanding, seek the meaning of analytic findings and un- certainties, and improve the ability of interested and affected parties to participate effectively in the risk decision process. The process must have an appropriately diverse participation or representation of the spectrum of interested and affected par- ties, of decision makers, and of specialists in risk analysis, at each step. Analysis and deliberation can be thought of as two complementary approaches to gaining knowledge about the world, forming understand- ings on the basis of knowledge, and reaching agreement among people. Analysis uses rigorous, replicable methods, evaluated under the agreed protocols of an expert community such as those of disciplines in the

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4 UNDERSTANDING RISK: INFORMING DECISIONS INA DEMOC~TIC SOCIETY natural, social, or decision sciences, as well as mathematics, logic, and law to arrive at answers to factual questions. Deliberation is any formal or informal process for communication and collective consideration of issues. Participants in deliberation discuss, ponder, exchange observa- tions and views, reflect upon information and judgments concerning mat- ters of mutual interest, and attempt to persuade each other. Government agencies should start from the presumption that both analysis and delib- eration will be needed at each step leading to a risk characterization. Deliberation is important at each step of the process that informs risk decisions, such as deciding which harms to analyze and how to describe scientific uncertainty and disagreement. Appropriately structured delib- eration contributes to sound analysis by adding knowledge and perspec- tives that improve understanding and contributes to the acceptability of risk characterization by addressing potentially sensitive procedural con cerns. Deliberation needs to be broader and more extensive for some deci- sions and at some steps than others. It should have, in addition to the involvement of appropriate policy makers and scientific and technical specialists, sufficiently diverse participation from across the spectrum of interested and affected parties to ensure that the important, decision- relevant knowledge enters the process, that the important perspectives are considered, and that the parties' legitimate concerns about the inclu- siveness and openness of the process are addressed. Organizing appropriately broad deliberation presents significant chal- lenges, including managing scarce resources, setting realistic expectations, identifying all the parties that should be involved, and nurturing the process. On the basis of limited research on deliberative methods, we can specify four guidelines. First, although potentially more time-consuming and cumbersome in the near term, it is often wiser to err on the side of too-broad rather than too-narrow participation. Organizations should seriously assess the need for involvement of the spectrum of interested and affected parties at each step, with a presumption in favor of involvement. If some parties that are unorganized, inexperienced in regulatory policy, or unfamiliar with risk- related science are particularly at risk and may have critical information about the risk situation, it is worthwhile for responsible organizations to arrange for technical assistance to be provided to them from sources that they trust. Broad participation is often needed "early" in the process, and especially in problem formulation. Second, the conveners of deliberative processes should clearly and explicitly inform participants at the outset about the legal, budgetary, or other external constraints likely to affect the extent of deliberation pos- sible or how the input from deliberation will be used.

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SUMMARY s Third, deliberative processes should strive for fairness in selecting participants and in providing, as appropriate, access to expertise, infor- mation, and other resources for parties that normally lack these resources. Fourth, managers should build flexibility into deliberative processes, including procedures for responding to requests to reconsider past deci- sions or to change procedures within externally established limits of time or resources. It must be recognized that even when successful, delibera- tion cannot be expected to end all controversy. It will not guarantee that decision makers will pay attention to deliberation's outcomes, prevent dissatisfied parties from seeking to delay or override the process, or re- dress the situation in which legal guidelines mandate that decisions be based on a different set of considerations from those that participants believe appropriate. Analysis is the best source of reliable, replicable information about hazards and exposures, and as such it is essential for good risk character- ization. Relevant analysis, in quantitative or qualitative form, strength- ens the knowledge base for deliberations: without good analysis, delib- erative processes can arrive at agreements that are unwise or not feasible. The chief challenges are to follow in practice analytic principles that are widely accepted and to recognize the limitations of analysis. Much attention has been recently given to analytic techniques for benefit-cost analysis and for making quantitative risk comparisons that attempt to reduce many dimensions of risk to one as an aid to decision making. These techniques necessarily simplify real-world situations and require value choices among dimensions of risk. Value judgments that are left implicit in analytic techniques and that are made without broad- based deliberation can cause many difficulties. The key to successful use of these techniques is that a broadly based deliberative process helps shape the analysis, determining which particular techniques are used, and how their results are interpreted. Much attention has been given to quantitative, analytic procedures for describing uncertainty in risk characterizations. Participants in deci signs need to consider both the magnitude of uncertainty and its sources and character: whether it is due to inherent randomness or to lack of knowledge; and whether it is recognized and quantifiable, recognized and indeterminate; or perhaps unrecognized. Unfortunately, the unrec- ognized sources of uncertainty surprise and fundamental ignorance about the basic processes that drive risk are often important sources of uncertainty, and formal analysis may not help if they are too large. Thus, uncertainty analysis should be conducted with care and in conjunction with deliberation and in full awareness of its limitations, especially in the face of unrecognized sources of uncertainty. It is best to focus on uncer- tainties that matter most to ongoing processes of deliberation and deci

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6 UNDERSTANDING RISK: INFORMING DECISIONS IN A DEMOCRATIC SOCIETY sign. The users of uncertainty analysis should remember that both the analysis and people's interpretations of it can be strongly affected by the social, cultural, and institutional context of the decision. The analytic-deliberative process leading to a risk characteriza- tion should include early and explicit attention to problewfor- mulation; representation of the spectrum of interested and af- fected parties at this early stage is imperative. The analytic-deliberative process should be mutual and recur- sive. Analysis and deliberation are complementary and must be integrated throughout the process leading to risk characteriza- tion: deliberation frames analysis, analysis informs delibera- tion, and the process benefits from feedback between the two. A recurring criticism of risk characterizations is that the underlying analysis failed to pay adequate attention to questions of central concern to some of the interested and affected parties. This is not so much a failure of analysis as a failure to integrate it with broadly based deliberation: the analysis was not framed by adequate understanding about what should be analyzed. Organizations need to be creative in integrating these two processes. Although a very broad analytic-deliberative process will be appropriate in relatively few instances, those instances have an impor- tance disproportionate to their number. Moreover, it is not always evi- dent in advance whether a risk characterization will require extensive deliberation, integrated with analysis. A key practical problem for organizations is resolving the tension between the desire for more analysis and deliberation and the need to reach closure. Reaching closure is likely to be most difficult when inter- ests are in strong opposition, when the number of participants is large, and when differences are based on fundamental values. Organizations should consider having the participants in a deliberation adopt proce- dural rules that enable closure even when substantial disagreements ex- ist. They should also consider two reasons to delay closure: to allow all parties to hear others and be heard and to bring to the surface additional information and concerns that will need to be considered. Structuring an effective analytic-deliberative process for informing a risk decision is not a matter for a recipe Every step involves judgment, and the right choices are situation dependent. Still, it is possible to iden- tify objectives that also serve as criteria for judging success: · Getting the science right: The underlying analysis meets high scien- tific standards in terms of measurement, analytic methods, data bases used, plausibility of assumptions, and respectfulness of both the magni

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SUMMARY 7 tude and the character of uncertainty, taking into consideration limita- tions that may have been placed on the analysis because of the level of effort judged appropriate for informing the decision. · Getting the right science: The analysis has addressed the significant risk-related concerns of public officials and the spectrum of interested and affected parties, such as risks to health, economic well-being, and ecological and social values, with analytic priorities having been set so as to emphasize the issues most relevant to the decision. · Getting the right participation: The analytic-deliberative process has had sufficiently broad participation to ensure that the important, deci- sion-relevant information enters the process, that all important perspec- tives are considered, and that the parties' legitimate concerns about inclu- sisreness and openness are met. · Getting the participation right: The analytic-deliberative process sat- isfies the decision makers and interested and affected parties that it is responsive to their needs: that their information, viewpoints, and con- cerns have been adequately represented and taken into account; that they have been adequately consulted; and that their participation has been able to affect the way risk problems are defined and understood. · Developing an accurate, balanced, and informative synthesis: The risk characterization presents the state of knowledge, uncertainty, and dis- agreement about the risk situation to reflect the range of relevant knowl- edge and perspectives and satisfies the parties to a decision that they have been adequately informed within the limits of available knowledge. An accurate and balanced synthesis treats the limits of scientific knowledge (i.e., the various kinds of uncertainty, indeterminacy, and ignorance) with an appropriate mixture of analytic and deliberative techniques. These criteria are related. To be decision-relevant, risk characteriza- tion must be accurate, balanced, and informative. This requires getting the science right and getting the right science. Participation helps ask the right questions of the science, check the plausibility of assumptions, and ensure that any synthesis is both balanced and informative Those responsible for a risk characterization should begin by developing a provisional diagnosis of the decision situation so that they can better match the analytic-deliberative process lead ing to the characterization to the needs of the decision, particu larly ire terms of level and intensity of effort and representation of parties. An agency or organization responsible for risk characterization be- gins with a diagnosis explicit or implicit that includes, at minimum, ideas about the nature of a hazard situation, the purposes for which risk

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~ UNDERSTANDING RISK: INFORMING DECISIONS IN A DEMOCRATIC SOCIETY characterization will be used, the kinds of information that will probably be needed, and the kind of decision to be made. Diagnosis should be conducted explicitly far more often than is current practice. Diagnosis begins with surveying what we call the risk-decision landscape, to see what decisions will need to be made. Risk characterization requires dif- ferent kinds of effort for different categories of decisions. For instance, unique and wide-impact decisions tend to create strong needs for breadth, inclusion, and attention to process; in contrast, for many routine, narrow- impact decisions, a simple, generic risk characterization procedure may suffice. Decisions to simplify should be taken with care, however, be- cause an inappropriate or inflexible decision to use a narrow, routinized, or nonparticipatory process for risk characterization can undermine the decision-making process. Diagnosis of risk decision situations should follow eight steps: diag- nose the kind of risk and the state of knowledge, describe the legal man- date, describe the purpose of the risk decision, describe the affected par- ties and anticipate public reactions, estimate resource needs and timetable, plan for organizational needs, develop a preliminary process design, and summarize and discuss the diagnosis within the responsible organiza- tion. Diagnosis should result in a commitment within the responsible organization about the nature and level of effort of the analytic-delibera- tive process leading to a risk characterization. Officials of the responsible organization should, however, treat the diagnosis as tentative and remain open to change, always keeping in mind that their goal is a process that leads to a useful and credible risk characterization. Each organization responsible for making risk decisions should work to build organizational capability to conform to the prin- ciples of sound risk characterization. At a minimum, it should pay attention to organizational changes and staff training ef- forts that might be required) to ways of improving practice by learning from experience, and to both costs and benefits in terms of the organization's mission and budget. These principles may be difficult to follow, particularly with respect to increasing input from some interested and affected parties, involving nonscientists in deliberations about risk analysis, broadening the range of adverse outcomes to consider in risk analysis, and more fully integrating analysis and deliberation, all of which may appear to prolong the decision process or increase its complexity. While we are sensitive to concerns about cost and delay, we note that huge costs and delays have sometimes resulted when a risk situation was inadequately diagnosed, a problem misformulated, key interested and affected parties did not participate, or

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SUMMARY .9 analysis proceeded unintegrated with deliberation. We believe that fol- lowing the above principles can reduce delays and costs as much as or more than it increases them. It is beneficial over time for an organization to use a broad analytic- deliberative process to get the characterization right the first time to accept immediate costs to avoid greater future costs. We recognize that parties dissatisfied with a risk characterization or risk decision may some- times seek redress through court challenges or other means. This is to be expected in a democracy, although it adds expense and may constrain efforts to involve the full range of interested and affected parties. It is critical for the organizations responsible for characterizing risk to have the capability to organize a full range of analytic-deliberative proc- esses, including the broadly participatory ones that some risk situations warrant. It is also critical that they develop the capability to cope with attempts by some interested and affected parties to delay decision, and to develop a range of strategies for reaching closure. To these ends, each organization responsible for risk characterization should consider mak- ing special efforts in training staff; acquiring analytic expertise with re- gard to ecological, social, economic, or ethical outcomes; and making organizational changes to improve communication across subunits and to allow for the flexibility and judgment necessary to match the process to the decision. Every organization should implement explicit practices to promote systematic learning from its efforts to inform and make risk decisions, so as to improve analytic-deliberative processes. It should work with the interested and affected parties to define criteria for evaluating these proc- esses. It should devise systems of evaluation and feedback to allow for mid-course corrections that save time and money, pretesting of materials summarizing risk information, and the use of retrospective analysis to improve future efforts. In addition, institutions that provide scientific support for these organizations, such as federal scientific agencies and industry-based research institutes, should support systematic efforts that build knowledge about analytic-deliberative processes and that may have general value for many organizations. Evaluation or feedback should take a form appropriate to the scale and nature of the analytic-deliberative process. Evaluation is important both during and after the process. It can use a variety of formal and informal methods, including surveys, experimental tests of informational materials, evaluation research methods, simulations, quasi-experimental evaluations of new procedures, feedback from broadly based advisory groups that review past practice, and systematic case study research on libraries of case files. An expanded concept of risk characterization raises legitimate ques

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10 UNDERSTANDING RISK: INFORMING DECISIONS INA DEMOCRATIC SOCIETY lions about practicality, such as whether it would unacceptably increase the costs and time for making decisions and whether any increased costs would lead to better or more acceptable decisions. These are reasonable concerns, but we believe, on balance, that the process we propose is likely to improve outcomes. Experience shows that analyses, no matter how thorough, that do not address the decision-relevant questions, use reason- able assumptions, and meaningfully include the key affected parties can result in huge expenses and long delays and jeopardize the quality of understanding and the acceptability of the final decisions. These dangers associated with past approaches to risk characterization are sufficient in our judgment to warrant making a serious trial of the broader concept. We also emphasize that the approach we propose expands the process only as appropriate to specific situations: ~. . .. . . . . . For many risk issues, relatively little change will be needed in risk characterization; for some of society's most important risk issues, however, a broad and extensive analytic- deliberative process can lead to better informed and more widely accept- able decisions.