2. FRAMEWORK FOR RISK MANAGEMENT


It is time to change the traditional approaches to assessing and reducing environmental, health, and safety risks, which have relied on a chemical-by-chemical, medium-by-medium, risk-by-risk strategy. That strategy evolved from multiple, unrelated statutory requirements from the various Congressional subcommittees that have jurisdiction over agencies responsible for protecting health and the environment. The result is our highly fragmented and adversarial system of conflicting actions that ignores the interdependence of environmental components, emphasizes the differences instead of the similarities between cancer and other health effects, and investigates risks associated with individual purified chemicals instead of environmental mixtures of chemicals.

Many effective risk-management decisions certainly have been made, but many other decisions have left stakeholders unhappy or problems only partly addressed. Testimony received from the U.S. Department of Energy (DOE) Office of Integrated Risk Management, the U.S. Environmental Protection Agency (EPA) deputy and assistant administrators, and the public repeatedly emphasized the need to address multiple chemical exposures and called for our environment to be addressed as a system, not as a fragmented collection of individual risks. A related difficulty is the need to combine characterizations of risks to health and the environment with values, perceptions, and concerns of affected parties, especially nontechnical people and communities.

Moving toward integrated, effective environmental management requires a risk-management framework that can engage a wide range of stakeholders and address the interdependence and cumulative effects of various problems. The framework must have the capacity to address various media, contaminants, and sources of exposure and an array of public values, perceptions, and ethics. It should be sufficiently understandable to be adopted and used by risk managers in a wide variety of situations and lead to acceptable and effective decisions. It should be flexible so that its use can be matched to the importance of the decisions to be made. Full implementation of the framework for federal programs will lead to a need for Congressional authorization and funding; however, much progress can be made with existing statutes.

The overarching goal of the Commission's framework for integrated risk management is to move beyond "end-of-the-pipe" command-and-control approaches to environmental protection toward means of achieving sustainable development. Such an ethic of environmental stewardship requires an understanding of the connections between environmental health, human and economic well-being, and the processes by which our society's actions create long-term changes, both beneficial and adverse.

The Commission believes that the integrated risk-management framework described here is timely. It is consistent with regulatory-reform goals of stimulating economic progress while improving the effectiveness of environmental protection and sustaining the accomplishments of the last 25 years of environmental regulation. Thus, it is consistent with the goals of the President's Council on Sustainable Development--to ensure that every person enjoys the benefits of clean air, clean water, and a healthy environment while maintaining economic prosperity and creating full opportunity for citizens, businesses, and communities to participate in and influence the natural-resource, environmental, and economic decisions that affect them (PCSD 1996). Its insistence on collaborative stakeholder involvement and empowerment, its commitment to place each problem in a public-health context, and its use, when appropriate, in an iterative manner to refine regulatory decisions make it applicable to diverse environmental regulatory problems. Although the Commission's mandate was to evaluate risk-management decision-making at the federal level, the framework is applicable to all levels of decision-making.

The framework reflects the importance of "participatory democracy" in resolving environmental dilemmas (Ruckelshaus 1995). It is consistent with testimony calling for risk-management partnerships among government, industry, and the public. For example, Walter Fields, of the National Association for the Advancement of Colored People (NAACP) in New Jersey, urged the Commission to define specific steps needed to bring communities into the risk-assessment and risk-management processes and to enable communities to engage in honest dialogues with industries. The Commission received similar testimony from a variety of people all over the United States, including Michael McCloskey, chairman of the Sierra Club; Linda Greer, of the Natural Resources Defense Council; Mark Van Putten, of the National Wildlife Federation; Peter Raven, of the Missouri Botanical Garden; Ronald Selph, mayor of Granite City, Illinois; Carol Henry, director of the DOE Office of Risk Management; and Phillip Lewis, of Rohm and Haas Company, Philadelphia. The framework incorporates various principles and recommendations set forth by the Carnegie Commission report Risk and the Environment: Improving Regulatory Decision Making, the National Commission on the Environment report Choosing a Sustainable Future, the National Research Council report Science and Judgment in Risk Assessment, the Annapolis Accords for Risk Analysis, the Harvard Group on Risk Management Reform, and the National Academy of Public Administration report Setting Priorities, Getting Results.

FINDING 2.1: After many years of management of environmental, health, and safety risks in the United States, there is still no generally accepted or uniformly applied framework or set of principles for making risk-management decisions. Current efforts to manage risks are often fragmented and sometimes in conflict, often reflecting different statutes. In addition, there is no systematic process for integrating public values, perceptions, ethics, and other cultural considerations into risk-management decisions.

RECOMMENDATION: A systematic, comprehensive risk-management framework should be used to reduce environmental, health, and safety risks. The Commission's framework comprises six stages (figure 2.1): formulating the problem in broad context, analyzing the risks, defining the options, making sound decisions, taking actions to implement the decisions, and evaluating the effects of the actions taken. The framework can be used iteratively and must embrace collaborative involvement of stakeholders.

Figure 2.1. Framework for Risk Management




RATIONALE

The Commission's risk-management framework constitutes a comprehensive strategy for reducing risks to public health, safety, and the environment. Each stage involves a different set of questions. The following is a description of how the six stages would operate and the collaborative and iterative processes that would occur throughout them.

1. Problem/Context: What is the problem? What is its context? Who is responsible for managing the problem, and who are the stakeholders? A potential or existing problem might be identified on the basis of environmental monitoring; emissions inventories; disease surveillance and epidemiologic observation; unexplained illnesses; a permit application; a bad odor; a need for national standards to control contaminant concentrations in air, water, soil, or food; or some other public concern. Attention might be focused on a "symptom" of an underlying problem.

The problem would be examined not just in a medium- and pollutant-specific manner, but in a comprehensive, multimedia, public-health context. Potential relationships among different problems are identified and considered. For example, the degradation of an aquatic ecosystem can be caused not only by point sources of water pollution but also by nonpoint sources, such as urban and agricultural runoff. It can also be affected by land-disturbance activities, including logging and grazing, construction of dams and reservoirs, diversion of surface-water and groundwater flows for domestic and agricultural uses, overfishing, and introduction of exotic species. Deposition of air pollutants--such as nitrogen, lead, cadmium, chromium, mercury, and radionuclides--can also contribute to the problem (see section 6.1.4).

Stakeholders are identified at the problem/context stage and are relied on heavily for problem identification and characterization. Risk managers can be people or institutions at the federal, state, or community level, depending on the problem's context. Once there is collective appreciation of (and possibly consensus on) the characterization of the problem, risk-management goals and objectives can be defined and pursued.

Appropriate contexts for a problem are likely to be situational. In some cases, the context can be overall public health. In other cases, it might be other risks (see section 5.1 for a discussion of risk comparisons). In still others, it might be its relationship to the interdependence of different problems (such as the degradation of an aquatic ecosystem, as described above).

An example of formulating a problem in its context might start with the consideration of the risks associated with hazardous air pollutants regulated at one industrial facility or category of facilities in the context of risks associated with stationary and mobile sources that emit the same pollutants in the same geographic area. The next layer of context would be comparisons with risks associated with other important air pollutants, such as particles and carbon monoxide. A multimedia context would lead to a comprehensive plan that includes risks associated with air, water, and solid waste in the region.

Putting a problem in its context will be needed when residual risks associated with hazardous air pollutants are characterized after technology-based controls are implemented under the Clean Air Act (see section 6.1.1). For example, EPA has promulgated a maximum-available-control-technology (MACT) standard for the petroleum refinery industry. That standard was promulgated partly on the basis of EPA's finding that emissions from petroleum refineries potentially pose a leukemia risk to exposed populations because they contain benzene, a known human carcinogen. The standard will reduce the emissions of benzene and other hazardous air pollutants emitted by the source category. After the standard is implemented, residual-risk assessments will include a calculation to determine whether a leukemia risk that can be attributed to benzene remains. In addition to being emitted from petroleum refineries, benzene is emitted as exhaust from motor vehicles. In fact, emissions from mobile sources represent the largest single source of airborne benzene in the United States. Residual risks associated with the benzene emitted from a particular petroleum refinery could be compared with those associated with benzene from mobile sources and any other important sources that might exist in the geographic area of interest, including consumer products used in the home. The advantage of considering the risk in that context is that if the residual leukemia risk contributed by the petroleum refinery proves to be significant in comparison with the leukemia risk contributed by other sources, risk-reduction efforts can be focused on modifying the refinery further. If it proves insignificant in comparison, more effective and more efficient means of risk reduction that focus on the larger contributors of risk might be possible.

2. Risks: What risks does the problem pose to public health? Risk would be determined by considering the nature, likelihood, and severity of adverse effects on human health, the environment, or public welfare (such as economic well-being or aesthetics). Risks would be evaluated primarily by scientists and risk managers with input from stakeholders. Community stakeholders should be consulted at this stage to help to identify groups with high exposures so that appropriate exposure assessments can be designed (see section 3.2). The factual and scientific basis of the problem would be articulated and incorporated, along with subjective perceptions of the problem, into a characterization of the risks to human and environmental health and consideration of cultural and societal values, quality of life, and environmental equity (see section 5.1). Health and ecological risks would be treated both qualitatively and quantitatively. The nature of the adverse effects, their severity, their reversibility or preventability, and the possibility of multiple effects must be understood before complex estimates of the magnitude of the risks and their uncertainties are presented (see section 3.5). Cumulative risks associated with related problems would be identified, where possible. Indirect effects on human health through disruption of the environment also would be considered.

3. Options: What can and should be done about the problem? What are the potential consequences and expected benefits of intervention? Are there other ways to reduce similar health effects in the same population or similar ecological effects in the same region? What are the estimated costs of each option? Approaches to addressing the problem would be identified by stakeholders, regulators, and scientists. A variety of regulatory and nonregulatory alternatives would be considered, such as permits, enforcement actions, pollution prevention, recycling, market incentives, voluntary reductions, and education (see section 5.4). Institutional, financial, and other arrangements for implementing each approach would be identified. The extent of risk reduction expected and the relationship between the costs and benefits of each approach would be determined and compared (see section 4). Cultural, ethical, political, and legal dimensions would be considered. Potential impacts of each approach would be characterized, including possible adverse effects on workers, the community, or the environment.

4. Decision: What is the best solution to the problem? How can that decision or set of decisions be reached? Who should make that decision? Will the actions required be compatible with the Unfunded Mandates Act of 1995? The most feasible, effective, acceptable, and cost-effective approaches to mitigating the problem would be identified, with the participation of affected and responsible parties. A mechanism for conflict resolution, or for reaching closure in the absence of consensus, might be needed. It is important to acknowledge that this framework will not always result in a consensus among those involved in the process. In fact, participation, negotiation, and attempted compromise sometimes can result in a hardening of opposite positions, a breakdown in negotiations, frustration with the process, and an inability to reach agreement. Those difficulties in reaching a decision should be viewed not as a failure of the process envisioned by the framework, but simply as a recognition that in some instances, notwithstanding the best efforts of all affected parties, consensus will not be achievable. At some point, the responsible regulatory authority must make its decision, including a decision to defer, if opposition is too strong or too credible. Deferral would require a later decision of whether to repeat the process from the beginning or to go on to other pressing needs.

5. Actions: How can the decision be implemented rapidly and flexibly? The action that has been chosen to address the problem is explained and taken. Several actions might be needed in various circumstances. Actions might be taken by public agencies, businesses, industries, and private citizens, alone or in combination. Objections or reassessments, even at this stage, may trigger an iteration of the process.

6. Evaluation: How effective are the actions? Too often, actions are mandated but there is little followup to ensure that they are taken, to analyze effectiveness and cost, or to compare the findings with estimates made in the decision-making stage. The effect of a chosen action on the problem can be characterized through monitoring and surveillance, through discussions with stakeholders, and through analyses of relationships between interventions and trends in health or environmental indicators. Criteria should be specified in advance. On the basis of evaluation, the original problem can be redefined, the actions reconsidered, and the various stages repeated if appropriate.

If the evaluation of the impact of the actions on a problem finds it unsatisfactory, another iteration of the process might be needed. But few effects on risk lend themselves easily to measurement and validation. To some extent, monitoring and surveillance can enable the study of relationships between action and effect, but often such relationships are detectable only when the margin between actual exposures and exposures associated with the health or ecological effect of concern is narrow or the health effect of interest is particularly rare. Most public-health risks are already low, compared with such measurable effects as occupational injuries or motor-vehicle collisions. For example, suppose an action lowers the lifetime incremental risk of developing cancer because of a particular exposure from 1 in 10,000 to 1 in 1,000,000. No health study or surveillance activity could be designed to measure the effectiveness of an action with such a small change, because cancer would be the cause of death in 24% of the population in either event. Conclusions about effectiveness in such a case would have to rely on environmental monitoring, changes in biologic markers of exposure, or some other indirect measure of impact on disease incidence. Developing good baseline and surveillance information about disease incidence, linking health and environmental data, and determining regional differences in disease prevalence, trends, and risk factors would improve the ability to implement effective public-health interventions and enhance our confidence that they are effective.

The Commission's framework is intended to be implemented collaboratively, with some level of participation of stakeholders or other affected parties at each stage. Figure 2.1 shows a particularly prominent role for stakeholder involvement in the first stage, formulating the problem in context. Such partnerships can facilitate the exchange of information and ideas that all parties need if they are to make informed decisions about reducing risks. Regulatory actions or decisions are more likely to be successful if affected parties are involved in scoping and decision-making than if they are not (Richards 1993). As NAACP representative Walter Fields testified at the Commission's meeting in New Jersey, if people are not included in risk-management decisions, such as facility siting, from the very start, they feel excluded from important decisions that affect their communities, and emotional, not rational, reactions govern their response. The importance of stakeholder participation was emphasized by the President's Council on Sustainable Development (PCSD 1996) and the National Research Council Committee on Risk Characterization (NRC 1996a).

Including stakeholders in the processes of defining a problem and assessing its risks can provide a forum in which to clarify the technical data and science-policy assumptions used in risk assessment. Our recommendation for serious involvement of stakeholders in active protection of ecologic and human health, especially at the community level, is well-supported by recent public-opinion poll results. For example, results from a survey in mid-March 1996 suggest that 80% of Americans think that government at all levels should encourage citizen involvement in health and environmental protection (Council for Excellence in Government 1996). They do not want government to do less about risks to health and the environment than it does currently, but they want government action to be more efficient and effective. They also think that responsibility for controlling risks should be shared by government, business, communities, and individuals.

Collaboration also plays a central role in effective implementation, especially if environmental protection is no longer considered solely a government-industry responsibility and the public is expected to participate directly in implementation of risk-management steps (McCallum and Santos 1995). Public actions include reduction and recycling of wastes at home, on farms, in offices, and in recreation, as well as bearing some of the cost. Public comment and public meetings are not adequate substitutes for collaborative approaches to problem-solving, although they can be useful in gaining broader participation. Effective stakeholder involvement in regulatory decision-making requires a shift in attitudes so that affected members of the public are seen as partners in the problem-solving process, rather than as obstacles to it (Van Horn 1988, Chess et al. 1995). It might also require a modification in the timelines that regulatory agencies must satisfy to meet statutory or court-imposed requirements.

A potential disadvantage of our framework might be the investments of time and money required to implement a collaborative, systematic process. Even if the process might lead to long-term savings, the up-front costs could be considerable. Moreover, there is no guarantee that consensus on a risk-management decision will be reached. However, the time and expense required are unlikely to exceed the experiences of the Occupational Safety and Health Administration and EPA, which have sometimes required years in preparing agency risk assessments, in notice-and-comment rule-making, and in litigation over the resulting decisions.

Implementing a collaborative decision-making process should include incentives for participation. An industry or municipality might be more inclined to participate willingly and cooperatively if it were to receive some relief in exchange, such as reduced reporting requirements, suspension of punitive damages, or elimination of parties' abilities to sue after a decision is reached.

The framework is intended to be implemented iteratively; that is, the process can be refined and its conclusions can be changed on the basis of research, new data, and new views. Iteration could apply to a rule that has already been promulgated or to a new rule or a new approach to a problem that is being developed. Public comment, negotiation, or analysis can redefine the problem or identify other issues of concern in a broader context. Research and information-gathering performed to clarify a problem or a risk might lead to a focus on a somewhat different problem. Analyzing risks and options can lead to a better understanding of how a problem should have been defined and scoped at the outset. However, iteration must not be allowed to become a device for indefinite delay. Using an iteration to scope a problem might actually speed up the risk-management process, as goals and issues are clarified, and possibly lead to a quicker and more cost-effective resolution than expected initially if it becomes apparent that proceeding with the entire framework is no longer necessary.

The proposed framework is intended to be a guide for an approach or thought process for risk-management decision-making. It is unlikely that all aspects of the framework would be required for every problem and some might be inconsistent with certain statutory requirements. Different levels of decision-making will require different levels of analysis. Risk managers should apply this process flexibly to accommodate the needs of individual circumstances.

A number of criteria might be used to determine when applying the framework would be most useful. A problem worth addressing according to the framework should involve achieving an agreed-upon goal, the optimal path to which is controversial. The problem should require resolution of interdependent or related issues. Enough facts should be available to permit meaningful discussion and resolution. Participants in the process should be representative of those affected by the outcome of problem resolution. In some cases, it might be particularly important for elected officials or their representatives to be included in the process so that their support of the result is likely. For example, including members of Congress in the stakeholder deliberations about Superfund reauthorization in 1994 might have enhanced the prospects for the success of that effort.

The framework can be applied at several levels.

National level. Congress could apply the integrated, multimedia approach of the framework to its future risk-management legislation and to its oversight of existing agency programs. For example, Congress could modify the Clean Water Act to establish a comprehensive, integrated, multimedia watershed-management approach and to provide for the development of state watershed programs (see section 6.1.4). The current EPA watershed-protection approach could be expanded with additional authorization and funding from Congress to accomplish multimedia environmental-risk management under the Clean Water Act and possibly under the Clean Air Act. In fact, using the current watershed-protection approach, EPA-sponsored estuary programs in Tampa Bay and Galveston Bay are good examples of how state and local governments and citizens can participate in a process that identifies high-priority, multimedia environmental problems and take action to ameliorate the problems.

EPA can use the framework to support its development of an integrated air-toxics strategy for urban areas, to link decisions on residual risks from major sources with risk-driven decisions on smaller stationary sources and mobile sources. Section 6.1.1 has a detailed discussion of the application of the Commission's risk-management framework to the determination of residual risks. EPA can also use the framework to support its Common Sense Initiative to integrate all the permitting that is required of individual manufacturing facilities, overcoming conflicting and redundant requirements.

State and regional levels. Under existing federal and state laws, states and regional airshed or watershed authorities can use the framework approach to address various environmental problems in an integrated manner, where applicable and feasible. Both the Michigan Department of Environmental Quality and EPA Region 5 have organized themselves into multimedia teams to facilitate integrated approaches to risk management. Several states have initiated programs to resolve and integrate potentially conflicting permitting requirements.

One example of how the problem/context and risks stages of the framework could be applied at the state level is the case of oxygenated and reformulated fuels. The 1990 Clean Air Act Amendments required that new vehicle fuels be introduced by 1992 in communities with of carbon monoxide concentrations exceeding national ambient air-quality standards. The new fuels contain the additive methyl tert-butyl ether (MTBE). In some states--particularly Alaska, Montana, Wisconsin, and New Jersey--there have been numerous complaints of unexplained symptoms of health effects. More that 70 million Americans are potentially exposed to evaporative emissions from oxygenated and reformulated fuels. MTBE has been singled out as potentially responsible for the symptoms. Assessing potential risks associated with these fuels in a public-health context should include evaluating not only MTBE toxicity but also risks associated with increased concentrations of nitrogen oxides, formaldehyde, and acetaldehyde. The health benefits of the MTBE-related reductions in carbon monoxide and benzene concentrations would also have to be considered, as would the role of ambient temperature and engine performance in exposures (HEI 1996). The risk characterization should also consider the different strengths of evidence for health risks associated with carbon monoxide, benzene, and MTBE. Using a common metric to compare the health effects of each chemical, such as a margin-of-exposure approach (see section 3.1), would be useful.

The following is an example of the framework in action at the regional level.

Beginning in 1978, the Association of Bay Area Governments (ABAG) developed and adopted an integrated, comprehensive environmental-management plan for the San Francisco Bay region (ABAG 1978). The plan recommended actions to improve and manage the region's air-quality, water-quality, water-supply, and solid-waste problems in an integrated, comprehensive manner. ABAG was designated as the lead agency by the state of California under various federal and state laws. The plan was developed to meet the requirements of the Air Quality Maintenance Plan under the Federal Clean Air Act Amendments of 1977, of the areawide plan under the Federal Water Pollution Control Act Amendments of 1972, of the Federal Resource Conservation and Recovery Act of 1976, of the California Solid Waste Management and Resource Recovery Act of 1972, and of California Senate Bill 424 of 1977.

  • Collaboration. The plan was developed through an extensive collaborative process that involved a broad range of stakeholders, including representatives of federal, state, and local regulatory agencies, business, labor, environmental groups, ethnic minorities, and city and county governments. A 46-member environmental-management task force charged with plan preparation was formed by ABAG with the stakeholders well represented. The task force was chaired by Dianne Feinstein, then mayor of San Francisco. Community outreach was extensive, and several hundred roundtables, meetings, and formal public hearings were held.

  • Problem/Context. Stakeholders were involved at the beginning of management-plan development to identify environmental problems in the region. For example, photochemical oxidants in the air, toxic materials in the San Francisco Bay, and inadequate solid-waste disposal practices were identified as some of the important problems. Potential relationships among the problems were also identified so that they could be considered in a multimedia, integrated manner. For example, solid-waste disposal sites could cause surface-water and groundwater contamination and could produce dust, gases, and odors that affected air quality. Therefore, properly managed landfills were considered to be control measures for air and water pollution, as well as for solid-waste disposal problems.

  • Risks. Risk information was compiled and communicated to the stakeholders. For example, health effects of photochemical oxidants and harmful effects of toxic materials on aquatic life were described to the stakeholders at various meetings. However, risk assessment was not performed extensively, because control measures were chosen on the basis of federal and state requirements.

  • Options. Options for control measures were developed with extensive input from stakeholders. The most controversial measure was land-use controls for maintenance of air quality after 1985. The proposed control measures were evaluated for their environmental benefits, consequences, and costs and for their probable social and economic effects on the region.

  • Decisions. Control measures were selected by the environmental-management task force, which was composed of locally elected officials and other stakeholders. Many of the control measures were voted on and adopted by the task force. However, after many months of discussion and the expression of substantial concern by labor, business, and many of the cities and counties in the region, the land-use control measure for maintenance of air quality was eliminated from the plan. In the decision-making process, several important issues were raised, including federal-state-local relationships, the social and economic impact of land-use controls, the extent of air-quality improvement likely to be obtained, and the suitability of including these measures in an air-quality plan.

  • Actions. Because so much care that was taken to analyze problems and solutions and to make decisions with broad stakeholder participation, many of the actions recommended by the plan were taken by public agencies, businesses, industries, and private citizens. The plan continues to serve as a blueprint for environmental-management activities in the bay region. For example, a state implementation plan for air quality was developed in response to the plan and, as a result, the region was designated as an attainment area for ozone under the federal Clean Air Act in 1995. Almost all the industrial and municipal wastewater-treatment facilities have been upgraded. Erosion-control measures to reduce nonpoint-source pollution have been in place for many years. A council of water-supply agencies has been formed and has engaged in cooperative efforts, such as the development of a drought-response strategy for the region. Hazardous-material spill response teams have become available at the city and county levels. ABAG also provided technical assistance to local agencies to initiate recycling programs.

  • Iteration. The plan recommended procedures for continual adjustment as new information or new technologies became available. Iteration was, in fact, carried out over the years.

  • Evaluation. As a result of this collaborative, integrated environmental planning effort, the San Francisco Bay region has enjoyed substantial environmental improvement over the last 15 years. Although ABAG's designation as lead agency has expired, a planning process was continued by state and local agencies. Although no formal evaluation of the plan has been performed, much of the environmental improvement in the region can be attributed to implementation of the plan. The San Francisco Bay region is now considered by many to be one of the environmentally best managed metropolitan areas in the country, as a result of the comprehensive, integrated, collaborative environmental-management effort started almost 20 years ago.

Local and Community Levels. A city or a community can use the framework to address risks to its citizens. For example, radioactive-waste cleanup is a community-level, multimedia problem and should include effective local stakeholder involvement. When DOE began to address the cleanup problem at Hanford, the surrounding community was not adequately informed or involved, and that led to outrage and distrust. Involvement of the community as partners in risk management at the site since then has led to improved cooperation and more readily accepted decisions.

Other uses of the framework at the local level include the development and operation of industrial facilities or waste-disposal facilities.

Our risk-management framework constitutes a major shift in the emphasis that risk assessment plays in risk-management decision-making and has three critical advantages. First, it is consistent with using an integrated, holistic, top-down approach to a public-health or environmental problem instead of a chemical-by-chemical, medium-by-medium, bottom-up approach to characterizing individual risks; decisions about how to use risk assessment, and how extensively, are made from the perspective of risk management. Second, it emphasizes collaboration, communication, and negotiation in an open and inclusive process among stakeholders so that public values can influence the shaping of risk-management strategies; the results are intended to be decisions that are more pragmatic and more easily implemented than those made in the absence of consensus and solutions that incorporate the diversity of interests, knowledge, and technical expertise represented among stakeholders. Third, like the scientific process, the proposed risk-management process is iterative; at any stage of the process, the discovery of new information can change conclusions and decisions and lead to reformulation and re-evaluation of the problem at hand.

The Commission emphasizes that the proposed framework will need to be refined with experience. As illustrated by the examples described above, some elements of the framework, such as stakeholder involvement and multimedia analysis, have been tried. However, no risk-management effort to date has used all aspects of the framework. Many of the questions and concerns associated with this framework will be clarified as it is more widely used. We recommend that evaluation be an integral component of the process.




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