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Issues in Risk Assessment (1993)
Commission on Life Sciences (CLS)

Page
247
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Issues in Risk Assessment

2
Scope of Ecological Risk Assessment

All the case studies and most of the discussion at the workshop focused on technically sophisticated assessments performed in narrowly defined regulatory contexts. The scope of ecological risk assessment within the general environmental decision-making process is much broader. The committee recognizes a hierarchy of types of risk assessments, each with its own characteristics. The basic focus of this report is risk assessment in support of day-to-day agency decision-making, as exemplified by the case studies. Ecological risk assessments are driven by specific laws or regulations with carefully circumscribed objectives, are science intensive, and provide the principal focus for the quantitative assessment methods and research needs identified in this report.

Risk assessment has a clear role in strategic planning and priority-setting. Several plenary session speakers addressed the need for higher-level risk assessments that assist agencies in their planning process or help society to determine its environmental priorities. The U.S. Environmental Protection Agency's (EPA) Relative Risk Reduction Project (EPA, 1990) was cited as an example of such an assessment. The purpose of these assessments is to set priorities and define budgets, and they can be used within agencies and as a means of setting priorities between agencies. Assessments at this level are based principally on expert judgment, rather than on quantitative analysis, but they can benefit from use of an explicit risk assessment framework to organize information and present results in a form useful for decision-making.

There is a less obvious, but no less important, role for risk assess-

Page
247
Front Matter (R1-R18)
Executive Summary (1-12)
Use of the Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity (13-14)
1 Introduction (15-20)
2 Correlations Between Carcinogenic Potency and Other Measures of Toxicity (21-42)
3 Advantages and Disadvantages of Bioassys That Use the MTD (43-52)
4 Options Considered (53-60)
5 Conclusions and Recommendations (61-66)
References (67-78)
Appendix A: Workshop Summary - Maximum Tolerated Dose: Implications for Risk Assessment (79-90)
Appendix B: Workshop Organizing Subcommittee (91-92)
Appendix C: Workshop Federal Liaison Group (93-94)
Appendix D: Workshop Programs (95-96)
Appendix E: Workshop Attendees (97-110)
Appendix F: Correlation Between Carcinogenic Potency and the Maximum Tolerated Dose: Implications for Risk Assessment (111-172)
Appendix G: Informal Search for Supercarcinogens (173-184)
The Two-Stage Model of Carcinogenesis (185-186)
Issues in Risk Assessment (187-216)
References (217-222)
Appendix A: Workshop Summary - Two-Stage Modelsof Carcinogenesis (223-232)
Appendix B: Workshop Program (233-234)
Appendix C: Workshop Federal Liaison Group (235-236)
Appendix D: Workshop Attendees (237-238)
Appendix E: Workshop Organizing Task Group (239-240)
A Paradigm for Ecological Risk Assessment (241-242)
1 Introduction (243-246)
2 Scope of Ecological Risk Assessment (247-248)
3 Revision of 1983 Framework to Incorporate Ecological Risk Assessment (249-258)
4 Key Scientific Problems Limiting Application of Ecological Risk Assessment (259-264)
5 Conclusions (265-266)
6 Recommendations (267-268)
References (269-272)
Appendix A: Workshop Participants (273-278)
Appendix B: Workshop Organizing Subcommittee and Federal Liaison Group (279-280)
Appendix C: Workshop Introduction (281-282)
Appendix D: Opening Plenary Presentations (283-292)
Appendix E: Case Studies and Commentaries (293-308)
Appendix F: Breakout Sessions (309-336)
Appendix G: Contemplations on Ecological Risk Assessment (337-342)
Appendix H: Workshop Summary (343-346)
Appendix I: References for Appendixes (347-350)
Appendix J: Workshop Program (351-356)

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OCR for page 247
Issues in Risk Assessment 2 Scope of Ecological Risk Assessment All the case studies and most of the discussion at the workshop focused on technically sophisticated assessments performed in narrowly defined regulatory contexts. The scope of ecological risk assessment within the general environmental decision-making process is much broader. The committee recognizes a hierarchy of types of risk assessments, each with its own characteristics. The basic focus of this report is risk assessment in support of day-to-day agency decision-making, as exemplified by the case studies. Ecological risk assessments are driven by specific laws or regulations with carefully circumscribed objectives, are science intensive, and provide the principal focus for the quantitative assessment methods and research needs identified in this report. Risk assessment has a clear role in strategic planning and priority-setting. Several plenary session speakers addressed the need for higher-level risk assessments that assist agencies in their planning process or help society to determine its environmental priorities. The U.S. Environmental Protection Agency's (EPA) Relative Risk Reduction Project (EPA, 1990) was cited as an example of such an assessment. The purpose of these assessments is to set priorities and define budgets, and they can be used within agencies and as a means of setting priorities between agencies. Assessments at this level are based principally on expert judgment, rather than on quantitative analysis, but they can benefit from use of an explicit risk assessment framework to organize information and present results in a form useful for decision-making. There is a less obvious, but no less important, role for risk assess-

OCR for page 248
Issues in Risk Assessment ment in the process by which society establishes environmental goals. During the closing plenary session, the relationship of ecological risk assessment to goal setting was discussed: Is a particular goal (e.g., preservation in a pristine state) implicitly part of ecological risk assessment, or is risk assessment a value-free tool for transforming politically determined goals into functioning regulations? These issues are important, and the committee believes that it is appropriate and necessary to address them in this report. The committee emphasizes the need to maintain the clear conceptual separation between risk management and risk assessment. Goal setting is a risk management function; therefore, the definition of ecological risk assessment cannot contain implicit ecological preservation or restoration goals. The committee agrees, however, that risk assessment can play a vital communication function in goal setting. During the workshop, Dr. Lovejoy, from the Smithsonian Institution, noted that society must define its goals in a scientifically informed way and suggested that ecological risk assessment should play an educational role in this process. Dr. Yosie, from the American Petroleum Institute, touched on the issue of goal setting and suggested a role for risk assessment in clarifying public debates over environmental policy by making explicit the environmental consequences of particular policy choices. This process is continuous in the United States and worldwide, as exemplified by the climate change debate and by the current discussion of the idea of sustainable development. Risk assessment clearly can help by providing operational definitions of generally understood but vaguely defined concepts, such as sustainability, by identifying the scientific information needed to evaluate policy alternatives, and by delineating the consequences of particular choices. The definitions, research areas, conclusions, and recommendations discussed in the remainder of this report are intended to lay the foundation for an approach to ecological risk assessment that can contribute to environmental decision-making at all levels, for all types of environmental problems.

Representative terms from entire chapter:

goal setting