National Academies Press: OpenBook

Issues in Risk Assessment (1993)

Chapter: Generic Issues

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Suggested Citation:"Generic Issues." National Research Council. 1993. Issues in Risk Assessment. Washington, DC: The National Academies Press. doi: 10.17226/2078.

Appendix F
Breakout Sessions


A. Maki and D. Patton

The hazard identification group examined the case studies in light of the 1983 Red Book paradigm and experience with Environmental Protection Agency (EPA) guidelines for health risk assessments to set the context for discussing hazard identification in ecological risk assessment. Generic issues related to paradigm flexibility, scope of ecological risk assessment, the role of uncertainty in research, and the role of nonscientific consideration were discussed. Specific issues were examined for each case study in terms of ecological hazard.

Generic Issues

There was general agreement that flexibility existed (even if not always applied) in the 1983 paradigm and in forthcoming EPA health guidelines. Flexibility is desirable for ecological risk assessment. Although the four components of the paradigm—hazard identification, dose-response assessment, exposure assessment, and risk characterization—are appropriate for any ecological risk paradigm, they may be combined in different ways. For example, hazard identification may be combined with other steps or treated separately case by case. The group also agreed that uncertainties that were not fully analyzed for hazard

Suggested Citation:"Generic Issues." National Research Council. 1993. Issues in Risk Assessment. Washington, DC: The National Academies Press. doi: 10.17226/2078.
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The scientific basis, inference assumptions, regulatory uses, and research needs in risk assessment are considered in this two-part volume.

The first part, Use of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity, focuses on whether the maximum tolerated dose should continue to be used in carcinogenesis bioassays. The committee considers several options for modifying current bioassay procedures.

The second part, Two-Stage Models of Carcinogenesis, stems from efforts to identify improved means of cancer risk assessment that have resulted in the development of a mathematical dose-response model based on a paradigm for the biologic phenomena thought to be associated with carcinogenesis.

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