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PAPERBACK price:$45.75 add to cart Rights & Permissions Free PDF Access Sign in to download PDF book and chapters Free Resources PDF SUMMARY Display this book on your site! Related Titles Enhancing Food Safety:The Role of the Food and Drug Administration Ethical and Scientific Issues in Studying the Safety of Approved Drugs Other Related Titles A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011) Board on Environmental Studies and Toxicology (BEST) Citation Manager Export the bibliographic data for this book in your chosen format Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Citation Manager . "Appendix E: Factors Hypothesized as Important in Understanding Risk." A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration. Washington, DC: The National Academies Press, 2011. Please select a format: Page 191   E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. Appendix E Factors Hypothesized as Important in Understanding Risk The following is a list of some characteristics of hazards that have been hypothesized as important in understanding risk. They were compiled from the following sources: Lowrance (1976); Rowe (1977); Vlek and Stallen (1980); Hohenemser et al. (1983); Litai et al. (1983); Slovic et al. (1984), Jenni (1997). Ability to contain adverse effects Ambiguity about probability of harm Ambiguity about severity of effects Availability of options or alternatives Avoidability Blame assignable Caused by humans Common vs dreaded hazards Confidence in decision-making strategies Confidence in experts or regulators Consequences foreseeable Continuous vs occasional exposure Controllability (institutional) Controllability (personal) Delay or timing of effects Distribution of effects (general population vs sensitive groups) Ease of change or correction Ease of escape from harm Familiarity vs Newness Frequency of accidents Importance of intended benefits (for example, necessity vs luxury) Knowledge about risks and benefits Page 191 Front Matter (R1-R14) A Risk-Characterization Framework for Decision-Making at the Food and Drugh Administration (1-2) Summary (3-10) 1 Introduction (11-16) 2 A Risk-Characterization Framework (17-45) 3 Case Study of a Mitigation-Selection Decision (46-65) 4 Case Study of a Targeting Decision (66-91) 5 Case Study of a Strategic-Investment Decision (92-110) 6 Case Study of a Targeting Decision That Spans Food and Drug Administration Centers (111-138) 7 Conclusions and Future Directions (139-148) Appendix A: Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks (149-176) Appendix B: Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II (177-178) Appendix C: Scenarios Provided by the U.S. Food and Drug Administration to the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II (179-184) Appendix D: Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II (185-190) Appendix E: Factors Hypothesized as Important in Understanding Risk (191-192)

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OCR for page 191
A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration Appendix E Factors Hypothesized as Important in Understanding Risk The following is a list of some characteristics of hazards that have been hypothesized as important in understanding risk. They were compiled from the following sources: Lowrance (1976); Rowe (1977); Vlek and Stallen (1980); Hohenemser et al. (1983); Litai et al. (1983); Slovic et al. (1984), Jenni (1997). Ability to contain adverse effects Ambiguity about probability of harm Ambiguity about severity of effects Availability of options or alternatives Avoidability Blame assignable Caused by humans Common vs dreaded hazards Confidence in decision-making strategies Confidence in experts or regulators Consequences foreseeable Continuous vs occasional exposure Controllability (institutional) Controllability (personal) Delay or timing of effects Distribution of effects (general population vs sensitive groups) Ease of change or correction Ease of escape from harm Familiarity vs Newness Frequency of accidents Importance of intended benefits (for example, necessity vs luxury) Knowledge about risks and benefits

OCR for page 192
A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration Natural vs manmade causes Nonhuman impacts Number of people affected Occupational vs nonoccupational exposure Personal awareness of risk or danger Personal experience and knowledge Personal influence or responsibility Possibility of error Preventable Probability or frequency of adverse events or effects Recurrence Reversibility of effects Severity of effect (for example, major vs minor, large vs small, fatal vs survivable, painful vs painless) Size of the population at risk Spatial distribution of risks Speed with which adverse events occur Transgenerational effects Voluntariness REFERENCES Hohenemser, C., R.W. Kates, and P. Slovic. 1983. The nature of technological hazard. Science 220 (4495):378-384. Jenni, K.E. 1997. Attributes for Risk Evaluation. Ph.D. Dissertation, Carnegie Mellon University, Pittsburgh, PA. Litai, D., D. Lanning, and N. Rasmussen. 1983. The public perception of risk. Pp. 213-224 in The Analysis of Actual Versus Perceived Risks , V. Covello, W. Flamm, J. Rodericks and R. Tardiff, eds. New York: Plenum Press. Lowrance, W.W. 1976. Of Acceptable Risk: Science and the Determination of Safety. Los Altos, CA: W. Kaufmann. Rowe, W.D. 1977. An Anatomy of Risk. New York: Wiley. Slovic, P., B. Fischhoff, and S. Lichtenstein. 1984. Behavioral decision theory perspectives on risk and safety. Acta Psychologica 56:183-203. Vlek, C. and P.J. Stallen. 1980. Rational and personal aspects of risk. Acta Psychologica 45:273-300.