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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
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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.