title: Are societal judgments being incorporated into the uncertainty factors used in toxicological risk assessment?
abstract: The aim of this paper is to show that the uncertainty factors used in toxic risk assessment to develop exposure standards do contain societal judgments as well as technical judgments. The process generally used today originated in the 1950s, when a deterministic approach to risk was the norm. Technical judgments are required concerning the nature and the quality of the evidence used in the risk assessment. Judgments taken are essentially cautious. This caution may not matter when measured exposure is significantly below the standard and may be accepted when exposure occurs only following an approval process based on "gate keeping." More sophisticated judgments are required when actual exposure may exceed this type of standard or when risk needs to be compared with benefit. These circumstances can occur with patient exposure to human medicines and with occupational exposure to chemicals. Under these circumstances more explicitly considered societal judgments concerning what constitute "broadly acceptable" and "tolerable" risk criteria, and hence what are appropriate uncertainty factors, are required. The outcomes of those societal judgments are likely to vary according to the circumstances surrounding the exposure and have led to smaller uncertainty factors being considered appropriate for occupational exposure, when compared with widespread public exposure.
authors.affiliation: Medical School, University of Manchester, Stopford Building, Oxford Road, Manchester, M13 9PT, United Kingdom.
authors.forename: H P
authors.initials: HP
authors.lastname: Illing
mesh_terms: D006801:Humans; D007881:Legislation, Food; D019055:No-Observed-Adverse-Effect Level; D011336:Probability; D011640:Public Policy; D018570:Risk Assessment; D012308:Risk Management; D006113:United Kingdom