Risk Assessment and the Law: Evolving Criteria by Which Carcinogenicity Risk Assessments are Evaluated in the Legal Community

Abstract

Where scientific uncertainty precludes the definitive resolution of factual issues, there has been a tendency among decision-makers in the regulatory and judicial arenas to use policy-making as a substitute for fact-finding. This tendency led several regulatory agencies in the 1970s to limit the use of risk assessment because of the complexity of the risk assessment process and because of their concern that methodologies were not sufficiently developed to remove uncertainty. Several judicial decisions have since reversed the trend. Agencies are now moving in the direction of scientific risk assessment, although there is much ground yet to be covered. Simultaneously, trial courts appear to be replacing scientific fact-finding with policy-making when confronted with the uncertainty of cancer causation. This paper reviews these two developments and provides a contrast between the criteria currently used by courts to evaluate carcinogenicity risk assessments by regulatory agencies and the criteria used by a recent trial court to evaluate evidence of cancer causation.