Improving the Regulation of Carcinogens by Expediting Cancer Potency Estimation
Abstract:The statutory language of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65; California Health and Safety Code 25249.5 et seq.) encourages rapid adoption of “no significant risk levels” (NSRLs), intakes associated with estimated cancer risks of no more than 1 in 100,000. Derivation of an NSRL for a carcinogen listed under Proposition 65 requires the development of a cancer potency value. This paper discusses the methodology for the derivation of cancer potencies using an expedited procedure, and provides potency estimates for a number of agents listed as carcinogens under Proposition 65. To derive expedited potency values, default risk assessment methods are applied to data sets selected from an extensive tabulation of animal cancer bioassays according to criteria used by regulatory agencies. A subset of these expedited values is compared to values previously developed by regulatory agencies using conventional quantitative risk assessment and found to be in good agreement. Specific regulatory activities which could be facilitated by adopting similar expedited procedures are identified.
Document Type: Research Article
Affiliations: 1: Reproductive and Cancer Hazard Assessment Section, Office of Environmental Health Hazard Assessment, California Environmental Protection Agency, 2151 Berkeley Way, Annex 11, Berkeley, California 94704. 2: Environmental Health Sciences, School of Public Health, University of California at Berkeley, Berkeley, California 94720. 3: City and County of San Francisco, Department of Public Works, Environmental Health and Safety, San Francisco, California 94102. 4: State of Washington, Department of Ecology, P.O. Box 47703, Olympia, Washington 98504-7703. 5: Department of Philosophy, University of California at Riverside, Riverside, California 92521.
Publication date: 1995-04-01