title: A probabilistic framework for non-cancer risk assessment.
abstract: Risk assessment involves an analysis of the relationship between exposure and health related outcomes to derive an allowable exposure level or to estimate a low-dose risk. Acceptable levels of human exposure for non-cancer effects generally are derived by dividing an experimental no-observed-adverse-effect-level or a lower confidence limit benchmark dose by a product of several uncertainty factors. This paper presents a hierarchical modeling framework for a probabilistic approach to non-cancer risk assessment. The hierarchical model integrates the distributions of uncertainty factors and the distribution of the actual exposure level to construct the dose-response model for the proportion of population at risk and the dose-response model for the expected proportion of population at risk for a given exposure distribution. The proposed approach is based on the use of the BMDL (lower confidence limit on the benchmark dose) as a POD (point of departure) for risk assessment of non-cancer effects.
authors.affiliation: Division of Biometry and Risk Assessment, National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR 72079, USA. jchen@nctr.fda.gov <jchen@nctr.fda.gov>
authors.forename: James J
authors.initials: JJ
authors.lastname: Chen
authors.forename: Hojin
authors.initials: H
authors.lastname: Moon
authors.forename: Ralph L
authors.initials: RL
authors.lastname: Kodell
mesh_terms: D000818:Animals; D004305:Dose-Response Relationship, Drug; D004781:Environmental Exposure / Q000009:adverse effects*; D004782:Environmental Health; D006801:Humans; D016013:Likelihood Functions; D015233:Models, Statistical; D008962:Models, Theoretical; D019055:No-Observed-Adverse-Effect Level; D011336:Probability; D018570:Risk Assessment