title: Epidemiology and quantitative risk assessment: a bridge from science to policy.
abstract: Quantitative risk assessment provides formalized scientific input to regulatory agencies that set occupational and environmental standards for potentially toxic exposures. Current practice relies heavily on statistical extrapolation from high-dose animal studies. Human data obviate the need for interspecies extrapolation and reduce the range of high-to-low dose extrapolation. This paper proposes a framework for classifying individual epidemiologic studies as to their adequacy for use in dose-response extrapolation. The framework considers five criteria: (1) a stable positive association with an adverse health outcome; (2) high overall study quality; (3) no substantial confounding; (4) quantitative exposure assessment for individuals; (5) evidence of a dose-response relationship. With these criteria, studies can be categorized as (1) suitable to serve as a basis for extrapolation; (2) inadequate to be the basis for direct extrapolation but appropriate to use for evaluating the plausibility of animal-derived risk estimates; or (3) useful only for hazard identification, not for dose-response assessment. Methods for using studies in the first two categories are briefly described. The emphasis is not on establishing rigid rules, but rather on ensuring a consistent, reliable process that makes optimum use of available data.
authors.affiliation: Department of Epidemiology, University of North Carolina School of Public Health, Chapel Hill 27599-7400, USA.
authors.forename: I
authors.initials: I
authors.lastname: Hertz-Picciotto
mesh_terms: D000818:Animals; D002273:Carcinogens / Q000633:toxicity*; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D004813:Epidemiology; D005260:Female; D006801:Humans; D008297:Male; D011050:Policy Making; D018570:Risk Assessment
chemical_list: D002273:Carcinogens