title: A rational approach to risk assessment requires the use of biological information: an analysis of the National Toxicology Program (NTP), final report of the advisory review by the NTP Board of Scientific Counselors.
abstract: The National Toxicology Program (NTP) Board of Scientific Counselors met on April 14 and 15, 1992 to review the NTP. This paper provides an overview of the Board's Report with an emphasis on the recommendations made by the Carcinogenesis Working Group. The prime overall recommendation is that the NTP should move from a focus on hazard identification to an emphasis on providing the type of biological information that needs to be incorporated into the risk assessment process. This would involve a hypothesis-driven mechanism of action approach aimed at understanding the basis for the actions of the chemicals of interest. Relevant examples are provided. Scientists from the National Institute of Environmental Health Sciences' (NIEHS) intramural program and those outside of NIEHS should be included in the research effort. This strategy would permit a more rational approach toward both test development and design (e.g., selection of the high dose to be employed), and the interpretation of test results (e.g., addressing questions pertaining to dose-response relationships and species to species extrapolation). The overall goal would be to provide a reasonable assessment of the possible hazard that a chemical might pose to people in light of realistic conditions of exposure.
authors.affiliation: Department of Pharmacology and Toxicology, Michigan State University, East Lansing 48824.
authors.forename: J I
authors.initials: JI
authors.lastname: Goodman
mesh_terms: D000818:Animals; D015197:Carcinogenicity Tests / Q000592:standards*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008954:Models, Biological; D012307:Risk Factors; D014116:Toxicology / Q000592:standards*; D014481:United States