Environmental Health Perspectives: Moving Forward in Human Cancer Risk Assessment

Environ Health Perspect. 2010 Dec 13. [Epub ahead of print]
Moving Forward in Human Cancer Risk Assessment.

Paules RS, Aubrecht J, Corvi R, Garthoff B, Kleinjans JC.

NIEHS.
Moving Forward in Human Cancer Risk Assessment. [Environ Health Perspect. 2010] - PubMed result
Abstract

BACKGROUND: The current safety paradigm for assessing carcinogenic properties of drugs, cosmetics, industrial chemicals and environmental exposures relies mainly on in vitro genotoxicity testing followed by 2-year rodent bioassays. This testing battery is extremely sensitive but has low specificity. Furthermore, rodent bioassays are associated with high costs, high animal burden and limited predictive value for human risks.

OBJECTIVES: Respond to a growing appeal for a paradigm change in human cancer risk assessment.

METHODS: To facilitate development of a road map for this needed paradigm change in carcinogenicity testing, a workshop was held entitled "Genomics in Cancer Risk Assessment." This workshop brought together toxicologists from academia and industry with governmental regulators and risk assessors from the United States and the European Union, to discuss the state-of-the-art in developing alternative testing strategies for carcinogenicity, with emphasis on potential contributions from 'omic technologies.

RESULTS AND CONCLUSIONS: The goal of human risk assessment is to decide whether a given exposure to an agent is acceptable to human health, and to provide risk management measures based on an evaluation and prediction of the effects of exposures on human health. Exciting progress is being made utilizing genomic approaches. A new paradigm, utilizing genomics and accessible human material when possible, can provide mechanistic insights that could inform new predictive approaches, e.g. in vitro assays, and facilitate development of genomics-derived biomarkers. Regulators appear to be willing to accept such approaches where use is clearly defined, evidence is strong, and approaches are qualified for regulatory use.

PMID: 21147607 [PubMed - as supplied by publisher]
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Environmental Health Perspectives: Moving Forward in Human Cancer Risk Assessment