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Modification and Application of Quantitative Risk Assessment Techniques to FDA-regulated Products


In response to requests from scientists and regulators at CDRH, CDER, CFSAN, and CVM, using available toxicological data, conduct cancer and noncancer risk assessments of FDA-regulated products to assist in establishing conditions of exposure to toxic substances.

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FY 2000 Accomplishments: 1) Developed a biologically based dose-response model for predicting the risk of mouse liver tumors as a result of FB1 exposure. Integrated data on tissue size, cell proliferation and sphingolipid metabolism. 2) Successfully predicted liver tumor risk for female and male mice. 3) Presented one talk and two posters at the FDA Workshop on Fumonisin Risk Assessment. 4) Two manuscripts accepted for publication. FY 2001 Plans: Re-initiate collaboration with CFSAN colleagues to explore extending the threshold-of-regulation concept, now applied to indirect food additives (e.g., contact materialsfrom packaging, etc.), to direct flavor additives.

Kodell, Ralph
DHHS/FDA - National Center for Toxicological Research
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