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

Investigators
Kodell, Ralph
Institutions
DHHS/FDA - National Center for Toxicological Research
Objective
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.
More information
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.
Funding Source
Nat'l. Center For Toxicological Research
Project number
S00174
Categories
Sanitation and Quality Standards
Natural Toxins
Risk Assessment, Management, and Communication