Director: Ralph L. Kodell, Ph.D.

The Division of Biometry and Risk Assessment is primarily concerned with conducting research that addresses the FDA need for new and improved methods of risk assessment, assessing the uncertainty associated with current approaches, and developing and applying new methods for the assessment of human exposure, susceptibility, and risk. The regulation of toxic substances in foods, drugs, biologics, cosmetics, animal drugs, and medical devices requires an engagement in risk assessment.

Risk assessment is a process for determining the extent of human health hazard as a function of the conditions of exposure to toxic substances. It may involve the quantitative determination of estimates of risk corresponding to specific exposure levels, or it may simply involve a general determination that given exposure levels are sufficiently low to pose a negligible risk to those exposed.

The research conducted by the Biometry and Risk Assessment division is relevant to the FDA’s strategic goals of improving the pre-market review process and of establishing strong post-market assurance standards. This research spans all of the NCTR’s strategic research goals: the development of knowledge bases; the development of new strategies for the prediction of toxicity; and the conduct of method-agent- and concept-driven research.

The NCTR Research Plans and Accomplishments Document contains information on the latest accomplishments and plans for the Division of Biometry and Risk Assessment as well as project and publication listings.