The risk assessment process is described with a focus on the hazard id
entification and dose-response components. Many of the scientific ques
tions and uncertainties associated with these components are discussed
, and the role for biomarkers and specimen banking in supporting these
activities are assessed. Under hazard identification, the use of biom
arkers in defining and predicting al biologically adverse events; b) t
he progression of those events towards disease; and c) the potential f
or reversibility are explored. Biomarker applications to address high-
to-low dose extrapolation and interindividual variability are covered
under dose-response assessment. Several potential applications for spe
cimen banking are proposed.