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|The link between
health risk assessment (RA) and toxicology were discussed and briefly substantiated in
Lecture 1. In the next lecture, an effort will be made to discuss in greater depth their
impacts on each other, with more specifics and a focus on the use of toxicology in the
regulatory process and in RA.
To be discussed in Lecture 3 are the statutes and regulations (primarily those in the United States) that have an effect on the acquisition of toxicity data and on the toxicity testing procedures. Included as examples are the ‘Benzene’ decision briefly discussed in Slide 20; the Delaney clause of the Federal Food, Drug, and Cosmetic Act; and the recent Food Quality Protection Act of 1996.
Toxicity testing procedures can vary greatly among health regulatory agencies, depending on the statute under which they operate. These different testing procedures provide different types of toxicity data required or available for the completion of an RA. The interpretation of adverse effects and the perception of risk may also differ considerably between two statutes or two social groups and hence two regulatory agencies or two communities. These differences in risk perception and disease interpretation too have an effect on toxicology as well as RA, and hence will be discussed.
Also to be included in the next lecture is a discussion of the recent advances in exposure assessment techniques and laboratory analysis, both of which have an impact on how toxicologic studies and RA can or should be conducted.