ABSTRACT
Food and Drug Administration (FDA) practice of risk assessment, and its flip side, safety assurance, has undergone some significant changes through the several years. It may be useful, in order to gain more perspective on the roots of the controversy, to take a look at the historical development of risk assessment as practiced for approximately 80 years by the FDA—primarily by the "Foods" part of the Agency. The analytical process described in the Committee's Concept of Safety has in come to be called "risk assessment," as it has also become more complex and arguably more quantitative. There is little question that some form of risk assessment needs to be used, even more so in the future. Extrapolation-based risk assessment is not at present a fully adequate procedure, but with new developments in defining effective target organ doses and applying pharmacokinetic modeling techniques, it is improving.
