This week, I welcomed back to the studio Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group. Karin and I discuss an old but evolving concept in FDA circles called GRAS — Generally Recognized as Safe. As listeners may know, “food additives” require pre-market approval by FDA. Substances “generally recognized” as safe under the conditions of a substance’s intended use are excluded from the definition of “food additive,” are not subject to mandatory pre-market review by FDA, and may be added to human and animal food. How companies make GRAS determinations, FDA’s role in the process, and whether the GRAS concept should be modernized are a few of the hot topics Karin and I explore.