Safety and Risk Assessments: Fit for Purpose

FDA conducts safety and risk assessments to inform decisions about the products we regulate. The specific approach taken and methods depend upon the nature of the question these assessments are intended to answer. This presentation will describe the use of FDA tools including FDA-iRISK and will also examine the decisional context that guides when a safety assessment or a risk assessment approach is needed. Case studies will illustrate the value of using probabilistic approaches that take into account variability in parameter values and quantify uncertainty for both microbial and chemical hazards in food