This session will upgrade your skills to conduct toxicological risk assessment of E&L compounds. This includes a review of the types of data needed to conduct a risk assessment, leveraging such information to support a safety position (using margins of safety and Permissible Daily Exposure values), and the use of safety thresholds such as the Threshold of Toxicological Concern (TTC) in leachable and extractable work. This session will also highlight some common mistakes and misconceptions surrounding addressing the safety of extractables and leachables, and an interesting actual case study concerning potential pediatric exposure to a leachable impurity