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The Need to Identify “Unknowns” from a Risk Management Perspective

May 14, 2020

Presenter: Ron Brown (ex-FDA; now Director at Risk Science Consortium LLC)

The toxicological risk assessment of extractable and leachable (E&L) compounds is ideally based on compounds that have been identified with a high degree of confidence. However, challenges in the analytical chemistry process may make confident identification difficult for some E&L compounds. This talk explores the toxicological implications of not identifying compounds with a high degree of confidence, of misidentifying compounds, and of not uniquely quantifying compounds in an extract. In addition, the presentation will describe proposals for conducting a toxicological risk assessment on tentatively and partially identified compounds and will describe how to prioritize compounds for more confident identification based on their potential toxicological risk.