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FDA’s Analytical Method for PFAS Detection
Susan Genualdi Ph.D.
Research Chemist, Food and Drug Administration
Richard F. Jack Ph.D.
Global Market Development Manager, Phenomenex
Co-authors: Wendy Young, Elsie Peprah, Cynthia Srigley, Christine M. Fisher, Brian Ng,
& Lowri deJager
The development and expansion of analytical methods for per- and polyfluoroalkyl substances (PFAS) in food is essential for the continued monitoring of the United States (US) food supply and assessments of dietary intake. In March of 2022, the European Union Reference Laboratory (EURL) for halogenated persistent organic pollutants (POPs) in Feed and Food released a guidance document covering priority PFAS of interest, including analytical method parameters and limits of quantification (LOQs). As a result, the Food and Drug Administration (FDA) began method extension work to incorporate ten new additional analytes to method C-010.02 including long chain perfluorosulfonic acids, fluorotelomer sulfonates, and perfluorooctane sulfonamide. In December of 2022, The European Union published Commission Regulation 2022/2388, establishing maximum levels for perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorohexane sulfonic acid (PFHxS) in certain foodstuffs, primarily fish, molluscs, crustaceans, and eggs. As a result, the FDA method was evaluated for performance in reaching EU required LOQs for both compliance and monitoring purposes. The FDA method was found to be able to reach all required LOQs for analytes in matrices with established maximum levels and with further method modifications, required LOQs could be met in fruits, vegetables, and milk.
Susan Genualdi is currently a Research Chemist in the Center for Food Safety and Applied Nutrition at the Food and Drug Administration. Her research over the last 12 years has focused on developing methods for the analysis of direct and indirect food additives in food and food packaging and for the last 6 years has focused on PFAS analysis in foods. Prior to her work at the FDA, she received her PhD in Analytical Chemistry at Oregon State University and was a postdoctoral fellow at Environment Canada.
Richard F. Jack, Ph.D. Richard is the Global Market Development manager for the environmental and food markets at Phenomenex corporation. He has over 18 yrs. experience with chromatography and mass spectrometry for the environmental, semiconductor, chemical, and pharmaceutical industries. Richard is a former EPA Scientific Advisor for the EPA’s panel on Hydraulic Fracturing, a coauthor for EPA 557 and 557.1 along with ASTM D8001 and updates to D4327 and D6919 methods. He is currently the Second Vice Chairman for the ASTM D19 subcommittee on water analysis. Richard received his Ph.D. in biochemistry and anaerobic microbiology from Virginia Tech University and Master’s in ecology from the University of Tennessee.