May 27, 2022

Volume XII, Number 147

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Modernizing Foodborne Illness Outbreak Responses

  • As a part of its work to implement the Food Safety Modernization Act and New Era of Smarter Food Safety initiative, FDA has released its Foodborne Outbreak Response Improvement Plan (“Improvement Plan”).  This Improvement Plan is designed to help FDA and its partners enhance the speed, effectiveness, and communication of foodborne outbreak investigations.  To create this Improvement Plan, the Agency collaborated with the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS), Centers for Disease Control and Prevention (CDC), state health officials, industry and consumer foodborne outbreak experts, and FDA leadership and staff.

  • FDA will also work with the University of Minnesota’s School of Public Health to assess the Agency’s capacity to support, join, or lead multistate outbreak investigations and to provide recommendations in an independent public report.  This report, “An Independent Review of FDA’s Foodborne Outbreak Response Processes,” provides an objective assessment of the Agency’s structural and functional capacity to respond to multistate foodborne illness outbreaks.  According to FDA, the report played an instrumental role in the development of the Improvement Plan.

  • The Improvement Plan focuses on improving four specific priority areas, which FDA believes will have the most impact on outbreaks associated with human food.

    • Tech-enabled product traceback: a digital resource to collect voluntarily provided consumer purchase data to better facilitate and expedite how FDA receives outbreak data.

    • Root-cause investigations (RCIs): a set of protocols and procedures to help standardize and expedite the release of outbreak investigation data to industry and the public.

    • Strengthen analysis and dissemination of outbreak data: FDA will work with CDC, USDA’s FSIS, and other partners to strengthen data sharing among the agencies, which should help identify reoccurring, emerging, and persistent strains of pathogens

    • Operational improvements: the Agency will focus on improving its performance measures to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities

© 2022 Keller and Heckman LLPNational Law Review, Volume XI, Number 344
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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