November 30, 2020

Volume X, Number 335

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FDA Releases New Outbreak Investigation Table

On November 18, 2020, FDA released the Coordinated Outbreak Response and Evaluation (CORE) Investigation Table, a tool to publish early information on all foodborne outbreaks that the FDA is investigating.  While FDA issues public health advisories or recalls for any outbreak that results in specific, actionable steps for consumers to protect themselves against an unsafe food or product, this new table allows FDA to share information at the earliest phases of an investigation, before actionable steps have been identified.

In the press release announcing the table, FDA emphasized that releasing early information about investigations in their beginning stages does not mean FDA will announce early actions for consumers to take.  Rather, the table furthers FDA’s goal of improving transparency in outbreak investigations and complements its New Era of Smarter Food Safety initiative and implementation of the FDA Food Safety Modernization Act (FSMA).  The investigation table will be rolled out as a six-month pilot after which FDA may adjust the table per stakeholder feedback.

The table lists the outbreak investigation’s FDA Reference Number, the pathogen involved, the products linked to the outbreak, case count, investigation and outbreak status, and whether any additional steps have been initiated, including recall, traceback, on-site inspection, and sample collection and analysis.  The table is updated weekly with data from both the Center for Disease Control (CDC) and FDA’s CORE Response Teams and tracks outbreaks from beginning to end.  Upon its release, and as of the date of this post, the table listed seven ongoing investigations at various stages of development, including three recently announced investigations into ongoing E. coli O157:H7 outbreaks. 

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 325
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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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