June 25, 2019

June 25, 2019

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June 24, 2019

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Criticism of FDA’s Produce Safety Rule Implementation Delay Following Romaine Outbreak Report

  • As reported on this blog, on February 13, 2019, FDA released findings from the Agency’s investigation of the November 2018 outbreak of E. coli O157:H7 infections involving romaine lettuce. Those findings concluded that water from on-farm water reservoir, which was likely not effectively sanitized, most likely led to contamination of some of the romaine lettuce. In a statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Frank Yiannas, the leaders noted that moving forward, “[o]ur first goal is working with federal, state and industry partners on implementing best practices to try and prevent these outbreaks in the first place.”

  • The recent romaine lettuce outbreaks in 2018 occurred after FDA sought to extend the compliance dates for the agricultural water requirements of the Produce Safety Rule by an additional two to four years (for produce other than sprouts) in a September 2017 Proposed Rule. (82 FR 42963). The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms and very small farms would have until January 26, 2023 and January 26, 2024, respectively.

  • Chair of the Congressional Food Safety Caucus, Congresswoman Rosa DeLauro condemned FDA’s delay of the Produce Safety Rule in light of the report on the romaine lettuce recall. “The FDA’s investigations into last year’s romaine lettuce recalls have confirmed what we already knew to be true: dirty irrigation water contaminates produce and makes people sick…Eight years after the Food Safety Modernization Act was signed into law, it is long past time these important rules went into effect—not delayed into the next decade.” FDA has yet to finalize its proposed extension of the Produce Safety Rule’s agricultural water requirements.

© 2019 Keller and Heckman LLP


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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...