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FDA Announces Release of Environmental Assessment for E. Coli Outbreak Associated with Romaine Lettuce
Friday, November 2, 2018
  • As previously reported in the Daily Intake Blog and many other sources, there was a widespread outbreak of E. coli O157:H7 in the Spring of 2018.  The outbreak, which was linked to romaine lettuce grown in the Yuma, Arizona growing region, was responsible for over 200 confirmed infections and five deaths.  During FDA’s Leafy Greens Food Safety Task Force meetings on July 31 and August 1, The agency posited a theory that the contamination was due to use of water from a canal adjacent to a Concentrated Animal Feeding Operation (CAFO) and they promised an environmental assessment report once the investigation was complete.

  • Onn November 1, FDA Commissioner Dr. Scott Gottlieb announced the release of the environmental assessment report.  Of note:

    • FDA found E. coli O157:H7 in several samples of canal water but not in any other environmental samples tested;

    • FDA believes that the most likely source of contamination was from the canal water, but FDA could not rule out other causes; and

    • FDA believes the CAFO is the most likely source of the contamination, but did not find an obvious route of contamination.

  • FDA provided a number of recommendations regarding the growing and processing of leafy greens, including full implementation by growers and processors of the Food Safety Modernization Act (FSMA) provisions (see our blog posts relating to FSMA here).  This includes

    • Continued development of the Food Produce Rule and the agricultural water standards;

    • Implementing traceability systems; and

    • Conducting thorough root cause investigations and implementing corrective actions.

  • Dr. Gottlieb also announced that the FDA is taking steps to provide consumers with more timely information and to respond to food safety issues sooner.  This includes a newly announced plan for FDA to collect and analyze samples of romaine lettuce for contamination with human pathogens.

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