According to Frank Yiannas, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Food Policy and Response, FDA, along with the U.S. Centers for Disease Control and Prevention (CDC) and the agency’s state and local partners, are working to investigate two outbreaks of Shiga toxin-producing Escherichia coli O157:H7 (STEC) illnesses. A specific food product has not yet been identified. However, FDA has seen similar recurring, emerging, or persistent strains of E. coli in recent outbreaks.

He notes that FDA is issuing this update early in its investigation as part of the agency’s continued commitment to transparency and early communication. Investigators at the agency are also working toward making a new resource available soon on the FDA website to provide early updates on new and active investigations.

FDA is closely working with its partners at the CDC and the states to pinpoint the sources of the E. coli O157:H7 illness outbreaks and will share information as it becomes available.

To support CDC’s epidemiological investigation, FDA is conducting traceback investigations, on-site inspections, and sampling in an effort to rule in or rule out suspect foods.

One of the outbreaks is being caused by a strain of E. coli that is genetically related to a strain that caused the 2019 STEC outbreak linked to romaine grown in the California Central Coast Salinas growing region. To date, 23 cases and no deaths have been reported.

The second outbreak is being caused by an E. coli strain that is genetically related to a larger, diverse genetic cluster including the strain that caused the 2018 STEC outbreak linked to romaine and environmental isolates from the Yuma, Arizona growing region. To date, 21 cases and one death have been reported.

While there have been no specific foods definitively linked to these outbreaks, FDA has taken a number of actions to prevent foodborne illness outbreaks and strengthen safeguards for consumers as part of its New Era of Smarter Food Safety initiative, including the issuance of the Leafy Greens STEC Action Plan, which outlined actions that the FDA plans to take in 2020 to advance work in three areas: prevention, response, and addressing knowledge gaps. Actions completed this year include:

  • Published a report following the investigation into three 2019 outbreaks of E. coli O157:H7 in leafy greens grown in the Salinas Valley, California, which further increased the agency’s understanding of how leafy greens may have become contaminated and the impact of animal activity on adjacent and nearby land.
  • Prioritized inspections and other surveillance activities, in collaboration with the California Department of Food and Agriculture (CDFA), at farms identified by traceback in the 2019 outbreaks during the 2020 growing/harvest season specifically to further investigate harvest operations and factors in the environment that may have contributed to the introduction and transmission of E. coli O157:H7 that led to the contamination of romaine lettuce in the Salinas Valley growing area.
  • Initiated a longitudinal research study with CDFA and other agricultural partners in California to improve food safety through an enhanced understanding of the ecology of human pathogens in the environment that may cause foodborne illness outbreaks. In addition, FDA’s inspection activity in the Central Coast, Central Valley, and Imperial Valley in California and in Yuma, Arizona, includes sampling and testing for pathogenic E. coli and Salmonella with a new sampling assignment as well as sampling assignments for the last few years.


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