October 28, 2020

Media Inquiries

Amanda Turney

The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response:

"The FDA, along with the CDC and our state and local partners, are working to investigate two outbreaks of Shiga toxin-producing E. coli O157:H7 (STEC) illnesses. We do not know what food is causing people to get sick or whether it involves an FDA-regulated food product. However, we have seen similar recurring, emerging or persistent strains of E. coli in recent outbreaks. E. coli O157:H7 can contaminate many foods, and we cannot assume that the current outbreaks are linked to historically associated foods like romaine and other leafy greens. There is no information currently to indicate that people should avoid any specific food.

"We are issuing this update early in our investigation as part of our continued commitment to transparency and early communication. We are also working toward making a new resource available soon on our website to provide early updates on new and active investigations.

"We are closely working with our 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."

Additional Information

• The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC), and state and local partners, are conducting investigations of two distinct outbreaks of foodborne illness of E. coli O157:H7 (STEC) that are recurring, emerging or persistent strains. To support CDC’s epidemiological investigation, the 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, the FDA has taken a number of actions to prevent foodborne illness outbreaks and strengthen safeguards for consumers as part of our 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:
  • Publication of a report following our investigation into three 2019 outbreaks of E. coli O157:H7 in leafy greens grown in the Salinas Valley, California, which further increased our understanding of how leafy greens may have become contaminated and the impact of animal activity on adjacent and nearby land.
  • In collaboration with the California Department of Food and Agriculture (CDFA), prioritized inspections and other surveillance activities 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 our enhanced understanding of the ecology of human pathogens in the environment that may cause foodborne illness outbreaks. In addition, our 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.