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Outbreak Investigations
The following is an outbreak update from FDA of concern to our subscribers. 

FDA Investigating Multistate Outbreak of E. coli O157:H7 Infections Likely Linked to Romaine Lettuce Grown in California

Update: December 6, 2018

The FDA, along with CDC, state and local agencies, is investigating a multistate outbreak of E. coli O157:H7 illnesses likely linked to romaine lettuce grown in California this fall. The Public Health Agency of Canada (PHAC) and Canadian Food Inspection Agency (CFIA) are also coordinating with U.S. agencies as they investigate a similar outbreak in Canada.

The FDA continues to conduct a traceback investigation, which involves reviewing shipping records and invoices to trace the romaine that ill people who are part of this outbreak consumed backwards through the supply chain to identify where it was grown and where in the supply chain it may have become contaminated.

Information collected through December 6, 2018, continues to indicate that contaminated romaine lettuce from the Central Coast growing regions of northern and central California is the likely source of the current outbreak of E. coli O157:H7 infections. The California counties FDA is including in this region remain the same: Monterey, San Benito, San Luis Obispo, Santa Barbara, Santa Cruz and Ventura. Counties may be added or removed as the investigation progresses.

Traceback information from four restaurants in three different states so far has implicated 10 different distributors, 12 different growers, and 11 different farms as potential sources of rthe contaminated lettuce. The information indicates that the outbreak cannot be explained by a single farm, grower, harvester, or distributor.

FDA’s Produce Safety Network (PSN) is assisting with this investigation. The PSN includes regionally-based personnel from FDA’s Center for Food Safety and Applied Nutrition that provide region-specific expertise on produce safety policy and science, and regionally-based personnel from FDA’s Office of Regulatory Affairs that specialize in conducting produce safety inspections and investigations. Members of the PSN work together to support industry and government partners on implementing the Food Safety Modernization Act (FSMA) Produce Safety Rule.

On November 23, 2018, staff from FDA’s Produce Safety Network, investigators from CA Department of Public Health and the CA Department of Food and Agriculture, and CDC began conducting on-site investigations of farms and lettuce cooling facilities in California that have been identified by the FDA, state, and Canadian tracebacks. The investigation teams have been collecting romaine lettuce, soil, water, and scat samples. To date, E. coli O157:H7 has not been found in any of the lettuce, soil or scat samples. Results of water testing being conducted by CDC are pending.

The traceback investigation is ongoing and additional information will be provided as it becomes available.


The FDA’s advice has not changed. Based on discussions with producers and distributors, romaine lettuce entering the market will now be labeled with a harvest location and a harvest date or labeled as being hydroponically- or greenhouse-grown. If it does not have this information, you should not eat or use it.

If romaine lettuce does have this labeling information, we advise avoiding any product from the Central Coast growing regions of northern and central California. Romaine lettuce from outside those regions need not be avoided. Consumers may notice that romaine lettuce is beginning to be available in stores with the new labeling.

Romaine lettuce that was harvested outside of the Central Coast growing regions of northern and central California does not appear to be related to the current outbreak. Hydroponically- and greenhouse-grown romaine also does not appear to be related to the current outbreak. There is no recommendation for consumers or retailers to avoid using romaine harvested from these sources.

U.S. Food and Drug Administration
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