Food

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

Romaine Lettuce

Sample Bag of Romaine Lettuce

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.

Recommendation:

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.

Case Counts

Total Illnesses: 52
Hospitalizations: 19
Deaths: 0  
Last illness onset: November 18, 2018
States with Cases: CA (11), CT (1), FL (1), IL (2), LA (1), MA (1), MD (1), MI (7), NH (6), NJ (11), NY (6), OH (1), PA (1), RI (1), WI (1)

Who to Contact

Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.

To report a complaint or adverse event (illness or serious allergic reaction), you can

Visit www.fda.gov/fcic for additional consumer and industry assistance.

Submit Questions Electronically

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What is the Problem and What is Being Done?

On November 20, 2018, FDA announced an investigation of a multistate outbreak of E. coli O157:H7 illnesses likely linked to romaine lettuce. The Public Health Agency of Canada (PHAC), and Canadian Food Inspection Agency, are also coordinating with U.S. agencies as they investigate a similar outbreak in Canada. In that announcement, FDA recommended that people should not eat romaine lettuce until more is known about the source of the contaminated lettuce and the status of the outbreak.

Genetic analysis of the E. coli O157:H7 strains tested to date from patients in this current outbreak are similar to strains of E. coli O157:H7 associated with a previous outbreak from the Fall of 2017 that also affected consumers in both Canada and the U.S. The 2017 outbreak of E. coli O157:H7 was associated with leafy greens in the U.S. and romaine in Canada. This year, romaine lettuce is the suspected vehicle for both the U.S. and Canadian outbreaks. There is no genetic link between the current outbreak and the E.coli O157:H7 outbreak linked to romaine that occurred in the Spring of 2018.

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 that FDA is still including in this region are: 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 contaminated lettuce. The information indicates that the outbreak cannot be explained by a single farm, grower, harvester, or distributor.

Preliminary traceback information indicates that ill people in several areas across the country were exposed to romaine lettuce harvested in California. Specifically, current evidence indicates this romaine was harvested in the Central Coast growing regions of northern and central California.

The specific California counties FDA is including in this region are: Monterey, San Benito, San Luis Obispo, Santa Barbara, Santa Cruz, and Ventura.

Given the widespread distribution of farms, growers, and shippers identified by our traceback, the FDA continues to recommend that consumers not eat romaine lettuce grown in the identified counties until the investigation identifies a source or sources to explain the outbreak. Additional counties may be added or removed as the FDA romaine investigation progresses. Updates will be provided as new information becomes available.

Romaine harvested from locations outside of the California regions identified by the traceback investigation does not appear to be related to the current outbreak.

What Products are Recalled?

Currently, the FDA does not have enough traceback information to identify the source of the contamination that would allow us to request a targeted recall from specific suppliers. On November 20, FDA recommended that the most efficient way to ensure that contaminated romaine is off the market would be for industry to voluntarily withdraw product from the market, and to withhold distribution of romaine until public health authorities can ensure the outbreak is over and/or until FDA can identify a specific source of contamination.

On November 20, the United Fresh Produce Association and the Leafy Greens Marketing Agreement issued statements committing to withdraw the potentially contaminated romaine from the market.

What are the Symptoms of E. coli Infection?

The symptoms of Shiga toxin-producing (STEC) E. coli infections vary for each person but often include severe stomach cramps and bloody diarrhea. If there is fever, it is usually not very high (less than 101 degrees Fahrenheit/less than 38.5 degrees Celsius). Most people get better within 5–7 days. Some infections are very mild, but others are severe or even life-threatening.

Around 5–10 percent of those who are diagnosed with STEC infection develop a potentially life-threatening complication, known as hemolytic uremic syndrome (HUS).

Symptoms of HUS include fever, abdominal pain, feeling very tired, decreased frequency of urination, small unexplained bruises or bleeding, and pallor. Most people with HUS recover within a few weeks, but some suffer permanent damage or die. People who experience these symptoms should seek emergency medical care immediately. Persons with HUS should be hospitalized because their kidneys may stop working (acute renal failure), but they may also develop other serious problems such as hypertension, chronic kidney disease, and neurologic problems.

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Who is at Risk?

People of any age can become infected with Shiga toxin-producing (STEC) E. coli. Children under the age of 5 years, adults older than 65, and people with weakened immune systems are more likely than others to develop severe illness, including HUS, but even healthy older children and young adults can become seriously ill.

What Do Restaurants and Retailers Need To Do?

The recommendation has not changed. There is no recommendation for consumers or retailers to avoid using romaine lettuce that is certain to have been harvested from areas outside of the Central Coast growing regions of California. For example, romaine lettuce harvested from areas that include, but are not limited to the desert growing region near Yuma, the California desert growing region near Imperial County and Riverside County, the state of Florida, and Mexico, do not appear to be related to the current outbreak. Additionally, there is no evidence hydroponically- and greenhouse-grown romaine is related to the current outbreak.

The FDA believes it is important that consumers and retailers have an easy way to identify romaine lettuce by both harvest date and harvest location. Labeling with this information on each bag of romaine or signage in stores where labels are not an option can easily differentiate for consumers romaine from unaffected growing regions.

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.

Restaurants and retailers should always practice safe food handling and preparation measures. It is recommended that they wash hands, utensils, and surfaces with hot, soapy water before and after handling food.

  • Wash and sanitize display cases and refrigerators regularly.
  • Wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store food.
  • Wash hands with hot water and soap following the cleaning and sanitation process.
  • Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross-contamination. 

What Do Consumers Need To Do?

Consumers may notice that romaine lettuce is beginning to be available in stores with the new labeling. 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 will be labeled as being hydroponically- or greenhouse- grown. If it does not have this information, you should not eat or use it.

If it does have this information, we advise avoiding any product from the Central Coast growing regions of northern and central California. Romaine from outside those regions need not be avoided.

The specific California counties FDA is including in this region are:

  • Monterey
  • San Benito
  • San Luis Obispo
  • Santa Barbara
  • Santa Cruz
  • Ventura

Additional counties may be added or subtracted as the FDA traceback investigation continues.

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. Consumers should always practice safe food handling and preparation measures. It is recommended that they wash hands, utensils, and surfaces with hot, soapy water before and after handling food.

Additional Information

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Page Last Updated: 12/06/2018
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