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 13, 2018

The FDA, along with CDC, state and local agencies, is investigating a multistate outbreak of E. coli O157:H7 illnesses 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.

As of December 13, FDA has further refined the traceback investigation down to the farm level, which narrows the list of romaine growing areas that FDA recommends consumers and retailers avoid down to the following counties: Monterey, San Benito, and Santa Barbara.

San Luis Obispo, Santa Cruz and Ventura counties in California have been removed from the list at this time. Other growing areas, for example Florida, Mexico and the desert growing regions near Yuma and Imperial County, Riverside County do not appear to be related to the current outbreak.

Investigation teams from FDA’s Produce Safety Network, California Department of Public Health, California Department of Food and Agriculture, and the CDC analyzed romaine lettuce, soil, water, sediment, and animal dropping samples at farms identified by the traceback investigation. Most of these samples tested negative for the outbreak strain, with some samples still undergoing analysis. However, the strain of E. coli O157:H7 causing the current outbreak was identified in one sample collected in the sediment of an agricultural water reservoir at one ranch owned and operated by Adam Bros. Farming, Inc., in Santa Barbara County. The strain isolated from this sample matched those collected from ill persons in this outbreak using Whole Genome Sequencing (WGS). The FDA is able to confirm that Adam Bros. Farming, Inc. hasn’t shipped any romaine since November 20, 2018. Experts are working with the farm to determine how contamination occurred and what corrective actions need to be taken before their next growing season.

Adams Bros is cooperating with the FDA and CDC in this outbreak investigation. They have committed to recalling products that may have come into contact with water from the water reservoir where the outbreak strain was found.

The finding on this farm, however, does not explain all illnesses. The FDA’s traceback activities of romaine lettuce will continue as FDA works to determine what commonalities this farm may have with other farms and areas that are being assessed as part of the investigation.

This information allows FDA to modify its recommendations slightly. Given the identification of the outbreak pathogen on the one farm, the location of farms identified in the traceback, and the fact that the lettuce on the market at the peak of the outbreak should be beyond shelf life, there is no longer a reason for consumers to avoid romaine from San Luis Obispo, Santa Cruz and Ventura Counties, in California, provided it was harvested after November 23, 2018. The traceback investigation is still ongoing and additional information will be provided as it becomes available.

Recommendation:

Based on discussions with producers and distributors, romaine lettuce entering the market will now be voluntarily 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 Monterey, San Benito, and Santa Barbara counties in California. Romaine lettuce from outside those counties need not be avoided. Consumers may notice that romaine lettuce is beginning to be available in stores with new labeling. Additionally, romaine from Ventura, San Luis Obispo, and Santa Cruz counties harvested after November 23, 2018 should be labeled with harvest area and harvest date, allowing it to be distinguished from romaine lettuce that should be avoided.

Romaine lettuce that was harvested outside of Monterey, San Benito, and Santa Barbara counties in 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: 59
Hospitalizations: 23
Deaths: 0  
Last illness onset: November 16, 2018
States with Cases: CA (12), CT (1), DC (1), FL (1), IL (2), LA (1), MA (1), MD (1), MI (7), NH (6), NJ (12), NY (7), OH (1), PA (4), 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 (CFIA), 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.

On November 23, 2018, staff from FDA’s Produce Safety Network, investigators from California Department of Public Health and the California 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 FDA, state, and Canadian tracebacks. The investigation teams collected romaine lettuce, soil, water, sediment, and animal dropping samples.

As of December 13, 2018, traceback information from five restaurants in four different states have identified 11 different distributors, nine different growers, and eight different farms as potential sources of the contaminated lettuce. The information indicates that the outbreak may not be explained by a single farm, grower, harvester, or distributor.

FDA’s Produce Safety Network, California Department of Public Health, California Department of Food and Agriculture collected romaine lettuce, soil, water, sediment and animal dropping samples at farms identified by the traceback investigation. FDA and CDC analyzed the samples. Most of these samples were negative for the outbreak strain. However, the investigation teams collected a sample that yielded a positive result for the outbreak strain in the sediment of an agricultural reservoir at the farm, Adam Bros. Farming, Inc., in Santa Barbara County. The strain isolated from this sample matched those collected from ill persons in this outbreak using Whole Genome Sequencing (WGS) the most precise DNA analysis currently available. We are able to confirm that Adam Bros. Farming, Inc. hasn’t shipped any romaine since November 20, 2018 and our experts are working with the farm to determine how contamination occurred and whether corrective actions are needed before their next growing season.

Adams Bros is cooperating with the FDA and CDC in this outbreak investigation. They have committed to recalling products that may have come into contact with the water from the water reservoir where the outbreak strain was found.

This is an important piece of information for this investigation; however, the finding on this one farm may not explain all illnesses. The FDA’s traceback of romaine will continue as FDA works to determine what commonalities this farm may have with other farms that are being assessed as part of the investigation.

As of December 13, FDA has further refined the traceback investigation down to the farm level, which narrows the list down to the following counties: Monterey, San Benito, and Santa Barbara. San Luis Obispo, Santa Cruz and Ventura counties have been removed from the list at this time.

Given the identification of the outbreak pathogen on the one farm, the location of farms identified in the traceback, and the fact that the lettuce on the market at the peak of the outbreak should be beyond shelf life, there is no longer a reason for consumers to avoid romaine from San Luis Obispo, Santa Cruz and Ventura Counties, in California, provided it was harvested after November 23, 2018.Romaine harvested from locations outside of the California counties identified by the traceback investigation does not appear to be related to the current outbreak.

What Products are Recalled?

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.

Based on the latest sampling information, the FDA is working with Adam Bros. Farming, Inc. to ensure that romaine and other produce from the ranch that may have come into contact with the reservoir water is removed from commerce. The firm is cooperating in gathering information and voluntarily recalling produce that may have been contaminated. Produce that did not come into contact with the reservoir water, because it was grown on other ranches within the farm, is not of concern to FDA at this time.

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?

There is no recommendation for consumers or retailers to avoid using and consuming romaine lettuce that have been harvested from areas outside of Monterey, San Benito, or Santa Barbara counties in 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. Also, there is no longer a recommendation to avoid romaine from Ventura, San Luis Obispo, and Santa Cruz counties in California, provided it was harvested after November 23, 2018. 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 romaine from unaffected growing regions for consumers.

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.

  • Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross-contamination.
  • 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. 

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 voluntarily 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 Monterey, San Benito, and Santa Barbara counties in California. Romaine from outside those regions need not be avoided.

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

Romaine lettuce that was harvested outside of Monterey, San Benito, and Santa Barbara counties in 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. Produce items should be rinsed in clean, running water without the use of additional cleaners or soaps.

What do Suppliers and Distributors Need to Do?

It is important to note that suppliers, distributors and others in the supply chain should not be shipping or selling romaine lettuce from the identified growing regions in California: Monterey, San Benito, and Santa Barbara.

FDA continues to recommend that labels are placed on romaine lettuce entering the market to help consumers and retailers determine that the romaine is from unaffected growing regions, those outside of Monterey, San Benito, or Santa Barbara counties in California.

Additionally, romaine from Ventura County, San Luis Obispo County, and Santa Cruz County should be labeled with harvest area and harvest date that allows it to be distinguished from romaine lettuce that should be avoided.

Additional Information

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Page Last Updated: 12/13/2018
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