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                Outbreaks of Foodborne Illness

Outbreaks of Foodborne Illness

                        Investigations of Foodborne Illness Outbreaks
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          Outbreaks of Foodborne Illness
          Outbreak Investigation of E. coli: Romaine from Salinas, California  (November 2019)Outbreaks of Foodborne Illness Outbreak Investigation of E. coli: Romaine from Salinas, California  (November 2019)
  
  					FDA publishes Investigation Report and shares key findings
	
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    PrintMay 21, 2020

Today, the U.S. Food and Drug Administration published the findings of an investigation into the contamination of romaine lettuce implicated in three outbreaks of *E. coli*O157:H7 during the Fall of 2019.

The investigation was conducted at several farms identified in the outbreak tracebacks, as well as at other businesses and public access areas and resulted in several key findings:

Each of these three outbreaks, identified in the report as Outbreaks A, B and C was caused by distinctly different strains of *E. coli*O157:H7 as determined by whole genome sequencing (WGS) analysis;
	Traceback investigations of multiple illness sub-clusters and supply chain information identified a common grower with multiple ranches/fields which supplied romaine lettuce during the timeframe of interest to multiple business entities associated with all three outbreaks.
	The same strain of *E. coli*O157:H7 that caused Outbreak A was found in two different brands of fresh-cut salads containing romaine lettuce in 2019;
	This same outbreak strain of *E. coli*O157:H7 in Outbreak A was detected in a fecal--soil composite sample taken from a cattle grate on public land less than two miles upslope from a produce farm with multiple fields tied to the outbreaks by the traceback investigations;
	Other strains of Shiga toxin-producing *E.coli*(STEC), while not linked to any of the  outbreaks, were found in closer proximity to where romaine lettuce crops were grown, including two samples from a border area of a farm immediately next to cattle grazing land in the hills above leafy greens fields and two samples from on-farm water drainage basins.These findings, together with the findings from earlier leafy greens outbreaks dating back to 2013, suggest that a potential contributing factor has been the proximity of cattle—a persistent source of *E. coli* O157:H7 and other STEC—to the produce fields identified in traceback investigations.

Because of  the reoccurring nature of outbreaks associated with leafy greens, the FDA recently released a 2020 Leafy Greens STEC Action Plan, which outlines a three-pronged approach for tackling this problem.  It describes the FDA’s plans for working with industry, federal partners, state and local regulators, academia and others to address the safety of leafy greens by advancing work in three areas: prevention, response, and addressing knowledge gaps.

**For More Information**

Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Three Outbreaks of E. coli O157:H7 During the Fall of 2019
	2020 Leafy Greens STEC Action Plan
	FDA Outlines 2020 Action Plan to Help Advance the Safety of Leafy Greens

On this Page

What Products are Recalled?
	What is *E. coli*?
	General Food Safety Tips for Retailers
	General Food Safety Tips for Consumers
	Who to Contact

Case Counts

Total Illnesses: 167
Hospitalizations: 85
Deaths: 0
Last illness onset: December 21, 2019
States with Cases:  AZ (4), CA (8), CO (6), DE (1), FL (4), IA (1), ID (4), IL (15), MD (5), MI (2), MN (7), MT (1), NE (2), NJ (9), NC (3), NM (2), NY (3), OH (12), OR (1), PA (21), SC (1), SD (1), TN (1), TX (6), VA (6), WA (6), WI (35)

CDC Outbreak Page

What Products are Recalled?

On Nov. 21, 2019, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced a recall by Missa Bay, LLC, a Swedesboro, N.J. establishment, of approximately 75,233 pounds of salad products that contain meat or poultry because the lettuce ingredient may be contaminated with *E. coli* 0157:H7. Products in this recall were produced with the same lot of lettuce that was used to produce the packaged salad that the Maryland Department of Health found to contain*E. coli*0157:H7.

The products subject to the recall can be found in a spreadsheet on the FSIS website. FSIS will likely update the poundage as more information becomes available. FSIS has posted product labels on its website.

The products subject to recall bear establishment number “EST. 18502B” inside the USDA mark of inspection. These items were shipped to distribution locations in Alabama, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Virginia and Wisconsin.

Consumers with questions regarding the recall can contact Mary Toscano, Consumer Affairs Manager for Bonduelle at 1-800-800-7822. Members of the media with questions regarding the recall can contact the Bonduelle Newsroom at (626) 678-2222 or bfa-newsroom@bonduelle.com.

What is *E. coli*?

*E. coli* are mostly harmless bacteria that live in the intestines of people and animals and contribute to intestinal health. However, eating or drinking food or water contaminated with certain types of *E. coli* can cause mild to severe gastrointestinal illness. Some types of pathogenic (illness-causing) *E. coli,* such as Shiga toxin-producing *E. coli* (STEC), can be life-threatening.

People infected with pathogenic *E. coli*can start to notice symptoms anywhere from a few days after consuming contaminated food or as much as nine days later. Generally, the symptoms include severe stomach cramps, diarrhea, fever, nausea, and/or vomiting.

The severity or presence of certain symptoms may depend on the type of pathogenic *E. coli* causing the infection. Some infections can cause severe bloody diarrhea and lead to life-threatening conditions, such as a type of kidney failure called hemolytic uremic syndrome (HUS), or the development of high blood pressure, chronic kidney disease, and neurologic problems. Other infections may have no symptoms or may resolve without medical treatment within five to seven days.

Due to the range in severity of illness, people should consult their health care provider if they suspect that they have developed symptoms that resemble an *E. coli* infection, including HUS, but even healthy older children and young adults can become seriously ill.

People of any age can become infected with pathogenic *E. coli*. Children under the age of 5 years, adults older than 65, and people with weakened immune systems are more likely to develop severe illness as a result of an *E. coli* infection. However, even healthy older children and young adults can become seriously ill.

**Learn more:**

FDA – *E. coli*
	FoodSafety.gov – *E. coli*
	CDC – *E. coli* (STEC)General Food Safety Tips for Retailers

Restaurants and retailers should always practice safe food handling and preparation measures. It is recommended that employees 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.General Food Safety Tips for Consumers

People should consult their healthcare provider if they suspect that they have developed symptoms that resemble an *E. coli* infection.

Consumers should follow these steps for preventing foodborne illness:

**Wash** the inside walls and shelves of the refrigerator, cutting boards and countertops, and utensils that may have contacted contaminated foods; then **sanitize**them with a solution of one tablespoon of chlorine bleach to one gallon of hot water; **dry**with a clean cloth or paper towel that has not been previously used.
	**Wash and sanitize surfaces**used to serve or store potentially contaminated products.
	**Wash hands with warm water and soap**following the cleaning and sanitation process.Consumers can also submit a voluntarily report, a complaint, or adverse event (illness or serious allergic reaction) related to a food product.

Previous Updates

**January 15, 2019**

FDA will continue its investigation into potential sources and contributing factors that led to the outbreak in order to inform future prevention efforts.

FDA, CDC, and California health and agriculture authorities concluded their investigation of the common grower noted as having supplied romaine lettuce linked to three concurrent outbreaks; this outbreak which includes cases in the U.S. and Canada; one outbreak in Washington state potentially linked to leafy greens; and the third outbreak, with cases in the U.S. and Canada, linked to Fresh Express Sunflower Crisp Chopped Salad Kits.

When investigators arrived on the ranches there was no romaine lettuce in the ground and the fields had been plowed, as the growing season had already ended. Investigators collected water, soil, and compost samples to be analyzed. So far, sample results have come back negative for the three outbreak strains of *E. coli.* FDA did find a strain of *E. coli* that is unrelated to any illnesses in a soil sample. This strain of *E. coli* was determined to be of low risk to people. Although this grower was determined to be a common supplier for all three outbreaks based on available supply chain information, the romaine lettuce from this grower does not explain all the illnesses seen in the three outbreaks.

The outbreak linked to Fresh Express Sunflower Crisp Chopped Salad Kits, with cases in the U. S. and Canada, was declared over by CDC on January 15, 2020. There are no products that caused these illnesses left on the market. The outbreak in Washington state sickened 11 people. This outbreak has also been declared over.

As part of FDA’s ongoing efforts to understand and prevent foodborne illnesses linked to leafy greens, the FDA will conduct a root cause investigation. The investigation will be conducted throughout this year’s romaine lettuce planting, growing, and harvesting season. Results will be shared publicly when the investigation and analysis are concluded.

**December 19, 2019**

FDA continues to actively investigate the cause of this outbreak. An investigation team consisting of staff from FDA, CDC, the California Department of Public Health and the California Department of Food and Agriculture are attempting to identify any factors that could have led to contamination at a common farm identified by traceback. This investigation involves assessing and sampling soil, animal droppings, compost, water, and other potential environmental sources at the ranches of this grower. The samples and information collected during the farm investigations will be analyzed.

The Wisconsin Department of Health Services recently reported that they identified the outbreak strain of *E. coli* O157:H7 in an unopened bag of Fresh Express brand Leafy Green Romaine collected from an ill person’s home. The source of the romaine identified in the bag was Salinas, California. It was determined that one of the growers of this product also supplied romaine linked to other *E. coli*outbreaks that FDA is investigating.

These outbreaks are each caused by strains that are different from each other and different from the larger outbreak. One of the additional outbreaks, in Washington state, is potentially linked to romaine lettuce. The other outbreak, with cases in the U.S. and Canada, is linked to Fresh Express Sunflower Crisp Chopped Salad Kits.

**December 12, 2019**

Based on the information indicating that ill people in Maryland were exposed to romaine lettuce harvested in Salinas, California, FDA, with the assistance of staff from the California Department of Public Health and the California Department of Food and Agriculture, immediately deployed investigators to three farms in the Salinas area that were identified based on the traceback investigation.

FDA continues to actively investigate the cause of this outbreak. Additionally, FDA is investigating two other *E. coli* outbreaks, each caused by strains that are different from each other and different from the larger outbreak. One of the additional outbreaks, in Washington state, is potentially linked to romaine lettuce. The other outbreak, with cases in the U.S. and Canada, is linked to Fresh Express Sunflower Crisp Chopped Salad Kits. As part of these investigations, FDA and state partners are conducting traceback investigations to trace romaine exposures to the source.

Currently, the tracebacks on all three outbreaks have identified a common grower in Salinas. FDA, CDC, and California partners are deploying a team to conduct new investigations at several ranches used by this grower as we try to identify the source of the contamination. ****

**December 4, 2019**

FDA, CDC, and state health authorities are investigating an outbreak of illnesses caused by *E. coli* O157:H7 in the U.S. Epidemiologic, laboratory, and traceback evidence indicates that romaine lettuce from the Salinas, California growing region is a likely source of this outbreak.

According to the CDC, as of December 2, 2019, 102 people infected with the outbreak strain of *E. coli* O157:H7 have been reported from 23 states. The case patients report that illnesses started on dates ranging from September 24, 2019 to November 18, 2019. Illness onset dates reported to date are prior to the public warning issued on November 22.

Based on available traceback data, FDA requested that industry voluntarily withdraw romaine grown in Salinas from the market and is requesting that industry  withhold distribution of Salinas romaine for the remainder of the growing season in Salinas. This was the most efficient way to ensure that contaminated romaine was off the market.

Products that were part of the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced recall related to this outbreak investigation had a “Best By” of Nov. 1 or earlier, more than one month ago, and should no longer be on the market.

FDA continues to actively investigate the cause of this outbreak. FDA, with the assistance of staff from the California Department of Public Health and the California Department of Food and Agriculture, immediately deployed investigators to three farms in the Salinas area that were identified based on the traceback investigation. On the farms, investigators sampled soil and animal droppings, compost, water, and other potential environmental sources. The samples and information collected during the farm investigations are currently being analyzed . Investigators are attempting to identify any factors that could have led to contamination. Additionally, state partners are testing romaine lettuce samples for *E. coli* that they have collected from stores and from case patients’ homes.

The FDA and state partners are conducting a traceback investigation to determine whether a common supplier or source of contamination can be identified.  This investigation involves collecting and analyzing potentially hundreds of distribution records to trace the romaine that may have been available at points of exposure reported by ill people to their source. We are continuing to collect these records.

This remains an evolving and fluid situation. Information about our findings will be forthcoming as the investigation proceeds.

The Salinas region as defined by the United Fresh Produce Association and the Produce Marketing Association Romaine Taskforce Report includes: Santa Cruz, Santa Clara, San Benito, and Monterey counties in California.

**November 26, 2019**

According to the CDC, as of November 25, 2019, 67 people infected with the outbreak strain of *E. coli* O157:H7 have been reported from 19 states. The case patients report that illnesses started on dates ranging from September 24, 2019 to November 14, 2019.

The Maryland Department of Health identified *E. coli* O157:H7 in an unopened package of Ready Pac Bistro® Chicken Caesar Salad collected from an ill person’s home in Maryland. Analysis of this salad, through Whole Genome Sequencing (WGS), has linked strain *E. coli* O157:H7 to three Maryland cases and the multi-state outbreak.

The FDA and state partners are conducting a traceback investigation to trace romaine exposures to the source. Preliminary information indicates that ill people in Maryland were exposed to romaine lettuce harvested in Salinas, California.
FDA has deployed investigators to the farms in question to try to determine the source and extent of the contamination. More information will be forthcoming as the investigation proceeds.

Additionally, state partners are conducting laboratory analyses of romaine lettuce samples from case patients potentially linked to the outbreak.

The Salinas region as defined by the United Fresh Produce Association and the Produce Marketing Association Romaine Taskforce Report includes: Santa Cruz, Santa Clara, San Benito, and Monterey counties in California.

Genetic analysis of the *E. coli* O157:H7 strains 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 and the Fall of 2018 that 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. The 2018 outbreak of *E. coli* O157:H7 was associated with romaine in both countries.

**November 22, 2019**

FDA, CDC, and state health authorities are investigating an outbreak of illnesses caused by *E. coli* O157:H7 in the U.S. Epidemiologic, laboratory, and traceback evidence indicates that romaine lettuce from the Salinas, California growing region is a likely source of this outbreak.

According to the CDC, as of November 21, 2019, 40 people infected with the outbreak strain of *E. coli* O157:H7 have been reported from 16 states. The case patients report that illnesses started on dates ranging from September 24, 2019 to November 10, 2019.

The Maryland Department of Health identified *E. coli* O157:H7 in an unopened package of Ready Pac Bistro® Chicken Caesar Salad collected from an ill person’s home in Maryland. Analysis of this salad, through Whole Genome Sequencing (WGS), has linked strain *E. coli*O157:H7 to three Maryland cases and the multi-state outbreak.

The FDA and state partners are conducting a traceback investigation to trace romaine exposures to the source. Preliminary information indicates that ill people in Maryland were exposed to romaine lettuce harvested in Salinas, California.

FDA is deploying investigators to the farms in question to try to determine the source and extent of the contamination. More information will be forthcoming as the investigation proceeds.

Additionally, state partners are conducting laboratory analyses of romaine lettuce samples from case patients potentially linked to the outbreak.

The Salinas region as defined by the United Fresh Produce Association and the Produce Marketing Association Romaine Taskforce Report includes: Santa Cruz, Santa Clara, San Benito, and Monterey counties in California.

Genetic analysis of the *E. coli* O157:H7 strains 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 and the Fall of 2018 that 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. The 2018 outbreak of *E. coli* O157:H7 was associated with romaine in both countries.

**November 21, 2019**

FDA, CDC, FSIS and state health authorities are investigating an outbreak of illnesses caused by *E. coli* O157:H7  in the U.S.

Products in the recall noted above were produced with the same lot of lettuce that was used to produce the packaged salad that the Maryland Department of Health found to contain *E. coli* 0157:H7.

That product was Ready Pac Bistro® Chicken Caesar Salad, lot #255406963, UPC  0 77745 27249 8, “Best By” date Oct. 31, 2019, and it is included in this recall.

FDA is tracing back the supply of the romaine lettuce in the Caesar salad. FDA has identified possible farms in Salinas, California. FDA is deploying investigators to determine the source and extent of the contamination. More information will be forthcoming as the investigation proceeds.

Although the ill people interviewed in Maryland reported eating Ready Pac Bistro® Chicken Caesar Salad, at this time, ill people in other states have not reported eating this particular salad. Therefore, exposure to this product alone does not fully explain other cases in the outbreak.

State and local public health officials are interviewing ill people to determine what they ate and other exposures of interest in the week before their illness started.

**November 20, 2019**

FDA, CDC, and state health authorities are investigating an outbreak of illnesses caused by *E. coli* O157:H7  in the U.S.

According to the CDC, as of November 18, 2019, 17 people infected with the outbreak strain of *E. coli*O157:H7 have been reported from eight states. The case patients report that illnesses started on dates ranging from September 24, 2019 to November 8, 2019.

Two cases reported from Maryland have been linked to this outbreak by Whole Genome Sequencing (WGS), through analysis of clinical samples taken from those patients. The Maryland Department of Health identified *E. coli*O157 in an unopened package of Ready Pac Bistro® Chicken Caesar Salad collected from a ill person’s home in Maryland which was purchased from a Sam’s Club in that state. Preliminary information indicates that romaine lettuce used in the product that tested positive was harvested in mid-October and is no longer within current expiration dates. To date, the food sample has not yet been definitively linked to the Maryland cases or other*E. coli* O157 illnesses in the multi-state outbreak. WGS analysis is currently underway for this sample to determine if it is closely related genetically to the *E. coli*found in people in this outbreak.

As analysis is underway, FDA is tracing back the supply of the romaine lettuce in the Caesar salad. FDA has identified possible farms in Salinas, California. FDA is deploying investigators to the farms in question to determine the source and extent of the contamination. More information will be forthcoming as the investigation proceeds.

Although the ill people interviewed in Maryland reported eating Ready Pac Bistro® Chicken Caesar Salad, at this time, ill people in other states have not reported eating this particular salad. Therefore, exposure to this product alone does not fully explain other cases in the outbreak.

State and local public health officials are interviewing ill people to determine what they ate and other exposures of interest in the week before their illness started.

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

Call an FDA Consumer Complaint Coordinatorif you wish to speak directly to a person about your problem.
	Complete an electronic Voluntary MedWatch form online.
	Complete a paper Voluntary MedWatch form that can be mailed to FDA.Submit Questions/Get Assistance

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                                                                                  Content current as of:
      05/21/2020
              
              
Regulated Product(s)
		 Food & BeveragesTopic(s)
			  OutbreakOutbreaks of Foodborne Illness

          
                        Investigations of Foodborne Illness Outbreaks
          Public Health Advisories from Investigations of Foodborne Illness Outbreaks
          Food Safety Tips for Consumers & Retailers During an Outbreak of Foodborne Illness
          Food Safety Resources for Produce Shippers and Carriers During a Foodborne Illness Outbreak
          Outbreak Investigation Reports
          How to Report Seafood-Related Toxin and Scombrotoxin Fish Poisoning Illnesses
          About the CORE Network
          CORE Annual Reports
          CORE Publications


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