FDA has issued a release stating that the E. coli outbreak is likely linked to romaine lettuce grown in California during the fall timeframe. The agency’s traceback investigation is in progress, and it is looking at shipping records and invoices in order to trace the romaine lettuce supply from places in which ill people have been exposed to where the product was grown. Thus far this information has been connected to romaine lettuce harvested in the Central Coast growing regions located in northern and central California. Locations outside of California have not been linked to this particular outbreak, and thus the FDA is not recommending that consumers or retailers avoid romaine lettuce that has been grown outside of these California regions. The agency has not found evidence of any outbreaks linked to romaine that was grown hydroponically or in a greenhouse.
“During this new stage of the investigation, it is vital 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 would easily differentiate for consumers romaine from unaffected growing regions.” – FDA
As a result, FDA stated that romaine lettuce entering the market will be labeled with a harvest location and date to help consumers distinguish unaffected growing regions.
Just when we thought the E.coli O157:H7 outbreak involving romaine lettuce was over: Today CDC issued a Food Safety Alert informing consumers not to eat ANY romaine lettuce. Retailers and restaurants shouldn’t serve any either.
“Thirty-two people infected with the outbreak strain of Shiga toxin-producing E. coli O157:H7 have been reported from 11 states.
Illnesses started on dates ranging from October 8, 2018 to October 31, 2018.
Thirteen people were hospitalized, including one person who developed hemolytic uremic syndrome, a type of kidney failure. No deaths have been reported.” – CDC
The agency is urging against the consumption of romaine lettuce because they haven’t been able to identify a common grower, supplier, distributor or brand.
Could we be in for another widespread outbreak? Just last week during a panel discussion at the Food Safety Consortium, the FDA and CDC said that when the last outbreak occurred they knew it would get bad really quickly.
This year’s multistate outbreak of E.coli O157:H7 infections linked to romaine lettuce affected 210 people, killing five. Although the outbreak was officially declared over by the end of June, questions still remain as to the exact source. Given the widespread nature of the outbreak and the speed with which illnesses occurred, there are many lessons to be learned from the case.
During last week’s annual Food Safety Consortium, industry stakeholders from the FDA, CDC and produce associations gathered to discuss agency action upon learning of the outbreak and where there is room for improvement.
The investigation began in April 2018 when the New Jersey Department of Health contacted the CDC about a cluster of E.coli O157:H7 illnesses from people who said they ate salads at various locations of the same restaurant chain. Three days later, the agency was able to confirm eight O157 isolates from six states with the same patterns using PulseNet. And five days after that, the CDC posted a notice on its website about the investigation of 17 cases across seven states.
“We knew right away that this was going to get bad and that it would get bad quickly,” said Matthew Wise, deputy branch chief for outbreak response at the Outbreak Response and Prevention Branch of the CDC. “We saw illnesses ramp up quickly.” He added that the agency saw a lot of illness subclusters, all with romaine lettuce as the common ingredient.
The epidemiological evidence clearly indicated chopped romaine lettuce, and it appeared that all the affected romaine was coming from the Yuma, Arizona growing region, noted Stic Harris, director of the Coordinated Outbreak Response & Evaluation Network at FDA. But then things got even more confusing, as an Alaskan correctional facility was also investigating a cluster of cases. This allowed the agency to trace the source directly back to Harrison Farms as the sole supplier to the correctional facility. However, as the multi-agency investigation continued, they uncovered that the source was not just one farm. “There were three dozen farms in the Yuma region that supplied romaine lettuce,” said Harris, adding that we may never know which exact farm, and even if it was one farm, that was the source of the outbreak.
During June, July and August, the FDA sent a multidisciplinary team of 16-18 people to conduct an environmental assessment of the affected area. Upon taking 111 samples, they found 13 different Shiga toxin-producing E. coli strains, but only three matched the strain of the outbreak. Water from 14 locations, including discharge, reservoir and canal water, was also tested. The environmental assessment found pervasive contamination in the water. But here was the big problem, said Harris: “There was no smoking gun. We don’t know how the E.coli got into the water, and we don’t know how the water got onto the lettuce.” He added that additional research is needed, and that government and non-government work must continue to identify the source.
There are several challenges associated with the complexity of this type of produce outbreak, said Harris and Wise:
The production lot information disappears at the point of service
Having a commingled product hinders traceback
Records present a challenge because agencies try to look at each company and their individual records, and every company has their own way of doing things—this takes time
The breadth of the impacted area—trying to do an environmental assessment for that area was staggering work
People who eat lettuce eat it often
Many people don’t remember what type of lettuce they ate
The product has a short shelf life
Communication: The packaging isn’t transparent on where it’s grown
Scott Horsfall, CEO, California Leafy Green Products Handler Marketing Agreement, chimed in on the challenges posed by the complexity of the outbreak. “If you compare these numbers with the 2016 spinach outbreak…they’re very similar [in the] total number of illnesses [and] number of states involved. But in [the spinach outbreak], it led to a specific farm. What we saw this time was very different.”
When it comes to food safety compliance, learning lessons the hard way is never a good practice. Violations, non-compliance and documentation mishaps put a major damper on your business. From delays in production to the dreaded recall, these mistakes can cost thousands, if not millions, of dollars. Don’t learn these lessons the hard way. See our Case Studies and learn how companies are avoiding these costly mistakes with TraceGains.
One of the large successes in dealing with the outbreak is that the agencies issued public warnings quickly, said Wise. The produce industry also came together to form the Leafy Greens Food Safety Task Force. In addition, FDA is expanding its sampling for the coming harvests, according to Harris. “I think that in terms of the speed of the environmental assessment, we need to be quicker with that. We apparently hadn’t done one in quite a long time at FDA,” he said.
Harris and Wise also stressed that for industry to work more effectively together, they need to work with the FDA and CDC before there is an outbreak.
“This outbreak was a frustrating experience for all of us,” said Horsfall. “We have to communicate more and better when we can. And as an industry, stop these outbreaks from happening.”
Yesterday Cargill Meat Solutions recalled about 132,606 pounds of certain ground beef products over concern of E.coli O26 contamination. The ground beef products, which were made from the chuck portion of the carcass, were produced and packaged on June 21.
“On Aug. 16, 2018, FSIS was notified of an investigation of E. coli O26 illnesses. FSIS, the Centers for Disease Control and Prevention, and state public health and agriculture partners determined that raw ground beef was the probable source of the reported illnesses. The epidemiological investigation identified 17 illnesses and one death with illness onset dates ranging from July 5 to July 25, 2018. “ – FSIS, USDA
“FSIS is concerned that some product may be frozen and in consumers’ freezers,” stated FSIS in an agency press release. “Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.”
Following the multi-state E. coli O157:H7 outbreak linked to romaine lettuce from the Yuma, Arizona region, several groups have come together in the hopes of preventing future outbreaks. Despite the fact that the FDA announced that the outbreak was likely over weeks ago, 4 more deaths have occurred (bringing the total to 5 dead), and three more states have reported ill people.
Now the Arizona and California leafy greens industries, the Produce Marketing Association, Western Growers, United Fresh and other groups have created a special task force to improve food safety systems across the supply chain. The Leafy Greens Food Safety Task Force will consist of industry members, food safety experts, researchers and representatives from government.
“It is very difficult to identify an issue weeks or months after the fact, primarily because of the expediency with which our product is harvested and in the marketplace,” said Arizona Leafy Greens Marketing Agreement Chair Jerry Muldoon in a press release. “With our industry knowledge, scientific experts and the collaboration of state and federal agencies, we believe we can help get to the bottom of this and make changes to processes after our product leaves the farm, as well as closely examine other factors at play.”
The latest update from CDC puts the case count at 197 ill, five dead, 89 hospitalizations, with a span of illnesses across 35 states.
The multi-state E.coli O15:H7 outbreak linked to romaine lettuce may be nearly over. According to the FDA, romaine lettuce from the Yuma growing region is no longer being harvested or distributed, which means “it is unlikely that any romaine lettuce from the Yuma growing region is still available in stores or restaurants due to its 21-day shelf life,” the agency states. The last harvest date was April 16.
Spanning across 32 states, thus far the case count of infections is at 172, with 75 hospitalizations and one death, according to the CDC.
The FDA investigation continues, and the agency is looking at all potential avenues of contamination throughout the chain—including growing, harvesting, packaging and distribution.
3M Food Safety has received the AOAC Research Institute’s Performance Tested Method Certification for its Petrifilm Rapid E.coli/Coliform Count Plate. Introduced in February, the rapid microbial test helps food and beverage processors detect the presence of E.coli and other coliform bacteria. The test can recover E.coli and distinguish it from other coliforms within 18–24 hours.
The AOAC PTM designation validated the count plate as an equivalent alternative to FDA and ISO standard references to enumerate these bacteria. The evaluation was performed by an independent lab on food and environmental surfaces that include raw and pasteurized dairy products; raw and prepared meat; poultry and seafood; fresh fruit and product; and baby food, pet food and flour.
3M Food Safety is also pursuing MicroVal validation in accordance with ISO 16140-2.
The number of illness cases linked to the E.Coli 0157:H7 outbreak has jumped to 98. Fourteen more people from eight states were added since Wednesday, and three more states have reported sick people: Mississippi, Tennessee and Wisconsin. The current number of states affected is 22, and hospitalizations have increased to 46. No deaths have been reported.
Now the CDC is advising consumers, restaurants and retailers to get rid of all romaine lettuce—not just chopped romaine, but also whole heads and hearts of romaine, and salads and salad mixes containing the variety—if they cannot confirm the source. “Information collected to date indicates that romaine lettuce from the Yuma, Arizona growing region could be contaminated with E. coli O157:H7 and could make people sick,” the CDC states on its website.
The most current illness case count is 53, with illnesses reported in 16 states. There have been 31 hospitalizations thus far and no deaths, according to the CDC.
At least 35 people in 11 states have been infected with E.coli O157:H7, according to the CDC, and the FDA is investigating a likely link to these infections and chopped romaine lettuce from Yuma, Arizona. The reported illnesses occurred between March 22 and March 31, and 93% of the 28 people interviewed reported eating romaine lettuce (mainly from a restaurant) during the week that they became ill.
The FDA and CDC are advising consumers to ask restaurants and other food service establishments where they source their romaine lettuce from and to avoid any that came from Yuma, Arizona. In addition, they should not buy or eat it if they cannot confirm the source.
“Retailers, restaurants, and other food service operators should not sell or serve any chopped romaine lettuce from the winter growing areas in Yuma, Arizona. If you cannot determine the source of your chopped romaine lettuce, do not sell or serve it. The FDA currently does not have information to indicate that whole-head romaine lettuce or hearts of romaine have contributed to this outbreak.” – FDA
The agencies will continue to investigate this outbreak. FDA emphasized that this outbreak is not related to a multistate outbreak that occurred last November to December involving leafy greens, as those infections had a different DNA fingerprint of the E. coli O157:H7 bacteria.
Shiga toxin-producing E. coli in dry flour, and then romaine lettuce. E. coli O104 in fenugreek sprout seeds. Recent announcements of foodborne illness outbreaks have begun involving unusual combinations of bacteria and foods. These out-of-the-ordinary outbreaks and recalls are a small but growing part of the 600 million documented food poisonings that occur worldwide every year according to the World Health Organization. Preventing outbreaks from these new combinations of pathogen and food demand a range of accurate tests that can quickly identify these bacteria. Over the past several years, outbreaks from unusual sources included:
E. coli O121 (STEC) in flour: Last summer, at least 29 cases of a E. coli O121 infection were announced in six Canadian provinces. The source arose from uncooked flour, a rare source of such infections because typically flour is baked into final products. Eight people were hospitalized, and public health officials have now included raw, uncooked flour as well as raw batter and dough as a source of this type of infection.
E. coli O104:H4 in fenugreek sprouts: One of Europe’s biggest recent outbreaks (affecting more than 4,000 people in Germany in 2011, and killing more than 50 worldwide) was originally thought to be caused by a hemorrhagic (EHEC) E. coli strain that from cucumbers, but was but was later found to be from an enteroaggregative E. coli (EAEC) strain in imported fenugreek seeds—the strain had acquired the genes to produce Shiga toxins.
Mycoplasma in New Zealand dairy cows: While not unusual in cattle, the incident reported in August marks the pathogen’s first appearance in cows in New Zealand, a country known for strict standards on agricultural hygiene. The microorganism is not harmful to people, but can drastically impact livestock herds.
Listeria monocytogenes in food sources: Listeria monocytogenes causes fewer but more serious incidence of food poisoning due to a higher death rate compared to Salmonella and Campylobacter. Whereas Listeria has been historically associated with dairy and ready to eat cooked meat products, recent outbreaks have been associated with fruit, and the FDA, CDC and USDA are conducting a joint investigation of outbreaks in frozen as well as in fresh produce.
Listeria in cantaloupe: In 2011, one of the worst foodborne illnesses recorded in the United States killed 20 and sickened 147, from Listeria monocytogenes that was found in contaminated cantaloupes from a farm in Colorado. The outbreak bloomed when normal background levels of the bacteria grew to deadly concentrations in multiple locations, from transport trucks to a produce washer that was instead designed for potatoes.
The outbreaks underscore the fundamental need to have a robust food safety program. Bacteria can colonize many different locations and the opportunity is created by a change in processing methods and/or consumer use or misuse of products. So robust risk assessment and preventative QA procedures need to be frequently reviewed and supported by appropriate surveillance methods.
Food safety and public health agencies like the European Food Safety Authority (EFSA) or the CDC have employed a wide range of detection and identification tests, ranging from pulse field gel electrophoresis (PFGE), traditional cell culture, enzyme immunoassay, and the polymerase chain reaction (PCR). In the case of Germany’s fenugreek-based E. coli outbreak, the CDC and EFSA used all these techniques to verify the source of the contamination.
These tests have certain advantages and disadvantages. Cell culture can be very accurate, but it depends on good technique and usually takes a long time to present results. PFGE provides an accurate DNA fingerprint of a target bacteria, but cannot identify all strains of certain microorganisms. Enzyme immunoassays are precise, but can produce false-positive results in certain circumstances and require microbiological laboratory expertise. PCR is very quick and accurate, but doesn’t preserve an isolate for physicians to test further for pathogenic properties.
Identification of the pathogens behind foodborne contamination is crucial for determining treatment of victims of the outbreak, and helps public health officials decide what tools are necessary to pinpoint the outbreak’s cause and prevent a recurrence. Rapid methods such as the polymerase chain reaction (PCR), which can quickly and accurately amplify DNA from a pathogen and make specific detection easier, are powerful tools in our efforts to maintain a safe food supply.
Recently, scientists and a third-party laboratory showed that real-time PCR assays for STEC and E. coli O157:H7 could detect E. coli O121, O26 and O157:H7 in 25-g samples of flour at levels satisfying AOAC method validation requirements. The results of the study demonstrated that real-time PCR could accurately detect stx, eae and the appropriate E. coli serotype (O121, O26 or O157:H7) with no statistical difference from the FDA’s Bacteriological Analytical Manual (BAM) cell culture method.
Agencies like the World Health Organization and CDC have repeatedly stated that historical records of food poisoning represent a very small percentage of true incidents occurring every year worldwide. Many of today’s most common food pathogens, like Listeria monocytogenes, E. coli O157:H7 or Campylobacterjejuni, were unknown 30 years ago. It’s not clear yet if unusual sources of contamination arise from increasing vigilance and food safety testing, or from an increasingly interdependent, globally complex food supply. No matter the reason, food producers, processors, manufacturers, distributors and retailers need to keep their guard up, using the optimum combination of tools to protect the public and fend off food pathogens.
Strictly Necessary Cookies
Strictly Necessary Cookies should be enabled at all times so that we can save your preferences for these cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
If you visit and/or use the FST Training Calendar, cookies are used to store your search terms, and keep track of which records you have seen already. Without these cookies, the Training Calendar would not work.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
A browser cookie is a small piece of data that is stored on your device to help websites and mobile apps remember things about you. Other technologies, including Web storage and identifiers associated with your device, may be used for similar purposes. In this policy, we say “cookies” to discuss all of these technologies.
Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.
In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.
You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.