In the latest FDA update about the E. coli O157:H7 outbreak involving romaine lettuce, the agency has stated that consumers should not eat romaine lettuce that has been harvested from Salinas, California. Traceback investigations related to three different E. coli outbreaks (three different strains, all of which involve romaine lettuce) have pointed to a common grower located in Salinas. Frank Yiannas, deputy commissioner for food policy and response, called the identification of a common grower a “notable development” but also stated in a press announcement, “Because of the expansive nature of these outbreaks, our investigation remains a complicated work in progress, and it is too soon to draw definitive conclusions.”
FDA, CDC and California partners have sent out a team to conduct new investigations at ranches used by the grower as part of the process in finding the contamination source, according to an FDA update.
Thus far, 102 illnesses have been reported across 23 states, with 58 hospitalizations. No deaths have been reported. The last illness onset was reported on November 18.
Thus far Swedesboro, NJ-based Missa Bay, LLC has recalled more than 75,000 pounds of salad products because of a lettuce ingredient that might be contaminated with E. coli O157:H7. This lettuce was also found to be in packaged salad that the Maryland Department of Health said contained E. coli.
FDA states that thus far lettuce grown indoors has not been indicated in the outbreak.
Last month, the FDA held a public meeting to discuss its New Era of Smarter Food Safety initiative, with a rallying call to create a more “digital, traceable and safer food system.”
FDA Deputy Commissioner for Food Policy and Response Frank Yiannas made it clear that the FDA is not replacing FSMA. Rather, the goal is to build on it, recognizing changes in the food industry over the last 10 years and the technologies available to tackle new challenges.
This isn’t surprising given continuing quality issues resulting in food recalls and shelf withdrawals. Last year, two major outbreaks of E. coli that were tied to consumption of romaine lettuce made a mark on industry perceptions, impacting customer trust, brand loyalty and the bottom line of companies involved were affected. Research by Allianz found recall costs could reach $10,000,000 for significant events.
To achieve the FDA’s goal of end-to-end traceability, the amount of information carried by every food item needs to increase, as will information about its location and condition in the supply chain. Grocers are at the sharp end of the food chain, meaning everything the FDA is proposing will impact them. As well as being merchandisers, they are brand-owners in their own right. They work directly with farmers and growers, they are directly involved in food safety, storage and distribution, and they feel the impact of recalls more than most. Unlike others in the food chain, they interact with consumers daily. This is important to note, since consumers are expecting communication on recalls immediately. In a recent study of more than 15,800 global consumers, 66% of respondents noted that they expect immediate notification of a product recall and another 28% stated they expect notification within a week.1 Furthermore, 88% said if a retailer immediately informed them of an issue, they would be more likely or slightly likely to trust them. The study also found that only 16% of consumers completely trust the product information provided to them from retailers today. In short, the impact of recalls extends far beyond the empty store shelf, and gives the industry even more reason to strive for safety.
High-Tech Next Steps
The FDA plans to publish a strategic blueprint early in 2020 of planned actions to meet its goal, but food brands and grocers need not wait to act. Proven technologies like brand compliance solutions, combined with emerging blockchain track and trace solutions and Internet of Things (IoT) sensors can add new depth and detail to traceability in the food supply chain, and these new technologies are already helping grocers and retailers keep consumers safe.
As retailers have sought a better means to track supply chain movements, blockchain technology has emerged as a potential way forward. Originally developed to manage financial transactions involving cryptocurrency, blockchain has proven to be capable of providing a verifiable record of the movement of goods through a supply chain. In fact, one major retailer has been piloting blockchain for more than a year and has already proven its value on produce items, cutting traceability times from more than a week to a matter of seconds. Some want to go even further and use IoT sensors to monitor the condition (e.g., temperature) of food products in the supply chain. Together, blockchain can help trace the path a product took through the supply chain and IoT can monitor the environmental conditions en route, providing a more cohesive picture of its supply chain journey.
But while supporting a few simple products with one ingredient and a one-step supply chain, such as fruits or vegetables, is one thing, scaling to address the needs of the average private brand retailer—now handling more than 10,000 active products from 2,000 production sites globally—is another. Managing the complexity of a product like tiramisu or a ready-made meal with dozens of ingredients, all coming from different sources, needs a different approach. To address the complexity, many are turning to brand compliance solutions—trusted, real-time repositories of information spanning the entire supply chain. For example, those using brand compliance solutions now have complete visibility of the ingredients in their private label products, helping them ensure labeling accuracy and transparency for consumers. Brand compliance tools also bring improved visibility of the food supply chain, enabling them to verify the status of manufacturing sites and respond quickly to food quality issues.
This combination of detailed product and supplier information makes brand compliance a foundational enabler for any blockchain/IoT-based initiative to improve supply chain visibility and traceability. For example, using brand compliance solutions, grocers can:
- Confirm the ethical compliance of the supply chain at the point of selection or review, while using blockchain/IoT to monitor the ongoing conformance to these standards
- Validate shelf life claims during formulation, while blockchain/IoT monitors logistical movement and environments to optimise products’ freshness
- Record products’ formulation and ingredients to ensure safety, legal compliance and labeling accuracy, with blockchain/IoT monitoring the ongoing conformance to these standards
- Rapidly identify potential risks across the entire formulation and supply chain, while tracking the affected batches to stores using blockchain and IoT
This convergence of static factual data (e.g., formulation, nutrition and allergens) linked to near real-time traceability and checking offers grocers confidence in the data and supports the consumer’s confidence of an actual product in their basket.
It seems clear that the food business is moving in the same direction as airlines and banks and becoming much more data driven. For grocers looking to keep pace, they will need to:
- Treat data as a core competency. This means hiring information experts, investing for the future, and using data to identify ways to deliver better, safer products.
- Create a customer-centric value promise. Grocers must go beyond regulatory compliance and use data to improve consumer transparency, support ethical sourcing initiatives, expand sustainable packaging and speed innovation.
- Go above and beyond. Rather than waiting for FDA direction or simply complying with requirements, brands should take matters into their own hands, hold themselves to high markers and get started now.
In the future, improving the way that we manage the food supply chain is not just about how well we work with trucks and warehouses; it’s about how use information. The FDA’s initiative makes a clear statement that now is the time to modernize our food supply chains. As we look ahead to a new decade, the industry can come together to improve food safety and protect consumers, and we need not wait for the FDA’s blueprint or even the new year to get started.
- Setting the Bar: Global Customer Experience Trends 2019. (2019). Oracle Retail. Retrieved from https://go.oracle.com/LP=86024.
Following last year’s widespread E.coli O157 outbreak involving romaine lettuce linked to the Yuma, Arizona growing region (Spring 2018), FDA launched a sampling assignment to test romaine lettuce for pathogenic Shiga toxin-producing Escherichia coli (STEC) and Salmonella spp. The microbiological surveillance sampling began on December 18, 2018 in the Yuma region and focused on 26 commercial coolers and cold storage facilities to allow FDA to sample multiple farms from several locations at once. The agency collected and tested a total of 188 samples for both pathogens. It did not detect Salmonella in any sample; STEC was detected in one sample, but additional analysis found that the bacteria was not pathogenic.
“The findings of this assignment suggest that there was no widespread Salmonella or STEC contamination of romaine lettuce from the Yuma growing region during the period when sampling occurred. As a next step, the FDA is working with leafy green stakeholders in the Yuma region to consider a longer-term environmental study to identify and control risks that will prevent future outbreaks, with the ultimate goal of protecting consumers. – FDA
The point of the sampling assignment was to determine whether target pathogens were present, and if so, to respond quickly before contaminated products reached consumers.
The November 2018 outbreak of E.coli O157:H7 infections linked to romaine lettuce caused 62 illnesses across 16 states. The FDA zeroed in on the Central Coast growing regions of northern and Central California as being responsible for the contamination. The outbreak was declared over on January 9 and yesterday FDA released the report, “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”, which provides an overview of the investigation.
The report states that a sediment sample coming from an on-farm water reservoir in Santa Maria (Santa Barbara County, California) tested positive for the outbreak strain of E. coli O157:H7. Although this particular farm was identified in several legs of the Fall 2018 traceback investigations that occurred in the United States and Canada, as well as being a possible supplier of romaine lettuce in the 2017 traceback investigations, the FDA said that the farm is not the single source of the outbreak, as there is “insufficient evidence”. The traceback suggests that the contaminated lettuce could have come from several farms, because not all tracebacks led to the farm on which the contaminated sediment was found.
“The finding of the outbreak strain in the sediment of the water reservoir is significant, as studies have shown that generic E. coli can survive in sediments much longer than in the overlying water. It’s possible that the outbreak strain may have been present in the on-farm water reservoir for some months or even years before the investigation team collected the positive sample. It is also possible that the outbreak strain may have been repeatedly introduced into the reservoir from an unknown source,” stated FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas in a press announcement.
Although the exact route of contamination cannot be confirmed, the FDA hypothesizes that it could have occurred through the use of agricultural water from an open reservoir, which has increased potential for contamination.
The investigation teams also found evidence of “extensive” wild animal activity and animal burrows near the contaminated reservoir, as well as adjacent land use for animal grazing, all of which could have contributed to the contamination.
Although FDA did not directly name the farm in the report, it provided a link about the recall that was initiated by the farm, Adam Bros. Farming, Inc., in December.
Considering the significant effect that the past two E.coli outbreaks involving romaine lettuce have had on both the public as well as the produce industry, FDA made several recommendations on preventive measures that leafy greens growers and industry can take to avoid such pathogenic contamination, including:
- Assessing growing operations to ensure they are in line with compliance to FSMA and good agricultural practices
- Making sure that any agricultural water that comes into direct contact with the harvestable portion of the crop, food contact surfaces and harvest equipment is safe and sanitary
- Address and mitigate risks associated with agricultural water contamination that can occur as a result of intrusion by wild animals
- Address and mitigate risks associated with the use of land near or adjacent to agricultural water sources that can lead to contamination
- Conduct root cause analysis whenever a foodborne pathogen is identified in the growing environment, agricultural inputs like water or soil, raw agricultural commodities, or “fresh-cut” ready-to-eat produce
For the broader industry:
- The development of real-time procedures that enable rapid examination of the potential scope, source and route of contamination
- All leafy green products should have the ability to be traced back to the source in real time, and information include harvest date. In November, FDA requested voluntary labeling [https://foodsafetytech.com/news_article/cdc-alert-do-not-eat-romaine-lettuce-throw-it-out/] to help consumers identify products affected during an outbreak
- The adoption of best practices in supply chain traceability
- FDA report: “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”
- FDA statement from Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas
- FDA investigation of source of E.coli O157:H7 outbreak linked to romaine lettuce
Although FDA is continuing its investigation into the source of the E.coli outbreak involving romaine lettuce grown in California, the CDC has declared the outbreak over. Contaminated romaine that caused illnesses should no longer be available, FDA stated in an outbreak update. Consumers will not need to avoid romaine lettuce, and retailers and restaurants do not need to avoid selling or serving the product, according to the agency. Suppliers and distributors need not avoid shipping or selling any romaine that is on the market either.
FDA has recommended that romaine lettuce is labeled with the harvest location and date, as well as whether it has been grown hydroponically or in a greenhouse. “ In case of future product withdrawals or recalls of romaine lettuce, this will help to limit the amount of product to be removed from the market and it will help consumers, restaurants and retailers determine that the romaine lettuce they are buying is from an unaffected growing region,” stated FDA. In addition, the detailed labeling should be available in stores, the agency states.
The end of the year is always a time of reflection. At Food Safety Tech, it is also a time when we like to share with you, our readers, the most popular articles over the last 12 months. Enjoy, and thank you to our loyal and new readers, as well as our contributors!
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Yesterday FDA issued an update on the E.coli O157:H7 outbreak linked to romaine lettuce grown in California. The agency’s traceback investigation continues, and it is working with the Public Health Agency of Canada (PHAC) and Canadian Food Inspection Agency (CFIA), as there is a similar outbreak in Canada.
FDA stated that the contaminated lettuce likely originates from the Central Coast growing regions of northern and Central California (Counties of Monterey, San Benito, San Luis Obispo, Santa Barbara, Santa Cruz and Ventura).
“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 latest update states that 52 illnesses and 19 hospitalizations have been reported across 15 states (the highest cases are in California and New Jersey with 11 illnesses each).
–UPDATE– November 26, 2018 —
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.
Wait, wasn’t the outbreak declared over in June? What happened?
“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.
The investigation is ongoing.
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.”
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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.”
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