Following last year’s widespread E.coli O157 outbreak involving romaine lettucelinked 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 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.
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
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!
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 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.”
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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.”
These issues highlight how the increasingly complex supply chain further complicates problems once they arise. Ostroff emphasized the necessity of end-to-end tracing, from product origination to where the consumer can access the product, and that it needs to be efficient, standardized and rapid, especially for commodities. Regarding the E. coli O157:H7 outbreak involving romaine lettuce, FDA is still trying to determine the source and mode of the contamination. And while the recent finding of the outbreak strain in the irrigation canal water is important, it still does not answer the question of how the contamination got into the canal, said Ostroff.
The latest FDA update on the outbreak investigation stated that additional samples are being analyzed on an ongoing basis and any new matches would be publicly disclosed. As of June 28, the CDC announced that the outbreak was over.
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.
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