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FDA Report on E. Coli Outbreak in Romaine Lettuce Points to “Significant” Finding of Strain in Sediment of Water Reservoir

By Maria Fontanazza
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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.

(left to right) Stic Harris, FDA; Matt Wise, CDC; Dan Sutton, Pismo Oceano Vegetable Exchange; Scott Horsfall, California Leafy Greens Marketing Agreement discuss the first E.coli outbreak involving romaine lettuce during a panel at the 2018 Food Safety Consortium. Read the article about the discussion.

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:

For growers:

  • 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

Resources

  1. FDA report: “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”
  2. FDA statement from Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas
  3.  FDA investigation of source of E.coli O157:H7 outbreak linked to romaine lettuce
Lettuce

CDC Reports Romaine Lettuce Outbreak Over

By Food Safety Tech Staff
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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.

Lettuce

Latest on E. Coli Outbreak Involving Romaine Lettuce

By Food Safety Tech Staff
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Lettuce

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).

Earlier updates:

(UPDATE) CDC Alert: Do Not Eat Romaine Lettuce, Throw It Out

Alert

JBS Recalls More than 12 Million Pounds of Raw Beef, May Be Contaminated with Salmonella

By Food Safety Tech Staff
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Alert

Following an expanded recall issued this week, JBS Tolleson, Inc. has now recalled about 12,093,271 pounds of non-intact raw beef products over concerns that they may be contaminated with Salmonella Newport. The initial recall of nearly 7 million raw beef products occurred just two months ago. The Class I recall announced today involves an additional 5,156,076 pounds of raw beef products that were produced and packed between July 26 and September 7, 2018, according to USDA’s FSIS . The recalled products have the establishment number “EST. 267” inside the USDA mark of inspection.

According to the CDC, there are currently 246 reported Salmonella Newport illnesses across 25 states, with 59 hospitalizations. No deaths have been reported. FSIS and CDC have been working with case patients who have provided receipts or shopper card numbers to conduct traceback investigations. The agencies are urging consumers to check their freezers for any recalled product.

Alert

(UPDATE) CDC Alert: Do Not Eat Romaine Lettuce, Throw It Out

By Food Safety Tech Staff
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Alert

–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.

–END UPDATE–

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.

 

 

Romaine Lettuce Outbreak: We Knew It Would Get Bad Quickly

By Maria Fontanazza
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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.

(left to Right) Stic Harris, FDA; Matt Wise, CDC; Dan Sutton, Pismo Oceano Vegetable Exchange; Scott Horsfall, California Leafy Green Products Handler Marketing Agreement

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.”

FDA: 172 Ill, 1 Death, Romaine Lettuce E. Coli Outbreak Likely Over

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Alert

Outbreak of Salmonella linked to Raw Turkey Products Continues, USDA Facing Pressure to Name Brands

By Food Safety Tech Staff
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Alert

Just in time for Thanksgiving, consumers are worrying about whether the turkey they are buying for the holiday is contaminated with Salmonella. A multistate outbreak of drug-resistant Salmonella linked to raw turkey products has been going on for months, but now USDA is facing increasing pressure to name any associated turkey brands. According to the CDC, “a single, common supplier of raw turkey products or of live turkeys has not been identified.”

As of the agency’s last update (November 5), 164 people across 35 states have been infected with the outbreak stream of Salmonella Reading. 63 people have been hospitalized, and one death has been reported. Three people reported living in households where raw turkey pet food was given to pets.

Thus far the CDC isn’t advising retailers to stop sell raw turkey. It is stresses that consumers should follow the basic food safety steps to prevent Salmonella infections, including proper handwashing, cooking the turkey to the proper temperature (including reheating the meat), keeping food prep areas clean, proper thawing of turkey in the refrigerator and avoiding feeding pets raw food.

CDC states that if the information becomes available, it will provide notification related to the supplier(s) related to the outbreak.

Chipotle

Chipotle Retraining Workers Following Illnesses that Shut Down Ohio Location

By Food Safety Tech Staff
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Chipotle

Last month Chipotle Mexican Grill closed a location in Powell, Ohio after nearly 650 reported illnesses were tied to the location. The outbreak was caused by Clostridium perfringens, a type of bacteria that thrives at room temperature—in other words, food at this particular Chipotle location may have been kept at unsafe temperatures.

Following this latest incident, the company has decided it will retrain all of its estimated 70,000 employees on food safety and wellness protocols. Currently a source of the outbreak has not been found.

“Chipotle has a zero-tolerance policy for any violations of our stringent food safety standards. We are committed to doing all we can to ensure it does not happen again.” – Brian Niccol, Chipotle

In line with the company’ zero-tolerance policy, some employees who worked at the Powell location were reportedly let go after the outbreak.

Chipotle has had several outbreaks that have made headlines over the last three years.

McDonalds, golden arches

FDA Investigation of Cyclospora Outbreak Linked to Salads Continues

By Food Safety Tech Staff
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McDonalds, golden arches

Yesterday FDA provided an update on the multistate outbreak of Cyclospora infections “likely” linked to people who consumed salads from McDonald’s. The outbreak spans across 15 states and has infected 476 people, 21 of whom have been hospitalized. According to FDA’s latest release, the agency is reviewing distribution and supplier information for romaine lettuce and carrots.

Last month, USDA’s FSIS issued a public health alert on beef, pork and poultry salads and wraps, distributed by Caito Foods, LLC, that were potentially contaminated with Cyclospora. Fresh Express, Caito Foods’ supplier, had notified the company that the products with romaine lettuce were being recalled. However, no products related to this particular outbreak have been recalled, according to FDA. In addition, McDonald’s has reportedly ceased using the Fresh Express salad mix at restaurants impacted by the outbreak.

FDA stated that it currently does not have evidence suggesting that this Cyclospora outbreak is connected to the Cyclospora outbreak linked to Del Monte vegetable trays.

Del Monte

Cyclospora Infections Linked to Del Monte Veggie Trays Surpasses 230

By Food Safety Tech Staff
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Del Monte

The latest report from CDC puts the laboratory-confirmed case count of cyclosporiasis in people who reportedly consumed contaminated Del Monte trays at 237. The infections are in Iowa, Minnesota, Wisconsin and Michigan. Seven people have been hospitalized, and no deaths have been reported.

More than one month ago, Del Monte recalled 6- ,12-, and 28-ounce vegetable trays containing broccoli, cauliflower, carrots and dill dip. The products were sold to Kwik Trip, Kwik Star, Demond’s, Sentry, Potash, Meehan’s, Country Market, FoodMax Supermarket and Peapod. According to an FDA update, Del Monte is also recalling 28-ounce veggie trays that were distributed to Illinois and Indiana.

FDA, CDC and other federal agencies continue to investigate the multistate outbreak. They are advising that the vegetable trays are neither sold nor consumed.

More information is available on the CDC website.