The following is from a list of outbreak investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion.
A public health advisory will be issued for outbreak investigations that have resulted in specific, actionable steps for consumers to take to protect themselves. Please direct your attention to those pages for the most up to date information on the investigation and for consumer protection information.
Outbreak investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. If a source and/or contributing factors are identified that could inform future prevention, the FDA commits to providing a summary of those findings.
Date Posted – 14 Jul 2021 Reference No – 1010 Pathogen – _E. coli_ O121 Product(s) Linked to Illnesses – Not Yet Identified Total Case Count – 15 Investigation Status – Active Outbreak Status – Ongoing
Between August and December 2020, the U.S. Food and Drug Administration (FDA) and multiple state and federal partners were involved in an outbreak investigation related to E. coli O157:H7 illnesses and the consumption of leafy greens. The outbreak, which caused 40 reported domestic illnesses, was linked via whole genome sequencing (WGS) and geography to outbreaks traced back to the California growing region associated with the consumption of leafy greens in 2019 and 2018. FDA, alongside state and federal partners, investigated the outbreak to identify potential contributing factors that may have led to leafy green contamination with E. coli O157:H7. The E. coli O157:H7 outbreak strain was identified in a cattle feces composite sample taken alongside a road approximately 1.3 miles upslope from a produce farm with multiple fields tied to the outbreaks by the traceback investigations. In addition, several potential contributing factors to the 2020 leafy greens outbreak were identified.
Isolates within this cluster of illnesses are part of a reoccurring strain of concern and are associated with outbreaks that have occurred in leafy greens each fall since 2017. The two most recent outbreaks associated with this strain were an outbreak in 2018 (linked to romaine lettuce from the Santa Maria growing region of California) and an outbreak in 2019 (linked to romaine lettuce from the Salinas growing region of California). Clinical isolates from cases in this 2020 outbreak appear more closely related to those from the 2019 outbreak than the 2018 outbreak. In addition, several specific food and environmental isolates that appear to be highly related to this 2020 outbreak include a fecal-soil composite sample collected by FDA in February 2020 from the Salinas growing region and two leafy green samples collected in 2019 by state partners as a part of the 2019 investigation that traced back to the Salinas growing region.
As part of this investigation, tracebacks of leafy greens consumed by ten ill individuals from eleven points of service were conducted. Although that traceback investigation was based on a relatively small number of the total cases, it was based on those cases which presented the strongest evidence via purchase card information, invoices, bills of lading, and electronic data. The traceback investigation identified the Salinas growing region of California as a geographical region of interest.
In light of this most recent finding, combined with previous outbreak investigation findings in the region, FDA has identified key trends regarding the issues of a reoccurring strain, a reoccurring region, and reoccurring issues around adjacent and nearby land use of primary importance in understanding the contamination of leafy greens by E. coli O157:H7 that occurred in 2020 and previous years.
FDA also recognizes the interconnection between people, animals, plants, and their shared environment when it comes to public health outcomes. As such, we strongly encourage collaboration among various groups in the broader agricultural community (i.e. livestock owners; leafy greens growers, state and federal government agencies, and academia) to address this issue. With this collaboration, the agricultural community, alongside academic and government partners, can work to identify and implement measures to prevent contamination of leafy greens. FDA recommends that these parties participate in efforts to understand and address the challenge of successful coexistence of various types of agricultural industries to ensure food safety and protect consumers against foodborne illnesses.
Frank Yiannas, Deputy Commissioner for Food Policy and Response – Food and Drug Administration said in a release that as part of our ongoing efforts to combat foodborne illness, today the U.S. Food and Drug Administration published a report on the investigation into the Fall 2020 outbreak of Shiga Toxin-Producing E. coli (STEC) O157:H7 illnesses linked to the consumption of leafy greens grown in the California Central Coast. The report describes findings from the investigation, as well as trends that are key to understanding leafy green outbreaks that are linked to the California Central Coast growing region, specifically encompassing the Salinas Valley and Santa Maria growing areas every fall since 2017.
We released our preliminary findings earlier this year that noted this investigation found the outbreak strain in a sample of cattle feces collected on a roadside about a mile upslope from a produce farm. This finding drew our attention once again to the role that cattle grazing on agricultural lands near leafy greens fields could have on increasing the risk of produce contamination, where contamination could be spread by water, wind or other means. In fact, the findings of foodborne illness outbreak investigations since 2013 suggest that a likely contributing factor for contamination of leafy greens has been the proximity of cattle. Cattle have been repeatedly demonstrated to be a persistent source of pathogenic E. coli, including E. coli O157:H7.
Considering this, we recommend that all growers be aware of and consider adjacent land use practices, especially as it relates to the presence of livestock, and the interface between farmland, rangeland and other agricultural areas, and conduct appropriate risk assessments and implement risk mitigation strategies, where appropriate. Increasing awareness around adjacent land use is one of the specific goals of the Leafy Greens Action Plan we released last March, which we’re also announcing is being updated today to include new activities for 2021.
During our analysis of outbreaks that have occurred each fall since 2017, we have determined there are three key trends in the contamination of leafy greens by E. coli O157:H7 in recent years: a reoccurring strain, reoccurring region and reoccurring issues with activities on adjacent land. The 2020 E. coli O157:H7 outbreak associated with leafy greens represents the latest in a repeated series of outbreaks associated with leafy greens that originated in the Central Coast of California (encompassing Salinas Valley and Santa Maria) growing region (that’s me and Frank and the woman who wants to divorce me in our Kansas kitchen, 10 years ago)
In the investigation, the FDA recommends that growers of leafy greens in the California Central Coast Growing Region consider this reoccurring E. coli strain a reasonably foreseeable hazard, and specifically of concern in the South Monterey County area of the Salinas Valley. It is important to note that farms covered by the Food Safety Modernization Act (FSMA) Produce Safety Rule are required to implement science and risk-based preventive measures in the rule, which includes practices that prevent the introduction of known or reasonably foreseeable hazards into or onto produce.
The FDA also recommends that the agricultural community in the California Central Coast growing region work to identify where this reoccurring strain of pathogenic E. coli is persisting and the likely routes of leafy green contamination with STEC. Specifically, we have outlined specific recommendations in our investigation report for growers in the California Central Coast leafy greens region. Those recommendations include participation in the California Longitudinal Study and the California Agricultural Neighbors workgroup. When pathogens are identified through microbiological surveys, pre-harvest or post-harvest testing, we recommend growers implement industry-led root cause analyses to determine how the contamination likely occurred and then implement appropriate prevention and verification measures.
In response, Tim York wrote in The Packer that on April 16 the California LGMA Board took decisive action to endorse pre-harvest testing guidance. The guidance recommends pre-harvest testing specifically when leafy greens are being farmed in proximity to animal operations.
It’s the intention of the board to include pre-harvest testing as part of the LGMA audit checklist so the government can verify that all LGMA members are in compliance.
This is the first time an entire commodity group will be required to conduct pre-harvest testing.
This is a big deal, but a necessary response to the recent U.S. Food and Drug Administration report on outbreaks associated with lettuce in 2020. The findings and regulatory language used by FDA in this report were nothing short of a warning shot that calls on our industry to do more to stop outbreaks.
And so, we must do more.
Updating LGMA’s required food safety practices is an involved process that seeks input from scientists, food safety experts and the public. No other entity is capable of making such widespread change as quickly as we can.<
Some weeks ago, in the first piece I wrote for The Packer as CEO of the California LGMA, I stressed the need for collaboration with the retail and foodservice buying community, noting that we must lean on each other to make needed improvements together. And now, I am asking for your help.
Updating LGMA’s required food safety practices is an involved process that seeks input from scientists, food safety experts and the public. No other entity is capable of making such widespread change as quickly as we can.
The recalled “Tahina” were distributed in Mediterranean food stores in Michigan and Chicago, IL. between April 2020 to October 2020.
Please do not consume the product and immediately dispose of the product or return to 32816 Manor Park Garden City MI 48135. Or to the place of purchase. And send us a note to the email: firstname.lastname@example.org with the return receipt and product purchase date for a full refund.
The product comes in 1lb, 2lb in plastic jars and the 10kg in metal can. There is only one lot distributed. With expiration date 07-01-2022.
No illnesses have been reported to date in connection with the problem.
The potential for contamination was noted after routine testing from samples in the stores by the Michigan Department of Agriculture and Rural Development (MDARD).
Production of the product has been suspended while the FDA and the company continue their investigation as to the source of the problem.
Some time about 2009, I was walking the dogs on a Sunday morning on the Kansas State University campus with a Canadian graduate student who was getting her MS degree at K-State, and we ran into University president, Jon Wefald.
We exchanged pleasantries, he was enamored by the dogs, and soon the conversation turned a pet food recall that had sickened dozens of humans with some bad bug.
Jon asked me, how are people getting sick from pet food and I explained the sometimes lack of process validation in pet food, the wonderful world of cross-contamination, of and that sometimes people ate pet food directly.
Jon was aghast.
I was, meh.
So that’ why these pet food recalls s are important, because the product can all to easily sicken humans along with their pets.
This is a few months old, but if Frank’s in it, I’ll run it, late but not never.
The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response:
“The FDA is committed to providing innovative food safety approaches that build on past learnings and leverage the use of new information and data. Today we’re announcing a partnership with the California Department of Food and Agriculture (CDFA), the University of California, Davis, Western Center for Food Safety (WCFS), and agricultural stakeholders in the Central Coast of California to launch a multi-year longitudinal study to improve food safety through enhanced understanding of the ecology of human pathogens in the environment that may cause foodborne illness outbreaks.”
“The launch of this longitudinal study follows a series of E. coli O157:H7 outbreaks in recent years linked to California’s leafy greens production regions, particularly three outbreaks that occurred in Fall 2019. Due to the recurring nature of outbreaks associated with leafy greens, the FDA developed a commodity-specific action plan to advance work in three areas: prevention, response, and addressing knowledge gaps. We’ve already made great strides executing our 2020 Leafy Greens Shiga toxin-producing E. coli (STEC) Action Plan by engaging with state partners to implement new strategies for preventing outbreaks before they occur, collaborating with industry partners to assess and augment response efforts when an outbreak occurs, and analyzing past leafy greens outbreaks to identify areas of improvement important to enhance leafy greens safety.”
“In alignment with the FDA’s New Era of Smarter Food Safety initiative, the findings from this longitudinal study will contribute new knowledge on how various environmental factors may influence bacterial persistence and distribution in the region, and how those factors may impact the contamination of leafy greens.”
The California longitudinal multi-year study will examine how pathogens survive, move through the environment and possibly contaminate produce, through work with water quality, food safety, and agricultural experts from CDFA, the WCFS, representatives from various agriculture industries, and members of the leafy greens industry.
Chris Koger of The Packer reports that cases of Cyclospora infection linked to Fresh Express salads continue to rise, according to the Centers for Disease Control and Prevention, and Canada is reporting its first cases.
Lab-confirmed cases thought to be linked to iceberg lettuce, carrots or red cabbage in garden salads were 509 in the U.S, as of July 9, according to the CDC. The Canadian Food Inspection Agency on July 8 reported 37 cases in Ontario, Quebec and Newfoundland and Labrador.
The salads, including private-label bagged garden salads, were processed at Fresh Express’ Streamwood, Ill., facility, according to the FDA.
Fresh Express has recalled salads from the plant containing the three ingredients under investigation, along with Aldi, Giant Eagle, Hy-Vee, Jewel-Osco, ShopRite and Walmart issuing recalls of private label salads.
The Canadian Food Inspection Agency reported on June 28 Fresh Express had recalled products in Canada. They were distributed nationwide by Crescent Multi-Foods, Federated Co-Operatives Ltd., Fresh Express and Walmart Canada Corp., according to the Canadian Agency.
An edited version of the latest CDC update is below:
On June 27, 2020, Fresh Express recalled Fresh Express brand and private label brand salad products produced at its Streamwood, IL facility that contain iceberg lettuce, red cabbage, and/or carrots due to possible Cyclospora contamination.
509 people with laboratory-confirmed Cyclospora infections and who reported eating bagged salad mix before getting sick have been reported from 8 Midwestern states (Illinois, Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, and Wisconsin).
Illnesses started on dates ranging from May 11, 2020 to July 1, 2020.
33 people have been hospitalized. No deaths have been reported.
The Public Health Agency of Canada is investigating an outbreak of Cyclospora infections occurring in three Canadian provinces. Exposure to certain Fresh Express brand salad products containing iceberg lettuce, carrots and red cabbage, has been identified as a likely source of the outbreak.
Epidemiologic and traceback evidence indicates that bagged salad mix containing iceberg lettuce, carrots, and red cabbage produced by Fresh Express is a likely source of this outbreak.
CDC and FDA continue to investigate to determine which ingredient or ingredients in the salad mix was contaminated and whether other products are a source of illnesses. CDC will provide updates when more information is available.
Since the last case count update on June 26, 2020, 303 new laboratory-confirmed Cyclospora infections have been reported.
As of July 8, 2020, a total of 509 people with laboratory-confirmed Cyclospora infections associated with this outbreak have been reported from 8 states: Illinois (151), Iowa (160), Kansas (5), Minnesota (63), Missouri (46) Nebraska (48), North Dakota (6), and Wisconsin (30).
Illnesses started on dates ranging from May 11, 2020 to July 1, 2020. Ill people range in age from 11 to 92 years with a median age of 60 and 53% are female. Of 506 people with available information, 33 people (7%) have been hospitalized. No deaths have been reported.
Illnesses might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported. This takes an average of 4 to 6 weeks. If the number of cases reported by CDC is different from the number reported by state or local health officials, data reported by local jurisdictions should be considered the most up to date. Any differences may be due to the timing of reporting and website updates.
Additionally, the Public Health Agency of Canada is investigating an outbreak of Cyclospora infections occurring in three Canadian provinces where exposure to certain Fresh Express brand salad products containing iceberg lettuce, carrots and red cabbage, has been identified as a likely source of the outbreak.
Outbreaks of E. coli illness sickened 188 people last year who ate romaine lettuce in three separate outbreaks.
There have been so many outbreaks going back to spinach in 2006, and beyond that, my favorite salad now is a Greek salad – without the lettuce.
If the Leafy Greens Marketing Association was as rigorous as its press releases maintain this would be minimized.
Instead, between 2009 and 2018, federal authorities identified 40 food-borne outbreaks of E. coli in the U.S. “with a confirmed or suspected link to leafy greens,” the FDA said.
Investigators concluded the most recent outbreaks were centered on ranches and fields owned by the same grower and that were located downslope from public land where cattle grazed.
So if LGMA is doing internal audits, why didn’t they notice this dude?
Because it’s PR not gumshoes, people out in the field.
We figured out 20 years ago that gumshoes are required.
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.
Outbreak investigation of E. coli: Romaine from Salinas, California (November 2019)
Chipotle Mexican Grill Inc. will, according to Edvard Pettersson of Bloomberg, pay a $25 million criminal fine to resolve allegations by federal prosecutors that its food sickened more than 1,100 people across the U.S. from 2015 to 2018.
It’s the largest fine ever imposed in a food-safety case, according to a statement by the U.S. attorney’s office in Los Angeles.
The criminal charges pertain in part to norovirus outbreaks at Chipotle restaurants. The highly contagious virus can be transmitted by infected food workers handling ready-to-eat foods and their ingredients, according to the statement. It can cause severe symptoms, including diarrhea, vomiting and abdominal cramping.
“Chipotle failed to ensure that its employees both understood and complied with its food safety protocols, resulting in hundreds of customers across the country getting sick,” U.S. Attorney Nick Hanna said in the statement announcing the deferred-prosecution agreement.
The Newport Beach, California-based company said that, as part of the agreement, it will its strengthen its food-safety polices and practices.
“This settlement represents an acknowledgment of how seriously Chipotle takes food safety every day and is an opportunity to definitively turn the page on past events and focus on serving our customers real food made with real ingredients that they can enjoy with confidence,” Brian Niccol, chairman and chief executive officer of the company, said in a statement.
Prosecutors alleged that four norovirus outbreaks were caused by employees showing up to work sick, in violation of company policy, and by food products being stored at the wrong temperatures.
A fifth outbreak — which sickened about 647 people in July 2018 who dined at a Chipotle in Ohio — was from Clostridium perfringens, a bacterium found in raw meat and poultry that is one of the most common types of foodborne illness in the U.S. People who get ill from it usually recover in 24 hours and it’s not contagious.
Managers at the company’s restaurants failed on a number of occasions to notify Chipotle’s safety group at its headquarters when an employee had been vomiting at work, according to prosecutors. Instead, the safety analysts would find out only after contacting the restaurant because it had received a complaint from a sick customer. As a result, there were days of delay before the restaurants were sanitized.
Are these guidelines actually going to make fewer people barf and die?
It’s all about the implementation and verification, but that’s expensive and rarely undertaken beyond soundbites.
When Listeria killed seven people in Australia last year, linked to rockmelon (cantaloupe for you North American types) growers acted like it never happened before and just wanted to get product back on shelves.
They should never be cut in half, although all retailers do it, and it’s just greed over public health.
In the fall of 2011, 33 people were killed and 147 sickened from Listeria linked to cantaloupe in the U.S.
Domestic and export sales ceased for around six weeks. It has taken the following two years to regain market share.
To support rockmelon growers and combat foodborne illness risks, Hort Innovation launched a review of all industry food safety practices to strengthen food safety measures and provide training support for the industry.
Delivered by the NSW Department of Primary Industries (NSW DPI), the project involved working individually with all Australian rockmelon growers to review and audit current practice and critical control points.
One-on-one food safety consultations with growers, managers and key farm staff also took place.
The project also developed a Melon Food Safety Best-Practice Guide and a “toolbox” for grower use including risk assessment templates, training guides, food safety posters and record sheets to support food safety programs.
Enoki mushrooms from South Korea have been recalled and investigators are linking them to a multi-year outbreak of Listeria monocytogenes that has killed four people.
The importer, Sun Hong Foods Inc., Montebello, Calif., recalled the mushrooms March 9 after Michigan Department of Agriculture and Rural Development officials found two samples of the mushrooms were positive for the listeria strain.
According to the Centers for Disease Control and Prevention, public health agencies are using the PulseNet system to identify illnesses linked to the outbreak, using “DNA fingerprinting” through whole genome sequencing.
The agencies did not report when the deaths occurred. Patients in California, Hawaii and New Jersey died.
The cases traced to the mushrooms have a high rate of hospitalization, with 30 of the 36 patients identified requiring hospitalization, according to the Food and Drug Administration, which released a warning to consumers March 10 to not eat any enoki mushrooms from Sun Hong Foods.
Sun Hong Foods, Inc 1105 W Olympic Blvd, Montebello, CA 90640 is recalling All Cases Enoki Mushroom (Product of Korea) Net Wt 7.05/200g because it has the potential to be contaminated with Listeria monocytogenes, a bacterium which can cause life-threatening illness or death. Consumers are warned not to even if it does not look or smell spoiled.