Investigation of E. coli Outbreak Associated with Leafy Greens Comes to an End with Only One Positive Environmental Sample Found

FDA closed the investigation of an E. coli O157:H7 outbreak related to leafy greens that was reported back in October of 2020 by the CDC.  The outbreak which affected 40 people in 19 different states and was officially ended in December of 2020 was linked to leafy greens form Salinas, CA, however an intense investigation failed to identify the specific source.  The only significant finding -  "the outbreak strain in a sample of cattle feces collected on a roadside about a mile upslope from a produce farm.

FDA In Brief: Leafy Greens E. coli Outbreak Investigation Concludes, Identifies Environmental Sample with Recurring Outbreak Strain | FDA
FDA In Brief: Leafy Greens E. coli Outbreak Investigation Concludes, Identifies Environmental Sample with Recurring Outbreak Strain
January 27, 2021

FDA Outbreak Notice of Third E. coli Outbreak Occurring This Fall

FDA issued notice that they are investigating on third E. coli outbreak.  The notice goes on to discuss the sample of Romaine lettuce contaminated with E. coli O157:H7.  The company in this case had issued a recall the day before this notice was released.

This notice is a bit confusing.  It reports that there is a third outbreak and states this:

On November 6, 2020, the Michigan Department of Agriculture and Rural Development (MDARD) reported that as a part of routine sampling, they collected a product sample of romaine lettuce for testing. The sample tested positive for E. coli O157:H7 and subsequent whole genome sequencing (WGS) analysis determined that the E. coli O157:H7 present in the samples matches the strain that has caused illnesses in this outbreak.

Then the Notice states this:

At this time, there is not enough epidemiologic and traceback evidence to determine if ill people in this outbreak were exposed to romaine lettuce from Tanimura & Antle, Inc. Additional information will be provided as it becomes available.

The notice is a little vague on the outbreak itself, but does provide the CDC information.

From the CDC

Case Counts

Total Illnesses: 12

Hospitalizations: 5

Deaths: 0

Last Illness Onset Date: October 14, 2020

States with Cases: CA (2), IL (4), MI (2), OH (1), PA (2), VA (1) 

US FDA Outbreak Investigation
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o157h7-unknown-food-fall-2020
Outbreak Investigation of E. coli O157:H7: Unknown Food (Fall 2020)

Imported Meat from Canada Recalled Due to Potential Pathogenic E. coli Contamination

The USDA FSIS issued a public health alert for raw non-intact beef products derived from imported beef from Ontario, Canada that has been recalled by Ryding-Regency Meat Packers, Ltd. because it may be contaminated with E. coli O157:H7.

"The Canadian Food Inspection Agency is conducting a food safety investigation and determined that certain products produced by the company may be contaminated. While Canada is the recalling authority, FSIS is amplifying the recall through this public health alert."

https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2019/pha-101619-01
FSIS Issues Public Health Alert for Beef Products due to Possible E. coli O157:H7 Contamination

FDA Updates E.coli Outbreak Linked to Romaine Lettuce, At Least One Farm Identified

Updating the ongoing investigation into the E.coli O157:H7 contamination in romaine lettuce, FDA announced that one farm so far has been linked so far as a source of product.  FDA "identified a positive sample result for the outbreak strain in the sediment of a local irrigation reservoir used by a single farm owned and operated by Adam Bros. Farms in Santa Barbara County."    With that, they are leaving the romaine warning in place for "Monterey, San Benito, and Santa Barbara Counties".  While the E.coli organism found in the sediement matched the outbreak strain via Whole Genome Sequencing (WGS), the traceback analysis indicates that more than this one farm are probably involved.

They went on to state, "It’s important to note that although this is an important piece of information, the finding on this farm doesn’t explain all illnesses and our traceback investigation will continue as we narrow down what commonalities this farm may have with other farms that are part of our investigation. While the analysis of the strain found in the people who got ill and the sediment in one of this farm’s water sources is a genetic match, our traceback work suggests that additional romaine lettuce shipped from other farms could also likely be implicated in the outbreak. Therefore, the water from the reservoir on this single farm doesn’t fully explain what the common source of the contamination."

"As of Dec. 13, our investigation yielded records from five restaurants in four different states that have identified 11 different distributors, nine different growers, and eight different farms as potential sources of contaminated romaine lettuce. Currently, no single establishment is in common across the investigated supply chains. This indicates that although we have identified a positive sample from one farm to date, the outbreak may not be explained by a single farm, grower, harvester, or distributor."

Also as of the December 13th report, there have been 59 people infected in 15 states, with the last reported illness onset date being Nov. 16.

The farm with the positive E.coli sample in the sediment, Adams Brothers, has been cooperating.   They are a fifth generation farm.

FDA Statement
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628400.htm
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation
For Immediate Release
December 13, 2018

Two Utah Establishments Recall Ground Beef Products After USDA Testing Finds E. coli O157:H7

Swift Beef Co's Hyrum, Utah establishment is recalling approximately 99,260 pounds of raw ground beef products that may be contaminated with E. coli O157:H7.  This product was shipped to retail distributors for further processing and food service distributors for institutional use in locations in California, Nevada, Oregon, Utah, and Washington.  "The problem was discovered on November 15, 2018, when FSIS visited Swift Beef Company in response to a FSIS ground beef sample that was collected at a further processing establishment and was confirmed positive for E. coli O157:H7."

Majestic Meat Company of Salt Lake City, Utah is also recalling approximately 532 pounds of ground beef products (bulk ground beef, ground beef patties, and meatballs) after "FSIS identified that product associated with a sample that confirmed positive for E. coli O157:H7 had been shipped. The establishment held 2 of the 3 boxes of source material associated with the sampled product, however, the third box of source material was further processed and shipped."

Three have been no reported cases of illness in either case.


https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2018/recall-114-2018-release
Swift Beef Company Recalls Ground Beef Products due to Possible E. Coli O157:H7 Contamination
Class I Recall

114-2018
Health Risk: High 

Nov 17, 2018

Ground Meat Recalled after being Linked to 18 Cases of E. coli O26 Infection

Cargill Meat Solutions, a Fort Morgan, Colo. establishment, is recalling approximately 132,606 pounds of ground beef products made from the chuck portion of the carcass that may be contaminated with Escherichia coli O26.

CDC reports that there have been 18 cases in 4 states.  Of these, 6 have been hospitalized and there has been one death.  The product was packed in June with the onset of illness ranging from July 5 through July 25, 2018.  The outbreak appears to be over at this point, but there is the concern that some may have frozen the product.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2018/recall-081-2018-release
Cargill Meat Solutions Recalls Ground Beef Products due to Possible E. Coli O26 Contamination
Class I Recall
081-2018
Health Risk: High
Sep 19, 2018

Colorado Establishment Recalls Ground Beef for E. coli O157:H7

Cargill Meat Solutions, a Fort Morgan, Colo. establishment, is recalling approximately 25,288 pounds of ground beef products that may be contaminated with E. coli O157:H7.  The problem was discovered on Aug. 22 by the establishment when they reviewed their records and determined that the product may be associated with product that was presumptive positive for E. coli O157:H7.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2018/recall-069-2018-release
Cargill Meat Solutions Recalls Ground Beef Products due to Possible E. coli O157:H7 Contamination 
Class I Recall 
069-2018 
Health Risk: High 
Aug 23, 2018 

CDC and FDA Hold Off from Implicating Romaine Lettuce in E. coli Outbreak

FDA and CDC did not pull the trigger on making a public notice to avoid romaine lettuce for involvement in an E. coli outbreak.   The Canadians were first to issue a public notice implicating Romaine lettuce on Dec 14th.  At this point, however, there were no additional cases of E. coli infection reported with the last case on December 12th being reported (and recognizing there is a delay from infection and reporting).

In the end, that call was right.  Even if it is found that romaine lettuce was the source, that contaminated product would had already been through the system (considering the short shelf-life of product).  A public notice would have been missed the target and resulted in needless waste.

However, what we did see was a lot of confusion on the part of various entities issuing reactionary notices.  FDA and CDC would have done better to put their findings out there earlier.  Outbreak investigations are not perfect, and while it would have been easier on their part to trash the leafy green industry, relaying the findings would have gone a long way to quieting the alarmists.

https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm591989.htm
FDA Information about E. coli O157:H7 Outbreak Likely Linked to Leafy Greens
January 10, 2018

Canada - Public Health Notice Issued for Romaine Lettuce Due to E. coli Outbreak

In Canada, officials are investigating 30 E.coli O157 infections with one death and twelve hospitalizations.  They are linking this outbreak to romaine lettuce.  There is no more information at this time (chopped, whole, bagged, etc).  From the report, "Many individuals who became sick reported eating romaine lettuce before their illnesses occurred. The Canadian Food Inspection Agency is working with public health officials to determine the source of the romaine lettuce that ill individuals were exposed to."

CISION
http://www.newswire.ca/news-release
Public Health Notice - Outbreak of E. coli infections linked to romaine lettuce

SoyNut Co-packer, Dixie Dew, Slammed in FDA Inspection, Now Suspended

FDA suspended the food facility registration of the co-manufacturing facility of the Soy Nut Butter which was recalled for E. coli contamination.

CDC now reports that there are 29 cases of E. coli infection with 9 people developing HUS.  The majority of cases (83%) affecting people under the age of 18.

FDA inspected the facility (3/3/17 to 3/15/17)  at the same time the initial recall.  FDA issued a 483 report detailing issues in facility.
Here are some of the highlight from the 8 page report.  (For ease, a copy of this document is pasted below, this was converted from the pdf file)

• The firm leaves product in the mix kettle overnight and over the weekend.
• The mixing equipment just shuts off during processing, 1 or 2 times per day, and has had this problem for 15 years.
• They do not calibrate their thermometer used for monitor the nut butter.  
• The chart recorder also does not work.
• During production of product, a clear liquid was observed dripping intermittently form a hole in the ceiling onto the floor and splashing on the equipment.  This was supposedly coming from a leaky pipe.
• Product build-up  on floors and walls, and walking platforms. Standing water on floor.
• Poor employee traffic flow as well as forklift flow, no restriction of movement from dirty areas /waste areas to processing areas.
• Cleaning supplies not properly maintained.
• Wooden pallets sitting in standing water.
• Product piping system not disassembled since 2015, smaller pipes and filling not routinely cleaned.
• Improper employee handwashing.
• Pest control issues.

While this is clearly a co-packer issue, somebody had to approve this company.  Did the IMHealthy folks visit the facility?  Did they recognize the risk, especially considering who would be eating this product - children.  To me, they are just as responsible.

As part of the movement to small, unique brands, more and  more of these small brand companies are turning to co-packers to package their product.  This includes store brands as well.  There are risks however if these co-packers are not properly vetted and managed.  One of the key elements of FSMA, supplier preventive controls, was put in place to prevent this type of travesty.  (This is why I stick to my big brands with lots of food scientists and well developed QA/QC systems protecting that product).

FDA Safety Alerts and Advisories
https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm549734.htm
FDA Suspends Food Facility Registration of Dixie Dew Products, Inc.
No food may leave the facility for sale or distribution
March 30, 2017

Chipotle Tightens Produce Supplier Control, Will Impact Local Suppliers

Chipotle is tightening its produce supplier control program after getting slammed by a foodborne illness outbreak associated with produce.  The last outbreak, which was caused by E. coli 0126 contamination, affected 45 people in 6 different states.  (The earlier report had the number at 35).  This is the third major outbreak associated with this chain.

Chipotle's strategy was to utilize local growers wherever they could.  But increasing the supplier requirements may mean that some of the local growers/producers will need to adapt, and as indicated in this story, there may be some that will be challenged. Chipotle's overall food safety strategy has stumbled, costing them billions...in terms for having to shut down their stores in the northwest, and having their stock price fall by 23% .

It is great to use local suppliers, but regardless of location or of size of the supplier, the same standards must be met.

 

USA Today

http://www.usatoday.com/story/money/2015/12/02/chipotle-tightens-produce-supplier-guidelines-after-ecoli-outbreak/76681228/?AID=10709313&PID=4003003&SID=ihqdyp5zr200bv5i00dth

Chipotle to tighten produce supplier rules after E. coli outbreak

Aamer Madhani, USA TODAY 6:01 p.m. EST December 2, 2015

 

Chipotle Mexican Grill will soon have stricter guidelines for its suppliers that will mean the chain will be using local produce less often, a move the company is making in the aftermath of an E. coli outbreak that sickened dozens of customers in six states.

E. coli O26 infections linked to Clover Sprouts

Raw sprouts are responsible for another outbreak of foodborne illness and at least the fourth outbreak linked to the same restaurant chain, Jimmy Johns. In this latest case, there are 12 people infected with STEC O26 (CDC and AP link below). 

After the last outbreak linked to the restaurant chain in late 2010 where close to 120 people became ill with Salmonella, the chain switched from alfalfa sprouts to clover sprouts. But sprouts are sprouts – they are a higher risk food item in that it can be difficult to remove organisms such as Salmonella and E.coli from the seeds, and the process that allows the seed to sprout also may allow the organism to grow. Now, it appears the chain will drop sprouts from its menu (http://www.kirksvilledailyexpress.com/news/x1793836666/Jimmy-Johns-permanently-pulls-sprouts-from-menu). 

Tainted sprouts again linked to Jimmy John’s, outbreak is fourth linked to restaurantBy Associated Press, Published: February 15
http://www.washingtonpost.com/business/tainted-sprouts-again-linked-to-jimmy-johns-outbreak-is-fourth-linked-to-restaurant/2012/02/15/gIQAGxFVGR_story.html

WASHINGTON — Raw sprouts from the sandwich chain Jimmy John’s have been linked to an outbreak of foodborne illness — again.

The federal Centers for Disease Control and Prevention said Wednesday that 12 cases of E. coli poisoning in five states are linked to raw clover sprouts eaten at Jimmy John’s restaurants. The outbreak comes a year after raw alfalfa sprouts from one of the chain’s suppliers were linked to 140 salmonella illnesses. Sprouts from the chain’s suppliers were also linked to a 2009 salmonella outbreak in several Midwestern states and were suspected in an E. coli outbreak in Boulder, Colo. in 2008.

Expanding the list of bad [foodborne disease causing] bacteria?

There is currently a push to put a zero tolerance on four strains of drug-resistant salmonella in uncooked meat (link below). This comes after the 2011 outbreak of Salmonella linked to ground beef where 20 people were reported to become ill. (http://www.cdc.gov/salmonella/typhimurium-groundbeef/020112/index.html). The responsible organism was a multi-drug resistant strain of Salmonella Typhimurium.

Another recent expansion was the addition of 6 strains of E. coli non-O157 STEC. Although the testing program was to go into effect in March of 2012, it was pushed pack to June of 2012. The reason relates to the lack of validated test methods to detect the specific pathogenic strains (link below).

Looking for a given bacterial species is difficult enough, but when we have to look for strains of bacteria containing specific genes, reliable testing is not always easy. Throw in the fact that the product being tested is raw, and that the prevalence of bacteria is very low, and it makes one question to what degree can we track and eliminate the sources. (For example, FSIS reports the prevalence of Salmonella in ground beef is about 2% (http://www.fsis.usda.gov/PDF/Progress_Report_Salmonella_Testing.pdf), and in a 2009 study by ARS, the level for MDR Salmonella was only 0.6% (http://www.ncbi.nlm.nih.gov/pubmed/19201965)).  

Will consumers benefit? Will public health be better served? Will regulatory requirements for zero tolerance be enforceable or achievable?

Interesting note, a consumer group recently requested that FDA put a zero tolerance of Vibrio vulnificus on oysters (http://cspinet.org/new/201202091.html) to help protect those who choose to consume raw oysters. Vibrio vulnificus is a natural contaminate in waters where oysters are harvested, especially in the warmer months. In most all cases, the organism affects those who have underlying medical condition, primarily past or present alcohol abuse. Are oyster fisherman going to start testing oysters before delivering to the local shuck house? Why not just make it illegal to consumer raw oysters?

Salmonella Outbreak Spurs Call to Expand List of Banned Bacteria
February 08, 2012, 1:59 PM EST
Bloomberg Businessweek
http://www.businessweek.com/news/2012-02-08/salmonella-outbreak-spurs-call-to-expand-list-of-banned-bacteria.html
By Stephanie Armour