FDA Releases Investigation Report of 2020 E. coli O157:H7 Outbreak Linked to California Leafy Greens

Here are the bullet points from that report.  In a nutshell, cattle in close proximity are the issue and it will take more than the FDA to fix the issue.

• FDA has found that in this and past foodborne illness outbreak investigations "suggest that a likely contributing factor for contamination of leafy greens has been the proximity of cattle." 
• FDA "recommends 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."
• "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."
• 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."
• 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."
• FDA "alone cannot fix this issue. Industry leadership and collaboration among growers, processors, retailers, state partners and the broader agricultural community is critical to reducing foodborne illnesses. "

Associated Documents

FDA Investigation Report: Factors Factors Potentially Contributing to the Contamination of Leafy Greens Implicated in the Fall 2020 Outbreak of E. coli  O157:H7
FDA Leafy Greens STEC Action Plan

https://www.fda.gov/news-events/press-announcements/fda-releases-investigation-report-following-fall-2020-outbreak-e-coli-o157h7-illnesses-linked-leafy
FDA Releases Investigation Report Following Fall 2020 Outbreak of E. coli O157:H7 Illnesses Linked to Leafy Greens
Agency affirms need for new collaborative actions to build on accomplishments in its Leafy Greens Shiga Toxin-Producing E. coli (STEC) Action Plan

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

LGMA Updates Requirements to Improve Safety of Leafy Greens

California Leafy Greens Marketing Agreement Board has adopted additional requirements to reduce risk when it comes to water used in growing lettuce and leafy greens,  These new standards are "in direct response to investigations conducted by the U.S. Food and Drug Administration into last year’s e. Coli outbreak involving romaine lettuce."

The main action is to no longer allow the use of untreated surface water for overhead irrigation of leafy greens prior to harvest.    While the "LGMA program has always required growers to test their water because it can be a carrier of pathogens", the new requirements will now include additional safeguards including:  'categorizing the source of the water; considering how and when water is applied to the crop; conducting testing to assure the water is safe for the intended use; sanitizing water if necessary; and verifying that all of the above precautions have been taken.'

"The LGMA’s food safety practices meet, and often exceed, what is required under federal Produce Safety Rule regulations for other produce crops."

Perishable News
https://www.perishablenews.com/produce/leafy-greens-marketing-agreement-adopts-new-more-stringent-food-safety-practices-to-prevent-outbreaks/
Leafy Greens Marketing Agreement Adopts New, More Stringent Food Safety Practices to Prevent Outbreaks
April 22, 2019

Produce Company Linked to E. coli Outbreak Issues Recall for Leaf Lettuce and Cauliflower, WA Sandwich Company Recalls Product

Adam Brothers, the only farm identified by FDA as one of the potential sources of the E.coli linked Romaine lettuce recall, issued a recall for leaf lettuce and cauliflower.  In a statement issued by the company, "The recall was initiated after it was discovered that sediment from a reservoir near where the produce was grown tested positive for E. coli O157:H7. Filtered and treated water from the
reservoir may have come in contact with the produce after it was harvested. None of the filtered,
treated water has tested positive for E. coli, all E. coli tests returning negative."

A Spokane WA sandwich company is recalling sandwiches made with green leaf lettuce grown by Adam Brothers.

While the leaf lettuce filets have not been tested to determine whether or not they have E. coli contamination, the fact that the E. coli was found in a sediment sample was sufficient enough evidence for the produce grower to issue a recall.  From the sandwich company's notice, "The affected products distributed by Spokane Produce include green leaf lettuce that was originated and recalled from Adam Bros. Farming Inc. of Santa Maria, CA."

https://www.fda.gov/Safety/Recalls/ucm628722.htm
Adam Bros. Farming, Inc. Recalls Red and Green Leaf Lettuce and Cauliflower Because of Possible Health Risk
For Immediate Release
December 17, 2018

Impact on Produce Industry of E. coli Outbreak in Romaine Lettuce

A good read in FoodDive on the impact of the E.coli outbreaks in romaine as related to the produce supply chain.  In the latest outbreak, FDA called for people to avoid Romaine lettuce and this caused a massive dump of product and a huge decrease in sales.

"But the outbreaks have pummeled romaine lettuce sales, according to data from Nielsen. Sales of the vegetable, typically the most widely consumed salad green, slumped 13% during the year ending Nov. 24 to $631 million, the analytics firm estimated. With less romaine lettuce available, USDA said prices of other lettuce varieties have surged, including Boston and iceberg lettuce — which saw a nearly 170% jump."

A warning for more to come?  Without good traceback, FDA will probably follow a similar tact with the next produce recall.  So will the industry be able to do voluntary labeling.  What about testing of irrigation water?

The Food Safety Modernization Act, signed into law in 2011, called for growers to test their irrigation water and take steps to prevent contaminated sources from being used on produce. But the FDA announced in September 2017 that implementation would be delayed until at least 2022, beginning with the largest farms, in order to allow the agency to “consider how we might further reduce the regulatory burden or increase flexibility.” 

Water testing has its issues including setting acceptable standards that can reflect the presence of pathogens, being able to find incidental contamination, etc.  Product sampling provides no guarantee either that low level contaminants will be found.  Can there ever be a 100% guarantee in preventing pathogens in leafy greens...probably not.

FoodDive
https://www.fooddive.com/news/its-not-easy-being-green-romaine-lettuce-e-coli-outbreak-rattles-food-g/543448/
It's not easy being green: Romaine lettuce E. coli outbreak rattles food, grocery industries 
Dec 10, 2018
The FDA's decision to request that the popular green gets pulled from shelves sent "a strong message" to the produce sector while costing supermarkets millions of dollars.

FDA Investigation into E.coli Outbreak Linked to Romaine Lettuce Finds Cattle Feeding Operation as Potential Source

The FDA continues their investigation into the E. coli outbreak, but are looking at a Concentrated Animal Feeding Operation as a potential source.  This CAFO is stated as being able to hold up to 100,000 head of cattle.

E. coli and 100,000 pooping cattle....that may be a good place to be concerned about especially if there is access from that operation to the canal system.  But the release was short on information specifically the distances from the CAFO to the canal system, and then down to the farming area?  Can cattle ever get to the water?  Can rain water runoff make its way into the CAO? 

Had anyone raised a concern about the locale of the CAFO to the canal system?  Has anyone tested the water if there were a concern?  As a main component of produce safety, water quality and the potential for contamination should have been evaluated.  And as part of that, the potential contamination by farm animals should also have been evaluated.  While testing can be unreliable, a risk analysis of a nearby CAFO should have been undertaken.    But at this point, it is hard to glean this information that FDA has released.

In this outbreak, 210 were infected across 36 states with 96 hospitalizations and five deaths.  In a June 28th news release, FDA and CDC reported that the E. coli strain was found in the irrigation canal.

https://www.fda.gov/food/recallsoutbreaksemergencies/outbreaks/ucm604254.htm
FDA Investigating Multistate Outbreak of E. coli O157:H7 Infections Linked to Romaine Lettuce from Yuma Growing Region
August 6, 2018

USDA ERS Publishes Food Safety Costs for Produce Operations Complying to Increased Food Safety Standards (LGMA)

The USDA Economic Research Service released a 64 page report on the costs associated with meeting safety standards established by the California Leafy Greens Marketing Agreement (LGMA).  The costs with the LGMA should be similar to what will be required by the FSMA Produce Safety Rule.  This is based upon 7 produce operations and was conducted in 2012.

The paper acknowledged that it is difficult to assess the costs, and thus come up with average cost/farm or cost/acre for compliance.  They were able to determine where those costs went on average:

• food safety staff - 38%
• foremen food safety time - 32% 
• audits - 17%
• lost product due to animal intrusion - 11%
• water testing - 2%
• Other costs not uniformly collected included harvest worker training, glove use, raw product testing, and external record keeping management systems.

Estimated costs for foreman (based upon time allocation) ranged from 80,000 to 1,012,000 million.

Firms averaged

Table 3

Range of costs per firm for different food safety practices

                                                                        Range of costs ($) Number of observations  

                                                                        Low                High

Cost per firm:

Total field-level audits                                   27,150            305,430                 6

Raw product testing                                                0              90,000                 6

External record keeping                                          0                8,868                 7

Training                                                          19,900              71,398                 4

Protective clothing                                         12,000              52,000                  5

Total water testing                                           7,000               85,000                  7

Lost product                                                            0             304,000                 7

Equipment cleaning/sanitizing                       21,000             250,000                 4

Hired toilet/handwashing facilities                45,451              130,367                3 

and services

Note: In reporting individual costs per firm, there is a mix of costs for different-sized operations, and also a mix of costs for leafy greens and the whole produce operation. The  combination of firms reporting data for any cost also varies. As a result, the numbers in table 3 cannot be added together to get a low and a high for all costs. Source: USDA, Economic Research Service.

How solid are these costs?  Good question.  They are based upon interviews...so if you ask someone what they are spending on mandated oversight....there may be a tendency to look at worst case scenario. Plus were there savings from improved practices?...hard to say.  I believe these costs increases are there, especially compared to processing facilities that already have much of the infrastructure in place.

Economic Information Bulletin Number 173
https://www.ers.usda.gov/webdocs/publications/83771/eib-173.pdf?v=42893
Food Safety Practices and Costs Under the California Leafy Greens Marketing Agreement
Linda Calvin, Helen Jensen, Karen Klonsky, and Roberta Cook
June 2017

Bagged Salad Mix Recalled After Dead Bat Found in Bag

Walmart is recalling their Marketside Spring Mix Salad after the supplier "Fresh Express was notified that extraneous animal matter was allegedly found in a single container of the salad".   That extraneous matter was a dead bat.

While of course, everyone worries about rabies, but this would be an extremely low risk.  Rabies virus is an enveloped virus and does not survive in the environment well if at all. While there have been some rare, laboratory-created instances of it be transmitted through aerosol with depleted oxygen, this is really a non-factor.  The bigger risks are the normal foodborne pathogens that can be carried by bats, including Campylobacter, Listeria, Salmonella, Shigella, and Yersinia as well as some more exotic bacterial types.  Depending on where the bat entered the system would determine the amount of dissemination of these types of organisms.

Now how does bat get into a bag?  If not intentionally placed there by someone, and one had to guess....it would most likely come into the packaging area of the processing plant at night.  The greens are chopped and washed, so unlikely that it came in the loads of produce (unless some component was not chopped).  More likely, this flew into the plant at night when doors were left opened and took refuge in the equipment.  If this were the case, it occurred after sanitation.  When the greens started flowing, the little dude was crushed and loaded into the bag.  All a guess of course, but if true, would probably be in one of the bags from early in the production run..  Prevention....keeping doors shut at night, especially dock doors. X-ray equipment would have likely found this if in place.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm551649.htm
Precautionary Recall of a Limited Quantity of Organic Marketside Spring Mix Salad is Announced by Fresh Express
For Immediate Release
April 8, 2017

Salad Leaf Juice Enhances the Growth, Attachment, and Virulence of Salmonella

A study recently published in Applied and Environmental Microbiology shows that juices from leafy greens can enhance the growth, colonization, and virulence of Salmonella.  When chopping salad leaves, juices will be released from the cut surface.  The metabolites in these juices will enhance the growth of Salmonella as well as enhance its ability to form biofilms attaching to the leaf and bag surfaces.  There was even increased virulence.

While no one should avoid eating leafy greens, this study reinforces the need for good practices when growing, harvesting, processing and storing bagged chopped leafy greens.  Contamination on leafy greens is generally low, however, if improperly processed or handled, even a few inconsequential organisms can increase to the point where it becomes a problem.  For storage, bagged chopped salad should always be stored at refrigeration temperatures.

Reuters
http://www.reuters.com/article/us-health-salmonella-bagged-salads-idUSKBN13O2VM
Health News | Wed Nov 30, 2016 | 7:24am EST
Bagged salads may encourage Salmonella growth
By Carolyn Crist

Spinach Recalled after Sample Tests Positive by Michigan Dept of Ag

Taylor Farms of Salinas CA is recalling institutional sized units of fresh spinach after the Michigan Department of Ag had a positive Salmonella result in a sample they tested.  No illnesses have been reported.

 Schnuck's issued a recall notice for their pasta salad because they used that spinach.



The Produce News
http://theproducenews.com/news-dep-menu/test-featured/15640-taylor-farms-recalls-foodservice-spinach-in-response-to-michigan-testing
Taylor Farms recalls foodservice spinach in response to Michigan testing
by Joan Murphy | April 22, 2015

Salinas, CA-based Taylor Farms has notified foodservice companies of a spinach recall after Michigan inspectors detected pathogens in foodservice product during routine testing.

The Michigan Department of Agriculture & Rural Development’s Geagley Laboratory tested spinach that was pre-packaged and ready for institutional use and stored in a food warehouse facility as part of the state’s routine food-safety assurance program.

Romaine lettuce recalled due to Listeria

Fresh Express is recalling bags of romaine lettuce hearts due to a sample testing positive for Listeria.  The release below indicates the product was tested by FDA.  There have been no reported illnesses.  At this point, the expiration date on the product had passed so it is anticipated that there will be no product on the store shelf.

 

Why conduct a recall on expired product?  In the event product still might be on some store shelf, or in someone's refrigerator, it is important to remove it.  Especially considering that Listeria can grow at refrigerated temperatures.  Also, expired product may move through the food donation system (food banks and pantries).  Some of these outlets allow for the movement of product that has gone beyond the stated shelf-life.  Then on top of that, it is important that the company show it has taken corrective action.

Why test product about to expire?  This is probably a market survey, so product may have already traveled from the production facility to the retail level.  With a limited shelf-life product like leafy greens, there is not a big window of time.  Adding this to the time it takes for testing and positive confirmation, then it is likely that the product has already surpassed its stated shelf-life. 

But a sampling program such as this does give important information.  With little doubt, the FDA is paying a visit to this facility to see how the product may have become contaminated.  In a product such as this where there are processing steps including the removal of the outer leaves and a multiple wash step, which will include some antimicrobial agent(s), there is a good likelihood that the contamination occurred at the processing facility.

 

FDA News Release

Fresh Express Recalls Limited Quantity of Expired 10 oz. Hearts of Romaine Salad Due to Possible Health Risk

http://www.fda.gov/Safety/Recalls/ucm316923.htm

 

Contact:
Consumer:
800-242-5472
Media:
Tiffany Breaux
704-280-5938
Barbara Hines
972-724-3049

FOR IMMEDIATE RELEASE - August 26, 2012 - Fresh Express Incorporated is voluntarily recalling a limited quantity of expired 10 oz. Hearts of Romaine salad with the expired Use-by Date of August 23, 2012 and a Product Code beginning with "G222" as a precaution due to a possible health risk from Listeria monocytogenes.

No illnesses are reported in association with the recall. No other Fresh Express products are being recalled.

Fresh Express customer service representatives are already contacting retailers to confirm the product was removed from their inventories and store shelves in accordance with standard procedures for products that have reached their expiration date. Customers with questions may contact their Fresh Express customer service representative.

In an unlikely event that consumers may still have this expired product in their refrigerators, it should not be consumed, but discarded instead. Consumers with questions may call the Fresh Express Consumer Response Center at (800) 242-5472 during the hours of 8 a.m. to 7 p.m. Eastern Daylight Time.

The precautionary recall notification for the now-expired salad is being issued due to an isolated incident in which a sample of a singled package of 10 oz. Hearts of Romaine salad yielded a positive result for Listeria monocytogenes as part of the U.S. Food and Drug Administration’s random sample testing program. Fresh Express is continuing to coordinate closely with regulatory officials.

The limited quantity of recalled product is identified with a Product Code beginning with "G222" and a Use-by Date of August 23, which is located in the upper right-hand corner of the package. In addition, the UPC Code of 71279 26102 is located on the back of the package below the barcode. The 10 oz. Hearts of Romaine was distributed in limited quantities to predominantly eastern and southeastern states.

Listeria monocytogenes is an organism that can cause foodborne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, muscle aches, gastrointestinal symptoms such as nausea or diarrhea. If it spreads to the nervous system symptoms may include headache, stiff neck or confusion. The illness primarily affects pregnant women and adults with weakened immune systems. Most healthy adults and children rarely become seriously ill.

###

Note:
The expired Fresh Express Hearts of Romaine salads being recalled display a use-by date of August 23, 2012 with a Product Code beginning with G222.

BRAND	PRODUCT NAME	SIZE	PKG TYPE	UPC	POSSIBLE DISTRIBUTION STATES
Fresh Express	Hearts of Romaine	10 oz	Bag	7127926102	AL, AR, FL, GA, IL, IN, KY, LA, MD, MO, MS, NC, OH, PA, SC, TN, TX, VA, WV

CDC lists Multistate Foodborne Outbreaks for 2011

CDC has updated their Multistate Foodborne Outbreak listing for 2011 (http://www.cdc.gov/outbreaknet/outbreaks.html). This is a nice reference page for reviewing major food outbreaks that have occurred over the past 6 years. (An outbreak, as defined by CDC is “When two or more people get the same illness from the same contaminated food or drink”)

 A few things to note:

• This does not include recalled products – products recalled due to only the presence of pathogens (pathogens were detected in the product, but there were no illnesses reported). There have been many recalls that have occurred due to positive analysis for a pathogen, especially now with the Reportable Registry (http://www.fda.gov/food/foodsafety/foodsafetyprograms/rfr/default.htm). And so it follows, it does not include recalls for allergens – the major cause for companies to conduct recalls.
• This list does not include single state outbreaks – so this list is manly large companies that produce products. This does not mean that smaller establishments do not have issues.
• A few items were actually not food, but rather pets (frogs and chicks/ducklings in 2011, and water frogs and frozen rodents, which are used to feed slithering pets, in 2010). One item was dog food, which we will count as food – you dog food eaters know who you are.
• There appears to be an increase in the number of entries each year on this listing. I don’t suspect things are getting worse, but rather detection and reporting are getting better.
• Of the 41 entries over the 6 year period where a cause can be found (dropping the pet related entries and the laboratory entry), fresh ground meat had 6 entries, alfalfa sprouts had 5, leafy greens had 5, and cantaloupe had 3.
• Salmonella related outbreaks accounted for roughly 2/3 of the entries. This is due to the wide prevalence of Salmonella in the enviornment.
• FDA regulated product entries accounted for 25 entries, USDA for 11, and I suspect that two of the outbreaks were from facilities that had both USDA and FDA oversight.
• Roughly 27 are what one would consider ready to eat (no required consumer cooking step). 14 entries were products would be considered products that required cooking, that if done sufficiently by the consumer, would have prevented illness (reasons why vary - cookie dough traditionally eaten raw, pot pies – poor cooking instructions, raw meat – no thermometer use).
• As a consumer, I avoid alfalfa sprouts, use a thermometer to cook my ground meat, really wash my cantaloupes, pray my chopped lettuce was not harvested from a farm located next to a cow barn, cook my cookie dough to have crunchy cookies, and refuse to buy my kids turtles, frogs, and snakes (that have to fed frozen rodents.) I have also ceased from eating dog food.

 Multistate Foodborne Outbreaks

 http://www.cdc.gov/outbreaknet/outbreaks.html

When two or more people get the same illness from the same contaminated food or drink, the event is called a foodborne outbreak. Public health officials investigate outbreaks to control them, so more people do not get sick in the outbreak, and to learn how to prevent similar outbreaks from happening in the future.

CDC and partners ensure rapid and coordinated surveillance, detection, and response to multistate foodborne outbreaks.

Outbreaks by Year

 2011

 · Ground Beef - Salmonella Typhimurium

 · Romaine Lettuce - Escherichia coli O157:H7

 · Kosher Broiled Chicken Livers - Salmonella Heidelberg

 · Turkish Pine Nuts - Salmonella Enteritidis

 · Jensen Farms Cantaloupes - Listeria monocytogenes

 · Ground Turkey - Salmonella Heidelberg

 · Whole, Fresh Imported Papayas - Salmonella Agona

 · African Dwarf Frogs - Salmonella Typhimurium

 · Alfalfa and Spicy Sprouts – Salmonella Enteritidis

 · Travel to Germany - Shiga toxin-producing E. coli O104

 · Chicks and Ducklings - Salmonella Altona and Salmonella Johannesburg

 · Microbiology Laboratories - Salmonella Typhimurium

 · Turkey Burgers - Salmonella Hadar

 · Lebanon Bologna - Escherichia coli O157:H7

 · Del Monte Cantaloupe - Salmonella Panama

 · Hazelnuts - Escherichia coli O157:H7