The CDC has declared the Chipotle E. coli outbreaks over. As for its origin(s), we may never know. Yesterday the CDC provided its latest and final update regarding the two outbreaks, stating that investigators used whole genome sequencing to dig a bit deeper, and isolates tested from those sickened in the second outbreak (sickened five people in three states) were not genetically related to isolates from the people who fell ill in the initial outbreak (55 sickened in 11 states, with 21 hospitalizations).
“We are pleased to have this behind us and can place our full energies to implementing our enhanced food safety plan that will establish Chipotle as an industry leader in food safety,” said Steve Ells, founder, chairman and co-CEO of Chipotle in a company statement. “We are extremely focused on executing this program, which designs layers of redundancy and enhanced safety measures to reduce the food safety risk to a level as near to zero as is possible. By adding these programs to an already strong and proven food culture, we strongly believe that we can establish Chipotle as a leader in food safety just as we have become a leader in our quest for the very best ingredients we can find.”
While the outbreaks “appear” to be over, the fact that the source will remain a mystery is a bit unsettling. All the CDC can tell us is that the “likely” source was a common meal item or ingredient served at Chipotle Mexican Grill. Regulatory officials simply cannot trace a food or ingredient to the outbreak. “When a restaurant serves foods with several ingredients that are mixed or cooked together and then used in multiple menu items, it can be more difficult for epidemiologic studies to identity the specific ingredient that is contaminated,” according to the CDC’s final update on the outbreak.
The most recent reported illness started on December 1, 2015. No deaths were reported as a result of either of the outbreaks.
Today Chipotle released its Q4 2015 earnings, reporting a 6.8% decrease in revenue ($997.5 million) compared to Q4 2014. However, 2015 revenue increased 9.6% over 2014.
The problems are not over for the restaurant chain either. On January 28, Chipotle was served another subpoena that broadened the scope of the existing DOJ investigation. The company stated the following in a release, “The new subpoena requires us to produce documents and information related to company-wide food safety matters dating back to January 1, 2013, and supersedes the subpoena served in December 2015 that was limited to a single Chipotle restaurant in Simi Valley, California. We intend to fully cooperate in the investigation.”
Dole’s bagged salad was the culprit of three more Listeria cases last month. Last week the FDA released the latest figures on the outbreak, which began in July 2015. An investigation was not initiated until September, and the source of Listeria—a Dole processing facility in Springfield, Ohio—was not known until January 2016. The CDC reports that 15 people, all which were hospitalized, in eight states have been infected with Listeria traced back to the Dole facility since July.
On January 21 Dole told the FDA and CDC that it both stopped producing all packaged salads at the Springfield facility and stated that it would be withdrawing all packaged salads on the market that were produced there. The company initiated the recall of the salads, which were sold under the brand names Dole, Fresh Selections, Simple Truth, Marketside, The Little Salad Bar, and President’s Choice Organics, last week. The bagged salads were distributed in 24 states.
The Public Health Agency of Canada also issued a food recall warning for products made at the Springfield facility. The products were shipped to six Canadian provinces.
When it comes to preventing foodborne illness, staying ahead of the game can be an elusive task. In light of the recent outbreaks affecting Chipotle (norovirus, Salmonella, E. coli) and Dole’s packaged salad (Listeria), having the ability to identify potentially deadly outbreaks before they begin (every time) would certainly be the holy grail of food safety.
One year ago IBM Research and Mars, Inc. embarked on a partnership with that very goal in mind. They established the Consortium for Sequencing the Food Supply Chain, which they’ve touted as “the largest-ever metagenomics study…sequencing the DNA and RNA of major food ingredients in various environments, at all stages in the supply chain, to unlock food safety insights hidden in big data”. The idea is to sequence metagenomics on different parts of the food supply chain and build reference databases as to what is a healthy/unhealthy microbiome, what bacteria lives there on a regular basis, and how are they interacting. From there, the information would be used to identify potential hazards, according to Jeff Welser, vice president and lab director at IBM Research–Almaden.
“Obviously a major concern is to always make sure there’s a safe food supply chain. That becomes increasingly difficult as our food supply chain becomes more global and distributed [in such a way] that no individual company owns a portion of it,” says Welser. “That’s really the reason for attacking the metagenomics problem. Right now we test for E. coli, Listeria, or all the known pathogens. But if there’s something that’s unknown and has never been there before, if you’re not testing for it, you’re not going to find it. Testing for the unknown is an impossible task.” With the recent addition of the diagnostics company Bio-Rad to the collaborative effort, the consortium is preparing to publish information about its progress over the past year. In an interview with Food Safety Tech, Welser discusses the consortium’s efforts since it was established and how it is starting to see evidence that using microbiomes could provide insights on food safety issues in advance.
Food Safety Tech:What progress has the Consortium made over the past year?
Jeff Welser: For the first project with Mars, we decided to focus around pet food. Although they might be known for their chocolates, at least half of Mars’ revenue comes from the pet care industry. It’s a good area to start because it uses the same food ingredients as human food, but it’s processed very differently. There’s a large conglomeration of parts in pet food that might not be part of human food, but the tests for doing the work is directly applicable to human food. We started at a factory of theirs and sampled the raw ingredients coming in. Over the past year, we’ve been establishing whether we can measure a stable microbiome (if we measure day to day, the same ingredient and the same supplier) and [be able to identify] when something has changed.
At a high level, we believe the thesis is playing out. We’re going to publish work that is much more rigorous than that statement. We see good evidence that the overall thesis of monitoring the microbiome appears to be viable, at least for raw food ingredients. We would like to make it more quantitative, figure out how you would actually use this on a regular basis, and think about other places we could test, such as other parts of the factory or machines.
FST: What are the steps to sequencing a microbiome?
Welser: A sample of food is taken into a lab where a process breaks down the cell walls to release the DNA and RNA into a slurry. A next-generation sequencing machine identifies every snippet of DNA and RNA it can from that sample, resulting in huge amounts of data. That data is transferred to IBM and other partners for analysis of the presence of organisms. It’s not a straightforward calculation, because different organisms often share genes or have similar snippets of genes. Also, because you’ve broken everything up, you don’t have a full gene necessarily; you might have a snippet of a gene. You want to look at different types of genes and different areas to identify bad organisms, etc. When looking at DNA and RNA, you want to try to determine if an organism is currently active.
The process is all about the analysis of the data sequence. That’s where we think it has a huge amount of possibility, but it will take more time to understand it. Once you have the data, you can combine it in different ways to figure out what it means.
FST: Discuss the significance of the sequencing project in the context of recent foodborne illness outbreaks. How could the information gleaned help prevent future outbreaks?
Welser: In general, this is exactly what we’re hoping to achieve. Since you test the microbiome at any point in the supply chain, the hope is that it gives you much better headlights to a potential contamination issue wherever it occurs. Currently raw food ingredients come into a factory before they’re processed. If you see the problem with the microbiome right there, you can stop it before it gets into the machinery. Of course, you don’t know whether it came in the shipment, from the farm itself, etc. But if you’re testing in those places, hopefully you’ll figure that out as early as possible. On the other end, when a company processes food and it’s shipped to the store, it goes onto the [store] shelves. It’s not like anyone is testing on a regular basis, but in theory you could do testing to see if the ingredient is showing a different microbiome than what is normally seen.
The real challenge in the retail space is that today you can test anything sitting on the shelves for E. coli, Listeria, etc.— the [pathogens] we know about. It’s not regularly done when [product] is sitting on the shelves, because it’s not clear how effectively you can do it. It still doesn’t get over the challenge of how best to approach testing—how often it needs to be done, what’s the methodology, etc. These are all still challenges ahead. In theory, this can be used anywhere, and the advantage is that it would tell you if anything has changed [versus] testing for [the presence of] one thing.
FST: How will Bio-Rad contribute to this partnership?
Welser: We’re excited about Bio-Rad joining, because right now we’re taking samples and doing next-generation sequencing to identify the microbiome. It’s much less expensive than it used to be, but it’s still a fairly expensive test. We don’t envision that everyone will be doing this every day in their factory. However, we want to build up our understanding to determine what kinds of tests you would conduct on a regular basis without doing the full next-gen sequencing. Whenever we do sequencing, we want to make sure we’re doing the other necessary battery of tests for that food ingredient. Bio-Rad has expertise in all these areas, and they’re looking at other ways to advance their testing technology into the genomic space. That is the goal: To come up with a scientific understanding that allows us to have tests, analysis and algorithms, etc. that would allow the food industry to monitor on a regular basis.
While illnesses linked to Chipotle restaurants are grabbing headlines, the federal government recently took steps to improve how manufacturers and packagers process and handle food. Last year FDA released several final FSMA rules, giving food companies a roadmap for ensuring food safety. The proactive approach of the regulations can help companies avoid the hazards that lead to disease and allergen contaminations, and even legal troubles. Indeed, unsafe food handling can carry costly consequences from both a financial standpoint as well as in lives lost or harmed.
In 2011, the good intentions of a family-owned cantaloupe company produced tragic results. The company, seeking more natural melons, followed a consultant’s advice and discontinued the chlorine rinse used to wash off contaminants. A Listeria outbreak followed, killing 33 people and hospitalizing 147 more. Although prosecution is rare in foodborne disease outbreaks, the company owners were sentenced to probation, home detention, community service, and $150,000 each in restitution.
A more egregious case occurred in September 2015, when the former CEO of the Peanut Corporation of America was convicted of knowingly shipping Salmonella-tainted peanut butter, which had caused an outbreak that killed nine people and sickened hundreds more. Stewart Parnell was sentenced to 28 years in federal prison.
The new regulations require companies to undertake hazard analyses of their production, along with remedial steps. This scrutiny leads to the creation of a written plan that details the controls to prevent contamination and establish a schedule for periodic testing. This analysis and control system is called the Hazard Analysis Critical Control Point, or HACCP.
Adherence to regulations doesn’t necessarily protect a company from liability, but not adhering can sound a company’s death knell when there’s a problem. The following are five ways in which companies can protect themselves:
Put food safety first. The company culture must revolve around it. The message that the HACCP plan is to be followed must be relayed to all levels of the organization. Otherwise, companies can face severe consequences, based on the question, “Did the company behave badly enough to face strong punitive damages?”
Concentrate on internal communications. In many cases, food recalls happen because of a breakdown in the communication process.
Hire accredited consultants. Make sure that your consultants are qualified and have been accredited by an appropriate body such as the International HACCP Alliance or The Seafood HACCP Alliance.
Don’t overlook supplied products. Suppliers should adhere to strict contamination-prevention protocols, but don’t assume they follow guidelines completely or have flawless processes. Your contracts with them should require that they periodically audit their facilities and share the audit results with you.
Label clearly. Packaging language might state that a product is manufactured in facilities that also process allergens such as peanuts and tree nuts. These types of warnings allow consumers to make up their own minds. It is also a reminder that HACCP plans must address prevention of cross-contamination (i.e., putting cleaning protocols in place if products with and without allergens are processed on the same equipment).
Many problems involve internal slip-ups or problems with supplied ingredients that allow contaminated food to reach consumers. If the contamination becomes known—and it often is not, when victims don’t equate their illnesses with tainted food—the businesses involved often face strict liability, meaning they carry some blame even if they didn’t act in a negligent manner and cause the problem directly.
Keep in mind that liability isn’t the only consequence of non-compliance. A recall or outbreak can damage the reputation of the company and the product. The cantaloupe tragedy sent sales of the melons plummeting, even in states not linked to the outbreak.
To minimize the hit on sales, a recall team should be in place, with a plan modeled on crisis management principles. Team members should come from all divisions of the company, including transportation and distribution to track down products, and communications to manage messaging. Legal counsel should be on board to advise on the ramifications.
When it comes to foodborne outbreaks, it’s a matter of taking classic prevention and preparation steps. Do everything you can to keep it from happening, but be ready just in case it does.
Today Sample6 announced a new patent for phage engineering technology. Issued by the U.S. Patent and Trademark Office, the patent, “Recombinant Phage and Methods”, is the first awarded to the company.
“As an industry, we need to set a new bar for food safety programs – widespread illness outbreaks and massive recalls should not happen in this day and age,” said Tim Curran, CEO of Sample6, in a company release. “Contaminated food should be found and stopped before it ever enters the food chain.”
The Sample6 DETECT/L system is the first in-plant, in-shift pathogen detection for Listeria. A continuation of the company’s effort to prevent contaminated foods from leaving food processing warehouses and distribution centers, the phase-based bacterial detection assay has been approved by USDA and AOAC.
As of late, the problems for Chipotle have been endless. 2015 was a year of several Salmonella, norovirus and E. coli outbreaks for the restaurant chain. With the first full week of the new year wrapped up, 2016 is off to perhaps an even rockier start, with news of the company being hit with both a class action lawsuit and a federal grand jury subpoena.
Company stockholder Susie Ong filed a civil complaint against Chipotle on January 8, stating that the company made false or misleading statements and failed to disclose that its “quality controls were inadequate to safeguard consumer and employee health.” Filed in the U.S. District Court for the Southern District of New York, the complaint calls out a norovirus outbreak that occurred in August in Simi Valley, California; a Salmonella outbreak in Minnesota that sickened 64 people; the closure of all company restaurants in Portland, Oregon and Seattle, Washington in November following an E.coli outbreak; and the highly-publicized norovirus outbreak that sickened more than 140 students from Boston College in Brighton, Massachusetts last month.
Ong’s complaint also mentions the federal grand jury subpoena, which Chipotle made public two days prior (January 6) in an SEC filing. Served in December, the subpoena is part of a criminal investigation by FDA and the U.S. Attorney’s Office for the Central District of California into the Simi Valley norovirus outbreak, which sickened about 100 patrons and employees (some reports state that more than 200 people fell ill). Ong’s lawsuit states that health inspectors found “dirty and inoperative equipment, equipment directly linked to the sewer, and other sanitary and health violations” at the Simi Valley restaurant.
With December’s norovirus outbreak in Brighton and the CDC’s announcement that it was further investigating five new cases of E. coli that were reported the month prior, restaurant sales were down 30% for the month, according to the SEC filing. Ong adds up all of these unfortunate events in the lawsuit, stating, “As a result of defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the Company’s securities, Plaintiff and other Class members have suffered significant losses and damages.”
Chipotle has not yet publicly commented on the lawsuit.
Earlier in December, Chipotle called attention to improvements it was making to its food safety program by bringing in IEH Laboratories and Consulting Group to reevaluate its processes in an effort to prevent future outbreaks. Clearly that was not enough.
Food companies take heed. 2016 is off with a bang, and not in a good way. Last week industry was also buzzing about the DOJ’s investigation into Blue Bell Creameries over the deadly Listeria outbreak. FDA and the other federal powers-that-be are making it very clear that negligence will no longer be tolerated (Or should I say, alleged negligence, in this case). Compliance, accountability, and above all, ethical behavior are at the heart of the matter.
Will it all come tumbling down for Chipotle? It remains to be seen whether the company will be able to recover from these issues. And maybe an even bigger question is, who will be next?
Attend the Listeria Detection & Control Workshop, May 31–June 1 in St. Paul, MN | LEARN MOREAccording to the CDC’s Foodborne Outbreak Online Database (FOOD Tool), there were 29 Listeria outbreaks between 2010 and 2014, resulting in 325 illnesses and 68 deaths (nearly a 21% fatality rate). In light of the recent reports that the U.S. Department of Justice is looking into Blue Bell Creameries following the Listeria outbreak in its facilities that killed three people, food companies need to have a strong mitigation and control program before it’s too late. The government is placing is a higher level of accountability on employees at all levels within food organizations and no one, including company executives, are immune to it.
“It’s extremely important that we understand how deadly Listeria is,” said Gina Nicholson-Kramer, founder and executive director at Savour Food Safety International, Inc. during a Listeria workshop at the 2015 Food Safety Consortium. “We’re put here to protect our consumer.”
Containing what may be growing (and rapidly spreading) within the nooks and crannies of a facility is a challenge. To learn more about how to prevent product contamination within all areas of food production, read the column by Nicholson-Kramer and Jeff Mitchell, vice president of food safety at Chemstar, Activate Your Listeria Mitigation and Control Program.
As a result of the rising incidence of food contamination and foodborne illness outbreaks such as Listeria, Salmonella and E.coli, the North American market for food safety testing is expected to hit $6.4 billion within the next four years. According to a recent report by Markets and Markets, the 7.4% compound annual growth rate will also be fueled by the following factors:
Actions taken by food manufacturers to implement more testing at different stages of the chain in order to strengthen food safety standards
Increased concern to reduce the amount of product recalls
Increased consumer interest in ingredients and food safety
FSMA and the regulatory effort to reduce the presence of pathogens or contaminants in food
Update: (1/14/2016):According to a report released by Research and Markets on January 14, the global food safety testing market can expect to achieve a 7.1% CAGR over the next five years, hitting $16.2 billion by 2020.
After bringing in IEH Laboratories and Consulting Group to reevaluate its practices after an E.coli outbreak that sickened dozens, Chipotle Mexican Grill announced it is implementing a program to ensure it achieves “the highest level of safety possible”. According to a press release issued today, Chipotle is enhancing its food safety program and taking the following actions:
Conducting high-resolution DNA-based testing of all fresh produce prior to shipment to restaurants
Conducting end-of-shelf-life testing of ingredient samples to ensure quality specifications are maintained throughout ingredient shelf life
Engaging in continuous improvements throughout its supply chain leveraging test result data to measure its vendor and supplier performance
Improving internal employee training related to food safety and food handling
The CDC and FDA investigation of the E. coli outbreak is ongoing and the source of the outbreak is still unknown.
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