As a result of four additional confirmed illnesses, General Mills has added four more production dates to its flour recall (production dates through February 10, 2016). The initial recall was announced May 31, with an expanded recall taking place earlier this month.
“At this time, it is unknown if we are experiencing a higher prevalence of E.coli in flour than normal, if this is an issue isolated to General Mills’ flour, or if this is an issue across the flour industry. The newer detection and genome sequencing tools are also possibly making a connection to flour that may have always existed at these levels,” according to a company release on FDA’s website.
Thus far, illnesses have only been linked to consumers who said they ate or handled uncooked dough or ate uncooked batter made with raw flour, not with flour that was baked, cooked or handled.
Consumers should check their pantry. As a result of newly reported illnesses connected to raw dough or batter consumption, General Mills has expanded its recall of Gold Medal flour, Wondra flour and Signature Kitchens flour to include products made last fall. The FDA and CDC have warned consumers against eating any raw products made with flour.
According to the CDC, the multi-state outbreak of Shiga toxin-producing E. Coli O121 has sickened at least 42 consumers (with 11 hospitalizations) across 21 states. No deaths have been reported. The bacteria was isolated from samples of General Mills flour that was collected from the homes of those sickened in Arizona, Colorado and Oklahoma.
General Mills has already conducted a voluntary recall of 10 million pounds of flour (unbleached, all purpose and self rising). A full list of the products included in the recall are available on FDA’s website.
In recent years, several food products typically considered safe by consumers have fallen victim to recalls as a result of Listeria monocytogenes (Lm). Caramel apples, ice cream, packaged salads and frozen vegetables were responsible for sickening dozens of people and killing more than 10. These products are part of an alarming group of common foods that have caused outbreaks, including milk, spinach, sprouts, peanut butter, cheese, cantaloupes and raw cookie dough. And the broad range of pathogens causing these outbreaks is just as diverse, and they continue to find creep into food processing facilities, finished food products and consumer homes.
At the 2016 Food Safety Consortium, Shawn Stevens will moderate the workshop session, Bringing the final FMSA pieces together: You have a basic preventative control program, what’s left? | Friday, December 9 | LEARN MORERegardless of sophistication or expertise in pathogen control, there isn’t a single company out there that is immune to the risk of contamination. Why? Well much of the foods (or ingredients) that we consume are grown and harvested in environments that are susceptible to contamination. Fruits, vegetables and other products, such as spices, can easily become contaminated with Lm, Salmonella or E. coli in the fields where they are grown, in transit or in the processing facilities.
Once pathogens are introduced into the processing environment, they can quickly spread and contaminate food products. Recent studies reveal that Listeria is a significant concern in these environments. For example, out of 5,000 samples from the food preparation areas of 30 retail grocery establishments, approximately 10% tested positive for Lm. These are scary numbers considering almost 16% of those who become infected with Lm will die.
In today’s new environment, FDA will be seeking justification to bring criminal charges whenever a contaminated product causes human illness. You should be nervous about this: If your company sells finished goods into commerce, those products may be selected for sampling and testing, and your company runs the risk that the results will come back positive for a pathogen of concern. And what’s more troubling is the fact that many companies do not conduct environmental testing in their food processing facilities, and so they have no idea whether pathogens (whether transient or resident) are lurking within their facilities. Thus, a microbiological profiling study conducted under the veil of the attorney-client privilege should be conducted to determine the presence of any microbiological persistence issues within a facility. Upon completion of the study, a company should invest in pathogen-reduction technologies to decrease the chances that FDA will uncover pathogens in the environment during an inspection. Finally perform a criminal protection audit to help strengthen company programs and develop protocols that will further protect against criminal exposure.
The bottom line is that if food companies do not take extraordinary measures to identify Lm in their facilities, perform a comprehensive investigation to find the root cause or source, and then destroy and eliminate it completely, the pathogen will likely persist and, over time, intermittently contaminate their finished products.
Microbiological Profiling Studies
Lesson number one from the Blue Bell Lm outbreak is that pathogens can be extremely elusive and, as a result, a simple environmental monitoring program will never save your company from being involved in an outbreak or being the focus of criminal sanctions. All food companies should be aggressively testing for Lm (or other pathogens, depending upon the product risk profile) in their facilities and must take strong action against sporadic or intermittent positive findings. Although many food companies view a single operational failure as the culprit of an outbreak, the reality is that in most cases, the cause is something far more subtle, far more persistent, and far more dangerous. In recent years, a large number of outbreaks have involved Lm and antibiotic-resistant Salmonella that was linked to products that had been processed over multiple months.
Food companies should conduct a comprehensive one-time microbiological profile for pathogens in their processing facilities. Be sure to coordinate your profiling study with a lawyer experienced in food safety to make sure that the study is designed correctly and that the results will be protected under the attorney-client privilege. Once the results are reported, the company can take care of any positive findings, identify the contamination source, implement technologies to reduce and control the contamination, and develop a microbiological control and monitoring program to ensure that the pathogen remains controlled moving forward.
Pathogen Reduction Technologies
The second lesson learned from the Blue Bell case is that, when Lm or any resistant pathogen is found sporadically in the environment, what was once regarded as effective corrective actions (i.e., re-cleaning, re-sanitizing and re-testing) are no longer enough. In addition to existing cleaning and sanitizing procedures, companies should use new pathogen reduction technologies to help control the environment.
Inexpensive air and surface treatment technology that sanitizes the food processing environment is now available. The treatment is approved for use in occupied spaces and provides 24-hour treatment of the environment. By using active air and surface treatment, food processing companies can gain a level of control and decrease the possibility that any pathogen, if introduced, will persist or establish a niche.
Puradigm, LLC, for instance, utilizes a multi- patented, NASA-based active air and surface sterilization approach to control pathogens in the food processing environment. In studies performed by Kansas State University, the company obtained a 2.9 Log reduction on environmental food contact surfaces in the food processing environment. Similar reductions for other pathogens are displayed in Table I.1
I make this observation because, given the risk created by the FDA’s war on pathogens, food companies should invest in technologies to better control pathogens in their food processing environments. Once these preventative technologies are put into place, companies can perform periodic microbiological monitoring to validate that the controls are effective and working as designed. If such solutions are employed, there is a greater likelihood that when FDA arrives to perform microbiological profiling, the agency will be less likely to find positive test results from the food processing environment, better protecting food companies from additional regulatory or criminal exposure.
Criminal Protection Audits
In addition to commissioning microbiological profiling studies in facilities and employing active air and surface sterilization technologies, food companies should also perform internal criminal protection audits. These audits should be designed to identify gaps in existing company protocols and develop written programs designed to help navigate the challenges posed by any food safety issues uncovered.
If developed correctly, the written program should provide the company with a decision-tree to follow in the event of a positive environmental finding, a series of customer complaints relating to the safety of a product, or a notification from a governmental entity of a potential food safety problem. These protocols and programs, if followed in the event of a food safety issue, can help ensure that the conduct of the company in response to any such issues will in all cases be appropriate, and that there will not be any basis upon which FDA or DOJ could support criminal charges.
The FDA (in cooperation with DOJ) has launched a war on pathogens. The agency is targeting food products at retail and engaging in microbiological profiling of all food companies. Unless companies act now to better quantify and control pathogens in the food processing environment, they are exposing themselves to incredible food safety risk, including significant brand damage (in the event of a recall) and criminal sanctions (if their product is linked to human illness). Companies must carefully consider the emerging risks facing them and take measures to decrease and eliminate their exposure.
GC/MS Evaluation of Compounds in Air Samples in a Controlled Environmental Chamber Equipped with a Puradigm Advanced Technology Cell, November 5, 2013, Dr. James Marsden, Kansas State University Food Science Institute.
Yesterday FDA released its Reportable Food Registry (RFR) and cited Listeria monocytogenes as generating the greatest number of reports (223), along with undeclared milk (27), in Year Five (from September 8, 2013–September 7, 2014).
FDA defines a reportable food as “an article of food/feed for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.” The purpose of the registry is to allow FDA to track patterns of food and feed adulteration in order to help the agency focus its already limited inspection resources.
Year Five saw 909 reportable food entries, including 201 primary reports regarding safety concerns with food or animal feed and 464 subsequent reports from suppliers or recipients of food or feed that was the subject of the primary reports, and 244 amended reports. The following food safety hazards were identified within the 201 primary reports in Year Five: Drug contamination, pathogenic E. coli, Listeria monocytogenes, nutrient imbalance, lead, Salmonella, undeclared allergens and undeclared sulfites. In addition, Salmonella, Listeria and undeclared allergens made up about 88% of the total primary entries for all five years of the RFR.
The report’s complete breakdown of the RFR submissions by year, along with identified commodities and hazards, is available on FDA’s website.
The labor union International Brotherhood of Teamsters has been holding nationwide protests at Chipotle locations this month, taking issue with one of the restaurant chain’s suppliers. The supplier at the focus of the demonstrations is California-based produce company Taylor Farms, which supplies tomatoes and peppers to Chipotle, according to Teamsters.
“Over the past five years, Taylor Farms has had more than 20 food recalls for problems such as Listeria, Salmonella and E. coli. In November 2015, Taylor Farms products containing celery and sold at Costco and other retail outlets were recalled for possible E. coli 0157:H7 contamination,” according to a Teamster news release. “At Taylor Farms’ plant in Tracy, Calif., the company has also committed safety and health violations and violations of laws that protect workers’ rights. Recently, the company settled extensive labor rights violations that involved payments of $267,000 to illegally terminated workers and a required posting in which the company promises to never again violate a long list of employee rights.”
The Teamsters protested at 12 Chipotle locations across the country, following 30 previous protests at Chipotle over the past several months.
Teamster Vice President Rome Aloise points the finger at Chipotle for allowing Taylor Farms to “have a total disregard for consumers’ and workers’ health and safety, as well as workers’ rights,” he said. “Chipotle claims to serve ‘Food With Integrity’, but where’s the integrity when it turns a blind eye to its supplier’s behavior? Chipotle must not cut and run – which would hurt Taylor Farms workers – it must carry out its social responsibility and demand Taylor Farms treat workers fairly and with respect.”
Taylor Farms has not released a statement addressing the protests.
This article was part of our April Fool’s edition. 49% of poll participants thought this story was fake. Alas, it’s true! Better luck next time.
If you plan on visiting Switzerland any time soon, take your beverages without ice. Why? A recent study has found that more than 25% of ice cubes used in bars and restaurants in Switzerland contain bacteria, including E. coli, pseudomonas and enterococci. According to SonntagsBlick, the publication that released the information, the bacteria is an indication of unsanitary ice cube production, namely due to the machines being kept in basements and cellars and not being properly cleaned or maintained.
“Abroad you are always careful with ice,” Sara Stalder, director of a consumer protection group told SonntagsBlick. “But in Switzerland one would never expect one in four ice cubes to exceed legal limits.” Despite the fact that the ice cubes surpassed legal limits in terms of the presence of bacteria, the amount of bacteria isn’t enough to be dangerous to humans.
There was been a significant uptick in the amount of foodborne illness outbreaks and food product recalls (there were more than 500 food product recalls last year), many of which have been caused by dangerous pathogens. As FSMA plays a role in addressing this alarming trend, FDA is making several policy changes that will only continue to intensify. The agency is conducting microbiological profiling both inside food processing facilities during routine inspections and testing large amounts of food at the retail level. In addition, it has launched criminal investigations against food companies distributing products that have the potential to cause human illness. In many of these cases, company executives did not have direct knowledge that their products were causing, or had the potential to cause, illness. Many investigations involve Listeria monocytogenes (LM) found in food processing environments or in food products in commerce. Under FDA’s new approach, the failure to eliminate sporadic LM findings in the environment can subject companies to criminal liability. The immediate challenge to the food industry is to find a more effective solution to identify and reduce pervasive pathogens in the processing environment using pathogen-reduction technologies, while simultaneously employing written food safety protocols that can provide additional protection against criminal sanctions.
PulseNet Makes Foodborne Illness Link
Following the conclusion of the infamous the Jack-In-The Box outbreak that sickened 600 and killed four people more than two decades ago, the federal government recognized that similar outbreaks were probably occurring throughout the country, but there were no viable means of detection. As a result, the CDC created the PulseNet database, a mandatory foodborne illness reporting system to detect and track outbreaks in real time. From there, when a patient tested positive for a pathogen of concern (such as Listeria Monocytogenes, Salmonella or E. coli O157:H7), his or her doctor had to report that finding to the state health department. Each state requests copies of the isolates and tests them for the specific genetic DNA fingerprint of the pathogen of interest. These fingerprints are uploaded to PulseNet, and when indistinguishable genetic DNA fingerprints are uploaded from multiple victims, the CDC can recognize that an outbreak is emerging. The agency shares this information with FDA and other federal, state and local health departments as they work to determine a common source. Despite the fact that most illnesses uploaded to PulseNet remain unsolved, the database has helped CDC and FDA solve hundreds of outbreaks that have affected thousands of victims.
My subsequent columns will look at the emerging challenges faced by the food industry, including recent federal criminal investigations, some solutions designed to assess environmental contamination and reduce pathogens, and strategies that you can employ to reduce criminal liability.
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.”
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?
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