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.
If you watch the evening news or read the local newspaper, the chances are pretty good that you will read or see something about a food safety concern or incident.
While the American food supply is among the safest in the world, the Federal government estimates that there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year, according to Foodsafety.gov. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. Five types of organisms—Salmonella, Toxoplasma, Listeria, norovirus, and Campylobacter—account for 88% of the deaths for which the cause is known.
We watched from the sidelines when major retailers faced public scrutiny over their practices on safeguarding consumer credit card information when their websites were hacked. Today, consumer and regulatory interest in food safety are the new focus areas for the news media, especially in light of the Blue Bell Creameries Listeria and the Peanut Corporation of America (PCA) Salmonella outbreaks. Unlike consumer credit information, serious missteps in our industry can kill people, and in the case of PCA, can put you permanently out of business.
In 2008, peanut butter paste manufactured by PCA killed nine people and sickened 714 others, some critically, across 46 states and was one of the largest food recalls in American history, according to the CDC. Although still under appeal, PCA CEO Stewart Parnell was convicted and sentenced to a 28-year prison term for his role in knowingly shipping out salmonella-contaminated peanut butter. Parnell received one of the toughest punishments in U.S. history in a foodborne illness case.
In the Blue Bell case, a total of 10 people with Listeriosis related to this outbreak were reported from four states, with three deaths reported from Kansas, according to the CDC. Blue Bell pulled their products from store shelves on April 20, 2015. On May 7, the FDA released findings from inspections at the Blue Bell production facilities in Brenham, Texas, Broken Arrow, Oklahoma and Sylacauga, Alabama. The FDA reports highlighted serious problems across multiple sites.
Both cases shine a spotlight on what can happen if you don’t have an effective food safety management system (FSMS). So what makes up a good FSMS, and is it enough to keep you out of trouble? An effective FSMS is built on three elements: Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP) and a management system. Food safety issues are avoidable, and good processes and a strong culture within an organization make them more unlikely to occur.
Implementing a FSMS does not happen in a few months; it may take up to two years to establish one. No doubt, foundational activities need to be in place for factory operations. In addition to focusing on foundational elements such as making sure equipment is cleaned properly and procedures for allergens are implemented, the leadership team needs to make it clear that it is never acceptable under any circumstances to take shortcuts that could jeopardize food safety. This policy needs to be indoctrinated throughout the organization and thus does not happen overnight.
Underlying an effective FSMS are strong HACCP and GMPs, but food safety should always be the top priority for management and its employees, not share price, earnings or profit margin. Although financial performance is important, food safety must take precedence in the organization, and leadership at all levels needs to send that message loud and clear to all employees. In today’s environment, HACCP is pretty much mandatory from a regulatory standpoint and is an essential part of a FSMS. But the missing piece in many organizations is the support from the top—this is where culture becomes embedded in the organization.
The FSMS culture is the collective behavior from the organization around shared values and beliefs. The organization will follow the actions of leaders, not necessarily what they say—we all know actions speak louder than words. A good food safety culture is one where best practices are openly discussed, defined and rewarded. Food safety culture has become a buzz word and there needs to be a focus on making it come to life through a structured FSMS.
At this year’s Food Safety Consortium conference, Tim Ahn will discuss advancing food safety training and harmonization (November 19). LEARN MOREFood safety training is important not only for first line supervisors and operators, but also for senior managers and leadership, because they define the objectives and policies of the FSMS. What does it mean to conduct an effective management review? What does it mean to do an internal audit? What’s a good corrective action process? Training often misses the mark, because organizations fail to embed it correctly.
For FSMS to thrive, management must commit to the FSMS being a required way of doing things throughout the entire organization. A FSMS is most effective when it benchmarked against a proven standard and verified by an independent third party. Certification against a proven standard will reduce risk within your business.
Select your independent third-party verifier carefully. Do they have the resources and time, and do they know what they are doing? Do they add value to your organization? This is important since once you get certified, your journey starts and it doesn’t end. The value comes in two areas: Identifying risks and developing the appropriate control measures, and ensuring that the process drive continuous improvement in your organization. FSMS is focused on how continuous improvement applies to the management of risk and business operations.
The most effective way to establish an FSMS is to have leadership that recognizes its importance. The worst way is to have a recall or an incident, which draws attention to the fact that there is a problem and something needs to happen. In the case of Blue Bell, they probably understood the importance of food safety and thought they were taking the right actions. However, their management system led them to problems. FSMS must be independently verified against world-class standards to ensure effective performance.
Companies can develop blind spots where they cannot see their own bad practices, and they become institutionalized over time. Fortunately, experienced independent third-party assessors can shine a spotlight on those bad practices. That is the true value in bringing in outsiders to look at your operations and culture to uncover those blind spots.
At PCA, their poor culture and actions to the problem sealed their fate. In some ways, this criminal case presented a wake-up call to boardrooms across America and highlights how badly leadership mismanaged matters. This case came to light in the context of the public complaining to the regulators that they were not doing enough following several highly visible food poisoning cases. A FSMS would have prevented these problems because the structure would not allow such bad decisions to be made and would have been verified by an independent third party that would test and check everything. A reputable third-party verifier would not miss poor GMP/ HACCP processes.
A good assessor can help a company understand what is really important and what is not so important when it comes to findings (i.e., context). We don’t waste a client’s time with insignificant issues and that is where the experience and judgment of the auditor becomes critical. Last year I met with a client and said, “you need to be checking for Salmonella in your environment—how do you know it is not there?” I pushed them into checking because I understood the changing regulatory environment. I came back a year later, and they had confirmed that regulators were interested in their Salmonella monitoring program during a recent inspection. As an auditor, you have to be confident enough to provide advice and context to the client in a way that is understood and accepted, and that helps to build trust.
With FSMA, the government can now take specific actions against companies. If I am plant manager or CEO, how do I know for sure that I am in compliance with the requirements? How do I know that I don’t have any of these potential issues? The only way to know for sure is to have the FSMS assessed. Just like a bank or publicly traded company hires financial auditors to assure everything is done correctly, companies need to audit their FSMS to ensure compliance. Get a process audit and ensure they drill down deep into the organization—that is where we find issues and gaps. A thorough auditor will find your problems instead of looking the other way. It is important to call it the way you see it and not be too “soft” when getting an assessment.
If I am the CEO, I want to know where those problems exist. Independent third party assurance is the best way to find out how compliant you are with regulations. No CEO wants to deal with the inevitable lawsuits and lost business impacts. At least with an effective FSMS, you can show a level of due diligence when the regulators show up at your doorstep and the culture is such that you want to address any problems.
We have entered an important time for the food industry with FSMA implementation and other food safety regulatory requirements in the United States. These new rules place an emphasis on management accountability, risk assessment and control of supply chains. The bar for due diligence has been raised and it up to all us to show that we have done everything possible, and the best way is with an effective FSMS.
After receiving input from federal, state, and local regulatory officials, along with industry and trade associations, academia, and consumers, FDA issued its Voluntary National Retail Food Regulatory Program Standards last week. The standards address “what constitutes a highly effective and responsive retail food regulatory program,” according to the document.
The Retail Program Standards include:
Promoting the adoption of science-based guidelines from the FDA Food Code
Promoting improvement of training programs to ensure local, state, tribal, and territorial staff have the necessary skills, knowledge and abilities
Implementing risk-based inspection programs
Developing outbreak and food defense surveillance plans to enable systematic detection and response to foodborne illness or food contamination
The 2015 edition contains new worksheets that are intended to assist regulatory programs in looking at how their programs line up with the 2013 Food Code. This includes helping them assess the consistency and effectiveness of their enforcement activities, and a verification tool to help independent auditors with these self-assessments. Although jurisdictions can use the worksheets and other materials without enrolling in the Retail Program Standards, FDA encourages them to do so, as enrollment allows them to apply for FDA funding. The agency also lists the jurisdictions enrolled in the program here.
Food safety poses a global health problem. According to the World Health Organization, contaminated food can cause more than 200 diseases – and food- and water-borne diseases that cause diarrhea are estimated to kill two million people each year worldwide.
And food safety is not just someone else’s problem.
“Foodborne illnesses are a significant problem in the United States, with massive impacts on public health and the economy,” says Ben Chapman, a food safety expert and researcher at NC State. And the numbers back Chapman up.
According to a 2012 report from researchers at the Emerging Pathogens Institute, Resources For the Future, and the U.S. Department of Agriculture’s Economic Research Service, foodborne illness is estimated to cost the U.S. more than $14 billion annually. (The estimate takes into account factors such as medical costs and productivity losses.)
And a 2011 report from the U.S. Centers for Disease Control and Prevention (CDC) reported an estimated 9.4 million episodes of foodborne illness each year in the U.S. from known pathogens. An additional 38.4 million cases are estimated to come from unspecified or unknown pathogens. In total, foodborne illnesses are thought to contribute to 48 million illnesses annually – resulting in more than 128,000 hospitalizations and 3,000 deaths. It is, in short, a big deal.
So what are these foodborne illnesses? And how much damage does each of them cause? In advance of World Health Day, we wanted to explain a handful of the relevant pathogens implicated in foodborne illness.
Campylobacter is a genus of bacteria, many of which can cause an illness called campylobacteriosis in humans, with symptoms including diarrhea and abdominal pain. People can contract campylobacteriosis from undercooked chicken, from cross-contamination via raw chicken, or from drinking unpasteurized milk.
According to the 2012 paper, campylobacteriosis affects 845,000 people annually in the U.S., costing the nation an estimated $1.747 billion every year and leading to 8,463 hospitalizations.
This is a bacterium that causes listeriosis, which is characterized by fever, muscle aches, and sometimes by gastrointestinal problems, such as diarrhea. Listeriosis can be contracted from an incredibly broad range of foods.
According to the 2012 study, listeriosis costs the U.S. $2.577 billion annually, despite the fact that there are only 1,591 illnesses per year. But 1,455 of those illnesses require hospitalization – and 255 result in death.
Noroviruses are the most common cause of foodborne illness in the U.S., affecting an estimated 19-21 million people each year. Symptoms range from vomiting and diarrhea to fever and headache. Transmission comes from ingesting infected feces or vomit particles – for example, by touching a contaminated surface and then touching food or touching your mouth.
According to the 2012 study, noroviruses cost the U.S. $2 billion per year, with more than 14,000 hospitalizations and approximately 150 deaths annually. NC State is a leader in norovirus research, and home to NoroCORE – the Norovirus Collaborative for Outreach, Research, and Education. NoroCORE pulls together norovirus research from 18 institutions, with funding from the U.S. Department of Agriculture.
This is one species of the pathogen that has myriad of subspecies and types – more than 1,400 of which are known to cause human illness. Infection with Salmonella species causes salmonellosis, with symptoms including diarrhea, fever, and cramping. Salmonellosis can be contracted from a variety of sources, ranging from poultry to peanut butter to mangoes.
According to the 2012 study, the subspecies within S. enterica alone costs the U.S. $3.3 billion each year, causing more than one million hospitalizations and almost 400 deaths annually.
What are researchers doing about this?
The four pathogens listed above are just a few of the rogue’s gallery of bacteria and viruses that can cause foodborne illness. But researchers are constantly learning more about these health risks.
“New technology and new research on pathogens, practices and prevention are improving our ability to identify and address foodborne illness,” Chapman says. “The field is really opening up. It’s an exciting time to be involved in food safety research.”
Between now and April 7, we’re planning to publish a series of posts on various aspects of food safety – what we know, what we don’t know, and what we’re working on. We also hope to offer insights to help folks lower the risk of contracting foodborne illnesses. We hope you’ll learn something new.
Batz, Michael B., Sandra Hoffmann, and J. Glenn Morris, Jr. “Ranking the Disease Burden of 14 Pathogens in Food Sources in the United States Using Attribution Data from Outbreak Investigations and Expert Elicitation” Journal of Food Protection, Vol. 75, No. 7, 2012, Pages 1278–1291. doi:10.4315/0362-028X.JFP-11-418
Scallan, Elaine, et al. “Foodborne Illness Acquired in the United States—Major Pathogens” Emerg Infect Dis, Vol. 17, No. 1, 2011. doi:10.3201/eid1701.P11101
It can be frustrating to consumers to discover some rotten fruits or not-so-fresh vegetables in their grocery packs in spite of due diligence at the stores. It also leaves a bad taste in the mouth while in your favorite restaurant, you’re served cold food, observe that the taste is just not right, the color of your favorite menu is not the same again or become suspicious that the food texture has been compromised and it doesn’t feel crispy or crunchy any more.
These are the tell-tale signs of food spoilage that customers are confronted with on a daily basis. In foodservice and retail environments, food spoilage constitutes a major food safety and food quality hazard with far reaching regulatory implications as well as being an economic burden with considerable food loss and profit loss. Food manufacturers and processors have achieved a high level of food preservation through several advanced technologies including heat treatment, temperature and water control, pasteurization and canning, specialized packaging like reduced oxygen packaging, fermentation and antimicrobial preservatives. However, food spoilage remains a major challenge in retail and food service. This is mostly as a result of the many food processing and preparation activities, food storage practices, repackaging and food portioning that are required in retail.
In addition, the modern consumers’ preference for fresh foods and the backlash on the use of unnatural preservatives leave foods more vulnerable to spoilage resulting in substantial food loss. Here, we discuss some of the challenges of food spoilage and how to minimize its impact on food safety, quality assurance and profitability in retail food operations.
The most important proactive measure against food spoilage is a tight managerial control on Supplier Food Safety and Quality Assurance. The condition of the food items upon delivery to the retail units will impact the overall shelf life, taste, texture, structural integrity and pathogen level during storage and food preparation activities. Food transportation best practices, cold chain requirements, temperature monitoring system, freeze-thaw detection, appropriate packaging, adulteration prevention and food tracking should be addressed at the supplier level to ensure that deliveries are wholesome safe quality foods. Integrated pest management at suppliers’ facilities and delivery trucks are also essential. Random testing of food products for pathogen content and quality control will assist in compliance with FDA/USDA regulations and internal corporate standards.Thus, a comprehensive evaluation and verification of the supplier food safety and quality assurance programs will help to ensure compliance with all relevant federal/State/local regulations (see previous blog on Supplier Qualification and Compliance using GFSI Benchmarking).
After suppliers deliver safe quality foods, in-store food safety and quality assurance control measures must be activated immediately to maintain safe quality food status until food is served to the customer.
At the retail units, appropriate food handling and storage practices to eliminate cross-contamination is key.
The use of rapid cleanliness monitoring test swabs to validate clean and sanitary food contact surfaces will enable timely corrective actions that would eliminate potentially hazardous food cross-contamination.
Proper hand hygiene by all foodservice employees should be mandatory.
Keeping cold food cold and warm food warm is a food safety mantra that ensures foods don’t get to the temperature danger zone. Temperature monitoring systems for freezers and refrigerators using wireless technologies will ensure a better food storage control even during non-business hours.
Emergency preparedness training for natural disasters and power outages should be in place to avoid surprises.
Compliance with FDA regulations for safe refrigerated storage, hot holding, cooling and reheating of food within the time and temperature criteria will help eliminate spoilage organisms and preserve the taste, texture and overall quality of food throughout its shelf life, especially for meat and poultry products.
Proper management of products’ shelf life, expiration dates and observing the principle of first in first out (FIFO) should be encouraged. In fact, the food code requires a system for identifying the date or day by which food must be consumed, sold or discarded. Product date marking enables compliance with this food code requirement to date mark all prepared food products, and to demonstrate a procedure that ensures proper discarding of food products on or before the date of expiration. Local health inspectors reference these product date marking labels and enforce them, in addition to food prep activities that may lead to cross-contamination, adulteration or spoilage. Inventory control, forecasting and Lean Six Sigma are important tools for managing food supplies, storage, preparation, stock replenishing and elimination of excess food items that may get past their shelf life.
Raw proteins (meat, sea food and poultry) are arguably the largest cross-contamination sources for pathogens in foodservice. Any novel pathogen reduction or elimination process like the potential production of pathogen-free chicken would be a welcome relief, and will not only save money and labor; it would protect the public health as well.
Produce (fruits and vegetables) remains the largest source of foodborne illness outbreaks in United States, because it’s a ready-to-eat food that doesn’t get the benefit of cooking at high sterilizing temperatures. An effective pathogen kill step for produce using consumer-friendly natural washes like electrolyzed water may serve as a gate keeper in case the safety system fails at the plant level. Ice-cold electrolyzed water is also known to refresh produce and may extend their shelf life as well.
GMO-food products could be engineered to resist pests and spoilage organisms with improved shelf life, but its general acceptability and the FDA labeling disclosure requirements are still contentious issues.
While industry is racing to develop several promising anti-spoilage technologies, active managerial control of the various components of an effective food safety and quality assurance system remains the best practice against food spoilage and associated food losses in retail food operations.
In the past two weeks, this blog has covered how Norovirus is the leading cause of foodborne illness worldwide, some potential sources of outbreak, and the importance of proper handwashing, developing an employee health policy, building a comprehensive food safety program, and training of employees. One critical aspect of Norovirus management is proper attention paid to cleaning and disposal of body fluids.
Proper cleaning and disposal of body fluids
The food code requires that retail foodservice establishments have proper procedures in place for emergency body fluids clean-up. Body fluids incidents in the dining room, play areas or back of the house are arguably the single most important source of Norovirus cross contamination in the restaurant, if clean-up and disposal are not performed according to standard operating procedures. The components of an effective and compliant SOP for emergency body fluids clean-up may include the following:
Written step by step procedure to contain, isolate, clean and disinfect affected areas;
Ready and easily accessible emergency body fluid clean-up kit;
Use of PPEs like disposable aprons, gloves and protective eye glasses;
Norovirus approved disinfectant as a kill step before and after clean-up;
Containment of body fluids spill using absorbent yellow spill pads to reduce aerosols;
Affected area should be isolated to avoid accidental dispersal by guests;
Discard all affected open food and decontaminate all affected surfaces;
Stop all food prep until body fluids are contained, cleaned and affected area disinfected;
Perform clean-up with disposable towels and yellow spill pads for easy disposal;
Wear triple gloves to avoid contaminating the clean-up kit and storage area;
Dispose clean-up trash straight in outside dumpster without passing through kitchen; and
Employee must wash hands twice, first in the bathroom and then in the kitchen.
The pathogen kill-step is the most important step in the body fluid clean-up process. The preferred option is to use a disinfectant grade chemical instead of regular sanitizers.
Ecolab’s Insta-Use Multi-purpose Disinfectant Cleaner is effective against Norovirus (and other viruses), mold, mildew and bacteria. It cleans, deodorizes and disinfects in one labor saving step and packaged in an easy to use compact cartridge with less storage space requirement. Caution: Disinfectant is not approved for food contact surfaces and cannot be used as a replacement for regular sanitizers on food contact surfaces.
Proper training of team members and associates is required before use to encourage compliance.
In conclusion, Norovirus is still a major infectious pathogen associated with foodservice operations in spite of several regulatory control and technological advances to curtail its occurrence and prevalence. Until a viable vaccine or an effective drug becomes available against Norovirus, rigorous implementation of food safety procedures, behavioral changes and continuous training of both foodservice workers and customers will remain the industry’s best practices at prevention and control. Overall, it makes a lot of business sense to do all that it takes to protect your customers against the threat of Norovirus infection, and by so doing, equally protect your business brand and the entire public health.
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