McDonald’s made big news recently with something it didn’t want on its menu after at least 75 customers across 13 states contracted E. coli, leading to 22 hospitalizations and one death.
Even now that the outbreak has subsided, most consumers still know little about the federal regulations and regulatory bodies charged with protecting our food supply and investigating food-borne disease outbreaks.
Regulations have changed, laying the groundwork to prevent and detect E. coli and other outbreaks. The Food Safety and Modernization Act (FSMA),signed into law in 2011, became the first major act since the 1930s to address food safety, including how companies must comply with regulations and deal with recalls. As part of FSMA, the Foreign Supplier Verification Program requires companies to track the origin of all ingredients. Let’s not forget about the oversight of U.S. Customs as well.
But when it comes to being detectives and figuring out the source of outbreaks, it’s an entity few Americans even know exists. The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service, or FSIS, is a kind of FBI for the food industry. It has been at the center of solving the McDonald’s mystery. On October 29, FSIS said it found no evidence that E. coli came from beef after a “traceback of beef patties served on Quarter Pounders at McDonald’s.”
Cesar Piña, McDonald’s Chief Supply Chain Officer for North America, said the outbreak had been traced back to “a particular ingredient and geography” or onion slivers that have “been removed from our supply chain and is out of all McDonald’s restaurants.” They said they had worked with FSIS and other government entities to figure out what had gone wrong – and limit it from being worse.
Action and reaction
While McDonald’s seeks to portray itself as a victim of an item from a supplier, this McDonald’s moment is worth looking at and beyond. The company is facing lawsuits yet has sought to communicate and cooperate with regulators.
How companies react to a disaster is crucial in terms of limiting it and how they are perceived. Rather than hiding, McDonald’s executives have been speaking up, issuing press releases, and, if not controlling the message, contributing to the narrative.
This E. coli 0157 (the most dangerous strain) outbreak is hardly an epidemic, but it is a reminder that E. coli itself remains one of the most stubborn problems plaguing the food supply and the source of multiple regulations over the years.
It shines a spotlight on how produce, as well as beef, can be problematic. But it also reminds us that it’s not just about what happens but how you handle it in terms of the impact on a company.
The E. coli Issue
E. coli contamination remains a persistent issue for the food and beverage industry, causing … [+]
While E. coli isn’t an epidemic, it’s a regular issue in terms of contamination of food ingredients and a problem for the F&B industry. The CDC says 24 multi-state E. coli outbreaks have been reported since 1992, with nearly 70 percent coming from ground beef and a quarter from problematic produce.
While E. coli isn’t an epidemic, it’s a regular issue in terms of contamination of food ingredients and a problem for the F&B industry. The CDC says 24 multi-state E. coli outbreaks have been reported since 1992, with nearly 70 percent coming from ground beef and a quarter from problematic produce.
E. coli or Escherichia bacteria, commonly found in the intestines of humans and animals, includes some strains that cause illness. It leads to about 73,000 illnesses nationwide annually, about 2,200 hospitalizations, and 61 deaths. From 1982 to 2002, 350 “outbreaks” (at least two cases) were reported to the CDC, which resulted in about 8,600 cases, 1,500 hospitalizations, and 40 deaths in 49 states.
Foodborne pathogens sicken one in six Americans annually, leading to 128,000 hospitalizations and 3,000 deaths, according to the FDA. The Council to Improve Foodborne Outbreak Response (CIFOR) was created in 2006, and the federal Interagency Foodborne Outbreak Response Collaboration (IFORC) was formed in 2013. However, key entities play crucial roles in inspecting, investigating, and otherwise interpreting what’s been going on.
The USDA, including FSIS, the FDA, U.S. Customs, and state regulators collaborate. The FDA also deploys Rapid Response Teams (RRTs) in 20 states, using digital data and better collaboration. With all of this effort to “bend the curve of foodborne illness,” as the FDA says, outbreaks still occur.
Why the High Numbers?
With rules and measures to crack down on food contamination, why aren’t E. coli outbreak numbers plummeting? Better detection by FSIS leads to bigger numbers, in large part.
The CDC tracks “reported” outbreaks while acknowledging that “outbreaks captured by the CDC’s surveillance system likely represent only a small portion of outbreaks that occur.”
FSIS uses pulsed-field gel electrophoresis to detect E. coli. “Pulsenet” helps identify outbreaks and link cases, making it clear they are part of the same outbreak.
Food is a primary source of these outbreaks, with restaurant chains as part of it, but not the primary part.
Among 51 restaurant and food facility outbreaks, 22 were at chains, including 12 fast-food restaurants, and 29 were in single-unit restaurants.
Produce Problem
According to the CDC, produce is a “prominent food vehicle” for outbreaks. They are particularly difficult to police and prevent, since cooking can kill the bacteria, but produce typically doesn’t feel the same heat.
FSIS tracked one-third of produce outbreaks back to lettuce, about one-fifth to apple juice or cider, 16 percent to salad, and small amounts to coleslaw, melons, sprouts, and grapes. About 40 percent of those came from restaurants, with about half from contamination during food preparation.
According to the CDC, produce is a significant source of foodborne outbreaks, with lettuce, apple … [+]
About half of the produce-associated outbreaks come from contamination in the kitchen, but another half are contaminated products. Produce can be contaminated by manure or contaminated irrigation water, during processing due to contaminated equipment, water, ice, or poor handling practices, during transport or storage, or by contaminated products.
Washing hands can kill germs, but washing produce with water or a chlorine-based solution reduces E. coli 0157 risks “only modestly,” according to the CDC.
Once contaminated product reaches restaurants and individual consumers, “little can be done to prevent illness,” according to the CDC. “Further regulatory and educational efforts are needed to improve the safety of produce items.”
The Big Outbreak
E. coli has already single-handedly written or rewritten many of our food regulations, and it’s too early to tell whether the latest outbreak will lead to reform. Crisis, however, has already led to change. That could prove the case here, although it’s not clear what or whether that would be.
E. coli first made it onto the map long before this McDonald’s moment in 1993 when a virtual epidemic from ground beef patties at 73 Jack in the Boxes made it “broadly recognized as an important and threatening pathogen,” according to the CDC
Contaminated ground beef at Jack in the Box restaurants made 700 people ill in four states, including more than a quarter hospitalized, killing four children. The source was ground beef provided by Vons to Jack in the Box, later found to be undercooked.
Jack in the Box blamed the beef, while Vons blamed undercooking, leading to a class action and ten new cooking regulations after the case involved a recall of 250,000 hamburgers.
Following this incident, the U.S. FDA modified its Model Food Code for restaurants in 1993 with new temperature guidelines for ground beef. If you can’t stand the E. coli, turn up the heat in the kitchen. The National Livestock and Meat Board’s Blue Ribbon Taskforce developed new cooking guidelines and encouraged automated cooking.
Jack in the Box, which faced questions regarding its survival in 1994, instituted what the Department of Defense, in a case study, called “the fast-food industry’s first comprehensive food-safety program, the Hazard Analysis & Critical Control Points system” (HACCP).
The number of reported outbreaks began rising in 1993, as reporting requirements increased, peaking in 2000, even as regulations helped.
Other )utbreaks
While E. coli outbreaks are relatively common, major incidents are rare due to stringent regulations … [+]
While E. coli outbreaks have been relatively common, big ones remain rare even as the food supply system moves massive amounts of meat and produce. FSIS tracked a 1996 outbreak across three western states and British Columbia as the cause of at least 70 illnesses, one-third of which were hospitalized, and one child died.
FSIS, however, attributed this outbreak to drinking commercial, unpasteurized apple juice. This outbreak, like some others, also helped foster new regulations. Since 1998, apple juice and cider shipped interstate must be pasteurized and, if sold raw, must carry a warning label.
In 2022, Wendy’s removed lettuce in some states after suspicions that it was the source of an E. coli outbreak. In 2006, Taco Bell was singled out as the likely source of an E. coli outbreak that led to illnesses among 71. McDonald’s salads were linked to a Cyclospora outbreak in 2018, impacting 61 people in 14 states.
“Cyclospora is not commonly tested for in a health care setting,” FDA Commissioner Dr. Scott Gottlieb said at the time. “So consumers who may think they have been exposed should raise their concerns with their health care professional.”
The CDC says regulations and recalls have reduced outbreaks in general. Where’s the beef in these outbreaks? When the 9,000-person FSIS began tracking the McDonald’s outbreak, it followed a track record in which beef had not been the big source of danger it had been in recent years.
“No fast food hamburger associated outbreaks have been reported since 1995,” according to a CDC statement before the latest outbreak, adding changes in cooking regulations are “possible and effective.”
The FDA said recalls of 25 million pounds of beef, “likely prevented many additional infections,” noting home-cooked beef requires “teaching consumers safer handling and cooking practices.” Just as washing can beat off some bacteria, properly cooking can be the cure, killing this bacteria before it kills or causes disease.
The Food FBI
While we all know the USDA and FDA, little attention has been paid, even lately, to FSIS, which, working with state and federal organizations, does a lot of the detective work to determine the sources of contamination.
The USDA’s Food Safety and Inspection Service (FSIS) not only inspects but also investigates. So, who and what is the FSIS?
The Food Safety and Quality Service (FSQS) was created in 1977 as a chemical, investigative, and inspection arm of the USDA to inspect and grade meat and poultry. In 1981, it was renamed the Food Safety and Inspection Service (FSIS).
The USDA’s Food Safety and Inspection Service (FSIS) is crucial in investigating and preventing food … [+]
FSIS began researching what it called Hazard Analysis and Critical Control Points (HACCP) in 1996, issuing its Pathogen Reduction/HACCP Systems rule focusing on preventing and reducing microbial pathogens in raw products that can cause illness. These days, FSIS policies our food supply, looking for all sorts of issues beyond illness.
In late October, for instance, FSIS issued a health alert for meat and poultry products illegally imported from the Republic of the Union of Myanmar without being inspected. The items were shipped to retail locations in Arizona, California, Iowa, Kansas, Maryland, Minnesota, Nebraska, Oklahoma, and Texas.
FSIS discovered the problem while performing surveillance at a retailer, discovering meat and poultry from Myanmar that were not inspected in accordance with U.S. regulations and, therefore, not eligible to be exported to the U.S.
FSIS conducted an investigation only several weeks before, which led BrucePac to recall ready-to-eat (RTE) meat and poultry in schools due to Listeria monocytogenes. FSIS performed routine product testing of BrucePac products, finding Listeria monocytogenes.
Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance, and convulsions, sometimes preceded by diarrhea or other gastrointestinal symptoms.
FSIS, which also operates a hotline, issued a public health alert for Hans Kissel’s “Cranberry Chicken Salad” in October due to misbranding and undeclared allergens, since it contains wheat.
McDonald’s Moment
FSIS also was a key player in the investigation that concluded the McDonald’s outbreak is believed to be traced back to onions from Taylor Farms.
The company, owned by the Taylor family, was named Walmart’s 2022 Supplier of the Year in the food category. Taylor Farms, a producer of salads and “healthy fresh foods,” has production facilities across the United States, Canada, and Mexico. Their facility in Colorado is believed to be the source of this outbreak.
The CDC said Taylor “initiated a voluntary recall of some onions sent to foodservice operators,” including but not limited to McDonald’s. Based in Salinas, Calif., sometimes called “the salad bowl of the world,” Taylor Farms is a major supplier, not just to McDonald’s.
Taylor said it preemptively recalled yellow slivered onions from its Colorado facility that were “sent to select food service customers.”
They said the sickness at McDonald’s was limited to Quarter-Pounders. The CDC said food service customers were also contacted and told to remove these onions.
FSIS is charged with implementing regulations designed to keep the food supply safe, such as the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, and humane animal handling through the Humane Methods of Slaughter Act.
Lessons Learned
How Jack in the Box handled its incident may have impacted how other companies react when they face this kind of crisis. The company didn’t respond immediately, waiting a week before talking to the media. “At the time, I thought they were being unfair,” CEO Robert Nugent said later.
McDonald’s immediately responded, stressing actions and reassuring that it was working with FSIS and others. Its website provided a play-by-play, including statements and even videos, showing that it was working with FSIS and the government.
McDonald’s Chief Supply Chain Officer for North America, Cesar Piña, aligned McDonald’s with regulators, talking about “our commitment to food safety” and thanking the “health authorities with whom we’ve been partnering.”
He noted he has “worked in food safety for two decades” and said it has been “meaningful to see the strong partnership between McDonald’s and public health officials.” They were not simply someone regulated but someone trying to resolve a problem.
“It was especially important to all of us—across the entire system—when CDC noted that our proactive steps resulted in the risk to the public being ‘very low,’” Piña said. “This was also a reminder of how our values must guide us every single day: we put people first, and we do the right thing.”
He noted that “slivered onions from this facility were distributed well beyond McDonald’s system to other quick service restaurants and food service providers.” McDonald’s didn’t act like a wrongdoer, but like someone wronged, and said it would “continue to communicate quickly and transparently.”
What further investigation reveals remains to be seen. History, however, shows us that crises like this can lead to litigation and even regulation. At least so far, it’s hard to tell what the regulatory perspective on what happened will be. But talking about a problem is usually better than being talked about.
It’s likely that this case will be taught in business school one way or another for years to come, revealing the soft underbelly of our food supply chain as well as ways to respond. And at least as of now, unless things change, the narrative likely will be about how McDonald’s handled a tragedy very differently from one that occurred at another chain several decades ago, and how FSIS and others worked to try to limit sickness and loss of life, once E. coli appeared in the food supply.