Despite best practices and vigilance, foodborne illness-causing pathogens will enter your facility. When they are detected, next steps are key to preventing contaminated foods from reaching consumers. In this webinar, we will look at how businesses can prepare for contamination events, and how to respond when an event occurs.
The USDA Food Safety and Inspection Services (FSIS) has released its 2023-2026 Strategic Plan, the foundation document for both the long range and day-to-day operations of the agency. The agency announced that the updated plan continues to emphasize the importance of science and data to implement advanced and innovative approaches to food safety.
The plan includes three strategic goals:
Goal 1: “Prevent Foodborne Illness and Protect Public Health,” which focuses directly on FSIS’ public health mission and its activities.
Goal 2: “Transform Inspection Strategies, Policies, and Scientific Approaches to Improve Public Health,” which focuses on improving how the agency conducts food safety activities.
Goal 3: “Achieve Operational Excellence,” which focuses on maintaining and improving the strong internal foundation needed to meet goals 1 and 2.
As part of the primary goal, “Prevent Foodborne Illness and Protect Public Health,” the FSIS specifically plans to:
Chicken producers and processors must always pay close attention to listeria and E. coli. Their regulated to-market protocols incorporate intense testing and cleaning standards that help ensure the people who buy chicken sandwiches at fast casual restaurants, chicken fingers at sporting arenas and trays of fresh chicken legs at supermarkets don’t get sick.
The companies stay on top of listeria and E. coli because the USDA Food Safety and Inspection Service (FSIS) has considered them “adulterants,” or substances that should not be found in meat products, for decades. The federal agency banned listeria in 1987, and in 1994 listed E. coli as an adulterant in the wake of an E. coli outbreak at Jack in the Box restaurants that sickened 700 people in four states, and led to 171 hospitalizations and four deaths.
All along, however, another prominent bacteria, Salmonella, remained unregulated, despite its proclivity for making people ill—more than a 1.3 million cases of salmonellosis appear in the U.S. every year, leading to about 26,500 hospitalizations and roughly 400 deaths. It is the No. 1 cause for foodborne illness in the U.S., and most cases stem from chicken products.
But earlier this year the USDA announced that it now plans to consider Salmonella an adulterant in some chicken products. The matter is out for public comment now; if the USDA doesn’t change its clear intention to regulate Salmonella, federal food inspectors soon will be testing for it in select chicken products.
The chicken industry opposes the measure. In a news release issued shortly after the FSIS’ August announcement, the National Chicken Council (NCC) pointed toward the 1957 Poultry Products Inspection Act, which did not include Salmonella as an adulterant, as a set of standards worth upholding today.
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Well, a lot has changed in industrial agriculture during the past 65 years, and that includes a dramatic expansion of chicken farming and consumption across the country. In the 1950s, the average American ate about 16 pounds of chicken a year, compared to 56 pounds of beef and 50 pounds of pork. But by this year, Americans were eating close to 112 pounds of chicken a year, along with 56 pounds of beef and 50 pounds of pork. In terms of meat consumption, chicken now rules the roost. Regulating it might not have been necessary back when Dwight D. Eisenhower was president. But today I believe it most definitely is.
As a professional in the food safety industry, I champion the FSIS’ decision. It’s about time the agency added Salmonella to its list of adulterants; the bacteria causes far too much illness and death in the U.S. every year. Many of those cases could have been prevented through regulatory oversight.
It is true, as opponents of the proposed regulation argue, that Salmonella doesn’t always emerge in the processing plant; humans can inadvertently introduce the bacteria in their own kitchens. Why, the industry asks, should it be penalized for conditions outside of its control? In addition, proper cooking methods will kill Salmonella. If people don’t follow cooking directions on the packages of chicken they buy, and get sick from Salmonella as a result, the chicken industry believes it should not be held accountable.
On the first issue, it is unlikely that cases revolving around individual consumers introducing Salmonella to their chicken products would ever lead to penalties. Federal regulators scrutinize public health data for clusters of outbreaks, which often point toward entire product lines being infected with bacteria; isolated one-off cases, many of which indeed could be the result of human error, do not concern them.
For the second point, yes, people should read labels and closely follow cooking directions. But in my opinion, that is irrelevant; dangerous levels of Salmonella simply should not dwell in foods, and it’s the job of regulators to make sure food is safe.
Toy manufacturers, for example, must eliminate choking hazards from products designed for kids under 3 years, thanks to federal regulations. It shouldn’t be up to parents to constantly monitor their toddlers while they play with toys, to ensure they don’t gag on something potentially dangerous found on the stuffed giraffe.
Should the rule become policy, the FSIS will focus on just one category: stuffed, breaded and raw chicken products. These products, including dishes like chicken Kiev and chicken cordon bleu, often are heat-treated to set the batter or breading, but are not fully cooked. They have been associated with 14 outbreaks and about 200 illnesses since 1998.
This represents a solid start. Next, I’d like to see the FSIS pursue regulating Salmonella in other chicken products. Even if the agency doesn’t, however, many processors will have to implement new practices and testing procedures for all of their products anyway, as in many cases it won’t make sense to just incorporate new protocols within a few discrete product lines. Among other things, I would anticipate boosted commitments among producers and processors to cleaning and sanitation processes, environmental monitoring (probably the most important pursuit) and overall facility food safety measures.
Will this action by the FSIS completely eliminate Salmonella from the targeted products? Absolutely not. The rule sets a maximum threshold for Salmonella in the food the agency tests; in many cases, chicken products that contain negligible amounts of the bacteria will still make it to market. It’s just products containing dangerous amounts of Salmonella that will be subject to penalties.
Food safety serves as one of the foundations of a healthy society. It also reinforces and bolsters public trust in the products consumers buy, which nurtures and strengthens the entire food industry. With this proposed Salmonella rule by the USDA, the U.S. takes another important step toward ensuring the health of its citizens, and further enhancing consumer trust in the chicken products they buy.
A new Quantitative Risk Analysis (QRA) model using epidemic curve (EC) prediction (QRA-EC) could become a valuable new tool in root cause analyses of foodborne illness outbreaks. Researchers with the FDA Center for Food Safety and Applied Nutrition developed a QRA-EC model and evaluated it in a case study of a 2019 multistate Salmonella outbreak linked to melons. The study was published in Risk Analysis.
Amir Mokhtari, et al, modified the traditional QRA model to track illness timing (epidemic curves). They then compared the predicted number of illnesses and timing of illnesses identified by their model—the FDA-Melon QRA-EC—with the 2019 Salmonella melon outbreak epidemic curve.
The authors explain that QRA models are traditionally used to predict the number of illnesses associated with given food-pathogen pairs and to simulate previous foodborne illness outbreaks by comparing model estimates with observed outbreak size. The QRA-EC model extends that framework to include prediction on the timeline of illnesses associated with consumption of contaminated food products.
“This additional feature yields two-dimensional risk predictions that provide investigators with a more nuanced quantitative evaluation of potential/hypothesized illness outbreak root cause, as the shape and/or span of epidemic curves can give clues about potential sources and/or patterns of spread for an outbreak,” the authors wrote.
They found that contamination niches on the equipment were the most likely cause of the 2019 outbreak, as illnesses were linked to one processor of fresh-cut melons, while the contaminated melons (linked back to one supplier) had been sent to several processing facilities.
“Compared to the efficiency of whole melon washing, proper sanitation of contamination niches had a more pronounced impact on the predicted epidemic curves,” the authors wrote. Furthermore, the model and case study found that risk was greater when food was exposed to contamination niches on the assembly line versus in scrubbers and bins, likely due to the larger surface area of the assembly line and the potential for several contamination niches along the line.
“Using an Agent-Based Modeling approach, FDA Melon QRA-EC explicitly tracked the temporal and spatial movement of contaminated melons throughout the supply chain, which allowed us to predict both the total number and timeline of illnesses for various scenarios, which enabled us to identify conditions that can lead to an outbreak of certain magnitude and with a certain span of the epidemic curve,” the authors concluded.
While this particular model was developed specifically for Salmonella outbreaks linked to melons, the authors note that their model can be adapted for other food-pathogen pairings.
The FDA and CDC have entered into a Memorandum of Understanding (MOU) to strengthen food safety in retail environments. The goal of the renewed partnership is to help reduce the occurrence of foodborne illness in retail and foodservice establishments.
This MOU, which was signed on September 21, was developed to help increase the consistency and capacity of retail food protection programs across the country, promote a general culture of food safety and facilitate continued communication between the FDA and CDC to assist state, tribal, local, territorial (SLTL) and industry partners.
The three primary goals of the MOU include:
The agencies are seeking to: improve STLT’s effectiveness in conducting risk-based inspections and foodborne illness investigations; promote a culture of food safety and food safety management systems within retail and foodservice establishments; and improve research in support of foodborne illness risk factor reduction.
To accomplish these objectives, the FDA and CDC are both tasked with establishing metrics to measure the success of collaborations as well as establishing direct and consistent relationships at multiple organizational levels, sharing best practices, and identifying opportunities for leveraging the resources of both agencies to more efficiently and effectively support STLT retail regulatory programs as well as both FDA and CDC retail food protection initiatives.
In its announcement of the MOU, the FDA notes that it has historically worked with CDC to help control the risk factors for foodborne illness outbreaks in retail settings. “This MOU will ensure enhanced continued collaboration on this important work,” the agency wrote.
A multistate outbreak of Listeria monocytogenes infections has been linked to Brie and Camembert soft cheese products manufactured by Old Europe Cheese, Inc. of Benton Harbor, Michigan. The products are sold at various retailers under multiple labels and brands. Six cases of illness have been reported in patients in California, Georgia, Massachusetts, Michigan, New Jersey and Texas.
The FDA reports that epidemiologic information provided by CDC found that, of the five patients with information available, four reported eating Brie or Camembert cheese prior to their illnesses. An FDA inspection of the Old Europe Cheese, Inc. facility in Michigan, performed with assistance from the Michigan Department of Agriculture and Rural Development, showed the presence of Listeria monocytogenes. Whole Genome Sequencing (WGS) analysis determined that the Listeria strain found in the facility matches the Listeria strain causing illness in this outbreak.
The company has voluntarily recalled multiple brands of its Brie and Camembert cheeses produced at the facility in response to the investigation findings. The firm has also halted production and distribution of its Brie and Camembert products from the Michigan facility and is working with FDA on corrective actions.
Consumers, restaurants and retailers should not eat, sell or serve recalled products and should throw them away; this includes Best By Dates ranging from September 28, 2022 to December 14, 2022—all flavors and quantities. A full list of recalled products and stores that potentially sold these products is available on the firm’s recall.
A multi-state outbreak of E. coli led Wendy’s to take the precautionary measure of removing romaine lettuce being used in sandwiches from restaurants in the region of the outbreak.
The CDC reports that as of August 18, 2022, a total of 37 people infected with the outbreak strain of E. coli O157:H7 have been reported from Michigan, Indiana, Ohio and Pennsylvania. The illnesses started on dates ranging from July 26, 2022, to August 8, 2022.
A specific food has not yet been confirmed as the source of this outbreak, but among 26 people who have been interviewed, 22 (86%) reported eating sandwiches with romaine lettuce at Wendy’s restaurants in Michigan, Ohio or Pennsylvania in the week before their illness started. Based on this information, Wendy’s removed the romaine lettuce being used in sandwiches from restaurants in those regions.
A spokesperson for Wendy’s released the following statement: “We are fully cooperating with public health authorities on their ongoing investigation of the regional E. coli outbreak reported in certain midwestern states. While the CDC has not yet confirmed a specific food as the source of that outbreak, we have taken the precaution of discarding and replacing the sandwich lettuce at some restaurants in that region. The lettuce that we use in our salads is different, and is not affected by this action. As a company, we are committed to upholding our high standards of food safety and quality.”
The CDC emphasized that it is not advising that people avoid eating at Wendy’s restaurants or that people stop eating romaine lettuce.
The CDC, public health and regulatory officials in several states, the FDA and the USDA-FSIS are collecting and analyzing data at the ingredient level to identify the food source of the outbreak, confirm whether romaine lettuce is the source and determine if there are any other possible foods that could be the source of the outbreak.
In a recent Politico report, critics blasted the U.S. Food and Drug Administration (FDA) for chronic failures, including instances of contaminated baby formula, outbreaks of contaminated produce and the agency’s institutional reticence to implement changes.[1] Compounding the situation is the most fragmented global supply chain in history, making it a particularly challenging time for food and beverage companies.
Ingredients are the building blocks of the supply chain, so when circumstances threaten their integrity and availability, the ripple effect can linger for weeks, months or even years. As the FDA’s limitations become more apparent and supply chain challenges persist, brands must take responsibility for foundational change that addresses and mitigates risks related to food-, beverage- and supplement-borne illness.
As the Politico coverage pointed out, high turnover at the top of FDA has contributed to the agency’s challenges: five different commissioners have led the FDA over the last three years. In addition to concerns with federal oversight, brands are still navigating a broken supply chain, which has taken a beating over the last few years. And while the damage has come from war, trade tariffs and shipping congestion, food safety also emerged as a culprit when the FDA announced a recall of some of the country’s most popular infant formula brands. In February, the agency announced it was investigating consumer complaints of bacterial infections in four infants who were hospitalized. This bacterial infection might have contributed to death in two cases.[2]
While the recall emerged as a catalyst for the U.S. formula shortage, it wasn’t the only factor. Import restraints and market concentration (four companies produce 90% of the formula sold [3]) contributed to this perfect storm that rocked an already strained supply chain. National out-of-stock rates peaked at 70% near the end of May, and regulators announced that they did not expect relief until July. [4]
In scenarios such as this, the best defense brands can employ is to build a diverse supplier base and agile ingredient supply chain. Relying on a limited number of ingredient suppliers is a risky strategy even under the best of market conditions. But when disaster strikes, it can cripple a manufacturer and grind production to a halt. For the sake of consumers, creating agility and resilience around ingredients and sourcing is critical.
Equally important to cultivating relationships with alternate suppliers is the ability to have quick access to critical data. A robust digital document management system that offers manufacturers a unified view of products, data and processes across the business and the supply chain can help brands ensure they have a resilient ingredients network able to withstand supply chain or ingredient-sourcing issues. CPGs can benefit from instant access to millions of supplier documents to help fast-track sourcing, formulation and recipe development as well as protect themselves from potential disaster.
As the pandemic ramped up in March 2020, the FDA announced it would pause most foreign food inspections.[5] Additionally, regulators moved to virtual audits to keep their inspectors safe from COVID. Recalls fell. The FDA reported 495 recalls in the fiscal year 2020 and 427 in 2021. By comparison, the agency reported 526 recalls in the fiscal year 2019.[6]
The drop in recalls could be attributed to the ongoing rollout of the Food Safety Modernization Act (FSMA), which strengthened food production safeguards. In addition, a proposed rule change to FSMA, Section 204, would enforce better recordkeeping and quicker recall responses. The introduction of the Formula Shortage Reporting Act of 2022, requiring immediate action from manufacturers when future disruptions to production occur, is another step toward stricter food standards.
If passed, Section 204 would require companies who process, pack or hold items on the food traceability list (FTL) to capture and store ingredient data for two years, and submit it within 24 hours of a recall.[7] Without a formal system of record in place to manage food production, tracing ingredients—where, when and from whom they came—is a difficult and complex challenge to solve. Human error, overseas suppliers, recalls and other constantly changing variables all must be tracked and monitored constantly. This diligence demands automation and collaboration at scale.
Collaboration via holistic networked platforms can facilitate that diligence by enabling global ingredients suppliers, CPG brands, co-manufacturers and packing companies to build safer, stronger and more modern supply chain networks. Today, the stakes of not having a modern supply chain and access to real-time ingredient data have grown exponentially beyond profit and competitive advantage to a whole new level of costing lives.
On May 27, U.S. Sen. Edward J. Markey, D-Massachusetts, introduced the “Ensuring Safe and Toxic Free Foods Act.” The bill, co-sponsored by Sens. Richard Blumenthal, D-Connecticut, and Elizabeth Warren, D-Massachusetts, would—among other things—strengthen the Substances Generally Recognized as Safe (GRAS) Rule, which allows companies to avoid pre-market approval for food chemicals.[8]
The bill would direct the FDA to revise the GRAS Rule to include provisions that:
Brands must have easy access to ingredient data to ensure compliance with the GRAS revisions as well as be proactive about food safety. Software that monitors threats and regulatory risks throughout the supply chain in real-time is essential to prevent both food safety issues and supply chain disruptions. These systems transform massive amounts of data into user-friendly, actionable insights for fast and effective risk management.
Food safety remains one of the gravest public health threats to consumers worldwide. The U.S. Centers for Disease Control and Prevention (CDC) insists that foodborne diseases cause 76 million illnesses in the U.S. annually, leading to 325,000 hospitalizations and 5,000 fatalities.[9]
With the FDA still struggling to regain the agency’s pre-pandemic diligence, it’s incumbent on manufacturers to double down on food safety. Digitization—evolving from paper to relevant, real-time data—is a critical component of the path forward to improve safety and increase ingredient agility.
Technology and automation help manufacturers and suppliers work better together, collaborate on ingredient data, move more quickly and problem solve together. In today’s modern supply chain, more CPGs are investing in partnerships to increase agility and gain more resilience over the shocks we’ve seen the past few years. More flexible and collaborative tools for engaging with global ingredient supplier networks can increase safety while improving bottom line efficiency.
[1] Bottemiller Evich, H. (2022, April 8). The FDA’s Food Failure. Politico.
[2] U.S. Food & Drug Administration. (2022, May 12). Powdered Infant Formula Recall: What to Know.
[3] Muller, M. & Nyler, L. (2022, May 20). How US Baby Formula Monopolies Have Failed Families. Bloomberg.
[4] KHN. (2022, May 27). FDA Chief Suggests Stockpile Of Baby Formula Once Crisis Ends In July. Kaiser Health News.
[5] U.S. Food & Drug Administration. (2021, May). Resiliency Roadmap for FDA Inspectional Oversight.
[6] U.S. PIRG Education Fund. (2022, January 31). Food Recalls Decline in 2021, but That Doesn’t Mean Food is Safer.
[7] Govinfo.gov. (2022, June 13). Formula Shortage Reporting Act of 2022.
[8] Ensuring Safe and Toxic-Free Foods Act of 2022. (2022, May 27). Ensuring Safe and Toxic Free Foods Act.
[9] Centers for Disease Control and Prevention. (2018). Estimates of Foodborne Illness in the United States.
At the end of his reflection on FDA’s 2021 accomplishments in the food realm, Deputy Commissioner for Food Policy and Response Frank Yiannas stated that he believes collaboration will enable industry to “bend the curve of foodborne illnesses in this decade”. It would be a significant milestone, and in his latest FDA Voices blog, Yiannas reviewed a host of FDA achievements that bring his statement much closer to a reality:
FDA Acting Commissioner Janet Woodcock gives of full report on the agency’s work in the “FDA 2021 Year in Review: Working For You”.
Compare this year’s review with that of 2020, where Yiannas reflected on the agency’s Food Program achievements during the first year of the pandemic and the 10-year anniversary of FSMA.
The Interagency Food Safety Analytics Collaboration (IFSAC) has published its 2022–2023 Interim Strategic Plan, placing continued emphasis on foodborne illness source attribution for Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. Over the next year, IFSAC will address several short-term goals surrounding improvement of methods to evaluate and identify foodborne illness source attribution through the use of outbreak and non-outbreak-associated disease data, and continued collaboration with external partners in an effort to boost data access and capabilities. The group will be targeting several efforts in the coming year, including:
Formed in 2011, IFSAC is a partnership between FDA, FSIS and the CDC that seeks to strengthen federal interagency efforts and maximize use of food safety data collection, analysis and use. During 2022–2023, IFSAC will publish its yearly reports on foodborne illness source attribution for the previously mentioned priority pathogens.
